Agenda Item: Welcome

DR. BUSH: I am calling the meeting to order. Welcome to the March meeting of the Drug Testing Advisory Board. I'd like to remind you, as always, the sign-in sheets are available on the table where the handouts are. Please sign-in.

Agenda Item: HHS Update

DR. VOGL: We have been talking about revising the Federal Drug Testing Custody and Control Form for the past year and have finally arrived at what we consider to be the final revised form. The 60-day public comment period was from November 15 to January 14. We received 30 separate comments. Approximately 19 specifically stated they liked the proposed new form. Most commenters suggested changing something.

The comments were evaluated, and in discussion with DOT, we arrived at this final form. As of today, the package for obtaining OMB approval has been completed. We anticipate that approval will be obtained in May, which would give us approximately two months time for the laboratories, printing firms, and everyone else who uses the form to print the forms and have them available beginning August 1, 2000. There is also a need to revise the HHS collection handbook and the HHS MRO manual for use with the new form.

We have not provided hard copies of the new form to ensure that no one takes the form and prints it before approval is obtained. Otherwise, they may come back to us and complain that they printed a million copies and the form was changed. This is Copy 1 (slide). The current form is a seven-part form and it was proposed to be a six-part form. The final form is going to be a five-part form. We are eliminating the second laboratory copy as well as the split specimen copy. The remaining five-parts of the form are as follows: laboratory, MRO, collector, employer, and donor copies.

I am going to highlight the major changes to the form. We continue to have a one-inch space at the top with the title of the form. That is where the laboratory will have its name and address located, as well as the specimen ID number and any other information.

In Step 1 we have the employer name and address. In our proposed form we had considered putting in a box for the Federal agency, the acronym for the federal agency, to know under which program the specimen was collected, and that was deleted. There was a lot of controversy that in many cases a collector would not know for which agency the specimen is being collected. The MRO name and address and donor's SSN. There's a line here, but we would allow users of the form to put boxes or dashes or whatever they want. They can highlight the field. The line is just one example.

The reasons for the test are the same. The drug test performed is the same. We moved the collection site address up to Step 1. That's a big open space area and, hopefully, sufficient for the collector to write in the address where the collection is taking place. Lines for the collector phone number and fax number. These numbers are extremely important to allow the laboratory to contact the collector if there is a need.

Step 2, a box to check whether the temperature of the specimen is within the acceptable limits. We have added and changed how you mark the specimen collection, we put split before single since most specimens are split specimens. If for some reason there is no specimen collected, we included a box to indicate none provided, and that would require the collector to put a comment on the remarks line. Also added a box for an observed collection, if a direct observed collection was conducted. The collector would be required to put a comment on the remarks line explaining why an observed collection was conducted.

Step 3 is basically the same, instructing the collector to place the seals on the bottles, indicate the date on the seal, the donor to initial the seals on the bottles, and the donor to sign the statement on Copy 2, which is the MRO copy.

Chain of custody is quite different from the current form. The current form requires the collector to sign the form three times. This is now a one-step process. The collector will sign the certification statement. The statement covers receiving the specimen directly from the donor and preparing for transfer to the laboratory. It's a simple signature, printed name, date of collection, time of collection, and the specific delivery service to whom the specimen and the form is being released.

A heavy line separates the top half where the collector provides information from the bottom half where the laboratory provides information.

When the specimen is received by the laboratory, again it's a simple one-step chain of custody process where the accessioner gaining access to the specimen and the form will sign, print his or her name, date, and mark if the primary specimen bottle seal is intact. Then the bottles are either released to another person or placed in temporary storage, and that's the end of the use of this form at this point. Chain of custody continues on a laboratory internal chain of custody form.

In Step 5A, we added a box for the laboratory to report a specimen as dilute. We've changed the terms to include rejected for testing, adulterated, substituted, and invalid result to correspond with changes we made in the program over the past few months. It should be relatively easy for a laboratory to indicate the result on that specimen. In some cases a comment is required on the remarks line. If a different laboratory is doing testing from what's indicated at the top of the form, a line is provided for its name and address. The certifying scientist certification statement followed by lines for signature, printed name, and date.

If a split specimen is tested, the result is indicated on Copy

1. The two labels which currently were on the side of the form have been moved to the bottom of the form. We now have the form on a standard 8-1/2 by 11 sheet of paper, rather than having the labels sticking out to the side.

All of the copies will be white paper. When the form is printed, fields can be highlighted to ensure that the collector knows what information needs to be provided.

Copy 2, the MRO copy, will have the donor's name and phone number. Again, we added a dilute box and a box to indicate adulterated or substituted for the MRO when making those determinations. After the MRO records the certified result, this copy can be used to report the result to the employer. There is no need to use a separate memo because this copy does not have any laboratory result information on it. If there's a reversal of a test result, the employer would not get that information.

