December/January 2003-04
 
Inside This Issue:
DATIA 2004 Conference Positioned to be The Best Ever
As April draws near, excitement is building for DATIA’s 2004 Annual Conference and Exposition. And with good reason. Top notch speakers, unbeatable networking events, product launches, and the addition of sponsor hospitality suites all contribute to what will be the highlight of the year for those involved in drug and alcohol testing.

For 2004, a select number of industry leaders have partnered with DATIA to bring you the best possible educational experience. We are pleased to announce that the 2004 DATIA Annual Conference and Exposition is presented by Instant Technologies, Inc.; NWT-Northwest Toxicology; PharmChem, Inc.; and Varian, Inc. Their partnerships with DATIA to present the conference have enabled DATIA to make your conference experience the best that it can be. (See related articles on pages 7-10.)

An exciting development is that new speakers have been confirmed for the conference to further meet your learning objectives. Ron Fields, who works under Asa Hutchinson at the Office of Homeland Security, will be participating in a panel outlining the role of drug and alcohol testing in enhancing homeland security. Mr. Fields previously worked with Mr. Hutchinson at the Drug Enforcement Agency, and before that worked as a prosecutor where he dealt extensively with drug and alcohol issues. We are honored to have Mr. Fields at the conference, and look forward to the insight and knowledge that he will provide to attendees. Mr. Fields will be joined by Josephine Kenney of ChoicePoint, and Don Rothschild of Peak Paths, to deliver this cutting edge session.

All attendees at the conference are well versed in drug and alcohol testing practices, but how many utilize “smart testing”? Albert Jekelis, Ph.D., will discuss the aspects of smart testing and how you can employ these principles to enhance the services you provide to clients. Ultimately, this will result in increased client satisfaction. The principles of smart testing include monitoring return on investment, intelligent data management, using multiple types of testing protocols, and using products that are accurate the first time to provide a cost-effective and efficient program that ultimately affects the overall effectiveness of your drug testing program. Dr. Jekelis is the director of the Clinical Laboratory, University Behavioral HealthCare, University of Medicine and Dentistry of New Jersey. He is a published author and authority in toxicology, information processing, laboratory efficiency, pharmacology, and clinical chemistry. Dr. Jekelis currently serves as secretary of the Laboratory Information System and Medical Informatics Division of the American Association of Clinical Chemistry.

Featured in previous newsletter articles, the conference will also include sessions on Attracting and Retaining a Talented Workforce, Standardizing Company Procedures, Ask the Board, Creating and Maintaining Positive Client Relations, The Future of the CCF - Will Paper be Obsolete, Prescription and OTC Medications: Effects of Safety Sensitive Performance, and The Here and Now of Adulterants - Reports from the Frontlines.
A highlight for many attendees is the DATIA Exposition, and 2004’s Exposition is shaping up to exceed your expectations. As attendees step into DATIA’s version of Seattle’s renowned Pike’s Place Market, they will be amazed at the number of exhibitors with new products and services to demonstrate. Many new advances have been made since DATIA’s 2003 conference, and this is the place to learn what the new items are and how they can benefit you and your clients. In addition there will be products on-hand during the DATIA Exposition that are being introduced to the industry for the first time. We encourage you to be in attendance to witness these product launches.

Since “all work and no play makes Jack a dull boy,” DATIA has arranged for optional group activities that will allow attendees to make the most of their time in Seattle. On Thursday, before the opening reception, DATIA has arranged for a private tour of Boeing Company’s 747/767/777 plant. Attendees will view 747s in various stages of production as they are rolled from each assembly point.

During the conference on Friday, families of attendees can enjoy a day touring Snoqualmie Falls (actually 97’ higher than Niagara Falls), the Chateau Ste. Michelle winery, and shopping. This tour will provide your guests with the best that Seattle offers.

For the first year ever, Presented By sponsors of DATIA’s Annual Conference will host hospitality suites on Friday evening after the conference sessions. During this time, sponsors and attendees can mingle, relax, and explore how they can enter into mutually beneficial relationships. (See related articles on Presented By Sponsors on pages 7-10.) On both Friday and Saturday evenings, attendees can relax and mingle aboard the Spirit of Washington Dinner Train. This unforgettable dining experience provides breathtaking views of the Seattle skyline, Lake Washington, and Mount Ranier.

