ATDEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

 

 

 

 

 

 

 

 

 

 

NATIONAL MAMMOGRAPHY QUALITY ASSURANCE

ADVISORY COMMITTEE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Wednesday, August 22, 2001

9:05 a.m.

 

 

 

 

 

 

 

 

Gaithersburg Holiday Inn

Two Montgomery Village Avenue

Gaithersburg, Maryland

 

PARTICIPANTS

Maryanne Harvey, M.S., Chair

Charles Finder, M.D., Executive Secretary

MEMBERS

Amy F. Lee, M.D.

Kambiz Dowlat, M.D.

Debra M. Ikeda, M.D.

Nancy J. Ellingson, R.T.

Carolyn Brown-Davis, B.A.

Amy R. Rigsby, R.T.

Jessica W. Henderson, Ph.D.

Andrew Karellas, Ph.D.

Etta D. Pisano, M.D.

James F. Camburn

Catalina Ramos-Hernandez, M.D.

Donald C. Young, M.D.

C O N T E N T S

PAGE

Conflict of Interest Statement

Dr. Charles Finder 4

Committee Business

Dr. Charles Finder 10

Alternative Standards Requests

Dr. Charles Finder 11

Open Public Hearing 12

Overview of MQSA Inspection Findings

Walid G. Mourad, Ph.D. 12

Appropriateness of Current Inspection

Follow-up Actions

Dr. Charles Finder 29

Good Guidance Practices and Directions

for Discussion of the Proposed MQSA

Guidance under the Final Regulations

Dr. Charles Finder 43

Facility Satisfaction Survey

Nancy Wynne 108

Mammography Access Issues

Dr. Helen Barr 113

Priscilla Butler, M.S. 117

Mammography Access Issues -

Committee Discussion 127

Inspection Demonstration Project - Update

Dr. Helen Barr 157

Full-Field Digital Mammography Certification

Update

Ruth Fischer 171

Priscilla Butler, M.S. 175

States as Certification Agencies - Update

Kaye Chesemore, M.B.A. 187

Future Direction of the MQSA Program

Committee Discussion 193

Review of Summary Minutes of September 2000 Meeting 207

Future Meeting 207


P R O C E E D I N G S

MS. HARVEY: Good morning and welcome to this meeting of the National Mammography Quality Assurance Advisory Committee. We welcome you.

Dr. Finder.

Conflict of Interest Statement

DR. FINDER: I would like to begin this part of the meeting by reading the conflict of interest statement.

The following announcement addresses conflict of interest issues associated with this meeting and is made a part 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 prohibit 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 from full participation in general matters that come before the committee have been granted for certain participants because of their financial involvement with 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: Carolyn Brown-Davis, James Camburn, Nancy Ellingson, Maryanne Harvey, Amy Rigsby, and Drs. Kambiz Dowlat, Jessica Henderson, Debra Ikeda, Andrew Karellas, Amy Lee, Robert Nishikawa, Etta Pisano, Catalina Ramos-Hernandez, and Donald Young.

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

Several of our members also reported that they receive compensation for lectures they have given or will give on mammography related topics, however, they have affirmed that these lectures were offered because of their expertise in the subject matter, and not because of their membership on the committee.

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.

MS. HARVEY: Thank you, Dr. Finder.

I think I would ask first that we all give our name and a little bio, so that we will know each other a little better as we begin our day.

Dr. Lee, would you begin, please.

DR. LEE: My name is Amy Lee. I originally started out as an ob-gyn, but currently my specialty is public health and general preventive medicine. I am currently the program director for the Northeastern Ohio University's Master of Public Health Program and also an administrator for a local breast and cervical cancer project.

DR. DOWLAT: I am Kambiz Dowlat. It says Dowlatshahi, but everyone knows me by Dowlat. I am a surgeon in Rush University in Chicago. My expertise is in stereotactic, and I was just telling Dr. Finder there is hardly anything on the agenda on the stereotactic, but nevertheless, that is an area that I have been involved for the past 15 years. I spend most of my practice in the diagnosis and treatment of breast cancer.

DR. IKEDA: I am Debra Ikeda from Stanford University in Stanford, California. I am an Associate Professor, and I am Director of Breast Imaging at Stanford University. I am a radiologist.

MS. ELLINGSON: I am Nancy Ellingson. I am a radiologic technologist. I have been involved with mammography 40 years in one form or another. I am currently a program reviewer for continuing education at the American Society of Radiologic Technology. I have served on both Oregon and New Mexico licensure boards, so I kind of come at this from several different perspectives. My contact is with the mammographers and helping them with understanding our compliance with our regulations.

MS. BROWN-DAVIS: Good morning. I am Carolyn Brown-Davis. I am a consumer representative on this board. I am an eight-year survivor twice of breast cancer, and I am also the Executive Director of an organization called Breast Cancer Resource Committee. We are an advocacy group for African-American women diagnosed with breast cancer. Thank you.

MS. RIGSBY: I am Amy Rigsby. I have been a radiological technologist for 23 years and a dedicated mammographer for 16 years. Presently, I am a technical director at the Rose Breast Imaging Center in Houston, Texas.

DR. HENDERSON: My name is Jessica Henderson. I am a consumer representative. I was diagnosed with breast cancer seven years ago. In the meantime, I have just finished a Ph.D. in Public Health. I am a facilitator for the Corvales Breast Cancer Support Group.

DR. KARELLAS: I am Andrew Karellas. I am a medical physicist specializing in x-ray imaging and in mammography. I am also Professor of Radiology at the Department of Radiology at the University of Massachusetts Medical School.

DR. PISANO: I am Etta Pisano. I am Professor of Radiology at the University of North Carolina, and I am Chief of Breast Imaging.

MR. CAMBURN: I am Jim Camburn. I am Chief of the Radiation Control Program in the State of Michigan. We oversee approximately 10,000 different x-ray facilities, 350 of them are mammography facilities, and our staff is responsible for inspecting them all, both under MQSA standards and under independent State standards, as well.

DR. RAMOS-HERNANDEZ: I am Catalina Ramos, a consumer representative. I work for the National Breast Cancer Organization. Previously, I was trained as a medical doctor and I have worked in the area of patient advocacy for the last 15 years.

DR. YOUNG: I am Don Young. I am from Iowa City, Iowa, former Professor of Radiology and Director of the Breast Imaging and Diagnostic Center at the University of Iowa Hospital. I have had a quarter century interest in mammography and in-depth involvement, actually was project director of one of the early VCDDPs.

DR. FINDER: I am Charles Finder. I am the Executive Secretary of this committee. I am also a radiologist and the Associate Director for the Division of Mammography Quality and Radiation Programs at the FDA.

MS. HARVEY: I am Maryanne Harvey. I am the Chief of the Radiation Equipment Section and Secretary to the Board of Radiologic Technology of the New York State Department of Health.

My mother has had breast cancer, as has one of my aunts, and so I have interest from both a personal and a regulatory in mammography for over 15 years.

I am pleased to welcome everyone and to get to know you better.

Now, I think we will move into Committee Business.

Committee Business

DR. FINDER: This is Dr. Finder again. I am going to pass around these sheets of paper, asking all the members on the committee to give me their latest mailing address, phone numbers, fax, and especially e-mail because we have been having problems getting some of the materials out to you by fax, and I would like to try and do it by e-mail.

In addition to the committee members, I would ask any of the federal liaisons out in the audience and also the AV reps if they could give me the same information because again, I am going to try and send out all the preliminary information now by e-mail instead of by fax or even by mail.

MS. HARVEY: I would ask each of us to say our name, state our name before we begin to speak to help with the transcription of the meeting today.

The next item on our agenda is the Alternative Standards Requests. Dr. Finder, do we have any?

Alternative Standards Requests

DR. FINDER: The short answer is no, but let me go through a little bit of background on this. FDA may approve an alternative to a quality standard under the regulation Section 900.12 when the Agency determines that the proposed alternative standard will be as least as effective in assuring quality mammography as the standard it proposed to replace and the proposed alternative is too limited in its applicability to justify an amendment to the standard, or it offers an expected benefit to human health that is so great that the time required for amending the standard would present an unjustifiable risk to the human health, and the granting of the alternative in keeping with the purposes of the statute.

Since the September meeting, the Division has not approved any alternative standards.

MS. HARVEY: Thank you.

The next item on the agenda is our open public hearing.

Open Public Hearing

DR. FINDER: Again, I would like to make the statement that we did have one person who was scheduled to be a public speaker, however, late yesterday she called and said that she would be unable to attend, so at the present time we do not have any public speakers.

MS. HARVEY: Thank you.

Now, we will move on to the Open Committee Discussion and we will begin with Dr. Mourad, who will be talking to us today on an overview of MQSA inspection standards.

Open Committee Discussion

Overview of MQSA Inspection Findings

Walid G. Mourad, Ph.D.

DR. MOURAD: Thank you. Good morning. My name is Walid Mourad and I am with the Inspection Support Branch with the Division of Mammography Quality and Radiation Programs with the FDA.

[Slide.]

This morning I would like to give you a little overview of the MQSA program from day one and conclude with where we are today and where we hope to go.

[Slide.]

First, I will give a little, brief background about the history of MQSA and then I want to discuss the finding levels from a historical point of view, that is, from the first time we started conducting inspections.

Then, I want to concentrate on the Level 1 and Level 2 findings, the highest findings, and I want to concentrate on the last couple of years under the final regulations. Then, I will conclude briefly with a couple of programs that are underway.

[Slide.]

As you all know, MQSA was enacted into law in October 1992 by the U.S. Congress, and authority to execute the program was delegated to the FDA sometime in 1993. The Interim Regulations then were published in December of 1993 and they became effective in February of 1994, and MQSA was then ready to go for mammography starting October 1, 1994. So, that is the background.

Later on, of course, the Final Regulations were published in 1997, October, and they became effective for the most part, most of the requirements were effective on April 28, 1999.

In the meantime, also, before they became effective, MQSA was reauthorized by Congress and signed into law in October 1998. A couple of things came into being as a result of the reauthorization, and that is, the lay summary must be sent to all women, not just the ones that are self-referred as under the interim regs.

It also dictated the release of the original mammograms whether temporary or permanent upon request by the patient, and the third item that came in there was the demonstration program, or it stated that the Secretary of Health and Human Services may institute a program to inspect facilities at a frequency of less than annual. There will be talks about this later.

[Slide.]

Before we talk about inspection findings, I need to tell you what the inspection actually entails, so this slide shows you the inspection scope. I have divided it into several sections here to just give you a little perspective.

The first is the equipment performance section whereby the inspector goes in and performs some tests on the unit and the processor in the facility and the darkroom. So, these include dose, phantom image, quality, processing, and darkroom fog.

Typically speaking, this takes under an hour for a facility with one unit. The rest of the inspection is basically a records review, and it starts with quality assurance records and quality control test records, and these include the non-annual tests that are done by the facility, as well as the annual survey report and the annual reports of the equipment evaluations that are done by the medical physicists.

It also includes the review of the consumer complaint mechanism records or policy at the facility, and then followed by personnel qualifications, medical reports, and lay summaries, medical outcomes audit. All these are record reviews to make sure the facilities are doing their job.

[Slide.]

Again, before we talk about finding levels, I need to tell you what the levels are, and we start with Level 1. That is the most serious finding at any facility. Typically speaking, when a facility gets a Level 1, it is followed by a warning letter within 15 days from the FDA District Office, and it also requires a subsequent facility response also within 15 days.

The next level is also serious, but we call it moderately serious, if you will, and if a facility gets Level 2 as the highest finding, then, it is incumbent upon them to respond to the FDA within 30 days to tell us how they are going to fix the problems.

Level 3 findings are classified as minor findings, which are nice to have, and we normally ask facilities to check on them, to fix them as soon as possible, of course, but we, in practice, we don't really follow up until the next inspection.

[Slide.]

With that in mind now, we can talk about some actual inspection results. This slide shows you a history of facilities cited with the highest level of findings as listed in the slide. There are several columns for L1, meaning Level 1, L2, L3, and then No Findings meaning clean record.

The slide goes by fiscal year starting in '95, and I need to tell you that the first inspection was conducted actually January 15 of 1995, so '95 was not the full year, it was more like three quarters, a little under three quarters of a year.

After that, of course, we go on all the way to Fiscal Year 01, which is now, and this slide, of course, is truncated here because we have not finished with 01 yet, so this goes only to 7-31, so about 10 months under the Final Regulations here in 01.

If you look at the slide, if you look at the column where it says No Finding, you will see that the first year we started with 30 percent of the facilities having a clean record and then from there on, in general, it went up, which is a good sign, and if you look under all the other columns, you will that, in general, okay, I am going to say in general, they go down which is what we want.

Now, let's look at the next slide because then I can talk to each of these probably better on the graph.

[Slide.]

This graph depicts exactly what that other slide was. On top, you see the No Finding in the white line. The No Findings here means the number of facilities that have been found with nothing at all has been going up, and right here, in 1999, it basically leveled off, and then we took a little dip in 2000, and then we are back up here.

I will explain what happened here in 1999 and 2000. Level 3, which is the sort of green line here, started at about 40-some percent, and then went down, continued to go down, which is about 10 percent right now.

Level 2, it started at about 20 percent, went down, and in 1997, it sort of leveled off a little bit, and then in 1998, went up, in 1999 it went up. First of all, I want to tell you what happened. In 1997, you know, we had some requirements for the technologists at the time, that the continuing experience was no longer acceptable. In '96, by the time you got inspected, many technologists did not meet the training requirements, so that provided a little hesitation in the curve, if you will.

In 1998, the biggest contributor to the rise there was the fact that the continuing education requirements for all personnel kicked in, kicked in three years after MQSA went into effect, which was 1997, October, so the subsequent year was Fiscal Year '98, and that is where you see the jump in Level 2 findings here.

1999 is a different story altogether. 1999 is a composite year, if you will. About three quarters of 1999 was under the Interim Regs, and then the last quarter was under the Final Regs.

[Slide.]

This is a summation of Level 1 findings over the span of six years or so. Again, you can see the coming down and in '99, we picked up a little bit as a total result, and then 2000, and now we are backing down here, so the trend is starting to come down.

[Slide.]

This is a similar slide for only Level 2 findings. Again, we are coming down here, and this is the slight increase in 1997, 1998, and then 1999, and then, of course, after 1999, we are talking about Final Regs here, the last two years.

Again, this is a percentage of facilities where the highest finding is Level 2.

[Slide.]

This is the details of what happened in Fiscal Year '99. Again, the first line is the year in total meaning mixture of Interim and Final Regs, and this is the percentage of facilities cites at these levels.

If you look at the first three quarters, you will see that the levels again continued to go down here from the previous time, however, the Final Regs, when they went into effect, the last quarter was a jump both here and here, and a decrease in Level 2 and in Level 3. Of course, at the same time, the total number of facilities with no findings has come down a little bit, as well.

[Slide.]

This is 1999. It is a quarter by quarter, and you can see under the Interim Regs, we continued to go down. This is Level 1 findings, by the way. We continued nicely to go down until the Final Regs kicked up.

[Slide.]

Now, I want to talk about what happened when the Final Regs went in. I want to talk about the level changes and the subsequent findings, and where we go from here.

[Slide.]

In anticipation of application of the Final Regs, the Working Committee of the Conference of Radiation Control Program Directors, the CRCPD, and with input from the inspectors, with input from the States basically, and the National Mammography Quality Assurance Advisory Committee, your predecessors basically, as a result, we added, of course, some new requirements. These were dictated by the fact that the Final Regs were there, we had to do that.

That means we had new findings at all levels. That increased the number of findings in the first place, potential findings. We also elevated several Level 3 and Level 2 findings. By "elevated," I mean we raised the bar, so we made some of those Level 3 under the Interim Regs, we made them to Level 2's, set Level 2's also up to Level 1. At the same time, we deleted a few Level 3 findings.

So, as a result, the total potential findings at Level 3 decreased, and those at Level 2 and Level 1 did increase. So, that is a natural consequence, you can't do anything about it.

[Slide.]

To put this quantitatively, this slide shows you the number of potential findings both the Interim Regs, in the first three bars, and then under the Final Regs, you can see with the color coding that both Level 1 and Level 2 went up, and Level 3 went down.

[Slide.]

The next few slides I am going to show you some details of Level 1's and Level 2's for each of the Fiscal Years 00, 00, and 01.

This is of 2000. You can see overall, the dashed line is about 3.9, is the total for the year, but on a quarter-by-quarter basis, you can see how these findings did change. So, you can see quarter-by-quarter, we are going down here.

[Slide.]

This is a similar slide for Level 2 findings, Level 2 has continued to go down until about the end of the year, I think we were about 30 there.

[Slide.]

This is 01, the current fiscal year, going down here again with minor perturbations, if you will. The total for the year so far is 3.5. Again, this is to the end of July only, so the last bar is not a full quarter, it is only one month actually.

[Slide.]

The same thing for Level 2.

Notice here in Q3 and particularly in Q4, the Level 2 findings here just jumped up. Now, there is a reason for that, too. Every time a new requirement kicks into effect, the facilities don't react right away and behave themselves, so we find things go up.

So, what happened here, in the fourth quarter, this is the first month the continuing requirements for the physicists and the technologists went into effect, so we have some citations.

[Slide.]

To give you an idea of what is contributing the most to these Level 1's and Level 2 findings, I summarized this for you. The first line is the total of Level 1 findings, that is, the number of facilities cited, 245, the total is 3.5 percent. By the way, this data is taken to July 2nd, so effectively, it is three quarters of the fiscal year of 01.

The majority of citations at this level are the processor or the phantom QC. The reason for that again is because we raised the bar here, intentionally raised the bar based on input from the States, the inspectors, and NMQAAC.

The second item was results communication to the patients. Again, here, although this was a requirement before, what went in differently was the fact that the summary has to be sent to all patients, facilities didn't know exactly how to conform to that, if you will, and a lot of them were not used to the idea that a summary has to be sent to all patients, so as a result, this is a major contributor at this point.

The third item is the initial qualifications for any personnel. That has now become a third citation, third component.

I need to tell you here that what we are talking about is the lack of documentation on the part of personnel. We have never actually found, perhaps with the exception of one or two, any personnel not really qualified to do their job. It is just they never provided the documents to prove that, and that is what this is all about here.

The rest of Level 1's are minor. As you can see, there are under 9 altogether, some of them vary from the lack of a valid certificate, certificate would have expired and the facility would continue practice, you know, using an unaccredited unit in over a year, et cetera. They are listed down there, but they are really minor total numbers.

[Slide.]

This slide shows again a similar presentation, but for Level 2 findings. Here, of course, the total percentage is 27.6 of all facilities, and the actual number is about 1,900 facilities.

Again, the biggest contributor is processor or phantom QC. The next one is personnel qualification requirements at Level 2. What that means is we have things like continuing education, continuing experience requirements for all personnel is Level 2. Some of the initial requirements are also at Level 2, like initial experience, the training for the technologists, and experience and training for the physicists are all initial qualifications, but they are still Level 2.

The third item is medical reports without results or ID, identification of the interpreting physician, and this is mostly here the results are there, but they are not put in the prescription as dictated by the Final Regs, that is, they did not put down one of the six categories, so facilities are still having a hard time living up to that.

The rest of them are listed - medical outcomes, audit system is next, and then there is a listing on the survey report and mammography equipment evaluations, about 300 there, and this could mean any number of things, like time span between two surveys exceeded 14 months, that is a Level 2. If some of the tests that are supposed to be done by the physicists were not done or incomplete, again, it could be Level 2, et cetera.

The next two items are the fact that the facility did not have a consumer complaint policy or no center operating procedures for infection control. The rest are minor really.

[Slide.]

Now, when you take all that combined with our experience, and knowing that eventually, if you take the analogy to the Interim Regs, when MQSA came out first, we had 2.6 Level 1 citations the first year, but then within a year, it dropped to 1.6, and then continued to drop after that.

So, our experience plus extrapolation of the data over the last two years indicates to us with some confidence that in the foreseeable future maybe we expect the percentage of facilities with Level 1 citations to drop to below 2.5 percent, and those with Level 2 citations to drop below 25 percent. Level 3 citations, right now it is hovering around 10. It may or may not drop much below that.

If you add all this up, of course, that leaves you with about 62 or so percent of facilities with no finding whatsoever. Now, this is our projection perhaps for the next year. Where we go from there, I mean we are hoping obviously that things will continue to improve, but it's anybody's guess.

