DRUG TESTING ADVISORY BOARD
OPEN SESSION
September 5, 2001

Agenda Item: Welcome

MR. STEPHENSON (Chairman, HHS): We would request that anybody who is participating with us today sign in so we know who has been here.

Anyone who wishes to make public comments today, please check in with one of the people at the desk so that we can arrange a time.

I wanted to start with a couple of announcements that will be of some interest to not only Drug Testing Advisory Board members but also to the public that are here with us today.

We are having a workplace knowledge exchange conference, and it's a very interesting process. It's almost the culmination of three years of research. We're going to continue to do secondary data analysis and so on, but the primary findings from a number of our grantees who have been working in that nexus between the workplace policy issues, prevention as a concept, and the health care delivery system have been working on interventions and documentation of changes from baseline post interventions not only within their own individual programs but across the various research efforts to try to find the commonalities that exist and to come up with some general findings that could be helpful. The meeting is at the Hilton Crystal City Hotel tomorrow and the next day. We had deliberately made a decision to keep the Drug Testing Advisory Board meeting to a single day and want to strongly encourage and support the members of the Drug Testing Advisory Board who can come to stay with us and come down to participate. You're going to be there as our ambassadors to the technologies and to interact. We have over 200 registered individuals. We have 23 representatives from 18 international countries coming in addition to our United States participants.

I'm looking forward to hearing the findings myself because this has been moving so fast that I haven't had a chance to get up to date on all of the things that our researchers have found. So, this is an invitation. If you don't have a copy and you'd like one, please, you'll be able to find them out here on the table. We look forward to seeing any of you who can come.

Richard, we have you listed as doing the new workplace website.

MR. LIPOV (HHS): The site has been up for about 4 to 5 weeks now. At the last meeting, we were just showing a specimen of the data version. The home page hasn't changed much since then. This version is not connected to the web. This is the site that's loaded on this PC, and you can't go to outside links using this, but all the files are on there. The main URL or domain name is workplace.samhsa.gov. There's a secondary domain name, www.drugfreeworkplace.gov.

The site currently contains several hundred files and links, very comprehensive material on drug-free workplace programs. As you can see, the buttons at the bottom and the top are the titles for all the areas on the site. We are currently getting the site registered in the search engines out there. The site is a work in progress. Right now we're working on getting programming for a crisper navigation, some new content areas, for example, small businesses and EAPs and a portion on unions and a portion on confidentiality information.

MR. STEPHENSON: Let me just make a couple of comments here. One of the things that's happened here is that this website has gotten hot real fast. It's only been up for a few weeks, but already our own webmaster has told us we're getting as many hits on our workplace website as our agency is for the entire agency, and that includes the entire SAMHSA site.

The point is one of the things that's hot, which is a lesson we've learned from our comrades in arms over here from the Department of Transportation, is when you get a new regulatory release, make it available electronically.

Once we got our Federal Register published for public comments on specimen validity testing, we put it up on the website in two different formats that you can download, you can look at. You don't have to rely on just going to the Federal Register site at the Government Printing Office. We have an image of it here.

We also have at the bottom in that particular area a public comments area. Walt Vogl has worked in this area for some time and had looked at what we had learned from the electronic docket that DOT had used very effectively in their promulgation of 49.40. We are trying to do the best we can in a similar vein. We will receive the public comments that come in. We'll scan them in and then we will post them on the website. During this 60-day public comment period, which will end October 22nd, we will have as many of those already up on the site as possible.

I'm not going to get into the rest of this, but the point of this whole exercise for this website is it's a tool to help us communicate with the public and with our federal agencies and the DOT regulated industries, as well as NRC folks who want to use these resources in their own program areas. We've tried to do the best we can to bring this up online in a way that's professional, it's accurate, and it will be timely. It is government work, but we think we've done a pretty good job in at least getting it launched.

I want to thank Rich Lipov for the leadership that he's provided in this.

We welcome constructive feedback on what you like about the site and what you'd like to see more of. If there's anything that we can do to make the site more effective from your perspective, please let us know.

There is a press release. There is a one-page flyer that you have access to. The drugfreeworkplace.gov domain name is one that's easy to remember. It's a lot easier than all of the other kinds of things that you get stuck with in normal government nomenclature. You're welcome to use that as the primary contact link if you want to.

DR. BUSH (HHS): Just a reminder at this time. You can get our Federal Register notice as a PDF format or an HTML format. The public comments section will be for us to put the public comments that we receive in writing to the address noted in the Federal Register. We will scan those in and put them up as the public comments. That's not a site for the public to use to make public comments, but rather for us to display the comments that we receive.

I'd like to just caution. Again, learning from our colleagues at DOT, I'd like to caution folks. Sure, visit the public comments, but comment on the reg please, not necessarily on the other comments that are there. Sometimes it gets into commenting on the comments and maybe losing sight of the issue that really was meant to be commented on.

MR. STEPHENSON: The other thing we're going to talk about here on the update is MDMA. We have an issue that has been increasingly recognized in many ways thanks to the work of the military programs out there that took a gamble, went for broke, went out there and looked at a brute force analysis of the existing assays to try to find out what was happening through their military labs. They have presented to us in the past about this and have seen a small number but a huge percentage increase over a three-year period, which acted as a signal flare for the rest of us to realize that we all had to deal with an issue that many of us as adults had thought of as a harmless or as a moderately confined practice of kids in raves dancing, and that's not the case. This is a pervasive, very dangerous drug that has long-term consequences that the researchers are still discovering today and that has gone far beyond the young people who are pre-employment age and are now at the edge and entering in our workforce in increasing numbers.

We have looked for and have worked with all of the industry working groups looking at alternative technologies and specimens for the last three years. As early as a year and a half ago, we had asked very specific information about the ability to detect MDMA in other matrices. We are still seeking a good urine-based drug-specific MDMA assay. We think that there are a couple of them that are going to be out there, but we really have not yet seen the assay in action.

What I can tell you is that for the last year, we have had active help and support from our hair testing industry folks. We have had a report that came to us in our office, as well as on the website, of the two drug testing labs that do perform hair testing in significant numbers that suggests that MDMA is a rapidly mainstreaming drug that is being identified more and more often.

The folks from Psychemedics Corporation came to our office last week and shared what they had had as one year of experience with identifying it. You can go to their website and certainly pick up their information, but the bottom line is that when they began to run the modified analysis to pick up MDMA, they were almost finding an MDMA positive for every other amphetamine positive. And those were mostly meth. The idea is that about 42 percent, after a year of analysis of what they were finding total in the amphetamine class, were MDMA.

Now, realize 85 percent or so of their work is in workplace areas. The preponderance of their test results related to what we were finding in the workplace. This is critically important for us to take away from meetings like this and to operationalize and to continue to keep the pressure on and the interest of the commercial assay developers, as well as policy and program personnel in individual companies as well as government operations.

Again, I want to thank the military folks for the leadership that DOD has provided in this process. We will continue to pay attention to this area.

Agenda Item: DOT Update MR. EDGELL (DOT): We have had quite a busy summer since our last get-together. Part 40 went into effect on the 1st of August, and leading up to that time, the telephone has been ringing continuously. It is amazing what people find out when reading it for the first time in the plain English language of Part 40.

We are also working on what we term technical amendments to clarify certain provisions of the rule and to address omissions or problems which were called to our attention by many of those phone calls that I just mentioned. On August 9th, we published in the Federal Register our amendment of clarifications and corrections to Part 40. Because we realized that the regulated parties that will have had little time to incorporate these technical amendments, the department in its implementation and enforcement work will provide a reasonable time to permit parties to make necessary changes in their procedures to comply with the technical amendments. Actually they were placed on display on the 31st of July and actually published in the Federal Register on the 9th of August.

With the technical amendments, conforming rules -- the conforming rules apply to each one of the six operating administrations -- have gone to the Federal Register at different times. The Federal Aviation Administration, Federal Rails, and Federal Transit had their conforming rules published on the 9th of August as well. U.S. Coast Guard and Motor Carriers followed up shortly thereafter, and the Research and Special Programs Administration package went to the Federal Register yesterday.

Those conforming rules will simply allow clarification between items that previously existed in the modal rules and were taken on by Part 40. For example, all of the substance abuse professional duties and functions previously existed in the modal rules. They were taken out of the modal rules because they were now presented in rule text in Part 40.

Also, we had an additional item that we addressed in the common preamble that was associated with the modal rules, and that was we reopened the comment period on the paragraph 40.25 in Part 40 that had to do with an employer obtaining the past two years' worth of drug and alcohol test results, testing activity on hiring a new employee. This was an item that we put in Part 40 as an alternative to a proposal that we made in our NPRM. We were petitioned by several associations from the maritime industry, and we simply reopened the comment period in responsiveness to the maritime industry for an additional 30 days. The bottom line is that 40.25 remains intact and unchanged in Part 40. We felt that the procedural burden and safety policy issues were met and that the maritime industry arguments were not persuasive enough to cause us to make any change to that section in the rule.

Additional items that we have available now. We have on our website two manuals: one, the manual for the urine specimen collection guidelines, and the second, the substance abuse professional guidelines.

I brought some paper copies of the conforming rules, the collection guide, and the SAP manual today, and I have them here. I have 10 copies each. If you don't have the ability to do the download, you can come and get one of these. If you do have ability to do the download, then I suggest that you obtain those items off the DOT website.

There is a third manual that is still in preparation at our office, and that is a manual for medical review officers. I would like to give credit to Don Shatinsky in our office for preparing the collection guideline and Jim Swart for doing the SAP manual.

Another item that we are updating is our breath alcohol technician/screening test technician model course. Linda Cross, who is on detail to ODAPC, has been working on these model courses to update them with the provisions of Part 40. These items, because of their size, will probably not be available on our website. However, our website has been updated recently. If you haven't checked it out, please do so at www.dot.gov/ost/dapc/

Because of the size of the BAT and the STT model courses, we will probably make those available through the Transportation Safety Institute, TSI, out at Oklahoma City. The BAT manual in the past has been provided through the Government Printing Office for around $25, and we're trying to make this available through TSI for somewhere around the same cost.

Even though we have put out the technical amendments, we have been getting a variety of questions, and we are adding to our website Q&As. These are on Part 40. They provide more detail. They restate many things in Part 40 in bullet fashion. This is something that we will keep maintained in some sort of fashion to archive old Q&As and add new Q&As, perhaps on a quarterly basis. That time frame frequency is to be determined with the number of questions and the feedback that we get from the public.

One other issue I'd like to mention is the Federal Motor Carrier Safety Administration has extended the comment period on a study that they are doing back to Congress, as part of a requirement under the Motor Carrier Safety Act of 1999, whereby medical review officers would provide to some database positive drug test results. This has been put in the Federal Register with a series of questions seeking comment on the feasibility of this database.

The comment period I believe runs through September 8, or about that time. I know the first one ended August 8th, so if they added 30 days to it, then September 7th or 8th. So, if you have not commented, you have not seen that, you can obtain that through the Federal Register, and we also have copies in our office and we can provide that to you so that you can comment on it.

Agenda Item: NRC Update DR. WEST (NRC): I think it would probably be appropriate to give you a mini-recap of the Part 26 rule before I give you, as much as I can, on the current status.

As you may recall, at the end of last year 2000, the commission approved a final Part 26 rule, fitness for duty rule. As a part of that, the NRC staff was instructed to move forward with publishing the final rule in the Federal Register. Before you can publish a rule in the Federal Register, you need an OMB clearance, so we went through that process. As a part of that process, you also open the rule up. It's not designed for opening the entire rule up for public comment, but the OMB clearance process has to be noticed in the Federal Register and does, in fact, have a comment period. It has a much smaller scope than would normally be the case.

But nevertheless, when we went through that process, we received considerable comment from the industry, some having to do with technical issues, some having to do with cost, just to give you a flavor of it.

The long and the short of it was that based on those comments that we received, the staff has gone back to the commission with, if you will, a summary of the comments that were received from the industry and also staff recommendations with regard to those comments.

I might add too, about this same time period, about March or so, when the OMB clearance was noticed, we also had occasion to meet with stakeholders on the rule. So, we have the benefit of those meetings and feedback on the rule as well.

The current status, in a nutshell, is that the summary of the industry's comments, as well as the staff's recommendations, are before the commission for their consideration, and we're waiting to get a response back from the commission. Typically the kind of response that we get from the commission would tell us, as it did with the affirmed rule, specifically what approach we should take going forward and what schedule we should use.

One last point is probably worth mentioning. The OMB clearance, therefore, is pending until we get the final word from the commission. We do have a website for Part 26. You can access this website through the NRC website, which is basically nrc.gov, and then you can get to the website for fitness for duty through the external website for the public. I'll try to keep you abreast real time of where we are relative to feedback from the commission on that website.

I know sometimes it may be a little difficult to find the pathways when you go up on our website, so if you have any difficulty at all, you could send me an e-mail at fitnessforduty. That should be fairly straightforward to remember, just fitnessforduty@nrc.gov, and I can send back to you the exact URL, if that would be of any help to you.

Hopefully it's clear what I've described. I wish I could tell you more details. You have to sort of appreciate too anytime an issue is before the commission, it's a little delicate to talk about it at any level of detail that you'd probably want to talk about it because it's in a pre-decisional mode at that point. But we're hoping that we'll get a response in the short term, and once we get that response, then I'll be able to talk a little bit more. As I mentioned earlier, I'll put as much detail as provided on the website once we get it. Just as a speculation, I would anticipate certainly by the next meeting I would be at liberty to talk a little bit more about the specifics of where we're going, what schedule and what needs to be done.

MR. STEPHENSON: Dr. Bush had just pointed out that one of the things we're trying to do with our website is create links, not only provide information that's ours, but also to make relevant links. We'd like to do that with the NRC site and to maybe make a link specifically to your fitness for duty.

DR. WEST: I'll give you a call and we can figure out how we do that. Thank you.

DR. SAMPLE (DTAB): You may also put the DOT's website on as a link.

DR. BUSH: It will be done.

Agenda Item: Proposed Validity Testing Policy

DR. VOGL (HHS): Each of you should have a copy of the Federal Register notice, as it was published on August 21st. It's somewhat difficult to follow. As you know, we have the current mandatory guidelines, and when you make a revision to a current regulation or guideline, you have to go through a process of deleting paragraphs, adding new paragraphs, revising sentences, things like that. You really have to take the 1994 version of the guidelines, take this notice, and see exactly what is being changed as you go through the document. We are not only adding a proposed policy for validity testing, but are also making some other changes.