Finally, after the conference, attendees can participate in the Skagit Valley Tulip Festival. One of Washington State’s most popular events, the Tulip Festival is sure to leave attendees breathless.

As you can see, DATIA’s 2004 Annual Conference is the event not to be missed. We encourage you to register today, and look forward to seeing you in Seattle.


FDA Updates and Clarifies Draft Guidance to Industry on Drugs of Abuse Screening Tests
On December 2, 2003, the Food and Drug Administration (FDA) issued a revised draft guidance for manufacturers of drug abuse screening tests that updates two previous draft guidances published in 2000. This new guidance supersedes the previous documents and clarifies current FDA thinking for both laboratory and non-laboratory (workplace, sports, insurance, and home) tests.

“FDA intends to be clear about the regulatory requirements for drug abuse screening tests, and we intend to enforce these requirements fully, so that the public can be confident that drug abuse screening tests will be used both effectively and fairly,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D. “The tests available today can benefit the safety and well being of children in school, consumers buying products, and adults on their jobs. But they also should not be misused, because they can have important consequences for school records, professional opportunities, and insurance costs.” he said.
Tests covered by the guidance include screening tests for amphetamines, cocaine, methamphetamines, opiates, cannabinoids (marijuana), and phencyclidine (PCP). The FDA states that premarket review by FDA is required for these tests.

The guidance continues to describe the types of studies recommended by FDA to establish reliability, and also the types of information that the agency recommends be included on the label. However, it describes new and more flexible options for companies preparing marketing submissions for these tests. In particular, previous recommendations that the cost of confirmatory testing be bundled with the cost of screening tests have been replaced by recommendations for cautionary labeling and other controls to address concerns over possible inaccurate preliminary results.
Previous recommendations that performance testing for non-laboratory use be conducted with untrained lay users have been replaced by a wider menu of performance testing options. The revised guidance recommends performance testing using laboratory professionals, health care professionals, trained lay users, or untrained lay users, depending on the setting in which the tests are expected to be used. As a result, labeling for these devices may be designed to better match the broad array of testing personnel and arrangements used in non-laboratory settings. This increased flexibility should lower costs and increase access, while maintaining test quality.

FDA recommends that because of the potential for both false positive and false negative results from all such tests used in any setting, the label recommend that positive results be confirmed using a different test method.

FDA also recommends that the label explain that the tests are not always accurate. A positive test result does not always mean a person took illegal drugs, and a negative result does not always mean a person did not take illegal drugs. A variety of factors can influence the reliability of drug tests, and the agency suggests that manufacturers list substances known to interfere with the tests. Clear and correct labeling is likely to improve test use and meet a major FDA goal of promoting consumerism.

A copy of the complete guidance, as well as DATIA’s comments to the FDA regarding this issue can be found in the Issues Section of DATIA’s website.

Patent Infringement: Inverness Medical Aggressively Protecting Drug Testing Technology
By Tom Eden & Michael Jackson of Wallace, Jordan, Ratliff & Brandt, L.L.C.
Inverness Medical Innovations, Inc, based in Waltham, Massachusetts, has become a leading provider of women’s health, nutritional, and rapid diagnostic products, including tests for pregnancy and drugs of abuse. Inverness also owns patents on certain lateral flow immunoassay technology, a process that provides rapid results when used in a number of tests, including rapid screening tests for drugs of abuse (DOA). Recently, Inverness has filed a number of lawsuits throughout the country in a bid to protect its patents related to lateral flow immunoassay technology. Inverness has targeted medical and pharmaceutical companies, both large and small, and presently has as many as twenty lawsuits pending.

One of the companies recently in Inverness’s crosshairs was mammoth pharmaceutical company Pfizer, which Inverness sued for alleged infringement of two of its patents related to lateral flow technology. After a favorable appellate court ruling in October 2002 (see Inverness Medical Switzerland GmbH v. Warner Lambert Co., 309 F.3d 1373, Fed. Cir. 2002), the companies announced the settlement of that suit in June 2003. Though the settlement did not provide a damage award to Inverness, it did include certain injunctive relief. It also provided that Inverness would supply pregnancy testing devices to Pfizer for the next five years, and required Pfizer to make certain payments to Inverness prior to beginning the supply agreement.

