Dr. Bush (HHS): For meetings sponsored by the government as advisory boards, we would like to know the attendees present. Please sign in on the attendance sheets. I would like to introduce two new members of the Drug Testing Advisory Board. They are Dr. Barry Sample and Mr. Prentiss Jones. Would both of you give us a little bit of a background.

Dr. Sample (DTAB member): I am the director of the SmithKline Beecham Clinical Laboratories drug testing facility in Atlanta. Before joining SmithKline, I was with Indiana University. I held a position as Assistant Professor of the Pathology Department, and was responsible for running one of the service labs at Indiana. I have been involved in clinical toxicology, workplace drug testing, athletic drug testing for a while.

Dr. Bush: Did you have something to do with the Olympics that were in Atlanta?

Dr. Sample: Yes, a little something to do with the Olympics that occurred in Atlanta. Our laboratory was responsible for all the doping control for the 1996 Olympics in Atlanta. So there's a variety of applications of this technology and workplace drug testing that I have been involved with for a number of years.

Dr. Bush: Thank you very much. We're anxious and happy to have you on board as a member, to bring the depth of your technical experience to us. And, Prentiss Jones.

Mr. Jones (DTAB member): I am the responsible person at the South Bend Medical Foundation drug testing laboratory. I have been with the Foundation for 10 years. Prior to that, I was with SmithKline, in Schaumberg, Illinois. I was there for quite a while. I am excited to be a part of this Board. I'm looking forward to working with the group.

Dr. Bush: Thank you, Prentiss. We're happy to have you here, and looking forward to your active participation. We have the transcript of the September Drug Testing Advisory Board open session meeting on our Web site. The Web site is www.health.org/workpl.htm. That joins other open session transcripts that we have specifically concerning alternative specimen testing and technology. They date back to April 1997, when we started addressing these issues in a big way. We invite the Board members and the members of the public to visit that site and take advantage of the information that's there.

A long-awaited event happened recently. December 1st, to be exact. That was the day that changes to the Mandatory Guidelines were implemented. The immunoassay testing cutoff concentration for opiates was changed to 2,000 nanograms per milliliter, and the confirmation cutoffs for morphine and codeine to 2,000 nanograms per milliliter. Additionally, when the morphine concentration in that confirmation assay equals or exceeds the 2,000 nanogram per milliliter. And an assay for 6 acetyl morphine at a cutoff of 10 nanograms per mil will be carried out by the laboratories.

The Federal Register notice for that effective date and the final determination establishment of those cutoffs were published in the Federal Register on Friday, November 13th. I have spoken with many different laboratories, representatives from many different laboratories, who tell me the transition went smoothly.

Concerns that we had regarding reagent, quantities of immunoassay reagent, were resolved by the manufacturers and the laboratories. Open and blind quality controls and calibrations were no problem. Confirmation was no problem.

Research Triangle Institute (RTI) and the Division of Workplace Programs have been working with the laboratories to ensure continuation of accurate and reliable testing, especially with the new cutoffs. When you implement a large change for both cutoffs and then add an additional analyte at such a low concentration, it has taken a lot of work. I would like to acknowledge the work that RTI did to prepare the proficiency testing specimens, to work with the laboratories, communicate actively with them for technical help and for administrative guidelines, and also for the laboratories to respond when queried by RTI. Overall, it was a good process.

Mr. Stephenson (HHS): One other comment. Just in reflecting on the history of this event, we have with us today Dr. Donna Smith, who had almost jumped across the table about three years ago -- four years ago now -- indicating that the high rate of referrals to MRO's for the opiate testing was so unconscionably burdensome to the transportation industry that if we didn't do something to correct this problem and the impact that it was having, the DOT would stop testing for opiates. We took that seriously. But even as seriously as we might, it still took us four years to get all of the changes put in place that were necessary for those changes to be implemented today. I am not sure we could have done it back then, with the technology that we had. Maybe we could have. But we certainly have experienced a lot of efforts today that show that we do need every bit of skill and science and perseverance to make one of these things work. This is the kind of change that takes place in science over time. And I expect it to not be the only time you'll see major changes in this drug testing program, even as we're about the issues of alternative specimens and technologies. But, Donna, I wanted to acknowledge your presence and your ownership of this issue from the early days. And although it's taken us this long, it's an important event for us.

This is the event that I think is most important. I don't know exactly how much this is going to save. I was doing some math and I know that the impact of this thing has got to be several million dollars a year just for the DOT implemented areas and as a cost saving to the industry. Congratulations to everybody for making this work.

Dr. Bush: As a follow-up to that, you know it's a very difficult thing to make changes to a program that has been established for so long. Changes proposed need to be evaluated, reevaluated, digested, and then evaluated again and again, prior to making such a huge change for so many individuals, so many donors who are going to be tested by this program. We need to be sure of where we're going. Yet, following that statement, I'm going to say we are open to additional change. We believe we have come to the right place for a beginning, a new beginning, in opiate testing, focusing on heroin, taking a look at 6-acetylmorphine, specifically. Many, many specimens were not tested for 6-acetylmorphine in the past.

We believe, with a focused effort and evaluation of the workplace population, that we will have in our testing pool quite a large number, that we will be able to evaluate how effective we chose those cutoffs for this change. And we are amenable to evaluate that data and change again if that in fact is a necessary requirement. And so we're going to ask the labs -- and any laboratory doing the testing, implementing the new cutoffs on regulated industry specimens -- we know that they have a large base of non-regulated specimen testing. They may in fact be able to take a look at concentrations -- additional specimens with concentrations of analytes -- for morphine and codeine and 6-acetylmorphine -- at different cutoffs. And we want them to take a look at how this fares in detecting 6-acetylmorphine. We have a cutoff established at 10 nanograms per milliliter. We want to take a look -- is that the appropriate place to be?

We have heard from some Medical Review Officers that they would really like to see a five nanogram per milliliter cutoff. Well, let's take a look at the laboratory level and see what concentrations of 6-acetylmorphine are out there. And I'll be polling the laboratories, over time, just to see what they found in their workplace populations, and gather some additional data. It'll take a little bit of time -- a few months, six months -- to I believe get a representative sample. And we'll be more than willing to share that information with the Board as time progresses. We'll keep you updated. I've heard nothing but good things from those implementing the new cutoffs in the laboratories. They're very confident with their information technology systems in the lab, their analytical testing technologies and methods that are implemented. The next step is to see how well the new changes do in the workplace. We all will be looking for feedback. And I appreciate it.

Mr. Stephenson: I have one other comment to make at the beginning of the session. It's part of a segue in an area where we're talking about change and things that take a long time to do and to do it well. I would like to acknowledge Loren Bush, who has been an ex officio member of this Board for as long as I've been around and probably about as long as the Board has been around, on occasion of his upcoming retirement from Federal service, and to acknowledge the value that his friendship and his professional support and collaboration has meant to this Drug Testing Advisory Board and to the activities associated with substance abuse prevention and detection in key industries. I think the nuclear power industry has had a good friend and a strong ally in the area of safety and professionalism in Loren during the stint that he's had in his second career with the Federal Government. I wish him the very best of health and welfare in his retirement. We expect to have your presence continue here. I understand there has been a name change for the new body but, other than that, we expect to have many of the same spirit of aggressively attacking issues of accuracy and reliability, of looking at false negatives as an important part of the role of testing, as well as false positives. And I wish you the very best, Loren. Is there anything you would like to say to the group?

Mr. Bush (NRC): Thank you for those very kind words.

Mr. Stephenson: I'd like to turn the microphone over to Walt Vogl, who will review PD-35 and the DOT memo to MROs.

Dr. Vogl (HHS): I would like to spend just a few minutes to officially present the latest NLCP Program Document 35 and its associated DOT memo, which were issued back on September 28th. Since that time, or you know within a few days after those dates, we had sent copies to most of the trade journals, monthly periodicals, to the MRO organizations, to laboratories, everyone we could think of that would be interested in receiving these documents. Basically, it's been widely publicized. As you all are aware, the Mandatory Guidelines, as well as DOT regulations, permit laboratories to test specimens and for the validity of the specimen. Up to this time, it's been a general permission to validity testing without any specific guidance as to what tests might be performed and how to report out the results. We felt that we needed to do that, and therefore spent several months discussing a policy and guidance that we could issue. Basically, we issued program document 33 earlier in the year, which focused attention solely on the retesting of Bottle B (split specimens)specimens for validity testing and reporting out of results for the split specimen. This new program document establishes a policy of guidance for testing the Bottle A specimen and then any follow-up testing or reporting for the split specimen. And it's geared to the laboratories. The associated DOT memorandum is for MROs, and gives guidance to them for interpreting the validity test results that are reported out by labs. We defined what an adulterated specimen and a substituted specimen. We have given language to the laboratories on how to report out the results so there is consistency in the way the information is reported out to the MRO's.

At this point, we have had positive feedback from laboratories. They were very happy to receive this guidance. It establishes consistency in the program and among the laboratories. We are hoping to track the information on validity test results over the next few months. Many of the laboratories are voluntarily collecting this information and will hopefully share it with us.

This is not the last time we are going to look at this. We need to continually review the policy and get current information from the laboratories. If there is a need to change the guidance, change the levels that are used in reporting a specimen, be it adulterated, diluted, substituted, we will do that. We know that out on the internet there are a number of new products that are continually being sold for defeating drug testing programs. We need to stay current and to have a policy in place that is flexible to deal with it. We are quite pleased with what has happened so far and we will continue to look at it.

We had a few copies out on the table. If there is anyone here who would like to have a copy, just let me know and we will get you a copy. It is also on the DOT fax on demand, which allows anyone to call the 800 number and by punching in the correct code, the system automatically faxes a copy of the two documents. Both DOT and HHS have agreed that these two documents will always be provided together even though they were issued by two separate offices.

Dr. Bush: There are a couple of representatives from DOT. The DOT fax on demand number is 800-225-3784. And the documents we have been speaking about is item 123. And that's a good referral mechanism. I encourage people to use DOT's fax on demand and to visit HHS's Website. We have current lab lists, manuals that are significant to the program, the collection manual, the medical review officer manual, the mandatory guidelines, and Drug Testing Advisory Board information. It will be a good idea for members of the audience to get their customers up and running on the Internet. It will save all of us a lot of time from not just hand holding and restating what is already on there, but allow people to have a hard copy and use it as a reference device.