With regard to the laboratory reporting results to the MRO, we are going to allow negatives to be reported electronically, and there can be several ways of doing that. Everything that's non-negative would require a hard copy of Copy 1 being sent to the MRO. That's why we were able to basically eliminate Copy 2, since photocopying of Copy 1 would only be required for non-negative results.

That's a very brief summary the final form. We are hoping to obtain OMB approval by the end of May, and that will give us enough time to get it out to the public for use beginning August 1, 2000. We will have the form, the revised collection handbook, and revised MRO manual on our web site. The form will be a pdf file so that it can be downloaded with Acrobat Reader, saved to a file, and then used to print customized forms.

I just want to mention that we are also trying to get approval to continue using the old form for some period of time. It would be unfair to expect someone to discard thousands and thousands of copies of the current form. It's not unacceptable forensically or scientifically. It's just that it does have an expiration date. We are hoping to get approval to continue use of that form. If a laboratory did receive a specimen submitted on the old form, we would not want the laboratory to reject the specimen for testing because it's on the old form. Hopefully, if we can get the new form out, people will start reducing the supply of the current form as quickly as possible.

DR. SAMPLE: I was pleasantly surprised by a comment that you made, and I just wanted to make sure that I heard the right thing, that electronic-only reporting of negatives will be permitted.

DR. VOGL: Yes.

DR. SAMPLE: No requirement to send back a piece of paper?

DR. VOGL: That's correct. There are several ways of doing electronic reporting and we need to set some guidance for negatives.

DR. SAMPLE: There will be forthcoming guidance on how to do that?

DR. VOGL: Yes, we definitely will be putting guidance out for laboratories. Obviously, MRO's will also be permitted to report negatives electronically. We are trying to eliminate paper.

DR. SAMPLE: It's a wonderful thing.

DR. VOGL: We have to be very comfortable that the electronic information is correct.

DR. SAMPLE: Is there some discussion about a standardized format, as we have talked about at least during some of the earlier CCF meetings, for standards for electronic reporting?

DR. VOGL: It depends on how it is electronically transferred. You could provide a scanned copy of the form or you could fax a copy, which is what has been done historically for years. We consider that electronic.

DR. SAMPLE: By electronic you're saying image only?

DR. VOGL: No, I'm not saying that. I'm saying we have to discuss what will be an acceptable way to electronically report the result from a laboratory to the MRO with assurance that when the MRO sees it, it's the correct certified result.

DR. JACOBS: The military is working on an electronic reporting of negatives and positives on a web-based encrypted password means of getting them out, so that we hopefully are moving to no paper at all. If they need any information, they can request it.

DR. VOGL: Non-negatives can be electronically reported, but there will have to be a hard copy follow-up. On non-negatives there will always be a Copy 1 mailed/sent to the MRO.

DR. SAMPLE: That's what we had discussed.

DR. VOGL: That's what happens now. There's nothing different from what is happening now. It's just we're going to eliminate the hard copy follow-up on the negative, but we want assurances about the security and the correctness of the electronic information.

DR. BAYLOR: Is there a reason that Steps 6 and 7 are carried on Copies 3, 4, and 5, which Steps 6 and 7 would never be carried out on Copies 4 and 5?

DR. VOGL: No, only that it's there. Let's say the MRO copy is lost for some reason, the MRO could use Copy 3 or 4 to report a result. One other point. We changed the sequence of the copies. The donor copy is the last copy as opposed to the employer copy. This way the donor has the instructions on completing the form and how the urine specimen was to be handled, so it refreshes his or her memory if a problem occurred. It also has the Privacy Act statement and the Paperwork Reduction Act statement. And the donor can write on the back of it, as a reminder, any medications that he or she may have been taking at the time of the drug test. I think it's going to put the responsibility onto the collectors to make sure they're following the procedure, and that's been a goal for some time, how do we improve the collection process and make sure everything is done correctly.

MS. BERNSTEIN: What kind of time are we asking OMB to be able to use the current form? I know that's something that they have to give a decision on.

DR. VOGL: We are asking for at least six months. Practically speaking, if a specimen comes in two years down the road with the old form, we would not want a laboratory to reject it. I think when the laboratories see the new form and the collectors begin using it, many of them will discard the old form and bite the bullet on the cost, because the new form is so much easier to fill out and it only requires one collector signature instead of three. The laboratory accessioning procedure will be different. So from a practical standpoint, you would not want to handle two different forms for any extended period of time. I think they're going to intentionally make decisions to go to the new form and eliminate the old forms as quickly as possible, but we will allow their use for some period of time.

DR. SAMPLE: Would laboratories be permitted to put in some additional verbiage and lines in the collection site information area to facilitate the collectors' filling in that big blank?

DR. VOGL: You mean where the address is?