Another pharmaceutical giant that Inverness went after was Abbott Laboratories. This litigation also resulted in a major settlement that benefits Inverness’s drive to maintain and consolidate control over the market for products that utilize lateral flow technology. Under the settlement, which was announced in October 2003, Inverness acquired a significant portion of Abbott’s rapid diagnostics at a cost of roughly $92 million. The acquisition included additional intellectual property related to lateral flow and several lines of rapid diagnostic products utilizing that technology, including Signify®, the Abbott TestPack®, and TestPack Plus®, and the Factplus® pregnancy test line.

Other lawsuits filed by Inverness relative to its lateral flow technology patents include patent-infringement actions against Acon Laboratories, Inc., of San Diego, California, and Qualis, Inc., of Des Moines, Iowa. Both suits relate to Acon’s and Qualis’s alleged infringement of two patents for the methods Inverness uses in its ClearBlue pregnancy test and its ClearPlan Easy ovulation test. Inverness has also instituted litigation against Princeton Biomeditech for alleged infringement of three of its patents, obtaining a favorable appellate court ruling in October 2002, against that company. (See Inverness Medical Switzerland GbhM v. Princeton Biomeditech Corp., 309 F.3d 1365 Fed. Cir. 2002.)

Besides aggressively protecting its lateral flow patents, Inverness has also acquired additional rapid diagnostic lines and technology. For example, in addition to its acquisition of rapid diagnostics from Abbott Laboratories, Inverness inked a deal in August 2003, with Apogent Technologies, Inc., for the purchase of Apogent’s subsidiary, San Diego, California-based Applied Biotech, Inc., a manufacturer of rapid diagnostic tests for pregnancy, illegal drugs, and infectious diseases. Inverness paid Apogent approximately $13.5 million for the subsidiary, and released Apogent from all patent infringement claims it may have against Apogent relative to the lateral flow technology.

Inverness’s aggressive litigation and acquisition strategy does not, at present, show signs of relenting. As it continues to consolidate the market on lateral flow
immunoassay technology, its market share in the rapid drug test market will continue to increase.

Practical Counsel:

First, if you are using any rapid screening DOA device, request written confirmation that your supplier is not a defendant in a patent infringement action brought by Inverness.

Second, if you are a reseller of a rapid screening DOA device, ask the above question and additionally request a written warranty of non-infringement and indemnification from your supplier.

Third, seek independent legal counsel to determine if your use of a rapid screening DOA device may be placing you in the cross-hairs.

Disclaimer & Acknowledgements: The above should not be construed as legal advice or legal opinion as to any specific facts or circumstances. The contents are intended for general information only, and you are urged to consult your attorney concerning your own situation and any specific legal questions you may have. Tom Eden and Matthew Fridy are management labor attorneys with the law firm of Wallace, Jordan, Ratliff & Brandt, L.L.C. who advise collection sites, TPAs, employers, workers’ compensation administrators, and MROs on a variety of drug and alcohol testing issues, policy development, and risk-reduction programs. Tom Eden and Matthew Fridy may be reached by telephone at (205) 870-0555 or by e-mail at te@wallacejordan.com. Please visit our web site at www.wallacejordan.com (which contains federal drug-testing regulations and other drug-free workplace resources at www.wallacejordan.com/drugfree.htm).


Supreme Court Upholds Employer’s No-Rehire Policy for Employee Terminated for Drug Use
By Tom Eden & Michael Jackson of Wallace, Jordan, Ratliff & Brandt, L.L.C.
The United States Supreme Court held that an employer who refused to rehire a employee discharged for drug use in accordance with the employer’s no-rehire policy did not unlawfully discriminate against the employee on the basis of a disability. In Raytheon Co. v. Hernandez, a former employee who had been fired for drug use sued his former employer, Raytheon, for discrimination under the Americans with Disabilities Act. After the former employee’s termination for drug use, the employee, who had worked at Raytheon for 25 years, completed treatment and sought to be rehired. Raytheon refused to rehire him and cited a company policy of not rehiring employees fired for misconduct. The employee claimed that he was not rehired because of his past addiction to drugs, which he contended amounted to unlawful discrimination for a disability.

