DRUG TESTING ADVISORY BOARD OPEN SESSION September 3, 2003 Agenda Item: Welcome Updated: 05/12/2005 MR. STEPHENSON (Chair): Good morning. This is going to be a brief session. Most of this session will be dealing with procedural matters that are not part of the public meeting, but I want to take advantage of again saying that anyone who wishes to make public comments - we have five identified so far - let someone up here know that you are interested, probably Donna Bush, and we will try to allocate the time appropriately so that you will have an adequate time for a response. I apologize that we are not going to have a full-blown long and content-rich public session, but that should be coming hopefully the next time, and until then we have to have a continuation of our - we are moving at a long kind of statement that we have made. I read the minutes of the last Drug Testing Advisory Board minutes and I think I can almost repeat the same thing with one exception: the proposed revisions to the Mandatory Guidelines have been cleared by the Department, have been briefed to the Office of National Drug Control Policy and have gone formally to the Office of Management and Budget. Therefore, we expect sometime within the next 90 days to be given permission to publish the document in the Federal Register for formal public comment. Until that time we do not have permission to distribute it or share it with the public at this time, but it is getting closer, it really is. Quite honestly, that's my update. DR. BUSH (HHS): In light of all the plans that HHS has to engage in public comment to move forward with the technologies that we have been working with the Board and industry working groups over the last 5 or 6 years, we have had to take a look at the kind of support, technical support, we can gather for carrying out a program for developing - continuing to develop a program preparing documents looking at proficiency testing, looking at inspections, everything that goes with establishing an accurate and reliable drug testing program with all its paperwork, all its documentation, and timing was actually pretty good for us to move into a new bidding process on a contract for the existing National Laboratory Certification Program certifying urine drug tests in laboratories as we know them today. And looking ahead to the future with draft 4 of the guidelines on our Web site in mind, pursuing that avenue, that was a good work product that we developed over the years, and that served then as part of the plan to establish a new contract to support this program. And, when did that contract process start, in January 2003. We started with a Request for Proposal in response to the Statement Of Work that was published and went through a full and open competitive procurement process. This is where any and all bidders are asked to review the document to get back to us with any questions they might have. Contracts office would answer them in whatever manner was appropriate, whether it was one-on-one or whether to have a contract meeting. This whole process takes a few months and I will announce that yesterday, September 2, a contract was signed with RTI International. They were the successful bidder with the proposal that they presented. This is a 1-year contract with 4 option years. Those 4 option years are determined based on performance during that first contract year, and then each year evolves separately and on its own. MR. STEPHENSON: One of the things that has come out of this is that in developing the new contract, there was both an issue of timing and funds and focus that we had to look at and try to balance out. There are a number of tasks that will be developed now that the contract is in place that will have sufficient funding with it to tackle some of the remaining proficiency challenges, the new specimen-related issues that we had not been able or had funding enough under the prior contract to do. So there will be a lot of that that will be discussed probably over the next 45 to 60 days, but some of it will have to wait until we have had a public comment period and we have resolved some of the potential differences that could come out of the public comment process until we make a final decision as to which way to go and exactly what we are going to finalize on. But we will have a number of things that will deal with the alternative specimens and collections sites and medical review officer credentialing and standards, so that there will be a number of new and interesting processes to pay attention to over the next 6 months to a year. I want to thank Donna, Walt, and Charlie for all of the work that they did on this. This is one of those tasks that I was fortunate enough not to have to be personally engaged in, and I really appreciated that with all the other things we had going on. They did a great job, and this is going to serve the country very well. I think this is going to give us a kind of standards development and process that will help set a whole new level of competent forensic testing. Again, it will become a gold standard for this country, but even more importantly it will help guide some of the areas in other parts of the world too. Agenda Item: DOT Update MR. EDGELL (DOT): I remain as the acting director of the Office of Drug and Alcohol Policy and Compliance. How long now? It's 2-1/2 plus years. It is still the goal of the Department to fill that with a permanent replacement, but as of this date it's still me in an acting job. I have a few things to talk about since the last Drug Testing Advisory Board meeting. On July 25, the Department published in the Federal Register our final rule on the Drug and Alcohol Management Information System reporting. The MIS, or Management Information