[Slide.]

What we have underway is the Demonstration Program, and there will be a special talk on that later this afternoon, so I am going to briefly just tell you that it is scheduled to start next May, and there will be about 300 eligible facilities involved in the program from 14 States all together, and half of these, of course, will undergo the biannual inspection once every two years, and then the other will be used as a control group. It will be interesting to see how that turns out.

The other program that went into effect is the new modality, that is, the Full-Field Digital Mammography. It is only GE right now with their Senographe 2000D that has been approved since January of 2000. By the way, your hardcopy may say 6, so please correct that typo there.

Now, we expect some other companies to get approval in the near future, but again I can't put a date on that. So far, it is relatively still a small number of facilities and units around the country using the Senographe 2000D. We have not cited anyone yet. What we have done is asked the inspectors to check to make sure that the facilities are following the QC procedures as recommended by the manufacturer in this case GE.

The only thing that we have implemented that will trigger a citation regarding a new modality is the training, 8 hours training in the new modality, and we have gotten a very small number of those.

I believe that is it. Thank you very much. Sorry for all the coughing interruptions here, but I can still handle some questions, if you like.

MS. HARVEY: Any questions?

[No response.]

MS. HARVEY: Thank you, Dr. Mourad.

DR. MOURAD: Thank you.

MS. HARVEY: I see that we are scheduled for a break, however, we are ahead of schedule. Perhaps, if that is all right with you, Dr. Finder, we will move ahead with the agenda and have a break a little later.

The next item is the Appropriateness of Current Inspection Follow-up Actions with our Committee Discussion.

Appropriateness of Current Inspection

Follow-up Actions

Charles Finder, M.D.

DR. FINDER: As a lead into this discussion, I wanted to focus the committee's attention on the following and get their opinions on this.

Under our current system of inspection finding follow-up, Level 1 inspection findings result in the generation of a warning letter from FDA and a response from the facility within 15 days of receipt of that warning letter.

To streamline the process for responding to Level 1 inspection findings, FDA is proposing to modify the current system. We are proposing that instead of issuing a warning letter for all Level 1 findings, facilities would be told that they have 15 days to respond in writing to the FDA. This would be similar to the way that Level 2 findings are currently handled in which facilities have a 30-day response time.

Warning letters could then be reserved for those cases where the facility's correction action was deemed not to be effective or timely, and FDA is asking the committee's comments on this proposal.

Does anybody have any comments, questions?

DR. PISANO: Could you just summarize again? It is basically getting rid of the warning letter, is that the main change?

DR. FINDER: Let me again briefly go over how the system works right now. If a facility is found to have a Level 1 citation, a warning letter is pretty much automatically generated. When the facility gets that warning letter, they have 15 days to respond.

If they generate a Level 2 currently, at the time of the inspection, that report is left with the facility. They have 30 days from that time to send a written request. What we are proposing is to change the Level 1 so it is closer to what the Level 2 is, so that at the time of the inspection, when the inspector leaves the report, the facility has 15 days to respond.

At that point, if the response is deemed inadequate, then, a warning letter would be generated. What we are trying to do is make this system more efficient and more responsive to the conditions that are found in the facility.

I will say that it is not uncommon for certain citations to find out that when the facility responds, that there is really no violation in terms of quality.

To give you an example, we do have a number of Level 1 citations for personnel for initial qualifications, and generally, when the facility responds, they respond with the documentation that shows that the person is qualified, it turns out it is merely a documentation issue. So, what we are trying to do is eliminate those type of warning letters because they go out first under the current system.

So, that is what we are talking about, and we would like opinions and comments - should this be a general thing, should it be restricted to certain citations, things like that.

DR. YOUNG: The effect then would be to shorten the time to cure.

DR. FINDER: Right. Actually, that is one of the byproducts of this. We expect that we would actually get quicker responses and quicker corrections to these things than we have under the current system.

DR. KARELLAS: It sounds like a very reasonable approach, and it will avoid people having a warning letter, as you say, that later is found out that they may not have been in essential violation, although technically, they might be, so it sounds very reasonable.

MS. HARVEY: Are there any of the Level 1 violations that might be of such a serious nature that we could have a two-tiered approach to some of the violations?

DR. FINDER: That is certainly reasonable, and we have considered that. One area that I think we would want to issue a warning letter immediately is the case of a Level 1 phantom failure.

The reason for that is before we issue those, we generally have a verification process that checks those phantom images, so that those tend to be real, and we would want to proceed with further actions on that, so I think that is certainly one.

If there are others that people are aware of, I can quickly go through a list of some of them if the committee wants me to and if they feel that they should have an automatic warning letter on these types of things, we certainly can consider that if anybody wants.

DR. PISANO: The main question I have is how well informed the sites are about their violations when they leave, when the inspector leaves. I don't know if that is variable from State to State or pretty uniform across all States, because clearly then if you don't send a warning letter immediately, you open yourselves to concerns or complaints of not knowing that they had a Level 1 violation.

DR. FINDER: That is a very good point. I think some of that will be addressed in a later presentation where we have the facility survey that we did where we actually query the facilities on what they are told, what they think about the inspection, and those type of issues.

But obviously, the fact that those reports are left with the facility is notification of the citations that did occur during the inspection.

DR. PISANO: So, that is happening in all States is what you are saying. They are given a written document that tells them they are Level 1.

DR. FINDER: Generally speaking, most inspectors leave the report, because they have laptop computers that they take there with them, with printers, so they can actually generate a report in most cases.

Now, occasionally, they won't do that, they will send it in later, but even in those cases where they send the official report at a later date, they inform the facility. They have an exit interview where they tell the facility exactly what was found at the inspection, so they are aware of what is going on.

DR. PISANO: Who is generally at the exit interview?

DR. FINDER: Good question. Basically, it is the inspector going over the results with the people that are available. They try and get the most responsible person at the facility. It is a question of who is available at the time, though, so it is variable.

DR. PISANO: I am just concerned about any oral communication instead of written communication because clearly, even if they are told they very explicitly, they can always say later that they didn't hear what the report said. So, if you do have to delay a written communication, it seems to me you need to create some mechanism where if there is a delay in that written communication, there has to be some confirmation that they heard.

DR. MOURAD: The inspectors do hand out certain documents, if you will, in writing, that are left with the facility. If it is a Level 1, they tell them you have got a Level 1, and this is what you are supposed to do, and if they get a Level 2, the same thing, so everything is there.

DR. PISANO: I don't mean to keep hammering on this point, but my concern is that if you don't have a letter that comes from the FDA, if there is nothing in writing, then, there could be a claim that they didn't hear the reports.

So, what I am suggesting is similar to what we are doing for patients, which is to provide maybe a sheet that is preprinted by FDA for the sites that can't print something up, that just allows them to check something off and sign, so that you know that they were handed a piece of paper, and they know about their Level 1 violation.

I am just concerned about something kind of falling through the cracks.

DR. FINDER: Let me just add again in the vast majority of cases, the full, complete inspection report plus how to respond to the inspection results are handed out to the facility. It is rare when they are not given the written results of the inspection. Usually, if there is a question, there is incomplete data, and the facility wants some extra time to bring this in, but usually, they get that written report then anyhow in a few days.

I hear your comments about it is a verbal communication and how that can be documented, and things like that. We can certainly look into that and deal with that.

DR. BARR: I am Helen Barr and the Deputy Director of the Division of Mammography Quality and Radiation Programs.

One thing I wanted to mention is that in our very recent, this spring, facility satisfaction survey, we asked a question if facilities received citations, and if they did, did they understand the citations and how to respond, and I don't have my glasses on, but it looks like 96.7 percent understood their citations and how to respond to them.

Also, under general FDA workings, in all inspections, not just mammography inspections, but all other inspections that the Food and Drug Administration does, that the post-inspection report, which goes by other names in other inspections, but can legally serve as a written warning document, and does indicate the level on there.

DR. PISANO: I don't mean to keep hammering on this, but the concern I have, 96.7 percent sounds great and it is wonderful, but the 3.2 percent or however many are left are the ones that are going to give you problems, because those people, in a month or two, and they haven't responded, you end up moving to shut them down or whatever you are going to do with them, they will file a lawsuit if you don't prove that you told them about the Level 1 violation, and that is what concerns me is the downstream consequences for the few dissatisfied people.

DR. BARR: As I just said, the inspection report serves as legal written documentation.

DR. PISANO: Okay, but it sounds like not every facility gets one at the exit interview, and that is all I am saying is for those facilities, they need a way to document that the communication took place.

I am thinking legally here because I do mammography every day, and I can tell you that we all think legally. You know, 100 percent is the only acceptable criteria.

DR. KARELLAS: Dr. Finder, you mentioned about notification. When you mention notification, I understand it to be written, so I agree with Dr. Pisano that verbal communication is not adequate, but the way I understood it is that it will be written. It will not come from the FDA, but it will be written by appropriate authorities.

DR. FINDER: Let me just clarify one thing. When we are talking about the inspectors leaving the inspection report, that is documentation from FDA. They may be State inspectors, they may be Fda inspectors, but is part of the MQSA program, so that is our notification.

What I am trying to get at is that even in the cases where the reports are not left that day, they get it within a few days after that anyhow, so you are talking about a few days difference here, and I agree with you that verbal notification in and of itself is not sufficient.

I don't believe that in those few cases where it is not left that day, that there will be a problem in the sense that they are going to get that written report in a few days anyhow. Most of those times it is because the facilities and the inspectors have agreed to work out some issue, for example, that documentation wasn't present, but they could get it the next day, so they don't want to leave or generate a report like that. They will give them a day or two to do that.

MS. HARVEY: We have a comment from the audience. Please state your name.

MR. DEVINE: My name is Mike Devine. I work with the Division of Mammography Quality and Radiation Programs.

I wanted to address an issue which was brought up about how we notify people, and FDA has a policy which applies across the board in terms of how we notify and how they get the documentation like the warning letter.

Our policy is that we try to send the warning letter to the most responsible person at the facility, and also the issue of taking regulatory action, that notification in advance is very critical, so I don't think there is ever going to be any kind of serious action taken against a facility unless they have had some warning in advance.

MS. HARVEY: Any other questions?

MR. CAMBURN: Maybe this has already been addressed. I just have a question on behalf of the MQSA inspectors out there. When they complete the inspection, are they going to be in a little more of a quandary about what the level is ultimately going to be, or will they still have the information to tell the facility you are at a Level 1, and FDA, for this Level 1, is not going to give you a letter, or maybe you are a different type of Level 1, that is more serious, that you will get a letter, or are they just going to kind of throw up their hands and say, well, I am not sure exactly what is going to happen?

DR. FINDER: If we go ahead with this, right now what happens is in addition to the inspection report, there is also a letter that goes with it that explains how to respond, how the facility should respond to the level of citation.

A similar type letter would be generated for this, so instead of the current letter that says that you will get a warning letter from FDA for your Level 1, and then you have to respond, it could say you have 15 days to respond in writing to FDA.

Now, if we decide that some Level 1's will get a warning letter and others won't, they will have the 15-day response, we will put that in that letter and clearly explain to the facility what their responsibilities are and how they are supposed to act, so the facility would know and the inspector would know.

DR. BARR: I would just like to say that this isn't a unique or novel idea for us. The Center for Devices and Radiologic Health is doing a warning letter pilot with the device manufacturers to give them 15 days to come up with a satisfactory corrective action plan, and then decide whether to issue the warning letter.

The whole time frame, as Dr. Young mentioned, would actually we think be quicker than the current time frame where we are often getting Level 2 responses before we get Level 1 responses, and that is the whole idea behind it is to increase the correction response time and to decrease erroneous warning letters which don't need to be issued to the facility.

MS. HARVEY: Any other comments or concerns?

[No response.]

MS. HARVEY: I think not.

DR. FINDER: The next item on the agenda is lunch, but I think it is a little early for that.

MS. HARVEY: Perhaps we will move to Good Guidance.

DR. FINDER: Why don't we take a little break now?

MS. HARVEY: Okay. We will reconvene at 10:15.

[Recess.]

MS. HARVEY: Now, we are going to be guided with Good Guidance Practices and Directions for Discussion of MQSA Guidance under the Final Regulations.

Dr. Finder.

Good Guidance Practices and Directions for

Discussion of the MQSA Guidance under the

Final Regulations

Charles Finder, M.D.

DR. FINDER: Before we begin our discussion of the proposed Final Regulation guidance, I would like to briefly explain the procedures that FDA is following as it develops new guidance.

In response to public comment regarding the use of guidance documents, FDA held an open public meeting on April 16, 1996, and again on February 27, 1997, they published a Federal Notice outlining the steps the Agency needed to take prior to issuing guidance.

In brief, it stated the following:

1. Guidance had to be developed in an open manner that permitted input from the general public and the regulated industry. In most cases, new or controversial guidance had to allow for such input prior to its implementation.

2. While the statutes and their associated regulations were binding and enforceable, guidance was to present a way or one of several ways of meeting the regulations, but other ways would be acceptable as long as they met the requirements of the regulations or the statute.

Before we begin our discussions, I would like to emphasize the following: We are here to discuss the proposed guidance, not the underlying regulations. Regulations have already gone through their own extensive approval process, and while they are subject to future change, the purpose of today's meeting is to address proposed guidance.

The documents we will be discussing today contain a mixture of regulations and guidance. When you see words like shall require or must, the refer to the underlying regulation, whereas, the word should, may, or recommend, refer to the guidance.

The committee will be reviewing some documents, some of which have already been released to the public, and others that will soon be released for public comment.

Does anybody have any questions?

[No response.]

DR. FINDER: I would ask again the people in the audience who are federal liaisons or AV representatives if they could give me their most current mailing and e-mail address information.

With that said, any of the committee members missing their questions? I have a couple extra copies.

I will turn this back again to Ms. Harvey. You can go this question by question, or page by page, however you feel is most appropriate.

MS. HARVEY: Well, I think we will begin question by question and see how that works.

The first question has to do with measurement of focal spots at all possible magnification values. The answer that was given allows the test to be done at magnifications if clinically used and then at a magnification factor as close to 1.5 as can be achieved by the system.

DR. FINDER: Let me also explain a little bit about what you are looking at here. This question actually appears in our current guidance. The underlined portion is our proposed change. The reason that we are proposing it, as in many of the other areas where we have similar type changes, is because we got comments from the public that this was still unclear, that the guidance was still unclear, and we are hoping to further clarify it by making this modification. The modification we are talking about is adding the words "if magnification is clinically used and then at the magnification factor as close to 1.5."

So, just for people in the audience to understand what we are looking at here.

MS. HARVEY: Any comments? Dr. Karellas.

DR. KARELLAS: This appears reasonable in general. The only question I have is if there is a facility that they do routinely magnification of 1.7 or 1.8, where in my own experience, at least where I am, we don't do that, because we don't get good results, but should these people switch and do it at 1.5 versus what they do routinely at 1.8?

DR. FINDER: Basically, yes, because if you go to much higher magnifications, we found that the criteria that we have established may not apply, and that is why we are telling facilities, if you are going to do the testing, do it at close at 1.5.

DR. KARELLAS: The recommendation appears reasonable, and a qualified physicist can use appropriate judgment to evaluate the performance. I believe that 1.5 is a very good reference magnification for that assessment.

MS. HARVEY: Any other comments?

[No response.]

MS. HARVEY: Our next question has to do with the weekly phantom test. When performing the weekly phantom image test must we monitor kVp and/or mAs?

The major change that we see here has to do with the addition of a second alternative, which is the use of the Full-Auto mode to establish baseline mAs values corresponding to the specific kVp values usually encountered during phantom testing.

If the mAs value is within 10 percent of the baseline value for the post-exposure kVp value, the unit has passed that portion of post-move-pre-examination test.

DR. FINDER: Is that clear to everybody?

MS. HARVEY: That is to do essentially with mobile facilities?

DR. FINDER: Right.

MS. HARVEY: Who are required to do testing prior to initiation of examinations after they move the equipment.

DR. FINDER: If anybody wants some background on this, I will be happy to supply it. If everybody is clear on this and happy with this, I don't have to necessarily go into it. Of course, we are ahead of schedule, so I will be more than happy to offer background. No questions?

MS. HARVEY: Okay. Thank you.

Next question, page 2. What is considered adequate weekly phantom QC monitoring for a facility that has multiple processors and multiple units?

This is a new question and this is a new response. It has to do with interchangeability between units and the processors. If we have more than one unit and more than one processor, we have many alternatives for which processor will be used for each unit, and there is a desire, I believe, that the test is performed for all combinations that are available.

Any comments?

DR. FINDER: Before we leave this question, I would actually like to ask a couple of specifics because I want to be sure in my mind and FDA wants to be sure that these things have been considered.

In order to do this, we have established or created a definition here of what it means to be matched, for the processors to be matched, and we have set that as an optical density of 0.05.

Is that a reasonable definition for a matched processor? Do we feel that that is something that facilities can actually meet out there without too much trouble? We obviously don't want to create an option here and then find out that nobody can use it.

The other side to that is we don't want to create a situation where it is too easy to meet and we lose the benefits or we can negatively impact on the quality. So, the question really is do we believe that that is a reasonable definition for matching.

I see some heads nodding up and down rather than side to side.

DR. PISANO: Are you saying it's a new requirement?

DR. FINDER: It is not a new requirement. Actually, this is an additional option. Right now the way the regulations are written, facilities would have to do all permutations, and what we are trying to do is decrease the number of phantom images that have to be run, but we do want to do it under conditions that we feel would be adequate.

Obviously, if the processors are very far apart, you are going to get different values, and we are worried that you are not going to ensure the same quality. So, if we are going to allow this decrease in the number of phantoms that have to be run each week, we do want to make sure that the criteria that have been established are adequate to ensure quality.

Now, if people want to think about this a little bit and respond later, that is fine, too, but again I seem to be seeing heads going up and down rather than side to side, so I will take that as a yes.

Now, if we assume that this matching criteria is adequate, does anybody have any problem with the concept that we are coming across with about allowing the decrease in the number of films? Again, I see heads going side to side, not up and down, so I will take that as a no in terms of nobody has any problems with that. Is that true? Okay.

My third question about this, if we have now agreed on the previous two issues, can we apply a similar type process to system resolution testing? I know this wasn't included in this, but I am asking. Again, you don't have to answer or even nod your head at this moment. Think about it a little bit, and we can even talk about it later on in the meeting.

DR. PISANO: Could you explain what you mean exactly, what are you thinking?

DR. FINDER: There is also a system resolution test. In 2002, we are talking about basically evaluating the focal spot. Right now you can do it two ways. You can do it either through a system resolution test or you can do it by measuring the size of the focal test.

After October 2002, the only option is a system resolution test, and what we are saying is because you have to run films in order to check the resolution, can you decrease the number of films that you have to run through that system if you have got matched processors.

DR. KARELLAS: System resolution does not depend very much on the processor unless the exposure is way under or way over exposed. It is a function of the cassette itself, film-screen combination, and the focal spot, so it does make sense.

DR. FINDER: And that also brings up the other point of obviously, with these system resolution tests, we would be talking about people testing with their various film-screen combinations.

MS. HARVEY: Mr. Bailey.

MR. BAILEY: Ed Bailey from California.

Going back to that previous question, does this mean that a mobile facility that may be doing on-site film processing at a number of locations, all of them would have to fall within this percentage or within the 0.05 optical density?

DR. FINDER: Oh, you are going back to the previous question that we talked about.

MR. BAILEY: I am sorry, yes. For instance, if you had a mobile service that maybe had three vans that go around to five or six places, each x-ray unit and each processor at those facilities would then have to be matched.

DR. PISANO: You are allowing another option of them not being matched, right?

DR. FINDER: Basically, what these questions do is give more options than what they have got right now, but I am still unclear. You may be mixing--well, we have got two similar type questions here, the previous one which talked about the mobile and giving them the use of the Full-Auto mode and that 10 percent--you are not talking about that?

MR. BAILEY: No, I am talking about Question 3, the one at the top of the second page.

DR. FINDER: Okay. We are still on that question. If the processors are not matched, all they have to do is run the phantoms through those like they would anyhow. If they are matched, they could decrease the numbers, but if they are only using one mobile unit anyhow, this doesn't really come into play, I don't believe. It is when you have multiple units and multiple processors that you can reduce the number of phantoms that you run each week.

