FOOD AND DRUG ADMINISTRATION

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NATIONAL MAMMOGRAPHY QUALITY ASSURANCE ADVISORY COMMITTEE

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MEETING

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MONDAY,

SEPTEMBER 26, 2005

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The meeting was held in the Whetstone Room of the Gaithersburg Holiday
Inn, Two Montgomery Village Avenue, Gaithersburg, Maryland, at 9:04
a.m., Carolyn B. Hendricks, M.D., Chairperson, presiding.

[COMMITTEE MEMBERS PRESENT]{.underline}:

CAROLYN B. HENDRICKS, M.D., Chairperson

CHARLES FINDER, M.D., Executive Secretary

SCOTT FERGUSON, M.D., Member

ALISA GILBERT, Member

JACQUELIN S. HOLLAND, R.N., C.R., Member

[COMMITTEE MEMBERS PRESENT (Continued)]{.underline}:

MILES G. HARRISON, JR., M.D., Member

CAROL J. MOUNT, R.T. (R)(M), Member

DEBRA L. MONTICCIOLO, M.D., Member

MELISSA C. MARTIN, M.S., Member

LINDA S. PURA, R.N., M.P.A., Member

WILLIAM A. PASSETTI, B.S., A.A., Member

DIANE I. RINELLA, RT (R)(M), Member

JANE B. SEGELKEN, B.S., M.A., Member

MARK B. WILLIAMS, Ph.D., Member

[C O N T E N T S]{.underline}

[PAGE]{.underline}

Conflict of Interest Statement 4

Public Comment:

Dr. Carol H. Lee 13

Dr. Lawrence Bassett 24

Anonymous Comments 32

Dr. Richard Ellis 40

Inspection Observations, Dr. Michael P. Divine 48

Institute of Medicine Recommendations, Dr. Helen

Barr 77

Ensure Adequate Work Force , Dr. Helen Barr 256

Beyond Mammography, Dr. Helen Barr 277

[P R O C E E D I N G S]{.underline}

(9:04 a.m.)

CHAIRPERSON HENDRICKS: Good morning. I\'d like to call this meeting of
the National Mammography Quality Assurance Advisory Committee to order.

I also request that everyone in attendance at this meeting sign in on
the attendance sheet that is available at the door.

DR. FINDER: Okay. The following announcement addresses conflict of
interest issues associated with this meeting and is made a par of the
record to preclude even the appearance of any impropriety.

To determine if any conflict existed, the agency reviewed the submitted
agenda and all financial interests reported by the committee
participants. The conflict of interest statutes prohibits special
government employees from participating in matters that could affect
their or their employer\'s financial interests.

However, the agency has determined that participation of certain
members, the need for whose services outweighs the potential conflict of
interest involved is in the best interest of the government.

Therefore, waivers permitting full participation in general matters that
come before the committee have been granted for certain participants
because of their financial involvement with the facilities that will be
subject to FDA\'s regulations on mammography quality standards with
accrediting, certifying or inspecting bodies, with manufacturers of
mammography equipment, or with their professional affiliations since
these organizations could be affected by the committee\'s deliberations.

These individuals are Ms. Diane Rinella, Ms. Jacquelin Holland, Ms.
Debra Monticciolo, Mr. William Passetti, Dr. Mark Williams, and Ms. Jane
Segelken.

Waivers are currently on file for Dr. Carolyn Hendricks, Dr. Scott
Ferguson, Ms. Carol Mount, Ms. Alisa Gilbert, Dr. Miles Harrison, Ms.
Linda Pura, and Ms. Melissa Martin.

Copies of the waivers may be obtained from the agency\'s Freedom of
Information Office, Room 12A-15 of the Parklawn Building.

We would like to note for the record that if any discussion of states or
certifying bodies was to take place in any meetings of the committee, it
would be a general discussion only. No vote would be taken and no
consensus sought.

In the interest of getting as many viewpoints as possible all SGEs,
including state employees, would be allowed to participate in the
general discussion so that all viewpoints could be heard.

In the event that the discussions involve any other matters not already
on the agenda in which an FDA participant has a financial interest, the
participant should excuse him or herself from such involvement and the
exclusion will be noted for the record.

With respect to all other participants, we ask in the interest of
fairness that all persons making statements or presentations disclose
any current or previous financial involvement with accreditation bodies,
states doing mammography inspections under contract to FDA, certifying
bodies, mobile units, breast implant imaging, consumer complaints, and
mammography equipment.

CHAIRPERSON HENDRICKS: I note for the record that the voting members
present constitute a quorum as required by 21 CFR Part 14.

At this time we\'d like to move to the introduction of the panel
members. Beginning from the right side, I\'d like to have each member
make a brief introduction.

MS. PURA: Good morning. I\'m Linda Pura. I am Clinical Coordinator from
the Los Angeles County Regional Partnership for Cancer Detection; also
am a Susan G. Coleman Breast Cancer Foundation volunteer.

MS. HOLLAND: Good morning. My name is Jacquelin Holland, and I\'m
Program Director of the Diversity Enhancement Program at the James
Cancer Hospital and Soloff (phonetic) Research Institute in Columbus
Ohio.

MS. GILBERT: Good morning. I\'m Alisa Gilbert from the Office of Native
Cancer Survivorship in Alaska, Anchorage, Alaska.

DR. WILLIAMS: And I\'m Mark Williams from the University of Virginia,
and I\'m an Associate Professor of Radiology, Biomedical Engineering and
Physics there.

MS. SEGELKEN: I\'m Jane Segelken. I\'m a breast cancer survivor, and
I\'m a volunteer with the Ithaca Breast Cancer Alliance.

DR. MONTICCIOLO: Good morning. I\'m Debbie Monticciolo. I\'m a Professor
of Radiology and Section Chief of Breast Imaging at Texas A&M in Temple,
Texas.

DR. FERGUSON: I\'m Scott Ferguson. I\'m a diagnostic radiologist from
the State of Arkansas.

MS. RINELLA: Good morning. I\'m Diane Rinella, mammography technologist
and consultant.

DR. FINDER: Charles Finder. I\'m a radiologist. I work for the Food and
Drug Administration. I\'m the Executive Secretary of this Committee.

CHAIRPERSON HENDRICKS: I\'m Carolyn Hendricks. I\'m a medical oncologist
in private practice, and I focus on breast disease, and I\'m chairing
this committee.

MR. PASSETTI: Bill Passetti. I\'m Director of Florida\'s Radiation
Control Agency from Tallahassee, Florida.

MS. MOUNT: I\'m Carol Mount, a manager of the Breast Imaging and
Intervention Center, Mayo Clinic, Rochester, Minnesota.

DR. MARTIN: Melissa Martin. I\'m a consulting medical physicist in
Southern California area.

DR. FINDER: Dr. Harrison is coming in by telephone teleconference. Dr.
Harrison?

DR. HARRISON: Yes. Good morning. I\'m Miles Harrison of Baltimore,
Maryland, a breast surgeon.

DR. FINDER: Thank you.

CHAIRPERSON HENDRICKS: At this time I\'d like to make a brief statement
specifically addressed to the individuals who will be speaking in the
open public hearing sections of this meeting.

Both the FDA and the public believe in a transparent process for
information gathering and decision making. To insure such transparency
at the open public hearing session of this Advisory Committee, FDA
believes it is important to understand the context of an individual\'s
presentation. For this reason, FDA encourages you, the open public
hearing speaking at the beginning of your written or oral statement to
advise this committee of any financial relationship that you may have
with the sponsor, its product, and if know, its direct competitors.

For example, this financial information may include the sponsor\'s
payment of your travel, lodging or other expenses in connection with
your attendance at this meeting.

Likewise, FDA encourages you at the beginning of your statement to
advise this committee if you do not have any such financial
relationships. If you choose not to address this issue of financial
relationships at the beginning of your statement, however, it will not
preclude you from speaking.

DR. FINDER: Okay. Before we get to the public speakers, I want to
mention about alternative standards that we have approved since the last
meeting.

For those not familiar with this section of the regulations, FDA may
approve an alternative to a quality standard that exists under Section
900.12, when the agency determines that, one, the proposed alternative
standard will be at least as effective in assuring quality mammography
as the standard it proposes to replace; and, two, the proposed
alternative is too limited in its applicability to justify an amendment
to the standard or offers an expected benefit to human health that is so
great that the time required for amending this standard would present an
unjustifiable risk to human health, and the granting of the alternative
is in keeping with the purpose of Statute 42, USB 263(b).

Since last April\'s meeting the division has approved two alternative
standards. The first deals with the system artifact testing at remote
mobile mammography sites where film processing takes place using
processors permanently located at that site.

This alternative permits a special trained quality controlled
technologist to make system artifact films and phantom images at remote
processing sites used by mobile mammography facilities and then submit
them to the facility medical physicist for evaluation.

This relieves the facility from the need to have the medical physicist
visit each remote processing site as part of the annual survey.

The second deals with system artifact testing of target filter
combinations. The approved alternative permits the system artifact tests
to be performed without testing all target filter combinations during
the annual physics survey. These alternative standards in their entirety
are available on our Web site in the policy guidance help system.

If anybody has any questions about these alternatives, I do have copies
of the full wording for any of those.

I believe not.

CHAIRPERSON HENDRICKS: At this time we\'ll move it into the first public
session. We will introduce the scheduled public speakers one by one.

Our first speaker under the topic of approved alternative standards is
Dr. Carol Lee, and she\'ll be speaking from ACR.

Dr. Lee.

DR. LEE: I want to thank this committee for allowing me the opportunity
to address it. I am representing here the American College of Radiology,
which is a 30,000 member professional organization representing
diagnostic radiologist, radiation oncologists, and medical physicists.

And I also want to say that my travel expenses have been paid by the
American College of Radiology to attend this meeting.

Is there any way that I can advance these? Oh, okay. Could I have the
next?

I hope you can read these slides. They\'re a little busy.

The American College of Radiology has a longstanding record of a
commitment to quality in breast imaging. This began in part with a
voluntary mammography accreditation program that was begun in 1987 that
laid the foundation for subsequent Mammography Quality Standards Act.

In 1993, the breast imaging reporting and database system was developed
by the ACR, and provided a lexicon for description of breast findings
and a reporting system that helped standardize and clarify mammographic
reporting in this country.

In 1996, an accreditation program for stereotactic biopsy was developed.
BI-RADS was expanded to include breast ultrasound and breast MRI in the
most recent edition published in 2003, and this past year the American
College of Radiology established a permanent breast imaging commission
as part of its Board of Chancellors, replacing an ad hoc task force to
deal with matters relating to breast imaging in this country.

The ACR also has a record of providing educational and self-assessment
tools to breast imagers, including a biennial national conference on
breast cancer. The ACR has developed a self-assessment tool that\'s
available to the public and also sponsors a regular mammography
education program at the Armed Forces Institute of Pathology for
radiology residents across the country.

Next slide, please.

Now, in addressing problems with mammography interpretation, the IOM
report unfortunately did not really specify what particular problems
need to be addressed. It was sort of an overall assumption that there is
a problem. Whether or not this is manifest as too many false negatives
in mammographic interpretation, a recall rate that\'s too high or too
low, a positive predictive value of biopsies that\'s too low, too much
variability or all of the above was not specifically stated, and it\'s
difficult to know how to develop programs or mandates or regulations to
address problems when the problem itself it not specifically stated.

In terms of mammography interpretation, certainly there is room for
improvement. Certainly mammographic interpretation is not perfect, but
\-- next slide, please \-- I do want to point out that mammographic
interpretation in the United States has been compared unfavorably to
that in the United Kingdom. It has been published that the recall rate
from screening in this country is double that of the United Kingdom.

However, it should be kept in mind that practice climate, the
malpractice situation differs dramatically between the two countries,
and in looking at the report comparing U.S. to U.K. mammographic
interpretation, there actually are more cancers that were picked up in
the United States over the study period. There were 55 cancers per
thousand women screened over 20 years compared to 43 in the United
Kingdom. And most of the additional cases that were detected in the U.S.
were due to small, invasive cancers, and DCIS, which is just the type of
tumor that we hope to be able to detect through screening.

Next slide, please.

In addition, there are studies that have shown that the size of tumors
within stages has decreased since the advent of modern mammography, and
whereas in the period from 1975 to 1979, fewer than ten percent of
breast cancers were under one centimeter. One quarter of all localized
breast cancers were under a centimeter in the period from 1995 to 1999.

Next slide.

And it\'s important also to keep in mind that breast cancer mortality in
this country has decreased by 25 percent in the past ten years. The
decrease in tumor size within stage over the past 30 years accounts for
most of the observed improvement in survival in localized breast cancer.

Next slide.

Now, that\'s a quick summary of the good news. The bad news is that
there is an impending manpower crisis in breast imaging in this country.
For this past July, only 33 percent of breast imaging fellowship
positions within the fellowship match were filled. The proportion of
radiology residents who state that they want to spend a significant
percentage of their future practices in breast imaging has declined from
29 percent in a study done by Dr. Bassett, who will be addressing this
committee later this morning, and in a more recent study of
Massachusetts residents, only three percent said that they would like to
spend a significant portion of their time doing mammography.

Next slide.

When looking at this study a little bit more in depth, these were 63
senior radiology residents that were surveyed in Massachusetts, and they
were asked about their future career plans and about attitudes towards
mammography.

Next.

Only eight percent said they wanted to do any mammography in their
future jobs, and only three percent stated that they wanted to spend at
least 25 percent of their clinical time reading mammograms, and only one
of the 63 intended to pursue a breast imaging fellowship.

So it\'s a bit disheartening, and there\'s no reason to think that
Massachusetts is any different from any other state in this country.

Next.

When asked why they did not want to spend time doing mammography, the
majority said that they were afraid of lawsuits and the medical legal
climate.

Next.

Now, in talking about, in addressing the IOM regulatory recommendation
in the recent report improving mammography quality standards, I want to
address some of the requirements specifically.

Could I have the next slide?

One of these recommendations suggested requiring separate tracking of
results of screening and diagnostic mammographs in order to be able to
compare to established benchmarks.

The problem with this recommendation is that the definition of screening
varies among practices and makes comparison among facilities quite
difficult. I\'ve recently found \-- I\'ve spent the past 20 years doing
breast imaging at Yale University in an academic practice, and just this
past year I have been working as a breast imager in a private practice
in Honolulu, Hawaii, and I can tell you that the practice varies
considerably in terms of what is considered a screening mammograph, what
is considered a diagnostic mammogram.

Both facilities produced very high quality images, and I think the
personnel at both facilities are comparable in terms of their degree of
expertise, but I can tell you that the practice patterns vary quite a
bit.

Some facilities don\'t differentiate between screening and diagnostic
examinations, and some facilities in the way they handle the
examinations handle them differently to make this differentiation
difficult.

And I also question the applicability of benchmarks to individual
practices. As I was saying, my performance has not changed since I moved
to Honolulu, but because the patient population differs so much as a
high Asian population, women with very dense breasts are the norm rather
than the exception. There is a lower prior probability because the risk
of breast cancer in this population is inherently lower, and my
performance hasn\'t changed, but my benchmarks have. My recall rate is
higher. My positive predictive value is lower. So I really question the
applicability.

Next slide, please.

In terms of required tracking of outcome of all cases with BI-RADS 0
assessment, this is not easily achieved. It\'s quite difficult to
achieve this even with commercially available software tracking
programs, and again, I have experience with two different, very
widespread, widely utilized tracking programs, and this is a difficult
audit to achieve with both of them. This requires a substantial increase
in time and effort and expense, and we already track the BI-RADS, four
and five cases that come out of the BI-RADS 0.

As stated in the IOM report itself, there has been no provide benefit to
this additional tracking.

Next slide.

The inclusion of interventional mammographic procedures, specifically
stereotactic biopsy, in the MQSA, we believe, would be justified because
we do think that this would lead to quality in these procedures, and
there is a stereotactic program again sponsored by the ACR that is in
place.

Next slide, please.

Regulation of breast ultrasound and breast MRI are also mandates that
are likely to result in improved technical quality. Unfortunately this
is not yet feasible for breast MRI because the accreditation program has
not been established, and also, the hardware and software is still in
development in terms of technique for breast MRI.

Next please.

So increased regulation, particularly if it\'s unfunded, runs the risk
of decreasing access through worsening manpower shortages and increased
facility closure. I was recently at an ACR meeting where several of the
attendees stated that their practices were considering dropping
mammography services.

the goals of improvement inequality should be clearly understood, and
new regulations should have a high likelihood of improving these
targeted quality parameters.

Next please. Can you switch? In the interest of time, next slide.

So in conclusion, the ACR has a proven commitment to quality improvement
that has been demonstrated over the years, and certainly these efforts
should continue. The increased mandatory

auditing requirements have not been shown to translate into improved
quality that would justify the quite substantial commitment of time,
effort and expense involved, and this that I\'m referring to
specifically is separating the screening and diagnostic auditing and the
tracking of the BI-RAD 0 cases.

We do feel that stereotactic breast biopsy and accreditation of breast
ultrasound is likely to result in improvement in quality. It\'s
premature to require regulation of breast MRI at this time.

Thank you very much.

CHAIRPERSON HENDRICKS: Thank you, Dr. Lee.

Are there any questions?

(No response.)

CHAIRPERSON HENDRICKS: If not, we\'ll move then to our second speaker in
this open public hearing. We welcome Dr. Larry Bassett to the podium
from the Society of Breast Imaging.

Dr. Bassett.

DR. BASSETT: Thank you.

The Society of Breast Imaging is the largest national organization
specifically committed to the practice of breast imaging, and I can
refer you to the SBI Web site for position papers on the IOM report.
Simply www.sbi-online.org.

Next.

We are addressing now the issue of improving breast imaging quality
standards from the Institute of Medicine published 2005. The Society of
Breast Imaging commends the thorough data finding efforts and analysis
by the IOM in defining many issues that are confronting breast imaging
practices. However, some proposed solutions may have a negative impact
on the goals sought by both the IOM and society at large.

Here I\'ve kind of outlined the four main categories of the
recommendations to improve breast imaging quality taken directly from
the IOM report. One is to improve mammography interpretation; the
second, to revise MQSA regulations and inspections and enforcement; and
next to insure an adequate work force by breast cancer screening and
diagnosis; and the fourth, to improve breast imaging quality beyond
mammography.

Next.

So starting with the first of those, improved mammography
interpretation. This addresses, first, to revise and standardize the
required medical audit component of MQSA and, two, to facilitate a
voluntary advanced medical audit with feedback.

The SBI has found a concern about this in that increased regulations,
while aimed to improve breast health care, have to deal with also the
work force shortages and low reimbursement that will be aggravated by
implementation of such measures.

Dr. Lee has indicated the crisis in the work force for breast imaging.
This is something that has been identified and reported in at least
three papers in the literature in peer reviewed journals.

Why is this happening? I think we heard that there\'s not new people
coming into the field. There are people dropping out of the field and
people retiring, and some practices simply do not find it financially
feasible to have a strong breast imaging component.

We do feel that if we\'re going to increase regulations we need to have
sufficient incentives to create an infrastructure that will support the
improved delivery of care before these go into implementation rather
than have them occur concurrently with the imposition of additional
regulatory burden on a work force that\'s approaching crisis level
shortages.

We see this every day in my practice. We train many breast imaging
fellows. We\'ve trained 64 to date sine we started that endeavor. I had
two last year. Both of them had about ten job offers in the first month
of their fellowship. There\'s a real need out there, and it\'s not being
filled.

Next.

We are concerned that increased medical audit requirements may scare off
other current breast imagers.

Next.

The new audit recommendations are time consuming and require more paper
work. No payment is included for this, although to date the facilities
have used their own resources to pay for all of the requirements that
they have to fulfill. This is another one that may just be the one that
broke the camel\'s back.

In our own facility in order to try to do this kind of medical audit
which we have been doing, but it\'s an academic institution, we had to
hire a QA coordinator who keeps track of the zeros and so on and the
fours and fives.

We couldn\'t do it as a radiologist because we\'re already working the
work of two people because we\'re short staffed. We can\'t get someone
to take the open position that we have in breast imaging, and this is
true of most facilities that are academic facilities in the United
States.

Small, rural facilities may not have the same kind of resources, may not
be able to accomplish this. And the other thing that Dr. Lee referred to
is that we know that the results of medical audits depend largely on
your patient population. So we\'re not sure there\'s a real standard
that we can arrive at that will be uniform across all practices.

Next.

In addition, there was a recommendation to establish breast imaging
centers of excellence and undertake demonstration projects and
evaluations within them, and further study of the effects of CME, reader
volume, double reading and computer aided diagnosis and detection.

The Society of Breast Imaging supports the concept of centers of
excellence and thinks this should be pursued.

In terms of the other recommendation, there\'s a lack of evidence that
variables such as reader volume are related to interpretation quality
and requiring greater volume would further reduce the number of
physicians that are qualified to interpret mammograms.

Next.

The next issue was modifying regulations to clarify their intent and
address current technology and to streamline inspections and strengthen
enforcement for patient protection. And the Society of Breast Imaging
agrees requirements should be reviewed to determine which are the
effective ones in determining the quality of mammography and perhaps
remove and eliminate those that are not effective.

And the SBI strongly supports streamlining the process.

Next.

In the next group to college and analyze data on mammography work force
and service capability, to devise strategies to recruit and retain
highly skilled breast imaging professionals, and to make more effective
use of breast imaging specialists, the Society of Breast Imaging
supports any way to reduce burden on the current breast imaging work
force.

However, the use of radiologists to assist us to interpret breast images
is controversial, remains to be proven in effectiveness, and does not
reduce the medical legal responsibility of the interpreting physician
who is overseeing them.

We do want to improve output. We want to do that without sacrificing
quality.

Next.

Finally, to mandate accreditation for non-mammography breast imaging
methods that are routinely used for breast cancer detection and
diagnosis, such as ultrasound and breast MRI.

Also, we want to include the issue that as an X-ray examination of the
breast, stereotactic biopsies should by law be included in MQSA
regulations.

And as was mentioned, there\'s already an accreditation program that\'s
set up. So this would be an easy one to implement.

High quality ultrasound is crucial in breast imaging today, but there is
variable performance and equipment, and this also merits mandated
accreditation, and again, there is an accreditation program already in
process so that it could be easily adapted.

And, finally, breast MRI accreditation we feel should occur, but this
will have to come later because we don\'t know what the proper standards
are yet today.

Thank you.

One more slide.

Thanks for your time and service to the field of breast imaging. We
appreciate this very much from the Society of Breast Imaging.

Thank you very much.

CHAIRPERSON HENDRICKS: Any questions related to Dr. Bassett\'s
presentation from the audience or the panel?

(No response.)

CHAIRPERSON HENDRICKS: Then at this time we\'ll ask Dr. Finder to read
two separate sets of written comments from public speakers who are not
present today. The first is a set of anonymous written comments related
to the IOM recommendations.

the second is a set of written comments submitted by Dr. Richard Ellis
related to the IOM recommendations.

Dr. Finder.

DR. FINDER: For those in the audience, these comments are a part of the
packet of materials that you have.

The first one, as mentioned, was sent in by a person who wishes to
remain anonymous and wanted this read into the record. It says, \"I am\"
\-- and I\'ll try and go through as much as I can in ten minutes. It\'s
a rather long statement here.

Okay. \"I am a registered nurse of a woman\'s diagnostic center. As a
patient advocate, I am aware of the advocacy of other nurses, such as
Judy Wagner. I have some great concerns about the practice of
mammography and other breast imaging modalities if we do not make some
changes in educational requirements and tracking of competence.

\"Screening mammography still provides the best defense against a death
from breast cancer. However, this is only true when the quality of
radiologists\' reading accuracy is highly proficient.

\"As you may or may not know, studies indicate that doctors need to read
minimally 2,500 films each year to stay sharp. The government, however,
only requires 480 per year. It is ridiculous to think that anyone can be
proficient reading this few per year.

\"At this time the government does not require regulatory agencies to
monitor these levels of proficiency. Having the radiology groups monitor
internal performance is quite like having the fox watching the henhouse.
Most radiology department directors have neither the time nor the staff
to go back and find the false negatives.

\"A run a small center, and makes it a priority to go back with each new
cancer diagnosis and see if it fits into the false negative category.
This is time consuming, but very necessary.

\"To date I have discovered 18 false negatives read primarily by two
radiologists within the past two years. I work closely with the medical
director of the center who has been very supportive. He has helped me
get this information to the Physician Quality Committee and has made
recommendations to remedy the situation.

\"While we have discovered the actual cases of missed diagnosis, I can
only wonder how many more patients that were given a benign or negative
outcome may have a cancer already.

\"Several months ago we had a fellow trained mammographer join the
practice. She quickly spotted the above problem and stated that there
were two other physicians in the group who should not even read
mammography. She stated that this was more of a problem than just the
need for a few CMEs in mammography. The cancers that were being missed
were, for the most part, not small, difficult to see cancers. It seemed
clear to her that there was a real problem identifying what cancer
looked like in its early stages.

\"We have the R-2 image checker which is used, and still we have this
many missed diagnoses. She left the group after only a few months to go
to practice in a large hospital breast center. As with the majority of
community hospitals, the radiology group has the hospital radiology
contract. They are very good at many things. They rotate several
physicians through our center to cover mammography. They do not enjoy
reading mammography, and clearly, are not going to spend time and effort
to even go to a visiting fellowship in mammography as recommended for
correction of deficit.

\"My problem is that once you have a really good mammographer and see
what quality looks like, you can\'t go back. I have insisted that they
find us another mammographer, and so far the administration has backed
me up. They, of course, are dragging their feet because this new person
will not generate the same amount of revenue that other physicians in
the group generate.

\"My feeling is that there needs to be a new paradigm in the way
radiology groups think about practice recruitment and development.
Because the average radiologist would prefer not to do mammography and
other women\'s imaging, the group should be willing to subsidize
salaries for those who are willing to do this kind of practice.

\"Women deserve this vital service even if reimbursement is terrible. It
should be of some value to a radiology group to have one well trained,
passionate person take all the heat in this highly sued specialty. This
mammographer could help raise the bar for all radiologists in the
practice.

\"Mammographers should be allowed to just do mammography and should not
have to keep skills up in other areas as well. Breast imaging is
changing so rapidly that it is no longer just mammography. A breast
imaging specialist has to be able to read breast MRI, do minimally
invasive breast biopsy procedures, talk to patients and the public in
general. He or she should not be expected to take general radiology call
as well.

\"When I confront our radiology group with their individual statistics
for all BI-RADS categories, false positive, false negative, true
positive, true negative, and when I provide percent recommendations,
they tell me that they should not have to be held to the standards. They
say they don\'t read as many per year as mammography experts and can\'t
be expected to reach the same level of proficiency.