DR. SAMPLE: Yes.

DR. VOGL: You mean you would want lines or something?

DR. SAMPLE: Yes.

DR. VOGL: I think that's acceptable. After OMB approves the form we will need to do a Federal Register notice with a summary and a discussion of the public comments. We will include a list of changes that would be permitted on the form, like highlighting, putting boxes with the social security number. You may still want to use color pages for the other copies, but that would be an option, or borders, or just highlight the bottom legend.

We have to allow some flexibility in what it looks like without changing the format, where every item is, give or take an eighth of an inch or something along that line, or even font size could be changed, or style a little bit, or you might want to bold something.

DR. SAMPLE: Or change the verbiage?

DR. VOGL: You could not change the statements. I'm making a list and it'll probably have a dozen modifications that are acceptable. And users of the form can pick or choose from the list.

DR. CAPLAN: Has it been sent to OMB yet?

DR. VOGL: No. The package is complete with a discussion of the changes. This also includes the approval for continued use of other documents that are part of the Workplace program. It's not just the form. There's a need to get approval for the NLCP documents that are used also. The delay at this point is there was a Federal Register notice in February with burden hours for the different parts of the process. Until that 60-day period ends, we have stated that no public comments were submitted. If somebody does submit a comment, we might have to change the section. When we did the Federal Register notice for the form back in December, I specifically asked for comments on burden hours to complete the form and no one submitted a comment. We're using the same times that were used for the current form. If anything, the time to complete this form is slightly less, but they're rounded off for three minutes to do this and five minutes for that. We don't expect any comments suggesting that the times are wrong. MR. STEPHENSON: I want to respond a little bit in depth to some issues that we had to take action on separately from the Drug Testing Advisory Board, that hopefully will meet the criteria of objectivity by the group and for those of the public that are with us today. The issue, first of all, regarded an editorial by USA Today which appeared on February the 15th of this year, and basically it called for better cheater-proof tests, specifically in this case hair testing, although I'm sure it could have been a lot of different things. The emphasis was on the ability to beat a drug test as it's currently established and that people had died because of that.

We have provided a response that had balanced out the issues of accuracy, reliability, correct interpretation of results, and fairness, that specified the balance needed to look not only at the interests of the traveling public, but of the same individuals when they were on the ground not traveling and perhaps doing their jobs. The rights of individuals and the need to have those issues of accuracy and reliability cut across any kind of testing technology that we would put forth with an endorsement and a use for such technology in federally mandated testing.

What we couldn't do, unfortunately, was provide in-depth materials that had been finalized and cleared for release on February the 14th, the day before the editorial ran. That document was a State of the Science paper that deals with the issues of cheater-proofing our current technology and certainly point the way towards validating and updating any new technologies for alternative tests and technologies in the future.

Looking at urine specimen validity testing, in that document we captured and analyzed in a full text mode the materials which had been reviewed and the decisions -- that were used to base the decisions to go forward on the guidance that we had provided back in September of 1998 and had been in place for the last year and a half.

What had come out was that we couldn't say to the USA Today editorial board that even as we speak there are concerns of individual flight attendants and concerns of those who represent them in collective bargaining that the adulteration, dilution, and substitution criteria that we had developed and were being applied in their Workplace were fair, that they were accurate, and that they were based on science. Yet in fact we had that material, and in the day before the materials actually were completed I was very frustrated by not being able to discuss them because I didn't know exactly when we would get to a release point.

Now that material is up on our web site, it's out in the hands of the medical review officers and the laboratories, those that had been the specific target audience for this document. It's written not in plain English, but in the proper language to accurately communicate the technical issues that were presented in the document. It stands on its own, and Dr. Bush will go over some of the materials on this in just a couple of minutes.

I wanted to say that, just from our perspective, we welcome feedback. We welcome additional information on experiences of those individuals who have used a variety of techniques to validate the testing that they do, not only for urine but in the other specimens and technologies.

I have to tell you, this cottage industry of helping cheaters beat the system is certainly not going to be limited to urine. It will follow any technology that's out there that is proposed for use, because there are, unfortunately, those who would choose to continue a lifestyle of misuse of illicit drugs rather than confront that and address the issues of safety and their own health for the good of everybody in our society.

We would hope, as was said in our response to the USA Today editorial, that we can dissuade Americans from experimenting or using or becoming dependent upon illicit drugs. But for those who do not choose to do so voluntarily, to put them on notice aggressively that they will be identified and dealt with, that if they want their job, if they want to get it or keep it, that it's important for them to recognize that non-use is the best avenue of protection for them.