MR. BAILEY: Okay.

MS. HARVEY: One more speaker. Yes, sir.

MR. USINOFF: I am Bob Usinoff, Fuji Film Medical Systems.

On the language in this question, I think the committee should be sure. My question is about operating levels, and I think the intention is that that is a process aim [?] level rather than a point on a given day, and that might be clear if that is the language that is used in the regulations, that operating level means an aim point for a QC chart, I don't have a concern about that.

A second small point. Within 0.05 optical density, if the difference is 0.05, that wording might be ambiguous. I might suggest 0.05 or less, or something like that.

DR. PISANO: That is a good point. No greater than 0.05.

MS. HARVEY: Thank you.

Any other comment on this question?

[No response.]

MS. HARVEY: Our next question has to do with a private radiology practice that has applied for and became accredited and certified. They do not own the mammography x-ray equipment or employ a radiological technologist qualified to perform mammography. They have applied for accreditation using the x-ray unit and technologist from a certified mobile facility that visits the practice periodically.

Do we have to be inspected separately from the mobile facility and who is responsible for correcting any problems found? The answer, of course, is yes, and that both facilities are responsible. This is new language added to the guidance to explain to facilities their responsibility.

Any comments? I think it is pretty straightforward. Okay.

Next question, the bottom of page 2. We use FDA's guidance for mobile facilities where we produce a phantom image after a move of the mobile unit and we monitor the mAs. We then process the phantom image later prior to processing the mammograms.

If we move the mobile unit more than once per week, do we also have to produce a weekly phantom image in addition to the phantom produced after each move? The answer to that would be no, you have the phantom images that you have produced before each one of your moves. Am I reading that correctly?

DR. FINDER: Well, actually, it is a little bit more detailed. You have an option there. If the mode that you are using is the one that you use clinically, then, you don't have to produce another image, but if you are not using that mode, then, you would have to produce a phantom image, because the regulations require that the image that you use for the weekly phantom test be done in the mode clinically used for the standard breast.

DR. PISANO: What other mode would you use?

DR. FINDER: Well, especially with mobiles, when they were following our previous guidance, they didn't do onboard processing, and they would have to go to, let's say, an AEC mode and monitor the mAs, whereas, when they were doing patients, they would do them in a Full-Auto mode.

In that type of a situation, that is what we are trying to clarify here.

DR. PISANO: I have a question about this. What if a facility runs the mobile unit for two weeks at the same place, so they are not moving, they are staying in the same parking lot at the same factory, so they are not going to do a phantom except every two weeks in that case, is that correct?

DR. FINDER: No.

DR. PISANO: They would still have to do it weekly then?

DR. FINDER: Do a weekly phantom, right, they just don't have to do a post-move pre-examination test.

DR. PISANO: So, this question refers to the extra, they don't have to do the extra ones, but they still have to do one once a week.

DR. FINDER: Sure, exactly.

DR. PISANO: Okay, only if they move it more than once a week is the way the question is worded.

DR. FINDER: Right.

MS. HARVEY: Any comments? No. I think everyone is comfortable with that.

Next, page 3. We have an FFDM unit and do not keep hardcopies of our exams because they retain their images electronically. When patient request the release of their exam, we create a hardcopy for them. May we charge the patient for the cost of creating the hardcopy?

The answer has to do with the fact that the facility may not charge for creating the first hardcopy version of the mammogram, but may charge for second copies. They may pass that cost on to the patient.

Any questions? Dr. Karellas.

DR. KARELLAS: I have a comment on this that we ought to be aware that that means that the facility must have a hardcopy printer, and although I believe most will have for other reasons, educational, certification, or rather accreditation issues, but in the long term, people would anticipate having digital mammography with no printing, so that is a concern of mine from the financial point of view because filmless means filmless, and having to have a printer above and beyond that may be something that some facilities may not like, but the reality today is that most, if not all, facilities will have to have some capability for printing.

DR. PISANO: I have another comment on that issue, too. It is also not the case that you can just, as with the processor for mammography, when you print for mammography, you cannot necessarily print appropriately for diagnostic accuracy purposes without setting the printer up just perfectly.

So, if you have a printer that you use only intermittently for mammography, it is not likely to produce a diagnostic quality image. So, this is as little more complicated an issue than this question implies, because if they print up images that a patient is going to take to another facility to have an interpretation read, it is not likely--unless they are using it all the time for that purpose--it is not likely it will be able to be used for that purpose.

MS. BROWN-DAVIS: Then, that is a problem, that is a major problem.

DR. PISANO: Yes, it is.

MS. BROWN-DAVIS: Because every woman has a right to actually have in her hand her mammogram, because we have already, you know, gone through the issue of storing--and I realize later in this document we know that those facilities that are out of business have some responsibilities, and I have some comments about that--but that is a real problem. I am glad that you brought that up.

DR. PISANO: Actually, I have an answer, I think, but maybe not a good one, I don't know. I agree with you completely that every woman has the right to her mammograms and should be able to get second opinions with them.

The issue that comes in my mind--I am sure Andrew has the same experience--is that you can provide an electronic copy of the mammogram to a woman on a CD or some other media. The issue there then becomes if you have an electronic copy is the ability of the person who receives it to be able to display and read it, because there are issues of the way that the images are displayed.

So, any facility can provide an electronic copy with or without a printer, the question is can the user at the other end read the images if it is an electronic format, because obviously, there are requirements for that.

DR. KARELLAS: We may be a little bit ahead of the time, but I believe ultimately the patient could be given a CD. I think it is a little easier on a facility, and if she needs a second opinion, we are moving very fast forward in that direction in ability to read.

I believe that a CD with the information makes more sense than a printed film from a printer that may or may not be QA'd on a daily basis, and it would probably take more time to optimize that for each case.

DR. RAMOS-HERNANDEZ: I thoroughly agree because I think from the consumer perspective will be who is supposed to pay for that copy, the extract copy, is the patient, is the medical insurance, and we have several women that might not have access to those resources, so it will be barrier for women to get second opinions or even to carry their own files.

DR. PISANO: I just want to emphasize also that just because you provide a woman a CD with the image on it, doesn't mean that the person who is being asked to give a second opinion can read the images or display the images in an appropriate way at high enough quality for diagnostic accuracy.

There are lots of issues about the way the images are headed. Not all the manufacturers at this point, only ones that are FDA-approved, but the ones that are out there have the appropriate Dicom header for reading mammograms on it, the latest Dicom header I should say.

In addition, the display systems, if you try to read a mammogram on a Windows box in your office, just a regular IBM-PC or something, there is no way you are going to have high enough quality. You really need a very fancy workstation to read mammograms with adequate quality.

So, this is a very complicated issue. It is going to be a hard one. We are not there yet. We will be, I agree with Andrew, we will be soon, but we are not there yet.

DR. KARELLAS: I agree with Dr. Pisano. Giving a CD, it really automatically means that this patient will have go to some facility where they have virtually the identical equipment set up.

DR. PISANO: The other method is also through electronic file transfers. I mean that may actually be more useful and easier in the long run than actually providing a hardcopy. The patient could request please send to this FTP site or this location my images, and then it would be very quick and easy and cheap.

DR. FINDER: I would like to give a little background and hopefully clarify some of these things. The question that we are dealing with now basically deals with cost in terms of who pays for what, and what we basically said is in a similar manner to what is now required of facilities in terms of film-screen, the facility can't charge for the first copy of the digital image.

At the present time, we are talking about hardcopy for the patients, because the number of places that can actually use electronic versions is small at this point, and this has been discussed at other committee meetings earlier.

However, I believe we have addressed some of the issues that have come up already in a later question on page 5, beginning line 34, where we talk about what constitutes a mammogram and what you can do with it, and we do have a modification here to address actually the issue that was just discussed, about transfer electronically of these images.

At the present time, what we are saying is, we are talking about hardcopy for right now except in the case where both parties are agreeable to getting electronic, and that would basically relate to situations, as we gave an example, between two digital facilities that have the same equipment, that can actually use those things, but in other cases, we are talking about facilities having the ability to create a hardcopy, and we have stated in here that it has got to be of primary interpretation quality, so that these images are useful. It obviously does no good if you do it on a printer that makes it look like it comes out of the old fax machines.

These copies have to be of primary diagnostic quality, and that guidance has already been out. This isn't new.

DR. KARELLAS: I understand that this presents a problem, but that will require the radiologist to go back and review the case and print it, and the printers are slow, and it takes considerable amount of time. I am very sympathetic to the patient cost issue and the availability, and I am split between that and some allegiance that I have to the health care organization that becomes problematic in terms of the finances, so I think it is a real tough issue financially.

DR. BARR: Everything you are raising is certainly important. Let me just put in a reminder that at this point, though, anyone who wants to--which Penny Butler will be explaining later--anyone who wants to get accredited, which they are going to have to do shortly for the digital unit, is going to have to submit hardcopy for accreditation, so virtually, at this point in time, where we are now, is that all facilities have to have the ability to create hardcopy.

We aren't there yet, they are all good issues, but the accreditation procedure is going to be hardcopy, so that is pretty much where we stand right now. Thank you.

DR. KARELLAS: Again, to take much of your valuable time, but it is a very critical issue. For the accreditation providing a hardcopy does not necessarily mean that the processor and the printer is always on a day-to-day QA mode if you never use it for patient interpretation.

Theoretically, I do not know whether that is proper, but you may have the processor running properly only for the time that you need the accreditation phantom. You could turn it off and say the processor will not be used for any patients until we clean it and we recalibrate it, because it doesn't make much sense if nobody uses it for interpretation to QA the printer every day.

DR. FINDER: Let me just add nobody is saying that you have to keep these processors operating every day. It is they have to be in limits when you need to make the films.

I would imagine that, for example, the number of patients for times when a patient would actually need the hardcopy might be relatively small out of the total, but the end result or the end process that we have to get is that the patient has to be able to get her films, so that she can use them, she can take them for consults.

Many surgeons will want to look at these images before they do surgery. They need to look at these things, so there has got to be an ability to get them the information.

At the present time, electronic transfer just isn't there. Hopefully, it will be soon or in the not too distant future, but until that happens, all we are saying is right now you do have the option of doing electronically, but both sides have to be agreeable. If not, there has to be hardcopy available, and I think that is for the foreseeable future.

We have been telling digital facilities that they have to have this capability, so it is not anything new that they are getting.

MS. HARVEY: Clearly, this will be an issue we will be talking about in the future.

On to the next question, which is also about FFDM. We do not have an FFDM unit at our facility, however, some of our personnel use one at another facility. Are we responsible for maintaining documentation showing that these people have received their initial training in the new mammographic modality?

The answer is no, only the facility which the personnel are actively using the unit are required to maintain the document.

Question: How long must we maintain the records of our medical outcomes audits?

The answer to that is that it must be maintained for at least two years. If the facility has obtained actual pathology reports, these should be maintained until the next annual inspection.

Any comments?

[No response.]

MS. HARVEY: The next question. When we assign a negative assessment to the mammography report, our reporting system automatically generates a normal lay summary. In rare cases, we have patients that have negative mammograms, but for other reasons we want that person to have further workup or even biopsy.

In such cases, can we assign a different assessment category to the mammography report, so the correct lay summary automatically goes out? Can the medical report and lay summary have recommendations that are not the ones normally associated with a specific assessment category?

The answer: While circumstances as described above should be relatively rare, the decision of which assessment category to assign to a specific mammography report is left up to the interpreting physician. With respect to recommendations, the interpreting physician can make any recommendation he or she believes appropriate.

The doctors are pondering the question.

DR. IKEDA: As a radiologist, we will sometimes run into this situation, and I am glad that it has this clarification because on the rare occasion in which a mammogram is normal, and the woman deserves a biopsy, I think it is helpful to clarify that to both the referring physician and especially to the patient that she needs to have further workup, so I am glad that this is in here.

DR. PISANO: Actually, the way we have solved this problem is we actually don't give the patient--the regulation covers the way our report is supposed to read, and our lay language summary, if she needs a workup, says that she needs a workup. We don't give her a normal mammogram report. We tell her she needs a workup only. We also tell her she has a normal mammogram, but she needs a workup, so that is the bottom line that is communicated to the patient.

I am just surprised about this issue. I am surprised no one is doing it the way that we are doing it.

DR. IKEDA: I think a lot of facilities are doing that, but for those facilities who are unclear, I think that this regulation clarifies that issue.

DR. PISANO: That is good, I agree.

MS. HARVEY: Is that assessment incomplete?

DR. IKEDA: No, it needs a workup.

DR. FINDER: One thing that I do want to make mention of, these are actual questions we get in. We don't actually go hunting around and making up our own questions. So, this was a question that we got, and we assume that there are other facilities that have similar type issues, and we want to try and clarify it as much as we could.

DR. DOWLAT: As a surgeon, if I receive a report from Radiology saying that this is negative, yet, there is additional workup to be done, I find that very contradictory. You either are pregnant or not pregnant. Either the patient needs additional workup or doesn't need it. If they don't need it, you say so.

I don't know, what is the example that you have been given?

DR. FINDER: Let me give you the example that we have been given. A patient comes in with a palpable finding. A mammogram is done, nothing seen. There are a couple of ways that that can be handled, but one of the ways, and this is where we get the question from, is what do I do now. Obviously, the mammogram is negative, however, this patient needs further workup, needs a biopsy of the palpable mass or some other evaluation of it.

If the decision is made to go to a biopsy rather than some other type of imaging, the person is kind of left with a quandary as to which assessment category to put this in, because the mammogram is negative, it is not suspicious really although we do allow people to pick which category they want, but truly, the mammogram is negative, but that isn't enough, that is not enough because if the only report that goes out is negative, that patient won't be adequately served, so therefore, the recommendation has to be something else, biopsy or whatever.

DR. PISANO: I think I can clarify where this issue comes from. It has to do with the fact that the terms in the conclusion have to be those six terms, incomplete to suspicious, you know, the whole range of terms.

Those are similar to, but not identical to, the BIRADs terms, because the BIRADs terms are linked to action, as well. They say, you know, benign finding, one-year follow-up, probably benign finding, six-month follow-up, et cetera. That is what BIRADs does, and the FDA do not require the BIRADs action term recommendation to be linked to the impression, what do they call it, the final assessment category, the negative, benign, probably benign, et cetera.

So, I think there is confusion among radiologists, that Debbie is right, she is pointing out that it is good we have clarified that, because if you try to link those in your report, you come up with the contradictory negative, follow up in one year, when you really need to biopsy, but the patient, she needs to be seen by a surgeon, or perhaps have a stereo biopsy or something, but the point is she needs a further workup despite--or probably not a stereo biopsy--but an ultrasound-guided biopsy or maybe a palpable guided biopsy.

It is somewhat confusing to people, I guess.

DR. DOWLAT: I don't think this is a rare situation. We are talking about something like 10 percent negative finding by mammography for a palpable mass, and I see that relatively commonly, 1 in 10 or 1 in 15, with that kind of thing, totally negative mammogram and there is a palpable mass. So, it is not rare.

DR. FINDER: When somebody asks me that question, what I suggest to them is the following: Usually, if you have got a negative mammogram and a palpable mass, the next procedure to do would be an ultrasound. So, the assessment category on those mammograms basically would be incomplete, needs additional imaging evaluation.

However, there are some cases, and again, these are not questions we make up, these are ones that come in to us, what do I do when I don't want to go ahead and do any other type of imaging evaluation. It is still a negative mammogram, but there is a palpable finding, how do I handle that type case?

I would think that the number of cases where you have got a negative mammogram/palpable finding, and for whatever reason they don't want to go ahead and do some other imaging evaluation is small. Does anybody disagree with that from the radiologists?

DR. IKEDA: I think that the other category that this may come from, because I have been asked this question many times at national conferences, and the question is the patient comes in, she has a palpable mass that feels awful, that is really hard, and the radiologist does a physical examination, and it feels horrible. The mammogram is normal, the ultrasound is normal, spot compression, extra mammographic views are normal or within the range of normal, multiple masses, microcalcifications, nothing really to hang your hat on and say this is going to be cancer, but the radiologist still feels that for the patient's benefit, she should be seen by a surgeon and biopsy should be considered.

Ordinarily, radiologists are taught, in BIRADs are taught the assessment code 1 or 2 benign are linked to follow up in one year. On the other hand, these patients deserve a surgical opinion and the possibility of biopsy.

So, in those cases, the radiologist now has the option of going to say the mammogram is normal, however, because of the palpable finding, consideration for biopsy might be considered.

DR. PISANO: Actually, I agree with Dr. Dowlat, that this is not a rare event. What you are describing, Dr. Finder, is a rare event. In our practice, for example, we do the whole workup including extra views, ultrasound, et cetera, but there are still quite a few patients that fall into this category where you feel the hard lump or something that concerns you, and you don't find anything, you still feel they need to see the surgeon. So, I don't think it is that rare also.

DR. BARR: I agree with all the radiologists. It happens all the time. What this is doing is what Dr. Ikeda alluded to. This guidance is now giving the radiologist the freedom to assign whatever assessment category will get the patient taken care of within the limitations of how their computer system, lay summary system, whatever, operates.

In this case, the purpose of the assessment system is to get the patient the correct letter and the correct follow-up they need, and not to worry about technically where it fits. This gives you now the freedom to do that.

DR. DOWLAT: Why didn't you give it another number?

DR. IKEDA: It is hard enough with five numbers.

[Laughter.]

DR. PISANO: I think if you just eliminate the fact that it is rare, I think that that is the only part of the thing that you are hearing that we don't agree with. The rest of it is good. If you eliminate that whole first clause, then, you just have a perfectly reasonable answer.

MS. HARVEY: Next question is just a modification of previously issued guidance. Are all regulated mammography units in the facility required to be accredited and, if so, what documentation is necessary to establish that this has been done?

We have removed the comment "or medical physicist's survey."

DR. KARELLAS: I think the rationale for that is because you do not want to create a confusion because it says "or," because the equipment evaluation, that includes part of the medical physicist, is not one or the other, right?

DR. FINDER: The statement as originally written created a lot of confusion because what the unit actually has to undergo is an equipment evaluation, and an equipment evaluation covers certain areas that are not covered routinely in an annual survey.

So, we wanted to make it clear it has to undergo an equipment evaluation at this stage. That is why we took out those words.

MS. HARVEY: Any comments? All set.

The next question. This is a new question and answer. I qualified as an MQSA radiologic technologist in the past year and have been performing mammography for several years. I recently passed the test for the ARRT mammography certificate. Can I claim 24 CEUs for earning this certificate?

The answer is yes, you can claim the 24 credits.

All set? The next discussion that comes up has to do with a six-month provisional certificate. A facility operating under a six-month provisional certificate (including a provisional reinstatement certificate) may be eligible for a single 90-day extension to its provisional certificate. (A facility operating under a three-year certificate is not eligible for a 90-day extension.)

This is all new language.

DR. FINDER: Let me correct. It is my handling of Word, and I couldn't control what it was doing. Actually, this is current guidance. The changes here basically refer to the areas that have been crossed out, but Word made me do it.

[Laughter.]

DR. FINDER: Again, we are trying to be more consistent with how the process is actually working and trying to clarify and simplify some of this guidance here.

MS. HARVEY: So, it eliminates the base effort.

DR. FINDER: We don't go into the details of what they have to do. They have to go through the accreditation body.

The next question, I think I will handle. The addition was we left out the "a" for the word "at." I don't think there will be any comment on that one.

MS. HARVEY: Fine. Moving right along to the next question on page 5, line 21. Do units with multiple AEC detectors have to have each detector tested individually for AEC reproducibility?

Essentially, the answer is each one of the AEC detectors which functions independently must be tested.

Dr. Karellas, are you comfortable with this?

DR. KARELLAS: Yes, I am comfortable with this part, yes.

MS. HARVEY: Any other comments?

[No response.]

MS. HARVEY: Did we actually complete this next question when we referred to it or revisited it?

Question: With the introduction of Full-Field Digital Mammography, what constitutes a mammogram, the digital data or the hardcopy film?

Is there added language here? Facilities may transfer digital images electronically as long as that is acceptable to the recipient.

DR. KARELLAS: Today, when a patient takes their films, they have to sign. When this is done, is there any required documentation or simply just a casual transmit upon request? I don't know whether there are any other issues. The good thing is that the digital data always remains, so you can send the mammograms many times, which provides a margin of safety. Today, if somebody took their films and lost them, then, there is no record.

