HCFA's Gail Wilensky explains final CLIA '88 regs.

MLO: Could you give us the latest timetable on the issuance of the final CLIA regulations, and whether they will be issued in sections or grouped together somehow?

Dr. Wilensky: At least three of the four rules will be issued around the first of the year. I don't know if we're going to package three of the four, or if one of those three is ready a couple of weeks earlier, whether we'll release it first. But probably about the middle of January we anticipate having the final complexity rule--the major rule--and the user fee rule ready. It [the user fee rule] may be ready a couple of weeks earlier than that, but we may release them together. And then the enforcement regulation. The "deeming" regulation we anticipate would not be ready until February, approximately.

MLO: And is it correct that these final rules will supersede the so-called consolidated CLIA '67 regulations issued March 14, 1990?

Wilensky: That's right.

MLO: HCFA is now in the process of gathering information from more than 640,000 entities identified as currently performing clinical laboratory testing. Please tell us something about how those testing sites have been identified--and isn't it possible that some have been missed?

Wilensky: It is always possible that some may be missed. We have attempted to take lists that were available from different organizations, basically any that seemed a likely source.

I believe we mailed to somewhere around 650,000 known addresses--any of those we thought might be doing testing for human purposes. It was as complete a merging of lists as we could possibly manage.

Frankly, we are hoping that by working with a number of trade associations, magazines, and other groups that they will also have the word out, so that anybody who thinks they should have received something from us and hasn't would contact their organization or us directly.

We have tried to be as inclusive as we know how, in terms of merging mailing lists and other identifications. So it is certainly our intent to have a much broader circle than is, in fact, relevant. But there is always the possibility that there is someone we might have missed; some small independent laboratory or some physician with no known identification.

I think it would be unusual if we missed someone. Now, when you do a mailing process, I can't say there is no probability of error, in the sense that the person was never on somebody's list or that somehow in matching and merging all of these various lists, somebody could get left off. Again, that's why we've worked with organizations trying to make sure they know what we're doing.

MLO: You touched on the complexity model. Apparently there are some bootleg versions of the final regulations that have been circulated. They suggest the complexity model is undergoing substantial revisions. Could you give us an indication of what changes are likely and what the new structure might look like?

Wilensky: The overall structure is very similar. That is, we attempt to put tests into categories in terms of their risk and complexity and to have three separate categories in terms of the waivered tests, the moderately complex, and highly complex; to match personnel requirements, quality assurance, quality control, and proficiency testing with the tests that are in the various categories.

Having said that, there are some very important differences in terms of what goes in what category and in the requirements associated with a particular category. The general difference, as the bootleg version made clear--and we're not crazy about having that happen but it's now no big secret--is that there is a narrower list of waivered tests. And there is a very broad category of moderately complex tests, then a small but not insignificant grouping of highly complex tests.

What we tried to do, relying heavily on the Public Health Service, the Centers for Disease Control, the Food and Drug Administration, and their technical advisors, was to make use of the many, many comments we received to understand equivalency in terms of training and to recognize that for the highly complex tests you might need to have a baccalaureate or very specific certification. For moderately complex tests there may be different classes of people that need to be there: a medical director such as a physician who may or may not have had any specific training, and the analyst who can have experience in addition to some formal training.

We've tried to recognize the points raised in the comments that there are many people who have been out there doing tests who may have experience enabling them to perform the tests in a reasonable and safe way. This is not my own area of technical expertise, but it seems to me that [the other Government analysts] have done a very reasonable job in terms of the trade-offs between requirements of specificity and experience and what that means for providing assurance that tests are done in a safe way without making it so difficult as to seriously impede access for those who are in rural or sparsely populated areas.

So it is and always has been an issue of trying to balance the very appropriate concerns for consumer safety with making sure you are in fact applying [the complexity rules] in a way that is both consistent with the statute and reasonable for what is being provided for the public.

MLO: How would this affect technological change in lab equipment?

Wilensky: There is a recognition that as instrumentation is advanced and is able to reflect certain standards, it may well be possible to substitute instrumentation that has clear, known calibration and outcomes associated with it, allowing a test to move from one category to another over time.

It is recognized that the division is something that ought to be allowed to change as instrumentation, the FDA process, and the technology itself changes and improves. That could have some impact on the appropriate personnel requirements.