Some of the other things that are actually occurring within the Federal Register notice. We would be requiring the Federal agencies to do validity testing on all of their specimens just as DOT is requiring their regulated industry to do. We are also giving the donor, in our case a federal employee, the right to request a retest of either a single specimen or the split specimen. As you know, our Federal agency program currently allows a single specimen collection and a split specimen collection is optional. If a specimen is reported as substituted or adulterated, then we are giving the donor the right to have that single specimen retested in a second lab, just as the donor would have the right to retest a split specimen in a second lab. We are also requiring and changing the policy that the MRO would be reviewing results on adulterated and substituted specimens, just as they do now for positives. It's trying to be very consistent with what DOT has in its Part 40. The proposed policy and the way it's worded is based on the reporting categories which are on the new custody and control form. Those are some of the changes and issues that you need to be aware of as you go through the document.

I'd like to highlight and outline what the proposed policy is and Charlie will try to explain it. Testing for a drug is pretty simple but when we get into validity testing, for some reason, it becomes very complicated.

Basically, every specimen would be tested for creatinine. You would only be required to do specific gravity if the creatinine is less than 20. You would have to do pH on every specimen. You would have to do a test for oxidizing adulterants, and then any additional validity test based on what information you may gather through the drug tests that are conducted or some other evidence, appearance, odor, smell, whatever, that somehow triggers a belief that there's something else there besides what has already been tested for.

With regard to adulteration, we propose that for nitrite as an adulterant, the cutoff would be greater than or equal to 500 micrograms/mL. The unacceptable pH range to indicate that a specimen is adulterated would be less than 3 or greater than or equal to 11. Or a specimen contains an exogenous substance, something that should not be in a urine specimen. Or an endogenous substance that is greater than its normal physiological concentration. You may also notice that for pH, it is less than 3, not less than or equal to 3.

For substituted, you would be required to have both an initial and confirmatory creatinine test and an initial and confirmatory specific gravity test where the results for creatinine are less than 5, which is different than currently. We had less than or equal to 5. And specific gravity less than 1.002. We currently have less than or equal to 1.001 or greater than or equal to 1.020. Basically, you need four results: two creatinine results that meet these criteria and two specific gravity results that meet the criteria.

For dilute, you need to have either an initial or confirmatory test result where the creatinine is less than 20 and a specific gravity less than 1.003. Those are the same criteria that we currently have and the creatinine and specific gravity do not meet the criteria for a substituted or invalid result.

For an invalid result. We tried to list all the things that we could think of which would suggest a problem with the specimen. There may be some others, and if anyone can come up with some additional criteria or results that suggest a problem with a urine specimen, please submit those as a public comment. We are open to suggestions. We think we have covered them all. Some of these things already exist in previous program documents and we have just tried to summarize them and put them all under one category. Invalid result -- that's a check box on the custody and control form. The first one, you're unable to identify the adulterant or interferant substance. There's something there, but you just cannot identify it, so it's an invalid result. It's somehow interfering with your drug test. You repeat one colorimetric surfactant test on two aliquots, and we'll get to those things later on. If you're using the same test twice, in most cases, depending on what that test is, you would be required to report it as just an invalid result. There's some kind of interference on your GC/MS confirmation assay on two aliquots. Generally speaking, when you do your confirmatory test for a drug and there's some sort of interfering substance, in most cases the labs repeat that test, go back, get another aliquot and repeat the test just to ensure that, in fact, there was something interfering with the drug analysis. When that happens, it can be reported as an invalid result. Somehow the creatinine and specific gravity results do not seem to make sense. We are trying to create a category there for some unusual pairs of creatinine and specific gravity readings. Or the pH is less than 4 or greater than or equal to 10, but does not meet the criteria for adulterated specimens. It is between 3 and 4 and 10 and 11.

Quality control requirements for doing the tests. We tried to clearly talk about an initial validity test and a confirmatory validity test as opposed to just saying a confirmatory test referring to drug tests. We are trying to be very careful and we added new definitions so that it is an initial validity test. Basically, you would have to do an initial validity test on one aliquot and a confirmatory validity test on a second aliquot. You are always doing two tests on two different aliquots to verify a result. You have to document the performance characteristics for each validity test before you use it or before you can report out results for that particular test. LOD must be determined for those adulterants that do not have a cutoff. Right now nitrite is the only one that has a cutoff. For everything else, whatever method you are using, you need to establish what the LOD is. Each run, batch, for the test must include calibrators and controls.

For retesting, the donor can request a retest of a single specimen or a split specimen, the bottle B specimen. The request must go through the MRO, which has always been the case. For a single specimen, an aliquot would be sent from lab A to lab B under chain of custody, otherwise lab A would just simply send the split specimen, bottle B, to lab B. You still have the 72 hours to request a retest from the time the MRO contacted the donor and told him or her that the result was adulterated or substituted.

Retesting a specimen for drugs. The second lab uses the confirmatory test. If you fail to reconfirm a drug, we are putting in a policy that lab B would conduct validity tests on that split specimen or the aliquot that it received if it cannot reconfirm the drug. We are trying to establish a policy to find out why lab B was unable to reconfirm the drug.

As far as retesting a specimen for adulterants, when lab B gets that aliquot or split specimen, if it happened to be pH reported by lab A, then lab B needs to use its confirmatory pH test using the appropriate cutoff. If the original specimen by lab A was reported adulterated for nitrite, then lab B has to confirm the nitrite using the same cutoff, greater than or equal to 500, as lab A used for the bottle A. And if it's other adulterants, the lab would use the confirmatory test to reconfirm the presence of that adulterant that was reported by lab A.

If it's retesting a split specimen or an aliquot of a single for substitution, then for creatinine, lab B would need to use the confirmatory test with the cutoff less than 5. We are using the same criteria on the split basically that we have established for the primary bottle A specimen. For specific gravity, lab B is using the confirmatory test with the cutoff as we have for the primary specimen.

As mentioned earlier, submit your public comments in writing. We will scan them and then put them on our website under the public comment URL.

When the public comment period ends, we will begin working on the final policy which will take some time. We have to discuss and assess all of the comments submitted and provide either justifications or arguments for accepting or rejecting suggestions or comments. That goes in the preamble which is the first few pages of the Federal Register notice.

Time frames. I am not really sure. We will work as quickly as we can to go through all of the comments and come up with final decisions on what the policy will be. I would hope sometime early next year. At that point, we would still have to give the laboratories a few months to actually incorporate this within their programs. From a practical standpoint, I think the actual implementation of this is sometime next summer. The process takes time, and just as the NRC does, it has to go through OMB approval. They have 60 or 90 days to review documents. Hopefully, if they agree with the proposed notice and policy, it will go a little faster, but if they have any problems with it, then it just delays the process.

Attached to the Federal Register notice is a spreadsheet. It is a draft, but when we get to the final policy, the spreadsheet will be very helpful for the laboratories.

DR. SMITH (DTAB): If bottle B is sent to another laboratory to reconfirm substitution, does that laboratory just check for creatinine and specific gravity?

DR. VOGL: Yes, assuming that bottle A was substituted, it's normally an issue of what the reading is on the split. It's there. You are going to get a creatinine reading and a specific gravity reading. The issue is did the readings meet the substitution criteria.

DR. SMITH: What if it's normal? Bottle A is substituted, but bottle B is normal?

DR. VOGL: That would be reported to DOT and then to us. We would do an investigation if it's that different. If the substituted bottle A were 4.8 and 1.001 and B was 5.2, that's a canceled test.

DR. SMITH: I brought that up because you could envision some drug user diluting bottle A. You find no drug. You find a diluted specimen. Then you only check bottle B to see if it's substituted, and it's not, and he gets a canceled test. Essentially a drug user just got by.

MR. LoDICO (HHS): In that case, it is the fault of the collector because the collector is supposed to present to the donor a collection cup. The collector receives from the donor the collection cup with the sample in it and then splits it in the presence of the donor. I agree with you. In most of these cases, it ultimately revolves around the collection process.

DR. SAMPLE: This guidance, consistent with the guidance that was put forth in the new part 40, does specify the initiation of an investigation in such an event so that it's not left with the MRO. It will proceed beyond that so that any corrective action that needs to be taken can be initiated.

MR. EDGELL: I'd just like to make a comment on the collection itself. Just as a reminder, Part 40 has established a standard collection kit. As Charlie mentioned, the donor would have a cup rather than the two bottles, to take only the cup into the restroom to provide the urine specimen in. We have queried the laboratories, with a letter from DOT to each one of the laboratories, reminding them of the standard for the kit and the form, for that matter, and providing their responses to HHS to verify those products during the next inspection. That will take some time, six months or so, to play out. We are also strengthening this process by requiring specific training of all the collectors. While the collections have to take place using the current Part 40, we are allowing some time, about a year and a half, for all of the collectors to be trained. Hopefully the problem that Mick speaks of will be lessened greatly by training and by the standard kit. But in the case of a substituted specimen where the criteria is not met on the retest in the second lab, that would be a canceled test.

DR. BUSH: I just want to sum that up a little bit. This goes back to the beginning days of drug testing that was done in the military programs and civilian programs. One is always concerned about the integrity of the collection. We are looking at training and accountability of those trained collectors for their part in the process. This is why we want reporting to agencies, to us, to DOT, to try to get a handle on what is happening out there. Many times names, times, places are not attributed, but we want to change that around a little bit and look at exactly what is going on there with the detail sufficient to investigate and to look at accountability and retraining when appropriate.

MR. LoDICO: The decision tree or table originated from the last DTAB meeting. As Walt indicated, if you just read the Federal Register notice, it is very difficult to establish where some of the rules originated from. In an effort to explain this using plain English, we have created a summary table. This is a draft. The intent today is to try to break down the different types of possible scenarios that could occur when doing SVT testing.

What we have done is broken this down into the different categories. You have creatinine and specific gravity as one category. You have pH. You have nitrite, chromate, halogen, peroxidase, glutaraldehyde, and pyridine. And we have what is known as an oxidizing adulterant test, then surfactant, and lastly interfering substance.

At this time, I asked Barry Sample to assist in explaining the table.

DR. SAMPLE: This really was a team effort in drafting the Federal Register notice and this spreadsheet. I want to recognize the team. Yale Caplan, Denny Crouch, Frank Esposito from Lab Corp, Charlie LoDico, David Kuntz from Northwest Toxicology, Mike Baylor from RTI, and myself. We had a group of seven people who came together and had multiple marathon conference calls to put this together.

Recognizing that we did not necessarily have the option of writing in plain English we wanted a plain English type of document that would summarize and distill the words and the meanings into something that was easily understood by everybody. Again, I do want to emphasize at this point it is a draft corresponding to the notice of proposed rulemaking.

As we look at the creatinine and specific gravity, the definition of substituted was modified to be a less than 5 rather than less than or equal to 5 and for all of the cutoffs that were less than, in the interest of simplification, eliminating any confusion related to truncation or rounding and also being consistent with cutoffs for the drugs. The less than is really a mirror image, if you will, of a "greater than or equal to" cutoff. All of the "less than or equal to" cutoffs have been converted to "less than" cutoffs in this document.

For substitution, four tests meeting the requirements on two different aliquots. Creatinine and specific gravity on the initial test and creatinine and specific gravity on the confirmatory test must meet the criteria for substitution for the specimen to be considered substituted.

The laboratories had also found numerous instances of incongruent or inconsistent results. There are sometimes a number of specimens that have a creatinine that is less than 5 on two aliquots, but the specific gravity may not meet the criteria for substitution. It may be a 1.005. It could be a 1.010. Under previous guidance, that may be reported out as an invalid. Depending upon the cutoff, it could even be considered a dilute specimen. In the interest of clarification and I think pointing out that a less than 5 is clearly an abnormal result, two aliquots with a less than 5 for creatinine would be considered an invalid result.

We also have a remark section on the spreadsheet to clarify the meaning of the invalid result. If people remember the current verbiage for invalid drug test, it does not provide much information to the medical review officer reviewing the results. It just says invalid result, unable to obtain a valid drug test result. Well, that does not really say a whole lot to the medical review officer. It institutes a lot of calls and questions going back and forth between the MRO and the laboratory and certifying scientist. In this document we're proposing that there be additional remarks to provide the reason for that invalid result on the test.

There were some cases where a specific gravity of 1.000 was observed. In other words, the specimen was very much like water. However, there may be some amount of creatinine there, and the specimen still did not meet the criteria for substitution. In that case a specific gravity of 1.000 on both an initial and confirmatory test would be reported as invalid with an appropriate message.

The fourth case is where you have a creatinine in the range of 5 to 20, but a high specific gravity, 1.020 or above, again clearly an incongruent specific gravity and creatinine result. You would expect with a specific gravity of 1.020 that you would have a higher creatinine, something well above 20, and again two results meeting that criteria would be invalid and no change in the definition of a dilute specimen. That would only require one aliquot. You do not have to meet the dilute criteria on two aliquots in order for a specimen to be reported as dilute.

Moving down to pH, there are several scenarios from a methodological perspective for driving an adulterated result. The basic tenant for pH is that you have two validated analyses with validated methods that are capable of performing at the specified cutoffs. As much as possible, as we went through this spreadsheet, we tried to leave the choice of methodology open as long as it met the performance characteristics and was properly validated and documented.

If there is a colorimetric pH test -- and there may not be very many of them -- that is capable of performing at the specified program cutoffs of 3 and 11, that would be permitted as a valid initial specimen validity test, and then a pH meter test would be required for the confirmatory test, again at the specified program cutoffs of less than 3 or greater than or equal to 11.

In the next case, if the laboratory is using a colorimetric test that is not capable of accurately differentiating at the specified program cutoffs of 3 and 11, but they have a validated method that is able to provide accurate results at some other cutoff, such as 4 and 10 or 4 and 9, which is common for a number of the colorimetric pH tests, that could be used then as an indicator that a focused pH meter test would need to be performed on the initial aliquot, to have that required first validated procedure at the program cutoffs. There is no requirement that laboratories use a pH meter test on the initial test. It's just that if you're using a colorimetric test that is not capable of performing at the program cutoffs, you can use that as a reflex, if you will, to then perform a focused pH meter test on that initial aliquot. And then in order for the specimen to be reported as adulterated, it would require a second pH meter test at the program cutoffs.

Since the pH meter test is considered the gold standard for this analysis, two pH meter tests on two different aliquots for the initial test and the confirmatory test would be permitted, although I wouldn't expect very many laboratories to be using that because it is not very production friendly.