The Supreme Court held that Raytheon’s neutral policy of not rehiring employees terminated for misconduct was a legitimate nondiscriminatory reason for not rehiring the plaintiff. The Court wrote that Raytheon’s “no-rehire policy is a quintessential legitimate nondiscriminatory reason for refusing to rehire an employee who was terminated for violating workplace conduct rules.” However, because the plaintiff did not properly bring disparate-impact claim, the Court left open the question of whether a former employee could challenge a no-rehire policy like Raytheon’s on the ground that it has a disparate impact on disabled persons or, in other words, whether a neutral no-rehire policy is an employment practice that impacts more harshly disabled persons and cannot be justified by business necessity. The Court remanded the case for further proceedings, ordering the lower court to determine whether Raytheon had applied its no-rehire policy to the plaintiff in a neutral fashion.
Practical Counsel:

It is critical in light of this decision that employers implement a “no rehire” provision in their employee handbook. Including the provision only in a Drug Free Workplace would make it suspect and not recommended. The restriction needs to be applied across the board to be free from legal challenges under the ADA.

Disclaimer & Acknowledgements: The above should not be construed as legal advice or legal opinion as to any specific facts or circumstances. The contents are intended for general information only, and you are urged to consult your attorney concerning your own situation and any specific legal questions you may have. Tom Eden and Mike Jackson are management labor attorneys with the law firm of Wallace, Jordan, Ratliff & Brandt, L.L.C. who advise collection sites, TPAs, employers, workers’ compensation administrators, and MROs on a variety of drug and alcohol testing issues, policy development, and risk-reduction programs. Tom Eden and Mike Jackson may be reached by telephone at (205) 870-0555 or by e-mail at te@wallacejordan.com or mlj@wallacejordan.com. Please visit our web site at www.wallacejordan.com (which contains federal drug-testing regulations and other drug-free workplace resources at www.wallacejordan.com/drugfree.htm).
Conference Sponsor Spotlight: Instant Technologies, Inc.
Instant Technologies, Inc. exhibited at the DATIA conference last year in Nashville for the first time, after joining DATIA initially in 2001. Their response was so overwhelming as a Bronze Exhibitor that this year they are getting the most out of the DATIA experience, not only by signing up as a Presenting Sponsor, but by re-joining DATIA as a Sustaining Member as well.

Peninsula Drug Analysis Company was founded in December of 1996 as a drug testing collection site. Founder James Ramsey’s father had six psychological practices in Virginia, and among those practices were several chemical dependency programs. In order to complete the program, patients had to pass a drug test. Like many companies, Peninsula was contracting its drug tests to an outside collection site and laboratory, which was becoming increasingly cost prohibitive. After talking with their laboratory, Ramsey decided to purchase a large number of on-site test cups each month. He soon discovered, however, that he would be unable to use such a large number each month, and the money to the manufacturer was quickly coming due. Therefore, like any savvy businessman, he augmented his purchasing by marketing the on-site cups. The marketing strategy worked, and soon Peninsula was doing more marketing and distribution than it was drug collections. “After four months in business, it became obvious that the future of drug testing included onsite testing options,” said Ramsey. Therefore, in 1997, he formed Instant Technologies, Inc. Still located in Norfolk, Virginia, the company no longer does drug collections, but instead is involved in the development and design of new and innovative products in the point of care industry. These include not only onsite drug tests, but also women’s fertility and pregnancy tests and infectious disease tests, including strep and mono tests.

Six years after making the change from a collection site to a marketing, development, and design company, Instant Technologies continues to grow approximately 45% each year, growing nearly 50% in the past year. Forecasting for 2004, James Ramsey states that the company “will likely double in revenue by expanding both Instant’s market share and product line.”

Two products that Instant Technologies will be highlighting at the 2004 Conference will be the iCup® and their new iScreen Oral Fluids device. “The iCup is Instant’s best selling device,” says Ramsey. “It does all the testing for you.” Instant Technologies launched a new iCup® drug screen in March of 2003 and sales have grown substantially over the past year. The iCup® is the first integrated drug screen that enables the result to be photocopied. The iCup® also includes a patent pending copy template that produces a result form from the original device image. Another new addition to the Instant Technologies line up is the all-new iScreenTM Oral Fluids device. The iScreenTM has a revolutionary design that splits the specimen into a test and confirmation chamber. Training for both products is offered on their website, tryi.com.