Dr. Vogl: The next topic is regarding the Federal Custody and Control Form. When it was originally developed, it took about three years to develop the current form and then get it approved and used within federally regulated programs. The last time we had the form approved by the Office of Management and Budget for an additional three years -- OMB stipulated that we would need to establish a review process to look at the form, to see if there is any opportunity to simplify it, to make it some sort of electronic form, to make it more user friendly, to reduce the requirements in some way before the next request for approval. At this point, we have approximately 18 months before the next approval from OMB would be required to continue using the form. To accomplish this requirement, we are announcing a working group meeting to be held on January 20th and 21st at this hotel.

We are hoping to get approximately 30 individuals at the meeting, with an equal distribution of both companies that print forms and users of the form. We know there are a dozen or so companies around the country who print most of the forms for the laboratories, there are third party administrators and laboratories that use the forms. We also have collection groups who may have an interest in reviewing the form.

We are hoping to get good representation from all the different parties who use this form and spend the two days brainstorming changes that could be considered and to set up a game plan of going forward with any possible revisions. I have, to this point, sent this notice to as many people as we could think of who are interested in participating. Once we get a list of those that are interested, if it exceeds the 30 or so that we feel is appropriate, then we may have to unfortunately make some decisions or only select certain interested parties. We would ask for your help in getting this information out to as many people as possible who you think might be interested in looking at the form. By the end of December, we hope to have the list of people together who would be attending the working group, and then move forward, asking each of the attendees to bring whatever they can to the meeting, any suggestions, comments, other forms that they might be using for their private sector clients.

Mr. Stephenson: One of the things that's going to happen within our debate in work projects is going to be a major focus on electronic media element of chain of custody document controls, electronic signatures verification and so on. This is going to be an area that we will incorporate into a contract that will be let over the next months. This is a very important area. The last time we did it, it was not a lot of fun. It fostered an awful lot of acrimonious phone calls from one Federal agency to another, blaming the other for why it hadn't happened, why it was taking so long. But this is the reality, that these things have a lot of vested interest and so on. If we can move this into an electronic media and have the safeguards and security that are necessary in place, that should be one of our goals. We may not achieve it totally with this next iteration, but we should have it as a goal for where we want to go with it.

At this time we have an opportunity for updates from our fellow government agencies.

Ms. Bernstein (DOT): I just thought I'd give you a quick update as to what we have been up to, and talk a little bit just about a couple of the issues of the day from the DOT perspective. One, to piggy back on the opiate rule, is that we published in the Federal Register on November 25th the fact that DOT would be following the same cutoffs. In reality, that is the way the rules are written, that we are supposed to follow what HHS is doing. But it also, historically, is we have always published this announcement. We did when the marijuana levels changed and we have done the same now. And hopefully that will stop the phones ringing so much in terms of, well, what about DOT, what about DOT? I see colleagues of mine here from the Office of National Drug Control Policy. One of the things that we do, for better or worse, is represent our agency over in ONDCP. And one of the things -- I know people have heard me mention this before -- that may seem like a small step, and is in many ways, but I think a significant one -- let me pass these out because it's on my mind -- and that is the ONDCP went through a reauthorization process, as we all do. And it's a very long process, this one being particularly long. And they kicked around for a good time. But finally, when Congress passed the budget a couple of months ago, they did pass the reauthorization bill. And what we were able to negotiate over a period of time was one of the things they do in this bill is set forth the official government definition of demand reduction. And I think it's rather important in the sense that you find, from a Federal point of view, what demand reduction is. And when we had first looked at earlier definitions, we noticed there was no drug-free workplace and no drug testing. So we were able, along with HHS and other agencies, to work on that issue. And the way it finally went in there was to separate out drug-free workplace programs, because some workplace programs have testing and some do not. And the result of that was that drug testing got its own separate bullet.

So this is the first time. I do think it's important. It is important from an agency point of view, in terms of funding going forward, that testing is part of the demand strategy. Because we spending about $6 billion on demand reduction.

So it becomes an issue. And speaking of that, as most of you are probably aware of, it went through many reiterations. Basically, $10 million was asked for and $4 million was appropriated by the Congress for drug-free workplace programs for some demonstration programs for small businesses. And drug testing is included in that as part of -- this is where you get back to the definition stuff -- and drug testing is included as part of one of the components of drug-free workplace, of that Act. And, the Small Business Administration has the lead on that program. I think it's very important, because I think, as everybody here knows, we've been quite successful in terms of drug testing programs, in terms of large work organizations. We have been abysmally a failure in terms of small work organizations, in terms of non-regulated testing. And there would be some who would argue the same -- that regulated testing is not quite as fully implemented as it might be in some small business entities. We believe that this is a very positive step forward.

PD-35 - I would like to just talk a minute about the collaborative effort. PD-35 was very much a collaborative effort between our office and HHS. I certainly want to thank Dr. Vogl and Dr. Bush and Ken Edgell, from my staff, who was our point person, who we just kind of call Mr. PD-35 in the office. That also means, if you have questions, you can contact him. Documents like this just do not appear. There was an enormous amount of work. I don't want to talk about how many drafts that went back and forth. We kept those fax lines very busy. We look upon PD-35 as an interim kind of step. What we are trying to do -- and Dr. Bush said it in another meeting that I was at -- is we are trying to become proactive as compared to reactive. Because one of the problems, as you all know better than I, with adulterants is the reactive -- they're one step ahead of us. You know, by the time we get something out that really addresses nitrites, we're off and running to the next thing again.

So this is an interim step. I also want to thank many of you here -- Dr. Donna Smith and others -- who contributed to this document. I know several of you on the Board did, in terms of helping us with that review process. The only thing that I might mention is there do seem to be some efforts afoot from various quarters -- not that it might mean much -- about some kind of laws, both on the State and the Federal level, to ban the sale of things to adulterate drug tests with. But I think it might help things.

The only other thing is this is the quarter where theoretically the DOT operating administrations are going to be announcing the random rates. Some have. RSPA and the FAA have. We don't expect any major changes.

Mr. Bush: The only thing is that after spending seven years we are finally meeting with our major NRC internal policy review group next Wednesday -- not this coming Wednesday, but Wednesday a week. Hopefully this major rulemaking package will be before the Commission before I retire. I don't look for it to be published, but, at any rate, a couple of major milestones. I think it was the threat of me retiring that finally got some people to say we better move this thing on.

Dr. Vogl: Could you point out any differences between what's being proposed and what might be in the HHS Mandatory Guidelines or DOT regulations?

Mr. Bush: No, I can't because the Commission gets very distressed about discussing pre-decisional things. I will say, though, that the changes that we proposed a couple of years ago are quite similar to what is in PD-35. There are some differences, but not very significant. I don't regard them as significant. I'm sure some of the people on the Board would say they were significant, but I don't regard them as significant, first of all. Second, many of our licensees are already doing them with great success.

Mr. Stephenson: Given that you've just pointed out that some of your nuclear power facilities are already doing some of the things that might fall into the area of adulteration or dilution testing, what has been your experience with those being implemented? Have you seen a heightened detection rate? Has there actually been a change in the pattern of what you actually are checking over time?

Mr. Bush: To give you an example, we had one utility a couple of years ago that found a whole work unit of 17 people were flushing themselves, avoiding the drug tests. And they became very distressed. They changed a number of things in their policy. One of the things that they did -- and I know this is a sacrilege to those of us that are involved in drug testing -- but they emphasized interview techniques, and they used an experienced criminal investigator. Where the medical people were not able to break through this group of 17 people who were denying the allegations and the drug tests weren't supporting -- I mean they were supporting their denials, okay -- by the time the investigator got through, there were a number of people who not only confessed to doing drugs, but confessed to having subverted the testing process successfully for a number of years, but also dealing in drugs. That particular utility provided some testing to their collectors. We have talked a number of times about one of the weak points of the whole process is collection. They emphasize some of the things to look for during the collection process. And I got a report from them of one-liners, that listed five pages of discrepancies that they found in just one reporting period, people trying to subvert the testing process.

Mr. Stephenson: Thank you for sharing your insights on the last couple of years.

What we are going to do for the rest of the day is to begin the process of actual consideration by the members of the Drug Testing Advisory Board of information that's already been received regarding alternative technologies and specimens. There has been, and will continue to be, a great deal of interest in a number of alternative technologies and specimens that are out there. To that extent, we have had one working group that was formed like a pilot, for both process and content, with the hair testing technology group. They have had one meeting. We will hear some feedback on that later during the day. There's another meeting scheduled. The process of reviewing the material today will be guided by Dr. Caplan.

Our goals in the small working groups are to identify areas in which there is consensus and ability to move forward, identify known weaknesses, where there are opportunities for research that need to be conducted, and then to develop a strategy to see that that research is conducted and the results added to our store of knowledge.

The purpose is to move this process forward. It is not to study the process to death. To that extent, we're going to go through this for the rest of the day.

Mr. Stephenson: Before we begin this segment on alternative specimen technologies, we have a representative from the Department of Defense military program, Captain Jemionek, who would like to make a couple of comments.

CAPT Jemionek (DoD): Basically within DoD, we have been moving slowly towards increasing and standardizing the Drug Free Workplace Program. The memorandum that came out about a year and a half ago indicated that across the Federal departments and military services, the Drug Free Workplace Program will test at a level of 50 percent by 1 April 1999. It went in two stages. The first stage was to have all DoD agencies with a drug free workplace as of 1 April 1998, and proceed to a 25 percent random testing rate and then move on to a 50 percent testing random rate by 1 April of 1999. That does not apply to applicant testing. Applicant testing - everyone is tested for those positions. This is only for Federal employees who are covered by the Federal workplace program. It did eliminate some of the complexity. Because some of the Department of Transportation rules and regulations, which required the 50 percent testing rate, it now standardizes that and removes some of the differences and confusion. We only had one Federal agency which has contested that. I think we duly noted their objections. But the principal role in going to a 50-percent testing rate was the current level of 10 percent means that a Federal employee really stands a chance of being tested once every 10 years. And I don't think that will serve either as a deterrent or a method of detection for a drug user within the Federal workplace. So that program has moved out pretty well. We don't have a lot of statistics as to whether we see a linear increase or a reflection of what may be the population. But most of the drug testing has shown up in the applicant testing, which is not a surprise.

