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 change that at the same time if you change it here.

Ms. Murdoch: To address that point first, one of the things I think we need to keep in mind is that on-site testing is being considered. We're looking at it as a possibility because it's different from laboratory testing. Because it raises the possibility of getting a quick result that, at least with respect to the negatives, can be acted on. And I think we all agree that, if it's a preliminary positive, it needs to go the laboratory. But it's different from laboratory testing. We have 72 HHS certified laboratories. We have tens of thousands of collection sites where these tests may occur. If we tried to institute the same type of laboratory-based program at each one of these, then the program will fall of its weight. It's not going to happen. That's the bottom line. Let's have a reality check here. The other thing that we need to keep in mind, is there's no particular reason why we have to make this exactly parallel at the laboratories. If it ain't broke, don't fix it. If it works having the analysts blind to the donors' identities at the laboratories, then we keep it that way. But I will point out that in the non-regulated programs the laboratories know the donors all the time. And it's not an issue anymore. Maybe it used to be, but it does not appear to be anymore, when tens of millions of tests are occurring every year. People don't know that Joe Smith had a drug test, or care particularly. At least that's been my experience. With respect to the donor being known to the analyst, cost was a very big concern in terms of having -- we'll eventually have over 1,200 collection sites -- having two people or potentially three people involved in the collection analysis is just not fiscally possible. There's also a concern of losing control of the specimen. You lose the benefits of being able to use a logbook and not having to put every specimen under chain of custody, because custody doesn't switch. Why put it under chain of custody if you go with another analyst?

One of the concerns that we had, as well, when we were looking at devices, many of the devices are temperature sensitive. They increase in their rate of false negatives as the specimen cools. And that was something that we did not believe would be efficacious for the Postal Service, to increase our rate of false negatives. To the contrary. So looking at all of those both technical and policy concerns and legal issues, we decided to go with the donor being known to the analyst/collector being the analyst, as well. One of the things that we did early on was we avoid the use of the term "positive" when talking to the donors. Our collectors are trained, it's "further testing needed." And that's the way it's presented to the donor. All the materials refer to the specimen as "FTN, further testing needed." And that seems to have helped actually. That little bit of semantics seems to have helped in those cases where people's specimens do need to go to the laboratory. We haven't instituted that yet, because we didn't have enough specimens going. But now we will. I think it's either 3 or 5 percent. I'm not sure which. It won't be exactly -- it won't be random entirely. We will identify sites to send specimens in. And we're doing a quality control check on the collector, sending out spiked specimens. But, remember, any time you do quality control checks, you have to have a urine specimen, spiked with a known quantity of drug, to do the analysis. And that's costly. Blind specimens are costly. You need to somehow balance the needs to be reached. I agree absolutely that it needs to be done now. Absolutely. Somebody has got to watch the manufacturers.

Mr. Stephenson: One of the things that would be different in looking at this would be, is this a batch mode test, you know, an on-site test? Or is it an individual test, like a non-instrumented test that is in fact by the very nature of it run one test at a time? I think that's an important distinction. Second, is the donor watching as it's done? I know in a lot of the on-site testing, there is perceived a value in having the donor actually watch. I know, from work that we've done in the criminal justice system, there is a distinct advantage in having that person watch as that specimen goes through the chambers and so forth, and the slide, and come up either positive or negative. There is a lot that transpires during that process. If that's the case, and the person, the donor, is watching, that is actually a second person. And that's actually an additional safeguard in that process, too. One of the most interested persons possible is in fact sitting there watching it. If not, then that's one of the things that you need to consider for on-site safeguards.

Ms. Murdoch: We require the donor to initial the log book that the test results were accurately recorded in the logbook. Not that he necessarily agrees with it, positive or negative, or FTN or negative, but that they were accurately recorded in the logbook. And if the donor won't initial, the test is done and the person is not hired. And they know that up front.

Dr. Caplan: Do the people watch the test?

Ms. Murdoch: Yes. They sit there.

Dr. Caplan: And they see the actual result per drug?

Ms. Murdoch: Yes. And it's recorded per drug.

Dr. Caplan: Further test needed would be dependent upon a positive result then? They would see which drug it was?

Ms. Murdoch: Right. And it's recorded by drug.

Dr Vogl: Does that include if the collector or the analyst can't call it positive or negative, you just can't make a decision, and they just automatically have a further need for testing?

Ms. Murdoch: In cases of questioned results, our protocol is that it goes to the laboratory, "further testing needed." That's why we use the term "further testing needed" because that's what it is. It's not positive. It's further testing needed.

Mr. Bush: On the subject of second analyst, assuming the positives, or presumptive positives, would be sent to a laboratory for confirmatory testing, in that particular case, the second analyst I would suggest is really not needed. I would also say, though, that if there is some concern that the primary or the first analyst misdiagnoses or misreads negatives, either accidentally or deliberately, then that may be appropriate. I don't know whether that is a concern or not. If there is a concern about it being done deliberately, then it becomes more important that 11 -- factor 11 -- that there is no, repeat, no relationship somehow between the analyst and the donor.

Mr. Crouch: I think the devices vary considerably in their subjectivity. And in view of the studies we've done, we've had two people read the device -- and I don't have a percentage, but apparently a good percentage of them there was a discrepancy between the two readers. Again, it's device dependent. I think it's possible for a reader to look at one and call it positive and a second person to look at it and say, I don't think so. Manufacturers are very specific, if it's look negative, it should be called negative. But it still is a subjective call by the reader. So I think that's an important issue when talking about having a second person look at it. The other thing is someone can always make a mistake. They can look at this thing and say, well, it's positive. But like in the laboratory, there's a certifying scientist who goes back and reviews that and says, no, it isn't, or yes, it is. The other issue is, in my experience with these devices, they're usually quite sensitive. They may be detecting drugs below the immunoassay screening cutoff. They might not actually meet that criteria, even though they test positive. The potential for a sample that is less than the immunoassay screening cutoff to go to confirmation and test positive I think is certainly there.

Dr. Caplan: Dr. Willette, do you have a thought about that based on your studies?

Dr. Willette: No, I agree entirely with Mr. Crouch. That's been our experience, as well.

Dr. Caplan: So what you're saying is that, in the current practice, the discrimination favors a positive over a negative?

Dr. Willette: No, it's device specific. Some devices do detect drugs below the claimed cutoffs. I mean they're more sensitive than they espouse to be. But in discriminating positives or negatives, there's a lot of equivocal results, which we try to evaluate by classifying them as borderline results and see what impact they have on the outcomes. They don't impact the overall accuracy, because if you accept borderline positives as positive, you end up with more false positives and less false negatives and the accuracy stays about the same.

Dr. Caplan: I guess that's the question, just thinking back to your presentations. Are you asking that they are more variable and therefore more will go?

Mr. Crouch: I'm saying, since you don't have an objective cutoff like you have with a laboratory or an instrument-based analysis, that it's subjective, that's one issue to think about. And the second issue to think about is the reader can always make an error. I mean people look at immunoassay data off an instrument and call is positive when it should be negative or they make a clerical error. So there's always that potential. And I think it should at least be discussed by this working group.

Dr. Caplan: Yes, the second reader.

Dr. Vogl: If you go back to what the industry is doing and they recognize the need to convert this colorimetric reading to some analytical result, and they have these portable readers or whatever available, then this whole issue may become resolved.

Mr. Crouch: Part of it goes away. The subjectivity goes away. But the potential for just a clerical error by an analyst, that happens in laboratories all the time, does not go away.

HAIR TESTING DISCUSSION (AFTERNOON SESSION)

COL Jacobs (DTAB member): I have 20 handouts on what we have and the minutes of the meeting. The first two pages are some of the factors that we have been looking at. Unlike some of the other things that have been apparently discussed earlier, this is really an easy subject. There is no controversy and no problems. So I shouldn't take too much time at all.

Actually, let me also say that we have had one meeting of one day. When you get to page 3, you'll see a lot of areas that say "needs discussion." They need discussion. We're going to hold another meeting January 7 and 8. Anyone who is interested in attending, please come see me. I'll give you my phone number, my E-mail, we'll see how many we can have there. We're holding the meetings in San Antonio. I have a room we can use. And I'd like representation from anyone that wants to be there or anyone that has anything to say or add to this. I don't have money to get you there, however. We'll have to work on that if that needs to take place.

Some of the things that we discussed and I thought we had reached agreement on at this meeting later were re-discussed after the meeting. And some of those who I thought had agreed decided they didn't agree and wanted to either re-discuss or change some of the things that had been cited. To be specific, it was the amount of hair that was needed to do a test. We first discussed we needed enough for a screen, a re-screen, to test, to retest, some to be stored away to be tested at some other lab.

When we looked at what the minimum amount was we tried to go what would be the minimum amount for the lab that needed the most. And if my memory is right, it reached something like 150 milligrams, and actually maybe the discussion was higher than that at the beginning. And they decided that was quite a bit of hair, especially for someone who had very little or if they had pretty short hair. And that may be readdressed and re-discussed.

And I don't really think that it would be beneficial for me to go over this whole thing right now and say what we haven't decided unless somebody wants me to. I think it would probably be much better to go over some of the other areas that we have reached some decisions on. And when we get to a place where we have really something to say, then I can present that.

We basically followed the same format as you see on page 3, and going through B-1, B-2, E, G, H, whatever, listing the questions and answering it or saying it needs discussion. Some of the things that we are going to be discussing at the next meeting are -- and I'm just the moderator -- we are going to discuss, is there hair color bias or what other issues are there that we need to reach agreement on? What are wash kinetics? What can we agree on as minimum standards?

And we need to either reach 100 percent agreement and acceptance of the people there to say this is what we all can agree to -- if there is still some controversy, if there is something that cannot be agreed to, we will state the positions that individuals have, whether that is one view, two views, or six views. And then I am trying to get them to propose a series of experiments that can determine which of those choices are best.

If we can't reach agreement, that's going to be listed. And we'll just say here are some experiments we propose to answer that. Right now, my feeling is that on hair color, some say that there are enough samples out there to look at, to say we have X number of samples out there, and only a certain percent are positive for various drugs. Therefore, we have done that.