James Ramsey says that Instant Technologies is dedicated to bringing easier, faster, and more cost-effective solutions to the point of care market. They believe strongly not only in their mission, but also in that of DATIA. That is why, after signing up as a Presenting Sponsor, Mr. Ramsey has been working extensively with DATIA to increase the visibility and availability of its products, and has committed to joining DATIA as a Sustaining Member. “We appreciate DATIA’s hard work and feel it is our obligation to support organizations that support our industry.”

Joining Mr. Ramsey at the 2004 conference will be President Gerald T. Ramsey, Ph.D., Edward Bennett, Vice President of Sales, and Scott Taillie, National Products Manager. James, Ed, and Scott attended the conference last year in Nashville, and they are counting on it being just as successful in Seattle. They will be doing a “raffle” at their booth for $1000 worth of Instant Technologies’ equipment. They ask that you stop by and say hello at the conference, whether you are a current client or a potential new customer.


Conference Sponsor Spotlight:
NWT-Northwest Toxicology
What sets Northwest Toxicology apart from other certified laboratories? There are many items that Northwest Toxicology can identify, however, for more than 20 years service has been the top candidate. “Service excellence is part of who we are. When you call Northwest Toxicology you are going to speak with a person whether you need to speak with customer service, a certifying scientist, or a toxicologist,” states Michael Feldman, general manager and senior VP. As a Presenting Sponsor of DATIA’s 2004 Annual Conference and Exposition in Seattle, Northwest Toxicology is looking forward to sharing its commitment to “provide high quality drug testing at a fair value for our customers in meeting and exceeding their expectations.”

Founded in 1981, Northwest Toxicology has grown to be the largest provider of drug testing for federal agencies mandated by the Department of Health and Human Services, and is likely the most regulated and inspected laboratory in the country. As one of the first laboratories to be certified by SAMHSA (then NIDA), Northwest Toxicology has been SAMHSA certified since 1989.

As part of Northwest Toxicology’s sponsorship of the DATIA conference, they would like DATIA members to be the first to know of a great event happening this year. LabOne, Inc., has signed an agreement to acquire the assets of Northwest Toxicology. The transaction should be completed by early March of this year. Both laboratories are fully licensed (including SAMHSA), and will remain open and continue to provide drug testing services. Northwest Toxicology will focus on hair testing, specimen validity testing, medical professional testing, and esoteric drug testing. LabOne, Inc., will focus on traditional employment screening in urine and oral fluids. The overlap in credentials and certifications creates important back-up support for both labs. Clients will now have access to the broadest array of drug testing products and services in the industry. In addition, both laboratories will have access to more resources and be able to do what they do well even better.

In stating that one of Northwest Toxicology’s focuses will be specimen validity testing, it is important to note that Northwest Toxicology is the laboratory that began adulteration testing. Showing a strong commitment to maintaining the integrity of the drug testing process, Northwest Toxicology has developed processes to be able to identify adulterants as they are uncovered. Northwest Toxicology has consistently been the laboratory of choice for other certified laboratories when they can’t figure out the identity of an adulterant.
Considered innovators in the drug and alcohol testing industry, Northwest Toxicology also has a new service to offer to industry professionals. As a major laboratory for medical professional testing, Northwest Toxicology developed an advanced urine alcohol testing process at the request of the Federation of State Physician Health Programs. A problem was noticed that a combination of certain substances (sugar, yeast, etc.) could cause a positive in traditional urine alcohol testing even though the donor had not consumed alcohol. As such, Northwest Toxicology has developed ethyl glucuronide (EtG) testing for urine specimens. This testing detects a metabolite from ethyl alcohol rather than ethanol and has solved the problem of naturally occurring positives from sugars and yeast. The test is a more reliable forensic test, and allows companies and agencies to better monitor alcohol use.

When asked why Northwest Toxicology extended its support to the DATIA Annual Conference, Dick Etter, VP, director of marketing, was quick to say, "DATIA helps us educate our clients through the issues and training that you take on. You do a great job of educating industry professionals, and we see DATIA as the pre-eminent association representing the drug testing industry. Your association reaches all service providers in the industry, and we look forward to partnering with not only DATIA, but your members as well.”