I don't think it is a huge issue at this point. I think it is more of a logistics, who will receive them.

DR. PISANO: I am sure there are people in this audience who are more expert on this than I, but from what I understand, HIPAA regulations apply here very strongly, and before you can transfer electronic information to anybody, you have to have the permission of the person whose information it is. So, in other words, one of the main reasons we keep records now is to just have a document that says we released it to someone who the patient is giving approval for, so that still applies to this, so you still have to keep records, I believe.

DR. KARELLAS: This actually raises an interesting point. We haven't addressed this, but by your comment I see we have another question and answer that has to come out, and I do believe that the answer to that question will be greatly influenced, not by MQSA, but by the HIPAA regulations, which are still under discussion.

We have a little different concept here. A great part of the current sign-out is to show where the records actually are. In this new process, obviously, the original will still always be at the facility, but there, the need will probably be to document who they have been given out to, because you don't this to be sent out all over the place. These are patient records, and have to be handled with appropriate confidentiality.

The question actually is a good one for another document that will come up, but I think it is going to have to wait until the HIPAA requirements are better established and formalized.

MS. HARVEY: Dr. Karellas.

DR. KARELLAS: Of course, we have to consider the issue of confidentiality on the transmission through the web or other means, so that is a huge issue. Today, if we were able to do that today, I don't think we would do it, because we would be very concerned about the transmission part and the security.

MS. HARVEY: I was thinking that. Does everyone know what HIPAA stands for? Can we kind of guess what it might mean?

DR. FINDER: Portability and Privacy Act?

We have an answer.

MR. LARSON: Health Insurance Portability and Accountability Act.

MS. HARVEY: Thank you.

DR. FINDER: So, we have to wait for that to be formalized. In effect, I would imagine that there won't be anything different or unique about how it is handled under MQSA versus how it is going to be handled for everybody else in terms of electronic transfer of medical records, so we should wait and see what happens, but I am sure we are going to get more questions just about that issue.

MS. HARVEY: We were hoping that digital would make things easier, but it doesn't sound that way, does it.

We have a question. With machines such as the GE 500T and 600T, which do not have a separate mechanism for compression fine adjustment, can tapping the foot pedal for fine adjustment of compression force meet the year 2002 requirement?

We have just one change in the language here. Facilities wishing to modify their units may try contacting third-party vendors offering such modifications for more information, since clearly, more than GE provides this service to people.

DR. FINDER: Actually, GE does not provide the service, so that is why we crossed that out.

MS. HARVEY: Now, we have a change to table involving medical physicist involvement in equipment adjustments, changes, or repairs.

We have a list of a few adjustments in which, at one point in time, it appeared that we needed to have medical physicists to conduct the evaluation, and we modified that.

Dr. Karellas, how does that look to you?

DR. KARELLAS: I believe this was what was already worked up previously with the physicist, Mr. Pizzutiello, who was part of the committee prior to that. I agree with the modifications. They are quite reasonable.

MS. HARVEY: Excellent.

MR. CAMBURN: Maybe I just need some more clarification on this, but it sounds like some of these adjustments are adjustments that might have an impact on image quality or patient radiation dose. If the medical physicist doesn't do the evaluation, should an evaluation be done by somebody, or is this an area that is not going to have an impact on image quality or dose?

DR. FINDER: Let me go over a little bit of the background on this. This was an issue that we thought long and hard about and had gotten a lot of input after we actually published this, I believe it was in document number 3 or 4. Everything that you do can affect dose and image quality, virtually any change that you make in the system.

We got a lot of advice that the types of changes that we are talking about here should not impact adversely or significantly on dose or image quality. The other thing that you have to keep in mind here is that we are not saying that you can make these changes and not do anything.

What we have changed here is the fact that the medical physicist has to come in. We are saying if you are going to make these type of changes, the medical physicist should be consulted and have oversight, and if under the specific conditions they believe that it is required that they come in, then, they have that option. But we got a lot of comments that these types of changes are done fairly frequently, in some places as many as four times a year, and all you are doing is making minor adjustments to get these machines into better calibration with what they are supposed to be.

The concept of them having to wait for the medical physicist to come in to do relatively minor things just was out of proportion to the "risk" that might be there, that you might actually change dose a small amount.

The other thing that we were looking at was the fact that since these adjustments are usually done as part of preventative maintenance situations, you could have the situation where somebody comes in and makes a minor adjustment, the medical physicist can't come for a couple of days, and that unit is shut down for several days at a time. We didn't want to have that happen.

So, from all the consensus that we got from comments that we received from the physicist community, this was a situation where we could allow oversight and not place anybody really at risk, and, in fact, prevent a lot of down side, because units would be put out of operation for extended periods of time really for no good reason. So, that is why we made the change.

MS. HARVEY: A burden on rural community facilities, particularly, and an expense, a high expense.

Dr. Karellas.

DR. KARELLAS: This does not mean, of course, that the physicist should not be informed or consulted. It just relates to going specifically and generate a whole new report, a fresh report on the evaluation.

As Dr. Finder made reference to that these minor changes have relatively small effect, we all agree that there is always some exception to some rule, but the appropriate person or technologist should always notify the physicist if something unusual happens.

The other item that I would like to add is that if it is not the medical physicist or the person who performs the modification or adjustment from the company, there is really no other person other than the technologist, of course, who is the person who safeguards the entire operation because they are always there.

MS. HARVEY: All right. We move on to a discussion regarding accreditation and certification are two separate processes and both are required of mammography facilities under MQSA.

Dr. Finder?

DR. FINDER: Again, this is current guidance. We do have just a few minor modifications here. It is a lot of wordage to make these few changes, but again, it is basically just to be consistent with the way things are being handled at the accreditation bodies.

Again, I wouldn't call them really substantial type changes. So, I would suggest, unless anybody has any qualms about things, that we move to page 8.

MS. HARVEY: Are you moving past page 7, Question 1? Under what circumstances may FDA issue Interim Notices? You are including that, too.

DR. FINDER: Yes, this is all part of the same accreditation body guidance.

DR. YOUNG: Don Young with a question on page 6, beginning with line 36. It says, "To begin the process, it must first contact its selected accreditation body (the ACR or the States of Arkansas, California, Iowa, or Texas if the facility is located in one of those States)."

It is my understanding the States can go outside their respective boundaries for certification and accreditation. The wording of that sort of implies, it is not as clear as I think it could be.

DR. FINDER: We can look into modifying that language.

DR. YOUNG: It's line 36, 37, and 38 on page 6.

DR. FINDER: We can look into making the appropriate modification on that.

MS. HARVEY: Mr. Bailey.

MR. BAILEY: This may be my ignorance, but if a facility, a mobile facility, is accredited by one of the States, and it goes across to the other States, does that accreditation still apply? And the answer is yes, that they don't have to get reaccredited?

A specific example. Someone from California going to Nevada or Arizona or whatever.

MS. HARVEY: Correct, as i understand it.

DR. FINDER: I don't know if we have ever been asked that specifically. Do we have a definitive answer on that for him?

DR. BARR: No, I don't know if we have ever been asked that, but my quick blush thought is that the accreditation follows the unit wherever it happens to go would be my quick answer to that question.

That is a good point that Dr. Young brought up, and some of you may not realize that accreditation is not bound by State boundaries if accreditation bodies wish to accredit facilities in other States, that is a possibility. We don't have that situation right now. We may in the future.

MS. HARVEY: Page 8, Question 2. What should a facility do if its certificate expires before it is accredited or reaccredited?

We have changed the language to allow for a discussion of its options for continuing to perform mammography with its accrediting body. All right.

Next question. Before a facility--this is an important one--before a facility ceases operations and closes its doors, what actions should it take to avoid future MQSA problems and how should it deal with retention of mammographic medical records? "Before" because "when" is too late.

DR. FINDER: Basically, the addition here other than the fact that we are changing from "when" to "before," obviously, you want the facilities to take these steps in an appropriate time frame, is the statement that starts on page 9, line 18. That is new.

DR. IKEDA: I have a question. Changing the terminology from "when" to "before" indicates on page 8, line 42 and 43, so before the facility stops doing mammography, if you change "when" to "before," it will say before the facility stops doing mammography, they are not to display their MQSA certificate, and the facility may file or destroy its MQSA certificate. Before it stops operations?

DR. FINDER: Yes, that will have to be fixed. We don't want them doing that. See, you change one little word.

MS. HARVEY: It has ramifications.

DR. IKEDA: And you have got some nitpicker like me.

DR. FINDER: No, I am glad you picked that up, because otherwise, we would have this in the next modification document instead of the current one.

MS. HARVEY: Can you give us an idea of how many facilities close precipitously in a year's period, leaving their patients without--

DR. FINDER: I would say from our experience, the ones that we get and have to deal with, it is not a large number of facilities, however, the impact from any one facility can be very significant, and we take it very seriously and pursue and try and get these facilities to do what is right. It sometimes isn't easy, because sometimes by the time you find out that the facility has closed, there is nobody there, they are gone.

DR. BARR: Maryanne, we just published an article up on our web site about facilities' responsibilities in closure in this area of the process that we have in place, and you might want to take a look at that, and I agree with Dr. Finder.

We will be talking actually later in the meeting about mammography access a bit, and we may address some specific issues, but I agree with Dr. Finder that the impact on, you know, one patient who can't get her films is difficult, but we did outline our entire procedure in this article, which is the first of a series of three articles about closure and facilities' responsibilities.

DR. PISANO: I just have a question about enforcement of this or how you would possibly be able to make sure people did this, because the facility is gone, the people have moved away, the entity no longer exists, you know, you have a radiologist who practices somewhere else now. I just don't know how you will enforce this or what you are planning to do about it if people don't do it.

DR. FINDER: That is a very good question. We take a two-pronged approach to this. One is, as Dr. Barr was saying, we try and put out the word what facilities are supposed to do, and the vast majority of the facilities out there, if they are aware of what they are responsible for, they will take the appropriate actions, and even without that, the vast majority are.

The next question is what do we do with facilities that don't care, and we are looking at all our options, the fact that somebody goes out of business necessarily doesn't mean that we are dead in the water. There are legal steps that we are considering and talking with our general counsel about going after these people.

They do have responsibilities. You know, it is a problem. For example, if they go into bankruptcy court, there are laws that apply there. We are trying to find out who has precedence in those type of situations. We are dealing with situations where facilities have gone into bankruptcy, and we are talking with the bankruptcy courts to make sure that efforts are required, such that the films remain available to the patients.

So, there are steps we can take even if people walk away from things, but obviously, the more they walk away, the tougher it is to try and enforce things.

DR. PISANO: I just have a follow-up question. Why not require the facilities to send the images to the patient instead of to the facility of their choice, because it just would be much less problematic than having the patient tell the facility. Each patient is going to want them to send them to a different address, and you may not get all--you know, it is just hard to envision how you are really going to do this.

Hopefully, I will never face it myself, but I just don't know how a facility is really going to do it in practice, whereas, then, if you send them to the patient, you have the patient's address, you will know if the patient is not there, because they will be returned to you, you know, those kinds of things as opposed to just getting ahold of all the patients and finding out a place where they want them sent.

I am just asking, I don't know what the right answer is.

DR. FINDER: We have looked at this. What we are trying to do here is give options. The more options we can give that still satisfy the basic need for the patient to have access to the films is what we are trying to get.

There are limits to what we can require. Obviously, as you pointed out, if they are gone, we can require a lot of things, and it is not going to get done until we may have to take further legal actions about it.

Again, what we are trying to do is give more options here. Hopefully, the more options that are available, the more likely facilities will be to at least pick one of these options. Again, all we care about is the fact that the patients have access to their records, so we are going to try and do whatever we can to do that.

MR. CAMBURN: In the State of Michigan, we have had a number of problems with mammography facilities going bankrupt and just walking away from their films. About two years ago, we had five facilities under one ownership close down and go bankrupt. They were petitioning the bankruptcy court to allow them to put the films in a dumpster and walk way from them.

It took intervention from the Department of Attorney General, it took intervention from the American Cancer Society, from the Michigan National Guard to help box up films and transport them, and it took volunteer medical facilities to say they would accept the films and get them to the patients.

Just last fall, we had two more facilities file for bankruptcy, the same type of thing. They weren't going to throw the records out, but the responsible persons just disappeared, no money available to do anything.

Michigan currently is considering trying to do two things. I don't know if any of these will be satisfactory or not, but one is to require mammography facilities to post a surety bond when they become accredited and to make sure it is renewed every three years with that bond sufficient to cover the cost of closing their facilities down and storing the records, giving them to patients.

Another possibility is requiring them to have a contract with an independent mammography company or facility, such that if either one of them goes bankrupt, the other one has a contract to accept the other facility's films and maintain them, and give them to patients.

This is all early and some of the negotiations in Michigan maybe won't go very far, but I suspect this is a growing problem from what we see.

DR. LEE: We had a condition where a provider closed their doors, and after numerous phone calls, we were able to locate where they were, and they actually did have the films stored somewhere, but for the consumer who is trying to make an appointment with the provider that closed down, they had no idea where their films were.

It would be nice to, of course, have the films stored somewhere, but how is that consumer supposed to find out where to get ahold of her films?

DR. FINDER: This addition here to the guidance actually addresses that in some manner. We are asking facilities to let us know, because we get patient complaints when the patients can't get their films, and if we had the information of who they could contact, that would be a great help, and that is what we are asking for facilities to do, to send us that type of information, so we can then pass it along to patients. We do have an 800 number that patients can call if they have got a problem.

DR. LEE: So, you would advocate that the patient actually call you to find out?

DR. FINDER: Well, I wouldn't advocate it, but as a last resort, that they call us. Obviously, the best situation would be where the facility has notified its patients in some manner where to get the films or that their facility has been taken over by another facility, so it's seamless, but in those cases where it isn't, there are various degrees of acceptability, and down toward the bottom is that the patient actually has to call us to try and find out where her films are.

It is obviously not the optimum situation, but it certainly is better that she call us and find out how to get her films than have no way to find out where things are going.

There is no question. This is not a good situation when a facility goes out of business and goes bankrupt or, you know, locks up their films. We are trying to come up with ways to maintain access for the patients, and it is not easy. There is no simple solution.

As Michigan is looking at it, you know, they have got some ideas, we obviously couldn't require anything like that without having to go through a new regulation process, that would be a new regulation. Again, we are talking here about guidance. The best we can do at this point in terms of guidance is this.

The number of facilities that are in this type of situation are relatively small. Some of the corrections or solutions that are being proposed, I could see some of the radiologists kind of squinting about having to put up a bond to guarantee this when we have already got problems with facilities who have trouble staying in business.

These are things that we would probably discuss if it comes down to it, at a new regulation type, but not as a meeting where we are just discussing guidance. It is certainly something we can discuss in the future.

Hopefully, the processes that we have got going right now will prove fruitful and will help these patients who are in these situations get their films. In fact, we use the Michigan example of where they got various groups involved and went to the bankruptcy court. We are doing the same thing in these other cases where we are aware of the facility going into bankruptcy, and we are using Michigan as an example of how to deal with some of these situations.

MS. ELLINGSON: I just had a thought about Dr. Pisano's idea of them sending the films back to the patients. With a mobile population, I am afraid you would have a lot of films in a dead letter file someplace. I would favor in the guidance keeping that practice together and notifying the public by some means, newspaper or whatever, that this practice has closed, the films will be maintained, and sort of keep them together and let people draw them out one at a time rather than break up the practice and you don't know where they would go.

DR. RAMOS-HERNANDEZ: Would it be appropriate to add some language about digital mammography since there might not be several facilities right now using it, but which will be the form that the will keep the records, because let's say that one of them closed and they keep their records in hardcopy in the facility or anybody will not be able to use them?

DR. FINDER: I think we have kind of addressed that generally, but not in a specific question. The record retention requirement is irrespective of what type of modality, mammographic modality they are using, so the requirements are still the same. The patients still have to be able to get a usable copy whether it's digital, whether it's film-screen, whether it's xeroxed, whatever, not that there are any xerox out there anymore.

I think it's generally covered in that. We don't have a specific question. Maybe in the future we will get more questions specific to that, and we can address those as they come in.

DR. LEE: You already have in the guidance about arranging for the transfer of the medical records. I was wondering if it would be good to suggest that the facility also, as Nancy suggested, have something in the newspaper about their closing or even if you discontinue a phone number, you at least have the option of 30 days, this is the number that you can call to find out where we have your films or something like that, just so that the consumer knows where she can find her films.

DR. FINDER: I think that is a reasonable addition. We can come up with some wording to address that they should try and notify the patients.

MS. HARVEY: Mr. Bailey.

MR. BAILEY: Ed Bailey from California. We have had a little experience with bankruptcy. In one case, there were 4,000 patient films that we physically took possession of. They had sort of been thrown in a warehouse.

We went through the process of sending a letter to every single one of those people, and out of that 4,000 women for that facility, we got about 1,000 people requesting their films.

The question of bankruptcy, and so forth, I think is very important. We recently had one company go bankrupt, had 12 facilities. That represents 1.5 percent of all the facilities in California. To me, that is a fairly significant number. I mean 1 percent, you don't think of as too much, but what happened is the bankruptcy trustee has all those records, but they are not stored in any way where they can be readily retrieved. They are in a warehouse.

The problem of existing records, I think is significant, because a total of one-fourth of all the mammo facilities in California have gone out of business in the period of time that MQSA has been in effect, so we have got literally thousands and thousands of women whose mammograms are basically in limbo.

I saw Dr. Finder sort of raising his eyebrow there about the one-fourth. We started out with 1,200 facilities. We are now down to 800 facilities that offer mammography.

MS. BUTLER: Penny Butler from American College of Radiology. There have been some success stories. We have received a number of phone calls from consumers notifying us that their facilities have closed and the ACR staff has worked with tracking down various individuals at the facility, sometimes even going through the physicists to find out what may have happened, to find some contacts and things like that, and we have been able to help out some of the consumers, patients, retrieving their old films.

Obviously, there are some situations where we reach a dead end and we have been working very closely with FDA and trying to take some additional measures to help those individuals out.

In addition, I will be talking about this a little bit later this afternoon, but when have been notified about facilities closing, and we follow up with a closure letter, we are also asking for a contact person that we maintain in our database, so that if consumers call us, we can refer consumers to this individual to try to get their old films. It is not 100 percent, but there are steps that the various organizations have taken.

DR. FINDER: I wanted to add to what Mr. Bailey said about the bankruptcy in California. We are aware of that situation. We have been dealing with the bankruptcy court, and while it is true that at the present time, those films are sitting in a warehouse uncataloged, we have got the process started or an agreement that all those films will be cataloged and they will be made available to the patients, so we have worked to deal with these situations, so it is not totally bleak. Obviously, it is a tough situation, but when we are aware of these things, we try and deal with them to ensure that the patients maintain access.

MS. HARVEY: I think that one of the problems, we have had this problem in New York also, is how long it takes--

DR. FINDER: Excuse me, sorry to interrupt. I just want to add one thing. Those were radiology facilities. Mammography was just a part of it. So, we have actually been able to do more for the mammography patients than a lot of the other records that are being held by those places where nobody is pushing to keep those, so I just want to make that clear.

MS. HARVEY: One of the problems with this is how long it takes and people are looking for their films. They are not looking for them in six months or two months, when you finish, they really want them now, because they have a problem and they are facing a biopsy without a comparative film or whatever.

I certainly know that it is medical misconduct in our State not to maintain your records and to have them available. I don't know whether or not any of the other States can look at this, for the doctors that continue to practice in some other realm in there.

Yes, Dr. Pisano.

DR. PISANO: I just want to comment on that, the medical misconduct issue. I really feel that many of these facilities that close down are not necessarily administered by the radiologists, so that is the physician in the loop. So, raising whether they are guilty of medical misconduct, I think that it is probably not the case that the radiologists did anything wrong in the facility's closure.

It probably had to do with financial mismanagement and other issues, and it is almost certainly the case that the radiologists, if he or she were directly involved, would make sure the patients got the images, but the problem is they don't have control over it, and they certainly don't have the financial wherewithal to take care of it themselves.

I mean it is an administrative or business issue, so I don't really think it would be appropriate to punish the radiologists if this were to happen, at least that is the way I feel about it.