Others have said you don't really know where those hair samples come from, you don't know the population they're from, and we will try to list all those differences when the time arrives.

Anybody have any questions or suggestions?

Mr. Stephenson: Thank you very much for taking the time from your Army duties as an inspector to be here for this meeting today. We know that it calls for you to reprogram your day. Second, I would like your opinion as to what you think could be done as teaching examples from your experience for the other small working groups. For instance, I know that in your second meeting you have asked that we travel some known critics -- and by critics, I don't mean that in the negative sense -- but those critical reviewers of the science and of the practice of hair testing for your next meeting, so that they can become respondents to the things that are going on.

What would you suggest we do for other small working groups, and for your next one and the ones in front of that, that could help them as we set them up? Because we are not going to let you guys continue on by yourself out there. We're going to have to support these other groups, too.

COL Jacobs: I really didn't see problems with the group over there. There were some disagreements. And I think that the discussion went well. There were a few times that I felt they needed to be directed, to say what is the real question here, what are we trying to answer, and just focus back on, you know, pick a letter, pick a number, what is the question being asked here. We don't need to go into other issues at that time. If you can answer the question, then let's just answer those questions.

It could also be that this next time around, if we have more of those so-called critics or more of those different views, it may be more difficult to reach any answer. But I think, don't dwell on a specific question too long. Because, if you can, come back to it later or answer as much as you can.

There are going to be some that we will not be able to answer, we will not reach agreement on. And I think at that point we're going to have to lay out, again, what each side feels as truth or fact and what the other side feels is truth or fact, and then we are going to say, now, how did you prove A and B, and list how each one thinks they have proved A and B, and then it may take this group or somebody to go out and get someone to actually do the experiment, A and B, and see which one is the right answer, or maybe they both are.

Dr. Caplan: What we thought we would do is, since you didn't really want to comment on some of these and we have the two other documents which were circulated which have some comments, is I am going to, just so that we get a broader feel for some of these, ask Denny Crouch to read some of those which are out of the other documents. But I need you to tell me where the groups might be on that and whether that's a worthy thing to talk about. Because there were the two presentations and two documents that had a number of comments from before. And you have addressed some of these. So rather than do it in a total vacuum, we will just try to maybe spend the next hour or so checking on those, and seeing if those were considered and what you did. And if that's an area of total impasse, maybe we'll leave it alone.

But if it's an area that can be enlightening here, then maybe we will ask for a little bit more discussion. But we do need you to kind of, after they say that, tell us where that group is. Which is probably in some of the pages here which I haven't really looked at. Okay. We will see how this goes. And we will maybe spend an hour. And it might be worthy then going back to the on-site. Okay.

Mr. Crouch: In the first document labeled "Hair Testing," in the opening paragraph they talk about LC/MS, GC/MS, LC/MS/MS, which is different than what we're doing now. Did you guys go into that?

COL Jacobs: What's mentioned, we talked about it. I think that the consensus was that if we are going to go into these other things, then we have to get some kind of standards for going into other technology and into getting approval if we're going to go somewhere else. I think they'd have to define why they want to.

Dr. Caplan: So you're saying then that the feeling of the group was that GC/MS technology is -- (off microphone)?

COL Jacobs: Some of the group.

Dr. Caplan: Or GC/MS/MS technology?

COL Jacobs: Some of the group, also.

Dr. Caplan: Does anybody have any comments or questions on general technology, as to whether or not there is adequate technology there or whether other technologies would be necessary?

Dr. Vogl: I would suspect perhaps with oral fluid or sweat. There may be a need to look at some other analytical techniques, depending on the testing concentrations that we're interested in. This could be what you're saying is that the guidelines now restricts it to GC/MS. And you may need to broaden that and allow or specify the use of LC/MS or MS/MS.

COL Jacobs: Yes, we need to look at possibly -- and maybe the other technologies out there for looking at testing may want to look at some these others also, either for speed or cost or several other of those issues. One thing that this will impact on that we really haven't addressed, that I tried to ask them at these meetings are, each of these labs -- or many of these labs -- do not agree on what they want to report, what level they want to report. And I think we're going to have to have something with some of the others also. What level are we reporting and what does a hair positive at a certain level as compared to things that are already accepted. I am under the feeling that many of these hair testing are going down to much lower levels, and may be approaching level of detection. And is that the direction we want to go? And if then we say yes, that's the direction we want to go, we want to say it's there. Then dependent we want to look at other urine testing, for example, and say, do we want to go to a level of detection for urine? That's just a question laying out there. I'm not saying we do. But we need to relate somehow with sweat, with hair and with urine, what do the different levels mean.

Mr. Crouch: One of the major differences between the two documents was the testing cutoff concentrations for the initial test. I think this is on page 8 of the longer entitled document and page 3 of the one titled "Hair Testing." There are considerable differences in both the screening and confirmation. Was any consensus reached about where those should be?

COL Jacobs: No. Again, different layouts have different levels that they can go to, and depending on if we want to go to different levels of MS/MS or LC/MS or combinations thereof. Maybe we can't even go lower. We need some guidance or somebody needs some direction here. If this is going to be accepted for government workplace testing, it might be different than pre-employment that some of this is used for now. Where it may be important to somebody running the ABC Corporation to say, well, we want to know if there is a level of detection; we don't want to hire that person. That's different than what I think we're looking at and doing now. And this is where we are now. But I think we need to get some other people in there. And I don't find this acceptable yet, until someone tells me what this means in relationship to other testing that's already acceptable and going on. The THC cutoff was agreed upon, for example. If we say, cocaine, we did agree that everybody can do and it's acceptable to do the .5 nanogram equivalents per milligram, that's fine. If they all want that and I can put that forward and say everybody agreed to it, but my question still to them is, what does that mean and how does that relate? Is that a question that group is supposed to answer or is that a question they are supposed to say that this is what they agreed to, or somebody else decided what that means?

Dr. Caplan: I think the question that you are -- the information sought from the working groups is their best average buying in terms of this idea about this. So the question here is, is there an idea about what cutoff concentrations are, not whether we can reach them or not necessarily. If somebody can only do a higher or a lower number, that's not an argument for it. The argument or the question is, at least in my mind, whether or not there are adequate concentrations which can be agreed upon, which will detect the population with some degree of significance or completeness that's at risk?

COL Jacobs: I agree with that. And I think that those numbers can be reached. I'm not sure if we had our 100 people out there and had positive urine and positive sweat and positive hair that we would be able to correlate those numbers with any degree of accuracy.

Dr. Bush: I'm hung up on your word "correlation." Because I guess my bottom line with all of this is interpretation of what the result means, independent -- I mean you may not be able to link them all -- but when you have three different results from three different specimens, can you interpret them concerning passive exposure, concerning a particular ingestion, or exposure phenomenon? We're asked that many times concerning urine drug testing. You know, is this result consistent with this particular exposure pattern, projected exposure pattern, purported exposure pattern? I don't know that the results have to be correlated necessarily, but understood as to what they include and exclude.

COL Jacobs: I think, based on that answer, we can look at it. And it's an independent thing that won't be correlated. And they can look at it. And I will try to get focused on what does a level of -- you know, pick a drug and look at each drug, and say, where does passive inhalation come up, where does something else. But that's not exactly -- now if you look at urine separately, you know, our cutoff levels and passive inhalation of those may need to be re-looked at. I mean if we're looking at one, we better look at the other.

Dr. Bush: Absolutely, and we have. That's why we're looking at another study of passive exposure to marijuana metabolites.

COL Jacobs: So maybe those things that are of concern, we will be having answers that may correlate those different --

Dr. Bush: In the meantime, we've got to know what the laboratories can detect. You know, early on in the history of urine drug testing, we looked at best available technology and what could be done. That contributed a lot to the early establishment of the guidelines, what is possible in the laboratory and what it means. And the two questions, while separate, go together.

Dr. Caplan: That's something that can be addressed readily but has not been comprehensively looked at. Is that the answer? In other words, the first question is, what should the cutoff be? Second is, can we achieve that analytically? And the third was, do we need better techniques to do that -- better than GC/MS?

COL Jacobs: Of the numbers that are here, there was agreement that those numbers can be reached with the group that was there. So other individuals who were not there may have different feelings on numbers that should be there. And I think we'll have to address those at the next meeting, to see if what the first meeting came up with is acceptable to all.

Dr. Sample: Were these numbers LOD-type numbers for those people that were represented there? Or is the minimum reportable? Or is that something they all felt was somewhere above their LOD?

COL Jacobs: As I recollect, they all felt that this was above their LOD. But I can't say that for sure on all of them. And I don't know how far above LOD.

Dr. Bush: Can you pose that question back to the group?

COL Jacobs: Yes.

Dr. Bush: Conceptually, just taking a look at routine analysis in a large number of laboratories. You don't want to flirt with that lower quantitative edge. You need to have some play in that for reconfirm-type situations. And the cutoff then needs to be established, just as in the urine drug testing program. Conceptually, this has done us very well. And so have the cutoffs established at a level, at a concentration, above. And I say significantly above, but I don't know what that word means in the context of hair testing. So let's go above first, any limit of detection type testing. But we need to know those numbers, too, limit of detection. Because we don't know the difficulties that might occur if you have a hair specimen retested in a separate -- a different laboratory. You always need a little window of detection, analytical variability.

Mr. Stephenson: The issue that you have raised a couple of times in your comments, about of those that were there at the meeting. A concern with going back to a group would be to make sure that you have an inclusive group that has access to laboratory data from a different testing laboratories, to pose questions of where the standards are and where the LOD issues are. Is there any way that we can help make sure that there is a good inclusive group that's available for this? Was it just short timing.

COL Jacobs: It was the issue of we needed some jumping-off place and a starting point. And I think we have that. And HHS has been working with me in this group to get others involved in the next go-round. And I think we do have a broader group that will be at the next meeting. Again, it will be open to anyone here. If you have any suggestions of anyone you think should be there or you want to be there, talk to Dr. Bush or Dr. Vogl, or myself and we'll try to see that either you are their or your views are represented.

Dr. Caplan: One charge back is to essentially look at the cutoff and look at the LOD and look at whether what technologies are -- whether that can be met today and what technologies are needed to meet that. The next thing down there.