System, is a form that is currently used within the 5 U.S. Department of Transportation agencies, those being Federal Motor Carriers, Federal Aviation, Transit, Rails, and the Research and Special Programs Administration, as well as the United States Coast Guard, which as you all know was transferred from the Department of Transportation to the Department of Homeland Security. And they use this MIS form for the submission on an annual basis of drug and alcohol program data. The Department has streamlined this annual reporting of the data to a 1-page MIS data collection form. Previously there were a total of 21 different drug and alcohol forms and different instructions, so we have standardized across the industry for information that we are collecting, thereby, reducing the total amount of information reported by Transportation employers. This reporting mechanism will be offered to the industry in a paper format, and the form was included in the Federal Register along with the instructions, as well as available to Transportation employers to report these statistics through the DOT Intranet. The new reporting form will be available for use in calendar year 2004. The calls to the five agencies go out in late January to early March, and that will be the first utilization of this and the data that will be collected will be data from 2003 calendar year. And one of the things that this new collection offers is that it matches the new chain of custody item for item, so each item as it's reported to the employer will have a specific block mechanism for reporting that information to the Department. The second item is a notice that was issued in the Federal Register on August 22 of this year, a notice of a public meeting of our Federal Advisory Committee. This is the DOT Electronic Transmission and Storage of Drug Testing Information Committee. This will be the third meeting in a public session. The meeting will be September 22 and 23 at the Key Bridge Marriott Hotel in Arlington. The purpose of this committee is to recommend to the Department three things: the type and level of electronic security that should be used for the transmission and storage of drug testing information; to assess the format for reporting and the method; and to recommend the level and type of electronic signature technology that could or would support procedures used in the DOT drug and alcohol proposed testing program. The minutes of the two previous meetings are recorded in the docket. The docket number is 12148, that is on the DOT Web site, and this is planned to be the final meeting with a recommendation coming back to the Department on how to handle these issues that I've mentioned on electronic transmission and storage of drug testing information. The third item is that Don Shatinsky, senior policy analyst in the Office of Drug and Alcohol Policy and Compliance, retired from our office, effective August 1. Don had 36 years of federal service. He was with the Office of Drug and Alcohol Policy and Compliance for 8 years and he will be sorely missed. We ran an announcement and filled the vacancy rather quickly. We have an excellent individual in as a replacement for Don, if that is the right word, because Don has pretty big shoes to fill. But we replaced Don with Mark Snider. Mark has a 14-year career at DOT. He comes to us with a lot of program experience, being the drug and alcohol program manager for Motor Carriers for over 4 years and then followed that as the drug and alcohol program manager for the Federal Transit Administration for 3 years, so he is a welcome addition to our office, which is, as you know, a small office of four people That's the last item, other than I would like to just acknowledge your continuation of the contract with RTI. We contact RTI on a semi-regular basis and have always found them to be very helpful, very courteous in their responses, and always very professional. So it has been an enjoyable relationship with DOT. MR. STEPHENSON: I am glad you said that after we awarded the contract. We were going to have an update from the Nuclear Regulatory Commission, but unfortunately the representative is not here, and I will not try to engage any of the discussions on this behalf. At this time, are there any comments by the members of the Drug Testing Advisory Board that you wish to share or any of the issues that you need to bring up in public session? I want to offer this to you first. Agenda Item: Public Comments MR. STEPHENSON: I have individuals identified in an order. I don't know if they represent a particular order - but since they are on a piece of paper and I am a bureaucrat, I'm going to start from the top and work my way down. Let's try to keep each individual under 10 minutes and, if you can, 7 or 8 would be great. If you have any of your comments that are written and you wish to provide them to us, we will certainly accept them. We will start with N.B. Varlotta. MS. VARLOTTA: Mr. Stephenson, all members of the Drug Testing Advisory Board, my name is N.B. Varlotta. Recently, this Board revised the standards for validity testing of drug screening tests. The DOT is about to implement new standards as guidelines for companies to follow in drug screening tests for employees. In lowering the threshold for creatinine in specific gravity levels, this Board has acknowledged that the original test guidelines were unrealistic and lacking any scientific basis. After years of championing the cause, it is gratifying to see the change. However, the DTAB and the DOT guidelines fail to address specific and important problems with validity testing. First, there still is no due process for anybody who does not meet the threshold levels. Four years ago, it was considered not humanly possible