I hope that we'll hear some comments back. I wasn't quite sure who would be at this public session today, but we look forward to working with all the parties to make sure we have a balanced approach in dealing with our testing issues and with the educational issues that must accompany them. I think a part of the issue we must address is that as we ratchet up the ability to detect those who are using illicit drugs that we've begun to even differentiate between the use of illicit drugs and those who choose to cheat in even taking the test. It would be unfortunate if we lose sight of the fact that our goal is to prevent illicit drug use in the first place.

DR. BUSH: I would like to take a couple of minutes to share with you a little bit about the State of the Science Update No. 1. The handout is on the table should you need a copy. It is also on our web site at www.health.org/workpl.aspx.

It was issued on February the 14th. The format addresses the background, the scientific review and evaluation, and regulatory actions and conclusions that have been taken on the topic of specimen validity testing over the last couple of years. Attached both on the web site copy and on the paper copy is Program Document 35, from September 28, 1998, which was the guidance for reporting specimen validity test results, and additionally then Program Document 37, July 28, 1999, which was specific direction to the laboratories. We put it together for release to be the complete package, lest someone not have these backup documents.

This document, the State of the Science Update No. 1, is the compilation, the framework, of the work that went into PD Document 35, and it really is a state of the science paper that is a living document. We have reviewed the peer-reviewed scientific literature. You see all the annotations and the references that we have made to the topic material, extracted the literature several times in a comprehensive way, have discussed the items with nephrologists, surgeons, people at medical facilities who are intimately familiar with the functioning of the kidney and what urine's all about, and then layered on with that their understanding of where we are and how we use urine in our drug deterrent program.

As a living document, we look forward to continued research and peer-reviewed scientific literature to continue to build on the knowledge base that we could use as the cornerstone for this State of the Science Update No. 1. Quite frankly, I get anecdotal reports via telephone simply stating: Well, I know somebody who said that someone who drank a lot of water could beat this all the time and can easily provide a substituted specimen. And that doesn't help. That's not a peer-reviewed scientific approach to this. The hearsay part of this is not what we see documented in any of the literature of the clinical work that we have reviewed. We ask people, if you can structure studies, note the height, the weight, the size, the sex of the people that are participating in these studies, the quantities of water that they take in, whatever fluid, a little bit of history about where they were physiologically prior to that -- you know, did they start off with two liters of coffee and then start with an additional water loading study. These kinds of things are necessary to evaluate data that's provided in a comprehensive manner to us. Anecdotal studies don't help us. We get literally tens of them on occasion with people complaining that this is not fair.

It's one of those lines where in a very popular movie, a particular scene where a well-respected actor said: Show me the money. Well, I'm saying show me the data. We need some data here to help us understand better where we are and make this the living document that we intend it to be. Data, please, if anybody can provide us. We're more than happy to listen. We're willing to listen. We want to listen. We're asking your help.

MR. STEPHENSON: Are there any comments from any of the members of the Drug Testing Advisory Board? Since this document had gone out, has any of this posed any problem to you? Has it simply been what you expected to see or what you already knew? Is there anything new that was in this, either in the way it was formatted or presented? Any comments? (No response.)

DR. BUSH: The Board saw it.

MR. STEPHENSON: I know. Everything's fine?

MS. BERNSTEIN: I would just like to thank Donna and all the work that she put into this. This was a document that was critical for us, and I think, as most of you know, we've had some segments of the industry, particularly on the substitution issue, where we've been getting a very high noise level. And I'd just really like to thank Donna, Walt, and Janine and her troops for getting it out, and Ken, who also worked very hard on this from my staff, because the data was needed. But the other piece that I think is just as important in terms of the non-scientific community is the front part of the document, which I think really explains to a lot of people more this kind of testing. I want to get back to what Bob was saying about education, that one of the issues I think we're running into with validity testing is the fact that it's new to people and there are a lot of questions about it.

DR. BUSH: Thanks for that, Mary. I'll piggyback on that with one thing. Upon this document's release, medical review officers picked it up. We got a few calls expressing their gratitude and they said it was actually very good for them to use as a primer for their tested population, their employee groups, their unions, that it did -- the format we're finding was very good. It worked well, and it's helping the medical review officers get out the word and explain things. So that being the case, when we find out that this works, we'll try this style again next time when the need arises.

MR. STEPHENSON: I guess one comment in that area would be that this kind of document and the audience that it was intended to reach by necessity requires the use of the scientifically correct language, the words, the tabular formats, and so on. That does create a barrier to understanding by a lay person who would go to our web site and pick it up or someone from the medical community or maybe an employer who would simply take this document and then hand it, well meaningly, to a specific individual subject to testing. Our intent was to make this document free-standing to the target audience, to the medical review officers and to the laboratories. Our intent was not to try to communicate the background material in this testing process clearly to the myriads of people that would be required to understand the consequences of their act if they chose to adulterate or substitute a specimen. We've left that to the interpretation of the medical review officers in the specific Workplaces with the detailed knowledge of the working population that they must interact with. I think for us to do anything else would have caused more problems than it would have solved.