DATIA is pleased to have the support of a laboratory who feels that drug testing needs to be done right, does not take shortcuts, and is vigilant on validity issues. “Accuracy, timeliness, responsiveness, effective and accurate reporting, and top quality services are all aspects to which Northwest Toxicology is dedicated. We are committed to our clients, and we see ourselves as partners with them,” stated Michael Feldman.
Conference Sponsor Spotlight:
PharmChem, Inc.
A Presenting Sponsor of DATIA’s Annual Conference, PharmChem, Inc. has been in existence since 1971. The laboratory is now located in a new state-of-the-art facility located in Dallas/Fort Worth, Texas. PharmChem holds SAMHSA, CLIA, CAP, and all state required certifications, making it a premiere laboratory. PharmChem is the patent holder for the PharmChek® Drugs of Abuse Sweat Patch and the exclusive laboratory performing testing on this unique product. PharmChem also provides PharmView® & PharmScreen® on-site drug screening products and has many new items to introduce to attendees of DATIA’s 2004 Annual Conference and Exposition.

DATIA is excited to have “the most trusted name in drug testing” as a key supporter of its upcoming conference. While at the conference, PharmChem is looking forward to familiarizing members of the industry with its new products and services. One such new service is the Preferred Vendor ProgramTM. Becoming a PharmChem Preferred Vendor provides industry professionals with numerous benefits that will enable them to get more individuals exposed to their facilities, and will allow them to get better product and service rates than stand alone operations. Preferred vendors will be able to increase their revenues by collecting for PharmChem customers. They will also gain leads into major PharmChem customers for additional services such as occupational medicine, and will each be assigned a Direct Account Representative at PharmChem. The ability to purchase PharmChem products and services at substantially reduced prices is another benefit that can directly increase the bottom line for Preferred Vendors. While at the conference, attendees can meet with PharmChem representatives to learn more about the program and sign up to participate. Through the Preferred Vendor ProgramTM, PharmChem will be “working together for success” with the industry.

PharmChem shows its commitment to its clients in numerous ways, and continually takes into consideration the unique needs of their customers when developing new services or products. One way to show its commitment to its clients is through PharmChem’s stringent quality control programs. PharmChem’s dedication to protecting the integrity of the drug testing process goes far beyond industry standards. Not only does PharmChem participate in external proficiency programs, it also operates extensive internal quality-assurance programs to measure every aspect of laboratory operation. This leads PharmChem to ask “When the answer is so important, why trust anyone else with your drug testing?”

With more than 30 years’ experience, and over 3,000 customers, PharmChem has become “the drug testing expert.” Drug testing is their only business, which has allowed them to develop a full line of drug testing products. PharmChem offers three lines of FDA-cleared drug testing products - PharmChek®, PharmScreen®, and PharmView®, with a variety of panels available in each line.
PharmCheck® drugs of abuse sweat patches offer an increased window of detection, no worry of specimen substitution, quick application and removal, and a variable removal date. Unique features of PharmScreen®, a one-step immunoassay for the detection of drugs in urine, include the ability to read results in as soon as three minutes and as long at ninety minutes, a negative specific immunoassay that eliminates the possibility of “false-positive” results, and court tested analytical methods for confirmation. The PharmView® Drug Screen Cup is the simplest, easy to use drug test device on the market. With PharmView®, test results can be read within minutes and remain visible for hours.

The reason why PharmChem decided to sponsor the DATIA Conference? Steve Walter, Director of Customer Service stated, “Through our sponsorship of the DATIA Annual Conference, we want to strengthen our partnerships with those in the industry. We see DATIA as a valuable tool - many of our associates have attended DATIA training courses, have been listed on the website, and have increased their business. As part of our commitment to our clients and the industry, we intend to become more active with DATIA.”

DATIA encourages attendees to visit PharmChem during the conference to view their full line-up of programs, services, and products.
Conference Sponsor Spotlight:
Varian, Inc.
For the past decade, while exclusive manufacturer for Roche Diagnostics, Varian, Inc. designed and manufactured more rapid tests than all other manufacturers combined. Now, after purchasing Roche’s drugs of abuse testing business, Varian, Inc. has emerged as the acknowledged expert in all phases of toxicology and onsite drug testing. Once a part of 50-year old Varian Associates, Inc., Varian, Inc. became an independent company in 1999. The company is a major supplier of scientific instruments, diagnostics, laboratory consumable products, vacuum technologies, and electronics manufacturing services.