\"I say this is bunk. If I go to a surgeon and have my colon removed,
should he be able to say to me, \'Well, I missed some of the possible
cancer because I don\'t do as many of these as some others do\'? May it
never be.

\"At the last NCBC conference this past February I voiced my desire to
see minimal reading and CME standards improved.

\"One, additionally we must improve reimbursement for breast imaging. We
must find a way to provide incentives for bright, dedicated physicians
to go into breast imaging.

\"Two, we should encourage radiology groups to recruit breast images and
be willing to subsidize their salaries.

\"Three, regulatory agencies must find a way to do more than measure
accuracy of equipment in their surveys until such time as physicians can
adequately police themselves. In lieu of this, hospitals should be
required to have non-physician personnel or consulting physician
personnel monitor statistics for reading accuracy.

\"Four, the MQSA needs to become more comprehensive. I am in favor of
expanding it to Breast Imaging Quality Standards Act.

\"Six, with regard to stereotaxic qualifications, I have no problem with
surgeons doing stereotaxis in our center. If the radiologist has done a
good job of marking the recommended area for biopsy, our technologists
have no problem locating the lesion on the computer and preparing
everything for the surgeon. He then reviews the mammogram. The stereo is
set up and marks the area for biopsy.

\"I think when surgeons get into trouble doing stereotaxis is when they
interpret the mammograph which was done perhaps in their office, then
expect an aide other than a registered mammo technologist to set up the
equipment and position the patient.

\"Recently I read in the Mammography Regulation and Reimbursement Report
that the American College of Radiology would begin calling the false
negative a sentinel event for the hospital. This would have a big impact
on hospital accreditation.

\"I will now be attempting to track our cancer patients to see if they
die of breast cancer. If so, the sentinel event repercussions for the
hospital are significant. I can see if this happens, the individual
hospitals will begin demanding better quality readers of breast imaging.

\"I am only one voice, but I am a thorn under the saddle. Each time I
find another false negative, I see the patient\'s face. I am the person
who will counsel them prior to their first surgical visit. I am the
nurse who gives out her phone number to them for questions and comfort.
I am the nurse who runs the women\'s cancer support group. None of them
know that their cancer should or could have been caught earlier.

\"It is my job to market our center as a center of excellence. We meet
that goal in every single way. We have very high customer service
scores, and people rave about the quick and compassionate service they
receive. Indeed, we are a center of excellence in so many ways. It is
the physician component that lets us down.

\"In order to keep my job, I must fight this battle quietly within the
Physician Quality Improvement Committee. It has been of little value to
me. Recommendations for improvement are just that. The radiology group
has little incentive other than my constant nagging to do much about
anything.\"

And then she lists some percentages and indices for evaluation. I will
say that this person reported that she had no financial interest,
conflict of interest.

CHAIRPERSON HENDRICKS: Any questions or comments related to the
anonymous statement?

DR. FINDER: Okay.

CHAIRPERSON HENDRICKS: Next we move to the comments from Dr. Richard
Ellis.

DR. FINDER: Dr. Ellis is from the Gunderson Lutheran Medical Center. He
also reported that he had no financial conflict of interest to report.
We\'ll give him the full ten minutes.

He says, \"I appreciate the opportunity to submit a statement for review
and consideration by the FDA concerning the Institute of Medicine
Committee\'s recommendations for improving MQSA.

\"For over nine years I have practiced as a clinical breast radiologist,
subspecializing in the early detection and diagnosis of breast diseases.
Listed below are the issues that need to be reviewed and addressed both
by the FDA and IOM committees as you prepare recommendations for
reauthorization of MQSA.

\"If the intent of screening mammography is to reduce the mortality and
morbidity of breast cancer, then early interruption of the disease is
paramount. Over the past 100 years we have seen advances in surgical
techniques that have significantly improved patient morbidity but not
mortality. Likewise, we now have chemo and hormonal therapies that have
allowed moderate improvement in patient mortality.

\"However, it is the advent of early detection and diagnosis which
interrupts breast cancer early in its natural history that has resulted
in the greatest reduction in mortality from breast cancer.

\"Since the initiation of MQSA we have seen improvements in the
technical aspects of screening mammography given the standards required
for certification. However, even if we have the best equipment, X-ray
film screen systems, technologists, quality assurance programs, and
viewing conditions, but lack high quality interpretation of the
screening mammograms, we severely limit the potential of early
detection.

\"This is clearly demonstrated in the randomized clinical trials for
screening mammography as tumor size and stage at detection drives
subsequent mortality rates. In order to insure high quality
interpretation, a performance audit must be obtained, reviewed, and
action taken when deficiencies are noted. A screening mammography
interpretation performance audit should include one average size, mean
and median size of the screen detected invasive carcinoma for women
participating in 12 or 24 months screening intervals; two, total
screening volume per year; three, recall rate; and four, positive
predictive value for BI-RADS 4 and 5 categories. In order to help
achieve acceptable screening performance standards, radiology residency,
and breast imaging fellowship training as well as postgraduate training
programs that properly instruct high quality screening interpretations
are critical.

\"Although there are many mammography/breast imaging programs offered
for CME each year, unfortunately many simply do not provide the type of
education that will allow direct improvement in screening mammography
interpretive skills.

\"Two, many will argue that if physician performance standards are set
to insure a high standard of care, then access to women in many
communities will be lost as many general radiologists may not be able to
achieve and/or maintain the required standards.

\"This issue can and has been successfully addressed by other countries
including Sweden and the United Kingdom. Although the total number of
screening mammograms interpreted per year may serve as a surrogate
performance marker, Items 1, 3, and 4 listed above provide an objective
measure of performance. If inappropriate low interpreting physician
performance standards are set by MQSA to simply afford greater access,
mortality rates will likely not be reduced, and overall cost of care
will increase.

\"Reasonable and preferable high interpreting physician performance
standards need to be instituted. An exemplary model of postgraduate
training success can be found by examining the interpreting physician
performance improvements achieved by private practice, radiologists in
Albuquerque,\" and he talks about Linver\'s practice there.

\"Similar models of postgraduate training with proven success need to
become a fundamental part of physician CME for screening mammography
breast imaging.

\"On a similar issue, communities and medical institutions of sufficient
size should strive toward creating interdisciplinary breast care teams
which help provide improved overall care, efficient use of resources,
and substantial reduction in medical costs.

\"Third, with the use of screening mammography, the majority of breast
cancers are initially detected in the preclinical phase, nonpalpable.
However, other imaging modalities, especially breast ultrasound, are
frequently used in the diagnostic evaluation of screened detected
abnormalities to further segregate which patients may require a biopsy
for definitive tissue diagnosis.

\"Given the advancement in training and technology, most breast biopsies
can be performed under image guidance to include ultrasound and
stereotactic guided breast biopsies. In 1996, through the joint efforts
of the American College of Radiology and the American College of
Surgery, we have the stereotactic guided breast biopsy accreditation,
but which remains under voluntary accreditation.

\"However, breast ultrasound and ultrasound guided breast biopsies have
multiple guidelines and accreditations from various institutions and
agencies, to include the ACR, the ACS, the American Society of Breast
Surgeons, and the American Institute of Ultrasound in Medicine.

\"Both the FDA and IOM members need to investigate why they\'re on
multiple and varied physician training guidelines and accreditations for
breast ultrasound examinations and procedures. The FDA and IOM should
insist on a single universal standard for ultrasound examination and
procedure training guidelines and accreditations so that multiple
standards are not propagated.

\"Even amongst radiologists there is a wide disparity of performance and
interpretation for breast ultrasound. The universal accreditation
program will help insure that not only mammography, but also other
breast imaging examinations and procedures meet an acceptable MQSA
standard for accreditation. If the FDA and/or IOM through the MQSA does
not require and enforce the universal practice standard for breast
ultrasound examinations and procedures, then the qualification for
breast ultrasound will simply fall to whomever can afford the equipment
regardless of prior training and performance level.

\"In the very near future universal standards and accreditation should
also be established for breast MRI and imaging guided breast tumor
oblation.

\"Four, although not directly related to MQSA, a major issue to be
considered is the dwindling number of radiologists and training
residents that have a desire to provide mammography/breast imaging
services. Relatively low reimbursement rates and high exposure to
malpractice litigation must be addressed and appropriate incentives need
to be provided to prevent radiologists from abandoning
mammography/breast imaging services. Creative solutions, to include
providing graduated reimbursement rates for mammography/breast imaging
services based on physician performance and creating a balanced,
knowledgeable national committee to review and arbitrate medical
malpractice suits, along with placing caps on punitive damages, tort
reform will be important.

\"Should you have any questions or need additional information, please
contact me. I appreciate your review and consideration of my
recommendations.\"

CHAIRPERSON HENDRICKS: That ends the submitted comments from the public
speakers for this portion of the session.

Based on the itinerary, I\'d move to a break, but may be we should move
into the next speaker because we are ahead of schedule.

The next item on the agenda are some comments to be made by Dr. Michael
Divine, who is Chief of Inspection and Compliance Branch, to comment on
inspection observations.

Mr. Divine, welcome.

DR. DIVINE: My name is Michael Divine. I\'m the Chief of the Inspection
Compliance Branch, Division of Mammography, Quality and Radiation
Programs.

There will be two main topics for this particular discussion. One will
be similar to the inspection results from the MQSA inspections for the
last three fiscal years. The fiscal year for FDA runs from October 1st
to September 30th, and I\'ll also talk about from follow-up actions
involved regarding things we can do when we find serious problems.

Okay. The inspection results I\'m going to be discussing for this fiscal
year, which started October 1st ran through August 26th of this year.
All of our inspection observations from inspections are broken down into
three different levels. The first is level one, which we consider the
most serious. This is the most likely one that might result in us taking
regulatory action or conducting a follow-up inspection or warning the
facility if they don\'t have a history of problems.

The next level which we consider moderate but still significant is level
two, and the last one is level three, which we consider minor. No
significant problems.

This is probably the most important slide I\'ll give for this
presentation because it shows the overall performance of facilities over
time. If you looked at a chart like this spreading back to 1995 when we
started inspections, you would also see that it has been continuously
improving since the beginning of the program.

The level one observations has been very, very small, for several years
now almost nonexistent on this slide. You also see a drop in the level
two and the level three problems over time, and you\'re seeing that the
top line, the blue line is where things have gotten to we\'re about at
70 percent of facilities that have a clean inspection.

Starting with some level one problems for initial qualification of
personnel, the first set of bars has to do with the physician either
having board certification or the alternative of having two or three
months of training in mammography. This number has been dropping.

To give you an example of the perspective, we do about 9,000
inspections. So this is way less than five percent of facilities that
have this problem. The license problem, we still see some of that.
Mostly we think that\'s an issue of allowing the license to expire and
not getting it renewed, which is mostly a technical problem and not
really related to quality, or that they don\'t have any documentation at
the facility during the inspection.

For the medical physicist, pretty much has just gone away. We don\'t see
too many problems with the physicists at all anymore. We still see some
problems with the technologists. Once again, this is a very, very small
number of facilities considering the number we inspect every year, and
that has also been dropping.

In the QC area, once again, we have some problems, but they\'re not that
significant in terms of overall numbers. We have an observation for if
they have failed to do processor QC for five consecutive days or more,
that will get them a level one, and that\'s around 30 to 40 facilities.
Processing out of limits, when they\'re outside the actual limits on
their processor charts.

The third category is where we look at the number of days in a month,
the percentage. That is also very small, and the last column is when
there\'s standard QC missing.

The first few charts on this, these are tests that are done during the
inspection. All of the ones that are very low are relating to test
inspectors. As you can see, it\'s much less than 20 facilities for any
of those phantom tests, either the spec groups, the fibers or the masses
that are broken down individually. So there\'s a very small number of
problems that we\'re finding with phantom image testing.

Under processing, which is a test we do, it\'s called the step test,
which is a test of sensitometry where we actually run a film through the
processor and compare it against a standard. We find very few problems
with that these days. The processing has gotten much better.

We do find a certain number of problems with fog when we go in to test
the fog in the dark room, but once again, we\'re talking about much less
than five percent of facilities.

These are problems relating to the survey. The first column is where
there\'s more than 14 months between the annual survey. Even though
they\'re required to have an annual survey, we allow up to 14 months
between surveys before we consider it to be a problem.

The next column is when we go into the facility, and the last survey was
more than 14 months, but they haven\'t had a more recent survey during
the inspection. So it\'s a much bigger problem when we go in because of
the timing. We usually see the last survey and the one before that being
more than 14 months.

The next set of columns has to do with an incomplete survey where
there\'s either a problem with the tests that were done or there were
missing tests from the survey. So the survey was done, but there was a
problem with it.

The next column has to do with the X-ray unit. When they installed a new
X-ray unit or they have a major repair on the unit, they have to have
mammography equipment evaluation done by a medical physicist, and this
column has to do with \-- these were not done \-- once again, this is a
very small number because if it\'s a unit, they have to go through
accreditation. So they\'re going to have to have it done anyway. So this
is a fairly rare occurrence.

The next one is where they install a new processor or they have a major
repair on the processor. Once again, they have to have the medical
physicist come in and do an evaluation, and we\'re seeing very few
problems in that area.

These are testing that are done by the inspector during the tests, and I
added this slide for comparison purposes because we\'re going to be
talking about what things we do during inspections and streamlining
inspections during the next discussions.

The first column is zero, and there\'s an asterisk there to point out
that we have not seen a dose value exceeding 300 millirad in an
inspection since 1997. It has basically gone away as a problem.

So we\'re still doing the testing, but we haven\'t found any problem
since 1997. Exposure reproducibility, almost nonexistent. It looks like
about ten facilities out of about 9,000 inspections. This is a test to
see that shooting the X-ray beam several times with the phantom in the
beam produces the same level of radiation. Beam quality has basically
gone away as a problem.

We still see a certain number of facilities with the alignment tests,
but this involves several different tests we do in the inspection. One
is oversizing of the X-ray beam on the film. It also involves where the
compression paddle is in relation to the film and the chest wall of the
X-ray. So there are several different problems that can get a facility
here. So it\'s not just one test.

But even taking that into consideration, there\'s still a small number
of facilities, less than five percent.

Getting into some interpreting physician qualifications, radiologist
qualifications, and level two, one is the initial CME. That\'s either
having 40 hours of training in mammography or 60, depending upon why the
physician qualified. Once again, that\'s a small problem and has been
decreasing. The initial experience is the 240 mammograms read within a
six month period. That\'s very small.

We see more problems with continuing experience, continuing education,
but those numbers have been going down over time, and as you can see,
the continuing education has been dropping, too.

Technologists qualifications. The mammography training is that they have
to have 40 hours of training in mammography with supervised
examinations. Once again, we\'re almost seeing no problems with that. As
with the physicians, you\'re still seeing some problems with continuing
experience. The continuing experience is to have read 200 mammograms in
a 24-month period, and the continuing education in a similar position. I
still see some problems, but they are decreasing.

Medical physicist, initial training or initial experience requirements.
Once again, we\'re seeing almost no problems at all in that area. Also
having some problems with the continuing education and experience, but
as you can see, it\'s almost nonexistent compared with 9,000 inspections
a year.

Getting onto medical records and reports, we have a problem. The
facility has a problem with sending out patient letters or mammography
reports within 30 days. They can get a level one for that. We consider
that a very serious problem. Once again, this is just a small number of
facilities. Way less than five percent of facilities get this problem.
So it\'s pretty much a non-problem these days.

We do see some problems with the assessment categories. A lot of that
has to do with wording. We\'re still seeing problems with that, but we
don\'t consider that to be a significant problem, but it is decreasing,
and reports without the physician being identified, that\'s almost gone
away altogether.

the first one has to do with the X-ray unit. When we first went in with
the final regs. in 1999, requirements that, for instance, they have to
have two film sizes for each mammography unit to do the 24 by 30 and the
18 by 24. Most of those problems have gone away, almost nonexistent
problems these days.

We still see some problems, though very minor, with the procedure for
consumer complaints, and that has been going down, I think, as the
facilities get better educated as to exactly what we\'re expecting, and
the procedure for infection control, once again, that\'s a small number
of facilities. Once these procedures are in place we usually don\'t see
it from year to year. So a lot of these could be facilities that are new
or have changed their procedures and we find problems with them.

This has to do with the medical outcomes audit. The first one has to do
with not all of the positive mammograms are entered into the system.
Once again, this is a very small problem.

The second one, even though it says no biopsy results, what we\'re
actually talking about is they haven\'t gotten all of the biopsy results
for all of their positive mammograms or they can\'t document that they
have made an honest attempt to get all of those results.

The third one has to do with they have not identified an audit
interpreting physician for \-- this is an annual audit. The third one
is, which we\'ve seen more problems than the last three categories, but
still very small. The analysis is not done annually. They\'re required
to do an annual analysis of the results.

The last one is that they haven\'t broken down the analyses by each
interpreting physician, which they\'re required to do, an the last one
is that they haven\'t done an analysis for the entire facility. They may
have broken it down by each physician, but they don\'t have a complete
analysis for the whole facility or they haven\'t done it at all.

This one has to do with just if they have any problems, and if you go
back to all of those other problems where we talked about qualifications
of personnel, if they have any problem, they get cited for this, and
there\'s also a situation where \-- and it\'s a good time to mention
this \-- if they go in and there\'s something missing from the file, but
the facility can justify that the documentation exists and they can
obtain it within five days after the inspection and they can provide
that to the inspector, either fax it to the inspector or get it to the
inspector before they send the inspection to us. We allow the inspector
to remove that observation from the inspection, but they will still get
cited for this thing because they have to have their documentation,
their paper work ready for the inspection.

So we consider it a problem, and we want to track these problems. Of all
the things I\'ve show today, this is going to be the highest because,
you know, there\'s always going to be something at a lot of facilities
that they\'re going to have a problem somewhere, and so this is still
less than about ten percent of facilities, but still more. And once
again, it\'s still been something that is decreasing.

Okay. The next part of the talk is I\'m going to be discussing actions
that we can take after inspections and for facilities that have ongoing
problems, once again, most of what you saw in the previous slides have
to do with problems that aren\'t going to result in these kind of
things. It\'s just a very, very small number of facilities that have
problems over and over again, and that we\'ve decided we\'ve warned them
and they still have problems.

The types of things that we can do, the first thing we would probably
consider is a follow-up inspection, and the follow-up inspection would
be done, let\'s say, for a level one problem at a facility. Let\'s say
the facility had responded to the level one. Well, we knew the facility
had some problems in the past, and even though they\'re telling us what
they\'re going to do to correct the problem, because of their track
record, we want to go back in there to see that everything has been
corrected permanently. So we might go in. Since we\'re doing an annual
inspection, we might go in about midyear, about six months and go in and
check to see if everything is okay.

Another thing that we can do which has to do with evaluating whether the
problems at a facility could affect clinical image quality is we can do
additional mammography review. In the vast majority of situations the
facility\'s accreditation body would be done the additional mammography
review, but our regulations allow for us to have somebody other than the
accreditation body do the review, but that would be under very unusual
circumstances where that would occur.

Should the results come back from that additional mammography review
that the patient\'s facility\'s mammography quality represented a
serious risk to human health, we have the authority to require patient
and physician notification about those problems so that the patients are
aware that there\'s a problem or a potential problem with their
mammogram.

Another thing we can do if we have a facility that has a lot of problems
is something called a directed plan of correction. This is a list of
conditions in addition to what\'s in the regulations for them to
operate. This is something we can do instead of shutting the facility
down. We think we can work with the facility. It requires a lot of
monitoring.

For instance, a typical thing they might require would be that they
would have to send in records to FDA, let\'s say, on a monthly basis,
for instance, quality control records or any other things that we think
requires the requirements to be put in the facility so we are assured
that they are operating in compliance, and it also could involve
additional inspections where we go into the facility and requiring them
to come up with more detailed procedures than would be required of the
regulations so that we know that they\'re keeping track of things.

Civil money penalties is pretty self-explanatory. This involves fines
that we can levy against a facility that is in violation.

The next one is if these other things have not worked, if we\'ve tried
to work the facility. We\'ve given them warnings. We\'ve even put them
under a directed plan of correction or we believe that they have a
serious risk to human health, let\'s say, from an AMR, additional
mammography review.

We have the option of suspending their certificate. If we suspend their
certificate, they have to stop doing mammography until we lift the
suspension, and another option, which we have yet used, is revocation.
This would be a much more serious version of suspension. They would have
to stop doing mammography, but the owner-operator of the facility could
not own or operate a facility for two years if this occurred.

The last one is injunction. This is the only one on this list that would
actually go to federal court. We consider this somewhat of a last resort
because we have all of these other tools. We usually don\'t have to go
to court. We can deal with facilities in that, but up to this point we
have not used injunction.

Injunction basically is a court order that would shut the facility down.
There are only two conditions under which we can use this. One is that
the facility\'s mammography is a serious risk to human health. Since we
usually suspend the certificate if we find that to shut the facility
down, we would only go to court if they continued to do mammography
after suspension.

Another one is if they were performing without a certificate. Once
again, usually when we find a facility that\'s performing mammography
without a certificate, after talking to them they usually shut down
until they can get reinstated or apply to an accreditation body to get a
certificate. So most of those are not real problems, but if a facility
just decided they were going to continue without a certificate even
after warnings, we would have to go to court to shut them down.

Follow-up inspections. We checked on corrective actions for serious
problems. Usually it\'s a level one, though it could be repeat level
two. Usually if a facility has recent problems, if they haven\'t had
problems in the past, we probably will at least evaluate their response,
and if it looks adequate we probably won\'t need to do a follow-up
inspection. So it\'s usually a facility that has a level one or a repeat
level two, but now they have more problems in the past. So we can\'t
really take their word for it as far as their corrective action, and
it\'s usually limited to certain specific problems because something we
believe we can monitor without actually having to go in the facility.

Additional mammography view, as I mentioned, it\'s usually done by the
accreditation body. It can be anything from two mammograms all the way
up to 30 mammograms, and if there\'s a serious risk found in the review,
we would require patient and physician notification.

Some examples, if we find a level one phantom image failure at
inspection, we do a limited review, usually two mammograms to check
everything is okay with the clinical quality. The level one for the
interpreting physician, we theoretically could do that; in most cases is
related to qualifications. We usually are able to resolve those problems
without having to do an additional mammography review, and in many cases
it\'s more practical. If they can\'t document that they meet their
initial qualifications at a level one, we may actually have the
facility, have another qualified interpreting physician rereview all of
the mammograms read by that interpreting physician. So sometimes that
works better than having to do an AMR, and that assures that all of the
mammograms are read by a qualified interpreting physician.

If we have problems, we from time to time have complaints about clinical
image quality that need to be investigated, and really the only way to
do that is to have the accreditation body look at clinical images to
assure how bad the problem is or if there is a problem.

Overall, quality assurance failures, generally when we find a lot of
problems in that area, we\'re usually taking some other action, and
because we found these problems, we have to have some assurance that
they haven\'t affected clinical image quality. So we usually do
additional mammography review in those cases.

And with fraudulent record keeping, which relates to some of these other
areas, we usually do \-- we have to be able to assure that the clinical
image quality has not been affected by the fraud.

Once again, if the AMR shows a problem that\'s a serious risk to human
health, we require patient and physician notification. This provides the
patients and the physicians an explanation of the problems that were
found, how they were found, and some follow-up actions that the patient
may wish to have another mammogram. The patient may wish to have another
physician evaluate their mammogram to see if their mammogram is bad
enough that they do need another mammogram.

And we try to use plain language as much as possible. In the early days
we did some focus testing and found that we have to make sure that
everybody understands what\'s being included in the letter, and we try
to make it as readable level for all possible patients that could be
notified.

Directed correction imposes additional requirements in the facility and
allows us to monitor what\'s going on in terms of them sending letter
into us, and it could include additional inspections.

We only use suspension for very serious violations. Under the act we can
suspend for a variety of serious violations. However, we usually have to
give the facility a hearing in advance for them to contest our intention
for suspension. So they have the option for a hearing.

We usually do this when we\'ve tried to work with the facility. Usually
if it was rated with the quality assurance program, we would usually put
them under a directed plan of correction before going to this or we
would use, you know, some other method before threatening to close them
down.

And if we find a health hazard which is a serious risk to human health,
usually found through additional mammography review, the law allows us
to shut them down immediately, and that\'s usually our standard
procedure for doing that. If we find a serious risk, they\'re shut down
immediately, though they do have the option for a hearing after the fact
if they want to contest the fact that we shut them down.

Just to give you some idea of the numbers of actions we have taken over
the course of the program, this goes back to 1994 when MQSA started.
Sixty-four additional mammography reviews, 17 patient and physician
notifications, four directed plans of corrections, three civil money
penalties. The six suspensions include we have another option under the
law that if the accreditation body revokes the accreditation of the
facility, the facility certificate will remain in effect until FDA
decides that it should not remain in effect because of the problems that
were found.

In many cases we have taken actions directly from a serious risk to
human health finding, an additional mammography review, which also
resulted in the accreditation body revoking the accreditation of the
facility, and then we remove their certificate pretty much immediately.

As I mentioned in my earlier talk or earlier slides, revocations and
injunctions have yet to be used.

CHAIRPERSON HENDRICKS: Thank you very much.

Any questions for Mr. Divine? I had one.

DR. DIVINE: Yes.

CHAIRPERSON HENDRICKS: Carolyn Hendricks, panel Chair.

In your opinion, which aspects of the current routine facility
inspections could be completely eliminated without impacting the quality
of the inspections that are currently being performed?

DR. DIVINE: Well, one of the things that we have been considering
removing because, as I mentioned, we do a dose tester in each inspection
on each X-ray unit, and we haven\'t found any problems since 1997. So
it\'s very hard to justify doing that test every year if we don\'t find
any problems every year. That would be one I would mention.

And if we eliminate that, we would also probably be eliminating the
reproducibility test because that\'s all done in conjunction with it,
and the beam quality test also because we find very few problems, but
those are the things that stick out in my mind.

CHAIRPERSON HENDRICKS: Questions? Mr. Passetti.

MR. PASSETTI: Bill Passetti.

You mentioned that you haven\'t seen anything exceeding the dose limits
and how long. do you know what the current average is that you\'re
seeing throughout the facilities?

DR. DIVINE: I think it\'s about 1.7 milligray, which is about 170
millirad. That\'s my \-- 1.7, 1.8 I think. It\'s been going up a little,
but that doesn\'t result in any problems with the dose testing.

I think the reason it has been going up is that there has been a
preference for darker mammograms, and usually that\'s achieved through
using a little higher exposure to the patient, but that hasn\'t resulted
in any noncompliances by going up in the last few years.