The second area that we have a concern with is the issue of hemp oil in our military drug testing program. And we think it is also a reflection of the problem in the commercial market. If anyone has not been following the issue, there are nutritional products being sold in a variety of places, both in nutritional centers, health centers, even in grocery stores, which are hemp oil products. And these products can contain THC in significant quantities, enough to cause a drug positive. They are sold as a cooking oil, as salad oils, and as nutritional supplement gelatin capsules.

Mr. Stephenson: This is not going to be a briefing on hemp seed oil issues. But this is an area that we have been monitoring, both at the Federal level, in the civilian regulated and Federal agency programs, as well as in the areas of the military, over the last several months. We do have activities underway. There are programs of broad, basic research that are being developed, designed for implementation. But this is an area where, combined with the issues of adulteration and dilution detection issues that address an element of using any commercial product, such as hemp seed oil, as a, I would say, probably your excuse, your alibi, for a positive marijuana test will not stand. And there are already regulations out there that indicate -- I think not only for the military but for civilian forces -- that a positive drug test based on a hemp seed oil defense is not a legitimate protection at this point in time. We are being very careful to make sure that we do not cause harm to an individual who has truly used hemp seed oil without any awareness of its secondary effects. We are also very cautious to make sure that we don't create an environment that is going to permit people to begin to build a marijuana alibi using hemp seed oil. This will be an area where we are conducting ongoing work for probably the next six months to a year. We have developed some protocols, with the National Institute on Drug Abuse, that are going to be giving us a lot of new information in the coming months.

Mr. Bush: The comment was made about the frequency of random testing. And you get to a point where people aren't going to be tested to like a 10-percent rate and so on. There have been a number of court cases over the last year. When you put them all together, it basically says that the courts -- and the Supreme Court in particular -- buy off on random testing as a deterrent where there is a legitimate governmental need established. Where the courts have overturned that or objected to it was where the random testing conveyed to the court or the court concluded that this governmental entity that was requiring the random testing really wasn't serious about the random testing, and therefore they didn't have a legitimate government interest, and therefore the random testing violated the fourth amendment. And we're talking 10 percent or those kind of things. You must be careful that you don't go too far, and all of a sudden you find that the court is disagreeing with the whole purpose, the fundamental purpose of the testing.

Mr. Stephenson: I remember years ago we had some interesting activity, I think, developed by some of the NRC folks at your Pacific Labs, the Batelle Corporation, and I think with the Navy, the Marcovian Change and Probability, looking at the potential for detection in a drug test environment in a random testing arena. And this was one of those areas where who would have ever thought that now common sense and judicial oversight would be saying basically the same thing: If you have a very low probability of detection, you're really not serious, and therefore this is not a legitimate interest. That's a good and clear signal.

I would like to have Dr. Caplan begin the discussion of alternative specimens.

Dr. Caplan (DTAB member): Historically, the Drug Testing Advisory Board serves an advisory function to HHS, and particularly the urine drug testing program. It was never designed as broad based as some of the activities that we are dealing with now. Therefore, there's been a metamorphosis and perhaps some things moved a little more slowly in the beginning and perhaps can accelerate a little bit now. We started about a year and a half ago -- April 1997 -- with the first of two general meetings, because there was a growing interest and growing information acquired about other technologies and other processes which may facilitate ultimately more comprehensive and better drug testing programs.

We all, after a great deal of work, developed the original guidelines and the original process that led us to the current structure we have today. And most of the Board's activities were very simple relatively -- in other words, focused on one item at a time -- the cutoff change in opiates, the cutoff change in THC, adulteration, and a few other things. And I guess at that time the Board was able to operate effectively meeting quarterly and without a lot of other help and structure. The advent of the other technologies brought in a lot of information and to a group which has now struggled for a bit of time in trying to develop an effective process to deal with it.

I think we might honestly say that we started off in the beginning by wondering if we needed to do any of these things. But I think I'll probably speak for many or most people in that we have probably reached a point now where these things are generally considered to be inevitable and that we really do need to figure out the best way to do it and to accelerate the process, remembering that ultimately, after we do make lots of these decisions, there is still this two-year process of getting it actually through the Federal bureaucracy.

A number of things have happened to date, including several meetings, and ultimately the development of several working groups. And we are at a point where only one of these working groups was formed and has had at least one meeting. The other groups of the other technologies have not yet met. However, we left I think the last meeting with a draft of the potential regulations, how they might look, and things that we needed to fill in.

In trying to develop that process, what we thought we would do today, since we meet infrequently and we don't have an unequivocal structure, was to develop a little bit of a structure to get through today's meeting, and then maybe have some suggestions as a way to continue this process.

First of all, I think all -- and later on -- all the members of the Board are here, and one member who is not here will be here this afternoon. And it happens that Aaron Jacobs, that member is going to report on the only working group that has had a meeting so far, which is the hair working group.

The way we thought we would proceed is to start this morning by taking on-site testing and spend the morning dealing with on-site testing. And we will do that by having one of the other individuals of the Board -- Denny Crouch -- to identify the issues as they have been presented in the last documents that were submitted to the Board. These were the results of the various industry groups which made presentations at previous meetings and submitted the places where they thought information was needed as part of the grid.

We are going to have Denny read and identify one of those issues, have a discussion about those issues, and then we've also asked Dan Isenschmid and Walt Vogl to record in a bullet way, the major points which came up. Then, after we go through all these issues, we'll come back to the infamous grid, and try to see whether the information that has been generated changes that from an "i" to a "p" or to a blank, and then try to redirect the status of that information at that time.

I think we picked on-site testing first for a couple of reasons. One is that Aaron can't be here till this afternoon to do the hair, and I think it's the one that there probably is -- although the group hasn't met -- probably the greatest flurry of activity. There have been at least several studies by Dr. Willette and his group on on-site devices. Fortunately, he's here and will hopefully make lots of comments.

I would also ask all the people that are here -- and I know that there are several in the group that have specific experience with on-site programs -- we are looking for your comments and participation at the same time.

We will then review the grid, with the idea of looking at some outcomes. And they may be such things as, do we have an "i," a "p" or is it now a space, which is a white space may be indicating that there is adequate information? Do we need to change the status? Does this need to go back to a working group? And the working groups, up until now, have been technical working groups, mostly based on the industry representatives. And then there is a question as to whether we need to recommend a more specific type of technical working groups on an interim basis, or do we refer it to a subcommittee of the Board? Another issue that I think we need to deal with inevitably, and we might as well start today, are as we talk about these things, and we call them technical things, but some of them are really not technical. And we have to begin to wean out the things which are administrative and decide if they are administrative or not, and decide whether the Board would wish to comment on them as administrative things and advice or whether the Board feels that they should just go back to various agencies. So that would be one type of decision. And the other would be whether or not the technical information is there, as well.

We talked about the order of specimens, the process and the input. One other thing we will talk about later this afternoon, and which we haven't yet generally addressed as a group -- we are looking at all these technologies, but we have not really asked the questions about the fiscal impact to the government, to HHS, and what it's really going to take to get this thing going even if you write the guidelines. And we had groups of 10 or so people meeting every three or four weeks -- or three or four days -- before the first guidelines really got together. And then, ultimately, there was a lot of support in creating a staff, in creating of subsidies, to get some of these programs going. So we need to begin, since we've moved along with the technology, to decide what's it really going to take fiscally and administratively, in the way of money and an organization, to actually move some of these things over the hump. And I know the people from HHS, DOT, and other agencies will have a good feeling about what it's taking for you to run what you're doing today. And at a very minimum, at least in my opinion, if we get into these other areas, we at least double the administrative and support effort, and probably need a fair amount of fiscal support to develop the programs. We did dozens of inspector testing programs at cost to the government, that were run by the government, in order to get adequate inspectors to deal with all these various issues. Writing the guidelines is only one -- and dealing with these issues -- is only one part of the whole problem. With that, we will start, and take the issues one at a time. This is going to be informal. Because I am not sure that everybody knows who the other people are here -- maybe the people in the audience could just go around quickly and tell us quickly where you are from.

Note: Each individual gave his/her name and business.

Mr. Crouch (DTAB member): What we are doing is comparing the information that was provided by the various manufacturers, or on-site representatives in this case, for the questions that were either "i" or "p" in the grid. So we're working hopefully from the document that was presented at the last meeting, which is a draft of what the guidelines would look like. So what Yale has instructed me to do is to raise the response from the on-site group and facilitate discussion about the response, if it was adequate or if we need to further this information.

The first comment is on training. The response is initial training should be conducted by the manufacturer/manufacturers. Training should be documented and repeated as required. Subsequent quality control procedures help to ensure testing is performed appropriately. Under the Federal DOT alcohol testing guidelines, a similar process is used for on-site testing of operators. A test operator must have successfully completed the manufacturer's training program for the device. Training programs should also contain information on the following topics: drug abuse, specimen collection, chain of custody, specimen adulteration, interpretation of results, recording results, and confirmation of presumptive positives. The question is, does this respond to the needs of the grid? If not, what areas do we need to look at?

Dr. Caplan: Let me make an addition to that with regard to there is the parallel question here of -- and maybe we can get some comment on this first -- there is a DOT on-site alcohol testing program. And the attempt in this question is to model this collection for urine, and follow some of those same guidelines.

I think one of the first questions -- and maybe there is some comment from DOT or other people who are doing those kind of tests -- as to whether that is adequate, whether there are inadequacies which have been detected because of that process which has a certain level of rigor, but due to the nature of alcohol testing and the fact that it's practiced in a fairly limited arena, unlike urine drug testing, alcohol testing if pretty much practiced in the Federal regulator arena and not so much in the non-regulated arena. So the numbers are fairly low.

What is the feeling of either DOT, if you want to make a comment, or other members of the group, as to whether that approach is adequate?

Ms. Bernstein: The only issue that I see, if you look and you say the test operator must have successfully completed the manufacturer's testing program, and then you look and also see that here are other kinds of issues in addition to the drug abuse collection chain of custody -- the difference is that with alcohol, we have said that it does not have to be the person. My only issue is saying who has to provide the testing essentially. If you look at this, you're saying that it must be the manufacturer's training program and that is a difference.

Dr. Smith (Substance Abuse Management, Inc): If I could comment, again, a little bit from the past. When we developed, at DOT, the breath alcohol technician training program, we actually used a combination, where there was a standard model curriculum that was generic and basic to the procedures for collecting a breath alcohol specimen, if you will, recording it, et cetera. The proficiency portion of the technician training was designed by the manufacturers, in terms of device-specific.