For laboratories that have a colorimetric pH test in the range of 4 and 10, if they then follow that up with a confirmatory test and the confirmatory test falls in the range of 3 to 4 or between 10 and 11, that is really in an abnormal pH range but one that does not meet the criteria for an adulterated specimen. That would be reported out as an invalid result with the appropriate remark that an abnormal pH was detected. Likewise, if the laboratory did a pH meter test, as the initial test or as part of a focused follow-up initial test, and then on the confirmatory test, one or both of the aliquots were in that 3 to 4 or 10 to 11 range, that would permit the specimen to be reported out as invalid with an abnormal pH.

In the next grouping, we are starting to look at some of the oxidizing adulterants. This case specifically relates to nitrite. In recognition that laboratories may take a variety of analytical approaches for the detection of nitrite and oxidizing adulterants, those are represented in the initial test column. Some laboratories may opt to use a general oxidant type of colorimetric test that is capable of detecting not only nitrites, but could also detect chromates and halogens, such as bleach and iodine. If the laboratory is using a general oxidant type of test, it must be able to detect, from the perspective of requiring additional testing, at a minimum the equivalent to 200 micrograms per mL of nitrites or 20 micrograms per mL of chromate as chromium VI. Those really are equivalent since it is a general oxidant test. It is not a nitrite-specific test in this case or a chromate-specific test, but they must be able to detect either 200 of nitrite or 20 of chromate as a limit of detection to then require a confirmatory test on a second aliquot. In order to be reported adulterated for nitrite in this case, that would require a nitrite-specific colorimetric test that has been properly documented and validated, or laboratories may choose to use alternative methodologies such as ion chromatography or capillary electrophoresis. It is not meant to be limiting. The point of this is that specific validated methods would be permitted as long as they can specifically identify nitrite.

The other option for reporting a specimen adulterated for nitrite would be the use of a nitrite-specific colorimetric test as the initial test and then use a second nitrite-specific colorimetric test using a different analytical procedure. In order to call a specimen adulterated for nitrite, the laboratory would not be permitted to simply repeat the same method for detecting nitrite on the second aliquot of urine. That would not be considered a confirmatory test in that case. It must require two separate, different analytical colorimetric procedures in this case.

The third case representing nitrite here is if the laboratory is using a general oxidant colorimetric test as the initial test, and then when they perform the confirmatory test, they detect a nitrite using their nitrite-specific test in the range of 200 to 500. This really incorporates previous guidance published as part of PD-35 and 37 in recognition of the fact that there are specimens with nitrites less than the cutoff that may impact short term and certainly long term the ability to detect marijuana especially, and in that case, the specimen would be reported as invalid. Based on the literature review and previously published studies, 200 to 500 is still well above the levels that would be expected to be found in urinary tract infection or other clinical types of specimens.

The fourth case under nitrite is similar to the one immediately above it where the laboratory is using a nitrite colorimetric test, specific, method one, where the nitrite is greater than or equal to the program cutoff of 500, and on their second nitrite colorimetric test, they found a result greater than or equal to 200. That would be using the same method for both the initial and confirmatory test.

I should point out the remark in these two cases for the invalid result would be abnormal oxidant activity and will be consistent with that verbiage for the invalid for all of the oxidizing type of adulterants. In order for an invalid test to be reported, it does require two separate aliquots of urine.

We move to chromates. This is very similar to the flow that we discussed under nitrites. A laboratory may use a general oxidant type of colorimetric test with detection of an oxidizing adulterant, either using 200 micrograms per mL of nitrite or 20 micrograms per mL of chromate. And then that initial screening test would be followed with a more specific chromium VI -- it's not just a chromium test; it's chromium VI specifically, which is the oxidizing agent colorimetric test or ion chromatography or atomic absorption, ICP, MS, capillary electrophoresis, a variety of analytical approaches that would be able to accurately detect chromium VI as an adulterant would be permitted. In the event that it is adulterated, it would be reported as presence of chromium VI detected, not chromates or chromium. We are specifically keying in on chromium VI for this adulterant. If a laboratory has available to it two different chromium VI-specific colorimetric methods, that could be permitted. They could use method 1 for the initial test and method 2 for the confirmatory test and then report it out as adulterated. There are no program cutoffs for chromium as there are for nitrite. In the event that a laboratory does not have available to it two different chromium VI-specific methods, they are able to do one specific method for chromium VI, and then repeat that same method on a second aliquot of urine, then it would be reported as invalid - an abnormal oxidant activity.

For the halogens. If the laboratory is using a general oxidant type of screen and then they perform a halogen-specific colorimetric test, again that is documented and validated, they would be able to report it out as adulterated. Since they have not necessarily specifically identified either bleach or iodine with a test that responds to a variety of halogens, it is reported out as specimen adulterated and halogens present without specifying the specific halogen that was detected. If a laboratory does have available more specific means of identification for something such as iodine, then they could report it out specifically for the specific halogen that was detected in that event.

If a laboratory uses the sniff test, checks for odor, detects an unusual odor as the initial test, that would be considered acceptable as an initial test, if they followed that up with a halogen colorimetric test, but in that case it would not be permitted to be reported as adulterated. It would be reported as an invalid result because there are not two specific analytical procedures for the detection of halogens in that case.

For peroxidase, this is also the oxidant class. If a laboratory was to perform a general oxidant initial test and then a specific peroxidase test as the confirmatory test on a second aliquot of the urine, they would be permitted to report the specimen as adulterated and peroxidase present.

For glutaraldehyde, laboratories oftentimes have relied on characteristic immunoassay interference as their initial test or they may perform a specific aldehyde test for that initial test. If they follow that up with a GC/MS analysis for glutaraldehyde and they detect glutaraldehyde greater than their LOD, they could report the specimen as adulterated. If a laboratory is unable to have a specific confirmatory test for glutaraldehyde and they rely on either a colorimetric spot test for aldehyde or a repeat analysis on a second aliquot and are getting the same characteristic immunoassay response, they would report it as invalid and they would indicate an immunoassay interference, which is similar to how laboratories have been reporting those results currently.

For pyridine, perhaps fading in popularity of the oxidizing adulterant type, the pyridinium chlorochromate, but it is still out there, the laboratory could perform a chromium specific test as the initial test, and then do a GC/MS analysis of pyridine where it is detected greater than the LOD. The specimen would be reported as adulterated. Likewise, they could also do the general oxidant test followed by the GC/MS analysis of pyridine to report the specimen as adulterated.

For laboratories that don't have all of the specific confirmatory tests available to them for all of the oxidizing adulterants, if they were to perform a general oxidant initial test on the first aliquot and a general oxidant test again on a second aliquot of the urine, they would be permitted and should report it as an invalid result with an abnormal oxidant activity detected.

This approach was taken because the laboratories may not have all of the analytical procedures available to them to specifically identify all of the possible adulterants, and it leaves open the option of reporting an invalid result. But because of the implications of an invalid result in the new guidance, there is a requirement that the laboratory always perform two tests on two different aliquots of the urine in order to report a specimen as invalid.

In the case of surfactant, there are colorimetric tests available for the detection of surfactant. If a laboratory uses two different methods, two different analytical procedures, both with a cutoff of 100 micrograms per mL of the dodecylbenzene sulfonate as their reference material, they would be permitted to report a specimen as adulterated with the remark that surfactant was present. If they do not have two different surfactant methods available to them and they repeat the same surfactant method on a second aliquot of urine, then that would be reported as an invalid result with the remark of possible surfactant activity. If they are relying on a foam or shake test, that would be permitted as an initial test so long as all of the specimen processing staff or the individuals involved in interpreting that foam or shake test have been properly trained and it is documented that they can differentiate protein from soaps, from different types of agents that may cause bubbling in the specimen when agitated. If they have done that and they perform a colorimetric test on a second aliquot of the urine for surfactant, they would be permitted to report the result as invalid.

The last example is the GC/MS interference. What I think probably got a lot of this specimen validity testing, adulterant testing going for nitrites going in the first place, is that laboratories started seeing a characteristic loss of internal standard in the confirmatory assays, particularly for marijuana. If the laboratories do observe that type of characteristic GC/MS interference and they have observed that on two separate aliquots of a urine specimen, they are not just looking at the loss of internal standard in one analysis, but they are looking at it in two confirmation analyses, then they can also report the specimen as invalid with the remark of interfering substance.

MR. CROUCH (DTAB): Barry, should that be less than 70 percent recovery? Or am I misreading something?

DR. SAMPLE: Yes.

MR. LoDICO: Yes. We apologize. That's why it's a draft.

DR. SAMPLE: It's decreased by more than 70 percent.

DR. ISENSCHMID (DTAB): 30 percent recovery then.

DR. SAMPLE: 30 percent recovery or decreased by 70 percent or more. I remember we went back and forth on that one.

MR. CROUCH: So, it's less than 30 percent recovery.

DR. SAMPLE: Yes, right. And that's a "for example". That's not "an etched in stone." If it's 69, it's one way; if it's 71, the other. Or if you want to look at it the other way, 31 one way or 29 the other. That's an example, not a program cutoff of 70 percent. It's what the laboratory is able to document and set as a valid indicator for the procedures and methods they use in their laboratory.

MR. JONES (DTAB): Going back to creatinine and specific gravity and example 4, I recognize that on the CCF for the result, we are going to put "invalid result." But I'm just wondering, so there is no confusion whatsoever, if it might be worthwhile to just state the fact that the creatinine is greater than or equal to 5, but less than 20.

DR. SAMPLE: In the remark?

MR. JONES: Yes.

DR. SAMPLE: They don't think that it might be in the substituted range?

MR. JONES: Even though invalid is checked, you can just eliminate that question.

DR. SAMPLE: That's a good point. Again, I would encourage everyone to read and digest all of this. Please comment to the notice of proposed rulemaking by the comment period so that we can have all of your feedback in trying to put together the final rule.

MR. CROUCH: It may be beyond the scope of this table, but I think it would be nice if somehow we included the MRO's action on these various categories.

DR. BUSH: There is a separate table for that.

MR. CROUCH: Is that today?

DR. BUSH: No, because a lot of that is going to depend on what decisions are finally made concerning these criteria. These evaluation criteria that have been put up reference even what laboratories report, how they report. Then we've got to take a look at the MRO. We have a draft based on this, but I don't think it's time to roll that out now until we get a little further along with understanding the comments and concerns people have about this. Yes, we have the MRO table to go after this. Absolutely. The MROs who have seen this have asked specifically for guidance on that.

MR. EDGELL: I have a couple of questions. Talking specifically about, let's pick, nitrite where a laboratory could have method 1 and method 2 and another laboratory only has, let's say, method 1, could you list what you believe the reasons would be for a laboratory's inability or unwillingness to go the full nine yards and have two methods? Is it cost, personnel, possible litigation?

DR. SAMPLE: Probably the answer to your question is yes.

MR. EDGELL: What would be the primary reason? Top three.

DR. SAMPLE: I think that's going to vary from lab to lab based on their capabilities. It's not a trivial matter to set up a method and validate it and have the appropriate documentation to support their analytical results. While I think a number of laboratories probably will migrate to having specific methods, it is probably a process that's going to take some time just because of what is involved.

DR. CHILDS (DTAB): I'll just go out on a limb here. What we see, as regulatory things change and get added, the end users, the employers, say, I'm not going to have to pay for that because that's now included in the regulations. There is a tremendous resistance to want to include who's going to pay for the testing. The bottom line is the cost that the laboratories incur in the method validation, in supporting the extensive testing menus, and how you pass that through to an already challenging opportunity to continue to have licensed laboratories, certified laboratories and to have the end user, in this case the employer, in pre-employment settings, they're like, well, it doesn't really matter.

I'll be real blunt. I don't think they care. They want to be able to make an employment decision, and if somebody is adulterating their sample, they're not going to be sent to EAP because it's an adulterated sample. They're not going to handle it. The less information they have to have to make a decision, the better off they are. They don't see this as improving the quality of the program. They see this as a longer delay period in making an employment decision. That's the kind of feedback I've been getting for the last two years with all this specimen validity testing.

I think we are all trying to make the program better and trying to keep the erosion of the program from all these cottage industries that have sprung up, but the bottom line I think for most of the laboratories, the ones I've inspected, the ones I'm part of, really is the bottom line. It's the bottom line, whether how much does it cost, the staffing to do with the method validation, the certification, the litigation. The whole thing is really rolled together, and who is going to pay for that cost to do that.

MR. STEPHENSON: We all pay for the cost whenever someone decides that they're going to cheat on a drug test because every one of us winds up having to go through this kind of process and look at all of the other issues that are related to it. Somebody is making money by selling a product. We've written a code book and a cookbook, spreadsheet here that offers up the next product group for people to find a wedge in how to beat the drug test. Alternative specimens and technologies are another area we are going to go because this is going to be one of the ways that we are going to vouchsafe the process. Whenever you have someone who makes the decision that they're going to use either substitution or there's an adulteration process to get around their vulnerability of being tested, that individual is more of a threat to the whole system than anybody else. 95 percent of all the specimens that go through our labs are generally negatives, and they're good negatives. That's what we're buying in this kind of program. We're not buying positive test results. We're buying negatives. Our whole system is predicated on the deterrent value of this. When we have problems in this domain, this removes that deterrent and allows anyone who chooses to to step in. We are regaining our own safe streets by doing what we're doing here, and I don't know how you get around paying for that. That is a cost that every single person that we're involved with in all domains, whether it's the employer, the person who's being tested, the labs, the general public, winds up paying a price for.

We've got to do it right every time and we don't have that as an option. So, that means we've got to go through this kind of process every time that someone out there in a cottage industry decides that they're going to formulate and sell a new product.

Somehow we haven't reached the level of moral outrage that people are doing this, that they are selling these products, that we have perverted the science and the technology. It's an okay application of business principles to some. We have magazines and websites that are dedicated to this. We are overwhelmed in the web industry and the web environment by those offering to beat the test rather than to explain the problems of drug use and the difficulties that are out there for people who have drug problems.

We are tilting that back. This is a very good process we are going through. You guys have held the course in a way that is very hard for me to imagine happening even 10 years ago. I don't see this as a part of my mind set or my skills. We get to an age where most of us are and we have pretty well established habits and scientific principles that we've learned and things that we do because this is the ethical way to do it. But if you look at what's happened, we've been overcome by events. This whole issue that's out here with specimen substitution and adulteration is an issue that even today, as laboratorians or as program managers, we really don't want to understand that it's a real thorn in our side. We'd like to have it go away. We'd like to only deal with the negatives. We'd like to have it simple. We'd like to have it cheap. We'd like to have it one way. But it's those few people who are willing to push the envelope and say, oh, yeah? They're not going to get away with it. Oh, yeah? I'm interested in finding out what it is that's in that specimen that I don't see. That's a unique spirit that's out there, and some of the folks who have sat together to put this spreadsheet together represent that leading edge. It is there because that is an invaluable contribution that we are not paying for. That comes to us separate. So, somehow whatever that front edge group does, the rest of us get dragged behind, some willingly and some not so willingly.