to produce levels below the then-recommended guidelines. One was branded a cheater, a liar, and a drug user, solely on the basis of the threshold set by this board. Time and a lot of effort has proven the fallacy of that policy. Even with the new threshold levels, there remains the possibility of human and/or mechanical errors in providing the samples, collecting the samples, or testing the samples. How is this addressed? It isn't. Anyone can still be falsely accused and have no remedy for proving their innocence or clearing their name. Secondly, there remains the problem of clearing the reputations of those trapped in the original guideline testing nightmare. Despite all the evidence of improper testing, despite the acknowledgment that the original threshold levels were unrealistic, the DOT refuses to cancel tests that fall within the new guidelines. This problem is a continuation of the first problem. The corporations say seek remedy from the MRO. The MRO says seek remedy from the FAA. The FAA says seek remedy from the DOT. The DOT says seek remedy from HHS. HHS says seek remedy from the courts. The courts say there is no remedy because of federal preemption, although Congress intended federal preemption to protect airlines economically, not to allow wholesale disregard for labor laws and civil rights. No agency or individual is willing to take responsibility for correcting an egregious wrong. No one is willing to do the right thing. I am again asking that my validity test of January 6, 1999, be canceled, as well as all tests from October 1998 to present that fell below the original guidelines. There is no moral or ethical reason to have innocent people continue to suffer the embarrassment, the distrust, and the continued nightmare of a false accusation. I applaud this Board for having the courage to listen to the evidence and revise the threshold levels for validity testing. However, it is only the first step in a long road to justice and fairness. Due process is still a fundamental right in this country. Let us not forget those still trapped in the quagmire left by the original guidelines. Thank you . MR. STEPHENSON: Thank you very much. The next public comment to be presented by Julia Jones. MS. JONES: My name is Julia Jones. I'm a flight attendant from Denver, Colorado. As a result of fatal flaws in the federal regulations involving validity testing, I was out of work and poverty-stricken for 32 months. I have a little demonstration for you. As you can see, the same substance from this is going into both what we will call bottle A and bottle B. The same compound in both of these, each container, should test the same, correct? Well, they don't. Why? Because when you submit to a urine drug screen it's pretty much like playing Russian Roulette with your career. You're taking a huge gamble. Depending on the time of day you give the sample and most importantly depending on which lab your sample goes to, you may or may not continue to have your career. I brought to your attention in June of 2002 the unacceptable variances between the labs testing the same unit of urine. There is no recourse and there is no accountability. The blame is pushed from employer to lab to collector to MRO. This vicious circle continues. No one will admit to a system that is seriously flawed. My test was mistakenly marked return to duty, and was not a federal test. Dr. Robert Swotinsky testified at my trial that 10 to 25 percent of the time the wrong box gets checked on the chain of custody form, and it's no big deal. It is a big deal to me. It is unacceptable, that is one-fifth of the time, I will ask each and every one of you, is it acceptable if one-fifth of the time the brakes on your car fail you? What is acceptable to you? One percent? Two percent? One-tenth of one percent? What is acceptable to you? The longer you wait to take action to fix the current problems, the more damage you cause. No one ever thought this through, and although some significant progress is being made, it does nothing for those of us that fell under the old regulations. The damage will only continue to these people until you cancel all tests deemed substituted under the old regulations. You have recognized that old rules were flawed. There still remains no mechanism for us to clear our names. Thank you. DR. REID (DTAB): I have a question. What happened - you didn't explain what happened to those two specimens. How did they differ when the second lab tested it? MS. JONES: Bottle A tested a 4.94 creatinine and a 1.001 for specific gravity. Bottle B tested a 2.9 and 1.002 specific gravity. That was well over a year. It took a court order that I'm to have my Bottle B tested. MR. STEPHENSON: Thank you. The third public comment will be made by Brad Sheferin. MR. SHEFERIN: My name is Brad Sheferin. I am actually Julia Jones' attorney, and by way of introduction, before I went into litigation in the '90s I was a city attorney and I drafted some of the early policies for city governments that were used in the model in Colorado for drug testing for the government. This was back when the DOT amended its regulations to require both public sector as well as private sector DOT licensed drivers to submit to the drug testing, so that's part of my background in representing Julia Jones. We did have a trial, it was about a month ago, and first I want to share some of the revelations that we learned at trial, starting at the beginning with jury selection. One of the members of the panel was a pilot and his background was he graduated from the Air Force Academy and he went into military service and he had top security clearance before he left the military and became a pilot. And without provocation, unsolicited, this gentleman volunteered