So that there was a standard curriculum that required six and a half hours to present that was developed by the Department of Transportation, the Office of the Secretary, as well as NHTSA had a lot of input into developing that. The model used was from NHTSA's experience in model curriculums for the training of law enforcement officers in conducting forensic breath alcohol tests.

This document here would indicate that there is not necessarily a standard curriculum by the DOT or by HHS or someone else, but rather that it would simply be the manufacturer's training program. I think that represents a significant difference from the approach that was taken for the on-site issues of the technicians under the DOT alcohol program back in 1994.

Dr. Caplan: Remember as we do this, the statement that is given here was the statement which was provided by the industry group. I am just pointing this out as we go. We want to hear whether that's adequate or whether there are alternatives to that, that would be better, as well.

Ms. Murdoch (Benzinger Dupont): One of the things that we found when we were looking at on-site testing devices was that manufacturers’ tout their product as saying little or no training required. I mean that's one of the things that they say. So when we looked -- when BDA was looking for the product for the Postal Service, we took that with a large grain of salt. And we decided that -- and I had the benefit of having been at DOT and seeing that -- my belief was standardized training was necessary. However -- so we developed the training program. And it was fairly detailed and it covered some of the things that were mentioned there. And we provided "train the trainer" programs, and then that was provided further out. But we don't use the device in accordance with the manufacturer's instructions. That was a procedural choice that we made. So we couldn't use their standards, even what little training the manufacturer had, with the one we eventually selected. We couldn't use their standard training because it didn't match the use of the device in the situation for that company.

And I have a feeling that may be found in many companies; that it's not going to be used in precisely the way perhaps that the manufacturer would recommend. We use a test cup and we don't use it as a collection device. Not that it's not perfectly acceptable for one, but for a variety of reasons we don't. Now, we were very fortunate that the company worked with us and developed a modified training video that just covered the device itself and how the analysis was run. But, really, they're training wasn't useful. Most of the packages we looked at, the biggest part of the training was touting that particular manufacturer, or telling you about all the other great products. And I don't find that particularly useful. I also have found our experience has been, in the breath alcohol testing arena, that some of the manufacturers will hold the customers hostage to their training requirements, and have expensive training requirements or recurrent training. If you don't want to participate, the response is, we're not going to support you if you get a legal challenge to the testing procedure. I would like to see this process avoid those pitfalls if possible. That's all I have.

Mr. Crouch: I have been through a number of training classes offered by these manufacturers. I think most of them are fairly good in telling you how to run their procedure. What they don't cover very well probably is the third part of this, which is factors about drug abuse, specimen collection, specimen adulteration and interpretation. In the laboratories, the lab is responsible for training its employees on these areas. I think one question is, who is responsible for this? Is someone who is running the on-site testing facility, is it their responsibility to do this? Or should it be a program issue, like Dr. Donna Smith presented, where there is a standard protocol for training made by HHS or SAMHSA that collectors go through?

Dr. Caplan: There are two questions so far: Who should do it, and should there be standardized training?

Dr .Vogl: I think, when it comes to on-site testing, under collector training and certification, I think this has to do really with training certification of performing the collection procedure. The training is used -- I mean they are addressing the use of the on-site test kit and the training of testing the specimen collector, I think. I think there are two sorts of areas here under this topic for on-site. It's, you know, know how to collect it and all of that, and then what kind of training in doing the test. I think there are two separate issues here. They focused on conducting the on-site testing, you know, actually doing the test and the manufacturer training, right?

Dr. Caplan: I think it's pretty clear that it is a combination. And whether we keep them separate or together I think ultimately there is going to have to be a comprehensive process for collecting and training if it's an on-site device.

Dr. Smith: One other point I'd just like to bring before the group is, is it possible that you are going to restrict that there must be two people involved, that there will be a person who collects the urine specimen, if you will, and another technician, or someone else, who conducts the actual analysis outside of the laboratory, and interprets the result? Or are you in fact going to allow one individual to do that? And will it be, you know, basically a continuous or a contiguous process? And I believe those are things that the rule has to address.

Dr. Caplan: That actually is another part. We are going to try to keep to the points if we can. We need all the discussion. But that happens. And Denny is going to keep reminding me that specific point is coming up later. But that is clearly a factor.

Also keep in mind -- this was something we talked about at some of these previous meetings and it's always been a fundamental concern -- is while we do all this, how does it impact on the current process in the laboratory? Because we cannot, in the end, have a process which is less restrictive on site, for example, while you're making the laboratory do a whole variety of hoops to go through to do the same thing.

So I want people to think about, if we do, you know, the goose, the gander is still out there. And we do need to consider that.

As the example, which has come up before and I'll just repeat it now -- and that's along those lines and it's just as an example for our thinking process -- if in fact we do on-site testing, as Dr. Smith suggested, and only have one person do it -- and that is not otherwise, quote, verified or documented, why can't a lab release directly off a Hitachi 717 and download and put the answer out? Right now, a certifying scientist has to do it. There has to be a hand shake. So those are the kind of things we have to think of as we go in parallel.

Dr. Willette (Duo Research): I just want to remind the Board that on-site testing has been with us for nearly 25 years. And most on-site testing is done with instrumented systems. So the discussion is being oriented towards non-instrumented devices, which are relatively new to the marketplace. So I would assume that the discussion really is in all forms of on-site testing. We monitor how many sites there are in the 30-some instrumented sites within the Federal court system, and that's going to expand. As you may well know, the Department of Justice, together with the administrative office of the courts and with HHS's input, is looking at this whole picture for the criminal justice system.

We have a long history of how training and monitoring is done with instrumented systems. And a lot of that's going to extrapolate to non-instrumented. So, in those cases, they tend to be very device specific. Which would also apply to the non-instrumented. There can be a lot of variations between the 30-some devices that are on the market.

Whether it's a standardized protocol, like with the alcohol, could take into account a lot of the peripheral issues -- and it'll be similar, I think, to alcohol to have manufacturer-specific information related to each device. You also have to remember there are Federal regulations that have been in place for eight years -- nine years -- for doing on-site testing in the nuclear power industry. There are certain precedents on how that can be done.

Dr. Sample: In listening to these discussions and thinking about the impact on the more traditional urine-based drug testing, it seems to me that this section on collection has a number of items in there that really are operator related and not collector related. I'm wondering if a number of these items that are listed really should be related to the operator and that we should restrict this section just to the straight collection process and the work that the collector is doing.

Now, ultimately, depending upon the type of system, the collector and the operator may be the same person. But with respect to this section, I would restrict it just to the collection process, and keep operator training and certification as a separate item.

Dr. Caplan: That's kind of a critical point. Does anybody want to say anything further? Any other specific experiences about that? Probably either from Bob or Julie? Just anything further? I mean you have the experience out there as to separating collector and operator.

Dr. Willette: I would agree with Dr. Sample because at some point you're going to have to decide about whether collector and tester are different. Now, in the alcohol regulations, they are one in the same.

Dr. Caplan: Correct. That's why I want reaffirmation on that.

Dr. Willette: Yes. A lot of the nursing and paramedics that do these kinds of tests in the field say, what's the difference? We do it with alcohol, why can't we do the testing and collecting for drugs?

Ms. Murdoch: I think we went over 700 sites that are now trained in the field service program. And they do -- the collectors do the analysis right there in front of the donor. We don't use chain of custody unless the specimen is going to be shipped to the laboratory, in which it goes through the normal chain of custody procedures. We use a log book to document the analysis. And aside from State health and human services folks who don't understand that the Postal Service actually does have preemptive power, which is nice to have, we've had no problems. We have not had any reports -- and, trust me, they all have my phone number, because it's in the training -- we've had no reports of donors expressing objections. We've had no reports of the confrontation concerns, which we did deal with and we’re concerned about. And we've had no problems with things like the temperature of the specimen affecting the test outcome, because the analysis is run right away. And the training does encompass the collection issues. We do a dip to do adulterating training. So that's part of the training. And, you know, looking for a suspect specimen is part of the training. And then, running the analysis is part of it. And then the specific procedure for the company. So it's all in one package. It's all one person. It's all done at the same time. And all the written materials are standardized. And so far it has been remarkably successful. I will say -- this is not a big secret -- but the program was a pilot program. It was a sole source. And that expires at the end of March and it goes out to bid. And I don't know what's going to happen after that. We'll see.

Dr. Caplan: We're going to formulate these questions, then come back and see whether there is consensus about them. Right now we just want to identify the issues. We'll come back to it later.

Dr. Vogl: I believe, in the mandatory guidelines for urine, it goes into the collection procedure that is used to collect urine. I do not believe even in the mandatory guidelines we say anything about the collector and any requirements regarding the person doing the collection. We follow the procedure, but we don't, in general -- you know, or have not in the past -- required the individual to be trained to do the collection. Now, DOT, I believe, does have -- may have the words "a trained collector." I believe in our collection handbook we go into the fact that the person collecting the specimen should be trained. We use that term generally speaking. We don't go into detail who is going to do the training or how it's even documented, I believe. As far as on-site testing with regard to collecting a urine specimen and the training, we may need to go back and specify the trainer requirements, including the standard, current urine testing program, as well as on-site testing.

Dr. Caplan: Remember also -- and this is mentioned in many other meetings -- is that whatever we end up doing doesn't prohibit us from attempting to change the basic document for standard urine, as well. That's why I would ask, if there is input about deficiencies, particularly in the DOT and the urine collection in the current program -- and it would the alcohol with the DOT -- where -- I mean there are some apparent deficiencies. And either we are going to continue to live with them -- and we might make that decision -- or perhaps we might improve them. While we're talking about on-site, when this is all said and done, it needs to go -- at least I think it needs to go -- across all the boards. Anything from DOT's perspective or history on those things?

Ms. Bernstein: Yes, you get into some big budget issues here when you talk about this.

Some of the collections that are being done are -- in many, many areas -- are done by people who don't do this for a living. So, you get into all kinds of issues. But there are huge cost factors involved when you start mandating this kind of thing. I'm not saying that for better or worse, but just remember that the regulation has got to get through OMB. That needs to be taken into consideration.