Mr. Crouch: There were a couple of comments about retests and splits. So maybe we can just reiterate what was sort of decided. For example, on retests, the testing of the original specimen sample a second time, which is a little different definition of what we're used to. And on the other document, it says the -- (off microphone) -- a custody control form should be used rather than a 7 due to the fact that it's almost impossible to collect enough hair for a split. So maybe you could reiterate sort of what came out of that.

COL Jacobs: That all had to do with the amount of hair that was being collected. And if we have -- relating back to urine again -- like you would have two 30 mL samples that are enough to do the amount of testing that you can get done with that sample. If you start doing that for hair, you're going to be maybe possibly ending up with a bald spot on someone. That may not be too acceptable to most people. It was thought, what is a split sample going to be? Or is a retest of the original sample acceptable? Or because hair takes so long for that drug to grow out, if you can take the sample and get the testing done within a week, is it any problem to say, we can go back and take another sample to confirm the second one? I think these are still all a variety of issues that we can address. But it was thought that rather than have the split sample, that you should have enough in the first sample to do the retest, either in the original lab or at a second lab.

Dr. Caplan: We got to split specimens mostly from the government approach and the need for individuals to have some check on the system. Maybe someone from the government side can tell us whether it appears that that's an unequivocal, essential element or whether a retest of the previously submitted specimen would be adequate, as an adequacy issue.

Dr. Vogl: As far as the Mandatory Guidelines and the Federal agencies, we still have a single specimen collection procedure for Federal agencies. They can elect to do a split specimen collection. On the DOT side, I believe four of the six modes use a split collection procedure. There are still one or two that are permitted to do a single collection. It is, in a way, optional.

Dr. Caplan: I guess we feel it's a policy issue. If we define a split as the specimen, you'll retest. In other words, a specimen came into the laboratory and then was made available to the donor but wasn't actually an independently secured specimen, for the donor's purposes only, whether that would continue to meet this requirement for this feeling of, you know, protection for the donors. Coupled with the fact that you could go back and possibly collect --

Dr. Vogl: We think it could. Except one point is that the entire specimen that's collected is used for that first analysis or reporting out, right?

COL Jacobs: No. We were trying to get the numbers up high enough that there would be enough left for that retest.

Dr. Vogl: But right now, one view, they use the entire specimen. And if there's a retest, they collect another one.

COL Jacobs: That was one view there. But we tried to get the numbers up to the level where there would be enough for the retest.

Dr. Vogl: You would only use, say, half of it on that person?

COL Jacobs: With also the option that may again be, because hair grows slowly, that if you go back a week or 10 days later, it should still be positive. Unless somebody shaves their head or something.

Dr. Smith: If I could just address a couple of things. One thing is that there are increasing numbers of States that are -- for workplace testing -- that are making requirements for some kind of split specimen technology. Dr. Sample and I and others are involved in the athletic testing business, where a sample A and a sample B is an integral part of those testing programs. And the one thing that I think is important is that it's not so much whether the specimen was collected at the same time, but the laboratory that does the first analysis cannot have access to the split. So if you're collecting enough hair, for example, it would have to be packaged in some way that the laboratory that has done the first analysis and confirmed it as positive had no access to that specimen to in any way change it or in some way affect the outcome of the second opinion, the second independent analysis.

The other thing I'd like to mention, in terms of coming back to the person to get the hair sample -- and these are going to sound stupid, but very practical considerations -- is why wouldn't I shave my head or get my hair cut to a half-inch or an inch length, than coming back to get the sample, you would in fact not be able in most instances to repeat the same kind of segmented or other analysis. And I think then you run into a series of questions as to whether that really is doing what you intended to do.

Dr. Caplan: That's another adulteration question of sorts. I mean you adulterate the source of the specimen, and therefore you can't reevaluate the test.

Mr. Thistle: The lab I work with does both repeat testing and, if the client wishes, split specimen testing. It requires more hair to do a split specimen test. But with the ability to repeat the sample, I think requiring the split specimen with hair is actually imposing a urine deficiency on hair testing. If you had the ability to go back and take a second urine test, certainly that would probably be the more preferable way to go. You have the ability to go back and take a second hair test that should replicate the same sample. If someone comes back and shaves their head in the meantime, that might give you an indication of something there.

COL Jacobs: I agree, it would give you an indication.

Mr. Thistle: I think it might give you an indication of something. But also, you still have the first result. You have the repeat of the first result. And, again, we do in fact use split specimens. We find it unnecessary. And we have clients that want it. I think it's unnecessary. You have the ability to go back. We have not, in 10 years, had the situation of people going out and shaving their bodies. We haven't had it. Well, you MRO hair testing. How many people have you had come back on a second test with a shaved body?

Dr. Smith: Again, I think it depends on, from a policy perspective, whether you are going to permit the use of alternative sites. And I've read some of the documents here today, but I'm reading the one here for the first time, so I apologize at not being thorough. But that's the other issue. If a person has gotten a haircut and doesn't have the same hair sample available, then do you authorize the taking of axillary or pubic hair? And as I understand it -- and I'm not a scientist in this part -- there are differences with regard to the actual analysis that's conducted in terms of the rate of growth and other things because there is a difference in the matrix.

Mr. Thistle: But you already have the result from the first test from the back of the head. And you're looking now for backup information. This is someone who makes a claim that you have a sample mix-up.

Dr. Smith: But that is a policy -- you know, there are some policy considerations, whether we would opt -- you know, whether you'd want to go to the point of then authorizing the use of body hair.

Dr. Caplan: I think the question, then, to go back to the group, which is what we are trying to I think redefine, is what your group has done and what it stills needs some information on, is what is the practical and scientific ability to get specimens and follow which protocol. We need to refine that.

COL Jacobs: Exactly. And I think this may be one where we may list, here is one possibility, here is possibility two, here is possibility three, here is four. You tell us what's going to work best. If we're going to have some guidelines in this program, these are the four things that could be done with these, with hair testing.

Dr. Caplan: And I think that's a legitimate thing to do. For you to write whether they can be done, what is needed to do it, and then that kind of issue will come back to the Board, that some will be scientific, some will be policy.

COL Jacobs: And the other issue that I think there was some discussion at length, and maybe some answers in here that will be discussed more, is how do you a blind quality control of hair. And if we're trying to do it as close as we can, you know, you're going to have some source of human drug users that produce quality control samples. When you make some of your standards and controls, you can pretty well tell, if you send it out to all your labs, they better be very close to that because you know what it was. You can test the sample to determine what it is, but that's a little different than making it up and testing it and confirming that it is. This way you will only be testing the hair, saying it is at X level, and then testing the labs to see if they also get X level. If that's acceptable, that's fine. But it will be a little different than what we're used to. And we are testing some drugs that might be more difficult to get enough quality control samples to do a program on a large scale. I don't know. I don't know how much PCP hair is available out there. I hear animals. We talked about animal studies, and is animal hair the same as human hair? And can we do that? And can that interplay? I don't know. When I was at Fort Meade, I suggested going to the Laurel Race Track for a negative urine, and that didn't go very far.

Dr. Vogl: On the blind samples, if you have drug users and you get enough hair, it wouldn't be submitting 100 centimeter lengths of hair and splitting. Would you grind it up to try and make it a uniform concentration and then split? Would it be from real hair? Is that the idea?

COL Jacobs: I think that would be preferable. I think everybody agreed that that would be preferable and most identical to actual hair testing as to get actual hair positive, to test their system. Can they find it at these levels? And are the labs on the same level of reporting? And do they get the same answer? And then they will also need to be tested the same way that we are testing other samples, with ephedrine or pseudoephedrine or soaking hair. Or can wash kinetics work? Can anyone create a hair sample that takes up enough of this drug to say there was -- you know, that A Lab's wash procedures are not working? We've got a lot of work to do.

Dr. Caplan: Were there other comments, Denny, since we got off that topic, that were in there, in those two documents, along those lines?

Mr. Crouch: Yes. The other one about the use of human hair had to do with performance testing samples. And there were comments in one article that they also should be from human hair. Which, again, I think needs some discussion due to the availability of those samples and the fact that they would have to be pretested and pre-analyzed. It's going to take a lot of hairs to do that.

COL Jacobs: I agree.

Dr. Caplan: Certainly we're not going to solve that here now. But there is certainly another issue that at least we know about and we need to elucidate on more. Which is that concept of how to do both I guess internal lab and external lab PT with specimens. And certainly we need a technical recommendation on that.

Dr. Sample: As we are talking about adequacy or quantity of hair samples, one of the questions I had was the issue of rescreening. As I look at the document that you prepared and gave us today, it appears that the group that got together agreed that yes, that can be done. But was there any in-depth discussion that you can share with us regarding that? Because that obviously is going to have an impact on the availability, ultimately, of specimens for retesting purposes.

COL Jacobs: I think that that is the issue of how hair needs to be collected. Can you do a retest? Yes. Can you have enough for a re-screen? Yes. Can you have enough for the split sample and the retest and the retest of the split sample? Well, you end up with a bald applicant for the job, but you have your answers.

At what point -- and I asked this because I don't know -- at what point, if someone were to take 100 milligrams, 150 milligrams, what size patch is that off the back of someone's head that has relatively short hair? And you get up to a point where it probably is more than you'd like to see. So we tried to back off to the minimum amount of hair that it took. And rather than get into that, there was an agreement reached at the meeting that was torn up after the meeting, after others decided that that might be too much, and they could actually do less. And I think we will be discussing exactly how much -- what is the minimum amount of hair required for a screening. Do you require a rescreening? What if the first screen has a problem? They do occasionally.

Ms. Murdoch: Would there be any way to prioritize and analyze the analysis to test first, let's say, for marijuana and cocaine, and for the other drugs, so that you don't use as much sample up front? If you get somebody positive for one of those, who cares what the other ones are? If a negative comes back, then you go to the other ones to make sure you've got a negative across the Board. It seems to me that that might be a way to reduce your sample size.

COL Jacobs: I can bring that up. That might be a good idea.

Dr. Caplan: Okay. Let's go on to another one. Is the question generally one about whether a wash would or wouldn't be necessary in the process?