DR. FINDER: I would second that in the sense that the problems that the problems that we really had with facilities in these kind of situations are where the radiologists are not the owners and where you have got business type people, and this is a business decision for them, and it is easier for them to go into bankruptcy and deal with it that way.

We have had situations where we are talking with the owners and also the radiologists, and the radiologists or the physicians are involved, they are all trying to make sure that the films are available, but they have no say in a lot of these matters at this point, and once it goes into bankruptcy court, nobody has any say except the bankruptcy court, so it is not a very simple situation.

MS. HARVEY: Dr. Barr.

DR. BARR: We have heard some really good stuff from the State folks here, Ms. Harvey, Mr. Camburn, and Mr. Bailey, and I think that this might even be best attacked from a state level. We are going to do all we can under MQSA to help patients get their mammogram films, but I would encourage the States who are here or anyone who can proactively talk to their States, lobby their States.

I think the State is going to be a big piece here of solving this puzzle.

MS. HARVEY: We might have to look at like our State business laws.

DR. FINDER: Again, I would add that while we are talking about mammography films, that is a small portion of what happens when one of these places go out of business, and we can do what we can for that, but I do think that it is probably going to be up to the States to guarantee, or as best they can, the availability of all the other medical records that are involved.

The facilities around California, it turns out were not just radiology facilities, they were path laboratories, some pathology reports are involved, and I hate to even say how many documents and how many records they are talking about, but it is a huge number, much more than just mammography patients.

MS. HARVEY: Any more comments? All right.

I think there is one last question. What criteria will FDA use to determine that facilities meet the MQSA requirements for infection control?

Essentially, there has been just an addition of a line on one page. In those cases where there has not been an episode of contamination since the last inspection, the facility should make that clear to the inspector.

Thank you. This will complete our morning session. I will be hammering that gavel again at 1 o'clock.

[Whereupon, at 11:45 a.m., the proceedings were recessed, to be resumed at 1:00 p.m.]

AFTERNOON PROCEEDINGS

[1:05 p.m.]

MS. HARVEY: Good afternoon. We are ready to start the afternoon session. Welcome back.

Our first speaker this afternoon is Nancy Wynne. She is going to talk to us about how satisfied the facilities are with our program.

Facility Satisfaction Survey

Nancy Wynne

MS. WYNNE: I am Nancy Wynne, Chief of the Outreach and Compliance Branch. Today, I am going to give you a brief overview of the Facility Satisfaction Survey that we have recently just closed out the response dates on.

A little bit of background first, though. Many of you may know that in 1996, this committee recommended that DMQR administer a survey of mammography facilities to obtain facility opinions about the current inspection process.

The objective was to gather information about the existing MQSA inspection process as it was perceived by the facilities, identify problems or areas for improvement in the process.

The first Facility Satisfaction Survey was conducted in the spring of 1997. It was a randomized sampling of about 1,000 facilities out of approximately 10,000. There was a 65 percent response rate, which according to the Office of Management and Budget is a very good response rate.

Summary findings of the survey were published in the summer of 1998. In that survey, there were high levels of satisfaction with the overall inspection process.

Last fall, we decided to conduct a follow-up survey to see how we were doing with the inspection process under the Final Regulations. Using a computer-generated, randomized sampling, we surveyed 10 percent of existing facilities, once again about 1,000 facilities.

We used a contractor to conduct the survey, and we maintained strict anonymity of the facilities' identity. We had a very successful response rate. This response rate this year was 74 percent. Most of the information came from the radiologic technologists. Also, there was a fairly representative spread or sample of the FDA regions. The Central Region had the highest response representation, about 37.6 percent.

The findings. Well, we only have preliminary analysis at this point, but there were generally high levels of satisfaction with the overall inspection process. For example, regarding the usefulness of publications and other resources, first, the Internet, our mammography web site.

Even though 53 percent of the respondents are aware that MQSA information and guidance is published only on the web site, we found that of those 60 percent of the respondents that stated they did have access to the Internet at work, only 39 percent actually accessed our web site from work.

Of the 80 percent of the respondents that stated they have access to the Internet at home, only 37 percent have actually accessed our web site from home.

When asked if they had used the policy guidance help system on FDA's mammography web site, approximately 78 percent responded no. However, of the 22 percent who did access and use the policy guidance help system on the web site, a resounding 93 percent found it to be very useful.

Now, directly referable materials. By this, I mean hardcopies of documents, such as mammography matters, previous inspection handouts, and other documents. This type of information appears to be the most useful or perhaps the most available, consequently, the most used.

Preparing for MQSA inspections was one of the most referred to publications. There were 84 percent of the respondents that found it to be very useful. This preliminary information on the Internet web site versus hardcopy material indicates that we should focus on how to encourage facilities to use our web site to sign up for notification of information by way of our listserv.

Now, regarding the actual inspection process, we found that after notification, the average time spent preparing for an inspection was about 10 hours, however, only 10 percent of the respondents responded that they felt this was excessive.

Over half of the facilities indicated that they had to reschedule appointments because of the inspection, but they also stated that they had adequate time to do so. The average number of mammograms performed on a day when there was no inspection was 21. On a day of inspection, the average number of mammograms performed was 12. The average number of hours to complete an inspection was six hours.

When asked if the inspection was completed within the expected time frame, 95 percent of the facilities responded yes, and they were pleased with the time frame. When asked to rate the inspection process for the most recent inspection, 95 percent responded in the fair to excellent categories, with 65 percent of those in the excellent area.

Finally, when asked to compare the most recent inspection to the previous inspection, 30 percent responded that the most recent inspection was a better inspection. Even though the response period for this survey is over, we continue to get responses. While we can't factor these responses into the report, it is interesting to note that the latter responses are consistent with the positive responses that we received earlier on.

Next steps. We have collected a great deal of information and over the next few months we are going to be working with our contractor and statisticians to analyze the information and determine its best use.

The in-depth analysis, as well as the overall results of the survey, will allow DMQR to target inspection process improvement, and to varying degrees it is going to be in different areas of the inspection process.

We will, of course be comparing this survey results with the previous survey results. We expect to have the final summary report on our web site after the first of the year.

MS. HARVEY: Thank you. Any questions comments?

Thank you.

Our next item on the agenda has to do with mammography access issues, an area we are all concerned about. Dr. Barr and Ms. Butler.

Mammography Access Issues

Helen Barr, M.D.

DR. BARR: On behalf of the Division, I would like to extend my gratitude to you all for being here today. I myself serve on an Advisory Committee, and know what a chunk of time it is both in the preparation and the actual attendance of the meeting. John McCrohan, who is on travel and couldn't be here, and I certainly appreciate the dedication that you have to this process.

I am only going to briefly introduce the topic of mammography access because to date we do not have a lot of hard and fast data or numbers for you, although I will tell you some things we are working on.

We have all heard anecdotal reports of long wait times for women to be able to schedule screening mammography.

We have seen the headlines, for example, "Need a mammogram? It could take a while. Delays reach crisis levels as women wait up to five months for a screening mammogram." That was Time magazine in March of this year.

"Experts foresee crisis in access to breast tests." That was The New York Times in November of last year.

"As more women seek mammograms, many have to wait months, low payments from insurers, influx of patients put breast clinics in a bind." That was The Wall Street Journal in the fall of last year.

The House of Representatives and Senate have also heard these anecdotal reports, seen the headlines, and they have asked the Government Accounting Office to look into the issue of mammography access, and they are busily doing it at the time, and we, along with I am sure many others, are supplying them with information to use to look at that issue.

We, in the Division, have also contracted with a group to look at the question of mammography access. Specifically, although they are going to look at more than this aspect specifically, we asked them to look at the question of even if the numbers were to remain steady-state, is that enough access in the aggregate to serve the current population needs and the fact that women at a younger age are seeking mammography screening, so they are going to be looking at that for us.

It is interesting to note, I noted when Ms. Wynne was up here, that she presented that the average number of mammograms in the respondents to our Facility Satisfaction Survey said that they did on an average 21 mammograms a day. On the last survey, that number was about 16 1/2.

Some very preliminary data coming in from our contractors suggests that mammography facilities, although maybe there is not as many of them, have expanded their capacity to serve patients over the years.

An analysis of our own database where we keep track of the mammography facilities in the United States shows that from 1996 to the present time, there has been about a 2 percent decline in the number of fully certified mammography facilities across the country, which in and of itself doesn't seem like a large number, but issues like where the declines have been, for example, we heard Mr. Bailey express some things about California and the additional question of even if we were to remain at that 2 percent less facilities, is that enough for access.

Presently, we have about 9,548 facilities. That was as of a few days ago. The number actually changes a little bit every day.

We have been working closely with the ACR, and in April of last year, they added some additions to their closure memo, which Penny Butler mentioned when she was up here before, and they have begun to collect information about why facilities are closing.

Again, we hear anecdotal reports anywhere from insurance reimbursement is too low and financially, facilities can't stay open, to they can't find mammography technologists to do the exams, and all sorts of things. So, the ACR has begun to start to collect that information from the facilities who notify us and then that they are closed.

So, I will let Penny take it from here and tell you about what they are doing, and then I will be available for questions when she finishes.

Thank you.

Priscilla Butler, M.S.

MS. BUTLER: Hi. Penny Butler from ACR.

[Slide.]

As of August of this year, we accredit over 12,000 units at over 8,000 facilities just to put you into perspective. Some of the numbers I am going to be presenting in a minute.

[Slide.]

I want to go through the process about how we learn of facility closures and our approach to closing them out in the accreditation system and thereby transmitting this information to FDA. Every time a facility successfully accredits with us, whether it is initial or renewal, we instruct the facility that they have certain obligations as part of their accreditation.

Among these obligations is to notify us when they close. From the facility's perspective, it is usually the last thing on their mind when they are trying to go through all of their business dealings that they have to as they come to a decision to close, and that is to notify us that they have to close.

So, unfortunately, we don't always hear about closures directly from the facilities. So, when do we hear about it? Well, when we put the facility through a renewal or we have to communicate with them for any other reason. Occasionally, we will get an unopened renewal package.

At that point, we look into it and try to find out of the facility has closed. The State inspectors who get out there every year, if they can't find the facility anymore, the address where they think they are, they will notify the FDA or sometimes they will notify us directly that they have information that the facility has closed, and sometimes we have been notified from consumers who are contacting us to try to retrieve their old films.

[Slide.]

Our closure procedures. We have go to be very careful how we close out facilities in our system, and that is because we have had some accidents which can be very traumatic for facilities if we do this prematurely.

We will only close a facility once we receive a letter or a closure form that is signed by either the facility's president or CEO or the facility's lead interpreting physician.

We will also close out the facility after 10 business days of us sending them a closure memo if we haven't received a response. So, for example, in the previous situations where a State or the FDA may notify us that a facility has closed, and we send them a letter, we give them 10 days, and if we don't hear back from them, then, we close them out in our system and we transmit to FDA.

By the way, on this letter, the form that we send them, we do ask them to call us immediately if we have incorrect information about this. This is necessary, this process is necessary to prevent inaccurate closures. For example, we have had phone calls from techs or receptionists or lower level administrators and departments before, whose facilities are going through ownership change, and they have called us to tell us that their facilities have closed, when, in actuality, the facility didn't close, they are just going through an ownership change. So, we need to get verification of closure from somebody who has authority within that facility.

Sometimes facilities will relocated and they won't tell the State or other bodies, such as us, that they have moved to a different address, and when we follow up with them, we have found that they have just moved to a different address.

As Helen was saying, in April of 2001, we started manually tracking reasons for some of these closures because working with FDA, and also from the information we have been getting from facilities, we felt we were noticing an increase in closures, so we have reasons for the closures through this closure memo that I was talking about, and in addition to that, as I mentioned earlier, we are also asking these facilities for a contact person, so if we get a phone call from patients asking about retrieving old films, we can help them out and put them in touch with the right person.

[Slide.]

The analysis that I am showing you now basically goes back to April of this year, and we wanted to look at two things. One of them was confirmed facility closures, not just facilities that expired or facilities that were not currently certified because they were waiting to reinstate as they took corrective action, but those facilities who actually either notified us that they were closed or we formally closed them out in our system.

In comparison, we also wanted to look at those new facilities that were coming on line, because we are notified by new facilities all the time that they are starting up a mammography operation.

One thing that is very clear, even though you see a lot of blips here with regards to the data, is that the new facilities opening up do not compensate at all for the facilities that are closing.

Now, the number of facilities that we see here on that month-to-month chart, there is a lot of fluctuation going on, on here. We are talking about relatively small samples, 85 in April. Some of that may have been clean-up, 25, say, in May, and then a jump up to 65, on the order of 65 in June.

I want to point out that was only up until August 8th. We don't have the full month obviously yet for closures.

Another caveat regarding this bar chart is that these numbers are not the date that the facility closed, because a lot of times we don't know when the facility closed. We just know when we have confirmation of closure. So, this is what you are seeing here.

[Slide.]

I think from this limited data that we have right now, the most interesting thing is to note the reasons why facilities are closing. The primary reason is a global financial type of assessment that the facility has made that they cannot make a living staying in business doing mammography, and that is 26 percent.

The number of bona-fide bankruptcies that we are aware of is 3.2 percent. 7.9 percent indicated that they felt that their equipment either would not meet the 2002 requirements, or they were having problems with their equipment now, that it wasn't working, and they couldn't get it fixed, and this irrespective of any regulation out there.

6.7 percent indicated that they are having trouble finding qualified techs and sometimes finding qualified radiologists to do the interpretations.

2.8 percent had an ownership change, and the new owners made a business decision to close the mammography operations. I do want to point out that we don't close a facility if it's an ownership change if they are continuing to do mammography, because access and services haven't been stopped. We handle that in a different way.

Another thing which is very interesting, and I know the folks in California and other States are seeing similar types of things, is that a number of facilities are making business decisions to consolidate their mammography operations, so they will take a facility with a single unit and move it to a mammography center to try to use economy of scale, and this is occurring in a large number of facilities.

Now, what does this do to access? Certainly, the quantity or the number of patients that can be examined in the units is going to be the same, but since they are geographically consolidated, does this impact on access if that remote site was closed down because of that.

As with any other study, we have 5.2 Other, and I do want to point out that we do have a large number of Unknowns, and the reason for that is these are the facilities where we get a renewal package back that hasn't been opened, and we have no contact from the facility, so we have no information on it. So, that is why the Unknown number is so large.

[Slide.]

So, let's talk a little bit about access in this limited group that we have looked at since April, we have 252 sites closed where only 83 opened. I think what is really important is that 17 of these sites were mobile sites, and mobile facilities do provide a certain advantage to access for women in remote or underserved areas. During that period of time, only four mobile facilities opened.

The other theme from this is one we have been talking about all day, and that is patients are having difficulty accessing their old films for comparisons from these closed sites, and we have already discussed these last two bullets.

So, last slide.

[Slide.]

We are continuing to monitor, to collect and monitor this data. We share this with FDA on a routine basis, and hopefully, over a longer period of time, we will have more relevant information to look at some trends.

MS. HARVEY: Thank you.

MR. CAMBURN: I noticed you were tracking the number of facilities that were decreasing over time. Have you also tracked the number of mammography machines over time to see if they are also decreasing or perhaps increasing in number?

MS. BUTLER: We haven't analyzed on that yet. Our general feeling is that the number of units are also decreasing, but I don't have it in this analysis.

MR. CAMBURN: We have done some of that tracking in Michigan, and in the past eight years or so, we have dropped about 15 or 20 facilities, but in terms of mammography machines, that has increased by about 75 machines in that same period of time, so more machines out there in our State at least, but fewer facilities doing mammography.

DR. BARR: Yes, Jim, from the preliminary information we are getting in, that seems to be the case, he sort of expanding capacity, maybe fewer facilities but more units. I know that GAO itself is looking at this issue on a unit basis, so we will see what comes of it. That is interesting to know what your data shows in Michigan at this point.

DR. LEE: I was wondering if the sites that had closed, whether it was a regional phenomenon, or was it pretty spread out among your sample?

MS. BUTLER: We hope to be analyzing that. Some States seem to have a higher number of closures than other States, but because the geographic areas and the populations of the different States vary, we haven't really been able to sort through that data yet.

DR. BARR: That is also one of the issues that our contractor is looking at, too, to see if there is pockets or where exactly decreased access might be if it exists.

MS. HARVEY: Any other questions for our presenters? We are all set. Thank you.

DR. BARR: We will keep you posted on this, and probably by the next meeting we will have some information from our different sources to give you.

Mammography Access Issues

Committee Discussion

MS. HARVEY: We will have our own discussion now on any issues or aspects of this question that we would like to discuss.

DR. PISANO: I am glad that the organizations are doing kind of surveys and trying to get data on this. I know the Society of Breast Imaging has also done a survey, which I don't have the results of, but I know the membership of that organization, which is mainly radiologists and technologists, as well, as some physicists.

No one mentioned it, but there is a bill before Congress right now, the Harkin bill, which is intended to increase the number of radiologists who go into breast imaging, and I think it is a step in the right direction myself, but I think that it is unrealistic to think it is going to have an impact very soon.

My limited understanding of the bill is that it will add money to increase Radiology residents, and maybe there are other aspects of it, as well, that I don't know, but my concern is it is going to take quite a while before we have more radiologists who actually read breast imaging cases.

We have a short right now of radiologists nationwide apparently, and no one spoke to that per se, although it was mentioned briefly. I think part of the issue is even if we get more radiologists, we may not get more breast imagers, and I think it is important for everyone to understand how long it is going to take, even if the Harkin bill is 100 percent very successful, before we really are going to have more people in the pipeline to read these mammograms.

We need to figure out a way besides the Harkin bill, we need to figure out a way to incentivize radiologists to go into breast imaging. There isn't a strong motive for people to go into this field right now, and there really is a problem of getting people in the field.

We are all competing. I have two openings in my practice right now. We have four, 3.2, a part-time person, and three full-time radiologists reading all the mammograms, and I have two openings. So, we are quite short-handed right now, and you talk to other radiologists, who are in positions like myself, and everybody is hiring right now. No one is fully staffed, and all of the private groups are also hiring.

Last year, at RSNA, I always interview at RSNA every year, there were like maybe three or four people who were looking for jobs in breast imaging of all the jobs there at the RSNA, the ACR has a job fair there.

So, from my perspective, getting people to go into breast imaging is a real problem right now. I don't know how to incentivize people, but when you talk to residents, they have lots of options besides breast imaging, and you hear things like, well, it is easier to be MR specialist, I don't have to deal with the regulations, and the pay is higher.

Those are the kind of statements made by residents, so we need to figure out a way to make it attractive to the trainees.

MS. HARVEY: So, I can expect that we will probably lose more facilities as they struggle. In New York, we did a demographics curve of all our radiologic technologists and found a precipitous drop-off, just as it is in the nation, of rad techs that are under the age of 30.

We have lost schools, we have fewer people who are being licensed, and so I think some facilities are struggling also to have an adequate number of radiological technologists to do mammography, so it hits on both sides I think for staffing.

DR. PISANO: Absolutely. We are missing technologists in our practice, as well.

MS. HARVEY: There is also a bill, it's a HCFA bill to raise reimbursements under Medicare.

DR. PISANO: I believe that is correct.

MS. HARVEY: It is a proposed regulation?

MR. SHOWALTER: I am Charlie Showalter, Senior Director for Government Relations for the ACR, and I can tell you a little bit about the Harkin bill and what it contains.

Its fundamental intent initially was to try to get reimbursement to remain in statute and to set at a certain level. It has been in statute ever since screening mammography was approved for reimbursement back in 1990.

Last year, it got a bill passed, a budget bill that will remove it at the end of this year if nothing happens. We are trying to have something happen.

The Harkin bill is in the Senate, the King-Weiner bill is a parallel bill in the House, and negotiations are ongoing to see whether anything will pass or not, but what it contains is the reimbursement construct which would put the reimbursement back into the statute for another year, and set it. Right now the bill reads at $90 as opposed to the current $69 and change.

The second aspect of the bill is the increased funding for residencies, and right now the bill reads three additional residents in Radiology per residency program.

We are hearing that that is somewhat unrealistic for some programs because of faculty limitations and the general shortage of radiologists makes it difficult to add three faculty members, so that you can have a one-to-one ratio with your residents.

We are trying to get some negotiation flexibility in there. You know, if some residency programs can absorb five and others absorb one, why, they can sort of trade around, or we could spread this out over a longer period of time, and we don't know where that is going to go, but that is what we are working on.