Dr. Caplan: I guess for DOT, do you have any regrets about the -- I've asked this three times and I'm not getting an answer -- do you have any regrets about how the on-site alcohol thing finally went into place? You know, with the certification is the next issue.

Dr. Smith: It has been remarkably trouble-free from a litigation standpoint. I mean all of you remember my famous story from the lawyer at the rulemaking time who said, thank you for making my children and my wife's future secure by putting out these alcohol testing rules, because they will provide me with a legal income over the next 15 years. But that didn't happen. That really has not happened. And from the other side now, for five years, in terms of reviewing alcohol test results for their validity from the standpoint of the rules, we have had, surprisingly, a much lower percentage of invalidated tests on the evidential breath alcohol testing side than we continue to have on the urine drug testing side, where results must be invalidated because of collection errors and chain of custody fatal errors or omissions.

I think that the standardized curriculum and training, the requirement for proficiency with the actual device or instrument, did help in that arena. And so I don't have as many regrets there as I do. Again, Mary Bernstein is right, in terms of the issue of personnel. Certainly evidential breath testing is not as widespread as urine drug collections and we do have to be cognizant of that.

Dr. Caplan: It's pretty clear that we do need to differentiate the collector from the tester/collector or tester. And we'll do that as we go forward. Maybe we should move on to the next one, which has to do with training and certification, which we almost led into, but why don't you go through.

Mr. Crouch: Item two. It's under certification of collector. And it begins, the response begins with test operator should be certified in a process similar to the Federal DOT alcohol test operators. Please note that some States -- i.e., Oregon and Alaska -- have these certifications.

Dr. Caplan: Certification is and was a critical question when we did the DOT thing. And I think we need some comment on what everybody thinks about a certification and how it should be for -- and let's limit this not for the collector at this point, but to the tester.

Mr. Bush: I assume that the certification -- we envision that it's based on some kind of examination or demonstration of competence. Although it's certainly possible in some States to be certified just by paying a $5 fee.

Dr. Caplan: A lot of other comments on this. I think certification is one of the fundamental things we do need to do.

Dr. Smith: I do want to make a clarification. Unless my memory is really failing, the DOT breath alcohol technician rules do not require certification in the sense of an examination or whatever.

Ms. Bernstein: Correct.

Dr. Smith: What they do require is the completion of the curriculum and the completion of the proficiency trials on the actual device. But in terms of any kind of -- you know, when I think of certification, right, I think of some kind of licensure or some kind of certification that may expire or have some kind of renewal. The DOT rules say that the breath alcohol technician, if he or she changes devices, instruments, has to repeat the proficiency trials, the proficiency skill-building exercises if you will, on that new equipment. I do think it would be necessary, in this exercise, to really define what we are talking about in terms of certification.

Dr. Caplan: Clearly so. I mean the -- and I think the term -- again, that's why we're going through the document -- the term, as written in the document, is meant broadly, I think. But we need to define it. Do we want -- the question is, is the way DOT does the breath alcohol people adequate for drug testing? Or does there need to be something stronger, such as a, quote, certification process?

Ms. Bernstein: I want to reiterate what Dr. Smith said. And that has been our experience very much, that we seem to have a lot more questions and issues and problems come up on the drug testing collection side than on the alcohol test side. And if you look, everywhere in the process we have so far avoided, quote, unquote, certification. And the question is, what is it that we're doing that we would need to deviate from that?

You know, if you talk about some of these technologies existing side by side with one another, we would have to realize, if we put in certification, that that would be a deviation from all our other processes. And I just think that's an important point to make.

Dr. Caplan: Yes. And you have to remember, too, that we are talking HHS, which does the laboratory certification, and DOT, which has other regulations which really are not so much around certification. But if we do on-site testing, we've got them both together. And we have got to come up with an answer for it.

Ms. Bernstein: One addition to that, while we are certainly looking at the issue of training in the revised Part 40, which we hope is going to appear in our lifetime, that we are definitely looking at the issue of -- training is a very large issue. But I will be clear -- and it's probably telling tales out of school -- there is nothing that we are anticipating at this time that will involve certification. So that's where we're kind of parked.

Mr. Kunsman (STC Technologies): I think the overall benefit of DOT's alcohol training requirement and that standardized program was that it forced us, as the manufacturers, to rise to a level that you had set, and thereby eliminated any pretenders who didn't want to rise to that level and take on that responsibility. And while you correctly assert that there's no certification or there's no examination, there is my signature on a certificate. The manufacturer has put their name on the line and will stand behind anyone that they take through that certification. And the training requires that they -- the student completes that to the satisfaction of the trainer, or the facilitator in the case of the video program. I think by establishing some guideline -- and while I agree with what you're saying about the sheer volume of urine collectors that you have out there -- but by establishing some guideline, you'll require the on-site test manufacturers to rise to that level that you set and meet your generic guidelines, and then provide an adequate proficiency standard that they'll have to stand behind.

Mr. Edgell (DOT): The proficiency demonstration for alcohol training in DOT is done in front of another human being. So there's not a self-training that goes on. There is a limited amount of self-training with respect to how much education you might have -- screening test technician in law enforcement could be a breath alcohol technician, et cetera, with a certain amount of self-training. But the proficiency, the demonstrated proficiency, that you actually know how to conduct the test and use the instrument is done in front of an individual in all cases. Sometimes, with the questions that we get into the office with respect to those collecting urine, in some cases its easy to get the idea that an individual might have trained themselves on the way to a collection site by simply trying to read the back of the form. So I think that the involvement of another person, knowledgeable in the procedures and in how to use whatever instrument they're using, has served the program quite well.

We seem to be seconding what Dr. Smith is saying here, but we had 8,300 calls to our office this past year that required a response by one of the analysts there. And a very, very small percentage of those questions had to do with alcohol training in any way, shape or form. I would say -- just making a guess from my own standpoint -- approximately 10 percent. The number of questions is quite small.

Mr. Stephenson: Looking at where we have been, we had an analysis of on-site testing as one of our unresolved areas that was left over from the 1989 consensus conference that led to a pilot study at a number of sites doing instrumented on-site testing back in 1991 and 1992. Operator error was one of the primary areas of vulnerability that was identified in any future implementation of on-site testing as an area of concern.

What I suggest for today is that we examine what has happened in DOT in the use of both instrumented and non-instrumented technologies in an on-site application. I think it demonstrates an area where you may see the technologies evolving in an attempt to become idiot proof or non-instrumented. You may have less vulnerability or variability in the test based on who operates it or who conducts it.

That may be one of the areas you want to achieve some standard that the industry rises to, which demonstrates the proficiency of its test, to reduce the variability of a result by different operators. And to have that as one of the documentations that's put forward. To say that in a highly variable operator environment, you can still achieve this level of accuracy in the testing process. That was not the case with our all-instrumented processes. But it may well be a more achievable result in the future. It's not going to take away any of the administrative responsibilities in terms of the collection -- the legal basis and the accuracy of procedural things that need to be done. But if you can get at that, then that's something that we could strive for across the board with all of our alternative technologies in specimens. And that could be one of the requirements that the industry would need to take on.

Ms. Holliman (Marriott): I trained collectors for many years on the initial breathalysers, where you had to have people do a lot of activities, to the point where they are almost idiot proof although the manufacturer told me they are user-friendly. I think that with urine collection, there are a lot of steps where a lot of errors can be made by a collector, where, with the alcohol testing and the instruments that are out there now, there is very little that a person can forget to do except perhaps I.D. the person and his signature. That may indicate why there are less calls. I am not saying it's not some of the training, but I think it's the instrumentation that's so easy to use that it's difficult to make mistakes. Recognizing that cost is a factor, one of the things that I saw in training people was that you needed to go back and reemphasize what they were doing. Because we as humans all tend to take our own little shortcuts. And, before you know it, you're setting up areas that could open you up to be making a mistake or not doing it correctly. I don't know how you work that into an ongoing certification program, but I think it definitely helps to have the person go back in some way, given another proficiency a year or two years down the road so you see that they're continuing to do it the way they were supposed to.

Mr. Kunsman: While we keep in perspective that there are many more urine tests being collected than alcohol, the difference in number of urine only collectors versus urine collectors who have also been trained in alcohol is not as great. While I agree that there are many more urine tests out there, many of those collectors have gone through training on alcohol and could be reached similarly for training for urine collection.

Ms. Holliman: If I said that, what I meant was there were many more steps in the urine collection process.

Mr. Kunsman: No, I wasn't responding to that.

Dr. Vogl: I would like to go back to the category of collector training certification with all these comments. Can we set up a series of requirements for training or certification, either external or self-imposed, as to who is doing the collection? When I get calls regarding a certification training program for collectors, the answer is no. Basically, I tell employers or anyone else who wants to establish a workplace program, they should put the responsibility on whoever is going to do the collection to prove to them that they can properly collect a specimen and send it under chain of custody to the lab. They have to provide that verification of their knowledge and ability to do it correctly. The next step is the laboratory finds that they are continually getting specimens with forms that are incorrectly filled out, there needs to be feedback to the employer, providing that information, showing that this collector does not know how to do it, and they need to get someone else. There must be a feedback approach at this point to improve the collector's ability in doing the collection.

Dr. Caplan: Let's focus just on the issue of certification. There are a couple of questions. We will try to answer them later. Is there a feeling or an experience that certification -- meaning an external process, a document issued somehow by some source -- is necessary for an operator or not?

Ms. Murdoch: We use an examination with a combination of written and actual hands-on practice, required four specimens and test them and correctly identify the results. We do that for a couple of reasons. I'm an attorney and I can't help thinking this way. But this is novel technology in the workplace setting. And the liability exposure is significant, especially with the possibility of false negatives and negligent hiring and those sorts of concerns. We felt that it would be inadvisable, or worse, to allow people to be conducting these on-site tests, and potentially putting people to work for our client who shouldn't be there. We wanted to at least take reasonable efforts to ensure that the people who were conducting the analyses were able to accurately identify the results, to conduct the analysis and identify the results. And that was just CYA, to some extent. But also it has given us control over the information that's disseminated to the collector and analysts, and the information that they in turn disseminate to the donors or at their collection site. They have to conform to our written materials and pass our test or they can't conduct the analysis. And there is a significant financial implication in that -- you lose the business. It's a contractual element. It gives control over the process to the Postal Service. It also does provide documented evidence that the people are capable of conducting these tests in a reasonable and effective way. I think that's an important consideration, since this is all new territory.