COL Jacobs: The discussion went -- this was one where everyone knew that their way was the right way and the other way was not the right way. And I said we need to look at minimum standards. And I suggested, and I think it was pretty well agreed to, that the laboratory must have procedures in place that, when tested on test samples, can come up with proper answers. In other words, they can do whatever wash procedures they want, but they're going to have to be certified, and they're going to have to have samples sent to them to prove that their wash kinetics are working.

And if their wash kinetics, whatever they be, are working, then that's kind of like the test samples we send now to labs and say, can you give a positive amphetamine when we send you ephedrine? Can you sort your opiates out? This one is, can you tell a real positive sample when you get it?

And rather than go down, we looked at this as you can use different screening reagents and you can use different confirmation -- solid phase or liquid/liquid, or you can do different things in other lab testing, so why would we dictate this will be the wash procedure. You don't say this will be your cocaine extraction procedure. So they just have to demonstrate that they can answer these questions.

Dr. Caplan: Now, was there a general feeling that that's acceptable in that group?

COL Jacobs: Yes, that was acceptable. We did not address how they are going to specifically be tested to answer these questions. But I think they all felt that some test program, sending them samples, needed to be put in place.

Dr. Caplan: And that the methods are akin to -- the methods could vary as long as they were performance oriented, number one?

COL Jacobs: Correct.

Dr. Caplan: The only other aspect of the so-called kinetics would be whether or not those procedures do anything with regard to interferences or detection of passive inhalation?

COL Jacobs: Yes.

Dr. Caplan: That's being considered, I assume, also?

COL Jacobs: Yes.

Dr. Caplan: I don't know if that was in there later, but it probably is. Okay. Anybody else have any other comment on that? I don't know that we can go too much further.

Mr. Crouch: One thing that was mentioned on page 5 of this document that we're talking about, about quality control and quality assurance, it says that positive controls for their digests or their extracts, which was pointed out to me to suggest that maybe you don't have to run the control each time, but that you can do a digest and save this digest and run the digest, so that perhaps the processing is a little different for a quality control sample or a calibrater than it is for an actual sample. Is that discussed?

COL Jacobs: I don't recall discussing that. I think that it would look something like we prepare our quality control samples now to go as long as we can so we don't have to make them every day. And we freeze them. And I don't see why we couldn't do the same thing here with hair, and prepare this digest and have it ready to go, to put in whatever testing we're doing here, and have it kind of -- positive controls pre-prepared.

Mr. Crouch: But wouldn't say that you could pre-extract your GC/MS controls now, and it wouldn't have to be processed with each batch?

COL Jacobs: I don't think that they're going that far. I would not agree to that. I think that each -- I'm not sure what he means by "extract" here. I did not assume that that meant the extract, ready to put on the GC/MS, but an extract of the digest, to remove the hair, but have the liquid portion ready for the extraction process. But I'm speaking for someone else, and I don't know. We will address that.

Dr. Caplan: Again, the question is, for control purposes, can something other than an actual specimen be used? I think that's what they're asking, whether it can or can't. Is there something else on that?

Mr. Crouch: These were most of the things that were pointed out to me to discuss. But obviously --

Dr. Caplan: Does anybody else have any comment that they want to add on the general control situation? Any other issues in there, in the other document?

Dr. Bush: Concerning that control, just always go back to what a control is. It controls an entire process. And so, not knowing exactly what was discussed in that working group, do we go back to the process of taking the sample, weighing it out, adding the internal standard -- however this is done -- and then a chemical digest, an enzymatic digest, what if the temperature was off -- and the controls for all of that let's you know if all was well throughout that entire process. This may be out of ignorance, not knowing the process detailed, but I have real questions about taking something that's halfway along, three-quarters the way along, a third the way along, that's already been prepared, and then inserting it as a control over the entire process.

COL Jacobs: I don't recall we even discussed it -- it's on the list.

Dr. Bush: Thank you.

Dr. Caplan: This is a little different than what we're doing for the on-site, but are there any other issues which anyone wants to bring up to ensure that the working group adds it to its next meeting and begins some discussion about it that probably wasn't mentioned up until now but is on someone's mind? And I'm sure they have a lot of things that Aaron mentioned or might not have mentioned.

Ms. Murdoch: J-2, the one that we has a draft version, page 4 or 5. It's the minutes from the meeting. It says the group formed a consensus that alternative medical explanations, which may explain a positive result, include repetitive low doses of drug, including imperceptible doses due to living with a drug-using household member within the time period. Is that saying that an MRO should accept a passive exposure explanation as being an alternative medical explanation? Is the consensus of the group that passive exposure is, in point of fact, possible?

COL Jacobs: Yes, as I recall, there was some discussion of some this, that many there, or some there, said there are situations where someone can live in a place and be exposed constantly to enough that they are going to get a positive result.

Ms. Murdoch: It seems to me that perhaps maybe we should set the cutoff level so this explanation is not here and we don't have to worry about that.

COL Jacobs: That sounds like a wonderful idea.

Ms. Murdoch: Is that possible?

COL Jacobs: Well, that would be my suggestion.

Ms. Murdoch: My question was, can the cutoff be set high enough that we didn't have passive exposure, passive ingestion, arguments anymore. Can that be done in the hair testing?

Dr. Mitchell: Those experiments have never been run of an individual who is living in a household where there is continuous exposure to something, say marijuana smoke or something like that. Those experiments have never been run. All that we've done is those that are based upon studies mainly, in trying to determine whether or not -- I mean based upon those, the levels that are required -- but I don't think there's ever been an actual experiment run or any data to that effect.

Dr. Caplan: Is that question as formed something that's in front of your group? In other words, you talked about the cutoffs and all that before, about the cutoffs, and we did mention this, the cutoffs as they pertain to passive or some other kind of inadvertent exposure. Is that the same question.

COL Jacobs: I'm not sure that this was just specifically under medical review officer alternative medical explanations. And this was listed as a possibility of an alternative medical explanation, that, under discussion, it was felt that a one-time situation at a rock concert, you're not going to have a positive hair sample. And then the next part was, well, what happens if someone lives with? And I think more than a few felt that it was possible to reach a point, if you get enough constant low-environment doses, that you're going to be positive. And so that's why it was listed under J-2. That was not related back to moving the cutoff up to avoid that. Again, that may require some study being done.

Ms. Murdoch: Is the exposure occurring from -- is it being inhaled or is it being, you know, incorporated through the scalp, or do we know?

COL Jacobs: I don't know.

Dr. Vogl: Well, it's very general. It doesn't say what drug it's force. Any drug?

COL Jacobs: I just think that if someone said that this was a possibility under a circumstance, and it was listed here under J-2 as an alternative explanation, it's something that needs to be addressed.

Dr. Bush: Clarified.

COL Jacobs: Yes.

Ms. Bernstein: I would say that if you allowed things like that for an alternative medical explanation, it would make poppy seeds look like nothing.

COL Jacobs: That's right.

Ms. Bernstein: I mean I don't know what kind of testing program that you can have.

Mr. Thistle: We have testing programs right now -- the very one that we have in place now, you can't rule out this for a urine test either. Repetitive low doses of a drug, if we look at Dr. Cone's studies, 2 milligrams of cocaine can cause a positive. If someone here.  Well, how many is it?

Dr. Bush: No, I don't have the article with me. But I can send you a copy.

Mr. Thistle: Or the studies that we've seen with the higher levels of marijuana side-stream smoke that in fact can cause a positive. We can't eliminate that now.

Ms. Murdoch: No, not in a situation where somebody would be living day to day. And I don't think that it's ever been shown that this kind of low-level use would produce any kind of positive. All the tests were, you know, the Volkswagen Beetle/telephone booth tests, as I call them.

Ms. Bernstein: Mr. Thistle, are there existing hair testing programs where this is an accepted alternative medical explanation?

Mr. Thistle: No, I think that the studies that we have indicate that normal contact that a normal person would have, like an undercover narcotics officer or those kinds of things, show that it's not an issue. I think -- and this is just from talking with some of the participants in the group, and again, I have a difficult time knowing what was said, because I wasn't there -- but it's my understanding that this had to be more of a realistic -- that this discussion involved a more realistic approach to, can we rule this out completely? And the answer is no. I think there's probably a lot of people in this room that cannot rule that out completely for a urine test either.

Mr. Crouch: I think we are talking about two different things here. The studies that have been done on passive exposure in urine detection were done with acute doses. What we are talking about here is a chronic dose over time that accumulates in a specimen that's collected at a later period in time. And those are totally different studies. It's a totally different dose response study. If those are out there and can be provided, they would be very helpful in interpreting the question that we are working on now.

Dr. Caplan: I think this, again, is something we need more information from the working group, on the one hand. And in the end, it may be that it's a policy decision, on the other hand. I don't think we can come to the answer now. I'm not sure the data totally exists. And if that's the consensus, that's an alternate explanation, then it might not be worthwhile to do this in a program of this nature. So there are policy things that are going to probably follow some of these questions, as well. And we can't answer that one today.

Mr. Schoening: Back in 1991, I think it was May or June, during the time of the Marion Barry trial, the FDA published in the Federal Register the fact that radioimmunoassay for hair was not an accepted procedure. Has that ever been reversed?

Dr. Caplan: Who published it?

Mr. Schoening: The FDA.

Dr. Caplan: Well, that may be correct.

Mr. Schoening: Has it ever been repealed, though?

Dr. Caplan: Oh, I don't know.

COL Jacobs: My understanding was that -- somewhere it said -- is it at G-4-A -- and I asked would they have to get any get any FDA approval? And I think the feeling was that the FDA clearance was for reagents and not for a specific use. And if the reagents were in use, what was done with them was not what was at issue, but that they were acceptable for testing these things. And we had the gentleman from FDA talk to us two meetings back -- three meetings back --

Dr. Bush: Dr. Kaiser Aziz was at the last meeting.

COL Jacobs: My understanding out of that was that they didn't really have any problem with what was done with it, that it was not theirs to get into. They approved devices, maybe.

Dr. Bush: They go by analyte.

COL Jacobs: And if they approved the analyte --

Dr. Bush: They look at the analyte and detecting how the analyte is -- what the chemistry is around the testing for the analyte.