CHAIRPERSON HENDRICKS: I have a follow-up question. Would those changes
that you propose related to elimination of those steps in the inspection
significantly reduce the inspection time or expense of the facilities in
your estimation?

DR. DIVINE: The inspection time depending upon how many units at the
facility and the particular inspector. I think if we eliminated the
radiation exposure test, that might reduce the inspection time maybe
half an hour per unit. That\'s just a guess off the top of my head. I
don\'t know how much that would affect the fee. I couldn\'t really
comment on that. It certainly would be something we could consider, but
I don\'t know. I don\'t have any data on that.

CHAIRPERSON HENDRICKS: Yes.

DR. WILLIAMS: This is Mark Williams, University of Virginia.

Just a follow-up comment on the question of dose. I wonder if it
wouldn\'t be interesting to look at not just the average in the recorded
doses during inspection, but also look at the dispersion around the
average to see what kind of spreads they are, maybe in conjunction with
data from the ACR to see whether or not it might be useful considering a
different upper limit. If there is a fair amount of spread around that
average, then it may be that even though we don\'t see violations above
300, it may be useful to consider other thresholds.

DR. DIVINE: Yeah, one thing I would mention, since you brought that up,
is that there\'s an article. I think it\'s still available on our Web
site where we have a spread of the dose data that we found during
inspections, and so we do have that available.

One thing I will mention is that we\'re going to be looking into this
issue, and we\'re going to be recording the dose values that are found
by the medical physicists during the annual survey to compare against
the values that we\'re finding during inspection so that we have some
idea of how close we are to that and also, you know, if we\'re finding
any problems. We\'re looking to that also

DR. FINDER: Dr. Finder.

I just wanted to add that in addition to the fact that currently we
aren\'t measuring the dose every year, the medical physicist measures it
every year at the facility and the accreditation body measures it every
three years.

CHAIRPERSON HENDRICKS: Other questions from the panel, the audience?

I have another question. Related to your slide with the very high
proportion of facilities that do not have any violations or any findings
a tall, that would be a global lack of any findings in their audit,
including the other CME documentation, requirements with \--

DR. DIVINE: Yes, they get an inspection report that says all items in
compliance.

CHAIRPERSON HENDRICKS: And that represents just about 70 percent of all
the facilities?

DR. DIVINE: Yes. It has been continually increasing over the course of
the program.

CHAIRPERSON HENDRICKS: So in your view then, would those facilities then
benefit from less frequent screening if it\'s those facilities which are
operating at such high quality levels that it might be okay for them to
be screened at a less frequent interval and still maintain that high
quality of care as determined by the inspections?

DR. DIVINE: Yeah, that\'s a possibility. One thing we discussed at the
last meeting was the results of the inspection demonstration program and
what we found was that there seemed to be an increase in the number of
problems when facilities skipped an inspection, but you know, there were
problems with that study, but that\'s what we had found.

Yeah, we are open to suggestions on that.

DR. FINDER: Yeah, this is Dr. Finder.

I just wanted to enhance what Mike said about this. For those new
members on the committee, in the last reauthorization, Congress asked us
to take a look at that exact issue about whether good facilities could
be inspected less frequently and asked us to do a demonstration project
or program on that.

We did evaluate a number of facilities that had been basically
significantly citation free and had them inspected every other year, and
the results of that were placed on our Website, and what they tended to
show is that even the good facilities in the second year of inspection
were found to have an increased number of citations compared to even the
standard facility.

So it has been looked at at least to some degree, and at least the
preliminary results were not very conducive to the concept of having
every other year inspections.

CHAIRPERSON HENDRICKS: Thank you very much.

Any other questions from the panel members, the speaker or the audience?

(No response.)

CHAIRPERSON HENDRICKS: In that case, I think we\'ll move to the break.
We\'re scheduled on the agenda for a 30 minute break or for a 15 minute
break. So we\'ll reconvene \-- I just doubled the break \-- so that
we\'ll reconvene here in 15 minutes.

Thank you very much.

(Whereupon, the foregoing matter went off the record at 10:24 a.m. and
went back on the record at 10:45 a.m.)

CHAIRPERSON HENDRICKS: To start the next discussion, I\'d like to invite
Dr. Helen Barr to the podium. She\'s the Director of the Division of
Mammography Quality and Radiation Programs, and she\'s going to lead a
discussion of the Institute of Medicine recommendations.

Dr. Barr.

DR. BARR: Thank you.

Good morning, everyone. First and foremost, I\'d like to thank you all
on behalf of the division as well as the office, and indeed, all of FDA
for being here, taking time out of your busy lives and schedules to come
and give us your thoughts and opinion.

And as you\'ll hear when I tell you a little bit about my background, I
have been out in the real world. So I do know what it\'s like to come
from there, and I can\'t tell you how much we appreciate you all being
here.

First of all, before I start, I wanted to make just two minor
corrections. Mr. Divine mentioned that we will be in the process of
collecting dose data that the physicist supplies to compare to dose data
that the inspector actually measures during the inspection.

Actually we are already doing that so that we can make a comparison
because one issue we\'ve heard is that there\'s possibly a disparity
between the measurements a physicist makes and the measurements the
inspector makes, and I wanted to indicate that we will be doing that,
but we already are underway doing that, and we\'ll be able to compare
those results as we along.

Second, Dr. Finder mentioned that the inspection demonstration program
was in the last reauthorization of MQSA. That was actually in the first
reauthorization of MQSA. There has been a reauthorization since then. I
just want to make that minor correction.

In the interest of transparency and so that you know a little bit about
me because obviously my background informs naturally the way I work here
in the federal government. I graduated from George Washington University
School of Medicine and did my internship and residency in diagnostic
radiology there. I did a fellowship there and stayed on there on the
faculty for two years before I moved to Kaiser Permanente here in the
mid-Atlantic region where I was the Director of the breast imaging
services, including interventional procedures, for nine mammography
centers throughout the mid-Atlantic region that performed well over at
that time 60,000 mammograms a year.

We have the second stereotactic unit in the Washington metropolitan
area. So I have experience in that area since the very beginning of the
modality.

I came here to FDA \-- I was just counting on my fingers \-- I just
passed my sixth anniversary here at FDA, and I came on as a Deputy
Director of the Division of Mammography Quality and Radiation Programs,
and in I guess about a year and a half \-- I don\'t know how long \--
became the Director of the program.

So that\'s who I am. Dr. Finder asked me before we start on the subject
at hand to just mention to you a little bit about what we\'re doing
about what was one hurricane and now is two hurricanes in relation to
facilities and personnel throughout the Gulf Coast who may have been
affected by the hurricane. We have a significant amount of information
on our Web site related to what facilities can do in natural disasters
and, in particular, what facilities in the Gulf Coast can do.

Probably the biggest thing that we\'re doing is helping personnel who
are moving to other states be able to get employment at other
facilities. We here at FDA are looking at the last inspection that the
personnel would have been involved in, and based on findings from that,
providing personnel with letters so that they can document other initial
and continuing requirements so that they can go other places and obtain
employment right now.

These are folks that have had records destroyed in the wake of the
hurricane. So Dr. Finder just asked me to mention briefly to you that we
were hopefully doing good things.

I\'m sorry. This microphone keeps \-- if I lower it to where it needs to
be it keeps tipping.

I also apologize in advance that I am a great seasonal allergy sufferer.
So I\'ve got my tissues and my sneezing and everything else up here. So
I do apologize for that. Even though I am Dr. Finder\'s boss, my
constant begging of him to schedule this meeting after the first frost
doesn\'t seem to have gotten me anywhere.

(Laughter.)

DR. BARR: What our job \-- you can imagine what the rest of my days are
like.

What I\'m going to lead us through here for the bulk of today and
tomorrow is actually marching step by step through the Institute of
Medicine recommendations. There\'s a lot of material here, and we want
to get as much of your input as we can on these recommendations.

Some of them my guess is will require basically no discussion. Some of
them may engender a fair amount of discussion, particularly when we get
to the part on modification of MQSA regulations. What I\'d like to do is
perhaps not get stuck on the wording so much as the spirit of what is
being recommended to be changed because I personally think that some of
the new recommended wording is perhaps as confusing as some of the old
wording. So rather than get bogged down on wording, you know, perhaps we
can agree on the spirit, and then if something needs to be changed in
regulation then, you know, experts on writing that can take our thoughts
and put it down in the proper language.

Any questions before we begin about anything or shall we just dive right
into it?

Okay. Here we go.

The background for the Institute of Medicine report is that over the
last three years, and particularly the time of the last reauthorization,
a lot of questions regarding the quality of imaging interpretation in
mammography have been floating around, you know, through articles,
through public opinion in Congress, and Congress struggled with a way to
perhaps look at what the problems in image interpretation might be
before putting anything specific in the law or taking anything out of
the law and regulations.

The Institute of Medicine is a part of the National Academy of Sciences,
and Congress commissioned a study from them in preparation for the last
reauthorization \-- excuse me \-- at the time of the last
reauthorization of MQSA in reparation for the next reauthorization of
MQSA in hopes that the information from the IOM report could be used in
the next reauthorization to improve particularly image quality
interpretation.

Congress at that time also commissioned a GAO report on access to
mammography and a couple of other issues, and although I know GAO is
busy working on that report because we\'ve been working on it actively
with them, we do not have the results of that report yet, but luckily we
do have the IOM results. So we\'re going to go ahead and get started
with those.

The Congress\' intent that, based on commissioning a study, for the IOM
to look at a step to increase of interpretation, whether current
regulation should be modified, the effects of recommendation on access
to mammography, and identifying steps to insure safe and effective use
of other screening or diagnostic tools.

The report is called improving breast imaging quality standards, and it
was done specifically by the Committee on Improving Mammography Quality
Standards of the National Cancer Policy Board at the Institute of
Medicine.

There were four major areas of recommendation that the IOM came out
with, and as I said, this is a very long, comprehensive report. So
we\'ve tried to take their four major areas of recommendation, and
we\'ll be marching through them step by step.

Now, one was improve mammography interpretations.

Two, revise MQSA regulations, inspections and enforcement.

Insure adequate work force for breast cancer screening and diagnosis,
and improve breast imaging quality beyond mammography.

I\'m going to start with the first of those major categories, improving
mammography interpretation. The recommendations within this category
from the IOM were to revise and standardize medical outcomes audit, to
facilitate voluntary advanced medical audit with feedback to establish
specialized breast imaging centers of excellence; to study the
effectiveness of continuing medical education, that should say. I know
we had that slide changed, but somehow it\'s here wrong again. That
should be continuing medical education.

Reader volume, double reading, and computer aided detection. So I\'ll go
through the first of those recommendations to revise and standardize
medical outcome audit.

This is just a lot of information about the different forms of positive
predictive value, and if I can skip ahead here, I\'ll know which one we
should concentrate on, which looks like PV-2.

The proportion of all women recommended for biopsy after mammography,
Category 4 or 5, that are diagnosed with breast cancer. So particular
note is that value.

And also different definitions for different forms of false positive.

IOM recommends that the medical audit should include the calculation of
three core measures: the positive predictive value two, the proportion
of women recommended for biopsy after mammography, Category 4-5, or are
diagnosed with breast cancer; cancer detection rate per 1,000 women; and
the abnormal interpretation rate, women whose mammogram interpretations
lead to additional imaging or biopsy.

The rationale that they include in the report is that MQSA currently
does not require calculation of specific performance statistics; that
all of these three things together would be more useful than PPV-3.
It\'s easier to calculate. PPV-3 is easier to calculate than PPV-1 or
\-- excuse me \-- PPV-2 is easier to calculate than PPV-1.

That additional imaging assessment not included in the MQSA audit. I\'m
not sure what that means. Let me go back to that. I don\'t know. I
can\'t speak to that specifically.

So I guess we\'ll discuss those first. So I\'ll go back to the slide
that has the overall recommendations.

(Pause in proceedings.)

DR. BARR: Not only is Charlie Finder a great Associate Director, but
he\'s the best administrative assistant I\'ve ever had.

(Laughter.)

DR. BARR: Which I tell him all the time.

So here is the medical outcome audit, and I\'m going to turn over to Dr.
Hendricks and Dr. Finder if you have any discussion on this matter.

DR. FINDER: Yeah, it\'s Dr. Finder.

Basically as reported in the IOM summary, we do not require any specific
statistics as part of the medical audit. We do require that the facility
identify and track all positive mammograms, and we identify those read
as suspicious or highly suggestive of malignancy, the fours and fives.
They have to make a reasonable attempt to find out what happened to
those patients and include that in their audit, but we do not tell the
facility what specific statistics they need to do, whether they need to
do any calculations at all, in effect.

And the IOM is recommending that these three measures be included as
part of the regulation that all facilities must do, and we\'re
interested in hearing from the committee on what they think about this
approach.

CHAIRPERSON HENDRICKS: We\'ve got a couple of radiologists on the panel.
If we could solicit your opinions first on how these recommendations
would impact your practice, for example.

DR. FERGUSON: Scott Ferguson from Arkansas.

I see no need for adding increased mathematical calculations. It would
be a burden on the system and I don\'t think would add anything to the
system to increase the number of calculations that you have to make.

Where is that information going? I mean, who\'s using that information?
What good does it do I guess is my question.

CHAIRPERSON HENDRICKS: Thank you. I think we\'ll move along a little bit
and maybe part of your question will be addressed as to what the IOM
thinks about who should be using this information.

DR. FINDER: Any other comment?

CHAIRPERSON HENDRICKS: The next recommendation under this category is
performance measures should be stratified by screening and diagnostic
mammography. Rationale is difficult to interpret and compare performance
with current literature or established databases.

Any comments? Discussion? I know we heard some in the ACR. Dr. Lee gave
some opinions on this.

DR. MONTICCIOLO: This is Dr. Monticciolo. I\'m a radiologist.

Yeah, I agree with the comments that were made earlier. I think it\'s
very difficult to start discriminating between screening and diagnostic
when there\'s differences among practices, what somebody considers a
screen versus a diagnostic.

And so, like Dr. Ferguson next to me, I\'m not sure how useful that
discrimination will be and how that will help anybody. And I\'ll just
add burden where I don\'t see much gain.

DR. BARR: Thank you.

MS. MOUNT: Carol Mount.

I agree. Within our facility we have a number of satellite facilities,
and every one of those facilities also call screening and diagnostics
different. So I think it would be very difficult to differentiate.

CHAIRPERSON HENDRICKS: I\'d just add a comment. I think I\'m a medical
oncologist. So like the majority of my patients have breast cancer, have
been diagnosed and treated for breast cancer.

I actually think that this may be a very important point. I think that
just the fact that amongst the panel members out there is a great
difference, and it has been the definition of a screening and diagnostic
mammogram doesn\'t mean that we don\'t need to establish one. I think
the facilities in this community \-- and I practice in Bethesda,
Maryland \-- are really overburdened right now from women who are
seeking out diagnostic imaging, and they just don\'t have the resources
for the radiologist to read those films in prime time.

I think that if the public could be educated, the word well, the women
that we are targeting for screening could be educated on what the true
definition of a screening mammogram, which in my clinical practice is
the screening of a woman age 40 or older with no breast symptoms at the
time examination is done.

I think this is a very important public health issue, and I think it
could really lessen the burden that certainly the facilities in this
area are overwhelmed with women seeking out diagnostic imaging when
really they are more appropriate for screening.

So I don\'t think that we should abandon this idea that we could level
the playing field and create a definition of a screening patient that
all facilities could accept. But I\'d welcome other comments about that.

DR. MONTICCIOLO: Well, I think the problem comes in, just the variations
of practice. I have one surgeon who wants all of his patients with
cancer to be diagnostic, and so we fight this battle every year, and we
have another surgeon when I was at Emory. The main surgeon, who was a
well known, a nationally known cancer surgeon, said, \"I want my cancer
patients to be screened because I want them to feel as normal as
possible.\"

Now, you have the implant patients. You know, should they be screening
or should they be diagnostic? And I think you\'re right. It would be
nice to have a standard, you know, who falls in where, but some
facilities can\'t respond to those standards very easily. So we have to
keep that in mind. We put more restrictions on facilities about what
they can and can\'t do.

For example, implant patients. We now can\'t do them as screening. So we
have women that have to drive 40 miles \-- I live in central Texas \--
to get their diagnostic mammogram and they have no breast complaints,
but they happen to have implants.

So there\'s all of these variations, and I think you\'re right. If we
had something more standard, but when we do impose that standard it\'s
going to have implications. So I\'m a little concerned about access and
the difficulty of putting more layers on what we do.

CHAIRPERSON HENDRICKS: Yes, ma\'am.

MS. PURA: Linda Pura.

We use simple terms as asymptomatic, symptomatic, and then special views
for the implant. It could be as simple as that, and then, of course, you
have to start subdividing, but those are simple terms that can be
utilized.

CHAIRPERSON HENDRICKS: Also in response to the issue one of our tasks is
to try to decrease the burden that inspection and mammography has placed
on the system economically and clinically for the imagers. The concern
about my patients who seek out or are continually in this diagnostic
mode is the frequency with which they should be studied.

So a very high proportion of women are seeking mammography at intervals
more frequently than years. Whereas if we could establish some standard
or some period of time beyond which mammography more frequently than
yearly could be performed in women who are long term survivors of breast
cancer, for example, I really do think that the burden would be
decreased significantly.

DR. BARR: Thank you.

DR. FINDER: Would they be screening or diagnostic?

(Laughter.)

CHAIRPERSON HENDRICKS: In my community here in Bethesda, the women are
used to having \-- what has become quite commonplace is women want
face-to-face interaction with their radiologist. They\'ll call and
they\'ll schedule because they know that a certain physician is going t
be reading that day. Basically they want an appointment slot, you know,
to meet their mammographer after their imaging.

And, of course, when you look at flow through a mammography unit, that
can really cripple the flow and decrease the number of high quality
images that the facility can read and the radiologist can interpret.

So, again, it\'s more of a public health issue to educate women and
their families and their physicians on high quality breast care, you
know, at the expert level because there are experts in images, of
course, who understand the requirements and which women would benefit
from more frequent imaging and which women require screening and
diagnostic approaches.

DR. MONTICCIOLO: I agree with you. I\'m in favor of increasing
education. I\'m just not sure that separating out audit data is going to
help. To me that seems like an extra burden, but I like the idea of
getting a more standardized approach to who gets screening, et cetera.

DR. BARR: Thank you.

C under recommendations option, that facilities should have the option
of combining audit measures for physicians at multiple facilities. Their
rationale in the report is that the data would be more meaningful or is
more meaningful when larger numbers of exams per physician are analyzed.

Charlie, do you want to comment on what\'s currently the \--

DR. FINDER: It\'s Dr. Finder.

I just want to kind of provide some background of where we are right
now. Under the current regulations, each facility is required to do its
own audit. So the data has to be done. Whatever data they do or whatever
calculations they do, and again, we don\'t require any specific
calculations, has to be broken down by facility and by individual
physician at that facility.

Part of the reasoning behind that is we have authority over facilities,
not over individual personnel, and that\'s the entity that we can hold
responsible for making sure that that happens. Once you start expanding
out to other facilities, it becomes more problematic.

Another issue was that since we did not require that the audit be done,
either broken down by screening or diagnostic, we felt that if we could
at least keep it to the facility level, then all of the physicians at
that facility would basically be in most cases looking at the same
populations, and they would be able to compare whatever analysis was
done at that facility with the other physicians at that facility, and
that was our purpose basically for the audit. It was not for a national
collection or anything like that, but just so the physicians at the
individual facility could compare themselves with the other physicians
at that facility.

So in that sense, our regulations talk about these analyses being done
facility specific. Now, we have adjusted to that. We actually have
approved an alternative standard which allows mobile facilities in which
their mobile units are each individually certified so that their own
facility, but where the physicians are the same and these mobile units
all go kind of round robin to the same populations.

We have allowed them to combine their data into one audit, but we have
not done that yet for fixed facilities, and part of the reason is we
couldn\'t be \-- one, we didn\'t even get an alternative standard
request for that specific issue, but the other is we do have concerns
about how you\'re going to combine data from different facilities to
make a cogent analysis.

If, for example, one facility is screening basically and another one is
primarily diagnostic, what happens to the data when you combine those
two?

But that\'s why you\'re here, and we want to hear what you have to say
about this issue because it is being constantly brought up. As part of
our guidance, we do suggest that even though according to our
regulations you must base this on a facility, individual facility, we do
recommend that practice groups that practice at multiple facilities
combine their data and do a second analysis to get their data and look
at that also because we do believe that the increased numbers can supply
additional information.

But again, our current standard is the audit has to be facility based
and then broken down by individual physician at that facility.

CHAIRPERSON HENDRICKS: Any comments?

DR. FINDER: Comments, thoughts? Do people think it would be a good idea
if we allowed multiple facilities to combine their audits and just
produce one set of data?

DR. MONTICCIOLO: It seems to me as a radiologist that what you\'re
interested in is how the physician is performing. So if they read at
multiple facilities, I see no problem with that. I would be strongly in
favor of allowing them to combine data because the larger your numbers
are, the larger the sampling and the more accurate look you\'re going to
have at that person.

CHAIRPERSON HENDRICKS: I have a comment. In this area, in this
geography, there is multiple satellite offices. So certainly I would
support, you know, the data to be combined for multiple satellite
offices when there\'s one large clinical practice responsible for
providing the mammography services.

DR. BARR: Thank you.

DR. FERGUSON: My question would be are you talking about mandating or
are you talking about allowing them to combine their data?

DR. FINDER: It\'s a very good question. It could be either one,
depending on what kind of advice we get.

DR. BARR: And I think maybe D speaks a little bit to that. The
recommendation is that audit data collection and analysis be verified at
inspection, but not collected \-- I assume they mean collected \-- by
the FDA, and the rationale is no change in procedure one because
regulator is not able to verify the accuracy of the data.

DR. FERGUSON: I guess my question goes to this data is for the
physicians to judge among themselves how good a job they\'re doing.
It\'s not used for any other purpose, right?

DR. FINDER: Well, correct. Under the current regulations, the
information obtained from that audit is supposed to remain at the
facility. We do not collect that data. We do not create a national
database or use that data except to see that it has been done. That\'s
all we do.

DR. FERGUSON: And so I would favor allowing rather than mandating
because this is for physicians to improve themselves and see where
they\'re shortcoming, and I think they should be measuring those
standards against one another, and if someone needs additional training
or whatever, they take care of it.

But as far as mandating it, it doesn\'t go any further than the group. I
don\'t see where you gain anything from doing that.

DR. FINDER: One issue that I would bring up is what would happen if some
of the physicians are from multiple facilities and some of the other
physicians don\'t have data from some of them. It becomes an inspection
type issue that we have to at least look at to figure out the complexity
of that.

Who do we end up citing if some data isn\'t there?

DR. FERGUSON: Well, and the problem I see and the reason I don\'t think
it should be mandated is that one facility may have a whole different
group of patients that may be doing primarily diagnostic, and I\'m
reading, and the other is doing screening, and another guy is reading.
You combine that data, and you have a different subset of patients.
That\'s why I don\'t think it ought to be mandatory.

DR. BARR: And as best as I understand the recommendation here, at least
at this level of audit, and you\'ll see as we go along the
recommendations are for different levels of audit, I interpret this to
say, based on D, that we should allow facilities to do this, but there
would be no difference in the inspection procedure or any citation for
facilities that don\'t do this.

E in Recommendation No. 1 is increase reimbursement rates to cover new
audit procedures. Rationale is costs are already significant. The new
audit procedures will add to expense. Costs were not factored in past
reimbursements, and health care payers should cover costs.

That probably doesn\'t require much discussion.

DR. FERGUSON: I definitely support that.

(Laughter.)

DR. BARR: Recommendation 2, and here you see \--

CHAIRPERSON HENDRICKS: I\'m sorry to interrupt. I just wanted to return
before you move into the second set of recommendations because we have
so many talented diagnostic radiologists here on the panel and also Dr.
Barr.

If we\'re not able to accept these three metrics, for example, to try to
establish some quality parameters in mammography, for you in the
trenches who actually do this, which parameters are useful for
determining quality of care, either a simple or more complex? What can
we offer in lieu of?

If we do not accept these recommendations for the reasons that were
stated in the discussion we\'ve had so far, what is a good surrogate if
one exists?

DR. BARR: I do think your question is an excellent one. Id o think it
might be helpful if I run through the next levels of audits and bring
out different parameters, and then perhaps we can discuss this as a
whole on point to your question, which is very well put.

Although this is a different recommendation, it still relates to audits,
and this is a voluntary advanced medical audit with feedback. So we sort
of see the baseline that we talked about and then this, and then we can
address Dr. Hendricks\' question.

In this recommendation of a voluntary advanced medical audit with
feedback, the recommendations that the audit should include collection
of patient characteristics and tumor staging from pathology reports. The
rationale is to record more useful data from pathology reports, such as
tumor size and lymph node status, record patient characteristics, such
as age, family history, breast density, presence of prior films and time
since last mammogram.

I\'m just going to run all through this and then we\'ll go back.

Establish a data and statistical coordinating center to electronically
collect, analyze and report advanced level audit data and provide
regular feedback to interpreting physicians.

I think we see here why there were all the cost recommendations. I
don\'t think it pertains so much to that initial recommendation, but to
some of these more advanced ones.

Develop, implement, and evaluate self-improvement plans for interpreting
physicians who do not achieve benchmark performance, and aggregate
summary data on interpretive performance, including recall rates, PPV-2,
and cancer detection.

Under the same recommendation would be to test different methods of
delivering audit results to interpretive performance, study randomly
selected facilities using required basic audit procedures for impact on
interpretive quality, protect quality assurance data from
discoverability, and the rationale for all of this. The statistics and
analysis group needed for uniform feedback to improve quality, studies
needed on feedback to improve performance, national benchmarks needed
for facilities to assess performance. It would test the impact of basic
audit procedures, and the Breast Cancer Surveillance Consortium and the
Agency for Health Care Research and Quality should be utilized as they
are viable models for data collection procedures.

And, again, the report stresses several times the discoverability issue.

So now back to Dr. Hendricks\' question, I think we could use some input
on, you know, what you think of the ideas in these recommendations, and
if you don\'t think that these are the things that necessarily need to
be looked at to improve performance are the things that you do think are
necessary to be looked at and collected to improve performance.

CHAIRPERSON HENDRICKS: We\'d also like to invite comment from the
patient advocacy representatives on the panel, from their perspective.

MS. PURA: It\'s interesting. We\'re going through this right now with
our primary care clinicians in attempting to get them to report tumor
size and axillary lymph node status, et cetera, and this is required by
the CDC for payment for our state program.

Just getting the reports are unbelievable. I mean there are various
routes one can go, but surgeons notoriously do not return this
information to primary care clinicians. I can\'t see how they\'ll even
return it to a radiology group, more or less our primary care clinicians
who may have some input into treatment.