Dr. Caplan: Certainly that's one vote for a certification entity, however defined.

Mr. Bush: I was going to make almost exactly the same point -- that there are legal precedents that basically say that unless you have documented evidence of competence on certain tests, those tests can be overturned. In other words, the legal liability is a very important consideration in this.

Dr. Smith: I do think that it's possible to build a certification component into this without requiring the DOT or SAMHSA or anyone else to go into the examination/certification business. I think that you can write a regulation or a rule that would basically say these are the minimum criteria that an operator must have in terms of training, instruction and knowledge, and skill. And, then that is the responsibility of the employer of the clinic, of the collection site, of whatever it is, to make certain that those are met. And they ultimately then stand behind that signature. I would oppose thinking that we need to go into the business of DOT or SAMHSA getting into the certification business, the administering or controlling of exams, but rather that there is a way to accomplish what Ms. Murdoch and others have spoken of today through very specific language in the rule or the guidance document that would set that standard.

Dr. Welch (DTAB member): In Oregon, we have taken that route. We do not use the word "certification," and it might be a semantics thing. But, there's some minimum qualifications, and then the words are used "documented competency." It's the responsibility of either the lab doing the testing or the employer doing the testing, whoever is doing the testing, to document that competency. The word "certification" is never used. I don't know how you would -- it doesn't seem to me to apply there because there's no certificate given the test operator.

Ms. Bernstein: I agree with Dr. Smith and others. I do not think we want to get into the certification business. In addition, the government does not want us in the certification business. You are long past the days where an agency can just decide to do that. There is a real push in terms of that. There are all sorts of hoops that weren't there before. And if one wanted to do it, it would be extremely difficult to demonstrate that this was the only way to do it. I think there are ways as has mentioned. But, the one note of caution, and I think it's been very well said here today by many, that whatever we want to do, we seem to have been much more successful in terms of what we have required on the alcohol side as vis-a-vis what we required on the drug side in the collection process. Getting back to what Mr. Stephenson was saying in terms of there is a big difference between instrument and non-instrument. But, at the same time, they have two very different requirements. I think that should be a lesson to us that what was done on the alcohol was very, very successful in the sense that there has been less litigation and, as Mr. Edgell said, 90 percent of our questions are on the drug side.

I think that there are ways to do that without certifying, but yet do more than we did on the original drug side in terms of training and competencies.

Mr. Crouch: Number three, speaks to collection device, but the response speaks to tests, in terms of being certified by FDA. NOTA (National Onsite Drug Testing Association) recommends that on-site drug tests meet the requirements of the FDA for commercial distribution and can meet generally accepted cutoff concentrations such as those in the mandatory guidelines for Federal workplace testing.

Dr. Caplan: Comments on this? Dr. Willette, you probably have the most information on that. Anybody else? Do we want FDA clearance? Is it valid or not? I guess that's the question that they're saying.

Dr. Willette: We have a number of representatives of FDA here who can speak to the regulations, but it's my understanding you can't market these without clearing them through the FDA. They can only be used for experimental or research purposes without FDA clearance. That's a given.

Dr. Caplan: The question is whether it's a requirement for this program. It may be a de facto requirement for a product. And I think it probably is. But the other question is whether or not there are standards written in this guideline which ultimately FDA would agree to utilize in the evaluation of the products, which don't exist at the moment.

Dr. Vogl: I'm not sure if it is that clear cut because the workplace is not for medical diagnosis. Therefore, the FDA requirement -- the current requirement for our initial test was established by the guidelines as a requirement. We would not, I do not believe, we would have to require the test to be FDA approved. Because this is not medical diagnosis.

Dr. Caplan: Well, that is the question. So, do we want to require it or not? I mean, whether we think, as a program, having FDA clearance of these devices is useful, or just avoid it? They may have it, they may not. Or do they meet other criteria otherwise set for the program alone?

Dr. Bush: Keep in mind that in addition to the requirement of FDA clearance as stated in the guidelines for immunoassays used in the laboratory, we impose rigorous and very strict performance requirements that go above and beyond what the FDA requires merely to market something for implementation in any number of different settings. We have a very specific mission and very specific blinders on, driven performance characteristics, for all of those tests over and above FDA requirements.

Dr. Sample: I would like to ask the question, are we talking collection device or test device? If we are talking purely a collection device, unless that collection device is also a test advice -- as occurs in some cases, but in the majority cases a collection device is separate from the test device, and I don't think that FDA clearance would be required for purely a collection device.

Dr. Caplan: I think we're at the point where we're limiting the discussion to the test devices. We either get back to collection, as to whether we need to do other things there -- and they may merge -- but I think the things forward are basically on the test device.

Mr. Stephenson: On July 23rd, we were required to provide testimony for a subcommittee in the House of Representatives. At that time there was an FDA presence that was there. Subsequently, in a couple of other settings, we've had FDA discussion on the issues of their future intent, in terms of regulating areas. I would not rule FDA out in terms of having oversight over workplace or non-diagnostic areas, given that the nature of what we see as a collaborative effort with FDA in the future. If there is a meaningful place for the role of the manufacturer to document its standards or its quality assurance or its training or certification issues, as opposed to letting it be a free for all in the marketplace, with every individual purchaser having to do it themselves, or our program having to do it through a patchwork of efforts and special contracts to test batches of equipment, I am sure that that will come. I think that would be one of the areas where the area of interest and encouragement from this Board in these discussions would be helpful for FDA to determine where they choose to apply their resources. I would not simply rule anything out because it was not the case in the past or because it was workplace and it's not covered in the past. But I think you have an opportunity to form a basis for future actions based on what your recommendations are here.

Dr. Willette: You asked the question about whether any guidelines written to cover on-site testing should have specifications above and beyond the FDA requirements. I think Dr. Bush’s point is correct. Why would it be that much different than the current guidelines for laboratory testing? You don't have specific specifications. You have cutoffs and performance requirements and certain checks and balances. That can apply equally, as well, to on-site as it does to the laboratories.

Dr. Caplan: I agree. I think it's a question that we have to set up and address. Because if we decide to set up performance requirements, we don't have laboratories, we don't have a structure yet. We have to have a structure to do that. And the structure, obviously exists in a laboratory, but may not -- or does not -- exist and would have to exist in some form here. Who would do that? Would that be an additional manufacturer requirement? Or would that be a third party contractor or approval structure? You know, would someone like RTI be asked to review these devices on a contract basis and maintain the proficiency on them? It's a very real question.

Mr. Thistle (Psychemedics): Maybe I'm a little confused. Are we still talking about the collection device or have we gone on to the underlying assay?

Dr. Caplan: We're really talking about the testing that would be used in an on-site setting. We are leaving the collection as another issue. They may merge. At this point, we're trying to look at the criteria for the testing device.

Mr. Thistle: I think clearly in the FDA's recent proposal they are looking to regulate workplace testing. Although it's difficult to find or believe that in a workplace the employers are interested or intending to diagnose diseases or other conditions, which would be the FDA jurisdiction. And that does create a jurisdictional issue, I think, for FDA, although historically they have looked at assays that people have submitted to cover all workplace testing in a blanket regulation. And I think that presents a problem in that the jurisdiction of the FDA itself is restricted to devices which are intended to be used in the diagnosis, mitigation or treatment of disease.

Dr. Caplan: Right, but this program can ask that that be a prerequisite before a device is utilized in the program.

Mr. Thistle: Clearly, yes.

Dr. Caplan: And that's really the question.

Dr. Smith: I would like to call to the Board's attention that we went through a similar process with regard to the alcohol testing devices. And, Dr. Caplan, you remember because you were very involved at the DOT as a consultant at that time, what we looked at was the National Highway Traffic Safety Administration already had a device approval and evaluation system in place, again, for the use of the instruments in law enforcement. We simply added an additional criteria to those standards to make it applicable for workplace. A major example was, of course, that the cutoff levels that were used in law enforcement were significantly different for alcohol testing devices -- what we ultimately ended up with in the workplace alcohol programs under DOT. So we needed to go back to NHTSA and say, we've got all of these devices that are suitable for law enforcement work, but they have been judged, in terms of their accuracy, their reliability and their validity, on 0.08, 0.1 and 0.2 standards. Will you create a set of guidelines for the evaluation of these devices that is applicable to the workplace? So that the devices, if they were to be used for workplace testing, fell under an additional set of criteria for accuracy, reliability, and validity at 0.02 levels, other issues relative to the quality control measures that needed to be done to ensure the devices' continued accuracy. So something like that may also be possible in this arena for the use of on-site devices.

Dr. Caplan: Thanks, that is a critical thing. I hadn't thought about it recently until you mentioned it. But that was an ongoing program of more than 20 years prior. And there were well-documented ways and actually facilities to do that. All of which goes back ultimately to this question of cost and what resources are going to be needed to do this sort of thing as we go forward. I do have to, since you put me in the consultant mode like that, I have to put in my consultant disclaimer.

Any other comments on the first part of number three, which was whether or not the FDA -- you didn't actually ask the second part yet, right?

Mr. Crouch: Second part. Currently, all drug screening kits that have been cleared by the FDA contain internal procedural controls. These procedural controls verify that the testing procedure has been performed correctly and takes the place of controls or calibrators used to verify successful performance of the run on an automated laboratory analyzer.

Dr. Caplan: And the recommendation here -- is there a recommendation here?

Mr. Crouch: It's sort of out of place.

Dr. Caplan: Yes, it doesn't really recommend. It just makes a statement. This is another issue. And, again, we'll get back to, I think, hopefully, each of these. But this issue is the fact the concept of control as used in current programs. And most quality control programs are different than the concept that's often used in these devices. The control devices, for those that may be less familiar with them, these on-site devices, are often really just system controls. In other words, did it flow off the tube? As opposed to, is there really the right concentration of drug, and did it meet those other kind of criteria? That's why the question comes up. And it's been a point of care issue for a long time and has even caused CAP, which regulates or at least gives all sorts of -- to make a concession in this regard. Because a true external control -- and I think even the old CAP rules -- would say you had to run an external control once a day. And that's some other specimen that came from another source, tested on one of these devices and had some response.

Which, for someone doing point of care testing, one thing -- what do you mean you always have to run another one? It would increase the cost. Et cetera. So there is the fundamental -- and I think this response is sort of trying to address -- but it doesn't give a recommendation. Are there any thoughts that the devices can or should be self-controlled by these internal mechanisms that the manufacturer has or do they need external control? That is the question here.