COL Jacobs: So I had not heard that they had anything in 1991 that said that it was not to be used for hair testing. I'm not sure I understand that.

Mr. Stephenson: It's an issue that was based at the time on the lack of information that the test was accurate and reliable. And that was basically what was being said -- lack of information about accuracy and reliability. I think what we've done in the years since then is to try to go beyond that. And of course what we're doing it right now is literally substitution of that kind of lack of awareness that will come out of this will be definitive concentration of information that will either drive the answer or drive the research. So, you know, where we are now.

Dr. Caplan: Right. And that's a specific thing. There was that memo, the FDA memo.

And whether they rescinded it or not, I'm not aware of. I don't think they did.

Mr. Stephenson: To the best of my knowledge, they haven't. But it's a moot issue.

Dr. Caplan: Okay, any other comments or issues that should be brought to the attention of the working group relative to hair testing?

Dr. Isenschmid: Just regarding the QC issue. There was some consensus about using actual donor hair. Is that as a hair sample itself or a powdered hair sample? Obviously, another concern is homogeneity of the sample, especially when you're talking about a large-scale kind of thing. Maybe that's something we can find out more about.

COL Jacobs: That's correct. Then we get back to, is that sample as close to being real hair as other samples you're testing? If you powder it, then it isn't. For this purpose, it might almost have to be powdered in order to get enough of a sample to give to enough labs to make it worthwhile, to make sure that it's all at the same level. You're right. Then again, if it's powdered, it's not really like receiving a real hair sample, where they have to go through the procedures of either washing it before or powdering it or what they do to get the hair to do that.

Dr. Caplan: Any other feedback that you want to give back to this working group? We're a little early, but I'd recommend that we take a break, come back and do a little more so that we can finish up on-site.

We are going to continue discussing on-site testing and try to finish the document. Time permitting, we'll summarize the things that Dan and Walt have been noting as we have gone along. It's 2:30, and we have until 3:30 to basically do this.

Mr. Crouch: I think we were on question F-13 and page 4 in the document that was submitted, collection procedures, detection of adulteration, and handling requirements are the same for on-site testing as those currently in place for laboratory-based screening, except the sample may not require shipment if the on-site screening result is negative. We discussed that topic already, haven't we?

Part two of the response is: proper collection procedures are key to help prevention of adulterated samples. Checking for adulteration is the responsibility of the specimen collector, the use of temperature strips, et cetera, which we've talked about before.

Dr. Caplan: We did go through that to some degree. Are there any further brief comments on the aspects of handling adulteration at the on-site level? Does anybody want to add anything that we might have missed at this time?

Mr. Crouch: The next response is under quality control, quality assurance, H-1, the certified laboratory. We recommend that HHS certify operators, not sites, as is done with the DOT on-site alcohol test. Operators, on-site tests are cleared by the FDA. The quality control of the on-site test occurs at several stages, including the manufacturing process, operator training and when the test device is run. Do you want me to read the whole thing, or should we comment on that?

Dr. Caplan: We can do them one at a time. We did talk earlier about certification of -- I'm not sure what this is saying. I guess I have a little problem with the "sites."

Mr. Crouch: The question speaks to should the laboratory or the on-site facility be certified? The response, I think, said --

Dr. Caplan: But it says, as it is with DOT. And DOT does not certify sites. So that's what's confusing me.

Mr. Crouch: That's what they're recommending I think, is that the site -- the on-site facility does not require certification, only the operator and the device, which is already FDA approved.

Dr. Caplan: The question here is whether or not the sites should be approved? We have talked about operators and certification before. We haven't talked about sites. Any comments or thoughts about approval of sites? Now, if this is a laboratory with a laboratory-type piece of equipment, a lot of laboratories have mobile sites and screening-only sites or -- where they might be actually certified, but I think this is an exception to that more broadly.

Mr. Crouch: I think it's talking about the facility, which would speak to confidentiality, privacy, where the records are kept, and those sorts of things, which seems to require more of a review than just the competency of the person operating the test.

Dr. Caplan: The question is, should sites be inspected and certified? I know the military does do this in their program.

Dr. Isenschmid: I think one issue is also taking into account whether we are talking about on-site instrument-based or on-site non-instrument-based testing. That could change what kind of facility you may want to -- how you may want to consider the facility.

Dr. Caplan: It may. Again, this may just be my impression -- for the purposes of what the program is trying to do, the on-site entity could be treated together. If it is a laboratory, then I don't think that's what we're talking about. We can go into that if you think that's the direction we want to go. But my feeling is that's not really where we want to go. And if it were a laboratory doing it as a satellite site, then that's another issue. And if it's a laboratory-type piece of equipment that meets the qualifications of the on-site piece of equipment, then it probably shouldn't be differentiated. That's my opinion. Anybody else have any thoughts or comments on that?

Ms. Murdoch: I'm not sure exactly what we're talking about in terms of certifying on-site collection or testing sites. If we're talking about on-site, you could be talking about the HR manager's office, with the bathroom next door. Remember, we're talking about devices that can be used in very -- no pun intended -- fluid circumstances. We're not talking about necessarily a specific designated testing facility, like you would have at a laboratory or even at a doctor-in-a-box collection site.

They're intended to be used with great flexibility. If we're talking about doing some kind of inspection certification program, you're talking about tens of thousands of sites if you're just talking about collection sites. And even potentially more than that if you're talking about going into any Federal workplace where they might be used -- you know, with the bathroom or whatever. I mean it just doesn't seem to me to be particularly feasible or necessary. I do think putting requirements in place in the guidelines for privacy and confidentiality of results and that sort of thing is a good idea. But having to have certified, designated sites would, again, make the program so burdensome, both on the Federal Government and on the employers, that it's not worth doing.

Dr. Caplan: The question ultimately to be answered is, is this necessary or not?

Mr. Crouch: The benefit of on-site testing is the facility may be mobile and transient. That is, the testing is performed only when and where it is needed. Thus, an inspection facility becomes unnecessary. Certification of test operators, procedures, results of the facilities proficiency testing will ensure accuracy. I'd like to go back to the topic -- if this program is going to sanction on-site testing, is it interested in sanctioning someone testing in their office, on their desk, urine samples? And is it responsible for looking at that?

Dr. Caplan: I think the area here is certainly akin to requirements or general requirements for collection of urine. And it would certainly need to be expanded to have, as Ms. Murdoch was just explaining, some requirements. I don't know if you have to go as far as saying someone could use their desk. But there would need to be some guidelines certainly. And that maybe could take care of that as opposed to some specific site designation certification. I guess these two are actually the same -- what we just read.

Dr. Vogl: I believe there's an exception to the rule in this case with on-site testing as far as what is certification. It would involve the submission of blind samples or samples through a site that's using an on-site test that goes to the lab. There must be some criteria that they can confirm a certain percentage of those, or negatives submitted that are tested negative in a lab. Which indirectly show how well that site is doing the on-site test. If they don't meet those criteria, they're out of business or they need to switch to a different test kit or something along that line. But you don't directly necessarily have to certify that site. The key is to make sure that any sample sent to the lab gets confirmed.

Dr. Caplan: One question is whether or not we should certify sites. The second question is, what should the criteria for conducting the test procedurally be? What are the elements? And I don't think that's really addressed in here anywhere. But what are the elements that should be included in this process? Which is what you just said.

Now, you are practicing a number of those elements with a certain number of negatives going and a certain number of conditions. That just needs to be spelled out. Are there any other general comments more broadly on that?

Dr. Welch: Maybe a different way of saying certifying sites, if we're going to have regulations, somehow there has to be oversight. I don't know how you set that up with thousands and thousands of small sites. But there still has to be some measure of how procedures are being followed, is confidentiality being maintained, are the records being stored appropriately, are positives being sent to confirmation appropriately. I don't know that there is an answer at this point. But it's something that needs to be addressed.

Dr. Caplan: What are the elements of the answer? Because that is kind of a critical point. Short of certifying sites, if we do put in the process, what constitutes those elements? And what should we -- and how would you have to go about it?

Dr. Vogl: Under DOT's program, they audit employers' program, right? I would assume, includes a review of collection sites and records that are maintained there.

Dr. Caplan: The degree to which that is practiced might be an issue.

Mr. Edgell: Yes. I don't know how many collection sites we will actually inspect, but we do establish minimum requirements for collection sites -- what is expected at a urine collection site, what are the conditions for it -- and alcohol testing sites. The basic minimum requirements in any of this would have to be to some standard.

Dr. Caplan: I think the question that Dr. Welch is bringing up is the next step. How do we ensure that? Are there any suggestions on how that can be ensured? I mean you can have training. You can have all the things we're talking about for the operator and device, but how do you ensure that the practice is there? Any comments or thoughts about that, that's a significant element which is different in the laboratory?

Mr. Crouch: That was my comment, too. Do you want the program to write some criteria, which you have ownership for writing, but then you don't provide any oversight to ensure that that's what's really happening? And philosophically, I think that's a big decision to make.

Dr. Vogl: Right. We have the collection handbook, and a detailed description of what should be done at a collection site.

Dr. Caplan: But we are talking about testing. And unfortunately the model of the collection site, if that's the model to be used, would be a fairly poor model.

Ms. Bernstein: But I think what you're talking about is you also get into some real policy and regulatory issues. One of the things we're grappling with now is, from a regulatory point of view on the DOT side, all we do now is when there is a problem is enforce against the employer. When you go to an on-site test, the question is you've got to look at enforcement issues. And where does that go? Or whose purview is that from a regulatory point of view?

Dr. Caplan: Whose do you think it is?

Mr. Bush: Wait a minute. Unless I've completely missed the boat, this whole thing we've been talking about applies to the DOT program --

Dr. Caplan: And the Federal program.

Mr. Bush: And could possibly apply to the NRC.

Dr. Caplan: Yes.

Mr. Bush: And every Federal agency that tests a Federal employee.

Dr. Caplan: Correct. Well, actually, Mr. Bush, you might be the best one to try it. Because you are doing on-site testing.

Mr. Bush: We have about 27-28 sites that do on-site testing.

Dr. Caplan: Sites or nuclear facilities?