Unfortunately for the medical review officers out there, they're still going to be challenged with creating the right kind of language that's clear and responsive to the apprehensions and concerns of individuals subject to testing. That's going to be the nature of our dialogue and our interaction, I think, on the new testing technologies and other kind of areas, too. We will have to use the intermediaries that work specifically with Workplace populations to address these issues in a way that's compelling and understandable to the general public.

DR. BUSH: The next topic is a summary of laboratory directors meeting.

MR. LODICO: Back in December 13-14, 1999, DOT and HHS had a joint laboratory directors meeting, that provided an opportunity for SAMHSA-certified laboratory directors who attended to discuss issues concerning operational, technical, as well as MRO aspects of the NLCP program. This was a two-day meeting that began with welcoming statements made by representatives from DOT and HHS. Dr. Yale Caplan started the morning scientific presentation on" The Case for Specimens Defined as Substituted", this is the background information that was used to write the state of the science paper, written almost a month later. Other scientific presentations dealt with issues on adulterated specimens, relationship between MROs and laboratories, new informational technologies used to speed up reporting results (electronic transmission), and scanning and imaging in he laboratory. The afternoon time was used to break the participants into breakout sessions that focused on MRO, operational and technical issues. At these sessions we asked for comments and discussion on a set of questions from the laboratory directors. About 75 percent of the total laboratory directors attended the meeting.

This was a highlight of the meeting because it gave the laboratory directors an opportunity to discuss in detail their concerns and ways that we could address these concerns. One of the things we hoped to achieve was an avenue for discussion and a mechanism to act on these concerns or issues. On the second day we compiled the information from each of the breakout sessions and summarized by highest priority. This information will be made available to the Board for further consideration or follow-up.

On the evening of the first day a representative of DOT discussed the new changes to the CFR Part 40.

Agenda Item: DOT Update

MS. BERNSTEIN: What's new at DOT? I think that's an easy one. We've really been talking about Part 40, which is getting down to the stretch with the comment period, and talk a little bit about some things that are coming up and how we go off into the future with this. Basically, the docket is electronic. It's great fun to go read. As of Friday, 35 comments were submitted on the document, and most of them were very thoughtful. We have a few people who still think it's unconstitutional to do drug tests, but most of the comments are extremely thoughtful.

I want to reiterate for the record that we've posed a lot of questions if you look at the preamble, and there are still a lot of issues that we're very much seeking the industry support, and that very much includes the laboratories. So we would really like to hear from the laboratories.

We're getting ready for our public hearings. We're going to be having three public hearings on Part 40. As of next week at this time, we will be sitting in the Reagan Building doing that. The first hearing is March 20th and 21st in Washington, D.C., which is the longest of the hearings. Also, if you look, in today's Federal Register, we do have the agenda, because we said we would get it out before the meeting. The agenda, we have organized it by topic group. By the way, if for some reason it's not in the Federal Register, it's on our web site, www.dot.gov/ost/dapc.

The meeting will be a day and a half. On the second day of the meeting, from about 10:30 to 1:30, we will be having a roundtable discussion on public interest exclusions after the presentations. That will be an official discussion for the docket. It will be a roundtable discussion and we look forward to everybody's comments on that.

The following week, we go to L.A. on the 28th and Dallas on the 30th for similar meetings. We're looking forward to seeing folks around the country doing that.

Towards the very end of the comment period, April 3rd to April 5th, Ken is running a project where we'll have a bulletin board that will be open. And there will be details on that on our web site, which should be over the next week or two. That will be a three-day bulletin board. That too will be part of the docket.

In terms of Part 40, a couple of things. We have received several requests to extend the comment period and, since 120 days is one of the longest comment periods for the Department and, we really debated whether to make it 60 or 90 and then extend it, and we said, no, let's go to the whole 120 with the clear understanding that it will not be extended. And despite having a third of a year to comment, we are still getting people who want it extended. We will not be extending it. 120 days is sufficient for all segments of the industry to comment.

We also received a petition from a trade association for a negotiated rulemaking on the issue of PIE a couple of weeks ago, SAPAA to be specific. They put it up on their web site. Last week we turned down negotiated rulemaking. It is something that's usually entered into at the front of the process, nor did we feel it met all the criteria for that. I'm assuming, since they put the petition on the web site, they'll put our answer on their web site.

We have been very pleased with all the interest in Part 40. The comment period will be closing April 7th. We will be getting right to work. The Secretary has asked me to get the final rule out by the end of the calendar year, so that is what we are aiming for, which is we think doable. This is something we've worked on for a long time and I think the sense of things is that it should be done by the end of the year and so that's what we're going to try to do.