In addition to that, it contains funding for technologist training programs. I think that basically, the shortage of technologists, for one reason, is a problem of the good stock market over the last few years, and there have been a lot of opportunities.

Technologists, you know, they don't make a ton of money and some of the work is not a whole lot of fun, and they have had other things they could do, and they are doing them.

So, the radiologist shortage and the technologist shortage, the best thing that has happened over the last year is the fall of the stock market, so many radiologists are not going to be in a position to retire, and RTs may be attracted back to the field.

In any case, that is a short summary of the Harkin bill and what is going on in the Congress.

MS. HARVEY: Thank you very much.

MS. ELLINGSON: I work at the ASRT, and this is our major project of the moment, along with the Federal Minimum Standards Act, the CARE Act, the bill, excuse me, to make some kind of minimum standards across the nation. There are still a lot of States who have no licensure.

But to answer to the shortage, and mammographers, of course, are a big part of it, but it is across the board, we have found by our surveys that people are leaving the field in such great numbers, people my age are leaving and nobody is coming in the front door, and we are all going to have to be taken care of, and there is nobody to do that.

So, we are working with high school counselors. We have a new recruitment video that is aimed at young people that will be impressed with the music and the opportunities, and so forth, of our video, but we are finding that high school counselors are telling people don't go into medicine, there is no money, it is hard work, and bad hours, and they are steering our pool of new applicants into radiologic technology programs.

So, we are working really, really hard to recruit and to maintain. We call it our Work Force Development and Workplace Enhancement, and we want a better place for them to work, so that when they do come in, they don't want to leave.

It will take time to do this because you have got to recruit them in, you have got to go through the school, and then they will choose their specialty, but hopefully, our work will pay off, but it is going to be a slump before we get that done, but ASRT is working very hard on that at this time.

DR. IKEDA: I am from Silicon Valley, so I can tell you that in the last six or seven months, since the Nasdaq fell, the traffic problem has become better, and we have been able to recruit some people to clerical positions where we could not previously before all the dot coms kind of went into the ground.

But I am glad that we are recognizing this is a problem because as I can see from Ms. Butler's data, it looks like 26 percent closed due to financial reasons and 3.2 went bankrupt. So, as always, it ends up being a matter of money.

I was a little concerned when I heard that there was some consideration to having facilities post a bond, so that when they do go bankrupt, I mean it is kind of sending the wrong message, that they can send the film somewhere.

It is important that patients be able to access their films, but certainly this is recognition of a real problem, and it has to do with finances. It is a problem, and facilities want to operate. I have never seen anybody struggle so hard to get a mammogram on a patient who has a problem as a mammography technologist or physicians agonize over four films, trying to find cancer.

So, with reimbursement being the way it is, and the costs of operations, it has been a difficulty to stay in business, so the access problem, I am very concerned about.

DR. DOWLAT: Could I just make a comment, too?

MS. HARVEY: Certainly.

DR. DOWLAT: In Chicago, we have crisis on the number of radiologists, breast imagers. At Rush, we have certainly had it for two years, and it was sort of swapping with the University of Chicago, and now they are in the dumps, and Rush is in a better place because the radiologists moved back.

I have one question. I just want to know whether the litigation is still the highest among the mammographers. Can someone answer that question?

DR. PISANO: I don't know about recent. I have heard data from about two years ago, and I forget which organization put it out, but it was the leading cause of malpractice suits--missed breast cancer was the leading cause of a malpractice suit in the United States about two years ago.

DR. YOUNG: I just talked about this topic last weekend, and radiologists are the source or they are the main target, and followed by ob-gynees and general surgeons incidentally. The delay in diagnosis, of course, is the problem. Misreading the mammograms accounted for about 25 percent of the cases, and then another 22 percent were mammograms read as being negative, but truly contained a cancer, and we have discussed that today. So, this is a problem, it is a deterrent to attracting young people into the technologic aspects of mammography, as well as the physicians.

MS. HARVEY: Are scanners useful? Do scanners help for flow, to be able to do more patients?

DR. PISANO: I am not sure what you are asking.

MS. HARVEY: The R2 scanner.

DR. PISANO: Oh, the R2.

DR. YOUNG: I have had some peripheral experience, not with the one that FDA has approved, but another one very recently, and it has not made a significant contribution to the abilities of an experienced mammographer to detect breast abnormalities.

DR. PISANO: There was a nice paper published in Radiology by Berheni, Linda Warren Berheni, earlier this year. Linda Warren Berheni published a paper, she was the first author. There were about 20 authors. I think it was in January or February in Radiology about the R2 checker, image checker, and their data was very impressive, I thought, showing an improvement in ability to find cancers with that system.

Clearly, this was a study that was sponsored by the company, so we need to wait for independent--in my opinion, we need to wait for independent other studies. The first study can always be incorrect, and other studies need to verify that, but the data she published was very impressive.

The problem with those systems, and it just goes back to the cost, the cost, I can't afford it at the University of North Carolina. We are a public institution. It's a $150,000 piece of equipment, and you have to pay for someone to run it. Even with increased reimbursement, you have to do an awful lot. Now, there is increased reimbursement if you use this system.

It is still quite expensive, and I would have to do an awful lot of them to pay for it, and I think I would lose money on it, to be honest. We are, at the University of North Carolina, breaking even right now, so anything that increases our cost is potentially dangerous to us in terms of maintaining the facility, keeping it open.

So, that is the way we made that decision even with impressive data in the literature, I just can't afford it.

MS. HARVEY: Dr. Karellas.

DR. KARELLAS: Several institutions tried to streamline the process and upgrade their mammographic facilities. In my experience, we tried to get our administration to upgrade our facilities. That way, we can increase the level of service and the efficiency.

Although they value the service very much as a service to the community, it is always a very difficult thing to justify financially. So, although they are willing, and they are supportive, but the kind of model that we have in mind, and that I believe is very common in several other organizations, we have a model of efficiency and high quality of care for the patient, and that costs a little money.

Well, needless to say, the moment we bring it up for this new women's center, the way we think it should be in our community, it is not approved because it apparently, at least under somebody's assessment, does not make good financial sense.

MS. HARVEY: It doesn't provide enough value?

DR. KARELLAS: Well, I don't think anybody will dispute the value to the community and the patients, the issue is that some institutions are struggling to survive today, and if an institution is facing a $50 million deficit that will grow to $100 million deficit 10 to 12 months from now, they will tell you just do mammography as you do now and we are just not interested hearing about your plans for another year or two.

Although the institution still will continue to deliver a high quality service and we don't think much is compromised, but I believe that the waiting time is not getting shorter, the patients are not happy, and overall, radiologists are frustrated. In some cases, you cannot attract any radiologists anymore because nobody really wants to work under this kind of an environment, and we are really going in a direction that we don't want to go into.

What I am describing to you now is the situation that I am all too familiar with in the past year or so, and I believe that although some institutions have had tremendous progress and they have established just wonderful centers, some other institutions are not able to do that.

DR. RAMOS-HERNANDEZ: We have a very serious problem trying to get resources for people who live in the small towns, for people who are young, people that have no good medical insurance, and we have seen it, I think that today we saw it more clearly about the places that are closing against those that are opening.

What I see is just more a deeper gap between people who can get services and people who cannot get, because those who are moving, are moving to bigger cities or places where we have more resources, and those places that have few resources are getting without anything.

Also, about reimbursement, it is very low, and most of the institutions that are doing mammograms right now maybe are doing what you said, they are having women's center, and they do it as part of the charity of the hospital, part of the reimbursement goes to charity.

So, to do something, there should be done something done quickly because in one way, we are encouraging women to have mammograms, we are doing education. There are women who never think about that, and when they decide to get the mammogram, they need to wait five, three, two months, or they basically cannot get it.

So, what is our message and where are we going with this, how we are going to respond and how we are going to be sure that those women, especially latinos and African-Americans are developing breast cancer at the lower, earlier ages, and I don't want to talk even about quality because we know that women who have very large breasts need to have more than one site or more than one procedure, sometimes more than one film, and they are not getting that, because the reimbursement will not pay for two or three films, or they do not have in the facility, big films, bigger films.

MS. HARVEY: Any other points? Carolyn, do you have any other things to add from the consumer point of view?

MS. BROWN-DAVIS: No, I think that I concur, that when we talk about there being fewer services, there is going to be a large group of women in this country who are affected, not only the rural population, as you mentioned earlier, but those underserved populations who actually live in urban areas now, but what to do?

DR. KARELLAS: I will be very brief. I totally agree about the charity part, and I believe we all should be doing, in all institutions, should be very much involved in all kinds of charity, and I believe this is a most deserving kind of charity for underserved populations.

Some hospitals perhaps can do it better than others. I will give you an example. I don't think I would have much of a chance going to a hospital administration that is losing $50 million in a year, and two days ago announced that they laid off 200 people including 70 nurses, and they will lay off 500 people in a month, and 100 physicians will be laid off in mid-September.

This is not a fiction. This is, if you read the Worcester Telegram of a couple of days ago, that is on the front page, and they wouldn't listen to me on the charity part. Now, I think that some hospitals do a much better job that we can do, and I believe that we should not give up on the charity. If we cannot afford it today, perhaps a year or two from now, I think we can turn it around and with the help of the community and provide this charity.

By no means I want to say that this should not be done. I believe that it is perhaps possible. It takes some creative minds to do it. I know some institutions do that very well.

DR. YOUNG: Is Charlie Showalter still around? Does anyone know, is the proposed reimbursement by statute from 69 to, what was it, 90-some dollars, is that both for the technical and professional component, is that total reimbursement just technical or part professional?

DR. PISANO: It is total, isn't it?

DR. YOUNG: Does anyone know, does that pertain to Medicaid patients, as well as Medicare?

DR. PISANO: I thought it was total.

DR. YOUNG: Certainly, those that can influence thoughts along this line need to have the facts clearly in hand as they speak to it.

MR. LAWSON: Herschel Lawson, CDC. I believe that it relates primarily to Medicare. Medicaid are usually handled differently, but the rates may be comparable, but I think that they are managed just differently.

DR. FINDER: I just want to kind of put this into a little bit of perspective and then ask a question, which may have a very short answer.

A lot of the things that were mentioned here, not only apply to mammography, but to radiology and medicine in general. I don't believe that the hospital is losing $50 million just because of mammography.

The other issues that are brought up are not only radiologist, technologists - nurses, we have a problem in this area in terms of nurses, so it is not all radiology, it is not mammography alone.

My question that I am going to raise to you is do you have any suggestions to FDA in terms of the MQSA program, are there any things that you think we could do as part of our program, not as lobbyists for something else, but within our program that might help here?

[No response.

DR. FINDER: And I thought that would be the answer.

DR. PISANO: I would like to comment briefly. Obviously, being of this panel, there is a level of support for this legislation and this process. I want to start out with that, and then say but, I also wear the hat of having to get my facility accredited by the ACR and inspected annually, and the process, despite that fact that only 10 percent said that 10 hours was not too long, it is relatively onerous, and it is not something that people relish or enjoy doing.

So, I am not saying that it has to be something we enjoy doing, but perhaps there is a way that we could make it less burdensome, and I don't know if the regulations were ever looked at with that in mind, in the way you have created the program or imposed the program, or whatever word is appropriate.

I don't know if anyone has really look at each step, and I am sure every step along the way, people said, yes, that was a good regulation, that was a good regulation, that was a good regulation. It is just, you know, it's the straw that broke the camel's back kind of thing.

It is nice to know that every regulation is really urgently or very important for patient care and quality, and perhaps there are some things that could be pared back and perhaps reined in a little, because it really is a pretty enormous undertaking to follow all these rules.

So, if there is any way that we could go through them--and I am not volunteering personally to go through every line by line--but if there is any way to perhaps relook at the regulations to see if there are things that could be reduced. That would be my only suggestion to the FDA.

DR. LEE: One of the tenets they tell us, of course, in public health, is do your needs assessment, so I think the survey that you are doing right now is a really good start, you know, where are the areas in the country that women aren't getting access. I think, for example, in our area, just looking at some of our records, and the women are able to get mammograms in a few weeks, so I don't think it's a problem where I am, but certainly in other areas, such as rural areas or areas in which there are large parts of the population which are underserved, they would merit more looking at.

I think the survey that you are doing is a good start.

DR. IKEDA: I would ask FDA to carefully consider any addition of new regulations and be careful about added fees. I realize that MQSA has gone a long way to improve the quality of mammography, and it has really helped patient care and helped women across the United States.

At the same time, to add a new regulation that must be inspected, look at those carefully and see if they add to the quality. What I am concerned about is the burdensome aspect. I employ a full-time quality assurance person to follow my patients, do my letters, check up on the biopsies, make sure that the right letter goes to the right patient, make sure that we follow up on the patients, and I am in a relatively large facility, and we have problems getting technologists, and I need another mammographic unit, as I think everybody does.

But it is a concern of mine to add the straw that breaks the camel's back, that will decrease access to women even more, especially in the smaller facilities, may not be able to afford as much of the regulatory process as much as like a big facility like mine. So, that is what I am concerned about.

I think that the demonstration project of perhaps inspecting every other year that FDA has proposed, I think is a step in the right direction, if it's good.

DR. PISANO: The only other comment that I have direct to government in general, and I don't know if this is within FDA's purview or not, I think there is room for perhaps more automation in the QC process, and I think with digital we are heading in that direction, but even for film-screen systems, perhaps there is a way to make it less person-intensive.

This is really not, I don't think, within the FDA's purview except to be open to new ways to test things, but it seems that there is room for research in this area, and how we could automate some of these things, so it is not so intensive right now.

I do the same thing Debbie did when she just said about having a full-time QA person for the biopsies and things, but we lose a tech for a whole morning a week just to do the processor and QC stuff, so that is half a day a week for one person, so that is quite a bit of time, and if there is a way to make it easier, that would be good.

I don't think there is anything currently around that could do that.

MS. HARVEY: I would like to see the inspections take a shorter period of time. I would like to see if we could work out ways to consolidate some of the information about personnel, so that if a facility has, for example, five sites, that we could have a centralized location where the information about the doctors that read, and the physicists that serve, could be found to cut down the period of time it takes doing an inspection, which is time out of a person's full day, and also is an expense of the inspector to look over that kind of data.

I would even, if I could have a wish list, might have a centralized computer that would keep information on doctors or on technologists or on physicists, and I am thinking about doing that at least for New York on physicists, just a smaller group and one that we have a more limited number on, so that that information is currently updated, and the individuals don't have to send their documents to every one of the facilities in which they may read or work at or provide surveys for.

So, I thin, that is an area in which we might be able to shorten up the period of time to do some work.

DR. PISANO: I thought of another thing that takes more time than maybe it should have to, and that is each facility, each facility number, even if it's run by the same radiologist, had to keep separate data for each facility, so it would be nice if you could do it--

MS. HARVEY: Pool the doctors' data for medical audits?

DR. PISANO: Exactly, because knowing where--you know, I run only two facilities right now, but just it's a huge burden to have to figure out which facility that patient started from to me and separate their data out.

So, if I could do it per radiologist across several facilities, that would save a huge amount of time. That is just one thing.

MS. BROWN-DAVIS: I am looking at a process or hearing the end of a process and the beginning of a new one perhaps, because I can think that I have sat here for, I don't know, two and a half, three years, hearing various committee members representing professional organizations to which all of you belong, and they were to have brought as, you know, one does in that type of situation, the best experience from those organizations and people who belong to those organizations, and it sounds as if the people that are sitting around the table now are saying that some of that time spent coming up with the regs might have been used differently, I guess that is the best way to say that.

And yet I wonder if this is just a process. The regs have been around now four, five, or six years, and so we have actually seen how they actually work, so I suppose that one shouldn't be undaunted by that, because there is nothing new actually, and maybe this is just a part of the process.

MS. HARVEY: I think it is an evolutionary process where you look at where you might get the best bang for your buck.

MS. BROWN-DAVIS: Because I assure you in my opinion, the FDA did not come up with these regs by themselves, you know, they took the advice of those people that were invited to be on the board, wanted to be on the board, bringing their various expertise. That's it.

DR. IKEDA: Ms. Brown-Davis' point is a good one. As I said, the regulations, as implemented, I remember trying to implement them at my own facility, and seeing a great improvement of the mammograms that were brought in as second opinions, and so the MQSA regulations had a great impact on the improvement of the quality mammography and in diagnosing breast cancer.

So, I think that they were wonderful to start out with, I think that the regulations did a lot to improve mammography. I think we are at a place where we have to maintain that improvement and the quality, and I think we, as a committee, also recognize that the world has changed since the beginning in 1992, when the law first was passed.

Now, mammograms, I think are more regulated. People have an expectation of better quality. People are more informed. We want to keep that quality, but the economic things have changed, the eighties are gone for over 10 years, meaning that there was a great boom in doing well and then with the Nasdaq doing well, many people did well and people could spend a lot more money, but now the economic climate has changed, and I think that we have to recognize that.

So I agree with you that the regulations did a lot for improving things. I just want us to be careful while still improving, continuing to improve mammography quality and being sure that women get treated correctly and diagnosed correctly.

MS. HARVEY: Any final words? Is there anything that the committee feels that they can do? Any letters we can write, any banners we can put up?

[No response.]

MS. HARVEY: All right. Thank you.

I think we are still running a little bit ahead of schedule, so we will start with Inspection Demonstration Project Update, and we will invite Dr. Barr back again.

DR. BARR: Thank you for all those very good comments. I only heard one good thing so far out of the whole discussion, and that is that it seems like Charlie Finder and I, if they don't treat us right here, have our pick of jobs.

[Laughter.]

DR. BARR: I just wanted to invite Charlie Showalter up. There were some questions that came up while he was out of the room, and maybe he could address those now before I start.

DR. YOUNG: Pardon me. I had a couple of questions about the proposed legislation with the mammography reimbursement to statute for another year, that current rate is $63 going up to, what, 90 or 99, and is that just technical or is that technical and professional? The second part of the question was does this pertain to Medicaid patients as well as Medicare?

MR. SHOWALTER: It's a combination. Currently, the $69 is allocated, I believe, 68 percent technical and 32 percent physician fee, and that is a determination that was made by HCFA after the statutory amount was set.

It would apply to the same set of patients that it applies to now, and I am not certain about Medicaid. It certainly applies to Medicare. We would expect the same ratio to the 68-32 to be allocated by HCFA if the $90 gets passed, and it would not change, you may know better than I whether the current statutory amount applies to both Medicare and Medicaid, because I am not certain.

DR. YOUNG: I think that is a state-to-state determination because the States have to participate at a certain level, and that varies all over the place.

MR. SHOWALTER: That was my impression. It is my impression that in 1999, there were 4.6 million women who were examined and paid for by Medicare, and that is the population that we know we are working with. The Medicaid, as I was under the impression, was a state-by-state, and is not directly affected by the physician fee schedule, and that is what this is in lieu of is the physician fee schedule that is set for Medicare.

DR. YOUNG: Right, and I think everyone appreciates even the $90 rate doesn't reimburse the facility completely. I used to do cost accounting when I was in private practice with direct and indirect costs. It costs $130 or $140 to put a patient through for a screening mammogram.

MR. SHOWALTER: Well, we just finished a survey actually, a cost survey, and we divided it up by hospitals and private offices. Now, there are other things going on around this proposal or this legislative proposal. Anyway, the cost survey indicated that it costs about $86 in private offices to do a mammogram, and about $125 in hospitals. Now, that was from the sampling of 37 facilities, and that is not a complete sample by any stretch, and I am sure it is more expensive in some places and less in others.

HCFA has proposed in anticipation, in current law, it goes out of statute into the physician fee schedule the 1st of the January, they have proposed an amount of 88.50 for reimbursement under the physician fee schedule, which would apply to private offices.

So, these two things have happened since we had the legislative proposal put together, and now we are beginning to wonder does it make sense to divide this up into two sets, one for private offices and another, higher number, for hospitals. We are having discussions with staffers on that at this point. We don't know for sure where that is going.

If course, hospitals are paid under a different--our hospitals are reimbursed for outpatients under a different, this APC system. HCFA will make a proposal on Friday. They put on display their proposal yesterday up on their web site, and it is a very confusing situation for screening for outpatients, because they made no proposal for screening basically, for screening mammography. Those spaces are blank. So, we don't have any idea what they intend to pay, but we have thought that diagnostic mammography was underfunded in hospitals under the APCs, at $34 and change for the technical.