I don\'t know where this information would be very valuable in a
radiology audit to see capabilities of the radiologists themselves in
practice. Hopefully they\'ll be identifying tumors. I don\'t know if
they need to get into axillary node and if they need to get into staging
and tumor size, et cetera. I don\'t see where that, in fact, has
anything to do with their quality of practice, and obtaining that
information may be very timely and very costly for them.

I\'d like to see how everybody else feels about that.

CHAIRPERSON HENDRICKS: Yes, Dr. Lee. Could you step forward to the
microphone, please, and reintroduce yourself to the group?

Thank you.

DR. LEE: I\'m Dr. Carol Lee. I\'m from Yale University, and I also
represent the American College of Radiology.

I respect your comments, but I disagree. I think it\'s very important
for radiologists to know the stage of the cancers that we detect because
we\'re only picking up large cancers that have already spread. We\'re
not doing a whole lot of good, and the goal for mammography and one of
the indications of quality is that we do detect small, treatable
cancers. So that is very important information. I agree completely with
the difficulty associated with the collection of that data and also, if
I may just make a comment about what I believe is some useful metrics,
what we want to know is the cancer detection rate, and we want to know
what our false negatives are, and right now the discoverability of the
false negatives is very difficult.

There are no well established, widespread mammography registries. Tumor
registries exist, but they are hard to access that information, and I
think these are all issues that can be hopefully addressed.

MS. PURA: Again, I agree with Dr. Lee in evaluating size and so on, and
it\'s very important to know, but finding that information has become a
real difficult problem, and I am very concerned. The information is
absolutely important to the diagnosis, and the ability of the
radiologist, but I am concerned about them getting that information, and
will that, again, cause the access to radiology to go down because of
another stringent regulation on them.

DR. BARR: I think one thing the Institute of Medicine is trying to get
to here is that the way the audit is now it\'s fairly basic. You know,
you need to do an audit, and we go in at inspection time, and ask you if
you\'ve done the audit, and that\'s about it.

Do you think that in regulation there should be more requirements for
what the FDA looks at as far as what\'s been done for the audit? And
should that information just stay at the facility? You know, what should
be done with it other than the inspector seeing that it has been done?
Do you think there should be citations for people who don\'t do these
things?

I think that\'s what they\'re trying to get at, is the audit is pretty
basic, right now what FDA requires, and is there anything else that you
think is vitally useful in that arena.

CHAIRPERSON HENDRICKS: That\'s a good background. I think the way to
think of this is what\'s happening across health care. Certainly
hospital based health care in the United States is the creation of these
report cards for hospitals. They don\'t like them, but they\'re
certainly out there and maybe even before their time, but I think we
should think about we know \-- we can recognize good quality mammography
facilities and poor ones or maybe ones which don\'t have as high
quality. So we have to think about what would be on a report card and
how they can be evaluated without, you know, basically shutting them
down by creating some onerous regulations.

But yet we know that we need to be able to evaluate them and compare
them to one another. So what would be on a mammography report card to
identify an A-plus facility compared to a facility that is marginal or
offering poor quality imaging?

Dr. Monticciolo.

DR. MONTICCIOLO: I guess I\'ll just make a comment. I realize that the
auditing right now is under a lot of scrutiny. It\'s hard for me as a
practicing mammographer to think that adding these additional burdens is
going to improve interpretation because I don\'t see any evidence that
ultimate patient outcomes are affected.

I think what we\'re doing now is we\'re trying to look at certain
benchmarks in our practices to see how we compared to each other in a
certain practice setting, and those are somewhat useful, but the extent
of auditing here is going to be tremendously cumbersome, and I\'m not so
certain that it\'s going to affect the interpretative ability of the
physicians involved.

And so I\'m not convinced that there\'s evidence of that, and that\'s
why I\'m not a big fan of adding more and more layers to how much we
collect and look at. There\'s only so many hours in the day and already
my colleagues who are not trained in breast imaging, they usually follow
my lead, and so whatever mistakes I\'m making, I guess, are being
multiplied, but you know, usually I\'ll set the standard, and I\'ve
pushed the standard up for people who are just kind of doing other
things and doing a little bit of mammography, but you know, I look at
this and say, \"Well, if we add more and more layers, I think more and
more people will just drop out.\"

And the people who want to do a good job, I think, are personally driven
to do that, not that they shouldn\'t be looked at, but over scrutinizing
them and collecting more data I don\'t think is going to change their
interpretation tremendously.

And I agree with Linda\'s comments about tumor staging. These things are
important, but to acquire that data and to really try to dig this up and
put out reports every year on it is further going to diminish the desire
of people to enter the field.

So I\'m very concerned about that. So unless something is really proven
to improve the interpretive ability of physicians, I\'m not in favor of
just laying it on and hope that it would help.

CHAIRPERSON HENDRICKS: Yes, Ms. Holland.

MS. HOLLAND: Jackie Holland from Ohio.

I\'d like to know if anyone can tell me what the rationale was in the
first place for the FDA to verify that it had been done but not
collected. I don\'t understand why they were even verifying it if
nothing was going to happen and if it didn\'t really affect the
inspection.

DR. FINDER: It\'s Dr. Finder.

The rationale behind it was that this information which hadn\'t been
required of facilities in the past was to be used by the facility. In
fact, we do have regulations that talk about the audit interpreting
physician who oversees this process, and part of their responsibility is
to get back to the individual physicians involved in this audit with
their results and talk it over with them.

But we did not in regulation specify what actions were to be taken or
what were the benchmarks or what analysis was to be done. It was
supposed to be an educational activity for the facility to improve on
their own without getting into the specifics and telling them how and
what they had to do.

And the recommendation from IOM is to get a little bit more specific in
terms of what they should be doing. My understanding at least on the
simple audit, the general audit would be that there wouldn\'t be much
other change. We wouldn\'t collect this data for a national database. It
still would remain within the facility, but it would be more
standardized for them within that facility to look at their own data.

I will tell you some of the arguments that were brought up at the
original time when we were talking about audits and why we didn\'t ask
for specifics at that time were that any statistical data that you might
obtain is highly dependent on a number of factors, including volume, and
one of the worries that was brought up at that point was that you might
have a low volume reader whose numbers could be bouncing around all over
the place, and it wouldn\'t mean that there\'s any real change. It\'s
just the statistical variation that occurred.

Another was the business and discussion of what constituted screening
and diagnostic because the baseline benchmarks for those two groups are
different. Populations are different. You know, if you\'re dealing with
one population group versus another, the incidence of cancer can be
significantly different in those, and trying to compare over the country
certainly would cause problems, although again by trying to limit it to
just a single facility, we were hoping to kind of minimize that
variation because everybody reading at that facility presumably would be
looking at the same population.

So that\'s the history.

DR. BARR: And, Ms. Holland, this is Dr. Barr.

I don\'t really think that if you don\'t do the audit you don\'t get
cited. If there\'s no evidence that you can provide to the inspector at
all that an audit takes place, then you can get a citation for that, but
there are no specific elements other than that it has to be divided up
by physician, and we\'re asking if you all think there are any other
specific elements that should be in the audit that the inspector would
specifically take a look at to see if its\' there.

I don\'t want you to think you can just totally not blow it off and not
have some consequence. You can get a citation, but other than that,
there are not a lot of specifics in it, and I think that\'s what the IOM
is trying to get to.

DR. FERGUSON: I\'d like to say I agree with the other two panel members
that I think this would be a burden that we don\'t need, that will not
help the interpretive skills of the physician, which looking back,
that\'s what they wanted to know. How can we help with mammography
interpretations?

And I\'ll say the audit \-- I\'m thinking back when I first started
doing my audit is when it was required, and it has helped me personally
to look at my numbers and to hopefully improve every year and see what I
missed and go back and see what I missed and why I missed it, and it has
helped me improve in my interpretation.

So I think that the audit that we have \-- and I was surprised, like she
says. Why did we have an audit and it didn\'t go anywhere? It has helped
me personally as an interpreting physician. And should it go any
further? I don\'t know.

MS. PURA: Have there been any benchmarks that have been offered by
either ACR or by BIO of IOM for this particular categories in various
staging? Has anything come out, Dr. Finder, that you know of?

DR. FINDER: In terms of benchmarks, there have been a number of
publications that talk about various benchmarks for screening for
diagnostic and for mixed facilities. Dr. Sickles has done an article and
talked about various benchmarks.

Even before MQSA, there was a publication by the AHCPR, which is now
AHRQ; a study done by the federal government, a nongovernmental agency
of the federal government, whatever that means, published some benchmark
guidelines that can be used by facilities.

So, yes, there is information out there where you can kind of compare
yourself against some kind of national standard, but it doesn\'t really
take into account the variation that can occur in an individual
facility, and if a facility wants to look at that data and compare
itself to it, it\'s truly on an educational basis, whereas if it was
mandated that there be some benchmark, then that\'s a whole different
story.

But there are numbers that facilities can look at.

DR. BARR: Okay. So I think in summary what I\'m hearing then is that we
should continue at inspection to look that an audit has been done, that
it should be by individual physician, but that we should allow
facilities who can and want to to combine audit data across centers to
look at larger numbers.

That\'s what I\'m hearing so far, and we\'ll go on to the \-- there\'s a
little more in this advanced audit piece.

Recommendation 3 is to designate specialized breast imaging centers of
excellence. The first part under that in the report is that these
centers will participate in basic and advanced medical audits and test
approaches to improve quality and effectiveness. They would test effects
of high volume, double reading, quality assurance, patient reminders.
They would develop and evaluate interpretive skills assessment exams.

The rationale behind these recommendations was stated that several
countries have integrated centralized breast cancer screening programs,
but in the U.S. screening is decentralized and offered in diverse
practice settings.

These excellence centers could provide multi-disciplinary training and
work environments for diagnosis, could increase job satisfaction,
retention of practitioners\' productivity, and quality of the breast
care team.

High quality facilities could attract high quality personnel. Incentives
for becoming one of these centers of excellence would be similar to what
was stated previously: high reimbursement rates, and could be used to
recruit patients and referrals. I guess you would be allowed to put out
that you\'re one of these centers of excellence.

Rationale that supportive elements and incentives are critical to
encouraging facilities and personnel to strive for higher quality. These
centers should serve as training centers for breast imaging and regional
mammogram readers. The centers would have the expertise to develop and
host training programs in imaging.

Interpretation at centralized facilities could help alleviate access in
low volume areas. The centers should be linked with facilities that
provide comprehensive and multi-disciplinary breast care. The rationale
is that imaging based centers need continuity with facilities providing
non-imaging breast care treatment and follow-up.

And so any comments on these breast imaging centers of excellence?

CHAIRPERSON HENDRICKS: I\'ll start out with a comment. I just wonder,
Dr. Barr, in your opinion and with your familiarity of mammography
facilities in the United States, which centers do you think are already
meeting these criteria, if any, or how many?

DR. BARR: Well, I think that gets back to like a score card like you
said or a report card of facilities, and you know, various states have
tried to market facilities as being, you know, in the upper echelon or
in different strata and, you know, have found huge problems with doing
that.

The best that I can tell you from our data is that 70 percent of the
mammography facilities in the country practice quality mammography as
defined by MQSA, and you know, that\'s the best I can tell you right
now.

DR. MARTIN: Dr. Hendricks.

CHAIRPERSON HENDRICKS: Yes.

DR. MARTIN: Melissa Martin.

As a consulting physicist, I see what I\'ve usually referred to as the
good, the really good, and then the ones that barely meet the criteria,
and I would just highly encourage us to or encourage the FDA to pursue
this idea because there is definitely a vast difference in the quality
of care out there, and I think we do need to encourage this development
and designation for those centers that are doing upper level quality
care.

And if you ask me, I would say, well, we currently cover around 300
facilities, and I would say probably 100 of them definitely meet it
already, but they are definitely doing more, personnel-wise, skill-wise,
education-wise, than the local stand alone unit that does screening
only, and I think we need to differentiate what those facilities are
doing.

DR. BARR: And, Ms. Martin, would you put that information out publicly
and for patients that didn\'t have access to such a facility, what would
you tell them?

DR. MARTIN: To encourage them to get access to that level facility.

DR. BARR: Even though such a facility that you\'re describing might not
be available to them.

DR. MARTIN: Well, I function in a very crowded area, and I find it very
frustrating sometimes that we have the equivalent of a center for
excellence, and three blocks down the road we have a minimally qualified
facility that is still in practice and getting paid the same as the
facility that\'s a center for excellence.

DR. BARR: And at one time we say under MQSA, you know, we\'re talking
about standards across the board so that any facility who meets them,
you know, meets the criteria.

CHAIRPERSON HENDRICKS: Another question might be if we propose to the
mammography centers of the United States whether they wanted that
designation, how many would voluntarily want to undergo the steps that
it would take. What is your feeling on that?

Because we\'ve heard that the current basic, you know, bare minimum
audit is burdensome. So do you see that there would ever be any desire
for even the excellence centers to get this designation?

DR. BARR: You know, I think a lot of it depends on what a lot of people
have already said in how much money would be available to centers, how
the reimbursement would be affected by, you know, if you could receive
higher reimbursement for doing this, if Congress is going to give money
for doing this.

But like a lot of things, I think people might be loath to do these
requirements because they don\'t have the money or the manpower to do
it.

I also worry about, you know, the woman in rural North Dakota who
doesn\'t have access to what people \-- I don\'t even think we have the
criteria for what one of these centers of excellence is, but I also
worry what we tell the people who, you know, don\'t have \-- if
facilities become these centers of excellence, how do you get access to
them?

You know, perhaps as the digital age gets more advanced, that problem
might be decreased, but right now I do worry about what we would tell
patients who would say, \"Well, does that mean the center I go to isn\'t
good enough?\"

You know, MQSA, there\'s a certificate on the wall. My center has had no
violations that I\'m aware of. You know, does that mean I\'m not getting
good care, that I\'ve got to get on a plane and fly somewhere to go to
one of these centers of excellence?

CHAIRPERSON HENDRICKS: Yes.

DR. WILLIAMS: This is Dr. Williams.

With respect to the question of being able to afford establishing
centers of excellence, I know that many academic institutions have lots
of centers of excellence, cardiac centers of excellence, digestive
centers of excellence, and many of these programs have been to a certain
degree underwritten by grants from the NIH.

And one of the things that would be worth considering is whether some of
the funding, whether it\'s NCI or someone else, would be interested in
putting out specifically RFAs for establishing these centers and with
perhaps the express statement that there would be funding written into
the budgets for assisting access to these centers for women who are not
located necessarily right next to them.

DR. BARR: Yeah, I think that\'s an excellent comment. Thank you.

One thing I\'d just like to point out is as far as I know most of those
other kind of centers of excellence, you\'re not talking about a
screening modality, and I think that that, you know, plays a role here.

Yes, Dr. Ferguson.

DR. FERGUSON: I agree that a designation of a center of excellence will
cause burdens in more rural areas like mine. Women will say, \"Well, I
have to seek this facility,\" and facilities who are doing good quality
work will dry up and you will lose access.

Like Dr. Williams says, I think incentives are an excellent idea for
people to try to attain this, and the incentives in the form of grants
or increased reimbursement for facilities who meet these criteria are
excellent ideas, but to go out and designate them, still continue to pay
everybody the same and say one is better because they provide training
and multi-specialty facilities, I think, would ultimately harm access to
quality care that is out there.

CHAIRPERSON HENDRICKS: If I could interject before we go to Linda who
had a comment, a lot of the members of this panel don\'t have to deal
with payers, but the way that the big payers in this community are
headed, I think as this whole idea of pay for performance.

I think every big insurance carrier in the United States is very much
interested in reimbursement and lowering reimbursements for some
services, but increasing reimbursements for what they\'re certain is
high quality medical performance. So that\'s a little bit of a circular
argument because if we go to the payers to ask for support and increase
reimbursement for a breast center of excellence or even a center that
has met all of the criteria for our audit, we have to go to them with
some metric to demonstrate that, in fact, we should be paid for
excellent performance.

Linda, you had a comment?

MS. PURA: There\'s pros and cons, of course, for the centers of
excellence, but in the milieu that I live in and work in, the women that
we see, if we can have and be so blunt to say a one shop stop that has
many, many procedures that are offered and women don\'t have to come
back, that eases some of the access to going to various and sundry
places to get the procedures that they need.

I would, of course, want to see that a center of excellence does take
the Medicaid patients. That\'s another major problem that we are finding
now, is that centers are refusing to take, as I say, our women, and so
that would be, if I was looking at a facility, that would be something
that I would want to see.

However, I don\'t know if we have any impact on the federal
reimbursement for Medicaid at all.

CHAIRPERSON HENDRICKS: We have time maybe for one more brief comment on
this topic before you break for lunch.

DR. BARR: That sounds good. I\'d like to point out here that I think one
thing that IOM is saying in these centers of excellence is, you know,
not only would it be a designation that patients could use, but that
these centers would be the ones that would test out the different things
that are now on the table that might improve quality: the high volume,
the double reading, different things like that; that these centers would
sort of be our researchers, as it were, into what things might improve
quality.

CHAIRPERSON HENDRICKS: Yes, from the audience, the final comment before
lunch. Please introduce yourself.

DR. SHOPE: Yes. I\'m Tom Shope. I\'m with the CDRH.

I\'m not directly involved in the mammography program in great detail,
but it seems to me like it\'s worthwhile making one comment here, and
that is the discussion of this Institute of Medicine report is the
report was made to Congress. It was a report about the national
mammography situation and what Congress ought to do in order to improve
mammography, and so it\'s not a directive to FDA to do all of these
things.

And so I just wanted to say when it talked about a voluntary additional
medical audit kind of thing, the first word there was voluntary. I mean,
that seems to have gotten lost in the conversation here, that they were
suggesting there be some mechanism set up to perhaps provide some
recommendations as to what a good quality audit might look like in a
facility and some way to encourage facilities to implement these things.

I don\'t think there was any requirement that FDA make this mandatory,
and the same thing here with the imaging centers of excellence. It
sounds to me like a recommendation to Congress from the IOM that
Congress consider how could we foster the establishment of these kinds
of \-- and I see them as research facilities \-- to look at the effects
of the various things that one might do to improve mammography, not
necessarily that FDA would require all of the facilities to do these
things or that we would set up criteria for when you qualify to be one.

I think what Congress was doing is saying we need to have some ways to
encourage the establishment of these things. The IOM was saying to
Congress that which might, of course, get into the issue of who would
fund them, how would they be established, all the research activities
that need to go on.

So I don\'t think it was a message that FDA necessarily needed to do.
Pardon my butting in, but I think it seemed like there was something he
had missed here.

CHAIRPERSON HENDRICKS: I appreciate that comment.

And with that, I think we\'ll take a break, and then, of course, we\'ll
be resuming this same discussion and working our way through the
document after a one hour lunch break.

We\'ll return then in one hour and 15 minutes. We\'ll reconvene at one
o\'clock.

(Whereupon, at 11:47 a.m., the meeting was recessed for lunch, to
reconvene at 1:00 p.m., the same day.)

[AFTERNOON SESSION]{.underline}

(1:04 p.m.)

CHAIRPERSON HENDRICKS: I want to call to order the afternoon session.

We\'re going to resume the discussion that we held this morning with Dr.
Helen Barr helping guide us through a discussion of the Institute of
Medicine recommendation beginning with Recommendation No. 4.

DR. BARR: Thank you and welcome back.

Before I go on to Recommendation No. 4, I just wanted to make a very
brief comment about Dr. Shope\'s comment from the audience which we
ended with when we broke, and you know, he\'s perfectly correct. This is
a recommendation to Congress. I was actually going to talk about that a
little bit later when it becomes abundantly clear that it\'s not FDA;
that it would take, you know, a multitude of HHS and other agencies and
other venues to institute some of these things if they were to be.

However, with that being said, Congress will definitely be looking to
FDA, especially on the regulation part. You k now, I think the biggest
danger we all feel is that Congress will expect these things to be done
without appropriate monies, incentives, et cetera, along with it.

Recommendation No. 4 under the section we\'ve been working on is to
study the effectiveness of continuing medical education, reader volume,
double reading, and computer aided detection.

First, the recommendation is to demonstrate the value of CME for
improving interpretive skills. The report cites the rationale as this
would enable interpreting physicians to identify weaknesses and take
steps to improve interpretive performance. We could continue to develop
innovative teaching interventions to improve interpretive skills.

Anybody want to make any comment on demonstrating the value of CME for
improving interpretive skills?

I think this is particularly important because at the time of the last
reauthorization we almost had in the reauthorization, but didn\'t get a
proposal that was on the table to make five of the 15 CMEs for
physicians that we currently require into self-assessment type CMEs.

And I think it didn\'t go on the table because people raised the
question that we didn\'t really know the value of CME in improving
mammography interpretation. So I think this is an important area for
comment.

DR. MONTICCIOLO: Can I make a comment?

I just wanted to point out that I think it is an important area, and I
don\'t know that we\'ll need to address it because the American College
of Radiology and the American Board of Radiology are heading toward the
maintenance of certification to allow people to keep their licenses, and
part of that will be a requirement to have self-assessment modules. So
we\'ll have to have two every year over the ten years of practice.

So already that\'s going to be mandated to keep your radiology license.
I think that will be taken care of with that.

It\'s not directed specifically at mammography.

DR. BARR: Do you mean for your board certification?

DR. MONTICCIOLO: That\'s correct.

DR. BARR: Yeah.

DR. MONTICCIOLO: And so I think even if people that have unlimited
certificates will probably end up adhering to that program just because
of reimbursements, et cetera.

DR. FINDER: This is Dr. Finder.

I want to bring up that point later because we actually have a
discussion point in our guidance that we\'re going to try and discuss
this issue about expiring board certificates. So that is an important
issue that we will hopefully not forget about later.

DR. BARR: Thank you.

The next recommendation is to determine the effects of reader volume on
interpretive accuracy, the rationale being currently there\'s
insufficient evidence to recommend an increase in minimum interpretive
volume. No basis for specifying a higher level of reader volume, and
again, I think an important area to comment on, particularly when our
charge is to put things into effect that wouldn\'t affect access.

So we appreciate your input.

DR. FERGUSON: I would agree that I think the number is sufficient at
this time in order to insure access. There are physicians who don\'t
read as many as others, that do a very good job, and you know, 400 and
whatever it is a year I think is sufficient.

DR. BARR: Recommendation C is to look at the impact of double reading in
CAD on interpretive performance over time in different practice settings
and at different levels of experience.

Rationale here is cited as a second look by another reader or computer
program not verified by prospective clinical trials, and effects on
specificity are not fully understood.

CAD programs are being refined. So effective use could change over time.
Studies use \-- and I guess give us studies needed on effectiveness
findings could help us use the information more effectively. Studies
need to confirm, if consensus, double reading may be most effective.

Here we go again.

CHAIRPERSON HENDRICKS: Comments from the audience?

DR. BARR: In other words, I think that IOM is suggesting that there\'s
important things that may go into interpretation, but we don\'t have
enough information yet.

CHAIRPERSON HENDRICKS: We have a comment from an audience member. Please
identify yourself.

MS. WILCOX: Pam Wilcox, ACR.

These recommendations for studies seem very important to impacting
ongoing quality and knowing what tools we need, but there doesn\'t seem
to be any way of addressing the funding for these studies or where
they\'re going to come from in the IOM report.

Has FDA had an opportunity to think about that or look for opportunities
for funding for any of this, or is that what you\'re seeking from your
committee?

DR. BARR: As we mentioned before, you know, these are recommendations to
Congress, and hopefully Congress will be addressing where funding for
these types of things would come from.

MS. WILCOX: So are you sort of seeking input from this community to
point which ones you really want to push to Congress to get funded for
studies?

DR. BARR: Yeah, I think we\'re seeking input of which of these things,
you know, do we think might affect interpretive skills, if any, and are
they worth studying. Do we have enough information now on any of them to
require them? You know, do we need to study them?

I think the funding questions are obviously right up there on
everybody\'s mind.

Thanks, Pam.

Anybody have any comments on the funding issues or if any of these are
worth studying? I mean, it certainly seems that before we get something
in regulation, it\'s my understanding from people that we would like to
have data that shows that any regulations that we get are worthwhile
having and are on point to the task at hand of improving interpretative
skills.

MS. MOUNT: Carol Mount.

From what we have evaluated at our institution, I think that the CAD
program would be something that would be definitely worth pursuing. We
have run our own study and found that it did increase the early
detection rate by having the CAD.

DR. BARR: Thank you. That\'s good information to know.

If anybody else has experience with CAD that they\'d like to share.

Charlie, do you have any?

DR. FINDER: Dr. Finder.

I just wanted to point out a couple of things in terms of the past
history. It\'s interesting to note that as Dr. Barr mentioned earlier,
some of these items that IOM looked at were issues that were brought
before earlier versions of this committee in terms of possibly
implementing these as regulation, the idea of making some of the CME and
interpretive skills type CME. Raising the number of mammograms read over
a period of time has certainly come up many times. The issue of double
reading has been discussed many times, and certainly CAD is one of
those, and it\'s just interesting that the IOM when looking upon this
didn\'t feel that there was enough evidence at this point to actually
make any recommendations to FDA to actually implement any of these
things.

My question to the people here is: what type of evidence do you think
would be useful for somebody in the future to decide whether these were
actually useful things to implement or not? Does anybody have any idea
of what type of research, what type of study could be done, not
necessarily that FDA would do it? As has been pointed out, this is an
issue that Congress is going to hopefully eventually decide will be
looked at by somebody, but not necessarily FDA.

DR. WILLIAMS: This is Dr. Williams.

On the topic of CAD, I think probably quite a number of groups would
agree that that\'s something that kind of needs to be looked into and is
being looked into, and it shows a lot of promise.

I think there has on the topic of funding, there have been a number
through the years of very well funded basic studies on the effect of
CAD, and what it sounds like we\'re talking about now is a fairly large
multi-center trial that would evaluate the effectiveness of CAD across a
variety of different types of institutions, and the thing that springs
to my mind there as one possibility would be Akron.

Akron, as you know, one of its charters is to evaluate the early
efficacy of diagnostic tools, and now having the DMIST trial just
wrapped up or not wrapped up, but the first results now out, that might
be a reasonable thing to think of for the future.

DR. BARR: Thank you.

I think those are on-point comments, and I think these things are also
going to lead into people now, for example, CDC and its breast and
cervical cancer program, you know, paying for CAD or continuing to pay
for CAD or increasing paying for CAD, you know, paying for digital
mammography in their program.

So a lot of these things are, I think, important issues. Okay. So I
guess what I\'m basically hearing on this part is that we don\'t have
anything specific. No one is coming forward and saying, yes, X, Y and Z
are the things that we know improve a radiologist\'s interpretation, but
rather there are a number of areas such as reader volume and computer
aided detection that we need to continue to study.