MLO: On the subject of personnel requirements, might there be changes that will permit non-college graduates to qualify as technologiests/technicians and general supervisors?

Wilensky: Absolutely. Certainly as technicians for moderately complex testing and other roles. It depends, again, on the lab classification and the position. But there definitely are roles for non-college graduates.

MLO: Could you also address the proficiency testing standards, particularly the strict PT standards for cytology that were the subject of extensive comment?

Wilensky: That's really a level of specificity I would prefer to wait on until we have finally released the rules. Our concerns there are having proficiency testing that is doable, having the slides available. In many ways, that is obviously the ultimate quality control.

You can have processes in place, and you can have personnel requirements--but the fundamental quality control really lies in proficiency testing. And what the appropriate pass rate ought to be, how to have that done, and how often to have it done are details that will be associated with the final rule. Nevertheless, we have listened to the comments that came in.

MLO: Will each testing entity in a hospital to be required to have separate certification, or will one be sufficient?

Wilensky: My understanding is that that is their option. They can be grouped as a single unit or treated separately. It is their choice--at least the last time I asked that question, that is what I was told. There may be times when they may wish to have separate identification because it may keep a laboratory as a lower-level laboratory.

MLO: Will the fees that labs have to pay for their certificates cover the cost of the inspections?

Wilensky: There are two different kinds of fees. The first is an administrative fee for basic certification. The second is the actual fee that will precede the inspection that is geared to closely approximate, within different classes, the actual cost of the inspection.

This will all be part of the user fee rule. This is a self-funded activity, and it will be as close as we can approximate to what the cost of the survey and certification is. We will make some [fee] divisions, following the proposed rule, according to the size of the lab, the number of tests, their complexity, and whether there are follow-up visits required because of problems. Still, in the aggregate, it will be self-funding.

MLO: That will be quite an accomplishment.

Wilensky: Well, we will obviously have to guess to some extent in the first round in terms of how that distribution matches our cost. We know something about the anticipated time and the cost of doing the survey, but we undoubtedly will need some adjustments as well.

MLO: As you envision the final rules, do you think they will cause many physician offices to discontinue testing? And what will be the overall impact on patient access?

Wilensky: We do not believe they will cause very many physicians to discontinue doing some testing. It is possible that there are some physicians doing some types of testing for which they will need to seek some technical consultancy if they haven't had training or background in that area. If they don't wish to do that, they would then be in a position of not being able to continue.

I believe that the requirements really are consistent with common sense in terms of the kind of training needed, having substantial roles for physicians who have training in particular areas and rolexs for technical consultants to come in and provide assistance on a reasonable basis.

It is my sense that, in generall, if a laboratory, either [a physician's] office or an independent one, can't meet the qualifications we have set up, there are some very serious questions as to whether it ought to be doing those tests.

MLO: CLIA '88 certainly has faced a difficult journey toward the final rules, although we seem to be close to the end of that journey. Based on your discussions within HHS and with members of Congress, do you think clinical laboratories will be confronting additional broad changes in the way they are regulated or reimbursed?

Wilensky: What we believe is very important is to recognize that writing the rules has been difficult, time consuming, and stressful for all concerned. But it is only the first step. Then the serious issue is implementing them.

It is our hope that we are allowed to proceed in a fairly stable environment to actually start this. The whole survey and certification by its nature is a phase-in process; that is, it takes two years to cycle all laboratories through it. And the nature of proficiency testing requires some phase-in terms of just getting up and ready to do all this. It would be our very strong hope that we are allowed to fold in this process.

I certainly would want to suggest that there may be a variety of changes that seem desirable once you operationalize this hugh activity. But I think it would be useful to see how that goes, and when it appears to be necessary to have some changes, you then make those modifications. If we make modifications outside that process, because we get a new idea about something, I think it would be very hard to try to put that in any context as far as how it impacts all the changes that are going on.

We have very similar concerns with regard to physician payment reform. It's one thing to get the rules right, but the actual operational activities are really awesome. And [CLIA] borders on the order of magnitude of physician payment reform in the sense that you are having us move from regulating 13,000 labs to three, four, five hundred thousand labs in a way that brings all these laboratories into the survey-certification process and into proficiency testing.