They have proposed to lower that 6 percent come next year. So, if that is an indication of what you can expect for hospital outpatients, it is our opinion that this needs to be handled statutorily, or hospitals are simply going to not be able to continue to provide mammography on an outpatient basis.

DR. BARR: Thank you, Charlie.

Inspection Demonstration Project - Update

Helen Barr, M.D.

DR. BARR: I am going to give you an update on the Inspection Demonstration Program, which you have been hearing about. For some of you, this will be old hat, and for some of you, this will be new.

[Slide.]

As you already heard from Dr. Mourad this morning, the Mammography Quality Standards Act was reauthorized October 1998, and that will take us through October of 2002, so actually, we are beginning another reauthorization process right now.

As Dr. Mourad pointed out, the MQSRA gave us a number of different tools, and one of the things that did is gave us the opportunity, if you will, to conduct an inspection demonstration program.

[Slide.]

What MQSRA told us is that we could look at selected facilities getting less frequent inspections, and although the overall doing the project was a "may" and not a "must" or "shall," these things that MQSRA told us to do are things that we have to do, and not that we have an option of, that the program cannot be implemented before April 1st of 2001, that facilities included must be substantially free of incidents of noncompliance, that the number of facilities provide a statistically significant sample, and that the inspection frequency that we chose reasonably assure compliance with the standards.

[Slide.]

We have two goals in putting this program together, and one is to comply with the MQSRA and what it told us to do, and the other is to ask the question - can we reduce MQSA inspection frequency for high performance facilities and maintain an assurance of quality.

[Slide.]

To put the program together, we consulted with lots of different folks. We consulted with the States primarily through the Conference of Radiation Control Program directors, with this committee itself, with our own regional radiologic health representatives.

[Slide.]

And with other offices within our center, particularly the Office of Surveillance and Biometrics, which helped us look at the statistical end of this.

We put all these things together and came up with a program plan and a schedule for implementation.

[Slide.]

The program will include States and facilities using established criteria that we set out. It will include both study and control groups. The plan is to conduct biennial inspections for the facilities in the study group, and to conduct annual inspections for the facilities in the control group, and compare those results.

[Slide.]

For a State to participate, these are the criteria that we set out. First of all, the State can have no State laws, regulations, or unchangeable policy which require annual inspections of mammography facilities because obviously, if the State was going in there on a yearly basis by law or regulation, and we were asking the facilities that they be skipped inspection, that would be a bias to the study with the State going in there in the year between.

We decided that the States would have to agree to participate, and that they had to inspection participating facilities at the frequency that we would designate if they were to be participants.

[Slide.]

They would have to accept modifications in their State contracts based on the number of facilities to be inspected--we contract with most, but not all of the States to conduct the mammography facility inspections, and if facilities were skipping a year of inspection, that would cause modifications in the contract--and an agreement to notify FDA of any potential serious public health risks of which they would become aware of during the demonstration program.

[Slide.]

We solicited participation from all 50 States plus the District of Columbia, New York City, and Puerto Rico, and we received agreement to participate from 14 of the 53, the group of 53, and as you can see up there, our participants are in the States or jurisdictions of Arkansas, D.C., Florida, Mississippi, New York City, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Washington, Wisconsin, and Wyoming.

About 14 more States could have potentially participated, that is, they had no laws or regulations or unchangeable policy that would have prevented them from participating, but they elected not to participate for various reasons. Some of them we heard were financial, they didn't want the skipped income of the annual inspection, and others were philosophical reasons that they strongly felt that to maintain mammography quality, we needed to be in there on a yearly basis.

[Slide.]

We also decided to deal with the financial concern of the States, to limit the participation to no more than 10 percent of the State's facilities, so say, for example, 20 percent of the State's facilities turned out to be eligible under the criteria, which you will see for the facilities in a minute, we would make a ceiling at 10 percent of the facilities, which really breaks down to only 5 percent skipping inspection because the other 5 percent would be in the control group which would get annual inspections.

This was an attempt to not make this project financially burdensome on any of the States. We elected to include all the eligible federal facilities who met the criteria.

[Slide.]

For the facilities to participate, the facility has to maintain full accreditation and certification throughout the program. They have to anticipate providing mammography services throughout the program, and they need to undergo at least two annual inspections under the Final Regulations.

[Slide.]

During these inspections, they can receive no citations during their two most recent inspections under the Final Regulations. They can receive no regulatory compliance action or be currently considered for such regulatory action by us.

They obviously need to be located in a participating State, and they have to be selected by us to participate.

[Slide.]

Some of the limitations of the program that we see so far are that we do have a limited number of States participating, 14 States are participating, and that is obviously a small percentage of the overall States. So, that is going to limit what we get out of the program right up front.

Since we made the participation voluntary, that took out another large chunk of folks who didn't want to participate, and there is always the chance of self-selection bias from the States that agreed voluntarily to participate.

[Slide.]

Obviously, the limited number of States limits the number of facilities, and what we see now is that we are going to have about 300 facilities is what we are predicting based on the results that we see right now of facilities who will meet the criteria that we set forth and are in participating States and fall under that 10 percent number.

The fact that we limited the participation to decrease the financial burden also limits what we will get out of the study, and obviously, that the facilities have to be in a participating State.

[Slide.]

So, all in all, what our statisticians have told us to date is because of these restrictions, this is not going to be a statistically valid study, we think, in the sense that Congress hoped that it might be.

So, dealing with that, then, we have to see where we go from here. We have a limited participation. We have a lot of internal and external limitations that were put on the program, so what we will have is a lot of descriptive statistics, and we have to deal with those and what the power is or is not of those, and the applicability of what those results will mean to a nationwide program, and what Congress may or may not do with any results that we come up with.

[Slide.]

Timeline. We are in the process of picking the first 50 percent of the facilities inspected because the first group of facilities that would have been inspected twice under the Final Regs, that would have happened now, and we are going to distribute the letters of notification to them.

That will also give them a six-month notice period that they are not going to be inspected, that they are going to get the opportunity to skip an inspection. It will also give the States time to see who those facilities are and how that is going to affect their staffing and budgets, et cetera.

In May 2002, the first facilities will start skipping inspection, and we will begin to pick the second group. That is when the other half of the facilities will finally have undergone two inspections under the Final Regs. So, we are due to start in the spring.

I would welcome any questions or comments you would have.

MS. BROWN-DAVIS: I just had a thought as to how much did this cost, do you have any idea, you know, the project to date?

DR. BARR: No, we have not figured out internal costs. You mean as far as staff time, et cetera, to develop the program? We haven't figured out those costs, no, I don't.

DR. PISANO: Maybe you said this, but I missed it. What exactly are you going to be measuring as outcome measures, is it just citations, or what exactly are your outcome measures?

DR. BARR: We are in the process right now of developing exactly what we are going to be measuring in the inspections. The inspection itself will be the same inspection as the one that is done annually now, and we will be, of course, looking at primarily violations - did this citation-free facility bias not being in there or in the interim, while we weren't in there, then receive citations, and if so, what some of the reasons for that might be.

If they stay clean, they stayed clean, and we don't have a lot of work to do. If they did get violations, there is a number of parameters that we could look at, did they have a significant change in personnel, such as lead interpreting physician or QC tech, and those are the things we will be looking at, you know, did they slip only to the Level 3 violations, or did they go badly in a hand basket and go to Level 1's, and the reasons for those.

We are in the process of developing all of that.

DR. PISANO: Is that the reason, I mean is it because you expect only a small difference that you don't have enough power with 600 facilities? I mean there are 300 that are going to be the study population and 300 in the control population.

DR. BARR: No, 300 is the total population, 150 in the study group and 150 in the control, and it is not purely numbers that don't give us the statistical power, it's lack of random sampling, because we are only using the States that volunteered to participate, and a number of other things that go into statistics where we don't think we are going to get the power that we might have otherwise, say, with the Facility Satisfaction Survey, which is a purely random sampling of facilities, and hold a lot of statistical weight with that randomness attached to it.

This also does not, of course, address the issue that you raised, which is certainly one worth looking at, and was not in the minds of Congress at least at this point to do a truncated inspection. There is probably two ways to look at the whole inspection process.

We could skip inspections or we could shorten the inspection process for everyone, and those are different things to look at.

MS. HARVEY: At this point in time with so many financial pressures on facilities, sometimes another way to do things is shorter inspections more frequently, just to be remembered, you know. Nothing like having the Health Department call up and say they are dropping by to be an incentive for people to remember to do what they would normally be doing.

DR. PISANO: And there is a lot of pressure. What used to happen is people had time at the beginning of the day to do things, and now you are talking about 21 patients coming through on a unit. When it was 16, there was a little more time there to take care of some of these things.

So, that is another alternative is more frequent, but less intensive look at a few objects. Pick your performance indicators that you are interested in.

DR. BARR: Certainly, that is another alternative, as I said, not outlined by Congress at this point, but absolutely.

MS. HARVEY: Things changed quite quickly in some ways, didn't they.

DR. BARR: There are other alternatives, and there is lots of issues surrounding this. I mean we have States that say you have go to in there every year, we have States that say we are willing to see how this pans out, we have people who say, you know, we need all these things to be checked every year. There are people that say, some of them, we have never had a dose that has been out of limit, do we need to measure the dose every time.

Well, some people would say it has never in all these years of inspections been a problem, and some would say, yeah, but the one time it is a problem, it could be a big problem, so there is a myriad of issues to weigh in all this.

DR. FINDER: I would add that we did discuss and look into the possibility of doing shorter inspections and how that would impact, and it turns out that much of the cost of the inspection is just getting physically the person out there.

So, we looked at how much we would save in terms of being able to reduce the cost of the inspection, and it really wasn't much, if anything, because again the major cost is shipping the person out there, so it wasn't a cost savings from that standpoint, and how much the facility would benefit from having a slightly shorter inspection versus having inspection every other year.

The idea of the less frequent inspection, but doing the same type of inspection was the way we are going, and especially since Congress has put it in the Act that way, in the reauthorization act.

DR. BARR: Although we did analyze the shorter inspection from the cost standpoint, as Charlie points out, separate from that might be an analysis of what you really need to measure and sort of what are the key elements in the inspection, which really give us indicators of a problem facility, separate from the whole cost issue.

MS. HARVEY: Thank you, Dr. Barr.

Ms. Fischer will speak to us now about Full-Field Digital Mammography Certification - Update, with Ms. Butler.

Full-Field Digital Mammography

Certification - Update

Ruth Fischer

MS. FISCHER: This will be a very brief overview for you, and I will gladly yield the rest of my time to Penny Butler, even if she doesn't want to.

FDA has been extending certification to include full-field digital mammography systems under certain circumstances for the past year and a half.

First of all, the manufacturer's system must be approved by FDA. That is done in the Office of Device Evaluation. It is not where MQSA is located. We are in the Office of Health and Industry Programs, however, the two offices do collaborate on these reviews and discussing clinical testing, clinical design.

MQSA does make a significant contribution in the area of the review of the quality control tests of the manufacturer and the Quality Control Manual.

What we have presently been doing is we will extend the MQSA certificate to include a digital system if it is an accredited screen-film facility. We know that facility has gone through the rigorous standards process and that the surrounding infrastructure for the facility has been approved by one of our accreditation bodies and subsequently certified.

For the past year and a half, we have not had an accreditation body for digital, and so the units have been exempt to date, and the way we wanted to cover that more substantially was then in our review of the individual facility's applications.

The things that are in the application that need to be addressed, that are of most importance, are providing the list of personnel who began working in FFDM modality prior to April 28th, 1999, when the Final Regs became effective, and after that or projected to work in the field after that.

By working with the system, we mean the interpretation, the actual performance of the mammogram, surveying of the unit.

A key point is providing a satisfactory FFDM equipment evaluation. This includes an evaluation of the softcopy display system if that is going to be part of regular clinical use. This must be done by a qualified medical physicist, and it must be within six months prior to the facility's application for the unit.

We require, as we must by the Final Regulations, that the facility follow the manufacturer's guidelines for quality assurance and quality control tests. That is specifically specified in the Final Regulations.

Then, six months after using these tests, we require the facility to send us the results. We also take a look at that. In addition, in the application, we look at the results of the phantom image test and a sample phantom is sent in, as well.

These materials are all reviewed and if acceptable, then, we will extend the certification to include that unit for the facility. If it is not acceptable, we work with the facility, the medical physicist, in order to go through anything that we think may be deficient, but then is fully corrected, and then we can give an approval.

There has been one area of confusion that we have become aware of recently, and it has occurred at professional meetings, so FDA would like to clarify it. It involves all categories of personnel, the interpreting physician, the radiological technologist, the medical physicist. It is about the documentation requirements for the eight hours of initial modality training of personnel working with the FFDM systems.

Those who were working with the systems prior to April 28th, 1999, were considered the pioneers of the program, are considered to have met the eight-hour initial training requirement including that work, and such personnel may provide either an attestation on an FDA attestation form or its equivalent, or documentation of the work for review during inspections.

Personnel who began working with FFDM systems after April 28th, 1999, must provide documentation of their training for review during inspections.

We are aware that this position conflicts with our currently published guidance of January 2001, stating that attestation would only be accepted if the work with FFDM units took place before October 1, 1994, and the guidance is presently being revised to remove this conflict.

Thank you.

Priscilla Butler, M.S.

MS. BUTLER: Penny Butler from ACR. I am going to talk to you about the development of the full-field digital mammography accreditation process.

[Slide.]

Just a little history. I will skip over the first bullet. I think Ruth went through this. I want to discuss a little bit what ACR's process is and why we didn't have an accreditation program the moment FDA gave the blessing on the GE unit.

For all of our accreditation programs, we tend to develop them after our professionals - technologists, radiologists, medical physicists, have some experience with the modality, so don't come out with unreasonable standards and standards that have not really borne the results for some time.

For that reason, we didn't have a program right from the beginning, but the problem was that under the MQSA regulations, a facility has to be accredited before it can be certified.

[Slide.]

Ruth described the interim process for allowing full-field digital units to be used clinically in the United States right now, and that has been working very well. It has allowed us to obtain some data for the pilot programs, so that we can come out with a digital module.

[Slide.]

We have a subcommittee of the Committee of Mammography Accreditation. This is the Subcommittee on Full-Field Digital Mammography, which is chaired by Martin Yaffe. In fact, Andrew Karellas is one of the members of the committee.

The purpose of this committee is to develop and test a revised accreditation testing protocols and forms, and to conduct a pilot test, and this pilot test was conducted in the spring of this year.

[Slide.]

Our goals in this pilot test were to field test new phantom and dosimeter testing protocols, and I will explain why we need different testing protocols in a minute, to field test these revised instructions and forms for the facilities, and to determine if existing ACR image reviewer protocols, which were originally designed for screen-film, were going to be adequate.

We also need to set up a system for full-field digital mammography application internally by ACR staff, and determine what changes we need for our accreditation software. I also want to point out that all of these pilots test activities going on really followed some very early, what we call alpha-testing, sort of basic research on looking at some of the quality control and the testing protocols for digital that took place way before this.

[Slide.]

Why do we need different protocols for looking at phantom exposure and dosimetry? Well, each of the digital manufacturers have different exposure control mechanisms, which are different from screen-film.

We are finding that the instructions that we give to our facilities on how to expose a phantom and how to expose, in particular, the dosimeter that we send with the phantom, have to be unit-specific.

For example, the General Electric's exposure control system is going to be significantly impacted by the thickest or the densest part of the breast. Currently, screen-film systems have a relatively small ion chamber, which is used to measure the transmitted radiation, so the system can determine when and how to terminate the exposure, but the General Electric systems look at a much broader area.

Particularly with the phantom and the dosimeter that is used for accreditation, you do have a lucite rim around the phantom, around the block. In addition to that, we place an additional plastic holder, which contains the thermal luminescent dosimeters on top of the phantom, and that can skew the exposure and possibly the image quality results, so they would result in higher exposures of a 4.2 cm breast.

So, what the committee worked on was a revised set of instructions, were instructing the facilities for the GE units in particular to expose a 4.2 cm tissue-equivalent, homogeneous acrylic block, so it is just a piece of lucite under AEC conditions to determine the appropriate technique that is going to be used.

Part 2 involves the exposure of the accreditation phantom with the dosimeter in place. This will be done by the facility selecting the closest manual technique that came up after the AED exposure. So, the phantom and the dosimeter will be exposed under manual conditions.

[Slide.]

There is also other unit-to-unit differences among digital equipment that we need to be aware of, and I am just quoting part of the regs which Ruth had pointed out earlier, and I want to re-emphasize this, because this is a point of confusion among technologists and physicists in particular.

That is, "For systems with image receptor modalities other than screen-film, the quality assurance program has to be substantially the same as the quality assurance program recommended by the image receptor manufacturer except for the dose part, which stays at 300 miilirads."

With the different manufacturers that are coming out with digital units, we have to have a different set of criteria for evaluating the image quality in each of those cases. Under the regulations as they currently stand, it has to be based on what the manufacturers have come up with.

[Slide.]

Just for an example, this is a laundry list from the General Electric QAP Manual describing the technologist tests, and many of them look exactly the same as they are in the ACR-QC manual, which primarily applies to screen-film, but there are other items which are specific to digital, such as viewing conditions for the review workstation, flat field tests, MTF measurements, AOP mode and signal-to-noise checks, and certainly laser film printer QC. A lot of the others are exactly the same, however, as the Mammo QC Manual.

I also want to point out that some of the tests there are only if applicable. For example, if you are doing dry laser film processing, obviously, you are not going to have to do the analysis of fixer retention tests, which is very specific to processor quality control.

[Slide.]

Likewise, for the medical physicist, there are some tests which are specific. They are for the digital system using the SMPTE pattern to look at image quality, display device calibration looking at brightness and contrast, again, the review workstation screen uniformity, and again, a lot of the tests that are common to screen-film are there also.

[Slide.]

Let me talk a little bit about the pilot test that we ran. At the time, although we had some stragglers coming in, we had 10 General Electric 2000D units that we received test data from. We were fortunate because at the FDA approval, that we were not only able to obtain results from academic centers that were participating in research projects, and the primary research project that we drew from was the ACR Imaging Network, which is now called DMIST, and they have been very cooperative in participating in the program.

We also were able to obtain data from private practices across the United States. Our original goal was to try to pilot test some of the other digital units that were out there, such as Fisher and Fuji and Hilogic LoRad, but part of the stumbling blocks we came across were that they were not FDA approved, so there weren't many of them out there, and many of the research sites that we were hoping to obtain data from had not yet received their newer models when we were conducting the pilot test, so they weren't really available to participate.

[Slide.]

So, what did we find from our pilot testing results? The new phantom instructions that we had presented to these facilities turned out to be relatively easy to follow. We didn't have a whole lot of phone calls regarding how to do this. I don't think we had any phone calls. It was pretty straightforward.

Our subcommittee also feels at this time that there is no need to change the image evaluation criteria relative to screen-film, and this applies to both digital clinical images and phantom images. There is a few minor tweaks for, in particular, artifacts, because there is a whole genre of artifacts that may occur as a result of digital, which you wouldn't see under screen-film, but this is a minor change.

Our volunteer facilities generally felt that the process was easy to follow, and this was primarily because it was very similar to the screen-film documents that they were used to completing, however, there were some revisions that we made to these documents into the program as a result of this pilot.

One of the things that we were noting during review of the documents that were sent to us, that many of the physicists were not aware that they needed to comply with the manufacturer's recommendations for quality control. They were basically turning in quality control tests which were more specifically related to screen-film rather than what was included in the QAP Manual.

We are going to strengthen these instructions with our final documents when they are revised and approved.

Another thing that the committee decided as a result of this is that it is an undue burden to request from facilities quality control data on both processor QC and laser QC. They felt that facilities using laser cameras to produce hardcopy, that the quality control was important information, and they felt that we only needed to request that, we did not need to request the processor QC charts.

We will be requesting basically a checklist, so that we know that they do the QC, but we will be looking at the laser QC.

[Slide.]

The subcommittee also decided that due to the differences between the manufacturers, we have to develop separate application packages for each manufacturer at this time. That is because of the exposure control mechanisms that are different and the required QC that may be specific depending on the manufacturer.

Consequently, we are going to have to pilot test each of these manufacturer's models as they became available through the ACRIN research trials and as FDA grants approval.