But this is not a corporate bean counter cost issue, and it's not a litigation control issue. This is much more than that, but it's something that's a living, breathing process that we're all a part of and have to be a part of as long as we're going to do this work. If we're not going to do it just the way we're doing it here, we might as well stop because ultimately we're going to lose and the process will not be worth doing. And you've made all the difference in the world. The way I look at coming to work, it's still exciting, it's still interesting because it isn't stale, and it's something that is definitely going to be different and challenging from day to day. And I thank every one of you for working on this project and making this presentation to us. This is your template. Now you've got to go back and do this for all those alternative specimens and technologies as the next round. Learn what you've learned from this one and get ready for the next batch.

MR. EDGELL: The general oxidizing test. How would you characterize the laboratories' use of that, their decision to go in that direction? If you had, let's say, as Dr. Childs was talking about, laboratories that perhaps don't want to invest in the cost, the staffing, the validation, the litigation, faced with employers that would just as soon not know, does this offer an opportunity for a laboratory to meet the minimum requirements of the guidelines and nothing more? Or would this be used, say, I'll develop my two methods for nitrites and use this for other adulterants until I have the time and the wherewithal to come up to speed on those? Would you see this as taking an opportunity to take the lower road?

DR. SAMPLE: I think that we'll probably see a number of laboratories move in this direction. There are several commercial reagent vendors that are now marketing general oxidant type screens. From a laboratory perspective, I would find that much more convenient than running a specific nitrite test on every specimen, a specific chromate test on every specimen, a specific halogen test on every specimen, because as was put forth in the Federal Register notice, at a minimum the laboratories must test for oxidizing adulterants, which includes nitrite, chromates, and halogens. It's an "include but not limited to" menu. From a laboratory perspective, it would be a lot more economical, a lot faster and easier to do one test that covers the range of oxidizing adulterants, rather than having to focus my attention on each one of those groups or classes of oxidizing adulterants individually.

Will there be some laboratories that will do a general oxidant test as method 1 and a repeat general oxidant test on a second aliquot and report specimens invalid? Certainly. Some will do that as a temporary stop gap measure, if you will, because at a minimum that's what they would be required to do until they can develop specific confirmatory tests. There may be some market pressures that come to bear as some laboratories are able to offer specific confirmatory tests and others aren't, and for employers that care, that could make a difference. There probably will be some market pressures driving laboratories to do a specific test.

But there may be some employers, as Paula correctly pointed out, that do not care about a specific test and they would be just as happy with receiving that invalid result, particularly on a pre-employment test. It's a de-selection process. You know, I'm sorry you didn't meet all of our criteria, prospective employee. We will move on to the next guy that we interviewed.

There are some laboratories that are just going to continue to do the bare minimum that's required, and certainly that is going to occur. But I think you're going to see more laboratories migrate towards specific confirmatory tests, at least for some of the more common adulterants.

DR. CHILDS: I think that when we look at doing the B bottle, the splits, when there is no confirmation of the drug and then drop into looking for specimen validity criteria, this is a good map for that. I think it's probably going to be prudent or advised for the medical review officer, and that may be part of the medical review officer decision tree, to make sure that the lab that's going to do the split testing has the capabilities of doing the more extensive panels for the specimen validity testing so we don't have to ship it to yet another laboratory for that.

MR. JONES: I'd just like to say this is exactly what the laboratories would like to see, something like this, because it puts it in a format that's going to give some direction. I think this is a great step.

MR. EDGELL: Just to follow up, certainly if an MRO has a specific adulterant that they are trying to have reconfirmed, they would need to know where to send that. That to me seems like that it would be asking for a laboratory capabilities list. Do you think there would be reluctance on laboratories' parts or welcome to participate in such a disclosure?

DR. CHILDS: First of all, laboratory lists now are published on the website, which are the certified laboratories. Now the certification is for the standard menu of drugs and confirmation cutoff, et cetera. Perhaps have an appendix to that saying that these laboratories -- I'm going to call it willingly or have volunteered to put on the website here's the information we have for the laboratories. They're willing to say that they will take test B samples if they're looking for the specific types of analytes in the confirmatory process for the specimen validity testing. So, that might be something voluntarily, and as they bring up a new procedure and get it validated, labs could just send a quick note to the program and say we can now do halogen testing.

I had a call the other day from a laboratory on the west coast who was asking could we do iodine specimen validity confirmations, and we didn't have that up and running. But we do get those calls. The lab directors do call around to each other asking can you do this, we have a call about this particular type of situation. There's sort of an informal network now.

I think putting that on the web might be very helpful to medical review officers, to the laboratories. As you said, there may be some advantages from this lab has a full compendium of all the specimen validity testing.

MR. EDGELL: With many possibilities here, it seems like something more formal would almost be a necessity.

DR. BUSH: Just as an aside to that, we're recognizing that this is all new cheese, very new cheese for us as a certification program. We have always had a program where we certify labs that meet the minimum requirements of the mandatory guidelines. Yet, now we're talking about differences in capabilities. We're wrestling with that in our own division trying to figure out how can we do this. DOT certainly is wondering how they can do this and accomplish our goals, yet not become the marketing page for some labs and not others, and how do you keep it current. There's a whole bunch of additional issues that come to bear on that. So, any and all help and suggestions as to how to do this would be greatly appreciated, and it's all part of this development process once this Federal Register notice comes out.

It's funny. Try as we might to write this in words consistent with the old mandatory guidelines, where we all felt most comfortable was with these tables. We did the tables first, and then you try to write it to publish it in the Federal Register.

As we go through then, we have to figure out how to recognize, for the sake of the donor, the medical review officer, and the employers to whom these questions are going to be posed initially, I want my B bottle tested for this particular analyte. Well, right about now, Ken Edgell and I are getting an awful lot of calls. Our respective offices are getting an awful lot of calls about this. We are in this with you and looking for a reasonable way to approach this.

DR. GUARNIERI (DTAB): I just want to congratulate the group because I think as MROs, to see a table like this is great. It helps us in what was done and how it was done and why it was done. We look forward with finishing this off with an MRO decision tree.

MR. STEPHENSON: You are volunteering to lead that group. Is that correct?

MR. LoDICO: We want you to be a part of this group.

DR. GUARNIERI: Will be a part of.

DR. CHILDS: I just have one other question. Will a donor be able to ask for an invalid result specimen to be retested at a B laboratory? What's the outcome for an invalid result?

MR. LoDICO: We have not considered that as a condition for the donor to have an option to have a retest because it relies on the MRO, as it is written in the Federal Register, to do an interview. At that point they decide whether the invalid statement warrants a recollection under direct observation or is just put back in the pool.

DR. GUARNIERI: Or retested. They are the three options that we have as MROs.

DR. SMITH (DTAB): I have a related question. On a substituted specimen, does the MRO check out medical reasons why the specimen might have been that dilute or whatever?

DR. GUARNIERI: Yes.

DR. SMITH: To what extent?

DR. GUARNIERI: Doing a reasonable history, trying to understand how someone could have, but, at the same time, understanding there probably is not a real good reason for it either, but you have to ask the questions. You never know.

DR. SAMPLE: The language that was adapted here is almost verbatim the same, except it is not plain English. It had to be put back into the old Federal Register format, but essentially the same verbiage as what appeared in the Part 40, that there is an interview with the donor by the MRO for all adulterated and substituted results to determine if there is an alternative explanation for that. That also includes invalid test results and additional tests may be performed as part of that review process in order to document that the donor could have naturally produced, say, a substituted result or that there's a reasonable, plausible explanation for the finding that was made. It really is the same process that was first suggested in the new Part 40 rules.

DR. BUSH: And that said, here's a promissory note from us at the Division of Workplace Programs that we will have state-of-the-science update number 2 and number 3 coming down the pike to look at chromium (VI) excretion by humans. Anyone who has seen the movie Erin Brokovich knows that chromium (VI) is toxic, carcinogenic, all kinds of things, not to be confused with the chromium (III) that is in chromium picolinate and other dietary supplements.

One of the other hats I wear is training MROs. I can say this to my fellow chemists and to Dr. Guarnieri that the medical doctors went into medicine because that is what they do best. Then there are us chemists who went into organic chemistry because that's what we do best. Many times we have to bring that chemistry back to the docs. Now it's inorganic chemistry time and going back to chromium (VI) and chromium (III).

We are finding that because we live the interesting life of chemicals contained in specimen adulterants and their promiscuous advertising on the Internet and in High Times, we have to go to this level of detail. We have to put out a helping hand. As we did with our state of the science update number 1 on substituted specimens, we're going to have to do this on chromium to just get people to understand this isn't just chromium picolinate that is the cause of a chromium in the urine. Oh, but not at all is that the case. Yet, people don't understand that to the degree we want them to, and if we can get a document like this up on our website, it will be good common knowledge, good common ground from which all can read and then go seek out the references.

The same with nitrites. The calls have certainly come to me directly. Just how much bacon, bologna, and cold cuts do I have to eat to produce this nitrite positive because I am confident that is why my specimen contains nitrite at an exorbitantly high concentration.

We are going ahead with that and doing the literature reviews now and preparing the drafts.

Agenda Item: Draft #4 Mandatory Guidelines for Alternative Specimen Testing

DR. VOGL: Everyone should have a copy of Draft 4, dated September 5, 2001, Mandatory Guidelines for Federal Workplace Drug Testing Programs. It might be good to have that copy in front of you as I highlight the changes that were made.

Last December we presented draft 3 and it is on our website. As of today or tomorrow at the latest, draft 4 will also be on our new website. In draft 3, we had highlighted changes which were made from draft 2. Draft 4 does not have any highlights. All the highlighting was taken out. It is essentially the final document that we are planning to use in preparing the Federal Register notice. We are working on the preamble, which is almost as long as the guidelines. The preamble explains why we are doing all this, where we came up with our reasons for doing certain things, and the justifications for what we are proposing. Hopefully, early next year, we will have a Federal Register notice published with a rather long public comment period because this is totally new cheese. Just to remind you, this is written in plain English. It is totally different than the current guidelines. You have to take my word for it that everything in the current guidelines is in here. Let us start with the premise that I have not missed anything in the current guidelines in rewriting it in a question/answer format.

On the next slide, there are just a few general changes between this draft and draft 3. There were several citations to our old website, all that's been changed to the new website, http://workplace.samhsa.gov./ We have new questions, and as I go through the draft, you will see what those questions are. When you go through it, and if you look at draft 3, question 5.7 does not match 5.7 in draft 4. Do not be discouraged. It has probably moved because we did add questions and questions were renumbered. I do not believe we deleted any question.

Let's start going through the draft. This is where I think you might find it helpful to follow along by paging through the draft as I point out the changes.

Question 2.2. We revised the circumstances for testing. In the preamble, we will specifically ask public comment on this issue. Compared to draft 3, we had primary reasons for collecting a particular specimen and then secondary reasons. We are going back to an earlier draft and just listing the circumstances for the various specimens that would be in the program and asking comment on the appropriateness of all of those reasons for collecting each specimen.

Question 2.4, for oral fluid, would require collecting 2 mLs of a neat specimen. There is more detail farther down the road on collection, but we are talking about a 2 mL specimen being collected, oral fluid, not what a device collects. There are so many different ways of doing oral fluids, we felt it necessary to require a specific amount of oral fluid to be collected and then, depending on the device, either on-site testing or sending the specimen to a lab.

For the sweat patch, we have incorporated a specific time frame. We originally just had sweat. Now we are saying there is only a sweat patch, at the moment, that is FDA cleared. Let's say sweat patch and require that it has to be worn from 7 to 14 days. That is the requirement if you are going to use a sweat patch.

For urine, the current guidelines allow a single specimen collection and split specimen collection as optional. Keep in mind these guidelines are specifically for Federal agencies. We are going to request the Federal agencies to specifically comment on a proposal that all collections would become split specimen collections. When the new guidelines are in effect, whenever they're implemented, a single specimen collection would be eliminated.

Question 3.1. In the current guidelines, a Federal agency is required to do THC and cocaine and has the option to do the other three. For practical purposes, all Federal agencies are doing all 5. We may as well put that in the guidelines, require agencies to do all 5. Again, Federal agencies would be requested to comment on that specific change in the guidelines.

Question 3.4, proposed cutoffs. I'm going to skip over that. When I'm finished, Charlie is going to talk about the cutoffs.

Questions 3.4 to 3.8, are entirely new. We published a notice in the Federal Register for incorporating specimen validity testing into the guidelines. If you look at 3.4 to 3.8, you will see it is all validity testing and it is exactly what we have in our other Federal Register notice. But the assumption is, it's already in place by the time this is implemented. It is a draft and it uses the same wording, but it would change as the Federal Register notice for our current validity testing changes. It is in a question/answer format. I believe it is consistent with what is in the other Federal Register notice right now. We are going to specifically ask for public comment on validity testing for the alternative specimens. Since this is all new, we believe that for oral fluids, sweat, and hair, the laboratories doing the testing may have information that specifically deals with the possibility of specimens that they receive that are not valid specimens for their programs. We would ask for specific comments and information on potentially what validity testing might be necessary or could be done for some of the alternative specimens.

Subpart D, collectors. The only real change in that subpart is we had that the organizations that would certify collectors would maintain a list of certified collectors and that would be put on our website on a monthly basis. That is unrealistic. There is no way anybody can keep things updated monthly. By the time you get it there, you are creating another list. I think quarterly is more reasonable to keep an updated list of certified collectors on our website. That is the only change in that subpart.

Collection sites. The only thing, as I mentioned earlier, in section 5.5 is that we talk about collecting a neat specimen for oral fluids. It would be in an appropriate container. Some sort of container would be used for collecting the 2 mLs of specimen, and then it would be used either for on-site testing or sent to a lab for testing.

Subpart J, blind samples submitted by an agency. We have a requirement that each Federal agency, when they start testing and using a laboratory, include a certain number of blind samples in their program and then do it on a regular basis. The DOT Part 40, in its blind sample program, expanded it and said you can include adulterated and substituted blind samples, along with drug positives and negatives. We would do the same thing here. It has been changed just to make sure that the blind samples could also be adulterated or substituted to challenge the laboratory. And in 10.2, it might have been 20 percent and 3 percent when you started a program. It seems too high to have that number of blind samples going to a lab. With all the certification and PT programs and everything else that is going on, 3 percent, when an agency starts a program, seems to be more reasonable in including blind samples, and then after that on a regular basis, 1 percent. The 1 percent is consistent with the DOT program in its Part 40 for regulated employers.