Mr. Bush: Nuclear power plant sites. In some cases there are three nuclear units there that have just one contiguous site. And they have a mini-laboratory set up. Some of them have one instrument. Some of them have three or four instruments set up side by side. And they do their on-site screening.

Dr. Caplan: What oversight elements are associated with that?

Mr. Bush: We have the regulations that require everything, just the same as for a certified lab, all of the elements of quality controls and the training and all that sort of thing. And the licensee is required to audit that program. We go in and inspect from time to time. They provide information to us, the physical data, how they're performing.

They run lines through the on-site testing process. And from there, they go on to the lab. And of course the big report card is when they get the report back from the lab, not only on the blinds, but on the specimens that they send forward for testing. They also include 10 percent of negatives, specimens that are screened negative.

Dr. Caplan: But the number is 27?

Mr. Bush: Yes.

Dr. Caplan: A lab level essentially?

Mr. Bush: Yes.

Dr. Caplan: So that's pretty far removed from multiple thousands, with a low probability of lab instruments and a higher probability -- (off microphone) --

Mr. Bush: The instruments were, for the most part, acquired from the labs. In some cases, they're still leased. In many cases they were leased initially and bought. The personnel that operate the instruments were also initially on loan from the lab and in some cases even hired by the utility.

Dr. Caplan: I think this is an important point here.

Dr. Bush: It is a very important point.

Dr. Caplan: And it is one that hasn't been addressed as much previously in some of our other discussions. I don't really want to leave you without getting as much input as we can.

Dr. Bush: I am going to speak from the Federal side. To let you know where we are and where we are very comfortable and where our funding authority is very comfortable. The laboratories who choose to participate in the National Laboratory Certification Program pay for that service. We have developed with RTI over time the Gold Standard Program that consists of inspections and proficiency testing among correspondents -- additional correspondence with the laboratories -- that constitutes the oversight umbrella. Now, that costs money. And the laboratories choose to pay that to participate. When I hear the word "oversight," time is money. We all know that. Someone has to pay for this. I am going to suggest that it would be the users of the service who are going to pay for this. And if it's going to be an employer who decides that they want on-site drug testing in some form, because they are large enough to benefit by it, if there is some sort of oversight, however that shapes up in the end, they will have to pay for that oversight, for proficiency testing. Whether it turns out to be on-site inspection, I'm not sure. How do you inspect someone's desk, the HR manager's desk? I'm not sure how this would all shape up. I don't think it's going to come to that, where everybody is going to have three or four on-site test kits in their desk for use when they need it. Somehow I think that's conceptually the extreme of what people think about. Yet I think on-site drug testing will be perceived as a cost benefit to those who have that moderate number of employees who are covered under the drug testing part of their program. But I can just see back to user fees. There will be no Federal funding for this.

Dr. Caplan: Sure. Notwithstanding that they are fees, even assuming someone pays for it, how does it get done? That's the other question. There is always going to be the question of fees. In the end there's always going to be the question of dollars and somebody's dollars doing this. But how would we actually -- is there any suggestions or recommendations as to how that would be integrated or what would need to be in the guidelines to control that? I'm a little hung up on this one because I don't have a good answer in my mind either.

Dr. Welch: I think there's some information at the State level. In Oregon, people who do on-site testing have to register with the State, and they pay some -- I don't know what the fee is.

Dr. Caplan: But how do they oversight? You started this. How do they oversight? They pay the fee. Fine. They're registered. How do they check them?

Dr. Welch: I don't know the answer to that.

Dr. Caplan: Is there a process at all that anybody is doing?

Dr. Bush: What is the fee for?

Dr. Welch: Because you have to participate in a proficiency test, and the records go to the State. You know, there's that kind of deal. So it's probably paperwork fees. It's minimal. It's like $50. It's not going to pay for anybody to go do an inspection.

Ms. Bernstein: Are there are people here doing on-site testing, who can share with us how they're addressing these issues?

Dr. Caplan: But, see, that's in a tight program where you're doing your own oversight, aren't you?

Ms. Murdoch: Right.

Dr. Caplan: And how would you regulate the oversight is a different issue.

Ms. Murdoch: I come from the Department of Transportation, where the biggest program, the Federal Highway Administration, does virtually no inspection. I mean it does some minimal amount, but the bottom line is it's impossible to regulate. It's perfectly possible to put out all kinds of regulations, but when you have 7 million employees or, in the case of on-site testing, thousands of sites, you basically are going to have to either coopt to the State government and give them money to do your oversight, or forget about it.

And, so far, forget about it is probably -- I mean let's be realistic. If we're going to make on-site testing feasible, then we have to put in place a program that's got enough prescriptive elements that we think people are going to adhere to the minimum requirement, but accept that there is going to be no way that the government can do active oversight, I think. Just because of dollars and personnel.

Now, that doesn't mean that you shouldn't put in place, like with the laboratories, internal quality control responsibilities on the people who want to adopt these programs, whether it's on Federal agencies or on the employers, and hope for the best in terms of compliance.

Now, we've taken a very proactive stance in terms of quality control. As I said, we do the certification examinations. We have standardized training that every single collector who wants to collect a Postal Service specimen has to go through. They have to take and pass an examination. And they do get a certificate of completion issued from the Postal Service saying that they can do that.

And then the Postal Service, the district occupational nurse administrators have a contractual obligation to go out and look at their contract collection sites. Some of them do, some of them don't. And then we have the follow-up QC. We do our own internal QC of the device itself. We get devices, 100 of them, every quarter, and do reliability surveys of the device, both them and the adulteration sticks. And we are in the process of now sending out the blinds to the collection sites, and we'll be getting negatives in, as well, identifying those.

But it all takes money. The Postal Service is lucky. You know, they just upped your postal fee a penny a stamp. I will not say that this is why. But it's expensive.

Somewhere between the Gold Standard Program and if we want to get more small businesses involved in drug testing, no program, I think there has to be some middle control for quality control oversight. But I don't see any way that it is feasible for the Federal Government to go out and do certification and oversight inspections of on-site drug testing. They're not doing it now with laboratory-based testing. I don't know what would change. I mean they're not going out to collection sites. They're not going out to employers in many cases. The Federal Aviation Administration, which has probably the best inspection program, and the Nuclear Regulatory Commission are. But the other operating administrations are doing very little or no inspections. And it's a people and dollars -- and you just set your prescriptive elements as well as you can and hope that people adhere to them. And always go back -- I'm a firm believer that you should never call a specimen positive unless a laboratory has called it positive. And that's where our ultimate control is.

Mr. Davis: I would say that this is much less intense so far as any need for inspection than a laboratory-based inspection would be. It would require much less effort to inspect whatever records or whatever there is to inspect, whatever might be established by whatever guidelines are established. If it was done, if there was an inspection program, it would require much less in the way of resources, in terms of personnel to do those inspections. I will just stick my neck out here to a certain extent -- what about the possibility of a random inspection program?

Mr. Bush: First of all, Congress is not going to provide the money to inspect every program in every town. In fact, they probably wouldn't even give us enough money to do 1 percent. So, you're absolutely right, you'd have to make a decision of whether or not you're going to do any inspections at all. And what inspections you do, you're going to have to be very careful and select targets of opportunity. And with the NRC, we call those kind of things reactive inspections. In other words, there is something -- it's not a very good way to go, but sometimes it's the only way you can dice it -- you have had some indications that there's a need to go out and look, there's been a problem of some kind. And so you react to that situation and go out and look at that particular program. You either focus on just the root causes of the problem or you can look at the whole program. But there are all kinds of ways of maintaining oversight.

Dr. Willette: I am just going to relate some of our experiences. We've been doing this for a number of years. We inspect a variety of on-site operations. And it strikes me as sort of a sharp contract when the Federal Government feels it's necessary to monitor and inspect on-site testing operations for people that are being charged with criminal offenses and fall into the Federal judicial system. Because all of those on-site operations -- currently, all of the instrumented ones -- receive PT samples, which may be blinded or not depending on their operation. And they also get inspected. We do inspect nuclear facilities, but it's not mandated by the regulations at the present time. And if you look at the DOT regulations, the ultimate responsibility in all of these comes back to the employer in the relationship. Because the employer has the ultimate responsibility to make sure collections are done right and testing is done right. We have to make a distinction between collection and testing. Testing is inspected now in the Federal programs. And collections may or may not be. But if an auditor from one of the agencies goes out to an employer, the employer should then have the responsibility of having those copies of certificates of the people who are doing the on-site test. They should have copies of the quality control records. So you don't have to go out to a thousand sites, you go to the employer and say, let's see your documentation of your on-site testing program. Now, who does that? Maybe random spot tests, perhaps like NRC does at some minimal level. It's sort of like random drug testing. It serves as a deterrent to try to keep people in line, to make sure their on-site tests are done. And the whole philosophy behind that is that collecting errors affect small numbers of individuals, whereas testing errors certainly in larger labs could affect lots of individuals. So that's why the emphasis is always on the testing -- I mean the monitoring and testing. On-site testing, again, it depends on how fine you break it down, to how small a site it is. And somebody may be doing 10 collections and 10 tests a month. Do you need to inspect that level of site? But what if they're all wrong? Eventually the courts will catch up with the system and refine it. And that's what happened to us in the workplace drug testing. Early on, it was military courts martial. Later, as that decade went on, it was the civil court. You can do all these things. It's a matter of why should cost be a factor in ensuring that employees and applicants don't get accurate drug tests?

Dr. Smith: I have a question in terms of the CLIA regulations, whether there's any applicability in that respect. When CLIA put its -- I'm talking about from a standpoint of the regulatory process -- is there oversight of those being followed at all?

Dr. Sample: No.

Dr. Smith: There is not. So that's an --

Dr. Sample: Not for workplace drug testing.

Dr. Smith: I know that, not for workplace testing. But I'm talking about in the realm in which they are. Because those are regulations that would occur -- or that a variety of entities would be subject to them. You know, a lot of doctors offices, clinics, walk-in areas.

Ms. Murdoch: If they're doing the on-site drug testing by or on behalf of the Federal Government or under Federal imprimatur, then neither State nor Federal CLIA applies.

Dr. Smith: No, you're not getting my point.

Dr. Bush: You said as a model.