I think the Chair can recognize a speaker from the audience. Before we
get too far from audit, I had someone approach me who might be able to
shed some more light on audits and mammography situations. So if the
Chair might recognize, welcome and introduce yourself.

MS. MYERS: Hi. My name is Susanne Myers, and I\'m the Senior Vice
President of Mammologics. We have been in business for about ten years
now, and we assist mammography facilities with auditing, patient
tracking, the notification letters, and the reminder letters, and I
really just wanted to mention one of the things that we do in the
auditing process, and this goes back to the discussion about screening
versus diagnostic, which is really asymptomatic versus symptomatic, is
we feel it\'s very important to make that distinction because in order
for you to really understand your practice and really understand the
audit data, you have to know the mix of your patients, and that will
assist you down the line, and when you\'re looking at your data to kind
of get an idea of what the numbers mean.

We currently have about four million breast imaging procedures in our
database and we\'ve been assisting mammography facilities with
compliance issues. One of the things that I just want to point out is
that a lot of mammography facilities really want to do a better job, but
I think there\'s a lack of information out there for them to do a better
job, and I think from a guidance standpoint, I think we could really
help with coming out with some guidelines as far as the auditing
requirements. I think we could really make a difference in the quality
of the mammography services that we are rendering at this time.

And that\'s really all I wanted to say.

DR. BARR: I thought one thing that you said to me was interesting, that
you have facilities that do 1,800 mammograms. You have facilities that
do 18,000 mammograms, but yet you can, you feel, provide them with
significant audit data that can be used in ways.

MS. MYERS: One of the things that we kind of help our clients with is to
look at their data over time, and a lot of our clients that really are
interested in doing a better job, they have implemented quality
improvement programs when they actually use the data on an ongoing basis
to monitor what\'s going on in their practice.

So when you\'re looking at desirable goals, and that came up before as
well, is there desirable goals that facilities should be striving for,
and obviously it depends. It depends on your patient mix. It depends on
how many radiologists you have, how many facilities that you\'re
servicing. So all of these things need to be taken into consideration.

DR. BARR: Thank you. Appreciate the comments.

MS. MYERS: You\'re welcome.

DR. MARTIN: Dr. Barr, I know several of us \-- I get involved with
several facilities when they say \"help with the audit,\" and I think
one of the frustrations on the facilities end of things has been as you
have said. At this point the audit has been very wide open. As long as
they, quote, performed an audit, it wasn\'t really specified what was in
it, and I do think that would be a recommendation if some form were at
least a minimum of what information was required for the facilities to
have in their audit, but again, I think we need to figure out how we\'re
going to specify, if at all, what we do with the data when we get it,
and that\'s what the radiologists on the panel, I think, have been
saying.

Benchmarks are going to be totally dependent obviously on the patient
population that you work with, and at least the feedback I\'m getting
from most of the facilities is they\'re very antsy about having that
number, the magic number set unless we have very clear standards and
databases to go with, and frankly, obviously, that\'s not the physicist
role. So we\'re not a lot of input just because of the math, and
sometimes the facilities want help with it.

(Laughter.)

DR. MARTIN: So I\'m looking for input, and anything that you can help us
establish those standards or as the committee establishes those
standards, it would be welcome information, I think, to most of the
facilities if someone decides what is a minimum set of criteria that
they have to have ready for an inspector.

DR. BARR: Thank you, and certainly, you know, we brought that up for
discussion, and I directly asked, you know, what should be in the audit,
what should the inspectors look at, and the only thing that I heard that
there seemed to be a general consensus on was to allow combining of
facilities\' information to look at larger aggregate data.

Thank you.

Okay. Now a huge section that we\'re going to be dealing with and it\'s,
again, a lot of information, and this one is going to be particularly
tricky because we\'re going to be dealing with recommendations for added
wording to the regulations, deleted wording from the regulations. So see
if we can work our way through this.

The next section of the four big recommendations that I talked about at
the beginning that IOM made falls into the section of revising MQSA
regulations, inspection procedures, and enforcement.

Our Recommendations 5 and 6 that fall under this category is to modify
the regulations to clarify intent and to address current technology; to
modify inspections by streamlining processes, reducing redundancy, and
addressing current technology; and to strengthen enforcement for patient
protection.

So we\'ll start with the Recommendation No. 5, modify regulations to
clarify intent and address the current technology.

What IOM recommends in general are the following, and then we\'ll be
marching through specific regulations. I want us to remove the exemption
for stereotactic breast biopsy procedures and develop regulations, and I
believe \-- correct me if I\'m wrong, Dr. Finder \-- that tomorrow
we\'re going to have a more specific and dedicated conversation on this.
So probably just generally skip over this particular point today because
we have some speakers also on this issue for tomorrow.

To develop regulations for digital mammography; to update assessment
categories to reflect BI-RADS, including the known biopsy proven
malignancy; to establish luminance standards for viewing mammograms; to
eliminate modality specific CME.

As we march through this specific regulatory text, IOM\'s recommendation
to added text to the regulations will be in these kind of parentheses
and green print, and their recommendations to delete text from the
regulations will be the parens that look like greater and less than, and
in the kind of peachy-orangy print.

As I said, we\'ll skip over the stereotactic discussion until tomorrow.

Develop regulations for digital mammography. Should develop a uniform
set of quality control tests and test criteria. This should not preclude
performance of additional tests recommended by the equipment
manufacturer, and to update assessment categories to reflect BI-RADS.

So this is our Section 900.12 in the regs. The overall final assessment
of findings classified in one of the following categories, and you see
the \--

DR. FINDER: Dr. Barr.

DR. BARR: Yes.

DR. FINDER: Can we go back?

DR. BARR: Sure.

DR. FINDER: On the develop regulations for digital and just start on
that one.

DR. BARR: Oh, I\'m sorry. Yeah. I didn\'t realize we didn\'t have
anything specific read comments on that because we don\'t have any.

Yeah, Charlie. Could you go into where we stand now on the \--

DR. FINDER: Right. Let me try and give a little bit of the history
behind the current regulations, how we got here.

Basically, the regulations were developed before full field digital
mammography, any of the units were actually approved for commercial use.
So in order to address something that we really didn\'t know what was
going to happen, we put in a regulation that said that when these new
mammographic modalities come into existence, facilities would be
required to follow the manufacturer\'s recommended quality control, and
that\'s where it stood in 1997 through \'99 when the regs. went into
effect, and the first unit, I believe, was approved in 2000, early 2000.

Since that time facilities that have been using approved digital units
have been following the manufacturer\'s QC manuals. Each manufacturer,
because of their different technologies, has a slightly different or
sometimes not only slightly, but more than slightly different quality
control set of procedures.

And I think what IOM was suggesting is that a uniform set of quality
control procedures be developed, and that they be implemented through
regulation once they are, and I know that various groups are working on
developing a unified quality control procedure. The American College of
Radiology, amongst them, has been working to develop this. I believe
that there may be some information from the Akron trial, the DMIST trial
that could be a benefit in the future, and I think that the goal of
trying to standardize these processes is one that FDA is certainly
looking forward to. It would make everybody\'s life easier if it was one
set of procedures that the facility, the inspector, the medical
physicist would follow.

So I guess part of the issue that this committee can discuss is some of
the difficulties and the different technologies that are involved, and
if anybody has any idea now what we might do to encourage a development
of a uniform quality control set of procedures.

And I look toward the physicists specifically because they\'re good at
math.

(Laughter.)

DR. WILLIAMS: Yeah, this is Mark Williams.

Well, first of all, I agree 100 percent that things may be a little bit
different now than they were in the days when full field systems first
arrived. We have more data. The DMIST trial was certainly a good source
of data because most of the major FFDM manufacturers were involved in
that trial. There were systems from one of them.

So we have data for a large number of different types.

Having said that, I think the point that Dr. Finder raised right at the
end is also relevant, which is that we\'ll have to be careful when we
set up these unified guidelines to take into account the fact that of
the five different FFDM manufacturers involved, there were five very
different technologies involved.

Now, there have been several papers that have been published recently
that actually did sort of a systematic analysis that compared the
quality control guidance that right now, as Dr. Finder said, is really
the MQSA regulations, follow what the manufacturer says. And those
papers unanimously demonstrated that right now there is a huge disparity
in not only the details of the tests that are recommended, but also in
the actual types of tests that are recommended, with in some cases very
few detector specific tests, and in many cases the tests that are being
recommended, and this is a very logical and understandable thing, are
modeled very closely after the existing guidelines for screen film.

So I think that with that in mind, there\'s certainly a clear call for
some sort of a unified approach to quality control for FFDM. I think we
have now, well, we\'re in the process of getting some solid data to
establish what tests are relevant and what aren\'t, and I think the
DMIST trial actually identified several tests that probably are not as
relevant as they might be and, therefore, could be dropped to simplify
the FFDM quality control procedures.

And so I guess in my opinion there\'s clearly a very strong motivation
to do this, and I think that there\'s no doubt that this is the time to
push forward on it.

CHAIRPERSON HENDRICKS: A comment from the audience? Please identify
yourself.

MS. BUTLER: Hi. I\'m Priscilla Butler with the American College of
Radiology.

One of the things Mark had been referring to is an ongoing project at
ACR to develop a quality control manual for full field digital. This is
under the chairmanship of Martin Yaffe in Toronto, who\'s not subject to
the MQSA regulations right now, but there are a lot of people on the
committee who are.

One of the things that I think from the DMIST trial we\'ve learned a lot
of information about quality control. The DMIST trial was a research
study. All of the facilities were very tightly controlled in terms of
the QC that was done there and the attention that was paid to the
performance of the equipment.

Martin and his group has taken it one step further to try to come up
with a system that is going to be applicable not only to research sites,
but also to university, to small community centers that maybe begin
doing teleradiology.

So currently we have the technologist section of the manual in a
semi-draft form. It\'s going through as we speak pilot testing, right,
Mark?

DR. WILLIAMS: Right.

MS. BUTLER: Right. Okay. And we hope to make some changes to it from the
feedback that we get. So that\'s where we are right now.

Oh, yeah, and once we come out with something, we\'re going to have to
come to this group for an alternative standard to see if it can be
implemented under the regs.

PARTICIPANT: (Speaking from an unmiked location.)

MS. BUTLER: It is in draft form, and we are going to be pilot testing
it.

DR. BARR: Thank you.

So do we wait for that kind of thing to come out or, Dr. Williams, as
you indicate, is there enough information right now to write specific
regulations related to digital?

Also, I would like to add in this I think that one thing we\'ve learned
from our experience with MQSA is that equipment is, anymore in this day
and age, is really not where the problems in mammography lie, and we
wrote a whole bunch of equipment regulations.

And is that how we also want to go with digital or do we want to learn
from our experience that equipment is probably not where most of the
issues lie?

DR. WILLIAMS: Well, I think that to answer your first comment, I think
that we\'re probably not in a position at this moment in time to say
these should be the regulations for FFDM. I think we\'re getting there,
and I think that once we do some actual in the clinic evaluation of
these draft protocols that Penny mentioned, we\'ll have a lot better
idea.

Because they were called to a large degree from a kind of a super set of
the procedures suggested by the manufacturers. That\'s sort of how DMIST
was put together. Everything that was really possible was really done.

And so part of the process that\'s going on right now is identifying the
minimum useful set, if you will. We don\'t want this to be a big and
burdensome set of QC procedures simply because it\'s going to be applied
across the boards.

So I think that probably we should let the ACR subcommittee do a little
bit more work. That would be, I think, well worth the wait.

DR. BARR: Thank you.

MS. MOUNT: Carol Mount. I\'m just hoping that when these regulations are
written, it is taken into consideration the down time for the room to
perform the procedure. Currently we have one digital unit and 11 film
screen units in our institution, and the digital unit requires so much
more down time to do the QC on than the other rooms, and that\'s time
they\'re not doing a patient.

DR. BARR: Thank you.

DR. MARTIN: Melissa Martin.

I would just reiterate what Mark Williams has been saying and Penny. The
ACR group has put a lot of work into this already as far as trying to
develop a cohesive set of requirements that we would recommend at that
point to be included particularly for the physicist test and the
technologist test.

I hesitate to have the FDA start or recommend that you start developing
a different set at this point. I really would encourage us to wait until
the ACR program gets out because that\'s the group that\'s been working
on this, and the accreditation program is fairly advanced at this point
rather than starting another set of criteria.

DR. BARR: Thank you.

DR. WILLIAMS: Just to comment on the issue of the down time for the
digital rooms, that\'s probably true at the moment, and part of that has
to do with the, I guess, unwieldiness of what it is we\'re all trying to
do when we\'re in there doing these tests.

One of the things that, of course, we all hope is going to be a benefit
of digital, in addition to its clinical value, is being able to
computerize many of the things that right now are done in maybe not the
most efficient way, and that might be another virtue of a standardized
set of tests, is that if these things could be essentially incorporated
up front into the FFDM systems, then it may actually decrease the down
time because there would be a well established set of analysis,
routines, for example, for doing the test, and we wouldn\'t be shuffling
the images back and forth from one place to another and getting them off
and doing off-line evaluations and so on.

So hopefully that will be one of the benefits that will accrue.

DR. BARR: All right. Thank you.

Those are very helpful comments. So what I\'m hearing, I think, today is
that FDA should continue to require the use of manufacturer\'s QC manual
and check that folks have their initial training in modality, and that
there is hopefully imminent information that will, although not today,
soon allow us to write a specific set of regulations of the necessary
elements for digital units.

DR. MARTIN: Can you clarify? I guess I\'m asking for a time frame
clarification. What will it entail? In other words, if this program were
released from ACR and implemented arbitrarily January 2006, which it\'s
not going to be ready, but say it\'s ready January 2006. What is the
time frame for FDA then to adopt that so that the facilities are not
caught in the requirement to have an ACR program and an FDA program?

Can you elaborate a little bit on how that\'s going to work?

DR. BARR: Yeah, I think Dr. Finder, who is our regulations expert can
probably help with those time frames.

DR. FINDER: Now, is that January 1st?

(Laughter.)

DR. MARTIN: Fifteenth.

DR. FINDER: Fifteenth. Okay. Well, assuming it comes out on the 15th and
it\'s not a weekend, there are two different aspects to it. One is the
issue that Ms. Butler brought up about an alternative standard. They
could submit something to us. We would review it as an alternative
standard. Those usually go through within a matter of weeks or months in
order to get those through the process.

And what that would allow, it would allow facilities to use that
standard instead of what the manufacturer recommended. If you\'re
talking about regulations such that this now would become the only de
facto standard, then you\'re talking about going through I notice a
common process that would probably go anywhere from 12 months to 18
months, probably more on the 18 months side, and would have to come
before this committee and go through a formal process.

The alternative standard process can be done within the division
because, as I had mentioned earlier in the morning session, we do have
the ability, the authority to grant alternatives if those qualifications
that I mentioned are met. And this might be one of those in which there
were sufficient data to show that this would improve quality, speed
things up, and could be approved through that process.

DR. BARR: Thank you.

For the physicists on the panel or Ms. Butler, anyone who wants to
comment, do you feel that if we get to these tests that we feel are
necessary, that the technology \-- how do I say this \-- will stay
stable enough for a while that these will be, you know, implementable,
or are we in such a flux right now that we\'re going to be looking at
approving alternative standards or changing regulations constantly to
accommodate digital?

DR. MARTIN: I think for all of us concerned we hope it\'s stable enough
that whatever is developed would be adaptable to any of the new
technologies that are coming on.

DR. BARR: Thank you.

DR. WILLIAMS: Yeah, I\'d say there\'s probably no good way to predict
what new technologies might arrive on the scene, but presumably this
would be sort of a self-equilibrating thing. If there were a set of well
established standards for performance, then in the FDA approval process
for the instrument, then hopefully some of these things would get ironed
out.

DR. BARR: And you think we could make this adaptable to the technology?

Penny, did you have?

MS. BUTLER: The group has been trying to write the tests general enough
to accommodate the different technologies that are out there now, and
there are going to have to be different specific procedures, which is
going to be specific for each manufacturer just because of the way the
equipment works.

Be that as it may, currently working with the manufacturers and their
own QC manuals, we\'ve gone through numbers of different revisions of
their QC manuals for the same model of equipment based on software and
everything else.

So I think it would be worthwhile once we hit the regulatory stage to
try to build in some creativity to allow for some changes as we go
along. Hopefully we\'ll learn more from the pilot testing that we\'re
doing now and we can provide some advice as a result of that.

Maybe some of the manufacturers might have some input.

DR. BARR: Great. Thank you very much.

CHAIRPERSON HENDRICKS: Another comment from the audience. Please
identify yourself.

DR. BARR: I was looking around for him.

DR. SANDRIK: John Sandrik, GE Health Care. We manufacture and sell
medical equipment.

I think the idea that this will be stable is wishful thinking. I know
certainly in our own equipment at least two developments that will
affect QCs under PMA submissions right now. There\'s been presentations
to this group. A couple of years ago Dr. Kopans was into the total
synthesis systems. Certainly that\'s going to induce a lot of entirely
new QC concerns, but essentially it\'s an outgrowth of a digital
mammography system.

I guess he agrees.

(Laughter.)

DR. SANDRIK: But I know as Penny has mentioned \-- we must have lost
him. Should I continue or do we need to have a quorum in place?

Well, anyway, as Penny brought up, we\'ve gone through several issues
with our QC manual. We have software changes,. We have hardware changes,
and we anticipate that those are going to continue.

I think one big difference between sort of the evolution of screen film
and digital is that the mammography community had ten to 15 years of
experience since green film before we even thought about setting down
regulations for how it should be quality tested and evaluated.

You\'ve had at most five years on one system and probably only one or
two years on some of the other systems, and there\'s things you haven\'t
even seen yet. So there\'s just not that kind of experience.

And I guess one thing, if I would add one plea here, you know, I think
Dr. Barr had mentioned something before earlier. Having data before
regulations. You know, I think I\'ve looked at at least an outline of
what the ACR has presented. We looked at what many of the manufacturers
have, and I think there\'s a lot of consensus on what tests to do and
there\'s probably even some consensus on what tests we\'re wasting our
time on, but they\'re there because they\'re part of regulations or
whatever.

But I think the big problem is setting what the action limits or the
upper or lower bounds or whatever they are, the limits of acceptability.
And that\'s a place where I have concern in terms of having the right
data in order to make those limits relevant, and I know I have had some
discussion with some of the DMIST participants on whether that data from
the DMIST study could be used in QC development.

And at the time the response was that the study was never set up to do
that. You know, so the ability to take some of that data and work it
into QC limits may be something that still has to be worked out, but at
least that could be some sort of source of information.

But I would really like to see some of the things like we were talking
about with interpretive skills and all of the other applied to QC, that
there be some sort of data to say, yes, sending it at this level really
is going to make a difference between mammography quality, and it\'s not
just a number pulled out of the air.

Thank you.

DR. BARR: Thank you.

For our transcriptionist purposes, I don\'t think this was ever said
that DMIST is digital mammography imaging screening trial.

CHAIRPERSON HENDRICKS: Another comment from an audience member?

MR. UZENOFF: My name is Bob Uzenoff, and I\'m with Fuji Film Medical
Systems, and we have a digital mammography system that\'s currently
being reviewed in the FDA as a PMA.

And I would like to point out I think the wisdom in the original MQSA
act of allowing for innovation and new technologies, the technology in
our system which is under review is not the same exactly as devices that
have been approved already. It was part of the DMIST trial, and so there
is experience with that quality control program clinical experience, and
I think the kinds of tests, as the previous speaker mentioned, we have
an idea, I think a pretty good idea in physics of the types of things to
look at, but just literally looking at the recommendation, they are a
uniform set of quality tests and test criteria is a little strict.

Dr. Finder\'s recommendation of the alternative quality standards, I
think, would nicely accommodate evolution in technologies and
accommodate various technologies. In this X-ray realm, things are done
differently, but it\'s not totally new. It\'s not like the difference
between X-ray and MR.

We know about subject contrasts. We know things about resolution. We
know about noise. We know what\'s important, but how to measure them and
to set criteria, I think you\'ll find it\'s a little early to do that.

Thank you.

DR. BARR: Thank you.

DR. MARTIN: I was just going to reiterate the fact that, I mean, that\'s
what Dr. Williams and I were saying with the ACR program. The ACR
program will be pilot tested because, again, I agree complete with the
speakers. We do not want to bring a program; we should not be
implementing a program that has not been pilot tested to make sure it
will work with all of the manufacturers, and that is the purpose.
That\'s why that program is not out yet.

It\'s going to be tested before it\'s brought up.

DR. BARR: Thank you.

Well, I still think my idea of just flipping through this digital
section was probably the best thing, but you all stopped me. So you
know.

(Laughter.)

DR. BARR: Okay. Thank you for your comments.

And now we get to our green and peach shading and specific regulations.
This is Section 912. Overall final assessment of findings are negative.
There were no recommendations to change that. There was a recommendation
to add the word \"finding\" or \"findings\" after \"benign,\" also a
negative assessment.

Let\'s run through these and then we\'ll go back and see if anybody has
any comments on each one.

I see probably benign recommendation to add \"finding.\" Initial
short-term follow-up suggested a finding or findings has a high
probability of being benign.

Under recommendation for D was suspicious, to add \"abnormality biopsy
should be considered.\"

E, to add a biopsy should be considered after \"highly suggestive of
malignancy.\"

And new F, to add the wording \"known biopsy proven malignancy,
appropriate action should be taken. Reserve for lesions identified on
the imaging study with biopsy proof of malignancy prior to definitive
therapy.\"

Okay. B, adding the word \"finding.\" I mean, unless \-- is there major
comment point anyone wants to make?

C, adding \"finding,\" initial short-term follow-up suggested to the
probably benign category. Any comment there?

D, under a suspicious, to add \"abnormality biopsy should be
considered.\" Anything there?

E, \"highly suggestive of malignancy, biopsy should be considered.\" Any
comment?

And then F, the known biopsy proven malignancy, and this says,
\"Reserved for lesions identified on the imaging study with biopsy proof
of malignancy prior to definitive therapy.\" I guess I myself would
wonder, you know, what about during definitive therapy. What about, you
know, immediately following definitive therapy? Any comments on F?

Okay. In cases where no final assessment category can be assigned due to
incomplete work-up, incomplete needs additional imaging valuation. The
recommendation is to add \"and/or prior mammograms for comparison.\"

\"Show the assignment as assessment and reasons why no assessment can be
made shall be stated by the interpreting physician, and a recommendation
to add for cases rated zero because of need for prior examinations,
reassessment must be performed within 30 days to assigned category.\"

Any comments here?

MS. PURA: Dr. Barr, Linda Pura.

How come we don\'t just go right now the BI-RADS and use the BI-RADS as
opposed to the various categories that are medically reported? I think
the docs get very confused with they\'re reported in the BI-RADS. Why
can we not just use the BI-RAD category one to zero to six instead of
the alphabet?

I mean, it\'s not a major point, but I know a lot of our docs get very
confused with those. It sounds very basic, but it\'s very true in
practice.

DR. BARR: Well, maybe we should just get rid of BI-RADS and start over.
How about that?

Charlie, do you want to comment?

DR. FINDER: Well, yeah. Let me go back to a little bit of history and
kind of put some of this into perspective and where some of this is
coming from.

The goal originally was to create a system so that the referring
physicians would understand what the reports basically said. Before this
requirement went into effect, reports could be long descriptions of
things without any assessment whatsoever.

When we put into regulation the assessment categories, we basically
picked the wording from the BI-RAD system. We basically used that. At
that time, there was some discussion about using the numbers, and the
feeling of the committee at that time was that the numbers themselves
were not sufficient because then there would be confusion about what the
numbers meant.

So what we did was we said you have to sue the language of the
assessment categories. If you wanted, you could add a number with it,
but the wording had to be there. And as I say, we basically took the
wording from BI-RADS.

Now, over the course of years, things have \-- we\'ve learned. Let\'s
put it that way, and not only we have learned, but BI-RADS have learned,
and some of these have been modified to take that into account, not
always with the best of results, and I\'ll give you one example in a
minute.

But in addition to the language that was in the regulation for these
assessment categories, we found that some facilities were using slightly
different words, and what was happening was we finally had enough
problems with that, enough facilities were being cited that we came up
with a list of equivalence, and that\'s in our guidance, other wording
that we would accept as equivalent to the assessment categories.

What is now happening is those lists are enlarging, and it\'s now
getting to the point where you can pretty much write almost anything \--
well, I shouldn\'t say that. It\'s not that bad, but it\'s getting
confusing enough so that facilities are now having problems even
understanding the BI-RAD system because the latest BI-RAD system now has
broken down some of these categories even further, and you\'ve now got
things like low suspicion, moderate suspicion. It\'s getting more and
more confusing.

One of the problems that we\'ve done, and we\'ve actually accepted the
alternative standard for this one is the one that talks about the
incomplete category where we\'ve added and/or prior mammograms for
comparison.

We\'ve gotten feedback from some facilities and from some referring
physicians that now they don\'t know what this means anymore because in
the old days it would just be incomplete and need additional imaging
evaluation.

With the current wording, now they don\'t know whether the patient needs
additional imaging evaluation or they\'re waiting for a comparison. So
in order to be helpful, in order to be flexible, we may have created a
system that is even more confusing.

Another difference between our assessment categories and BI-RADS, as at
least written here is we did not tie the assessment category to a
recommendation. We gave the facilities flexibility to use an assessment
category and supply a different recommendation if they believed that was
indicated.

If we make this a regulatory change, then that won\'t be allowed. Okay?
Some of these will now be tied to specific recommendations. So those are
things to consider with this.

Another difference is that while IOM recommended that we add one of the
approved alternative standard assessment categories, number F here or
letter F here, they did not deal with one of the other ones that we had
already approved, and that deals with marker placement during an
interventional procedure. Why they didn\'t include that I\'m not exactly
sure.

And those were the comments that I wanted to make before you guys
started discussing these suggested changes. So that\'s where we
basically came from.

The whole idea of this is to make it as clear as possible to the
referring physician what the interpreting physician thought of this
mammogram and what should be done next.

DR. BARR: And I really wasn\'t being flip when I said maybe we should
ditch BI-RADS and start over. I was trying to get to what Dr. Finder was
saying, which was the original intent. I think we\'ve come full circle
now, and maybe the radiologist speaking his or her intent into the
dictation of what should be done with this patient and the results of
the mammogram is a viable alternative to keeping adding onto categories
and allowing more variations of words, et cetera, et cetera.

So I\'d like to hear your comments.