that, yes, he has to take a drug test every year and every now and then he's in the random pool and he has butterflies in his stomach every time he has to go in for the test, and he said, I'm not alone, most of the pilots do, and the reason is we're concerned, we've always heard comments we read in our employer's newsletter that sometimes mistakes are made in the test and somebody from the Air Force Academy with military security clearance -- I'm very concerned about losing my career because of a mistake. And in Julia Jones' case, of course we've all heard about the mistake, and in Julia Jones' case we had four separate MROs, and what I wanted to discuss with you, and part of the comments I submitted last week on the record, four different MROs were involved in this case, one from Massachusetts, one from Minnesota, two from Colorado. Four different MROs had four different opinions as to what the regulations required of them, four different interpretations of what those regulations required. We were dealing with four different people of the same background and the same type of certification, that could be a problem. The definitions currently require an MRO to be responsible for evaluating a medical explanation for certain drug results. That's part 40.3. Part 40.3 of the current regulations also provide for what's called qualification training and for refresher training. Refresher training is something that implies it's done frequently. Lawyers have to do continuing legal education, doctors have to do continuing medical education. And refresher training, under the regulations, is something that only the technicians are required to continue to do. Refresher training includes being refreshed on changes in regulations and changes in technology. Under 40.3, qualification training, that only means you have to have a certification, and that applies only to the MROs. In other words, the current regulation scheme suggests that the MROs be certified by their own kind but not be required to be updated on any changes in technology or any changes in the rules. In Ms. Jones' case, one MRO testified that in order for somebody to legitimately produce urine with a 5.0 creatinine level, that person must be chronically ill, having seizures, it's humanly impossible in other words. Four different MROs had four different viewpoints on how it's possible to produce a creatinine level of that 5.0. What we also learned is the gatekeeping role of the MRO, and by the way, one of those gentlemen that I was referring to authored this book, it's called the Medical Review Officer Manual from 1999, and this gentleman also served on a panel, one of two agencies in the United States that certifies MROs. And that gentleman talked about the gatekeeping role, what he referred to in his book simply as nothing other than we push paper, we make sure that the paper that comes through our office is done correctly. We're not responsible for mistakes that are made before us. As Ms. Jones just talked about, it was Mr. Swotinsky, the author of this book, Dr. Swotinsky, who testified that it's no big deal. Since 1987, we've known that the wrong box gets checked on the custody and control form as to the type of test 10 to 20 percent of the time. We've known about it since 1987, but it's no big deal, no big deal to the MROs, there's nothing differently we need to do with that knowledge. He also talked about it's okay in the drug test report that goes to the employer that adulterated and substituted are listed on the same report, no big deal if the employer reads a report from the MRO that says the employee substituted and/or adulterated. The reason the MROs consider it to be no big deal is the result is the same. That's the end of their obligation as an MRO. So the problem that I submit to you is under part 145 of the current regulations. Part 145 is the verification interview process. Great steps were taken I think since Julia's case to require the MROs to delve into why an individual's test results came back as substituted. Even by lowering the substituted threshold to now recognize somebody with dilute, you're still placing in the hands of the MRO discretion without education. And the discretion is under part 145 that the MRO is to interview the donor during the verification interview. That's supposed to take place immediately or within 72 hours of the results coming back from the lab. Now, the few people I've polled, when they get the phone call from the MRO, this is the very first time that donor is learning that their creatinine level was low, and it's probably the very first time the donor is even told what creatinine is. They have no idea, and therefore they are completely unprepared to provide any type of verification justification during that first phone call. So what do the regulations do? They allow the MRO to give, at his discretion, that donor 5 days, it doesn't say 5 calendar days, 5 business days, we assume it's 5 calendar days, but 5 days to produce medical information to justify, and now the burden of proof is on the donor. So they have 5 business days to justify the creatinine level that they've produced. Generally that's not a problem, but the poll that I've taken of everybody in my office and some people in this room, it's impossible to find a specialist in 5 days, to make an appointment, to go down and test, and to get those test results in 5 days, and to get them back to the MRO as your justification. And again, I'm referring to the majority if not the supermajority of individuals who don't even know what creatinine is until they have that first verification test. Now the regulations do provide elsewhere that there's a 60-day time period, and in 60 days the MRO can look at new information, but by then the