[Slide.]

So, where are we in the approval process? We are currently in the middle of it. I know probably many of you never had to deal with an approval process before, but sometimes it can take a significant amount of time in order to review the document and obtain approval.

Right now, the Committee on Mammography Accreditation, chaired by Judy Destaway, they voted on the documents in the program, and after some changes, they have approved it with some changes, I should say, and for every ACR accreditation program or module, our process is that it must be reviewed by the Council Steering Committee and then after that, and after we incorporate comments from the Council Steering Committee, it has to be approved by the Executive Committee of the Board of Chancellors.

We hope to get the package to go to the Council Steering Committee this week, and if there are no significant revisions, we hope to have final approval by the end of September.

[Slide.]

After approval, what are we going to do? Well, ACR has requested FDA to provide us with a list of facilities with the GE full-field digital units, so that we can advise them of the appropriate process for accreditation.

This is important because we are treating these digital units when they enter the accreditation process as new units, and depending on where the facility is in the accreditation process, we are either going to require the facility go through early renewal of all their units at this time or go through what we call the mid-cycle accreditation cycle.

So, if they have less than 13 months left on their accreditation, we will ask them to complete early renewal for all the units at the facility. If there are more than 13 months left on their certificate, we will ask the facility to go through mid-cycle accreditation, and this will be at a reduced fee. The full renewal will be at the usual accreditation fee.

I think that is my last slide.

MS. HARVEY: Any questions?

DR. PISANO: Someone mentioned before, I think Ms. Barr, that you were going to require submission of accreditation materials on printed film?

MS. BUTLER: Hardcopy?

DR. PISANO: Hardcopy.

MS. BUTLER: Yes, that is correct. Phantom images and clinical images will have to be submitted to us on hardcopy.

DR. PISANO: I just want to make a comment about that. As part of the ACRIN program, ACRIN is a multi-center clinical trial that I am PI of, which is going to compare digital to film-screen mammography diagnostic accuracy, and the name of the trial is DMIST, Digital Mammographic Imaging Screening Trial.

Anyway, as part of that trial, Margin Yaffe is also in charge of our quality assurance program for that trial, and we are pilot testing softcopy submission for that. I mean we are definitely doing everything through softcopy, so it will be interesting to see how that works, and it will be an interesting comparison.

MS. BUTLER: In order to get this off the ground relatively rapidly, we have to have hardcopy, and we are not equipped to handle softcopy at the time. That is actually a long-term goal for the College for all of our accreditation programs to be able to do, take softcopy, but it is not going to happen in the short run.

MS. HARVEY: Any other questions? Thank you.

I think we will break. Please be back about 3 o'clock.

[Recess.]

MS. HARVEY: Our next item on the agenda is from Kaye Chesemore, FDA, who is going to talk to us about States as Certification Agencies.

States as Certification Agencies - Update

Kaye Chesemore, M.B.A.

MS. CHESEMORE: Good afternoon.

Today, I will be talking about the States as Certifiers program, and throughout the talk I will often refer to it as SAC, which is an acronym, SAC, for the States as Certifiers program.

Since many of you are new to NMQAAC, I have been asked to provide you with a little bit of background information about the program.

In August of 1998, FDA delegated the responsibility for certification of facilities to two States. Illinois and Iowa applied to the FDA and were accepted into the SAC Demonstration Project.

One thing I want to point out, a word of caution, is not to confuse the SAC Demonstration Project with the Inspection Demonstration Project that was just discussed earlier by Dr. Barr.

The SAC Demonstration Project is beginning its third year and will continue until the SAC regulations are final, and barring any unforeseen circumstances, we are hoping that they will be published and in effect in 2002.

When the regulations are effective, we will close the period for the Demonstration Project and initiate the formal SAC program. We do anticipate a seamless transition for the two states who have been participating in the Demonstration Project thus far.

We also anticipate that several other States will apply to become SAC States at that time.

Now, what does it actually mean to be a SAC or a certifying state? The SAC program is based on subsection Q of the Mammography Quality Standards Act. That subsection permits FDA to authorize a qualified state to do the following within its boundaries: issue, renew, suspend, and revoke certificates for mammography facilities; conduct annual facility inspections, enforce the MQSA quality standards, and administer other related functions.

At the same time, FDA has made the decision to retain authority over certain inspection support services that it currently provides, such as inspector training, the provision of inspection of equipment including inspecting laptops, equipment calibration, and data systems.

These responsibilities have been retained by FDA in order to preserve a nationwide consistency in inspector training and equipment calibration, and to provide a national MQSA database that can be accessed by all accreditation bodies, as well as certification agencies.

FDA's oversight of the SAC program is mandated by MQSA, and there are four ways that FDA accomplishes this. The first is through the use of FDA staff, who act as liaisons to each state. Now, since we only have two in the demonstration program so far, I am the liaison to both, both Iowa and Illinois.

Secondly, indicators are used to measure how the States are performing as certifying agencies. The third, site visits to the States who are used to review performance, and strengthen cooperation between the participating States and the FDA, and finally, through audits and other means, we review inspector performance as part of FDA's oversight.

Through the Demonstration Project, FDA has provided feedback to the two participating States in the form of quarterly and end-of-year summaries to the two States participating.

Now, I would just like to say just a few words about the performance indicators that we use in these reports to report back to the States.

We first evaluate the State's technical staffing and training to determine if the State is adequately staffed to carry out certification responsibilities. We evaluate this in the State's initial application, and we follow it throughout the program to make sure that training and staffing are maintained in order to carry out the State's responsibilities.

Likewise, we review the State's information systems' capability, and their initial application, and we follow that indicator to determine if the State is continuing to transfer files between the SAC State and the FDA on a timely basis.

The third performance indicator evaluates inspection and compliance activities. This indicator records such information as the number and the percentages of facilities within the State that were inspected within the quarter. We also record inspection actions for the States' facilities.

At the end of the year, we look to see if at least 90 percent of the fully certified mammography facilities were inspected, and if any inspection findings were resolved within the four months, and if missed and deferred inspections were rescheduled.

The fourth and last indicator, which concerns the actual certification program, evaluates the percentage of certificates that were promptly issued within the required 10-day period in a given calendar quarter.

In addition to the performance indicators and the quarterly reports that I have just discussed, our oversight of the project includes site visits, and we anticipate that site visits will occur annually.

To conclude, we are presently revising the performance evaluation instrument, and these performance indicators will be expanded or may be expanded or revised throughout the program as it grows and expands. We do look forward to other States joining the SAC program in the future.

Thank you.

MS. HARVEY: Thank you. Any questions?

MS. RIGSBY: Is this a voluntary thing for the facilities in those two States?

MS. CHESEMORE: No, it is not. They automatically are certified by either the State of Illinois or Iowa in this particular instance, and any other SAC State that would come into being.

One thing I may tell you is that with SAC States, they cannot go outside their State's boundaries. With accreditation bodies, they don't have that restriction although it hasn't occurred yet.

MR. BAILEY: Presently, not all States are using FDA laptops or necessarily FDA equipment. Under certifying, I would assume that that would continue to be an option.

DR. FINDER: If you have got very specific questions about the program, I don't think this is the forum to air it. You can just discuss it amongst yourselves and get the details.

MS. HARVEY: Other questions, comments?

Then, let's go on to the next item, which is the Future Direction of the MQSA Program.

Future Direction of the MQSA Program

MS. HARVEY: This is an opportunity for us to look forward. We have talked today about the many miles the mammography program has come, and I can certainly speak for New York for some of the early facilities 10 years ago when we would try to put one of the old Kodak phantoms in the beam, and not visualize anything, to this point in time where we have such high expectations as to what these images are going to look like, every single one of them.

But then we say to ourselves we have come this far, now, when we look forward, what do we look forward to the evolution of this program over time.

I mentioned earlier one of the issues in particular that I am interested in, which is perhaps a reduced period of time for the inspection, but I am also interested in something that we have tried to do, is that during the course of the inspection, that the inspectors take a look at the completed clinical images, not because we are radiologists, not because we are rad techs, but because once in a while there will be a facility in which the image quality is unacceptable, and what the inspector can find by looking at those images is something that may have fallen through the cracks, which is what we have seen.

The point would be to find the very--these are some of the worse images you have ever seen as an inspector, not that you are making a split between good quality and better quality, but images that really call out to have some form of review by someone who would be in a better position than the inspector to actually look at them.

So, I think it is one of the important things for us to think about over time is how can we incorporate more of a review on the inspector's part while they are there at the facility.

I am happy to listen to your concerns or thoughts about that.

MR. CAMBURN: In our State, and I don't know how much this would be in the other States, but in our State, none of our inspectors are x-ray technologists. They are all people who have at least a Bachelor's or Master's Degree with a major in physics.

They right now would have no training or no skill whatsoever in looking at clinical films and judging whether they are good or bad. In fact, sometimes we seem to struggle over interpreting phantom films, and the way we do it, we have at least three independent MQSA inspectors look at every film we take. Then, a fourth person looks at their scores and comes up with a consensus. Sometimes we can't even agree very well among ourselves on something as objective as a phantom film.

I am not sure how successful we would be trying to evaluate a clinical film.

MS. HARVEY: What I am not suggesting is that you look at clinical films as though you were a radiologist or a radiologic technologist, but for serious problems in processing, developing, where you find extreme artifacts, films that haven't been properly cleared, films that the optical density is either extremely high, extremely low, very gross difficulties, very, very gross.

This is not looking at images to split hairs between, well, you could have done this a little better. That is not the point of this. This is the goal. Our goal here is the best quality we can get, and while we are not going to be the judges from a radiographic, we can learn, just like you can learn art criticism. You look at a picture long enough, you will learn by doing what is the extreme, and that is what I am looking for, it is the extreme.

MR. CAMBURN: In these cases, these are films that the mammographer would have looked at, and the radiologist would have interpreted, and not rejected?

MS. HARVEY: Right. So, we are only looking at a very few facilities out of all the 10,000, but we certainly had a case in New York where the end product films were, we believed, to be below diagnostic quality.

MR. CAMBURN: Even though the radiologist thought they were okay.

MS. HARVEY: Even though it was MQSA-accredited, certified, and passed the inspections.

DR. IKEDA: I have a concern about adding another layer of inspection. We have just discussed--you know, granted we want to catch bad films or facilities that do not have good diagnostic quality or something that may have fallen through the cracks, but my concern here, as we have already talked about, trying to limit the number of items that we are going to be looking at during the inspection.

My second concern has to do with interpretation or intra-observer and inter-observer variability. I know the ACR and FDA and the States have gone through a rigorous process to do clinical image evaluation, or maybe somebody from the ACR can speak to this, but I know that they have multiple training sessions.

As a facility director, we do a very tedious and thorough job looking at our images. I am concerned, I thought that most of the poor images, I think would be caught by that particular process, and like I said before, MQSA has done a tremendous job in trying to weed out bad facilities or, well, suboptimal facilities in this day of political correctness, but facilities that were not doing good images.

So, it was my thought that those images would probably be caught by those particular processes. My concern is to take this one step, even though it is a good thought and it is a noble aspiration, but to apply it to 10,000 facilities, that is more money, more time, more burdensome of a process.

I wonder, number one, what is going to be the training of the inspectors who is going to be the final judge, what is going to be the follow-up for it, and how many are actually out there in which this applies.

I know that there must be at least one, because it has been your experience, but I just want to raise my concern and say that I don't know, and it is something I would like to think about.

MS. HARVEY: I would trade you some of the other tests.

DR. IKEDA: That is something else we can talk about.

MS. HARVEY: Because when I started way back, my very first job when I graduated from college was to work for a company that made photographic film, and I worked in the Motion Chemistry lab, and I spent that year during quality control. So, when I went out to start doing my first inspections, I immediately saw the films, and this was back in the seventies--I am giving away more data here than maybe I wanted to--and I was appalled. I was appalled because of the quality I saw, and this was just when the FDA was starting to print all their huge quantity of wonderful books about how to do quality control.

Well, I was there, I was ready, because I was looking at films that were--my theory was any film that is worth taking is worth taking well or don't take it. So, I think to have a whole program, such as we have, and not to have, when we have an inspector in that facility every single year, to not spend the five or 10 minutes to get a feeling for what is happening at that period of time in that facility, it is an opportunity that we are not taking.

Like I say, I will trade you over tests, because to me, that is one of the major things we want there is quality images.

DR. PISANO: I think that we actually are getting the kind of information you are interested in already at the inspections. I think the case you cited is really quite exceptional because we are doing--I mean the inspector is already shooting a phantom, so we know how well the processor and the machines are functioning that day. The inspector is already checking a lot of other parameters that are going to reflect image quality.

So, I agree with Debra Ikeda on what she said about adding burden to both the facility and the inspector. I am actually quite concerned about the inspector's ability to do it, just as Dr. Camburn mentioned a minute ago.

I am concerned about, you know, I was a participant for many years in the ACR's film inspection program. I was radiologist reviewer for clinical images. I was impressed with how frequently my partner and I, who were both trained radiologists and who have been through the ACR's program--the way it works is they send you cases, and you review them blindly, you don't know what the other person is going to say--and how frequently we are given a report card by the ACR what percent of the time we agreed with each other, and how frequently we did not agree with each other, so I feel like this is a somewhat subjective process and that the more objective data is really already acquired by the inspectors.

So, I am not sure there is a lot to be gained. I think that the number of facilities it would actually help for the inspector to actually lay eyes on the images would be very, very low for the amount of time and money that would have to go into a program like that.

MS. HARVEY: Dr. Barr.

DR. BARR: I just wanted to point out some of the things that Etta started before I did, and that is, that we do have objective indicators that do have triggers, that if they are severe enough, they trigger looking at films, and in our experience it is mostly the other way around from what you are saying, say, a phantom image failure triggers looking at films, and in all the phantom image failures we have had, we only know of one case where that actually translated into poor image quality, so it is sort of the flip side that sometimes we find violations in an inspection where the clinical image is still good.

I haven't seen a documented case where the severity of the films, such as you are describing, would not be caught by one of the inspection parameters. In the case you cite, I would just like to point out that neither the accrediting body, the ACR, nor the FDA ever had a chance to evaluate the image quality, so that's still an issue of whether a case like that has actually come about.

Thank you.

MS. HARVEY: Any other comments on the future?

DR. YOUNG: I would like to offer what I hope is a constructive comment when we look at the future of MQSA, and I would hope that we would move foward--and I think the phrase has been used in some of the handouts--total system resolution with a particular emphasis on the clinical images, and by that, I mean not just measuring a focal spot, not the filter, not looking at your image receptor, your source image distance, all that stuff to processing.

Anecdotally, I had a problem with one of my units a couple of years ago where the molybdenum filter went bad, and I can't remember what happens from the standpoint of physics, it is like when window glass turns different colors, and it took us about a week, and our clinical images just deteriorated on that unit to the place we quit using it, and even the company had a hard time.

We took that problem to them finally, and those are the sort of things that this idea of total systems resolution relative to the clinical images, continuous quality improvement, things like that, that is what we need to keep in mind, and not burden some regulations that we are just doing a bunch of paperwork for paperwork's purposes.

MS. HARVEY: Yes.

DR. KARELLAS: I agree with Dr. Young. I believe that the agenda for the years to come would be perhaps some increase in the efficiency of what we do. I think we can cover the same ground, not necessarily recommending any elimination of anything unless everybody agrees to that, but I believe we can do things smarter and more efficiently.

There has to be a way that some of these things we can do them better and with relevance to what the ultimate goal, as Dr. Young suggests. It is perhaps premature to know exactly where we are going. The technology is changing, communication is easier now between the various parties, accrediting bodies, physicists, facilities, and I think that now we know the rules, we know how to live with the rules, I believe now that we can make it more efficient, and I believe that everybody feels that way.

MS. HARVEY: Dr. Lee.

DR. LEE: I strongly encourage you to continue looking at the access factor because you can have the best staff and the best machines in the world, but if you don't get that woman to that machine and to that staff, you are not going to really make a dent in breast cancer morbidity and mortality. So, I hope you really continue looking at access.

MS. HARVEY: Any other comments?

MS. ELLINGSON: I don't want to pass up the chance. One of the weakest links that I see in every-day practice is the quality control technologist. In a large facility, you may have a choice of a volunteer, somebody who has a background and they are interested in it, and that's great. Sometimes you just get named to be that person. You don't want to do it, you don't understand it, it is not something that you are even remotely trained to do.

We have CE, specific CE for modalities. I would like to see somehow require some basic documentation that these QC technologists have some kind of training, and I think it would help them. Then, they would say to their doctor, you know, I have to have this, you have to send me someplace or even develop a self-learning module that would be specific to the tests.

I know it is in the QC Manual, but people are asked to do this that don't understand what they are doing, and it is fine if the numbers are right, but the day something goes wrong, they don't know what to do. They are not trained in troubleshooting.

I would like to see that strengthened somehow, and I don't know if it is our place to do that, but if we required some documentation that they have had--some of the physicists around the country have developed a program, when they do their annual inspection, and they have applied to ASRT for approval of that course, and if it is a format is documentable, and so forth, and it is not just following them around watching them, we have approved courses, and things like that could be mandatory that they have had some kind of training that is documentable to help them understand average gradient, all those kind of things. Some people don't understand it. They just hope the numbers turn out right, and, woo, it did, but what if it doesn't.

That, I identify, and some of the time that is taken away from their mammography duties is because it is taking them three times as long to figure out what has gone wrong, when they could do it quicker if they were better trained. Just a suggestion.

DR. IKEDA: I also have a comment about that. I have several mammography technologists, some of who are named and some of who volunteered to do this. Our lead technologist, who has the most expertise in it, learned how to do it on the job with another lead technologist as she took over the other person's job, but we have several other technologists who do much of the charting, for example, because we have multiple units. As former director of a private practice who had 19 sites and 25 mammographic units, we had to go through many different people to get the right person and to train them.

Although it is possible to have such training, I don't know if it exists, for example, on the web, because I don't want to limit access in the small rural communities, for example, who may have one technologist or a couple technologists, and they need to learn what they are doing, of course, and I don't know if that exists now.

MS. HARVEY: Let's move on to the last agenda item of the day. Dr. Finder.

Review of Summary Minutes of

September 2000 Meeting

DR. FINDER: Once again, last chance. Any federal liaison, any AV rep want to give me their mailing information and e-mail address, polls close in 15 minutes, last chance.

Next, review of the summary minutes from the last meeting. Anybody have any comments?

MS. ELLINGSON: Radiologic technologists are quite sensitive. We don't like to be called technicians. In the minutes, we were called technicians again, so please call us technologists.

DR. FINDER: That was definitely an oversight. We didn't catch it when it went out. So, that will be corrected.

MS. ELLINGSON: Thank you.

Future Meeting

DR. FINDER: Any other comments?

Future meetings. I don't want to try and set any specific date because several of the members will not be here, we will have new members, and we have to arrange times with them, but I would want to get to try and get a feel from the current members in terms about which day of the week do they want, beginning, end, something like that, or middle of the week is better, because we can try and plan the meeting for that.

The other thing is we are probably going to be looking for another meeting sometime in the spring.

Does anybody have any preferences for beginning, middle, or end of week?

DR. PISANO: End of the week is more difficult to get home because the airports tend to be more crowded, so I would prefer to avoid Fridays.

DR. FINDER: What about Monday? That is when we used to usually have the meetings. Anybody have any problem with the middle of the week? We have heard in previous panels that they had problems because they had to travel during too many workdays, but if that is not a problem with anybody--

DR. IKEDA: It's all bad.

DR. FINDER: Well, that's another problem we can't deal with, the airlines, it is not a part of MQSA.

So, basically, I have heard that the only thing we don't want to do is on Friday.

With that, does anybody else have any other comments? I would want to thank two of our members who this will be their last meeting - Dr. Dowlat and Ms. Brown-Davis have served on our committee for the last four years. See how time flies when you are having fun.

I would like to thank them for their service. While I don't have it with me, when your term officially ends in the end of January, you will be receiving a letter and a plaque for your service, but we don't send them out at this point, so you won't be getting them right now, but you should be receiving those.

Once again, I and the entire Division want to thank you for the efforts that you have put in, in serving on this committee. So, thank you.

[Applause.]

MS. HARVEY: I believe that is it. Thank you for coming. Thank you for serving. The meeting is closed.

[Meeting adjourned at 3:30 p.m.]

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