DR. FINDER: One other issue that has come up is that the assessment
categories here basically are an assessment or some kind of graduation
or quantification of malignant status, how malignant you think this
mammogram represents.

We have had a case that\'s been brought to our attention where a
ruptured implant got an assessment category of negative because there
was no evidence of malignancy, no suspicion of malignancy, and that is
cases going to the courts now because they got a negative assessment
with a ruptured implant, and they\'re bringing that as an issue.

So I think there\'s some confusion as to what the purpose of these
assessment categories are supposed to be, whether they only refer to
malignancy, whether they refer to even benign conditions of the breast.

We\'ve always had complaints or comments about these assessment
categories don\'t necessarily fit male breast mammograms, and that it\'s
not appropriate for that.

So I just want to hear your comments, your thoughts. Should we be
looking at a new assessment category or should we try and define the old
one?

I would also state that most of the facilities, the vast majority of the
facilities are familiar with this, and to change this would be a huge
change in the way mammography facilities practice. So we have to be
very, very careful before we suggest anything.

I also see a hand going up, and I can answer this question. Any change
that we made in these assessment categories would cause a huge change in
software companies that have to redo all of their programs.

DR. BARR: From the audience.

MS. MYERS: Susanne Myers, again, with Mammologics.

One thing I just want to point out when you\'re looking at these. A lot
of facilities \-- and I think Dr. Finder was alluding to that \-- they
tie their patient notification letter messages to these categories, and
so if you make any changes to that, it\'s going to be a challenge for
the facilities to get the correct letters to the patients. That could
even cause more confusion.

So just something to consider.

DR. BARR: Thank you.

Yes, additional comments from the audience?

MS. BUTLER: Penny Butler from ACR.

If could move to the previous slide.

DR. BARR: Sure. Maybe. I don\'t know.

(Laughter.)

DR. BARR: Charlie, can you help me?

MS. BUTLER: I just wanted to point out that number E there, which is
BI-RADS Category 5, I believe the BI-RADS describes \"appropriate action
should be taken,\" not \"biopsy should be considered.\"

DR. BARR: Yeah. But do you think that this is the IOM recommendation, or
do you think we have the IOM recommendation wrong?

MS. BUTLER: I don\'t know. I would have to look at my IOM book.

DR. BARR: Yeah, I didn\'t know if you were intimately involved in that.

CHAIRPERSON HENDRICKS: Additional comment from the audience?

DR. BASSETT: I think that the BI-RADS has become not only national
standard, but an international standard. Most of the countries that have
developed accreditation programs have developed and incorporated this
into their programs. It works, and I think it\'s a mistake to change it.

When you give someone an F for what\'s really a five, basically you
don\'t have to tell the surgeon what to do. They may have different
options they want to take. They may want to take the patient directly to
surgery in certain circumstances, depending on the clinical factors and
so on, and that\'s why it was called \"appropriate action should be
taken.\"

And actually that\'s used for F, but it should also be for E, highly
suggestive of malignancy.

DR. BARR: Yeah, I think that\'s what Penny has.

DR. BASSETT: Almost 100 percent sure, and again, I\'d emphasize what was
spoken before, that many facilities have tied their auditing and so on
to these numbers, and they\'ve got it in their software and so on. And
we\'re trying to encourage them to do audits, and yet we\'re going to
make it even harder for them because all of their previous studies are
identified by the numbering system.

DR. BARR: Would you have a recommendation for the one that said to put
in \"and/or prior mammograms,\" \"additional imaging and/or prior
mammograms\"? Because clinicians have told us they don\'t know what
they\'re supposed to do. Does that mean the radiology department is
taking care of it? Does that mean they have to do something?

DR. BASSETT: No, it\'s a very difficult issue. It has to be clear that
what you\'re asking for is old films versus more imaging. For several
reasons it should be identified that way.

One is that you want to keep track of them. So our quality assurance
person would have to know which were old films because she would be
pursuing those until they are found or let us know if she couldn\'t get
them within a certain time.

And the ones with additional imaging are actually going to count as
call-backs in your medical audit. The old films really don\'t need to be
call-backs.

DR. BARR: Would you have a comment on the rated zero, giving a time
frame for the zero rating? I think I have it up on the screen now for
cases rated zero. A time frame for changing the assessment.

DR. BASSETT: Oh, I think that\'s a goal to go for certainly in terms of
if you can contact the patient and find the patient and so on to get
them back.

I think that\'s not inappropriate, and justify if you can\'t do it.

DR. BARR: Thank you.

DR. MONTICCIOLO: I agree with Dr. Bassett that that is a goal, the 30
days, but to make it must be performed in 30 days, I mean, we have
patients who think that if they get their mammogram right before they go
on vacation, somehow they\'ll be saved from anything bad because, after
all, everyone knows they\'re going on vacation.

And so we have this continual problem with little ladies who are going
off for a month or two and have their mammogram right before, and then
we try to get them back, and they say, \"But can\'t I come six weeks
from now?\" or whatever.

And so we have a hard time trying to track them and get them to comply
with the regulations when they aren\'t aware of them. So I think it\'s a
good idea to say, gee, every effort should be made, but to make it
mandatory that it be done within 30 days, I think it sometimes is
difficult.

I mean, we call them back right away, but there are just some patients
that won\'t comply with it.

DR. FINDER: It\'s Dr. Finder.

I just want to clarify one thing. The way this is written, the
recommendation, it\'s only those in which you\'re waiting for comparison
films, not in which you\'re asking for additional studies that would
have to be redone in 30 days.

So it\'s only \--

DR. MONTICCIOLO: Well, that\'s even a bigger problem for us, getting a
facility to send an old film. We have to put a tremendous amount of
resources into that. First of all, we often send letters, faxes, calls,
and if it\'s outside our general area, it takes weeks and weeks to get
these films. We have films show up six weeks later all the time. So the
question is what to do with those.

DR. FINDER: Well, that is the point because the impetus for this
recommendation from IOM is the situation where somebody reads a
mammogram as incomplete, needs comparison films, and send out that
report.

And right now under the current regulations, there is no requirement
that a, quote, unquote, final assessment category go out at some point
in the future. This is an attempt to require that that happen. So if you
don\'t get those comparison films, you will reassess those films and
give an assessment based on what you have at that point.

And they are saying 30 days. Is that a reasonable time frame? Isn\'t it?
But it\'s to address that issue and to prevent people from sending out
incomplete studies and never getting the comparison films and never
giving a final report, in effect.

So that\'s the issue that\'s really being addressed here.

DR. FERGUSON: Don\'t we already have a 30-day requirement?

DR. FINDER: The requirement is that a report has to go out in 30 days,
but if that report is a zero, an incomplete, that has met the
requirement. So that it is possible for somebody to send out that report
and then never get the old films and never have a final report go out.

So that was their attempt to address in regulation that issue.

DR. BARR: So \-- go ahead.

DR. FERGUSON: I was going to say I guess I was under the wrong
assumption that you had to do something in 30 days. So what we do at 30
days if we don\'t have the films, we send out a report, and I guess that
you\'re wanting to mandate that that be done. I thought it already was.
I guess I was \--

DR. BARR: This is an IOM recommendation, and if we keep BI-RADS because
it\'s standard and because it\'s attached to patient notification, so in
B do we accept a recommendation of adding a word \"finding\" because
somebody thinks it should be added?

Do we keep giving alternative wording? And how do we \--

DR. FERGUSON: I think we leave the words alone. I think that we\'re
pretty standard, and that\'s what we\'ve looked for for a long time is
standardization. I think it\'s everything we\'ve talked about. So I\'d
say leave it alone.

CHAIRPERSON HENDRICKS: Another question from the audience?

DR. LEE: I have a comment. Carol Lee from ACR.

I agree with what Ms. Pura said. I want to emphasize how our clinicians
now having been living with BI-RADS for the length of time that it has
been in existence now have a really good understanding of what the
numbers mean, and to change at this point, I think, would introduce a
lot of unnecessary confusion into an already confusing area.

The other comment I wanted to make is that the BI-RADS committee of the
American College of Radiology has devoted an incredible amount of time
and energy in developing the wording, and lots of effort by experts has
gone into this, and I would urge FDA in their regulations to keep the
same terminology as BI-RADS so that we\'re all talking one language.

Thanks.

DR. MONTICCIOLO: Carol, can I ask you a question?

DR. LEE: Sure.

DR. MONTICCIOLO: This is going to add something that\'s not in this, but
I just want to ask since you\'re familiar with the BI-RADS committee,
what about the patient who has a palpable abnormality but no
mammographic findings? Because in my \--

DR. LEE: This is something that confuses clinicians terribly.

DR. MONTICCIOLO: Absolutely, and my understanding, and actually Dr.
Bassett is a longstanding member of the BI-RADS committee; my
understanding is that the committee is addressing that question and
others, for example, the implant, you know, the cases that are not
suspicious for malignancy, but have other findings.

And the BI-RADS committee is not a one shot thing. It meets on a regular
basis, and it is addressing these issues that come up, and that\'s why I
would urge that that language in BI-RADS be adopted.

DR. BASSETT: That\'s another issue that ‑-

CHAIRPERSON HENDRICKS: Please reintroduce yourself every time you come
to the microphone.

DR. BASSETT: Larry Bassett representing Society of Breast Imaging.

CHAIRPERSON HENDRICKS: Thank you.

DR. BASSETT: One other reason that you might want to not jump into that
area is because it has now been extended to ultrasound and MR in a way
that whenever possible it is kept the same. Like if a mass is round on
mammography, ultrasound and MR, it will have that same terminology.

So when you start messing with the mammography when you\'re also going
to affect the ultrasound and the MR, which were developed by people who
spent a long time getting consensus because everybody was doing it
differently, and the same for ultrasound. They now have the standardized
terminology, and that\'s another big step forward.

So this is not just related to mammography. It\'s every imaging modality
in breast imaging, and it was made to be flexible. So if there is a
reasonable reason to change it, the committee will change it. They just
need the input.

And it has changed over the years. For example, Category F, which we
call Category 6. Category 6 was added because so many patients are
getting induction chemotherapy prior to having their definitive
treatment with surgery, and those patients need to be evaluated with
imaging a lot of times, and so to give them a four or five would be
appropriate. So we give them a six, and that\'s where that came from.

So that\'s another one that will be in all three types of modalities.

So I think it\'s a mistake to change something that has taken so long to
develop, and it has finally gotten national approval. It is flexible
though, and it can change for those ways.

For example, Category 4, which is suspicious, there\'s an option now to
make it 4(a), (b) or (c) because it\'s such a wide category. So if it\'s
just slightly suspicious, most likely a fibroid (unintelligible) cyst,
why not do a cyst aspiration? That\'s a 4(a).

And then if it\'s just intermediate in its suspicion, it would be a (b).
And if it\'s higher suspicion like 50 percent and above, then it would
be a (c), and then five is restricted for those that you\'d bet your
house on it basically.

CHAIRPERSON HENDRICKS: Does the committee right now perceive that
there\'s a problem with the Category 0, recognizing the two separate
sets of patients.

DR. BASSETT: They\'ve had a lot of comment and work on Category 0,
absolutely, and they\'re working that out, but they\'re trying to get
some consensus and input from all the other societies as well, not just
radiology, but surgery and so on. So it\'s a difficult process.

But you can subcategorize zero into zero-zero if you want to do that
here for old films, zero old for old films and zero (a) for additional
imaging, too. That\'s another option that you can use.

CHAIRPERSON HENDRICKS: I see. Thank you.

DR. BARR: Thank you very much.

I just wanted to show the rationale for these recommendations BI-RADS
categories to minimize confusion between interpreting physicians and
other clinicians, and that FDA has already approved the new Category F
in an alternative standard.

Thank you. Those are helpful comments.

D is the establish luminance standards for viewing mammograms and the
proposed wording to the appropriate regulatory section is viewboxes used
for interpreting mammograms and clinical image quality reviewed by the
technologist should be capable of producing the luminance of at least
3,000 candela per square meter. The illumination levels must be less
than or equal to 21 lux.

The committee says that evaluation of viewboxes during inspection is not
recommended. The rationale is viewing conditions are critical to detect
subtle contrast differences, and that the 1999 ACR quality control
manual has suggested standards.

The one comment I would make is the standard comment I have on dealing
with regulations, is it\'s important enough to put in a regulation, but
it\'s not important enough to have an enforcement tool for it, and
that\'s always a problem when you recommend putting something in
regulation and then there\'s no way to enforce it. The recommendation,
the evaluation is not recommended during inspection. So it\'s a
regulation that we can\'t enforce if we don\'t have a compensatory
inspection or enforcement component.

DR. MARTIN: Melissa Martin.

I\'m confused when you say there\'s no inspection because the physicists
do this. As far as those of us who are inspecting ACR accredited
facilities, I guess I would highly recommend that this be approved
because we\'re making this measurement on an annual basis as part of our
annual physics report already.

DR. BARR: Right, but it\'s not part of the inspection procedure, and IOM
doesn\'t think that it should be.

DR. MARTIN: I beg to disagree with IOM.

DR. BARR: Thank you.

Any comments on this standard?

CHAIRPERSON HENDRICKS: From the audience.

MR. MOURAD: Wally Mourad, FDA.

It\'s true that it\'s not in the inspection procedures, but if it\'s in
a physicist report and if the physicist says it\'s wrong, fix it, the
facility has to fix it. So in a way it\'s inspected.

DR. MARTIN: Well, it\'s inspected and it\'s part of the physicist report
for those that are ACR accredited, but again, it is a measurement we are
making. We can recommend, but it would be a lot more forceful if it were
part that they had to fix it because right now it\'s only a
recommendation. That is true. They do not have to fix it.

We can tell them all day, but there\'s no teeth to it.

DR. BARR: Exactly. Thank you.

From the audience?

MS. BUTLER: Penny Butler with the ACR.

One thing that AB\'s accreditation bodies look for during the three-year
accreditation is that we get a copy of the physicist report. If the
physicist says that a certain regulation is not met, we will not
accredit them until we get something back from the facility saying that
they have corrected the problem. So in that sense it is in force when
they go through accreditation.

CHAIRPERSON HENDRICKS: What is your take on this recommendation that the
viewboxes not be evaluated? I\'m just having a little trouble
understanding the background for this IOM recommendation that the
viewboxes not be inspected.

MS. BUTLER: Not be evaluated during annual MQSA inspection. I agree with
that, and I agree with that because it would be checked during the
medical physicist annual survey, and so there would be a measurement to
determine if it does meet requirements. There would be oversight by the
accrediting body to make sure that it meets MQSA requirements.

CHAIRPERSON HENDRICKS: You feel their intent might be that it was a
duplication of something that\'s already in place?

MS. BUTLER: Yes.

CHAIRPERSON HENDRICKS: I see. Is that also your understanding, Dr. Barr?

DR. BARR: I\'m interested in knowing how it can go from what Ms. Martin
says, which is a recommendation by the physicist that if this doesn\'t
meet, that it be fixed to something that, you know, if it\'s that
important, it needs teeth.

So I\'m a little confused about the recommendation.

DR. MONTICCIOLO: I think the issue here is time during inspection
because this would take extra time in the inspection, and as Penny
Butler pointed out, it already is required to be fixed by the
accrediting bodies and so there is some teeth in it, and I know that to
be the case because sites that I have checked when they had this
problem, the ACR\'s hand in it forced it to be fixed, based on the
physicist report.

DR. BARR: And that\'s an every three year process, the accreditation. I
just wanted to point that out.

Thank you.

DR. MARTIN: I would reiterate I\'m not in any way saying that this
should be done by the MQSA inspector during their annual inspection. It
is something to be handled by the physicist. I would just recommend
that, you know, if necessary, this body recommends that FDA adopt that
as a standard, but I\'m not endorsing at all that it be part of the MQSA
inspector\'s task. This is a physicist task.

DR. BARR: Thank you.

DR. FINDER: Yes. Dr. Finder.

I just wanted to kind of go back and give some history about this issue
because when the final regulations were being worked on, the issue about
luminance standards for viewboxes was discussed. In fact, viewing
conditions in general were discussed. It was decided at that point not
to mandate high luminance viewboxes for mammography.

Instead, what the recommendation from the committee was is to use or
require hot lights to be available which can produce these levels of
luminance without having the more expensive viewboxes.

There was an issue about masking, and that I think is an issue that
should also be considered if you\'re going to talk about the viewboxes
because some testimony we got was that if you don\'t mask appropriately
on these higher luminance viewboxes, it can actually worsen your
visualization of the image because you\'re getting all of this
extraneous light hitting your eye.

So I wouldn\'t necessarily just limit it to the viewbox. You might want
to also consider viewing conditions. I will tell you at the last time
this was discussed we got into the issue about practice of medicine, and
people at that committee were hesitant to go too deeply into this. In
fact, the recommendation from the committee was not that we require that
masking be used; just that the facilities have masking available.

So a lot of these issues probably go into this one thing. I guess the
question is do we look at viewing conditions in general and come up with
some specifications for the entire range, including use of masking, use
of certain types of viewboxes, illumination levels in the room itself
which are mentioned in this requirement that they suggest.

So what do people think? How far should we go on this and is this an
area that we should be getting into again?

DR. WILLIAMS: Don\'t we already have recommendations in ACR guidelines
for two out of those four things that you mentioned for the background
light that\'s hitting the monitors? So the illuminance and the luminance
of the monitors themselves.

As far as masking goes, probably for soft copy viewing it may not be
quite as much of an issue since you don\'t have the bright borders to
worry about, and I forget what the fourth one was.

DR. MARTIN: No, they\'re all in the ACR. Basically the question, if I
understand it, Dr. Finder, you\'re wanting us to \-- are you wanting to
know if the committee wants to recommend that MQSA or that we recommend
the adoption of what\'s in basically Test 11, the viewing conditions for
the ACR manual at this time?

Because all of those items are covered.

DR. BARR: Right, and I think that\'s the question, is this something \--
are viewing conditions, including the luminance and lots of other things
related to viewing conditions, something that we want to be into and
regulating?

DR. FINDER: Right. Another issue to keep in mind that have been
previously brought up before, that over the years the optical density of
the films has increased so that there are darker films. So that
increased luminescence or illuminant viewboxes might make more sense now
than they would have, let\'s say, five or ten years ago when we were
talking about some of the initial regulations.

So, again, just we want to hear your opinion on whether we should go
ahead with further regulation of viewing conditions.

DR. BARR: And if we put in regulations that you have to mask, how do we
enforce that? You know, does the inspector watch the radiologist read?

I mean, you have to think of when we do these things how do we go about
making sure that they\'re done, or do we?

DR. FINDER: And I would also add to that the issue of does anybody have
any idea about how many viewboxes would not meet these conditions and
how many facilities would have to get new viewboxes and whether you
could achieve the same result using a hot light versus this.

MS. RINELLA: Let me just add, I\'m Diane Rinella, a mammography
consultant.

I travel throughout the United States. I\'ve been all across this
country, and the majority of the places that I do work at, I\'m working
with them on actual patients and viewing films on their viewboxes that
they\'re using for their criteria image critique.

And the majority of these viewboxes when I ask the technologist are
these the same luminance as your radiologists, they look at me with a
blank face. They have no clue. They do not have hot lights. They don\'t
have masking, and their overhead lights are on, and they don\'t know
really that these are not the way to do films.

So I\'m glad you brought this up.

DR. FINDER: Are these the techs or the interpreting physician viewboxes?

MS. RINELLA: These are the technologist\'s viewboxes that should have
basically the same luminance as the radiologist reading the film.

DR. FINDER: Okay, because the regulations deal with the interpreting
physician\'s viewboxes, but we certainly recommend that they be similar
to.

DR. BARR: Well, this recommendation is for review by the technologist
also.

DR. FINDER: Right. I\'m just bringing up what currently exists.

MS. RINELLA: But like what you said. How are you going to keep the
technologist from turning on the overhead lights when they\'re actually
reading films or picking up a magnifying glass and masking their films?

You know, you really can\'t stand there and be the mammo police, but I
think the more aware I think that they are going to be made of this if
we do mandate something, I think that could only help.

DR. BARR: And there is an argument to be made that when you put
something in regulation, even though you can\'t enforce it, you know, it
obviously carries more weight, but I want people to realize our
limitations on some of these things that are recommended for regulation.

CHAIRPERSON HENDRICKS: I would welcome input from the accrediting bodies
as to whether these \-- you know, where poor viewing conditions is a
reason for failure to accredit a facility and how often that occurs. Are
there instances where facilities have failed on these viewing conditions
that we\'re discussing? And how often is that a significant issue.

Please, Penny.

MS. BUTLER: Penny Butler from the American College of Radiology.

Currently we don\'t fail anybody for this because it\'s not a regulatory
requirement. Our standards for accreditation have to be essentially the
same as the MQSA requirements. So even though we have it as a
recommendation, it\'s a recommendation.

CHAIRPERSON HENDRICKS: Thank you for your comment.

DR. BARR: Thank you.

DR. MARTIN: Dr. Barr.

DR. BARR: Yes.

DR. MARTIN: Melissa Martin.

I\'m sort of like Diane. We consult all over the place. I would say at
this point about 20 percent of our facilities would have to replace
their light boxes. A good probably 75 to 80 percent of them are already
in compliance, and I guess I\'m surprised at your question of how would
it be inspected because my understanding is every year the local MQSA
inspector is asking the facilities to demonstrate how they mask to
interpret their phantom films at this point.

Maybe that\'s just a local we have very aggressive inspectors, but my
understanding is they ask every one of our facilities to show how
they\'re viewing the mammography films and how do they mask off, and
they want to see the brightness. They\'re not making measurements, but
they are definitely looking at the viewing conditions every time they
come into a facility.

DR. BARR: Well, do you want to comment on that?

DR. MARTIN: \-- not an FDA?

DR. MOURAD: No, those are aggressive as you say inspections.

(Laughter.)

DR. BARR: This is Dr. Mourad from FDA.

DR. MOURAD: We tell them not to specifically look for those because we
don\'t have inspection questions for them, but we also tell them if you
see something totally abnormal and missing at the facility, you should
bring it to their attention. Now, some of them are more zealous than
others.

DR. BARR: Thank you.

Okay. So we currently don\'t have \-- we have the physicist report. We
don\'t have any current inspection procedures to deal with viewbox
luminance. Do we think that this luminance \-- do we think the numbers
in this recommendation make sense, physicists?

DR. MARTIN: The numbers are fine with me.

DR. BARR: Thank you.

DR. FERGUSON: It\'s aggressive. Being a radiologist, I don\'t know
numbers. So I don\'t know what these numbers mean literally.

(Laughter.)

DR. BARR: Well, that\'s why I had to ask the physicists. I\'m in your
boat.

DR. FERGUSON: I mean, I\'d like to see in the room what kind of
luminance we\'re talking about as far as background light to know. I
wouldn\'t know looking at how many candela per square meter.

DR. BARR: Yes. Ms. Martin.

DR. MARTIN: If you\'re reading in a normal, good radiologist facility,
you are nowhere close to violating these numbers. You probably are
sitting in somewhere with less than six for your local \-- your room
luminance, illuminance.

DR. BARR: What I was glad to see is that at least there\'s some idea of
paying attention to this, and particularly for the technologists, not
just the physicians. I thought that was at least an advance.

I think we have another audience.

MS. SPRINKLE-VINCENT: Hello. I\'m Susan Sprinkle-Vincent. I\'m a
mammography technologist and consultant from Houston, Texas.

I travel also like Diane all over the country training technologists, do
the 40-hour initial training in Houston, do lots of hands-on
positioning, accreditation assistance, and myself, like Diane, find most
facilities that I go to the technologists do not have appropriate
viewing conditions.

I struggle with that a lot, especially working with them to improve
their positioning skills and their technical factors, and find it a lot
of times pretty impossible to do in the conditions that they are given
to review their films in.

And then a lot of times unable to get into the radiologist area to use
their viewing conditions because they\'re busy and they\'re tied up.

A lot of the technologists would love to see this in force so that they
would be allowed or their facilities basically be forced to buy them the
viewboxes that they need.

Thank you.

DR. BARR: Thank you.

CHAIRPERSON HENDRICKS: We\'ll take one more question from the audience
and then move to the next area of regulations \-- thank you \-- just in
the interest of time.

MR. FLATER: I\'m Don Flater with the State of Iowa, and we are an
accrediting body, and we\'re also a certifying group.

And we do have very aggressive inspectors and we require that on every
one of our facilities. So it has been done at least in the State of
Iowa.

DR. BARR: Thank you.

CHAIRPERSON HENDRICKS: Thank you very much.

DR. BARR: I\'m not sure how exactly to summarize this, but I think what
I\'m hearing is that viewing conditions, not just the luminance of the
viewbox are important and should possibly be considered for some
regulation in MQSA. I think that\'s how I\'ll summarize that for now.

E is eliminate the modality specific CME requirement. The
recommendation, if we go to the bottom, is for eliminating the wording
\"this training shall include at least six Category 1 continuing medical
education credits in each mammographic modality used by the interpreting
physician in his or her practice.

To perhaps shorten discussion time we are, you know, totally on board
with this. We have not been enforcing the modality specific CME
requirement and are totally fine with removing it from the regulation.
I\'ve heard lots of positive comments on this. So what I\'d probably
like to limit it to is if anyone sees a major objection to removing this
requirement.

(No response.)

DR. BARR: Thank you.

I don\'t think we need to go through the rationale since I think
everybody thinks this is a good idea.

This is 900.4, requiring review physicians for accreditation bodies to
specialize in mammography. What IOM would like to have is wording that
says at least 50 percent of each year\'s practice in breast imaging and
that the physician be currently actively participating in the modality
reviewed at an MQSA certified facility.

I think what IOM is trying to get to here, if I understand it correctly
is that physicians who are reviewing films for accreditation should have
at least if not more experience in the modalities that they\'re
reviewing, then people at the facilities that they\'re reviewing for,
and I would like to hear if possible just a very brief statement from,
say, ACR and, Don Flater, since you\'re here as an AB what you do
require of your physicians looking at modalities, in particular, digital
modality.

Please reintroduce yourself for the transcript. Introduce yourself for
the purpose of the transcript of this meeting, please.

MS. BUTLER: Penny Butler, American College of Radiology.

CHAIRPERSON HENDRICKS: Thank you.

MS. BUTLER: The ACR requires a reviewer\'s practice to be in best
imaging, I think we say. So \--

PARTICIPANT: Modality.

MS. BUTLER: Thank you.

In the modality, yes.

DR. BARR: Okay. So if someone were reviewing for digital accreditation,
their practice would be.

MS. BUTLER: I take that convoluted language back then. It would be in
breast imaging, but they do have to meet \-- if they were reviewing for
digital, they would have to meet the MQSA requirements for digital.

DR. BARR: Thank you.