Subpart K is certified laboratories. If you look carefully throughout that entire section, we are talking about initial drug tests, confirmatory drug tests, initial validity tests, confirmatory validity tests. The questions have all been changed to be very specific whether we are talking about drugs or validity testing. The first example is 11.12. The question now relates to initial drug test not just initial test. And then adding a new initial validity test, a question on that. That is new. Then 19 and 21. It is all new on validity testing and it should be consistent with what we are proposing in the other Federal Register notice.

Question 11.25, guidance on storing records electronically. In draft 3, we just had some information forthcoming, so I dreamed up a few things and put it in there. You need something to start with. I became creative and hopefully it is reasonable as the starting point for what the requirement would be as far as storing records electronically.

11.26. I believe draft 3 had the quarterly statistical report. I think it might have even been monthly. Again, changing it to a semiannual statistical report from the lab to the employer, which is consistent with what DOT did.

Subpart L, point of collection test. There is a brand new 12.7. We know that there are some on-site validity tests that are available and it seems reasonable to allow them to be used in this program if we are allowing on-site testing for drugs. If a collector has a question regarding the validity of a specimen, it is an opportunity to immediately determine the possibility of its being adulterated or substituted or whatever and getting supervisory or agency permission to do a direct collection while that individual is still at the collection site. That is new and it talks about what the requirements would be.

In 12.9, again the agencies that we would recognize for certifying the POCT testers. I changed the list to quarterly. Monthly is just too short a time.

Question 12.21, guidance on storing records electronically. Pretty much the same language that I created in the previous subpart. Just trying to put something down as a starting point. Hopefully, there will be more information gathered as we go through actually preparing the Federal Register notice and getting comments back within our own agency on some of these issues.

Subpart M, the instrumented initial test facility. You can have full fledged initial test facilities. If they find presumptive positives or presumptive adulterated or substituted specimens, they can send them to a laboratory that does the confirmatory part of the test and would report the result out. You have new requirements. These freestanding instrumented test facilities can also do validity tests, obviously what we were talking about earlier. Every specimen coming into one of these facilities would be tested. They would do creatinine, pH, et cetera, based on the proposed policy and what will become the final policy. If they find anything, it is called presumptive non-negative at that point. They would send it to a certified lab for doing the confirmatory part of the test. The laboratory that receives it for confirmatory testing does not have to repeat the initial testing because that has already been accomplished by a certified instrumented initial test facility. For that type of facility, we would go to a semiannual summary report as opposed to either monthly or quarterly in draft 3.

Subpart N, the MRO section. Changing again to be consistent in 14.3, go to a quarterly update on the MRO list. It seems to be a reasonable change.

14.5 is new requirements to review non-negative results. We have incorporated in the earlier Federal Register notice MRO review of the non-negatives, the non-negatives being either a positive, adulterated, or substituted result. I needed to add all of that into this section of the MRO, and it will always be consistent with what we agree to when the other validity testing changes are made in the previous Federal Register notice.

14.6 is new, allowing the donor to request to test the split specimen. I believe everywhere in that section and throughout the document we have taken out all of the statements and anything to do with single specimen testing. It will be eliminated from draft 3 and you wouldn't see any reference to a single specimen. I know I changed all the questions that had single or split specimen in it, but in some of the discussions I might have missed a reference to a single specimen.

Split specimen tests. Delete reference to single specimen collections. Obviously, you have to add a new question on retesting for adulterants, a new question on retesting for substitution, and that matches what we are proposing. We will probably request some specific public comments on dealing with adulterants or substitution or any other issues that might be specific to the alternative specimens that we are unaware of during the public comment period that we would need to add to the final regulation.

The last, subpart P, problems with drug tests. If you go to 16.1, always reject for testing, I made some minor changes in that one. In other words, the discrepancies or problems that always lead to rejecting a specimen for testing. You need to just look at that and compare it to draft 3. I think I did make just some minor changes in that question.

For 16.2, reject for testing unless corrected, there are only, I think, two or three types of problems where the lab would reject for testing if the error is not corrected. You need to look at that carefully.

Question 16.3 is new. DOT had talked about some insignificant problems or problems of a minor nature that did not necessarily need to be corrected or documented or things like that, or that the MRO would take any action on or the laboratory. What I have tried to do in 16.3 is take some of what is in Part 40 and some of the things that we do see on the custody and control forms as you go through laboratories, the sorts of minor issues on a CCF that really do not impact on the forensic supportability of the document itself, the specimen, and the testing. You see there is a long list. I am not claiming that it is all-inclusive, but I tried to think of everything I could that was insignificant and would not need to be corrected. In other words, neither the laboratory or the MRO, whichever identified the discrepancy, would not need to get a memorandum for the record from either the collector or from the lab to correct the deficiency, whatever it is. You can look at that list and people can argue about whether something should or should not be there. I think it will give you some idea as to what we believe are some of the insignificant problems.

Question 16.4 is new. Types of errors that may require the MRO to cancel a test unless it is corrected. That subpart has been revised to make it consistent with Part 40 and going into more detail and being more specific about what some of the discrepancies are that occur. Again, we would be asking for public comment on issues that might relate to alternative specimens, especially on the custody and control form. We do not have a custody and control form for the alternative specimens. Somewhere down the road, we would start the process of working on it. My feeling is, if you look at the current custody and control form and you have this section where you are measuring temperature and whether it is split and all that, that little three-quarter inch line, it is possible that you could just substitute that and put in what is needed for hair, oral fluid, or sweat. Everything else is demographic kind of information and maybe it's a relatively simple modification of the current form when you're using it to collect other specimens, but that's all to be seen as we go through this process. It's not something we need to have at this particular time in going forward with proposed guidelines for the alternative specimens.

I believe I have covered everything that was changed between draft 3 and draft 4, except for the cutoffs. The draft will be on our website. We are not soliciting comments on it. Please keep that in mind. This draft is going forward for developing the Federal Register notice.

DR. CHILDS: On the POCTs, the MRO gets the report only if it is totally negative.

DR. VOGL: That is correct.

DR. CHILDS: What are the requirements for the POCTs for specimen validity testing?

DR. VOGL: POCT could use color strips, any kind of test, because when it goes to a lab, the lab is going to conduct both the initial and confirmatory tests.

DR. CHILDS: I am asking what about negatives. What we talked about before with the specimen validity was that 95 percent of the lab testing now is negatives, and we're also now going to be doing the specimen validity on all the negatives. What kind of specimen validity is going to be done on the POCTs?

MR. LoDICO: If there is technology to do a general oxidant test as a POCT, then that would probably be a part of that requirement, as well as, anything in terms of nitrite, specific gravity, creatinine, and pH. We have not thought this through long term. The purpose of a POCT is to give you the perfect negative, and if the negative has been identified as such, it ends right there.

It is only when you have concerns or doubt, whether it is from the collection, the temperature out of range, or in the validity testing, it is incumbent on that collector to forward that sample to the laboratory which then does an exhaustive detailed testing.

DR. CHILDS: I am going to bring up the point of nitrites. Nitrites are added to a sample at the time of collection, and if that's not tested in the POCT process, then the negatives will go out as negatives without any further testing. There's no way to know. Whereas, if that sample had come into a laboratory, it would be tested for nitrites.

MR. LoDICO: That is what I am saying about a general oxidant test which would not be in the category of nitrite.

DR. CHILDS: I guess my question is there is an expectation that part of the POCT will be specimen validity testing.

DR. VOGL: Yes, I think it will be.

MR. STEPHENSON: It has been raised as an issue. It is addressed in the draft guidelines as one of the areas of concern. Your point is well taken. To be effective, you can't use a point of collection test any more effectively or predictively than a laboratory-based test unless you perform specimen validity testing on it because a negative is going to be a negative. We all again are held hostage by this process, that we've got to drive the state of the science and the analytic capabilities far beyond just testing for drugs. That's just where we are.

DR. SAMPLE: I thought the intent really was for the point of collection tests to perform the same battery of specimen validity tests as you would in a traditional laboratory-based initial testing scenario or in the new IITF format. There certainly are point of collection adulterant tests either from a general oxidant perspective or again from a halogen-specific, nitrite-specific, chromate-specific perspective. The testers at a point of collection test event would have the ability to either do individual tests or a general oxidant test just as the laboratories would be able to do.

DR. CHILDS: The POCT type of strips, colorimetric things are really a challenge to try to see a cutoff at 20 for creatinine. I want to be specific for creatinine. A creatinine, if it was looking less than 20, would then go to the HHS certified laboratory for exact verification of creatinine. But the drug test is negative, so it's not going to be tested for drugs. It would just be tested at the HHS certified lab for creatinine?

MR. LoDICO: No.

DR. CHILDS: It would be the whole thing again. It would be screened for the drugs and so on.

MR. LoDICO: Right. It's one of those conditions that we specifically stated in the guidelines, that any sampling that has been forwarded from a POCT is received at the laboratory and is treated just like an initial sample coming in with all their batteries of tests.

The other thing that we wanted to try to explain is that we wanted the POCT or any other alternative matrix to be cross-equivalent. So, whatever is occurring in the laboratory, we want to try to create as much of the same routine testing and complete testing as would be conducted in an off-site POCT facility or IITF facility.

MR. CROUCH: If POCTs can do at least initial specimen validity testing, then why not make at least initial specimen validity testing part of the collection for all urines and not segregate them?

MR. STEPHENSON: Denny, you've been reading ahead in the book again. That's very logical and it's a good approach, and it's one of the areas, as we think about the technology being developed, that's probably where it would wind up. It would make a lot of sense to do that, but we've got to get there.

DR. VOGL: The POCT is where the collection takes place.

MR. CROUCH: What's the difference? I don't understand why we would segregate it and why we wouldn't want to think about at least looking at, across the board when the urine is collected, that it's tested at least initially for validity.

DR. VOGL: We think it will be. As the Federal Register is published and proposed, there will be more and more companies coming out with products to satisfy what we're proposing. Right now there may not be any competition or anything available, but by the time we get there and have an actual policy in place, there will be products and they should be used at the POCT.

MR. LoDICO: One of the more difficult parts of this draft document has always been to identify or to select what is a proper cutoff. What we tried to achieve in the last two DTAB meetings was to actually get some sort of consensus among the selected industry working groups to come back to the table and say this is our final proposed cutoffs based on these scientific criteria. What we have done is try to explain to the public here some of the rationale, as well as the changes that were made from draft 3 to draft 4.

Subpart C is the section of the guidelines which addresses drugs and validity tests, and question 3.2 is what is a cutoff concentration for each drug by type of specimen collected. In our guidelines, we are limiting the specimen collected to be hair, oral fluid, sweat patch, and urine.

Now, what are the factors leading to changing the cutoffs from draft 3 to draft 4? Well, one of the more important factors was the laboratory result of RTI's special PT sets. There were three special PT sets sent out to the different participating laboratories or interested parties, if you want to call them that. From that, we generated the data and put it into a tabular summary format. Dr. Mitchell, who is from RTI, was at the last DTAB meeting back in June and he presented some data suggesting that there was loss of THC, just as an example of loss in THC from the sample collected to the testing laboratory. There were high CVs in certain inter-laboratory data. All of that information was brought to our DTAB for review.

The other was the recommendations from the industry working groups. We tasked the industry working groups with a series of questions relating to both cutoff and other issues that were of non-consensus and therefore we needed them to either among themselves come up with the right wording, better phrase, or more information so that the DTAB members could then make a decision based on that information.

Thirdly, after all of this information was provided to the DTAB members, we had a post-DTAB conference with some DTAB members, we reviewed the data, discussed it among ourselves, and then came to a conclusion based on all the information.

The first specimen was hair, and there were no changes to the initial and confirmatory test cutoffs from draft 3. There were some changes to the footnotes for confirmation to report a positive. In footnote number 2, we have benzoylecgonine and cocaine must be above the cutoffs, and BE and cocaine ratio has to be greater than or equal to 0.1. That is a condition for the cocaine and its metabolite to be called positive in hair.

Footnote number 3 is that the morphine must be at a concentration greater than or equal to 200 picograms per milligram.

For oral fluid, there were some changes made. On the initial test, the PCP concentration was changed from 4 nanograms per mL to 10 nanograms per mL. For the amphetamine, we changed the amphetamine from 160 nanograms per mL. We reduced it to 50 nanograms per mL.

In confirmation testing, there were three changes made, and we decided to change the THC from 2 nanograms per mL to a 4 nanograms per mL, and for PCP, we changed the 2 nanograms per mL to 10 nanograms per mL. Likewise for amphetamine, we reduced the concentration from 160 nanograms per mL to 50 nanograms per mL.

Continuing with oral fluid, there were some footnotes changed in confirmation. For footnote number 1, we had that cocaine or BE must be detected. It's an either/or presence, where in draft 3 it was only limited to BE.

In footnote number 2 for the amphetamine, we are putting an LOD concentration. If you have methamphetamine at the cutoff, you have to have at least the LOD concentration of amphetamine to call it a positive methamphetamine. This is similar to the amphetamine rule that we have for urine testing.

In the sweat patch, there were no significant changes made to the cutoffs. We have changed and converted all the cutoffs to nanograms per patch. In the draft 3 guidelines, we had it as nanograms/2.5 mL eluate. We felt that was a little confusing. We multiplied all of the existing cutoffs by 2.5. If you look at the cutoffs, they're all in a nanograms per patch unit. With the exception of phencyclidine -- that was originally 7.5 and we multiplied by 2.5 and just rounded it off to 20. In the case of marijuana, again it was 2.5 in the initial test and we decided to keep it at 4. For the THC parent, originally it was at 0.5 for the confirmation and we rounded it down to 1. We made it for the sake of ease, reduced it from nanograms per 2.5 eluate to the nanograms per patch.

The footnotes were changed. There are three significant changes. Again, in the footnote number 1 for the confirmation, to call it a positive, you needed to have either cocaine or BE. So, either/or present greater than the cutoff would be sufficient to call that a positive result. In footnote number 2, we indicated that you would need to have the presence of morphine, codeine, or 6-acetylmorphine above the cutoff to report that as a positive result. In footnote 3, which would be the amphetamine concentration at an LOD, which is consistent with the amp rule that we have for urine, again to call it a methamphetamine positive.

For urine, there were no changes to the initial and confirmatory cutoffs from draft 3. It seems that that's been the stable specimen so far and we don't see any changes in the cutoffs.