Agenda Item: Alternative Specimen Guidelines

DR. VOGL: This is an outline of the first draft guidelines. The current guidelines, the table of factors, the collection handbook, and MRO manual were used in developing this draft, as well as the highly regarded Part 40 revision. In the spirit of re-inventing government and trying to use plain language in writing policy, we are going to call this draft one. The first slide is just a list of the major sections of the revised guidelines - for any kind of specimen that could possibly be tested under our federal Workplace program. The title "Mandatory guidelines for federal Workplace" does not mention "urine." It can be for any type of specimen.

The subparts, if you think of what the current guidelines, are four parts: collectors, laboratory, MRO, and then suspension-revocation.

Going to the table of factors and the Part 40 revision, we came up with this sequence of subparts. You can see how you go about developing this new approach, who it applies to, the kind of specimens to be tested, the drugs that you test for, collectors, collection sites, etcetera.

The next several slides give the details on what is in each subpart. Just as in the Part 40, you ask questions and then provide the information to answer that question. You need to ask the right questions. You need to ensure that the correct questions are asked so you get all the information you need to put into the document.

I am not claiming that these are all the questions that should be asked. That's why this is draft one. It's my attempt to use this new approach. The questions and answers are written for a person reading the guidelines. That's important to keep in mind for this plain language approach. Applicability. I don't think it's necessary to go through each question, but you can see where applicability, for our case it's for the federal agencies. It's basically what's in the current guidelines. Just the format's changed.

I'd also like to point out one thing. Part 40 is a couple hundred pages long. Our mandatory guidelines will only be a quarter of that. We do not include alcohol and we do not include guidance and policy for employers, which is what DOT regulates. In some respects our needs are much easier or simpler. It talks about who would have priority for the guidelines, how exemptions are requested, how we revise the guidelines. Then we have definitions, just as we have now, and we've concluded there would be additional definitions because we have more types of specimens that could be collected and tested.

Under specimens, we would specifically say what kind of specimens can be collected and under what circumstances the different specimens can be collected. It may be that you don't collect any specimen for every reason for doing a test. Drugs. It's similar to what we have now with drugs, how you test for the drugs or can they be tested for other drugs. It's taking what's currently in the guidelines and putting it in a different approach. Collectors. This is where we did a mirror image of what DOT has. I've taken a lot of the language out of their proposed policies and training collectors and how you document the training.

Collection sites. You talk about what we have now, where you can do a collection, the security, privacy of the donor, what supplies are needed. It's pretty much all in there. It's just that you ask a question and then you take information out of the current documents and put it in a bullet type format rather than detailed paragraphs. It's easier to read and follow. The Federal drug testing custody and control form. Very simply, you need to use the form. We might have one question about what happens if you use a non-approved form or something like that. And there may be other questions that we need to include.

Collection device. What is a collection device? I think that's a very important question now that we're talking about different kinds of specimens. Does it have to be cleared by the FDA?

Collection Procedure. How do you start the collection, basic requirements. I believe there are some basic requirements for collecting any kind of specimen, and that would be in the guidelines. Then as we get to the collection manual, you'll see specific requirements and discussion in the collection handbook. You don't have all of that in the guidelines. You have what's required and what can't be changed in the guidelines and other parts, the details of actually doing some of this, would be in the other documents.

Under NLCP, clearly describing what the NLCP. The requirements for PT inspection may be the same regardless of what specimen is being tested; blind samples being inserted and submitted to the laboratories, laboratory requirements. What we have now is a long list of questions that are related to the laboratory. It's taking what's in the guidelines now and separating it into more specific sections and simplified answers. On-site testing. That had to be put in a separate subpart. At this point, it looks like there's on-site testing for urine and possibly on-site testing for oral fluid. You would have the basic requirements, quality control requirements, etcetera, if you're going to do on-site testing. The MRO, who serves as MRO, responsibilities, how do you review results. I know a lot of work needs to be done on that section, whether some of it remains in the guidelines or would be put in the MRO manual. You will see that when I get to the MRO manual.

You have an issue regarding single specimen retest and split specimen tests. There are probably other questions that would need to be addressed regarding when you're dealing with the different types of specimens that could be collected. You may not be able to generalize an answer in all cases. That will have to be looked at very carefully. Problems with drug tests. There may be some problems that should be included in the guidelines for the different kinds of specimens that are collected, so that everyone knows what happens when different types of problems occur. The last part is laboratory suspension/revocation. It's written so that a human being can understand it, as opposed to needing a law degree. That's my own personal opinion. It's not an official agency opinion. The next document that would be revised and put in a similar question-answer format is the specimen collection handbook. The questions are written to deal in general with any kind of specimen.

A collector would need to know what the requirements are at the collection site, supplies, etcetera, and then the procedure that they would follow, and then how to deal with problems, and inserting blind samples.