MR. FLATER: That\'s exactly the same for ours. In fact, we even like to
use people that work for Penny to be part of our system.

DR. BARR: Thank you, and that was my understanding of what the
accreditation bodies did do.

Does anyone see a problem or have any objections if something were to be
added that reviewers had to meet this requirement?

DR. FERGUSON: No, I\'d just say that it says \"specialize in
mammography\" and then in quotes down there it says 50 percent. I\'m one
of those that I do general radiology, but over half of my practice is
mammography, and when people ask me do you specialize in mammography, I
say no, but I do over half of it. So just so that was clear, you know.

DR. BARR: Thank you.

This is Section 900.4, the results of equipment evaluations. With its
initial accreditation application, and IOM would like us to add \"the
results of,\" a mammography equipment evaluation that was performed by a
medical physicist no earlier than six months, et cetera, et cetera, I
don\'t see a major problem with adding \"the results of.\" Does anyone?

Charlie, do you have a comment on this?

DR. FINDER: No. I just wanted to mention that the next couple of slides
really deal with a very specific process, recommendations for changes to
the regulations dealing with accreditation bodies, and I wouldn\'t want
to spend too much of the committee\'s time on going through in detail
some of this material. If we can kind of go through it quickly, I think
that would be the best thing because many of these changes we\'ve
already accomplished through changes in our procedures, and I do think
we have some other issues that are more important in terms of facility
issues.

So if we can just try and go through them quickly, maybe all at once.

DR. BARR: Yeah, I agree, and some of this is minor wording. So I think
we\'ll just flip through them, and if you see something that you think
is a big issue or that you really object to, then chime in.

Again, we have wording in 900.4 to add the words \"annual survey\" and
change the six months to 14 months.

Charlie, any issues here that people might ‑-

DR. FINDER: I think that this works out fine for reaccreditation where
under our current situation we allow facilities to have up to 14 months
for the annual survey to be done between inspections. It certainly makes
sense to allow that similar type time frame for the reaccreditation
process so that the facility doesn\'t have to do two surveys within the
same year.

DR. BARR: Okay.

DR. FINDER: So we didn\'t have any real issue with that. The wording on
some of this would have to be crafted so that we don\'t create a problem
with a new facility. We won\'t allow them to do things 14 months before
they actually start in practice.

DR. BARR: Right.

DR. FINDER: Six would work there, but it can be worked out.

DR. BARR: I think the intent here is fairly reasonable.

And this is to delete a section of how the facilities submit their
information. Any issues here, Charlie, that need to be brought to the
committee\'s attention?

The bottom line here, I think, is the second bullet. Submission to the
accreditation body each year is redundant.

Again, some minor wording changes that I think clarify intent. Charlie,
any issues here?

DR. FINDER: No.

DR. BARR: And this is consistent with other suggested changes that the
IOM has made.

Again, I think a minor wording change just for clarification purposes,
which doesn\'t change the meaning. This is to make sure that facilities
know that all units need to be accredited.

And, again, wording to clarify what facilities must do when they have a
new unit. I think that\'s pretty straightforward.

This is a section in the reinstatement policy to delete some wording.
Any comment on that, Charlie?

DR. FINDER: No. Just to clarify that the way it\'s written it kind of
gives the impression that if you reinstate you become a new facility.
That is not the case, and by getting rid of those words it would make it
clearer.

DR. BARR: In this case they\'re saying the facility retains its original
ID numbers. So we don\'t want to reinstated facility to be considered a
new facility.

This one is change to \"continuing experience,\" and this one might
require a little bit of discussion. I\'m going to let Charlie sort of
lead you with how it ended up this way and what we might do here because
I think this one probably would engender a little bit.

DR. FINDER: Yeah. The continuing experience and continuing education
requirements for all three personnel categories are written in a similar
manner, and they talk about measuring back from the date of the
inspection, 24 months or 36 months depending on whether it\'s experience
or education that you\'re measuring.

And the history behind it is that under the interim regulations, the
requirement was that you have to have certain requirements met. It
didn\'t give any specifics of how we were going to inspect against it or
measure against it.

And what we were finding was while that I think everybody at the time
those regulations were written had the idea that everybody should always
meet all of these requirements, the problem that we encountered was that
some of our more zealous inspectors were trying to inspect and insure
that on every single calendar day somebody met this requirement because
you can go back for the last two years and check every single day and
see if they met it.

In order to avoid that, we by policy informed the inspectors that they
were to measure it in a certain manner, either measuring back from the
date of the inspection or from the end of the previous calendar quarter
or any day in between. The choice would be left up to the facility.

Well, that was in guidance, and when we rewrote the regulations, it was
worked into the regulations themselves, and that\'s what we have here.

Now, we have gotten many times from many different sources the request
that instead of measuring it back from the date of the inspection we go
from a calendar date, the first of the year, making it more simple for
the facilities to keep this requirement in terms of bookkeeping.

It has been considered multiple times. It was considered before we even
put these in the regulations. That concept had to be weighed against the
idea of do we want to make sure that everybody always meets all of the
requirements all the time.

And we felt that when the final regs. were written, this was a
reasonable compromise. In effect, the way these regs. were written and
the guidance that\'s associated with it, if a facility keeps up on a
quarterly basis and makes sure all of their people meet their
requirements as of at least the quarter, they will never have any
problems.

This, however, would make it simpler on the facilities if we went to
just a calendar date, and that\'s one of the things that is being
considered.

Another part of this requirement that I think is very important that you
need to consider is that they also say continuing experience obtained
outside of the U.S. is also acceptable, and we wanted to know what
people thought about that.

So there are two aspects to this, and it\'s very similar in one sense
for continuing experience and continuing education. Do we want to change
how we inspect against these requirements? Do we want to change it to a
calendar date or not? And what do people think?

And once you start talking about that, I can give some more background
as to what we have found in the past.

DR. BARR: Okay. So we\'ll start with the previous two calendar years\'
additional wording instead of all the current wording that\'s in here.
Any comments on that?

DR. FINDER: Anybody think it should change to what they\'re
recommending, leave it the way it is?

DR. FERGUSON: I don\'t like the way it is. My technology \--

DR. FINDER: You\'re in the majority then, but the question is what \--

DR. FERGUSON: My technologist comes to me every time and says, \"We have
our inspection coming up. Now we have to go calculate,\" and we\'ll
spend an hour calculating whether my hours are done according to the way
they ought to be done.

And it would be simple and I don\'t know when you say a calendar date if
you\'re saying January 1st to December 31st.

DR. FINDER: Right.

DR. FERGUSON: I think it would be simpler on the people checking as well
to be able to look and say, \"Well, in this year you had five, five, and
five\" or however you did it.

MS. MOUNT: Carol Mount.

I agree 100 percent. It\'s a nightmare trying to sort back from the date
they came for inspection to try to figure out if everybody has the right
numbers.

Our numbers in our institution happen to be big enough that we have kind
of been doing calendar year anyway, and it works just fine for us.

DR. BARR: Charlie, again, could you just tell us quickly what the reason
was for doing it this way in the first place, what the simplicity would
not allow for?

DR. FINDER: Right. Some of the advantages and the reason we decided to
go with the inspection date is that\'s when the inspector is there. The
inspector can actually see what\'s going on, can look at the numbers,
and if necessary can cite the facility.

If we go on a calendar basis, we would have the following type
situation. We would hope that the facility would do what they\'re
supposed to do on the first of January. If they didn\'t, however, the
inspector wouldn\'t be there. There would be no citation at that point.
The inspector could come in 11 months later and find that on January 1st
the person didn\'t meet the requirement.

Of course, at that point it would be questionable whether they should
cite or not because by the time the person came in, the inspector came
into the facility, that person probably would be up to the requirement
or could be, in which case, we didn\'t want to cite somebody for
something that happened 11 months before when they\'re now qualified.

So it really came down to an issue of could we \-- what would be the
most efficient way in order to deal with the inspection when the
inspector was there, could address the records, and could make the
finding at that point rather than leave it up to the facility at some
point earlier in the year?

DR. BARR: What if we just used the 24 months from the date of the annual
inspection and not the second part of that getting to choose or choosing
a quarter?

DR. FINDER: Well, we put that in there to give the facility more
flexibility because in many cases while the facility knows approximately
when the inspector was going to be there, by allowing them to go back to
the end of the previous calendar quarter, they wouldn\'t have to rush
around as soon as they got the phone call from the inspector and say the
inspector is going to be here in five days, to start looking at those
records then.

They could get their records set as of the previous calendar quarter
when they expect the inspection to actually occur. So it was an attempt
to make the bookkeeping easier on the facility.

Basically if you\'re dealing with a single facility what this says is
you just have to figure out your numbers once a year, the end of the
calendar quarter, before you expect, you know, the inspector is supposed
to come in.

The real problem comes up with people that work at multiple facilities
where they will be inspected at different times, and that can make it
more difficult for them. Each individual facility could do this on a
quarterly basis, but the individual would have to keep their records up.

That was not felt by many on the committees in the past to be such a bad
thing because their understanding or their idea was that everybody
should be qualified every single day anyhow. So it shouldn\'t be that
big a deal for somebody to document that.

But obviously there are other issues, and it\'s not as simple as if you
just pick one date. So you have to weigh those two things.

DR. BARR: Yeah, I think it\'s pretty clear that the initial wording
wasn\'t just designed to be confusing, that there were reasons.

Any ideas of how to solve this problem?

DR. MARTIN: Melissa Martin.

I don\'t think it\'s a solution, but I would reiterate what Carol said.
The facilities go through great contortions to meet \"oh, the inspector
is coming today.\" The inspectors come within a 14 month period, and at
this point maybe because we are a state where apparently there\'s been a
disagreement or not a signoff, and MQSA inspections have been postponed
literally at four o\'clock on the day before the inspector is supposed
to be there the next morning.

The facilities have gone to great lengths to get all of their data
together, and they\'re now told, \"We\'re coming in six weeks,\" which
puts them into a different quarter and they were told to redo all of
their data.

Talk about an absolute waste of time. This is what\'s going on whether
we want to acknowledge it or not. It is an absolute waste of time to
gather all of this data twice. It would be much more simple just to put
it into the calendar years.

DR. MONTICCIOLO: I agree. Those are excellent comments because we\'ve
been through exactly that, having to recalculate and recalculate, and we
provide our physicians with their audit data on a year to year basis,
and so this would match the audit data.

And I would also point out that this type of change, just allowing the
use of the calendar year doesn\'t introduce much danger to the patients
or the quality. You know, I don\'t expect my physicians if they do their
CMEs six months later are going to forget everything they knew up to
that point.

So I think that if they want to a course three months later or whatever
and just stayed in the calendar, they\'re going to remember it better
instead of having us have to badger them because our date is coming up,
a date that doesn\'t relate to anything in their minds and we say,
\"Hey, you know, you have to get your CMEs.\"

If they had it yearly stuck on the calendar, it would be easier for them
to remember and to accommodate us. So it would be actually a benefit to
go to the calendar system.

DR. BARR: Okay, and I think I\'ll summarize it that way.

I have to agree when I practiced under MQSA I found this confusing, and
I still do, but there were reasons in mind when this was set. So
summarize here that the current wording is confusing and that we should
work on perhaps a calendar year process to simplify.

CHAIRPERSON HENDRICKS: There is a comment from the audience.

MR. MOURAD: Wally Mourad, FDA.

Sorry I did not bring this up earlier. I just thought of it. When we try
to calculate the continuing experience and continuing education, it\'s
always referred to the individual starting date. The starting date is
the date when the individual has met his or her initial qualifications.

So for people that have met the initial qualifications several years
ago, it\'s not an issue. But for people coming into the fold today, if a
person qualified today, they become eligible for meeting the continuing
requirements 24 months from today and 36 months from today,
respectively.

If you do it on a calendar basis, that equation has to be changed
somehow. Just be aware of that.

DR. BARR: Thank you.

Okay. So I think we get the spirit of this, and with our collective
brains I think we can work on this issue.

I think the last line of this continuing experience obtained outside of
the U.S. is also acceptable. I think we should go through some of the
comments on this. I don\'t know where the rationale is on that.

Well, be that as it may, what do people think of \--

DR. FINDER: There it is.

DR. BARR: Oh, physicians who initially qualified in the U.S. under MQSA
should not be prevented from using foreign experience. I think some of
the things that we\'ve heard as a concern is how do we know what\'s
going on in these facilities.

Charlie, what have you heard on this issue?

DR. FINDER: Well, yes, we have heard concerns about using foreign
experience. Under the current guidelines and regulations, foreign
experience is not allowed. Our feeling was that we have no idea of what
kind of quality is being put forth in those other countries. We have no
idea what type of facilities they\'re at, what type of equipment
they\'re using, whether there\'s any quality assurance at all being
done, whether there\'s any audit procedures being done.

And we also believe that the two-year interval that we allow continuing
experience to be recorded took into account the fact that people may be
going out on sabbatical, may be going out for medical reasons, may not
be doing a lot for some period of time, as much as a year, and they
could still meet our requirements.

We felt that there was enough leeway put in here that the issue about
allowing foreign experience wasn\'t necessary, but that\'s why it\'s
being brought up before the committee, to hear what you people think.

DR. MONTICCIOLO: Okay. Well, Dr. Monticciolo.

You know, there certainly are a lot of good mammographers in other
countries, but I do think it is hard to decide how you\'re going to
gauge quality, and I\'ve done mammography projects in different
countries, Panama, China, India, South Korea, and those are all
completely different and so I would have a hard time just making a
blanket statement to allow it to be used.

Our initial requirements to get somebody to be an interpreting physician
I don\'t think are so onerous that it would prevent people from other
countries from practicing. So I don\'t know. It would be very difficult
to gauge those levels of experience.

DR. BARR: Yeah, I\'m not sure what prompted this recommendation. I
don\'t know if there\'s a pressing need to have foreign experience
included. On balance, I think I\'ve heard more concerns than positives,
but I don\'t know what prompted this.

Thank you.

Are we on closed facilities already? I\'m sorry. Charlie, am I at the
end of my thing yet?

This is a change to continuing experience for medical physicists, and
what IOM is recommending is to take out the wording in the requirement
of at least two mammography facilities and a total of, and I think we
can sort of shorten this discussion.

What they\'re saying is it\'s difficult to medical physicists to provide
services to more than one facility in a 24 month period. Outside
consulting is sometimes prohibited. Units\' facility ratios increased,
and physicists have adequate experience surveying one facility.

I\'m not sure what prompted this because our current regulation is that
this requirement can be satisfied by the regs. the way our regs. are
currently written. So I\'m not sure exactly where the issue is here.

If anybody sees where the issue is, I\'d be glad to entertain it.
Otherwise, any physicist want to comment on this?

DR. MARTIN: I don\'t think there is an issue.

DR. BARR: I thought it was pretty clear, but obviously it wasn\'t clear
enough.

CHAIRPERSON HENDRICKS: Comment from the audience on that?

MS. BUTLER: Penny Butler from the American College of Radiology.

One thing that prompted this is that there were physicists at large
institutions with a large number of units, and because the way the regs.
are written, that they provide services at two facilities. Sometimes by
their contract they\'re not allowed to practice outside their own
facility. So they would have to really be forced to providing services
someplace else in order to meet the regulations.

DR. BARR: But you can\'t do it by being at a single facility. You can
meet the requirements.

DR. FINDER: Right. This is Dr. Finder.

The regulations allow the medical physicist to do a survey. It\'s a
requirement, two facilities and six units over two years. So by doing
the same facility twice in the two-year period, which you are allowed to
do, one each year for the surveys that are necessary anyhow, you would
meet that requirement.

The same for the number of units. We do allow \-- for example, a medical
physicist who is in a facility that has only one unit can by doing two
surveys and resurveying the unit as much as every 60 days can actually
meet this requirement at one facility.

MS. BUTLER: Okay. If that is, indeed, the intent, although I don\'t
recall that from the original regulations, and I\'m pleased to hear that
interpretation; then if that\'s indeed how it\'s being interpreted, I
think it\'s \--

DR. FINDER: Well, yeah.

MS. BUTLER: \-- it\'s right the way it\'s written.

DR. FINDER: All right. It\'s written that way.

CHAIRPERSON HENDRICKS: Dr. Williams.

DR. WILLIAMS: This is Mark Williams.

If that\'s truly the intent, then why is the word \"facility\" even
brought into it. Wouldn\'t it be clearer if we just took it out?

DR. FINDER: No. Actually it probably wouldn\'t because the idea here is
that there\'s a difference between the survey of a unit and the survey
of a facility. There are different aspects to both. So if you just did
unit surveys, you wouldn\'t look at the QC for the entire facility, and
that\'s part of what is required for the annual survey.

So that\'s why it was specifically written referencing two facilities
and six units, but they all can be done. It can all be accomplished in
as small a facility as a single unit facility.

DR. WILLIAMS: So would there be some merit in explicitly putting that
in?

DR. FINDER: It is. It says here, \"No more than one survey of a specific
facility within a ten month period or a specific unit within a period of
60 days can be counted toward this requirement.\" That\'s in the
regulation.

We thought it was clear. We also put it in our guidance, too. So it is
possible for a physicist who cannot work outside his one facility to
still meet the requirements. They don\'t have to go anyplace else.

DR. BARR: Clearly, we all believe in the spirit of this. We can look at
it and see if there\'s any way the wording can be any different, but the
interpretation is as we\'ve said.

Thank you.

The next is changes to the lead interpreting physician requirement, and
IOM recommends adding language that the lead interpreting physician must
provide regular feedback to technologists on the quality of images. It
seems to me that was already their job, but I guess this makes it more
explicit.

DR. FINDER: Actually there is a requirement that all interpreting
physicians have to give feedback.

DR. FERGUSON: Does that have to be documented in any way? That\'s the
problem you get into.

I mean, we interact every day and say this looks bad, this doesn\'t, but
if you come in and want a piece of paper saying, \"Where did you
document that you did that?\"

(Laughter.)

DR. FINDER: Dr. Ferguson, I know you must tell them this looks good and
this looks better.

(Laughter.)

DR. FERGUSON: No, sometimes it\'s pretty rough.

DR. BARR: Yeah, I don\'t think there was any requirement that this has
to be documented. I don\'t know if that\'s what IOM was trying to get at
since already this is a requirement. Anyway, I think obviously the
spirit is that people should be communicating with facilities to get
better mammography.

The rationale here was the on-site surveys. ACR does suggest facilities
could benefit from improved physician technologist communication. As my
kids would say, \"Duh.\"

And requiring regular feedback may improve quality.

Next is changes to weekly phantom image, quality control test. This
would be a change in the optical density of the film at the center of an
image of a standard FDA accepted phantom, and it would delete 1.2 and
change it to 1.4 when exposed under typical clinical condition.

Yes.

DR. MARTIN: Melissa Martin.

My only comment would be why are you leaving it at 1.4. Shouldn\'t it be
at least 1.5?

DR. BARR: Well, you\'ll have to ask IOM that. I think the point is well
taken about \--

DR. MARTIN: One, point, four is way too low.

DR. BARR: I\'m not sure why they picked this number.

Anybody else have comment?

So we think it should be at least 1.4 is what I\'m hearing.

Okay. Rationale seems pretty logical.

Screen film contact. They want us to take out the word \"semi\" and put
in \"annually,\" and the test shall also be carried out initially for
all new cassettes as they are placed in service, and whenever reduced
image sharpness is suspected.

The rationale is that this only needs to be performed annually or on new
cassettes, and we already have guidance on this that says screen film
content tests must be performed on new cassettes prior to clinical use.
So I think we\'re okay here with what IOM intended.

Change to kVp accuracy and reproducibility. They would like us to add
facilities with older three phase screen film systems. Take out the end
reproducibility part. Take out the most commonly used clinically part,
and say that is obtained when the accrediting body phantom is imaged
with the mammography X-ray unit set to the most commonly used clinical
AEC mode.

And take out the wording in the orange on the kVp and add newer units
with medium and high frequency generators will not require this test.

They feel the phrase \"most commonly clinically used kVp\" is confusing.
Data from DMIST shows test really fails during the annual survey.
Equipment voltage regulation is tight. Unnecessary on an annual basis.

Anybody have any comments on this area?

DR. MARTIN: Yes. Melissa Martin.

I would agree that I have no problems with that recommendation. The
biggest problem we would have is if you tried to enforce the kVp. That
does fluctuate on some models, but obviously if you\'re going to
eliminate it for high frequency generators, you just eliminated it on 95
percent of the units. So it\'s a moot point.

DR. BARR: Okay. System artifact test. They want us to take out tees and
target filter combinations and add targets and filters used clinically.
The rationale to assess image quality and artifacts, only one test of
focal spot size, filter, and target is necessary.

We already have an approved alternative standard for this. So again,
I\'m not sure what the recommendation is made for, but I think we\'re
okay with this, that we don\'t have to do all of the combinations.

This is changes to mammography medical outcomes audit. They want us to
add facilities with the same interpreting physician should combine
medical audit data. I think we kind of covered this earlier in the audit
section, that we should allow that combining of data. to make things
more meaningful.

And again, they recommended that people not be cited for not doing
aggregate data.

Changes to mammography medical outcome audit. The general requirement
section they want us to take out \"individually and collectively for all
interpreting physicians at the facility.\" I guess that\'s so we can
combine data, and add this whole section here.

A screening exam or a positive exam is defined as incomplete or
suspicious or highly suggestive, and diagnostic exams or a positive exam
is defined as suspicious abnormality. Biopsy should be considered. And
diagnostic exams where positive examination is defined.

Again, this is all rationale for combining data. Not being able to
compare facility practice performance with literature.

The BI-RADS committee said the audit of screening examinations requires
recommendation for recall, including Category O be considered positive,
and it would make the regulations more consistent.

Any comments here, Charlie? Anything that can help a discussion here?

DR. FINDER: Well, we pretty much discussed this earlier, at least some
of the aspects of it, and I just want to hear what people think.

I mean, here they have defined screening exams and diagnostic exams, and
we have the whole debate about can we do that, should we do that. If we
can\'t define it, it becomes very difficult to write a regulation that
talks about those as examinations.

The other thing I found interesting in the way they have it worded \--
and I\'m not sure if they meant this \-- but the way it sounds here is
that if you read a diagnostic examination as incomplete, it doesn\'t
have to go into the audit.

Now, maybe I misread, and I doubt it\'s what they meant.

DR. BARR: Right.

DR. FINDER: But there\'s nothing that prevents anybody even right now
from labeling a diagnostic examination a zero.

DR. BARR: Yeah, I had the same comment on my notes. What about a zero?
Isn\'t that a positive? I thought they already defined that as a
positive.

DR. FINDER: And, again, this issue about the screening exams, this would
increase the work load for facilities because they\'d have to track the
incompletes, which could be a fair number, and that also brings back the
issue of the incompletes due to comparison with old films versus the
additional studies.

So anybody have anymore comments other than what they\'ve already
discussed earlier? Is this something that we should put into regulation
at this point or should we think about it a little bit more?

CHAIRPERSON HENDRICKS: Comment from the audience? Yes, Dr. Monticciolo
first.

DR. MONTICCIOLO: I have to put my glasses on. This is Debbie
Monticciolo.

Well, I am reiterating what was said earlier. I do think it would be
onerous to have to follow ever zero. I mean, we do ourselves make sure
every patient we ask for additional imaging, we make an attempt to get
them back and make sure they know they need it.

But to follow all of those to whatever you consider the outcome would be
very onerous for any screening site to do, and specially if you include
the zeros. So that was actually very well put, Dr. Finder, that I think
this is a huge burden, another burden, that we\'re going to lay on
screening sites, and I don\'t think it would be that productive.

DR. BARR: Okay. Thank you.

Next is Section 900.13, change to FDA action following revocation of
accreditation. This is really just a wording change that needs to be
done and we agree with.

Okay. Modifying inspections and strengthening enforcement. Under this
section IOM said that FDA should eliminate several on-site inspection
tests, such as dose and other radiation tests; should require the
facilities to cease performing mammography after two consecutive
unsuccessful attempts at reaccreditation even if the MQSA certificate is
still valid; that we should require a facility that closes or has its
certification revoked to notify patients and referring physicians; and
regulations for film retention should apply to closed facilities.

So we\'ll take the first one. Several on-Site inspection tests are
redundant and have few failures, and we talked about dose. We haven\'t
had a dose violation since 1997. Dose testing is monitored by ACR and
the medical physicist. Other tests are already done by the medical
physicist include beam, quality X-ray, film alignment, et cetera.

Again, this just shows you what Mr. Divine showed you about the
violations or lack thereof, and we did hear the comment before about
possibly looking at the scattering of the dose data around what we
currently consider upper limit of normal.

The one thing that didn\'t come up earlier, I think, related to dose is
that you think, well, big deal, the inspector going and modifying it,
and if you don\'t measure dose, is it really going to cut down the
inspection time?

But we also have to buy, calibrate, maintain equipment for the
inspectors to perform those measurements. So that\'s another just piece
of the pie here.

And the objections I have heard are, as I\'ve said before, about the
disparity between the physicist and inspector\'s measurements, but
we\'re looking at that and I don\'t expect that to be the case, but
we\'ll see.

FDA should have the authority to require facilities to cease performing
mammography after two consecutive unsuccessful attempts at
reaccreditation. Our legal eagles here tell us that FDA cannot require
facilities to cease mammography if their MQSA certificate has not
expired.

Charlie, do you want to lead a little bit of this discussion on this?

DR. FINDER: Right. Again, some of the background on this. Usually this
situation occurs when a facility is coming close to the end of its
certificate. It\'s in the reaccreditation process, and it doesn\'t pass
the accreditation process.

Our lawyers have told us that that process deals with the next three
year accreditation and certification, not with the current one. What
they have told us is that we cannot automatically tell the facility that
they must stop doing mammography based on their failure to get a new
accreditation.

We can tell them that they should stop. They must stop when their
certificate expires, and they have told us that if we feel that they
represent a risk to human health, we can take action either to suspend
their certificate if necessary.

So what they\'ve told us basically is you cannot take actions against
the facility more severe than you would for a suspension, and in most
cases when we suspend a facility, we have to give them notice. We have
to allow them for a hearing, and they have told us that you cannot just
because they don\'t pass the accreditation process for their next three
years automatically tell them to stop where in a situation where the
accreditation body tells you that they represent a risk to human health,
a much worse situation, you have to give them a legal process to go
through.

We certainly have that ability in these situations to take that more
extensive action, but the reality is that by the time we could actually
suspend a certificate under those types of circumstances, their
certificate would have expired anyhow. Usually it\'s a matter of a few
weeks at most, in most cases.