Ms. Wikstrom (BioSite Diagnostics): It's important to understand that each manufacturer's device differs in terms of the way their internal procedural controls can work. I know that our device, as a matter of fact, is truly accepted by CAP as being reactive controls and there are true positive and negative controls in there. But I think what's interesting to note is that you need to look at the on-site difference versus instrumentation. You do need to have a control that verifies it, because it is a unitized device that works. It's not just -- when we refer to the run on instrumentation, you can run this for eight hours, 24 hours, and not know whether that particular result was within calibration or not until you go in to recalibrate. So that's where the importance of knowing, every time that you run a device, it has been checked procedurally -- whether that varies for on-site devices -- but that it has had some check as you run this individual device.

Mr. Konehe (Forefront Diagnostics): Our test does have a control. And, like you said, it is a control that is basically testing the device for the process: was there liquid present? Did it flow through the device? We also recommend to our purchasers of the product that they buy positive and negative external controls, they test their box of tests, their lot, when they get it in, and then they periodically test it. And we have some users that test it once a month, or every time they open up a new box. And our boxes are 25 tests. They are running a series of tests. In fact, at that level, they're actually running more controls than laboratories are running. And we're not opposed to that. But it is -- and you had mentioned earlier in your comment the possibility of having this true positive and negative built into all the devices. And with certain devices and with one-step devices, that test in itself is not an easy task. Because of the way the tests are designed as one-step devices, they are there to test one specimen. And that's the person's test. Because of that, you need to have separate external controls. I would just like to make that point that -- to limit it, that it has to always be built into every test device, I don't think would be really attainable. And I think that needs to be looked at.

Dr. Caplan: Okay. I don't think I recommended that. I may have said that.

Mr. Konehe: No. You just made a comment that that should be built in, or it could be built in.

Dr. Caplan: The process, not necessarily the device.

Mr. Konehe: Okay.

Mr. Crouch: The next response is to item D-3 -- which essentially says, can you split the specimen? And the response is, on-site test specimens can be split.

Dr. Caplan: I don't know that we should spend a lot of time on that unless somebody has some point they think is pertinent. I mean you can split -- we're splitting the specimens now. I think the assumption is they can be split for on-site purposes.

Dr. Bush: I think it was possible in the context of we needed written guidelines, we needed information as to how to do it in the collection site or the site, wherever this was going to happen. That's why.

Ms. Murdoch: I remember part of the discussion. Some of the on-site testing devices, if you are supposed to collect in that device and analyze in the device, there is no split procedure built into that device. You know, you collect, analyze and you have one now, potentially, at least optically, tainted, quote, unquote, specimen. So it's not split. And I think that's why it was a "p," should that issue be built into the procedures when you have devices that are designed for collection, analysis, shipping, and laboratory analysis? I think the answer is yes.

Dr. Caplan: Again, there are certain elements here which I think, once you do develop a policy, as we've seen with the other industries, that the manufacturers will rise to the occasion. They just haven't done that rule, so they therefore haven't had to rise to the occasion. The issue there is if we require that there be a split process, then there will have to be a split process written into that. And maybe that's as far as we need to go with that. What's the next one?

Mr. Crouch: The next statement is responsive to E-6, which is, essentially, deter tampering or adulteration. The response is, proper collection procedures are the key to the prevention of adulterated samples. Checking for adulteration is the responsibility of the specimen collector. The use of temperature strips on the specimen container, visual inspection of the sample and dipsticks to check for adulteration are tools the collector can use to detect adulteration prior to performing an on-site test. In addition, the built-in control in the on-site test provide a degree of protection.

Dr. Caplan: The question is generally that of adulteration testing as opposed to the question -- I don't know if the question is whether or not it needs to be built into the device. Are you reading the response that way?

Mr. Crouch: I think maybe what Julie Murdoch brought up might be important in, essentially, in the program for urine-based testing now, we don't really allow people to put dipsticks in the samples. We don't do a test like, for example, with a test cup and pour part of the sample over and call this a split. So there's a change in philosophy.

Dr. Caplan: I think the fundamental question here would be whether and to what degree adulteration testing should or shouldn't be included in the preliminary testing. Right now, we made a lot of recent changes with regard to the laboratories. And whether or not that should carry over, and how, into the on-site devices is the question.

Ms. Murdoch: Our perspective is that adulteration testing has to be part of an on-site testing program. Whether it's incorporated into the device or separately done through a dip or something, our feeling is it's imperative. Because you don't have the laboratory looking at your negative test results, or your negative specimens, to see whether it's diluted or there's nitrites present. Only at the point of that initial analysis will you be able to find something that's negative only because of the adulteration. Especially with nitrites, if we don't have any analysis for nitrites on site, you get a negative test result. You hire somebody who otherwise would have been identified as having adulterated the specimen if you used a laboratory-based program. And that appeared to us to be -- I hate to use the word "negligent" -- but potentially negligent.

Because you're doing that initial analysis and because there are products that will circumvent the testing process and not be identified by the on-site testing device, some sort of adulteration testing has to be included. And I think it should be mandatory. I mean we saw what success we had with making it advisory in the laboratory-based urine program. Laboratories didn't do it. We don't have to do that. How many times did you hear that? I think that whatever HHS comes out with, there has to be some sort of procedure for doing an immediate adulteration check of some kind. Not that that's necessarily easy.

Dr. Bush: I have a concern here. When you think about a testing device -- you may have a collection device -- you have the specimen on site. You've got it in some container. You're going to be performing the test for illegal drugs of abuse. If you incorporate in a strip or as part of the device a particular profile of adulterants, just remember these are adulterants du jour. As soon as we get nitrites under control, I assure you that we will face another adulterant. What if this device was cleared through FDA with a particular test for nitrite already incorporated? What does that mean to the manufacturer, who may have a particular production run of them or -- you know, just think about those things. How would we want to address adulterant testing? And do we want to link it intrinsically with the drug testing as part of the same device?

Dr. Caplan: Well, I think that is the question. And there could be a requirement that's not linked or a requirement that is linked, I think. Do the manufacturers want to comment? I'm sure they're going to say they don't want to link. I mean I wouldn't want to link it. I think the question ultimately before the Board is whether to include the same criteria and the same guidance-type documents that we now have for urine testing to on-site. And that would need to be done, but it would not necessarily need to be done, and probably wouldn't be done, as a function of the device itself. Another device or another process perhaps.

Dr. Bush: A procedural link as opposed to a device link.

Dr. Caplan: I don't think the question here is that complex, but I would like to hear a little more.

Ms. Murdoch: On the other hand, you may have a company that wants, for marketing purposes, to include an adulterant. And that shouldn't be prohibited. I mean I think the important point is that I don't think HHS should countenance an on-site drug testing program that has no mandatory provision for some sort of adulteration screening.

Mr. Bush: I think the problem with having the specimen adulterant testing along with the drugs of abuse testing in the same instrument is that you're going to have results for both tests. If the person is successful in adulterating his specimen, you're going to have negative results on the drug test. There are courts who would probably be more inclined -- in fact, our infamous Niagara Mohawk case, the court said, basically, he was successful in adulterating his specimen, and that's okay. And the specimen that was tested was negative. Therefore, he wasn't using drugs. That's the way the court came out. I think you're playing with legal fire if you permit the tests to go on once you've established that an individual has adulterated his specimen. Because then you're providing evidence for the drug abuser to bring into court.

Dr. Caplan: You only disagree with the second part of what Ms. Murdoch said, which is that the manufacturers could have the option to put it in there if they want?

Mr. Bush: I don't think they should be given the option.

Ms. Murdoch: One thing I forgot to mention is if the specimen -- under our particular protocol, if the specimen identifies with an adulteration stick as potentially suspicious, as we call it, or further testing needed, then the reserve specimen is sent to the laboratory for confirmation. And we have step-wise procedures for looking for the adulterant and then for the drug, if possible. An analyst doesn't make any final determination on any potentially negative industry -- or derogatory information.

Dr. Sample: While I agree with Julie Murdoch that it's certainly ideal and recommended that there be adulterant testing with the on-site test, I think it would be difficult for that to be a requirement for the on-site testing since currently it's not a requirement for the more traditional urine-based testing. There is no set menu or adulteration protocol currently for the rest of the drug testing that's going on. If we set that requirement for the on-site testing, I think we are then also obligated to set that requirement for all urine-based testing.

Dr. Caplan: I agree. They probably should be parallel at least in minimum requirement. We are all saying the same thing, although differently.

Ms. Bernstein: Yes, I think you've got to address adulterants at the negative level on on-site testing, whether it's a separate device or part of the same device. I think it is something that needs to be studied. But I think one of the current problems is the minute we develop protocols, before we can get them through all the hoops to do anything, they're on to the next adulterant. I think we have to find a way, in both programs at this point, to be more successful at that. I think it's simply you're going to have to look at mandatory adulterant testing. I mean if there are multiple specimens in a process, they should apply equally to those, whatever happens to be use at that time.

Dr. Caplan: I think we've probably exhausted that one. What's next?

Mr. Crouch: Well, we're still in collection procedures, item number 7, transportation of the specimen. The response is urine samples that have been screened with an on-site device may be transported and stored the same as any other urine samples.

Dr. Caplan: I think that's probably obvious. The only question was -- although there would have to be some guidance as to what the nature of the container is or if it's a -- let's go to the next one.

Mr. Crouch: The next one is back to the issue of should the testing have FDA clearance. It's F-1. NOTA recommends that on-site drug tests meet the requirements of the FDA for commercial distribution, and they meet the generally accepted cutoff concentrations, such as those in the mandatory guidelines. I guess the one issue now would be -- and we have two manufacturers here -- do they meet the opiate cutoffs of 2000?

Speaker: Yes. We already have FDA approval on our opiates 2000 assay. And I'm sure other manufacturers are working towards that, as well.

Dr. Caplan: Unless there's a comment, I really do think we probably already covered that one fairly earlier.

Mr. Crouch: Two specific drug classes, on-site urine screens test for the same analytes at the same cutoff concentrations as the urine-based screening -- or laboratory-based screenings. That was an insufficient -- I guess -- going back to how accurately can they establish the cutoff concentration, right?