The other issue that was important to raise was subpart B, question 2.2. The question was concerning under what circumstances can the different types of specimens be collected. The changes that were made was that in hair we are including random testing as part of the battery of tests for reasons to collect. For oral fluid, we are including pre-employment, return to duty, and follow-up as reasons for test. Sweat patch had no changes made for reasons for test. It's still listed only as follow-up and return to duty. In the urine, we did include return to duty and follow-up included in their reasons for test.

In addition to that, we eliminated option B on question 2.2.

MR. STEPHENSON: One of the things that has been added to the mix of information that we received is a technical offering by Psychemedics Corporation on a dual-derivative test methodology. It's proprietary in nature, but it's shared as a test for THC in the hair specimen. It's offered to the members of the Drug Testing Advisory Board and any of the other laboratorians that would need to look at this as a method of trying to get at the sensitivity for THC which has been a special challenge in hair. We want to thank Psychemedics for making this available. If there are members of the DTAB or other folks here who need a copy, I have sets of them up here that are available.

Agenda Item: Hair Testing meeting in Atlanta

DR. SAMPLE: The title of the symposium was the Hair Analysis Panel Discussion Exploring the State of the Science. It was sponsored by the Agency for Toxic Substances and Disease Registry. One of their missions is to determine the overall utility of hair analysis as an exposure assessment tool, not the only exposure assessment tool, but one exposure assessment tool.

What perhaps wasn't clear from the initial information is that this meeting pertained primarily to exposure of environmental contaminants such as metals. It really was not specifically related to our type of business, but nevertheless an interesting one and a half day meeting. It was sort of interesting listening to the discussions because they seemed to be wrestling with a lot of the same types of things that we deal with on a regular basis in the drug testing environment, not just with hair, but with really all of the specimen types that we're dealing with.

One of their primary goals, as I mentioned, was to assess the state of the science, just like we're trying to do.

There were a number of topics. One was review of the physiology of hair, and there was a brief overview on growth rates and cycles of hair, the keratinization process. They talked some about drug effects. For example, the anti-neoplastic agents may be cytotoxic and that can have an impact on hair and then ultimately an impact on the incorporation of metals into hair.

There was an overview of analytical methods where they talked about the advantages and disadvantages of hair as an exposure assessment tool. They talked about the identification of reliable methods.

Reasons for test. To a certain extent, is hair useful for the measurement of health effects, essentially for diagnostic purposes? Is it useful for forensic purposes? Is it useful in an industrial hygiene setting? How much sample? How much hair do you need in order to conduct a test.

A discussion about laboratory variability, intra-laboratory availability, inter-laboratory availability, and what impact that has then on the interpretation of results as they're trying to assess exposure.

A discussion on the variations in the sample collection and preparation methods, talking about the scalp location, homogenization, laboratory preparation methods, what are the normal reference ranges in hair, what's abnormal or toxic concentration ranges, and how does that relate to exposure.

What about the external environment? Shampoos, bleaches, dyes, relaxing agents. What impact does that have on the measurement of metals, not drugs but only relating to metal analysis.

And then trying to distinguish between endogenous and exogenous sources of metals in hair, which is probably a little more challenging for them than for us because the drugs we're dealing with obviously should not be naturally occurring as metals may be in hair.

A topic on the toxicologic considerations. What's the relationship between the chemical concentrations in hair and blood and target organs and is that really a good assessment for the impact on the target organ that the metal has? Dose-response relationship between the chemical concentrations and the target organ effects.

Really not so much a discussion but a query on data gaps and research needs. That was all on the first day.

On the following day, which was a half-day session, there was discussion about identifying scenarios for which hair analysis may be appropriate. Is it a useful tool for assessing an individual's exposure to metals in the environment or in the workplace, the community in a larger setting or a broader scale population type of exposure, and relating that to the exposure pathway in the air in an industrial hygiene setting, in soil perhaps in more of a neighborhood/community environmental type of setting. Is it useful for acute or chronic types of exposures?

All in all, a very interesting meeting from a toxicologic perspective, but unfortunately not as directly relevant to our business of trying to measure drugs in hair and other biological fluids.

DR. BUSH: You mentioned data gaps and research needs. These are terms that tend to be familiar to us in our business all the time. Did they look forward to gathering together again, taking a look at these pending questions and maybe plan for the future, make a plan, and then come back and talk about how they're going to do things? Or was this a one-time thing?

DR. SAMPLE: I think that this was a one-time thing for this panel to put together recommendations for CDC/HHS to assess the utility of hair as a monitoring tool for exposure and to see where they needed to go.

DR. BUSH: Was there any report requested from the panel and any possible date associated with that?

DR. SAMPLE: Is Mike Schaffer still here? Mike was also there. I don't remember a specific date coming out of it.

DR. SCHAFFER: I think the recommendation was that they put together some kind of draft and send it to all the committee members again for review.

DR. SAMPLE: Right, but not for the participants, only for the panel.

DR. SCHAFFER: Only for the panel.

DR. SAMPLE: The people that were participating may never see that report again. It was really data gathering and there wasn't a lot of interaction outside of the panel. It was mostly discussion among the panel that was open to the public at large to hear those discussions and perhaps ask some questions or provide some additional information, but it was very much an open panel driven discussion.

MR. STEPHENSON: From the discussion, was it a review of heavy metals specific as to poisons either in mining or in manufacturing or in some kind of environmental exposure kind of situation? Was there a sense of how big the target group that they were dealing with or where they hoped this to go in terms of establishing some kind of government regulation or process?

DR. SAMPLE: I think that's what they were trying to assess. Yes, it was heavy metals, and they were trying to assess whether or not hair is useful in measuring exposures in those different group in those different settings.

MR. STEPHENSON: It's an expenditure of some valuable time to do it, but you never know, until you make that investment.

DR. SAMPLE: You never know.

Agenda Item: Laboratory Data Packages

DR. BUSH: I believe you probably picked up one of these handouts out front, criteria for NLCP certified laboratory data packages.

We've been putting out data packages in previous lives known as litigation packages. That's got a putative name to it. We've tried to soften this up and treat it as what we believe it to be and that's a data package.

We've had many different flavors of data packages over the years coming from many different laboratories with many different approaches at providing the information on any donor's specimen that has been tested. As you know, donors do have access to the data pertaining to their specimen analysis as part of the agreement and part of what we state in the mandatory guidelines. When that data is presented, many times it's in different formats. It may not have descriptions that are clues, cues, informational to the donor on trying to assess and analyze the information provided.

Many times in the past when information packages have been provided to the donor and the medical review officer upon their request, when we've had some challenging data packages to review, it's kind of been said, well, you need to hire a technical expert to review these and to understand the data. We are not so sure that that's the way it should be to the degree that we've seen in a couple of cases. And it's always a few cases that bring to bear the review. When does the review happen and when does some change or approach or standardization take place? It tends to be after enough pings happen concerning particular cases that are of issue and bring to bear points about ease of understanding by the donor and the medical review officer the information surrounding the test.

I pretty much gave you this slide so far, but let's go to what we consider to be primary and essential components of any laboratory data package. What we have in current practice is we've got the wide variety of formats with or without an affidavit or a cover sheet, with or without custody and control forms, screening data custody and control information related to that screening process, and custody and control information pertaining to the confirmation data that's provided. Actually we have many different approaches to how that's given to the donor and the medical review officer now.

We find that in these data packs cover sheets appeared optional.

Tables of contents many times were inaccurate or lacking.

Description of procedures that were used to perform the testing or anything about the data were lacking.

Pages were not numbered for consecutive review. There were no Bates stamps, one example that we use. Many times when we have to provide information up the chain, when you have a very large document, to ensure that every page is present, there's a Bates stamp. It's a sequential numbering device that you just flip through page by page, but you ensure then the completeness of the data package that is provided. We're not finding that there are always numbers for the consecutive pages.

We have sometimes found information in the donor's data package that's been redacted; in other words, it's been whited out or obscured from view by the one reading that information. And it's varied and sometimes inappropriate. Sometimes what one may perceive as very important information has been covered and noted as redacted from view. Immunoassay instrument printouts are not self-explanatory. That needs no more description. Quantitative GC/MS printout with the SIM panels are varied and not self-explanatory. Batch QC may not be identified when reviewing all the numbers and the information from a particular run. QC acceptance criteria are not specified. Forms and notes contain unique codes or jargon that may not be clear to the donor or MRO.

This leads us to observation number 1. By issuance of a non-negative result data package, the lab's result is essentially being challenged, challenged for review and challenged for understanding by the donor.

Observation number 2. Review of packages, even by knowledgeable parties, is often difficult without access to the SOP. It has been stated in the past by some donors who are bound and determined to understand every nuance within that data package that they will get the laboratory SOP. And I'm thinking to myself if you're having a problem with the data package, I assure you you're going to have a massive problem with understanding the SOP that can be the size of a small encyclopedia. Unfortunately, high tech is high tech and it's difficult to understand.

These two observations beg a question. Should laboratory data packages be reasonably self-explanatory to interested parties? We find ourselves in our common regulatory quandary. It's one or the other. We either do or we don't, and there's a price to pay for either one of those choices.

What we have decided as a program is to require all labs to conform to a basic six-part data package format. This will include a cover sheet, synopsis of procedures and results, to include a brief description of drug testing or brief description of adulteration testing, conclusions for the specimen in question, indicate total number of pages. And we're looking at this cover sheet/synopsis to be a half a page to one page in length.

It may appear to be a big deal, but honestly this becomes rather boiler plate after it is conceived and developed the first time. I'll tell you some labs have this and more at this time, so some have chosen to show us the model that we're actually going to use partially in this approach.

We would like it to contain a table of contents that lists all additional materials and pages in the documentation package, to also include external custody and control form documentation which would be a copy of the CCF, information concerning the screening data to include description of the immunoassay, the QC, and the screening data itself, any internal custody and control forms used in the handling of that aliquot in the screening process, and all QC identified in the immunoassay data provided for that specimen.

In the confirmation data, for any confirmation testing performed on the specimen, we would like a brief description of GC/MS, QC, and the confirmation data itself, any internal custody and control forms which pertain to the handling of that specimen in the testing, and confirmation data with all calibrators and QC identified and included.

And a very brief statement, resume, or a CV, concerning the qualifications of the certifying scientists and the RPs who were involved in the lab and in the testing process.

The program is going to issue revised guidance on this data package process and what we want to see as a program on this data package process. We will have minimum standards of uniformity and we will not allow redaction of pertinent information. The exception to this is going to be information from non-regulated specimens that reference donor Social Security numbers or names.

We are planning to present this at the NLCP inspector training and laboratory director workshop at the Society of Forensic Toxicology meeting at the very beginning of October in New Orleans. You are getting a sneak preview of what we are going to release and put out as our minimum requirements for the data pack that we request and receive from all the labs when we're looking at sections B, C, and D. We have a multi-part checklist that is part of our semiannual inspection process. Some of this is certainly information that we already have on file from the laboratory. Sections B, C, and D are what we ask the laboratory to provide to us. This is information concerning their analytical processes, the systems that we use. This is so that our inspectors, before they even get to the site, have a good understanding of what they're going to be seeing when they go in to look at the SOP and the processes in the lab.

In addition to the B, C, and D, the text type of information and tabular form information that we request from the labs, to exemplify what they do, the process and how it's going to look to the inspectors when they're performing these inspections, we have always asked for a data package. We have found over the years that they're very different. Sometimes they don't give the inspectors quite the knowledge, the flavor, and the understanding that they should have before they even walk in the door of the laboratory.

We are going to ask the laboratories to provide this format, this style, this content in the data pack they provide to us with the B, C, and D, and we also ask that the laboratories use this as the standard format then when they provide any data packages on federal employee specimens that are requested by MROs and federal donors and bridge this out to what is provided to DOT regulated industry employees and their MROs who request information packages.

We recognize that in courts of law and in certain types of review, whether it's an administrative law judge before which information is brought for discussion or other types, that jurisdiction by jurisdiction legal requirements for what is necessary and sufficient for a data package vary. It's just a fact.

We're not looking to supersede or supplant that. We're looking at this from our program point of view. If you need, for whatever jurisdiction you're handling and working in, more information provided as part of data packages, that's fine. Don't say that the NLCP says you only do this. That's not what is intended. But we're looking to raise the bar a bit in terms of information that donors have to understand their specimen result.

This is all part of serving the customer. We all have that duty, and as a program, this is intended to get the inspectors off on the best foot. But we see a double-edged benefit to this, and this is to be able to give the donor a good snapshot, a better snapshot, a more standardized snapshot of what that data package really looks like.

DR. SAMPLE: I just had one question on the last slide regarding redaction. There may be other documents as part of the packet that would include Social Security numbers of other regulated donors, those you would not see as being redacted, only non-regulated?

DR. BUSH: No, not at all. I guess I'd have to take a look at your package. I would suggest that if you have questions like this, in terms of redacting data packages to send to RTI for inspection purposes, call RTI about those because they'll know exactly what they're looking for. They're handling the B, C, and D's and getting them out to the inspectors who are going to do the inspection. That said, we still want to redact because once information is out in the form of a Social Security number and a name, it is there forever.

DR. SAMPLE: Obviously, there are no names for regulated specimens, but there are Social Security numbers that potentially would be part of some information packets at probably a variety of labs. I think it might be helpful to clarify that before the meeting with the inspectors in October.

DR. BUSH: We can do that. We'll take a look at what we have in our hands as examples of litigation packages from which all this discussion came in. But what we find really and what comes to my mind when I see data packs, I just see specimen ID numbers. I don't know that I've seen SSN's, but I will look into it because they too are a protected kind of information.

DR. SAMPLE: That's what I thought. Okay.

DR. BUSH: Good question.

MR. STEPHENSON: Donna, one of the things that might not be obvious to some of the members in the public -- and I think it's important to point it out here -- is background as to why this is happening now, what it is that has gotten us to this point in time coming out of case reviews and looking at certainly litigation issues that we've had to look at and the requirements for expert witnesses to go in and look at a case cold, not ever seeing it before, but looking at what was purported to be the data package for a specimen -- is it accurate? Is it reliable? Were the tests done in accordance with procedure -- and then trying to figure that out in order to deal with a case that's before the court.

And what we did in terms of the data audit, looking at 13.5 million specimens over a two-year period and then sorting through those that fell into that group that ultimately wound up with some 300 being reversed on decisions, and then the proactive thinking part that you and the contractors at RTI have sat down with, saying how can we make the system better, what do we do. And the shift was to get more non-negative test results into the data audits for each and every inspection as the emphasis on how to get at the system better.