“Looking back 10 years, there weren’t many drug test manufacturers. Today, there are many distributors of products coming out of the Far East. Our goal is for people in the industry to understand the difference between value and price,” states Jacquie Sheehey, marketing manager, Diagnostics. A key component of understanding the difference between value and price is knowing what you are buying and what it can and cannot do.

Setting Varian apart from other manufacturers is their advanced, patented manufacturing process that uses latex technology to deliver results within five minutes. Varian’s newest innovations, OnSite CupKitTM and OnTrak Testcup II, are the emerging standard for price and performance. CupKit’s workstation design is as cost-conscious as it is complete. Each test eliminates specimen handling, clock watching, or repeat testing. Its patented yellow stripes offer enhanced readability for unmistakable answers within five minutes and the ability to read results for up to two hours. TesTcup II is the single, packaged version of CupKit that offers enhanced chain-of-custody features.

Another key component to understanding the difference between value and price is knowing whether or not you are getting the most out of your drug testing program and seeing a return on investment. Jacquie counsels clients to look at how they are developing their programs, and to pay attention to product information and package inserts. She also encourages industry professionals to look at the number of false positive and false negative results they are seeing with the products they use. All of these factors impact a drug testing program so you are running your program in a “smart” way.

Varian is more than a company that offers drug testing products. Varian has a strong commitment to education and solid knowledge. Rather than providing just drug testing products and services, Varian provides its clients with a benefits package. Through partnerships with national associations, TPAs, and customers, Varian educates and trains customers on the fundamentals of their SMARTesting™ program that offers you SMARTknowledge, SMARTdata, and SMARTresults though their commitment to education, 24/7 support, expert consultants, intelligent data management, and laboratory services.
Varian recently announced its strategic partnership with Sageful Corporation to develop and market intelligent data management solutions that are integrated with Varian’s rapid drugs of abuse testing (DAT) products. SMARTdata solutions, one component of the SMARTesting program, offers an automated means for gathering, analyzing, managing, and sharing outcomes. The result is enhanced accountability, improved cost-savings, and streamlined processes.

When it comes to Varian’s commitment to its clients’ satisfaction, they feel that education is the best means to ensure that client programs are effective. “We want to partner with people in the industry that see the need for the development of quality products. Our rapid drug test results secure your world by providing safety in the workplace and the community. If the product is inaccurate, there is reduced safety, and the client faces costly litigation. High standards are needed on all products in the industry,” states Jacquie.

DATIA is pleased to have Varian, Inc., a pioneer in the drug testing industry and an advocate for quality over price, as a Presenting Sponsor of its upcoming conference. At the conference, attendees will have the ability to learn much more about SMARTesting and Varian’s complete line of urine and oral fluid testing products.
Washington Headlines

Modal DOT Agencies Issue Conforming Rule Changes Concerning One-DOT MIS Form

On December 31, 2003, five Department of Transportation (DOT) modal agencies issued conforming rule changes to their drug and alcohol testing regulations in regards to submission of Management Information System (MIS) reports. Previously, each agency utilized their own form for the submission of these reports. In July of 2003, however, the DOT issued regulations revising the MIS forms thereby creating one form for use by all DOT agencies. The most recent rule change issued by the agencies simply makes corrections to the modal regulations to ensure consistency with the One-DOT MIS form. The final rules can be downloaded from DATIA’s website.

FMCSA Denies Application for Exemption From Certain Federal Drug and Alcohol Testing Requirements
On January 13, 2004, the Federal Motor Carrier Safety Administration (FMCSA) denied an application from Mayflower Transit LLC and United Van Lines LLC seeking exemptions from parts of the federal drug and alcohol testing requirements. Both companies had requested that they be allowed to combine non-DOT and DOT covered employees into one pool. This request came after an audit determined that non-DOT drivers were in the DOT pool. In the FMCSA’s decision, they specifically referred to the reasons why DATIA felt the exemption would have negative effects on the FMCSA drug and alcohol testing program. Of the ten comments received by the FMCSA, eight were in opposition to the exemption, one was in favor, and one stated no opinion either way. In its reasons for the exemption, the FMCSA stated that “the agency agrees with certain commenters that the administrative burden is not overwhelming, and the management of two pools within the same company is a relatively common task managed easily either within the same company, or by TPAs and MROs.” The complete FMCSA announcement and DATIA’s comments can be viewed at www.datia.org.