Dr. Caplan: Is there an experience in point of care testing in either local or other oversight that we could hang out hats on?

Dr. Smith: Yes. My point was -- and I obviously am not articulating it well -- let me try it one more time.

Dr. Bush: The bottom line is looking at CLIA as a model.

Dr. Sample: I agree, it's a model. But they're not really looking at any of these tests. And it doesn't matter whether it's federally mandated testing or not.

Dr. Caplan: What requirements do they have for oversight? And how does that work?

Dr. Smith: Right, that's my point. What are the requirements under CLIA, for example, for my doctor's office, who runs diagnostic and clinical tests in his practice under CLIA? And there are some. There are prescriptions for how he must do that. Is there any oversight? Does somebody come to my doctor's office and see if he is running those tests?

Dr. Welch: That depends on whether the tests are waived or not. And the simple ones, the point of care, you know, glucoses, they're waived.

Dr. Caplan: What about are there ones in which there is oversight?

Dr. Welch: Anything, instrument based.

Dr. Bush:  Dip and read, with a visual end point, simple in their operation --

Dr. Welch: They are waived.

Mr. Crouch: But that is a model, as I think Dr. Smith was trying to point out, of how a large organization at the Federal level reaches out into small towns and counties and communities to do this sort of stuff.

Dr. Caplan: But it does it primarily through the use of local health departments.

Mr. Crouch: But it's not impossible to do.

Ms. Murdoch: But if we're looking at that as a model, then they've already made that decision that they're going to waive for these small tests, because it's not reasonable.

Dr. Bush: We can change our definition. We are not CLIA. We can take the best of CLIA and apply it to situations for workplace drug testing. Just because it's exempted under --

Ms. Murdoch: No. I'm using it as a model. I'm saying maybe the CLIA organizations have already looked at this issue of going into the point of care testing and doing inspections or whatever for point of care testing, and saying it ain't worth it.

Dr. Welch: Except that drug testing is not waived under CLIA. So they did make the decision that that one had to be looked at.

Ms. Bernstein: Do we know what pattern they used to look at them? Is it random? Is it one out of every 20,000?

Dr. Caplan: It's random and problem-oriented generally. They have the right -- all State health departments essentially have the right, under CLIA, to do inspections. Usually someone calls up and has a complaint, then they go look at them.

Dr. Welch: Or you miss a PT.

Dr. Caplan: Yes, you miss some criteria.

Dr. Sample: But they don't go to every site every year.

Dr. Caplan: And they may not go to some sites ever.

Dr. Smith: May I make one more comment as an observation. In the workplace arena, for laboratory-based urine testing, even though we have not regulated, nor inspected, nor had direct oversight of the collection piece of this three-part process -- which is really collection of the specimen, analysis of the specimen and the review and interpretation of the result -- there was oversight, if you will, to some extent of that because of the process. The custody and control form became a measure for both the laboratory process and the medical review officer process to look at the quality of the collection.

Now, granted, you couldn't tell whether all 26 steps were followed accurately by looking at the CCF, but you could look at many of the parts of the process. So maybe something that we ought to learn from that model too is, whether it's instrumented or non-instrumented on-site devices, is, is there a way to look at that through some kind of documentation that follows the process?

And I know Ms. Murdoch, in her program, and two of the programs that we're operating at our TPA, we also have a -- we don't use a logbook for the ones that need further analysis, but we do have kind of a rudimentary form as a check-off kind of thing that occurs with that specimen. And those are looked at. Then, for the specimens that require sending to the laboratory for either because of a preliminary finding of drug or because of something else having to do with the integrity of the specimen itself, we do have the chain of custody procedures.

And so the review of that then becomes, to some extent, an oversight of what has occurred at the various locations where the on-site process is initiated. So maybe we can, again, even though the collection end of the regulated programs has perhaps been its most troublesome to some extent, there are some things that we may be able to look at for developing this paradigm or this criteria for an oversight process.

Dr. Caplan: I think this is a really good discussion. There are a couple of critical points here, and I think this is one of them. If this is going to go, we're going to have to find a way to interface this and make it either similar to or deal with the laboratories on an equivalent basis. So I don't think we can talk about this point too much. This is where the work, I think, in the end, is if we come down to a policy that we'd like to work.

Dr. Mitchell: In the issue that you just made, about the equivalency with the laboratories, this could have a great impact upon the oversight of laboratories on the initial screening of regulated samples also.

Mr. Bush: I think there's something else we ought to recognize. And I don't know that it's within our power to deal with. And that is, if we do bless on-site testing for application of Federal programs, the private sector -- all the people that manufacture these devices and are going to be marketing these things out in a non-regulated industries. And if we're not careful and have some kind of oversights, some mechanism to ensure that those kind of efforts are not trampling on rights, you're going to find court cases and you're going to get swept up in the whole mess.

Dr. Sample: How many sites -- collection sites -- are there involved in doing on-site testing for workplace drug testing currently? Does anyone have that number overall? And then, maybe if you were to look at 80 percent of the tests, is that a smaller number?

Dr. Smith: In Sammy's database of 6,500 collection sites, we have only now about 1,000 -- right around 1,000 -- 980 that have told us that they are doing one or more on-site drug screen for workplace places.

Dr. Sample: And that's one or more per day, per month?

Dr. Smith: I would have to see if we have got that data. I'm not sure.

Dr. Smith: Certainly for the majority of the ones that I know of, their on-site collections for workplace purposes are significantly less than the collections that they do under HHS or DOT guidelines for going to laboratory-based testing. So if a clinic is doing 30 collections a day, the vast majority of those collections are under the current guidelines and a very insignificant number of those total-wise are. But the point is, out of 6,500 collection sites -- and those range from doctor's offices, urgent care centers, hospital departments, et cetera, which we have 6,500 that our various clients use throughout the country -- there's less than 1,000 of them that have acknowledged to us that they are doing on-site collection and testing.

Dr. Caplan: Then, I think we'll shift to see if there are any other issues.

Ms. Bernstein: I believe that's a growing percentage. I find that a high number, not a low number.

Dr. Smith: Ms. Murdoch, are you surprised at that, or is that representative of what you would have thought based on your experience, too?

Ms. Murdoch: Yes, it's growing drastically.

Ms. Bernstein: I think that the trade association of collection site people might be able to gather some data from their membership in that area. All I can tell you is if you go to one of their conferences, or any conference -- and Mr. Edgell and I have both had this experience with our drug testing people -- is the on-site people are outnumbering everybody else. I mean there are just vendors everywhere you look. So even though we are concerned with regulatory testing, the fact of the matter is this is a growing share of the market I think in terms of non-regulated workplace.

Dr. Caplan: I think there is a working group that hasn't met yet. And contact of that group with this group would certainly be recommended. Let's see if we can finish this. There might or might not be more questions in the protocol. And then I think we want to take a couple of minutes to talk about this financing thing we mentioned earlier. And, as a further result, we are going to maybe ask Dan and Walt to summarize the decision points -- we're not going to get to go through them again today -- and distribute them to the Board and maybe we can work with that secondarily after we leave.

Mr. Crouch: There are a couple more points here. The next one is on-site drug screening should be tested with quality control materials at two concentrations. Quality control positive and negative should be performed upon receipt of new shipments by customers for each lot received to verify the kits are performing correctly and have not been damaged by shipping. Which, of course, is quite different than what laboratories are asked to do, which is batch quality control. Some discussion needs to occur about how often quality control should occur at the on-site facility or with the devices themselves.

Dr. Caplan: Any comments on that? The issue is -- we talked about it somewhat before -- how is this quality control going to work, whether -- and this is suggesting the quality control might be operator oriented. I mean there are some at least police experiences. And they tend to certify or approve or check on people by having them do their own personal quality controls. Any comments along the lines here?

Ms. Murdoch: Tend to run in the 20,000 to 100,000-unit range. So doing QC on each lot, you know, for a small. I'm not sure if that's terribly useful.

Mr. Crouch: I think this requires some discussion. The expiration date on our KIMS reagents is about a year and a half. So if we only had to quality control those when we receive them, we'd be in good shape. I mean it's the same concept. It's analogous.

Dr. Caplan: I mean the concept, if a batch is controlled and the batch is distributed to somebody else, there has to be something minimum that somebody else does is what Mr. Crouch is saying.

Dr. Vogl: It's not a blind QC program or a blind QC question. It's a daily quality control question.

Mr. Gorsky (ATN): Just a couple of points about that from a reagent producer point of view. There's a big difference in the stability of reagents when they're in liquid form versus the on-site hand-held unit tests, where the reagents are in a solid base. The stability dynamics are vastly different. But there is a model. And so let me just add one more sentence to that. That is the reason why, with liquid reagents on a large analyzer, you have to test them continuously. But there is a model which you may be able to use. And that is the Dupont HTA. If you're familiar with that analyzer at all, they have -- it's an analyzer that's used in large laboratories. It used to be extremely popular in hospitals. There are still a number of those models available today. And they have unitized tests. That is, there is a plastic pouch that has reagents that are -- some are liquid and some are solid based -- and each pouch is one single test on one single specimen. Now, those analyzers have been around long enough in hospitals and they do perform and they do have packs for urine drugs of abuse tests. It's the EMIT technology that's incorporated into those packs. So there would be some experience from the CAP point of view in inspecting laboratories. And there may be guidelines that would be appropriate or helpful or applicable to this same situation.

Dr. Caplan: Dr. Welch, can you comment on that? I know the concept of the Dupont HTA. It's an independent test. You can put any number on in any order.

Dr. Welch: It's like an HTA or a Kodak Actichems. Any of those kind of instruments. And I believe that the quality control rules for those kind of instruments are each day of use -- two levels of control each day of use. That's a general clinical chemistry kind of, you know -- so, for drugs, we interpret that to mean a positive and a negative.

Dr. Caplan: Okay. But if you're doing two controls day of use, that's not inconsistent with everything else we're talking about. What Ms. Murdoch is saying is there may not need to be control on certain batches of products with very little users. Control not by each individual, assuming there's control elsewhere.