That's the heart of this, that this is a systems driven desire to be proactively improving everything we do and make it better for all users. This is our effort now to say this is the next step forward. We're going to use this every time we come to your lab. Every time we see a submission for the next inspection, we're going to be looking at your data package to make sure that it's up to snuff and we're going to be looking at examples of that that you're going to be preparing for us as a representative sample of your non-negative test results that we're going to be reviewing that are mirrors of what is in fact going out to the MROs and could, in fact, be used by anyone who asks for that information. Is that fair?

DR. BUSH: That's exactly right on. I've been in this job since the middle of December 1989 and I could never have envisioned what today would be on that day that I came into this job. The configuration of laboratory systems, laboratory themselves, how many specimens each individual lab handled, the type of results that were coming out of laboratories, specimen validity testing issues, none of that had the same face and the same facets that it does today. We have had to, for better or for worse, sometimes with just right off the top of the head, good, forward thinking, looking head, sometimes with, hey, here's an issue, look at me and now think ahead, sometimes something put right in front of your face to make you look ahead -- we've had to review and revise how we do laboratory inspections to ensure for the laboratories that we are providing a good service. This is a fee for service program. Laboratories pay a fee. They deserve good quality service, and we have many, many donors.

It's another one of these things. I always joke about DOT being our favorite 800-pound gorilla who, once upon a time, when our federal program was so small, took a look at how good it was and said, yea, verily, we're going to jump on board this wagon because this is a really good program. It has safety-sensitive interests at heart. You add a lot of volume like this over the years and a lot of the interesting challenges that specimen donors are trying to get over on the tests, as well as illicit drug users try to send you, we have to make sure that we audit and know these. It's hard to do because when you go into any laboratory, 95 percent of what you're auditing, what you're looking at, is going to be negative. There's no doubt about that. So, when you have laboratories that are testing thousands and thousands of specimens a day, that's an awful lot of non-negative results that come around the bend. How do you get a handle on these when you go in to do an inspection process? And certainly many of these donors are going to be asking to look at their data, just like we should be.

That's how this whole thing came about. I guess it started about October of 2000 when we had to take a look at making a lot of changes to this process. We believe small steps well taken are the way to do it. This is one.

We've heard from people, you're requiring us to do a summary sheet. You're going to have to have people doing a Bates stamp. This is time. Time is money. There's labor involved here. It's different from what we were doing. We're going to have to get a little process going here that's different. I'm believing that it's going to take a change to the SOP on how you handle data package production, but I'm not sure that the cost investment over the long haul is going to be too great to provide a much better product for everybody to see.

This is why for the NLCP B, C, and D supplement for the inspectors to read on their wonderful airplane ride on the way to the laboratory this is a good start, and we will expect to be seeing this then for all our federal specimens and DOT regulated industry specimens in the future.

Agenda Item: Electronic Reporting

DR. VOGL: The next topic is electronic reporting. Its subtopic is format for the electronic lab report. When Part 40 was issued a few months back, it allowed laboratories to report results using an electronic report. About three or four months ago, RTI, our contractor, and all of the inspectors going out to labs started looking at the electronic reports as labs were converting over to use of the new custody and control form. There was a misinterpretation of what information can appear on the electronic lab report. This information will be presented at the SOFT meeting to lab directors and inspectors. We still have to talk about a single specimen collection as well as reporting results for the primary bottle A specimen.

Those who are familiar with the new custody and control form will recognize that these are the categories for reporting results. We would love to see every result being reported as a negative, but that's unfortunately not the case. You do have these other categories that are on the report, and a box needs to be checked. In the case of a negative dilute, there would be two boxes marked, or for a positive and dilute.

According to Part 40, in reporting a negative result, you can use an electronic lab report by itself or you can transmit a legible copy of the completed copy 1 of the custody and control form. You can transmit that legible copy by fax. You can courier a copy. You can mail a copy or transmit it electronically. Those are the choices of reporting a negative result.

Today, we are focusing on what this electronic lab report looks like. We all know what the CCF looks like and I think understand the way it can be transmitted.

For reporting a non-negative result -- a non-negative result is a positive, adulterated, or substituted result -- you have to transmit a legible copy of the completed copy 1 by one of the four means. And you also may provide an electronic lab report, but then you'd have to follow it up with a transmission of a legible copy.

The electronic lab report may be transmitted through any means that ensures accuracy and confidentiality. That's a requirement in the Part 40.

When may the electronic report be released? It's only after review and approval by the certifying scientist. That's important to keep in mind. It can only be released, if it's a negative, by a negative certifying scientist. If it's positive, adulterated, or substituted, it cannot be released until approved by a certifying scientist.

DOT, when they put out Part 40, did have a list of information that needed to go on this electronic report. In the technical correction that they published recently, it modified what information needed to go on the electronic report. Basically, I tried to summarize the information if you combine the two documents, the original Part 40 and the technical correction. I call it specimen identification information. This is a list of everything that must appear on every electronic lab report. You can see for yourselves and read that, and everybody has a handout of the PowerPoint presentation so you can look at it and make sure you understand what needs to be there.

This is what I call the results section. If the top half of the report has all of the specimen identification information, then when you come to what's the result for this specimen, it has to have one of the result categories that was listed on one of the earlier slides. You can't have anything else but one of those results on that report. The only other information you can have is a remark. It's required, depending on what the result is. If it's adulterated or substituted, you have to have the remark that you would be putting on the custody and control form, on the written hard copy of the CCF. That same remark must appear on the electronic lab report.

Those were the mandatory requirements as far as information and how to report results. You may also include quantitative results when the MRO has a blanket request for all specimens. Part 40 says that an MRO has a right to request quantitative results. Theoretically if an MRO does have a blanket request to receive quantitative results on all specimens that they're getting results, you could include the quantitative results on there. And you must provide for opiate concentrations of over 15,000 nanograms per mL, a quantitative result on the electronic lab report.

The bottom line to all this is that, at a maximum, the electronic lab report may have all the information that appears on the CCF.

There are a couple of things that you cannot have on the report. They don't appear on the CCF either. Interpretive comments. That could be almost anything you can think of. We have seen, going around to the laboratories over the past few months looking at electronic lab reports, everything under the sun, and it's not permitted. You can't do that. You can't have comments on alternative explanations. You don't give information to the MRO on anything other than just the result. That's what the lab's purpose is, to provide an analytical result and any required comment that supports that result, but not interpretive comments.

You cannot provide a status of the split specimen. If the split doesn't exist or it leaked in transit, you cannot put any of that information on there because it doesn't come into play until the donor requests the split to be tested. If the donor doesn't request the split to be tested and it was positive, it goes forward that way.

Prior to inspections of laboratories, when they submit their B, C, and D information, each lab is required to submit copies of its electronic lab reports for each of the different results that can be reported. They are being reviewed to ensure that they do not contain information that they should not contain and that they do have all of the minimum information.

We are working on standardizing the electronic lab reports through the inspection program. Hopefully, within a few months, the lab reports will be standardized and satisfy the requirements as stated in Part 40 and the technical correction.

DR. CHILDS: In the sending of, for example, scanned images or the equivalent of effects, can one also send an electronic report that isn't exactly the same, in other words, saying this is a preliminary report and your scanned image is going to follow? Or can you only send one? That's been a little bit of a confusion in the lab with respect to scanned final images and how they can be transmitted and so on.

DR. VOGL: You mean a scanned CCF?

DR. CHILDS: In other words, they have a negative report that has most of the elements, the Social Security number and all the things that could identify the individual donor, but then it takes some time to get the scanning done and that approximately one hour to two-hour time frame is causing some challenges in terms of reporting times. What I'm asking. Could an MRO act on a negative call based on -- I'm going to call it -- a preliminary electronic report, especially for the negatives that are just negative and don't have other issues with them, and then a scanned image or a faxed image or a hard copy comes that has all the rest of the information?

DR. VOGL: That preliminary is not your lab electronic report?

DR. CHILDS: Right. It would not be replacing the faxed or the scanned image. The big differences are information like the collector name. I'm going to tell you I looked through about 250 to 300 forms last week to see in entering the collector name, how much of that could be done pretty quickly with data entry or done without any kind of "oh, my goodness, what does it say." I'd say probably 90-95 percent of those you could actually quickly make out the printed name of the collector. The phone numbers were a different discussion, and there were, I would say, at least 5, maybe as many as 10 percent of the collector names were somewhere between illegible and not much better than a scrawled signature.

So, in trying to capture that information, how do we go about processing that electronically? Because if you wait until you've certified the total result on a form, mark the form, and then scan that form -- if the electronic has to have all that information, does that mean you couldn't send a scanned image? Could you say in the electronic, this is preliminary and your scanned image or your faxed image or your hard copy is coming? And it would have the critical elements: the collection time, the Social Security number, the identifiers for the donor, the fact that it's negative -- but it doesn't have all the information that was on your list that you just showed because a second copy is coming with all that information.

DR. VOGL: If you're talking about a one- or two-hour difference in time, why you wouldn't just wait until you actually have all the information to send out as your electronic lab report.

DR. CHILDS: Well, part of it is the data capture and then downloading that in terms of a file. But also those two or three hours are sometimes very critical in terms of medical review officer practice. That's the input we're hearing back. I'm kind of the messenger.

DR. VOGL: Has RTI or an inspection team looked at it yet?

MR. LoDICO: When you're talking about that delay in time between the capturing of the data and the release of the report, you're really only focusing on what? The negatives. Right?

DR. CHILDS: Yes.

MR. EDGELL: We had this very same question. We feel like we've entered into a new era with the allowance of the electronic report on negatives from all laboratories to all MROs. There's work that's done with the laboratory and the MRO in making this decision, but you now have a standard format. We've had problems before with confusion in preliminary reports differing from the final reports. I think a lab here makes a choice, a decision to follow one path or the other, and if you have an electronic report and you use that for your negatives, that follows the standard format of Part 40. It used to be that labs used the electronic reports as unofficial notification and the official notification was always the CCF. That day has passed. The official notification now can be the electronic report and that electronic report is a standard based upon the 40.97 paragraph that you outlined there.

The addition of the collector's name is -- we queried MRO groups and they said, well, if I get an electronic report and I have some issue, some problem that I'm trying to chase, such as how do I get my CCF copies that many MROs are just coming to the realization that they really need now, I don't have anything. I don't know who the collector is. So, that's why that's on there.

I think that all of the information is explainable, or at least I think I can explain it. But the bottom line is that we now have a new era and that new era brings with it a standard electronic report format.

DR. GUARNIERI: Walt and Ken, can I ask you both a question? There's a slide here that says that the electronic lab report must include. If all of these various items are not included, even on a negative, would you consider that to be a fatal flaw from the perspective of the MRO?

MR. EDGELL: No. I think that from the DOT perspective, we have defined the fatal flaw list.

DR. GUARNIERI: Yes, you have and this is different.

MR. EDGELL: While a laboratory's electronic report may not contain all of these data elements, there is a process in place to remedy that by having the inspection teams look at and point out deficiencies in electronic reports. I believe that that is something that will be corrected over time and our inspectors are aware that you're not going to make these programming changes overnight but that you cannot ignore them. You need to have a plan to put them in place.

We're finding that a lab puts out a data stream and all the elements are there, but the MRO does not have software changes to accept that new data and place it into the new format. That's an issue. When you think of a laboratory producing an electronic report, they're going to just magically produce something that's going to appear on the other end and be reformatted or deciphered, throw it on your screen or on a piece of paper and it looks exactly as intended.

We thoroughly understand that there are two sides here. You could have a system where you pull the data and it looks fine, or when you push it and then you leave it up to someone else to interpret it. That's the word I was looking for.

DR. GUARNIERI: I'm looking at this slide where it says "must include," and it's in the eyes of the beholder as well. A lab can look at a fatal flaw when it receives forms, as well as the MRO can look at a fatal flaw from his or her perspective.

MR. EDGELL: At any time an MRO desires, if there's something on the electronic report or the scanned image or on the fax that is not completely legible or clear, however you use that word, the MRO can say to the laboratory, please send me a copy of the CCF that is legible and clear because the CCF goes through the entire process at the laboratory. So, that's maintained and that is on file.

MR. STEPHENSON: Aren't we focusing on negative test results?

DR. SAMPLE: Yes.

MR. STEPHENSON: What is a fatal flaw of a negative result? And I don't mean to be flippant here. Are you going to have somebody called positive because they had a fatal flaw on their negative test result?

DR. GUARNIERI: No.

MR. STEPHENSON: You're looking at a process which is, in fact, codifying a common practice that's been in existence for some time, which is to provide a compact, fast-moving, non-paper image, a notification of those 95 percent negative test results. You want to be able to do that in a method that's time and labor conservative, in terms of it's a savings, it's an improvement in the process. It's going to reduce the confusion. It's going to reduce the blurriness of an image or the fact that a data element doesn't exist.

Paula, to go back to your question, your comment, the choice between one or the other, the negative test results are basically your validation process for converting that collection originated paper copy into your electronic domain that you work in your lab. Virtually every collection site that's out there is going to be generating 95 or more negative test results for every positive one that they've got out there. If you've got a blurred image on a collector's name or you can't get a phone number, those are system changes that need to be improved because that's the part that you've got to drive into your electronic environment. Once you've got it fixed for the negatives, you're going to also accrue that benefit for your non-negatives. It's going to be there in the cases where you go back and get remedial action to get one of those correctable flaws taken care of that have got to go back to the collection site and have got to go back for training of a specific person that you can't otherwise identify.

If I were to answer your question the way you'd ask it, I would say you want to make the commitment systems-wide for migrating the data into your electronic environment, and that that's the one that you want to focus on doing systems improvement on from this point on.

DR. CHILDS: Part of what I was asking too was having two different reports. I think Ken gave a very good explanation for that. I think that's very good. Thank you.

DR. SAMPLE: Is there a sense of what a reasonable time frame is? I'm guessing that probably the two items that are causing the most difficulty for the majority of laboratories with respect to these required elements -- and I'm really only talking about laboratories that aren't already scanning the completed CCF and transmitting it to the medical review officer, but it's the addition of the collector's name and telephone number because those are probably elements that most, if not all, laboratories were not previously capturing as part of the standard data entry process, again except for those people who were doing imaging previously.

The notification of the requirement for those two additional elements, as Ken pointed out, really came out in the technical amendments essentially on the first of August. While a reasonable time frame is indicated for the adherence to those guidelines, I'm just looking for a sense of what that is. Is that one month, three months, six months?

MR. EDGELL: What do you think is reasonable?

DR. SAMPLE: Well, what may be reasonable for me may not be reasonable for every laboratory. But I think that the laboratories would appreciate some line in the sand.

MR. EDGELL: I'll go first. I don't think one month is reasonable.