This version would not include the form as an attachment. The form is going to be on the web site. These are all going to be separate documents rather than trying to put them all in as attachments or enclosures. They are all going to be on our web site and dated and numbered so that people know it's the latest version or when changes are made.

For the MRO manual, again the responsibilities and functions for the MRO. Then there's basically an administrative review of the documents. There's a scientific review of the results, and you have a series of questions related to that. Then we'll probably have some other, under scientific review, questions related to the different kinds of specimens, retesting issues, split specimen, or retest of a single specimen or a split specimen in question, reporting results to the employer.

What else? There may be a different form for each specimen, or possibly one other form for all other specimens except for urine. All those things do need to be addressed and decisions made before the guidelines are finalized.

I thought we would break out the discussion of each of the drug classes as sort of separate sections. They pretty much have the same kind of questions in each one -- what are the sources -- this is for the MRO, what sources are there for each drug or class; the metabolism and excretion, that's going to be very important dealing with the different types of specimens that may be collected; and valid medical explanations for positives. Again, the question asked may change, but there's going to be a need to give guidance to the MRO how to review the results for each drug class and for each specimen that's collected.

Documentation and Recordkeeping. It's the same as what we have now. Then additional responsibilities, how the MRO handles blind samples, donor unable to provide a specimen, etcetera. These are discussions currently in the MRO handbook. It's just put in a different part of this revised document.

That's a very brief summary of the outline of draft documents. There's a lot of work to be done. I would say 90 percent of the information, the comments, the answers, the guidance, is there with the question. There are just a few blank spaces where we will need to get information from the industry involved. Hopefully they'll also be reviewing what we currently have written to make sure it's consistent with the testing for each type of specimen that might be collected.

MR. STEPHENSON: I think you got a sense that this is something you're going to need a chance to look at. Realize that this was our internal first process based on what we think we've learned and a process that mirrors the existing documents in the way we communicated about the technical issues in the past for urine.

We're going to need to get a chance for the Board to look at some of the underlying issues and then we're going to have to provide an opportunity for more public comments and for some responses by our working groups. That will happen by our next Board meeting, and we're going to work on some creative ways to get this on the web site and make some meaningful compression of the learning curve in this area.

This is a daunting task. This reflects a whole new range of interests and of requirements, to not only generate a capability of doing the test and of doing the quality assurance for those tests, but to educate those that are out there in the field who must do the collections and who must do the transporting and interpret the results.

We've got a lot of work cut out for us. In that context, we are moving forward with the premier group that we've been working on, which is the hair testing group. In that area, we are going to have a meaningful pilot program and PT session for it and some of the other specimen types in the near future, around the 1st of April.

Our intent is to create an environment where we encourage the laboratories who are currently in the business of doing hair testing, but in addition those other laboratories who might have an interest in learning more about it or have used hair testing in some bench modes, not necessarily for production work but in certain other areas, to also participate.

This will be a mutual learning process. No one's going to be held accountable or responsible or slapped on the wrist. That is not our intent. But we do want to get the results of those out in a format that will help inform everybody as we go forward in this area, as we did, almost ten years ago when we did our first work with on-site testing.

We learned some important things. You can't ask folks to participate with you and then pin the results on the barn door and pretend that nobody is going to hold you accountable for what your score was. In that context we will not permit the disclosure of test results specific to a particular laboratory by name. We will mask those, and we will have internal discussions with participating laboratories to identify particular problem areas. There is a process we have committed to, which is going to be open meetings and full discussion in a public setting, and we will continue that. We will balance it so that we can make it work well for everybody.

At this time, I'd like to open it up for any public comments or questions that members of our public might have that are here.

MS. SILLS: I am a public consultant. I work with Psychemedics. You said that there was actually going to be a regular open DTAB meeting reviewing urine with a matrix, and that hasn't been scheduled to my knowledge. In other words, just as they did with saliva and hair and all the others, have a DTAB meeting to review urine. Is that scheduled? Is that going to take place some time soon?

MR. LODICO: The DOT/HHS laboratory directors meeting was an effort to discuss the urine matrix. Some of the issues raised included lowering of the cutoffs, using a specific 6-AM assay. Those are operational issues. The amount of quality controls that are needed. Those were all discussed at the laboratory directors meeting.

MR. STEPHENSON: That certainly is part of the response, but I think in that context we have committed to doing that review in this arena. In this arena that means a full and open meeting. We have had several different competing needs for the participation and focus of the Board, but we are committed to doing that meeting.

It's not scheduled yet for this DTAB. We have identified a working group that's focused on urine and the updates in that technology, to use the same criteria, and to fill in the grid in the same way. I guess we could put some of the other technologies on hold for a while and go back to urine if it would be of particular interest to your group to have us do that. I mean, it might set us back in doing some other things.

Would that be the appropriate response?