Dr. Caplan: Maybe Dr. Willette wants to comment on that one, because he has now done the second study. Which, if I understood it correctly, they're a little better than the first I think.

Dr. Willette: It really goes to the FDA clearance process and what the FDA requires manufacturers to provide in terms of evidence that they do meet the cutoffs. It would not be that dissimilar from liquid reagents used in high-volume testing now in automated instruments. The guidelines currently don't specify what tolerances or what variability of precision there is around those cutoffs. But they're met indirectly through the performance requirements. Again, I don't see why on-site devices, whether instrument or non-instrument, should be treated all that much different than what's going on in the laboratory.

Dr. Caplan: I think there were two questions here. One is, is there the feeling that these devices can meet those criteria? I guess the work that you've done is moving in the direction that it seems like they're getting better.

Dr. Willette: In terms of meeting the cutoffs, they're getting better. But there's tremendous variability across devices. There's no question about that. They don't all meet those cutoffs certainly with the same degree of precision.

Dr. Caplan: The question then is whether the industry could rise to that occasion, you know, when the time really came. I guess the indication is that -- the question was whether or not the devices, in and of themselves, prohibit that. I think that's really the question. I don't know the answer to that. But I suspect that the answer is that they don't prohibit that. More refined manufacturing processes could lead to more precision around the cutoff once rules are established for that. It's always been a personal feeling that the on-site testing devices industry is doing the best job they can, guessing, much like a lot of the immunoassay manufacturers, like Roche did with the amphetamines and things, trying to figure out what the best way to build the assays to deal with a particular response or issue. The other one then goes to performance. Which it's becoming fairly clear that there have to be some performance criteria for these devices, which we don't have, because we have a lab inspection process which checks performance. If we go to on-site, how are we going to check the performance? That seems to be a fundamental requirement that's going to have to be devised and added and would cost -- there is a cost factor there -- because it's got to be by some external means. It can't be by the manufacturers themselves. It has to be by somehow the government, akin to the NHTSA approval process for breath test devices.

Dr. Bush: FDA does have a guidance document on their fda.gov/cdrh web page, with guidance to the manufacturers of these devices -- you can find it there -- trying to tighten up the performance characteristics of the various -- and very different in approach -- immunoassay on-site testing devices.

Mr. Crouch: Step three, on-site testing, permit documentation of collection. And the response is, in this regard, on-site testing is comparable to that of laboratory-based urine screening.

Dr. Caplan: Why don't you go down to whatever ones are substantive.

Mr. Crouch: Number four, which is documentation of on-site testing. In this regard, on-site testing is comparable to laboratory-based urine screening.

Dr. Vogl: I'm not sure of documentation. But the documentation, it's not the same as a laboratory based program, where you have analytical results of printouts, it's something that you can put your hands on and go back to over time. Most of these devices, they have to be read within 10 minutes or whatever, and then, somebody would have to write down what their determination is, positive or negative. But it's not something that you can put your hands over time and document what that result was.

Dr. Caplan: Do any of the manufacturers want to comment on automated reading systems? Any more thoughts about how you think it's going to work?

SPEAKER (Unidentified): Rumor in the industry has it that there is a number of manufacturers working on devices which will read the on-site test kits, trying again, as people have indicated today, to eliminate the subjectivity of the results. Those things I think you're going to see in the future. As of now, there's nothing specific on the market that we're aware of. But I think they're coming. I think one of the things that is done routinely as far as covering this documentation is recording the results, photocopying the results. Most of the kits can be photocopied. They can be photocopied and a copy made of it. And as he did indicate also that you do have to read them in a set amount of time. So that does limit if you have to go somewhere to have the photocopy made. But, as a manufacturer, we think obviously that's an issue that has to be addressed.

Dr. Caplan: Is it likely these devices would be just reading things, which is subject to the view of the operator, or could they be -- which was the theory of the alcohol DOT program -- required to have sequential numbering and documenting systems, so once something is inserted, that's it, it's going to give a reading, and you have to have a result for that? Which would allow for DOT and others who do inspections of organizations and agencies to check on that to ensure that the devices that are tested actually get in to be read and the people are not otherwise discarded?

Ms. Bernstein: Could I as a question? Do you have any idea of what the timetable is looking like in terms of some of these devices? And I'm assuming they're using some kind of computer chip. Could you comment on that?

Speaker (Unidentified): No. I'm not trying to be evasive about it. It's just, you know proprietary. Industry rumor has it that these things are available -- are not available -- being designed and developed, and a lot of the things that you're addressing is coming into play. We realize it, as an industry, that these are the issues, if there's ever going to be the full, widespread DOT blessing of this technology. So we're addressing it. Now, up to this point on on-site testing -- I've been involved in this for 12 years, starting way back with APPA, when they were starting to get these into criminal justice -- and they've progressed a long way. We're looking at them. We know that, as an industry, that DOT approval and their blessing of these products is important for us to move forward.

Dr. Caplan: Technology is there, and that's really where the question is at. But ultimately, the next step is to computer link those into some central base and track things, just like the laboratory.

Mr. Edgell: I just have a general comment. One, on your interpretation of DOT procedure with respect to looking at each sequential result of a test. I'm not sure that that's actually --

Dr. Caplan: On the analyzer. No, the ability to do an inspection and see the output of each instrument, and match that to the people, exists, because of the requirement. Whether it's being checked or not is something you might not want to tell us.

Mr. Edgell: That ability exists. I wouldn't call that an actual requirement. But the documentation itself from the laboratory side serves a purpose in that you have two additional points to reflect the quality of the test. You've got the laboratory to review the collector's work. You've got an MRO to review that work. So that documentation goes other places. And with that, can determine the quality of the test and perhaps divulge some problems that we're having. We talked a minute ago about the alcohol side is not really showing problems. It could be the simplicity of the instrument or it could be the timing of the test or it could be an indication as to what's really being done out there. So the documentation with the urine to laboratory is much more difficult to throw away. I hope I'm getting my point across.

Dr. Caplan: I think your point, if I'm hearing you correctly, is what and whether there should be external documented review of the on-site process as part of this system.

Mr. Edgell: Checks and balances.

Dr. Caplan: Because it exists today in the laboratory-based system, right? I mean that's for those who are forming the questions here. That's a question that needs to be answered. Well, I didn't think the ones that had no comment would have so much discussion, but I guess we've got to go through them all.

Mr. Crouch: The next question is pretty similar. It's a documentation of the results. And in this regard, on-site testing is comparable to laboratory-based -- the discussion we just had.

Dr. Caplan: The same thing.

Mr. Crouch: Defining testing concentration. In this regard, on-site testing is comparable to laboratory screening. I think we might want to keep in mind here what Dr. Willette said earlier, in that some on-site screening is done with instruments and some with on-site devices. Obviously, those with instruments are very similar to laboratory-based testing. Number eight, subjective differentiation of a positive and a negative. In this regard, on-site testing is comparable to laboratory-based urine screening. On-site test indicate positive and negative results and have a built-in control.

Dr. Caplan: We did discuss that.

Mr. Crouch: Number nine includes appropriate controls. Currently, all screening devices are cleared by the FDA, contain internal procedural controls. These procedural controls verify that the testing procedures have been performed correctly and take the place of controllers and calibraters used to verify successful performance of an automated laboratory analyzer.

Dr. Smith: Is that response indicative that this would be a requirement for all devices, that they would, in fact, have the same kind of positive and negative control in each individual device?

Mr. Crouch: I don't know that anyone said individual device. I think this is trying to compare it to laboratory-based testing, what quality control is needed. This is a response to that.

Dr. Smith: I agree. I think it goes back to comments we've heard earlier, that there are many devices on the market today, that the positive and negative controls are not a part. It is simply a control, if you will, that the procedure that urine has been placed, and that it's been read within X amount of time or that the device itself is functioning in terms of the flow of the sample, you know, through the device or whatever. But there are a number of things that I think that, again, in the early days, back in 1989, from the consensus conference when we were discussing this, we were discussing possible options, such as did a certain percentage of the negatives need to go on to the laboratory as a QC, for example? Was it possible to build into the device that an individual device would be a "send to the laboratory" even though it had not identified drugs as a part -- you know, so that many of the "send to the laboratory" results, you could not distinguish between whether they had found a drug analyte, a prohibited drug analyte, or whether it was just part of the QC program, and thereby that would address some of the issues of a person being identified, as a drug user based solely on what the preliminary screen, the on-site device, instrumented or non-instrumented, had shown?

I guess one of my recommendations would be that the Board really look at the variety of means of building in the control factor. It may be something as simple as if it is not internally into each device -- we are talking about a non-instrumented device now -- that then it would be mandated for what the gentleman earlier indicated that they recommend now to their clients that you perform an external control, positive and negative, at the beginning of each lot, and every 30 days. Again, that is not dissimilar to what we have done in the evidential breath alcohol arena, where the operator, the employer, whoever is administering the breath alcohol test, must perform the calibration check every so many days, every so many tests, or in some circumstances, it is after every confirmation positive in the NRC rule. I think those are things that the Board needs to look as a part of this whole area.

Dr. Caplan: Obviously, as we go through this, there are some redundancies. And this is the same question, posed a different way, I think with the same concept. So, unless there is anything new to add to that, the point is already taken.

Mr. Crouch: Training of the testing analysts, which was actually answered under the collection person. Do the analysts know the donor identity. And the response is there are several ways to set up on-site testing so the test operator does not know the donor's identity. This will depend on the policy of the employer.

Dr. Caplan: I think the next two things are two fundamental questions which might be more policy based and that we might, as a Board, either comment on, but may or may not ultimately be able to come up with an answer, other than we think it should be one way or the other, and might have go on to some policy thing. But let's have some discussion about that, if anybody has any comments.

Mr. Crouch: I think one of the things that brought this up was the cost issue. And one of the arguments was, if you have to have more than one person at the collection site and doing the on-site testing, then there is an additional cost to the people doing the on-site testing. So the argument was that maybe that's not needed, that one person could do the whole thing. Which I think is sort of a philosophical thing that needs to be discussed.

Dr. Caplan: Are there any kind of policy comments? Do people want to start off with that, to think about that? I mean these may not be technical things, as to how the tests work or whether we can do it, but policy type things, as to whether the policies are acceptable. And remembering also that some of these things very strongly impact how the labs works and how the labs -- and you are going to have to c