DR. SAMPLE: I don't either. I think probably by the end of the year --

MR. EDGELL: Maybe six months. You pointed out that the discrepancies in the inspection, and by the time you have your next inspection, it's corrected. Now, that will give some a little longer than others, but still bring it all to closure as part of the system and let the system take care of it.

DR. SAMPLE: And that's fine, but I think the laboratories would probably appreciate knowing what that drop-dead date is. Everyone probably works better with deadlines.

DR. VOGL: I think Ken's answer is about the best we can do, really. It's an issue that would be looked at by the inspection teams and then follow-up remedial action. The lab would have to give some sort of indication how long it will take to do this. It will be between RTI and the laboratories.

MR. STEPHENSON: I think Ken gave a very reasonable answer in that we're looking at this being done within this inspection cycle, so in January every lab will have gone through one inspection cycle following the publication of this issue. All of them will have been looked at, and if there are issues that need to be corrected, they will have all been advised. It would be unreasonable to expect there still to be systems problems after that first inspection cycle. That makes sense.

DR. SAMPLE: You mean by the time of the follow-up inspection.

MR. STEPHENSON: Right.

DR. ISENSCHMID: This is such a new thing. I don't think it's on the inspection checklist yet. So, it's not something that's going to be checked in the current round of inspections.

DR. VOGL: RTI is looking at formats. Granted, it might not have the collector's name and phone number on it. They're looking at the format of what's on there, and the feedback will go to the lab. But it will take time. It will not happen as of August 10th. August 9th was when they issued the technical corrections.

DR. SAMPLE: But January 2002, February 2002 certainly would be a reasonable expectation.

DR. VOGL: I would think by then for all the labs, if they have read the technical correction document carefully. At the SOFT meeting, these things will be pointed out directly to laboratories who have maybe not had an inspection yet.

I think it would be nice if laboratories who are being inspected actually retrieve from some MROs a copy of the report the MRO does get electronically from a data stream or whatever, print it out, and send a copy back to the lab. I think you could learn an awful lot about what's on there and what it looks like. The laboratories keep saying they can't print out what it looks like from inside the labs.

DR. CHILDS: Yesterday I had the opportunity to actually see what the laboratory sends and I was asked to translate what all that meant. I realized that even if I was to get a copy back at the laboratory, I don't have the translation program at our lab to see what it is at the MRO's office.

DR. VOGL: No. They would print it out.

DR. CHILDS: They'd have to print it out.

DR. VOGL: Yes, and then mail it back to see what it looks like. I think that would be useful to the inspectors. I know I would like to see it. It verifies that it is correct and it does have all the necessary information on it.

MR. LoDICO: Recently we have also had to go out to inspections, and one of the most important things that I've tried to obtain from the lab inspection is copies of the electronic report. I must tell you that they have a unique data stream that doesn't necessarily comply with all of the elements that are found in a CCF, but at the same time, that particular client who is comfortable with that information or that MRO is served by the lab.

I'll use an example. And Mike Feldman is here. The reason why I'm making that example is because we challenged Northwest Tox with that electronic report, and when he provided the electronic report, he also had a copy of the CCF. Now, looking at this one line of notation and letters and a combination of numbers, you can tell the collection time, collection date, whether it's positive or negative, where the collection site was, but that was particularly focused for that MRO. Now, the question would be, since it doesn't have all the elements, is that an acceptable electronic report or not?

DR. CHILDS: I guess that's a question for Ken.

MR. EDGELL: It says that we must include the following elements and cannot include more than is on the CCF. If you had a report that had our 13 required elements and if you had an electronic report that made a digital image of the CCF, including employer's name and address and the C/TPA's name and address, if that were on there, and the time of collection and things of that nature, so you had our 13 plus 10 others that were on the CCF, I think that it would be hard to say that that's not in compliance because it does include the required elements and it includes additional information that is contained on the CCF. While I think that might be a little unusual, it would be not out of compliance. But we have seen and you have seen as well some of the previous reports that reference that a cocaine positive might be caused from food products or some such nonsense. It's just ridiculous information. That's gone.

Just another comment here. I would expect that the incorporation of a standard minimum electronic report would go easier than the incorporation of the new CCF has been. And I say that not really joking that much. Your comment was we like deadlines. Okay, we can give you a deadline. I think that we can put a deadline, when it's pointed out on an inspection report, that it needs to be corrected by the next inspection.

MR. STEPHENSON: One of the things that Dan had raised earlier was that it's not on the inspection checklist right now, so it's not going to be checked.

Again maybe to remind some of the members of the public who are here, we had modified the inspection process, and the number of inspectors had been scaled back but increased the number of inspections that they're required to do and the updates and so on that they need to do. I think although we may have a challenge of getting this into a process, we have a better machine to do it with. We have a better, tighter system that's been created for those fewer inspectors so that once you get into one, the chances are they're going to be able to get it in play very quickly.

DR. CAPLAN: I might point out that there was training already for some and there is training in a couple of weeks for the rest of the inspectors. It won't be that long.

Agenda Item: New Federal Custody and Control Form

DR. VOGL: You all have a copy of the handout. It's called the New Federal Custody and Control Form. Just a few slides.

Basically, it was approved a long time ago, and you could begin using it August 1, 2000, but no one did. We are supposed to start August 1 of this year and have been given until 1 November or 1 October.

The Federal Register notice on June 23, 2000, announcing the new form, had a list of 16 acceptable modifications. It's the third page of the handout. I made a copy of it because I'm sure no one has it memorized. When we put out the form, these were modifications which we felt were acceptable when a laboratory or a user of the form had it printed and they wanted to change things to make it perhaps more user friendly.

Obviously, labs are ingenious and always come up with requests to do other modifications to the form. I want to highlight four modifications that we have approved recently on the CCF.

First, in the top 1 inch of the form. You can preprint a corporate name and phone number. When the form gets to the lab, the laboratory that's getting the specimen will print the address at the top of the form.

MR. LoDICO: Also, remind them that on the top of the form that has the corporate name and the phone number, the donor has an 800 number that's associated with that corporation that that donor can call that number and get assurance as to which of the laboratories that specimen has been sent to.

DR. VOGL: Right, and the employer.

The second choice is at the top of the form you could put several lab addresses with check boxes. The collector receives the form and it has six, or whatever number, street addresses for the certified labs and a check box, and they mark the box for which lab is going to receive the specimen. At a collection site, they send all of the specimens to one lab. They can check that box off prior to actually using the form because it's always going to that lab.

But if it does get to the lab without that box checked, the lab needs to print the lab address in the results section in step 5a and inform the collector that they did not check the box. They need to document notifying the collector that they did not check the box to ensure that with future submissions, the collector does check the box because otherwise it is a discrepancy that needs to be corrected.

The third modification that we're permitting is on the new form in the "specimen bottle released to" box, which is a rectangular box, a laboratory may preprint two or three carrier names like FedEx or whatever with a little box next to it and also the word "courier" with a box. It makes it relatively easy. They always know they're using FedEx or they're always using a courier. They can just check the box without having to write it in or print it. We think that that's a reasonable modification if a lab is interested in doing it. And we've given permission to one lab to do it, so others can do the same thing.

The fourth modification is at the bottom of the form. The current form in the sample that we have is just two bottle label seals that go across the primary and split specimen bottle. There was a request to shorten the labels to allow room for what they call a tracking label. It would be a bar-coded label, have the same specimen ID number as for the form itself. Basically, it would go on the outside shipping containing. A shipping container could have 10 specimens in there, and there would be 10 tracking labels on the outside. When it's received at the laboratory, the lab would know how many specimens are in there, and they could even wand them and determine what's in there and that they're all regulated specimens, that they were sent to the correct lab for testing. It's not a custody label in any way to document or prevent tampering of the outer shipping container. It's strictly for tracking.

The last item is not permitted. That is, preprinting the names of certifying scientists with check boxes. You're not allowed to do that. You can't have 10 preprinted certifying scientists' names on there with little check boxes. There has to be strictly a line, as we have now, where you can use a stamp for the printed name, but then there also needs to be a signature.

That covers what we have agreed to allow in using the new form beyond what was in the original Federal Register notice. If labs come up with any other ideas on modifications, they really should submit them to our office and we'll discuss them with DOT and come up with a decision and pass it on to everyone.

Agenda Item: Closing Comments

MR. STEPHENSON: Are there other issues that the members of the board want to cover or if there are general questions that the public has.

MR. THISTLE (Psychemedics): As I think we're all aware, it is easier to get toxicologists to share toothbrushes than it is to share data. Nevertheless, over the last several years, we found ourselves in a room with competitors, researchers, end users, detractors, and supporters in the industry working groups, and largely through shared data, we have forged consensus in those groups.

After all this bloodletting that took place, if some of those recommendations were not picked up, for the sake of expediency, is there someone that we could have the chairman contact directly. I know we can do the letters back and forth, but to speed the process along, if we have a couple of specific issues and want to know what the board's thinking was so that we can maybe produce data to bring you around to the group's way of thinking, is there someone we can contact directly on those individual issues? Would each group have a contact person then?

MR. STEPHENSON: We've tried to establish a liaison, but the best way to do it is probably to have you simply contact Donna or myself.

MR. THISTLE: Okay. I just didn't want to breach the protocol.

MR. STEPHENSON: You are right, but the issue, when we set this process up, was that it was a bloodletting process to take part within the industry working group, that it was an agenda-setting process where the industry led that process and then made the input. The modifying system was that all that input would go to the board for consideration, and that would often lead to further questions until you were finally able to get to an endpoint when you could make a decision or frame a recommendation for guidance or for regulation.

MR. THISTLE: I think it was absolutely the way to go. I applaud the system as it was set up.

MR. STEPHENSON: What we've got to do is we've just got to make sure that we keep that system on track and try, wherever possible, to make sure that we get internal consensus from the working groups and that from that, that there are issues that are brought to the members of the board for discussion. And then -- you're right -- we need to make sure there's a mechanism to get that information back.

So, this is going to be an ongoing process. This is a living system that isn't just going to fold up with one publication or one set of regs.

MR. THISTLE: Okay. Thank you.

DR. CHILDS: Earlier we talked about maybe a mechanism where we could identify labs that have developed some specialty or expertise in certain specimen validity testing strategies. With the impending new cottage industry that's going to take whatever came out of this meeting and go to the next level, is there a way that the labs could share the information that is identified about different kinds of products? For example, some of that gets done actually at the scientific meetings and a lot of phone calls and so on. But would the SAMHSA site be a site for that shared information?

Two reasons. One is it gives the labs, okay, here's what else is out there. The second thing is it gives the vendors who sell these products the opportunity to see that we know that it's there, and it keeps them changing their products too very quickly. Their development time, by the way, is clearly a lot shorter than our response time. But it keeps them having to change and swap out, and it makes their jobs more difficult in terms of presenting new opportunities because they have to try to validate the fact that whatever product they're going to introduce is really going to do the job because many of them give money-back guarantees and double money-back guarantees. I just don't know. I just thought I'd toss that idea out and see if there's an interest in wanting to do that.

MR. STEPHENSON: I may sound a little cynical here. I don't mean to be, but I'm not interested in giving the cottage industry any more heads up than we have to.

What I am interested in is following up on your suggestion that there be a forum or a mechanism of carrying that information in and around the labs. To do that, we do have a secured site activity which is a sign-in kind of thing, more of a proprietary controlled access environment that we could certainly do. I will make sure we take action on it as soon as we go back. I think that there is a great value in that.

And I think that is in fact itself a signal to that cottage industry. Don't believe everything you read because half or three-quarters of what we know we're not telling.

MS. HANDLER (International Piuresis Association): My name is Melissa Handler. I'm a social worker and a staff member at the International Piuresis Association. Another word used for piuresis is shy bladder, which is in the new regs under Part 40.193, which is a social anxiety disorder rendering somebody unable to provide a sample.

I was just wondering. I know that it's in Part 40, but I was also just wondering how many people have come in contact with somebody that has stated that they have this condition. And if so, what were the procedures or measures that were taken at that time.

MR. EDGELL: Shy bladder procedures have been something that we've had in our rules for a number of years. I've heard the condition that you're mentioning. The calls have been limited. Shy bladder calls to our office -- and we field 10,000-12,000 calls a year -- might be counted on one or certainly two hands over the last six or seven years. So, it's not a problematic item that reaches our office.

Anything that is pre-documented as a psychological condition, the medical review officer, through the help of another physician, would determine that that documentation exists and in all likelihood that attempt for a collection would be canceled with a valid reason.

In a situation where there's a psychological condition that is not documented, situational anxiety, there's something that I see in the bottom of that cup that prohibits me from providing a urine specimen on demand, that would be a problem if it could not be substantiated by this physician.

If there is a physical condition that exists, then that would be, hopefully, detected during this medical evaluation and handled as a canceled collection. The person would stay in the random pool to be called again because they could be subject to alcohol testing as well.

MS. HANDLER: Has it occurred frequently where you've heard about just situational anxiety? I think people get confused a lot of times.

MR. EDGELL: No. I'm talking about a handful of calls, one, two, five, over the last seven years that Part 40, through the Omnibus Transportation Employee Testing Act, has been in place, that have reached our office. Have you heard differently?

MS. HANDLER: I am working primarily with DOJ and prisoners with the random drug testing, but I am working also with employees because a lot of times what happens is not only is it a hindsight, but a lot of times people don't apply for a job that they know is going to give drug tests because of this problem that they have. In the DSM-IV, if anybody is familiar, it's documented as a medical disorder, and I actually have some information if anybody wants it.

I think it's kind of how you look at the statistics and the numbers because I know that a lot of times refusal is seen as a positive.

MR. STEPHENSON: Think about it this way. Look how empowering it will be to have alternative specimens and technologies available.

MS. HANDLER: Oh, I'm all about that.

MR. STEPHENSON: Or it could be a sweat patch or it could be other kinds of things that will be out there in the future other than a blood test or some other kind of much more fearsome kind of alternative. I think that everyone would welcome that, and it's a kind of area that I think we're getting much closer to right now.

MS. HANDLER: That's what I'm trying to do in DOJ, which is obviously not really involved in hair. But a couple cases were tried and in Massachusetts they use a sweat patch. In Maryland here, we use a dry cell technique.

MR. STEPHENSON: Look forward and stay in touch. Stay involved with what's going on. You've got our website information. If there's something you'd like to submit that we can consider from your perspective, please do.

MS. HANDLER: Thank you very much.

DR. BUSH: Our next DTAB meeting will be December 4th and 5th at the Marriott Residence Inn. One more time we're moving. Theoretically we have a contract for all four meetings at one place. We have had a meeting there once before. Our website gives the dates for future meetings.

The meeting was adjourned at 3:00 p.m.