individual has been terminated. In dealing with four different MROs, four different interpretations, four different people who look at the same results and come up with four different ways as to how they can result, I suppose I could tell you I'm inspired by Mr. Stephenson's comments earlier that there's going to be some MRO credentialing or standards created. That needs to come sooner than later. And if anybody's interested in obtaining some of the transcripts from the testimony of Dr. Swotinsky, it really is a shocker. Thank you. MR. STEPHENSON: Thank you for your comments. I'm going to challenge you, Brad, to be a careful reviewer in the public comment period of the section on MRO standards and to look at the issues that you've addressed and to make comments regarding that. Can I count on you? MR. SHEFERIN: Sure. MR. STEPHENSON: Okay. Richard Drake, next public comment. MR. EDGELLL: Can I just address one thing? I'm not sure of the timing of Brad's comments on the MRO and their refresher training, but as of the revised rule in August of 2001, medical review officers are required to have continuing education training once every 3 years. MR. STEPHENSON: Richard Drake MR. DRAKE: Last time I was here, which was the last DTAB meeting, I spoke to Dr. Vogl, and he very clearly made the point that this group is not really responsible for developing the rights of those to be tested as far as their legal rights and remedies. This group is solely interested in and responsible for the development of part 40. MR. STEPHENSON: No, I'm sorry, sir. That is incorrect. MR. DRAKE: Oh, it is? MR. STEPHENSON: This body is responsible for federal agency drug testing of federal employees and those standards. Those standards are in addition used by other authorities in the Federal Government under their own separate authority. This Drug Testing Advisory Board is chartered by the Department of Health and Human Services and is responsible for the testing of federal employees and federal job applicants. MR. DRAKE: But not responsible for the development of the rights of those people being tested as far as they both manage their rights to due process. MR. STEPHENSON: I am correcting your statement on one issue. MR. DRAKE: But as far as my statement as to the rights of the individuals that are being tested, this Board does not develop their rights as far as their right to due process, which is something that two of the previous speakers represented. Is that correct or am I incorrect? MR. STEPHENSON: I am not going to respond to you at this point. I will suggest that you make your comments as comments of fact and that you try to do so within 7 minutes. MR. DRAKE: As a comment of fact, I have in my hand the 1989 regulations which were in effect when I was terminated under the drug testing program. I'm still in court trying to have - not to prove that I'm guilty or innocent of adulterating my sample, but I'm in court for 10 years now just trying to be heard on the issue of whether or not I'm guilty or innocent. I have never been able to find a forum to present the facts, closed out of the courts, no rights to due process whatsoever. So this body has made it more difficult by shielding those people that are responsible for the testing. In the 1989 copy of part 40 that I have in my hand, it says the employee - this is reading 40.25-22ii, the employee may not be required to waive liability with respect to the negligence on the part of any person participating in the collection, handling, or analysis of the specimen or to identify - sorry, to indemnify - any person for the negligence of others. That was removed. It's not in the regulations anymore. It's not in the regulations anymore because it was too specific. It was removed by you, this group, somebody removed it from the part 40 regulations to shield the negligence of the people participating in the program, in the collection. There is no other reason for removing it. It certainly does not help the individuals to protest it. It does not in any way impinge on the accuracy of the testing. All it does is shield the negligence of people, some of which are sitting here, and other people that are doing the testing and are responsible for the collection, the handling, and the analysis. I ask that this Board consider, and I'm sure if I ask, no one knows who eliminated this particular paragraph, that this Board consider putting it back into part 40, because it's important and it helps protect us, and it does not in any way affect the outcome of the test. That is my public comment. MR. STEPHENSON: Thank you very much. We have one remaining public commenter, Mike Feldman. DR. FELDMAN: Mike Feldman from NWT in Salt Lake City. As some of you know, we've had a long commitment to providing testing to address adulteration in specimens coming in to certified laboratories. However, we are becoming increasingly frustrated by the fact that there does not appear to be a coordinated effort amongst the laboratories to address this very important issue. I would like to recommend to this Board to use its influence in maintaining or developing support for the laboratories to continue its vigilance in being able to identify adulterants in specimens and to provide support for research in order to be able to determine the clinical significance of the findings of such testing. Thank you. MR. STEPHENSON: Thank you for your comment. Are there any other public comments that individuals need to make? At this time, we conclude the public session of the Drug Testing Advisory Board. I thank you all very much for being here. I know it's brief, but we'll have an opportunity to do this in more detail in the near future. The public session of the Drug Testing Advisory Board adjourned at 9:25 a.m.