So this is true, and the recommendations from IOM that we put ourselves
or grant us the authority in regulation certainly would address this
situation. I\'m not exactly sure that we could still do it because we
cannot put in a regulation that negates the entire appeal process, the
entire process for a hearing. So I\'m not sure we could even implement
it even if we tried to write a regulation.

But that said, I think the concept of is this enough of a problem that
we should try to develop some method for dealing with it or is it so
self-limited that we should just pretty much leave it the way it is and
let the certificate expire, understanding that these are facilities that
we have no indication that they represent the risk to human health.
It\'s just that they didn\'t pass their accreditation process.

So comments, thoughts?

(No response.)

DR. FINDER: Okay. Moving on.

DR. BARR: And the other recommendation is close facilities or facilities
with revoked certificates must notify patients and referring physicians.
Film retention should apply to facilities that close.

IOM says the complaints from patients who were not informed when their
facility closed and were unable or unsure how to access mammography
records. If facilities are incapable of notification FDA should notify
patients and physicians.

Again, I totally sympathize with patients in this situation. We take an
active role with the accreditation bodies in helping patients in this
situation, but again, I don\'t know what authority we can have over a
closed facility who\'s out of business. I don\'t know what exactly we do
to make them do these things.

Charlie.

DR. FINDER: Yeah. Dr. Finder speaking.

This is an issue that come sup not that infrequently, and it can be a
big impact on patients, but then the question is what can we do under
certain circumstances.

Let me backstep. We have guidance out there to inform all facilities
that when they are planning to close what steps they should take, and
one of the major steps that they should take is to make arrangements for
the retention of records and mechanisms so that patients can access
those records, and most facilities do that.

We also ask that the facility notify their accreditation body of those
steps and also the FDA so in case anybody asks either the accreditation
body or contacts us through our hot line, we can tell the patient what
steps they need to go through to find their films.

And those systems do work when we have cooperative facilities. However,
when we\'re dealing with a facility that has gone bankrupt, it is very
difficult to deal with those situations. Sometimes there\'s nobody we
can talk to, nobody to reach. Sometimes the records are now part of the
bankruptcy hearings and are outside of our jurisdiction. If we can find
a sympathetic judge and explain the situation, they have in the past
made some type of arrangements.

But, again, it\'s outside of MQSA. It\'s outside of the facility\'s
hands because they no longer control the films. They\'re now in the
hands of the bankruptcy court.

In other situations, we have the case where the facility has
disappeared. We have no idea of what\'s going on. The films are gone.
The facility itself no longer exists, and while we would like to notify
patients of this, we have no information to give them in that situation
other than to tell them that their films are gone.

So this is a very tough problem when we\'re dealing with a truly closed
facility, and we would certainly like to hear from the committee about
any suggestions they may have about what actions we can take under these
conditions, and if there\'s any way to help the situation.

But there\'s no question that when a facility goes out of business and
doesn\'t take care of the records and goes into bankruptcy or just
closes its doors, shuts the doors, locks them, and disappears, that
there are problems for patients. The question is what we can do at that
point to help them.

DR. MARTIN: Melissa Martin.

Just a question. Is there any way that you track the physicians, the
radiologists tied to those facilities that have closed? So that, in
other words, he can\'t close the facility on one corner and go down the
street and open the facility on the next corner and start out as a new
entity?

DR. FINDER: Right. Usually in the situation where you\'ve got a
physician or facility that has multiple locations, what they\'ll do in
those cases is they\'ll just transfer the films to the other locations.
Those are usually not the problems that we have.

It\'s individual facilities that go out of business or we have had
facilities that have multiple sites where the entire organization went
out of the business all at once and affected 100,000 patients.

The interesting thing is that most of those are not mammo patients.
These are usually large radiology practices or medical specialty
practices. It\'s not just the mammography records.

We have in those cases worked with the state because they have their own
state laws that they can enforce sometimes, and they find it very
difficult, too because if they\'re gone, they\'re gone. It\'s very hard
to track some of these people.

DR. BARR: I know some states have a requirement that facilities put a
bond in case this happens and they can use the money, and I\'m not sure
at the federal level if we can do that.

I\'m wondering if this is something just to make it work really needs to
be a state issue.

DR. FINDER: Again, if anybody has any other suggestions, we\'d be more
than happy to hear about it because, as I say, it\'s infrequent. When it
does occur, it\'s not pleasant for anybody involved.

DR. FERGUSON: You said there was guidance out there. What is the
recommendation for a facility that is closing?

DR. FINDER: The recommendations that we have basically are that the
facility inform the state, inform our facility hot line that they\'re
closing; that they make arrangements for those films to be available.
And what we suggest is the first suggestion is that they be transferred
to another actively and active mammography or radiology facility so that
patients can go there and get those films.

If that\'s not available, we suggest that they go and put them into some
type of storage facility where the patients can have access, and as part
of that, it\'s very important that they have some mechanism to inform
their patients of what\'s going on so that it\'s not just that they do
this and nobody knows about it so that patients can\'t get it.

So we suggest that they have either something on their phone line, an
answering machine that gives this message out or that they send out some
type of notification or at a minimum that they notify their
accreditation body and us so in case patients call us we will know how
to forward that information along.

So those are the basic recommendations to the facilities that close. The
problem is that if they don\'t, there\'s not much we can do after the
fact.

MS. RINELLA: Question. Diane Rinella.

What percentage of time do you find that this happens where they
actually truly notify that they are going to close versus just closing
the doors and going?

DR. FINDER: I can\'t give you actual numbers. I do know that we get in
the mail from facilities this type of information. I can\'t give you the
exact numbers. I will tell you that the number of facilities that close
and leave problems like this is a relatively small handful, but when it
does occur even at a small size facility, you\'re probably talking about
thousands of patients being affected. So in that sense it is a big
issue, and we have had some major facilities that have closed where I
think at most there was a group out in California with millions of
records, but most of them were not mammography. They were everybody\'s
exams, CTs, medical records of all kinds.

So it\'s more than jut mammography, and we found that that\'s usually
the case. It\'s not just a single mammography facility that closes down.
It\'s either a radiology practice so that you\'ve got other patients
that aren\'t even affected or don\'t have any recourse to us at all for
those exams.

MS. PURA: Dr. Barr, that suggestion you had about the bond issue, have
states done that before?

DR. BARR: I believe that there are states that have done that. I\'m
trying to recall. Michigan comes to mind, but I don\'t want to speak out
of turn that they have done it.

We have worked with states and some state have done that. But as I said,
at the federal level I\'m not sure that that\'s an option.

Charlie, do you remember?

DR. FINDER: I\'m not sure about which, if any, states have instituted a
bond. I know that it has been talked about even at this committee, and
one of the issues that was brought up is if you\'re going to have all
facilities post the bond when they start, that\'s another disincentive.
It\'s another issue about, another burden on the facility, considering
the fact that the vast majority of facilities that do close do take care
of this issue appropriately without anything.

DR. BARR: And I think that\'s something we have to keep in mind. Since
we deal in the public health, we also have to look at is the energy
spent on this, although it is very adverse to the patients affected, you
know, how do we deal with it in a public health sense and is it a few
bad actors and would the state be better able to deal with this and also
it\'s a difficult problem.

MS. PURA: Oh, I know because we go through it quite a bit in Los Angeles
and of late it has been a major problem.

DR. FINDER: You know, there are two aspects. One is do you put some type
of requirement on all facilities with the idea that in the event that if
this happens you can then use that as a fund to accomplish something,
although even there you\'re never 100 percent sure because when they
close, we have had the following situations happen where they have their
records in some type of filing system that is well known to them. Of
course, they\'re no longer around, and now you can\'t even categorize
these films anymore and hand them out even if you could.

The other is to try and take action against the people that have gone
and closed shop, and as I say, when possible we have tried to deal with
the bankruptcy court, and in the cases where we have been able to deal
with them, they have been receptive and taken some actions.

The states also have power in this area, and recently we did have a
state go after a facility and force them to reopen and distribute the
films. So it can be done. It\'s a very tough problem, and I think, as
Dr. Barr mentioned, probably our best bet right now is to try and work
in conjunction with the state to deal with these problems, but it is a
tough one.

DR. BARR: We were just hoping someone would have a brilliant idea we
hadn\'t thought of yet.

And despite Dr. Finder\'s being sure I wouldn\'t get done, I finished
the section before the break. So, Dr. Hendricks, is it time?

CHAIRPERSON HENDRICKS: I think it is a good time. We\'ll take a 15
minute break and reconvene at quarter till.

Thank you.

(Whereupon, the foregoing matter went off the record at 3:28 p.m. and
went back on the record at 3:50 p.m.)

CHAIRPERSON HENDRICKS: We\'ll reconvene for the final session this
afternoon, which is Dr. Barr on a marathon leading us through the two
final topics on work force and beyond mammography.

DR. BARR: Thank you.

I will try to get through this last section. I need to leave here about
4:30-ish. So if we\'re not finished, then either Mr. Divine will come up
here and continue or Dr. Finder can switch seats, but we\'ll see what we
can do.

The next major category for recommendations from the IOM report falls
under adequate work force for screening and diagnosis. Under here are
Recommendations 7, 8, and 9.

Recommendation 7 is to collect and analyze data on the mammography work
force and service capacity; eight, device strategies to recruit and
retain highly skilled breast imaging professionals; and, nine, make more
effective use of breast imaging specialists.

And we\'ll start with data on the mammography work force and service
capacity. IOM recommends that volume information be collected during
annual inspection. HRSA reports on mammography volume by region, state,
and type of service. And I think they mean that their reports, which we
could contribute to, should include number of facilities, number of
mammography units per 10,000 women, number of FTE physicians reading
mammograms per 10,000 women stratified by type of service where
appropriate.

That we provide unique identifiers for all interpreting physicians,
technologists, and medical physicists to get volume services by
individual.

That we collect data by facility and waiting times for screening and
diagnostic appointments.

That Congress, I assume, not FDA, provide funding to HRSA to model
future work force supply and demand on a regular basis.

And the rationale for these recommendations which then we can go back to
is to be able to assess accurate real time data to monitor and track
capacity on a national and regional basis; to be able to assess the
status of the work force; assess appointment waiting times, and assess
impact of new regulations and voluntary programs.

So we\'ll go back to the volume information. Currently the information
we have on volume is provided by the facilities to their accrediting
bodies on an every three year basis when they apply for reaccreditation,
and I don\'t know how it is in other facilities, but I can certainly
tell you when I was practicing, I didn\'t write down on the form an
exact number. I would certain give my best guesstimate of the number of
mammograms we performed.

So it has always been debatable how accurate the information we have
when we are asked to give volume statistics.

I don\'t know if that would change if the inspector was asking the
question versus the accrediting body, but we\'d like to hear your
thoughts on how important this information is and the best way to
collect it.

Okay. No comments? Okay. Yes?

MS. PURA: Would this invitation by any chance be helpful to such as the
CDC, et cetera, to expend monies for reimbursement if we knew that there
were so many mammogram units per facility, et cetera, across the country
and the ratio of staff to \-- do you think that would be helpful, Dr.
Barr, or do you think that would be helpful?

I\'m always pushing for reimbursement.

DR. BARR: It\'s really hard to gauge. I myself have been to CMS talking
about the costs of at least meeting MQSA regulations if nothing else,
and it doesn\'t seem to affect their reimbursement.

You know, certainly one would think intuitively that more information
would inform them to make decisions, but I can\'t say for sure.

DR. FERGUSON: Does ACR not already kind of have this information about
facilities and locations? Would it be easy for them to, I guess,
interpolate the number of patients in a geographic area?

DR. BARR: I think the volume information they have is through
facilities, but we\'ll let Penny. I mean through facilities on the
accreditation form, but we\'ll let Penny comment.

MS. BUTLER: Penny Butler from American College of Radiology.

We do collect information, but they\'re annual patients examined and
breakdowns between diagnostics and screens, but we don\'t have really
good, reliable FTE information and some of the other information that is
asked for here.

DR. BARR: And certainly asking a volume question during inspection is
not a big deal. I mean the inspector could spend two seconds asking
that. I think probably the bigger issue here I would say is this unique
identifier information. I mean I think that\'s really where it\'s at if
we want to get some of the data that\'s being recommended here.

Some of the data that\'s being recommended here, I can say that from our
standpoint there is the problem that if we go to a unique identifier
system, then our database has to meet the Privacy Act requirements which
it does not have to because we collect data based on facilities. We
search by facilities.

And so there would be work and possibly financial burden associated with
that. The other thing is, you know, the whole discoverability stuff.
Could this be tied into how much mammography you do and what your
results are, et cetera?

So just be anxious to hear your comments on B, the unique identifiers,
so that we can get volume by individual and perhaps other data.

MR. PASSETTI: Bill Passetti.

I just think it would be nice if some of this standard information was
collected on a nationwide basis. In Florida we\'re having a situation
where our legislature is looking at mammography accessibility and
different things, and they\'re already talking about requiring us to
collect volume data or how many exams are performed per machine and all
this type of data that would be nice to have, but it would be nicer to
have on a nationwide basis and not just our state.

DR. BARR: Right. Understandable.

DR. MARTIN: I would just like to \-- Melissa Martin \-- to take an idea.
If you\'re developing a database to collect this data, put the thought
in that if you\'re going to assign all of the providers\' unique
identifier numbers, it would also be the option of providing at least on
an optional basis the qualifications so that we don\'t have to kill the
trees and provide that.

If we\'re going to be qualified, then give us one qualification, that
we\'ve got all of our CEUs and continuing experience every two years and
update it so that we\'re not having to copy all of the paper work for
every facility. Either our physician is going to be qualified or our
physicist is going to be qualified or our technologist is going to be
qualified.

We\'re qualified once. It\'s not going to matter where we\'re qualified
in 15 different facilities.

DR. BARR: Thank you.

DR. FERGUSON: I agree. That was brought up at our last meeting as well.
There ought to be a way where we don\'t have to produce every piece of
paper at every facility and have a book that thick. It would be helpful.

CHAIRPERSON HENDRICKS: Comment from the audience?

MS. WILCOX: Pam Wilcox, ACR.

I think there\'s more complexity to this than even what we\'re talking
about here because even if you look at interpreting physicians and you
look at their screening and diagnostic volumes, that doesn\'t address
the capacity of the system because you still have those who are doing
biopsies and those who are not doing biopsies. You have patient mix.

There\'s a whole lot of variables that would make this \-- although
really it would be great to know and be able to predict where we need to
be and what we need to recruit, I\'m not so sure it\'s as simple as it
seems even here.

DR. BARR: Thank you.

MR. MOURAD: Wally Mourad, FDA.

During inspections we do download during the previous inspection where a
certain person has met the initial qualifications or not, and so those
are there, and we don\'t recheck them every time except for expiring
items, like license or approval letter or something like that.

So the only thing we check on continuously every time that\'s different
is the continuing requirements, education and experience. We don\'t have
a database for that. That\'s the other thing.

DR. FINDER: Right. Dr. Finder.

I just wanted to also mention that for medical physicists because we
consider them a special group of \-- no, we don\'t.

(Laughter.)

DR. FINDER: Because they do go to so many different facilities usually,
much more than the other personnel categories, and because their
requirements tended to be more complex in terms of the documentation
that they need, we actually will supply medical physicists a letter
stating that they meet all of the initial qualifications, and all they
have to do is show that letter to any of their facilities. Give them a
copy of that letter, and that is acceptable for all their initial
qualifications.

So we have attempted to address some of those issues through that
mechanism. We have looked at the issue about having a database with
individuals. It does raise a number of issues. One is how do you
identify them.

You\'d have to assign numbers. It would become a privacy system, but
even more so than that there is the issue about how do you get the data
in; who do you give that data to; and even if you were allowed and we
could figure out a mechanism to give it to our inspectors, what would be
the mechanism to give it out to the facilities because it wouldn\'t do
much good if our inspectors knew that you were qualified, but when you
showed up at the facility you had no documentation and they would have
no way of verifying that.

That\'s one of the situations we\'ve got right now with the hurricane
where people have no documentation. They\'re showing up at new
facilities, and we in this case are providing them with some
documentation because of the problems that they have encountered, but we
don\'t give it to the facility.

And then the other issue is how would we deal with the situation where
somebody doesn\'t give us the information at some point in time. What
would we do then? Would we search them out and cite them in all of the
facilities that they\'re out because they haven\'t provided us with
data?

So the reason that it keeps coming up is because it would certainly be
more convenient if we had this type of system, but there are always
these problems that come up that seem to make it difficult to actually
implement. And I guess at one point we can take a look at this, have a
meeting, and discuss this in detail to see if we can actually implement
something like this, but it\'s not very simple to do.

MR. FLATER: Flater with Iowa.

Just a couple of points. Number one \--

CHAIRPERSON HENDRICKS: I want to remind all of the speakers at the
microphone to please identify yourself for the purposes of the
transcript being prepared of this meeting.

MR. FLATER: Flater, with Iowa.

Just a little bit of a point. Us small people that do everything,
including accreditation and certification do have all of the information
you\'re talking about on every place in the State of Iowa, and some
physicists outside the state that come in and do some work within our
state.

Another thing you might want to look at is the new thing being set up by
the Nuclear Regulatory Commission where they\'re tracking all kinds of
sources and everything. There are systems available that will track
everything everybody does.

DR. BARR: Thank you.

Recommendation 8 is for strategies to recruit and retain highly skilled
professionals. First is to encourage federal and state agencies and
health care payers to develop incentives to recruit and retain skilled
breast imagers.

Loan repayment awards through the National Health Service Corps, and for
J-1 visa waivers for physicians working in underserved areas.

And, again, HRSA should identify and designate shortage areas for breast
imaging.

IOM says that existing supplied physicians who read mammograms are high
level performance, is a valuable resource, is unproductive to invest in
efforts to increase the number of entrants without addressing factors
that lead to early departures.

Retaining highly skilled practitioners should be cost effective way to
maintain high quality breast imaging services, and the NHSC program that
J-1 waivers have been used to bolster work force in other shortage
areas.

I think we\'ve heard some of this throughout the discussion today. I
think when Dr. Lee from NCR spoke, she addressed some of these issues,
as did Dr. Bassett.

Are there any new thoughts about what incentives would work to recruit
and retain qualified personnel? Anything that we may be able to do to
stop this steady bleed of people leaving the field or not going into the
field?

Okay. No new ideas. Again, a tough issue, but certainly what we\'ve
heard is that more burden would not help the situation.

IOM says we need to encourage federal and state agencies and health care
payers to develop incentives. I think I already did that. Sorry.

IOM says we should support the radiologist assistant training programs
and new roles for radiology assistants in breast imaging; that this
career option for skilled technologists is an incentive for new entrants
and could improve quality, productivity, and efficiency.

And I know we heard at least one, if not more, comments in the public
speakers on this. I\'d be interested to know if the committee has any
thoughts on the radiology assistant area, particularly related to
mammography.

Anybody here have experience? Anybody using this type of \--

MS. RINELLA: Diane Rinella.

I don\'t know if any of the radiology assistant programs to date have a
specialty for breast imaging, and something tells me they don\'t, and
for right now, the radiology assistants are going through a very
comprehensive program for two years for fluoroscopy. You know, so barium
enemas and whatnot, and somebody that wants to focus on breast imaging,
I don\'t think that that\'s something that they would need to or even
want to go through.

So I would think that there would need to be something if the RAs were
going to be used in the future. A training program specific, an RA
format for breast imaging technologists.

DR. BARR: As a technologist and someone experienced in this field and
talks to a lot of technologists, do you think that something like this
program to go into would make the field more enticing?

MS. RINELLA: It really is very new still. A lot of techs out there still
don\'t know what an RA is, but I have been to I would say a handful of
facilities, and the text word going to \-- that was one of their goals,
go through the RA program \-- but it was to become a full blown
radiologist assistant. It really wasn\'t something that was dedicated to
mammography.

So I can\'t speak on just specifically breast imaging.

MS. MOUNT: Carol Mount.

I don\'t specifically at our facility. There are about three that are
just finishing up their bachelor program, and breast imaging is what
they would want to do. They\'ve had a lot of questions for me. Of
course, I do not have the answers as to what would they be able to do
once they were in that field.

And I agree with Diane. There would need to be a specific modality
training course in order for it to be effective.

DR. BARR: Thank you.

CHAIRPERSON HENDRICKS: Dr. Monticciolo.

DR. MONTICCIOLO: Debbie Monticciolo.

I guess I have a little bit of a unique perspective because I have
worked with a radiologist assistant in a private practice in one of my
past jobs, but I would say that I think unless the technologists are
willing to accept the medical legal burden, that many radiologists would
be, I think, hesitant to pay another individual to help them, but not
take the legal burden because that\'s a huge issue for radiologists.

I don\'t know if I should say this or not, but I guess I\'ll just go
forward. I worked with a radiologist assistant, and he was very good. I
thought he was excellent and was an asset to our practice, but I believe
that he was over-utilized by some of the radiologists, and that the
radiologists didn\'t oversee his work as closely as you would expect.

And so that also is another side of this issue that would probably need
to be looked at.

DR. BARR: Thank you.

Can ACR help us out on this?

MS. WILCOX: Kim Wilcox, ACR.

There has been an agreement to the responsibilities of a radiologist
assistant, and that has been agreed to by the American Registry of
Radiologic Technologists, which will be the certifying agency, the
American Society of Radiologic Technologists and the ACR, and there will
be no interpreting on the part of the radiologist assistant.

So while they might be able to help in the biopsy area or some of these
other areas, I\'m not sure what they would do to help the radiologist
shortage that we have in breast imaging right now.

And as was said this morning and as Debbie reiterated, the medical
liability issue is huge.

DR. BARR: Thank you. That really helps a lot.

DR. FLATER: Flater with Iowa.

Number one, if we did anything with the radiologist assistant, we would
have to completely change our rules because interpreting physicians in
Iowa must be radiologists. There\'s no choice.

The other side of it that\'s coming up that we\'re going to talk to
later is in the stereotactic. Dr. Finder has just spent some time with
us in Iowa because we have an RA in training right now that is trying to
get us to agree to allow him to go through the training program to do
stereotactic. There are radiologists that are willing to do training.

So that\'s an issue we\'re trying to deal with right now. Today we
wouldn\'t allow it.

DR. BARR: Thank you.

MS. PURA: Dr. Barr.

DR. BARR: Yes.

MS. PURA: Linda Pura.

DR. BARR: Oh, I\'m sorry, Linda.

MS. PURA: You know, these are the growing pains that physician
assistants and nurse practitioners had in the past, and we all know
that, and certainly this might be something to look at to give
futuristic kind of career growth for the rad techs, and I don\'t know if
they\'re not allowed to interpret at this point now, would they be able
to do secondary reading for the double reading? Would that be a
possibility?

DR. BARR: I think those are all good points, and it sounds like in this
area we probably don\'t have enough information yet of how this is going
to and how these people can possibly help us in the mammography area.

So I think as this goes on we\'ll certainly have to keep an eye on this
program and see where it can possibly be of use to radiologists and as
an incentive.

Good points. I think we have models probably of other professions having
gone through this. It\'s a good point.

IOM says that support should be given to demonstration projects to
evaluate potential for double reading by non-physician clinicians, and
again, this is based on the rationale that double reading has the
potential to improve interpretation and perhaps that\'s an area where
the RA would fit in.

And to evaluate the roles of ancillary personnel and mammography,
productivity will be maximized according to IOM if radiologic
technologists focus on performing mammograms and interpreting
physicians\' focus on interpretation, ancillary personnel, technical and
nontechnical responsibilities, including quality control and
administration.

Now, when I first read this, I was like, \"Well, gee whiz. You know, we
have this whole QC tech thing where you have to be in this area,\" but
I\'m not sure that\'s exactly what they mean.

Charlie, I know when you read this, you had a little different thought
about what IOM might be saying here.

DR. FINDER: Well, I think what they\'re trying to get at is the idea of
basically having the radiologic technologists spend all of their time
doing patients, interpreting physicians just doing the interpretations
and leave any of the other paper work, quality control areas to
nontechnologists, nonprofessionals or nonpersonnel, as we define
personnel.

DR. BARR: With oversight.

DR. FINDER: Including quality control because we do allow personnel or
people other than RTs to do the QC procedures. As long as they\'re under
the supervision of a quality control technologist, other people who have
received adequate training can perform these various tests.

So I think what they\'re trying to get at is they realize that there are
shortages for the techs and for the physicians, and to focus them on
just doing the aspects of mammography that only they can do.

DR. BARR: And as you say, MQSA does allow for this oversight type of
responsibility at the current time.

Next is this new topic is improving breast imaging quality beyond
mammography. Any comments on any of the personnel incentives before we
move on to these final comments?

(No response.)

DR. BARR: Okay. Recommendation 10 in the report is accreditation for
non-mammography breast imaging modalities, such as ultrasound and MRI.
The rationale is accreditation already exists for breast ultrasound and
general MRI and a breast specific MRI accreditation program is under
discussion.

Accreditation for breast imaging methods would lead to standardization
and improved quality of breast cancer detection and diagnosis.

I think we heard earlier in some of the talks that the MRI accreditation
or anything in federal regulation of breast MRI probably isn\'t in the
immediate future, but that perhaps breast ultrasound is an area for
exploration.

Any comments from the committee?

MS. RINELLA: Diane Rinella.

I am also RDMS in breast ultrasound and in my travels I do question the
facilities and who is doing their breast ultrasound examinations, and I
asked what type of equipment, what types of transducers and things that
they\'re using, and it\'s unfortunate that they aren\'t all up to the
same standard of care.

And so I would support standardization of and accreditation for breast
ultrasound just because of what I\'m seeing out there in the field.

DR. BARR: Thank you.

Anybody else?

(No response.)

DR. BARR: I guess that\'s it. Yeah, I think that\'s it, except for the
stereotactic section, which we\'ll discuss tomorrow. The
recommendations, I think we\'ve pretty much gone through the
recommendations.

One thing I wanted to point out is that the final printed version of the
IOM report actually just came out. So although there are no major
changes, there could be like when Penny Butler was up here talking about
the BI-RADS thing. There could be wording changes that in the draft were
one way so that we have them on our slides, but in the final report have
come out slightly differently.

Charlie.

DR. FINDER: No, I just want to say the version that you have is the
current one now.

CHAIRPERSON HENDRICKS: That\'s going to bring to a conclusion a long
day.

I do have one housekeeping detail. The woman who is transcribing the
meeting has had difficulty throughout the day today understanding the
names of the speakers who have come from the audience. So she requested
of those speakers to get full recognition of your comments just stop by
her desk to clarify the spelling of your first and last name.

Thank you.

Otherwise, this concludes the meeting, and we will reconvene again
tomorrow morning at 9:00 a.m.

(Whereupon, at 4:18 p.m., the meeting was adjourned, to reconvene at
9:00 a.m., Tuesday, September 27, 2005.)