Dr. Sample: Thinking back to my old HTA days, I seem to remember that the hospital at that time was running one control a day rather than two, but they alternated the levels. But, I think in Ms. Murdoch’s scenario some sites may find that to be very expensive. If they're only running one specimen a day or two specimens a day, then they're running one control. It seems that the basic tenets of quality control, the models that are already out there, suggest that at a minimum for this unitized type of testing, once a day at a minimum would be a requirement.

Dr. Welch: I think we should remember also that quality control controls the unit packet or whatever. But it also controls the operator. And there are more issues -- you can run quality control almost like a patient sample, so you control the clerical piece, the result reporting, and all of that. And someone who does testing once a week or once every other week maybe needs more of that kind of help than is the device still operating properly.

Ms. Murdoch: But we are talking about dock-in-a-box collection sites. And they're going to have to buy  -- to run every day?

Dr. Welch: But control specimens to run each day of use.

Dr. Sample: But they probably would need to subscribe to some proficiency testing program.

Dr. Welch: That's the next one.

Dr. Sample: Yes, which is the next point here.

Dr. Smith: One of the other things, Dr. Caplan, that you could consider, again, is taking from our experience with the quality assurance programs for the evidential breath testing devices. Where there, the frequency of running some kind of QC was every so many days. Or the other thing that would maybe account for the smaller operations is every so many tests.

Dr. Caplan: But that's generally was for positives. It had the proviso that if you failed after 30 days, although you're permitted to do it, you had to go back and negate all your previous runs.

Dr. Smith: That's correct.

Dr. Caplan: And that's not practical for anybody. This is kind of a negative-based program. I'm not sure if that would work. Because you're positives aren't allowed anyway. We are trying to control the negatives more so than the positives. But the DOT program is controlling the positives. It has a tendency to control the positives more than the negatives. But it is an issue. We're not going to resolve that today. But we have questions there.

Mr. Crouch: There is probably one more major one, but it's sort of a confusing response, in that the responses to external PT samples, there are a number of companies and professionals who provide performance testing using blind samples, which I think is a little different than performance testing samples. In fact, I think we maybe need to segregate controls that are run on a daily basis from proficiency testing samples which are known samples to test the proficiency of a laboratory from blind quality control samples which are submitted totally -- (off microphone) --

Dr. Caplan: Since we're running out of time, I would like to ask Dan and Walt, who were taking notes and trying to summarize these things into bullet form and specific questions that we might need to answer, if they would, to do that, look at the couple of things and add questions from the few things like this PT and all that, that were on there. And hopefully, if you get that together and distribute it from the Board, we can use that the next time we move on this issue.

I just want to take a minute and ask HHS, just as a recommendation, to appoint a small subcommittee of the Board -- and you can do this later, but I am just asking for approval to do this now -- to begin to look into some of the financial impacts of these potential changes on the HHS administrative structure as well as the development of the programs. I think we are talking about all the technical and programmatic things -- and hopefully we will be moving at a stronger pace during the course of the next year, and we should look at some of this financial thing as well.

I am just recommending this, making a motion I guess, from the Board that a small group be appointed by HHS to meet independently so we don't wait to do all these things later on.

Dr. Bush: So that was a motion. Do we have a second?

SPEAKER: Second.

Mr. Crouch: Can we vote?

Dr. Bush: Sure.

Dr. Bush: Okay, we'll call for a vote. All in favor of the motion that has been proposed and seconded, please raise your hand, Board members, for an affirmative response.

COL Jacobs: I'd just like to comment that it looks to me like we looked at the on-site and we've looked at hair, and I'm still a little bit unsure whether we're trying to mimic what's already in place, as nearly as we can, the urine testing. Are we trying to duplicate it in every way we can? Or are we trying to design a separate program with other rules and other criteria that will be acceptable? And I am just going to leave that there. I don't really expect an answer. For example, with hair, I'm seeing that cutoffs may be much closer to level of detection. And that may mean something. That may mean extra interpretation. And I see -- or from what I think I'm seeing here with this on-site testing, there seems to be a direction of doing away with a lot of controls, of maybe having different, in my opinion, lower standards than what we're having with urine testing; maybe no longer being blind and having the individual tested and the tester face to face when the result comes out; having no longer a second person reviewing this result. If this is the direction we're headed, that's fine. I just am trying to get a feeling here if that's -- you know, is this a new program or are we trying to mimic what's already in place? I understand that in each of these there are financial interests, that there is a real reason why some of this may not be able to do it exactly the same. Any comments from anybody?

Dr. Bush: My comment is to always consider the Gold Standard. We spent an awful lot of years, together with industry, with laboratories, with technical experts, and with critics, to establish an accurate and reliable, reasonable drug testing program that has been challenged many times for its credibility analytically in court, by individuals, as well it should be. And it has withstood those challenges and has served as the gold standard. It is never the intention to walk away from a gold standard. So, based on what we do know and how we developed this table, the factors for accurate and reliable workplace drug testing, that's how this whole table came to be -- what were the common elements that were important; not necessarily each and every detail, but certainly the elements. And that HHS and DOT do not want to move away from it. That's never the intention. Everything shall rise to the Gold Standard occasion.

Ms. Murdoch: Dr. Bush, you might as well not do on-site drug testing -- (off microphone) -- laboratory testing. If you hang enough burdensome requirements on it, it's not worth doing.

Dr. Bush: I didn't say that it had to be identical. Looking conceptually at critical elements to the accuracy and reliability. Okay. And so I'm sure that's why we're all meeting here. This is why we're doing this. We're not excluding any process, any technology. We're looking for all to present everything they have so that we can evaluate it in the context of good forensic practice and a single specimen collected in workplace.

Mr. Edgell: Just a second. I think that you certainly want a credible test that you can use. That means that the individual used illegal drugs, was not exposed by walking through the wrong room at the wrong time or eating legal foodstuffs or any of the other things. And I know everyone wants the on-site litmus test that costs a quarter. But workplace drug testing, where somebody is going to lose their job, you might not be able to get it.

Ms. Murdoch: I didn't say that. And I've always said that laboratory -- (off microphone) -- on-site drug testing. And I think that should be remembered.

Mr. Edgell: But the negatives are just as important as the positives.

Ms. Murdoch: I don't disagree with that.

Mr. Edgell: The credibility of that device over a long period of time needs to be assured.

Ms. Murdoch: Absolutely. That's where you get into the device reliability factors. And that's where we really need to focus the Gold Standard.

Dr. Willette: I would suggest to the Board that they might go back and read the preambles to the 1988 regulations, both DOT and HHS, and the rationale that the agency used for not permitting on-site testing, which was requested prior to the issuance of the final regulations. And the rationale was we stopped one item short in this paper on on-site testing, which has to do with reporting. The question is, what do you do with an individual who tests positive on-site? And time doesn't permit discussing or debating that now, but it's the primary issue. And that's what quality control and that's what operator training and that's what accuracy and reliable results lead to. Because the fear was that people would be stigmatized. If they're in a critically dangerous occupation and they have to be removed from, let's say, driving the locomotive and are off for two days, what repercussion does that have if the laboratory comes back negative? The NRC addressed this in terms of which tests are invariably illegal? Cocaine and marijuana. And they coupled with that, that you can't remove somebody from a nuclear -- a job at a nuclear facility if they test on-site for amphetamines or opiates because of obvious cross-reacting problems. And the second criteria was that the operator had to have a proficiency that exceeded 85 percent -- that basically was the confirmation rate -- or on proficiency samples or blind samples. So all this is oriented towards is trying to make that on-site result so accurate and reliable that people that have specimens that don't confirm aren't stigmatized.

Mr. Bush: One other feature we have on our regulation -- there was a lot of internal debate as you can imagine -- one thing we were adamant about was that the record should be purged, that there is just nothing left for anybody to see that this person has a presumptive positive test and was removed. A person gets a written letter that explains the thing and that the person does not have to report the removal or anything else, and that all the records have been destroyed. If we go out and inspect and we find any records like that.

Dr. Willette: In a nuclear plant, it's a little different environment. It's a different kind of program than these deterrence programs. What do you do, Ms. Murdoch, for an on-site test for somebody in the Postal Service, do they stay on the job?

Ms. Murdoch: We're only using it for applicant testing. And they're advised that they'll be notified whether they're qualified or not when the result comes back.

Dr. Willette: What would you do with employees?

Ms. Murdoch: Absolutely, that's one of the things -- that's one of the reasons that -- (off microphone) -- at this point -- (off microphone) -- have to be addressed for each category of employee. And they do have, let us remember, 900,000 employees.

Mr. Edgell: Maybe that's something that we -- that should be added to the matrix, is that question, is each one of these alternative specimens appropriate for all reasons for testing? And the answer there might be no. I mean they might be very good in certain usage areas and not in others.

Ms. Bernstein: I want to comment kind of both sides of that, and it's something that I think is important. And I think Ken's idea is a very good one in terms of matrix, because I agree with my colleagues that we definitely want it to be the Gold Standard, but let's look at where it's been successful and where it hasn't been successful. And it has not been successful in small businesses, by and large. We still have tons of people who are not complying with the regulations because, you know, they find them burdensome. And we've been very successful in terms of, I think, both regulated and non-regulated testing, in terms of large work organizations. So can we somehow, in a Gold Standard kind of way also, have a process that would lend itself to growth in terms of small businesses? And I think those are some of the issues that we also need to address on the policy side of the house.

Dr. Willette: One of the on-site distributors has put a package together, with videotapes and custody forms and manuals and on-site test kits and collection kits, which they've submitted to FDA to get cleared to sell through Office Depot's for small businesses. So it's a do-it-yourself collection test, MRO, everything, all in a box.

Ms. Bernstein: I wouldn't be so quick to laugh.

Dr. Willette: No, I think there's an 800 number you can call.

Dr. Willette: I'm not saying that people should not be removed from certain occupations if they test positive on-site. I'm saying it's how that's done, how the information is controlled. And all that has to be very carefully considered. And I think there's ways of doing it. But it puts a greater emphasis on the need for more accurate and reliable results, however, you accomplish that.

Ms. Bernstein: I agree, in terms of whether you remove people from duty. That's an issue we don't need to look at -- (off microphone).

Dr. Bush: Any other additional questions or comments from the Board at this time? I thank you all for your participation, attendance, and attention all day long.

The meeting adjourned.