MS. SILLS: I just think we'd be very interested in having the same open meeting, just to review it in the context. I mean, we're all being compared to one another. I'm not sure how you can go forward with proposed guidelines until they're all reviewed under the same structure.

MR. STEPHENSON: I agree. Well, that's an important ingredient. I had hoped that we would have had all of that done by the end of this last year, but there have been some events which have overtaken us. The reality that we are out there dealing with these events, I think, will become more evident over the next two or three months. I think one of the things we can do is commit to it again, and it will happen. It'll happen in both the working group meeting context, just like we've done with all others, with the industry folks dealing with it, and then that'll be followed up by a presentation in the DTAB.

DR. BUSH: I would like to say, in the working group's defense, they did get together in the middle of December and we have not had a Board meeting since then and this is the first one out, and we're still evaluating. There was a lot of information provided at that meeting and we need to prepare it for presentation in this arena in a very usable form.

If it was a two-day meeting, we don't want to have a two-day meeting necessarily to recap it. We need to boil it down to the essentials. We can do that, but that will put other things on a slower time frame.

MR. STEPHENSON: That's okay.

MR. PEACOCK (FDA): This is very important to us right now because we are reviewing saliva and drugs of abuse and it's very difficult for us to review some of these things without some guidelines. Like when you compare urine results with saliva, the submissions come in and they pick their own screening cutoffs, they pick their own confirmation cutoffs. It's very difficult for us to decide how accurate this test really is. In other words, we need to get some feedback from you to get some guidelines to evaluate some of these devices that come in. They're not here yet, but we're expecting some hair testing devices to be coming in. If we could get some feedback from you, it would really be quite helpful for us. We don't want to approve a device and then you come up with a guidelines where you've got something already approved out in the field with a different cutoff.

MR. STEPHENSON: Yes, that's a good point. Any way we can work with you, we will. Again, we don't want to punish any participant in any of our PT cycles by providing detailed information on a particular laboratory response. I think what we could do would be to provide what the industry has already said are their performance parameters, and then where we've been able to validate that by the PT's in a more general sense to give you a range. We should be able to do that for each of the alternative specimens, and that would give you a framework to understand where some of these things, according to the industry itself, these are going.

It's more helpful when there's more than one particular participant, but where there isn't then we'll take what they have said, and then as that part grows, if it does, as an industry component we'll update it. Our intent is to keep all of these as living documents and living processes.

DR. BUSH: Al, it was back at the September Drug Testing Advisory Board where we finally got consensus by everybody, all the industry partners and the working groups, moving forward with agreed-upon cutoffs. That is how we are formulating our specimens for this pilot PT program. What we are finding now, quite honestly, is we have some industry partners who are coming to us saying: We are not really sure we can meet these cutoffs. They have some concerns now that they really did not have before because they have taken the time to go back to the laboratory and get ready to meet the challenge of these PT's. Even though we have the cutoffs that the industry has agreed to, let's see how they perform with the PT's. We can provide the cutoffs to you now. In the context of this Board, we certainly will keep everyone posted with the actual analysis at those cutoffs. These cutoffs may be a moving target right now, Al.

MR. STEPHENSON: Anticipate that it will continue to move. I think the most important thing is where there are approaches being made to us or to our contractors to modify the cutoffs and characteristics of the samples in the PT cycles. I object to doing that in a telephone conversation, in a dialogue between two sets of people. I would much rather have a telephone conference of the entire industry working group and have them work through the issue as a telephone conference working group. Then come back with that being a part of the record, part of the dialogue.

I think we are committed to doing this in a way that does not scapegoat any particular performance or performer and keeps the playing field even. I do not want any legacy to come out of this process damaged because of the setting of a performance criteria that they couldn't meet and didn't have a chance to discuss. We are setting this up for success. We are setting this program up to accomplish the implementation of alternative specimens and technologies, not to prove that it can't be done. How we go about it is an issue that does require changing the targets as we learn more about it.

I would suggest that we not bank too much on where it is the first time, but what we learn out of this first round will certainly give us a tighter focus for going back to the individual members of the industry and some head-scratching that will certainly take place, I guarantee it, and then from there some modifications will be made.

What will come out next time will be much tighter. It's got to mirror what we learned a long time ago in the urine area, where as people think they can do one thing, but when charged to perform there are some initial difficulties. But they learn, and we do get a lot better, and it's amazing how fast some segments of the industry have in fact been able to modify assays or techniques to get much more precise.

I think our biggest challenge is communicating this in a meaningful way to all those thousands of people that have to understand what it is that we are about and how to use the test results in dealing with an individual drug positive situation. But that's a different issue and it's a different group. We can get the test down first, then everything else will follow. No more questions. I'd like to call this meeting to a close. Thank you.

Open session adjourned at 10:22 a.m.