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Inside This Issue:
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DATIA Addresses Lack of Education on Student Drug and Alcohol Testing
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When the U.S. Supreme Court announces its ruling concerning drug and alcohol testing of students in extracurricular activities later this month, will you have the knowledge to implement an effective student drug and alcohol testing prgram? Most drug and alcohol professionals and school administrators won’t, due to the lack of education in this area. To combat this, and prepare professionals to develop and implement effective student drug and alcohol testing progrms, DATIA has developed a comprehensive workshop on this subject. The workshop will be held on Thursday, July 18, 2002 at the Hyatt Regency Washington on Capitol Hill in Washington, DC. Co-sponsors for this workshop include: Arizona HIDTA Demand Reduction Task Force, Drug Free America Foundation, Inc., Drug Free Kids: America's Challenge, Drug-Free Schools Coalition, Institute on Global Drug Policy, International Scientific and Medical Forum on Drug Abuse, Legal Foundation Against Illicit Drugs, National Institute of Citizen Anti-Drug Policy, National Student Drug Testing Steering Committee, Save Our Society From Drugs, and The Start SMART Foundation.
This workshop is aimed at educating administrators of student drug and alcohol testing programs and their service providers on implementing a successful student drug and alcohol testing program. Attendees will receive the tools necessary, including a step-by-step guide, on how to implement a successful student drug and alcohol testing program.
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Leading professionals of student drug and alcohol testing programs will discuss all aspects of a sound and responsible student drug testing program including any new policy/procedural information resulting from the U.S. Supreme Court's decision. Attorneys will address the legal climate and basis for student drug and alcohol testing programs, and other industry experts will explain how to find funding and develop policies for student drug and alcohol testing programs. Each session will be an intensive learning experience that will provide attendees with case studies illustrating the benefits of student drug and alcohol testing programs.
This one day workshop will walk administrators and service providers through the process of developing a student drug and alcohol testing policy, and will address how to implement the best standards and practices. Speakers will discuss key issues such as determining consequences for positive results, outlining who will be tested, due process for students, what type of specimen to test (hair, sweat, saliva, urine), and how drug and alcohol testing combined with substance abuse prevention can act as a deterrence within the education system.
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DATIA's Annual Conference Brings the Industry Together
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The Drug and Alcohol Testing Industry Association (DATIA) recently held its most successful event to date at the 6th Annual Conference and Exposition, “Roaming the Range of Drug and Alcohol Testing: Case Studies Illustrating What Works and What Doesn’t” in San Antonio, TX from May 2-4, 2002.
DATIA’s record attendance reached over 440 participants and resulted in the drug and alcohol testing industry’s biggest event of the year by far, providing attendees insight, information, and advocacy on issues that impact providers of drug and alcohol testing services.
DATIA’s conference reflected the commitment, dedication, and concern members and other industry professionals have for the drug and alcohol testing industry. DATIA training courses in conjunction with the conference were sold out several weeks before the conference.
During the valuable sessions, top-level speakers from the industry addressed the conference and interacted with attendees to discuss information and advocacy on issues that impact providers of drug and alcohol testing services. The DATIA conference provided the opportunity for individuals to learn from the experiences of other industry professionals on how to best implement drug and alcohol testing.
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Advancements in technology have been made at an unprecedented pace within the drug and alcohol testing industry, and have already begun to have an effect on professionals that provide services in the industry. This conference provided attendees with comprehensive information on the technological advancements made within the industry and what they mean for both providers and end-users of drug and alcohol testing.
DATIA's unique and needed role as an educator for the industry ensured that the conference agenda promoted real world solutions including case studies for the industry.
We're certain that every attendee of DATIA's 6th Annual Conference and Exposition had a positive learning experience and took with them concrete information that can immediately be applied to their specific operation. Mark your calendar, DATIA's 2003 Annual Conference will be held May 29-31, 2003 at the Opryland Nashville Hotel in Nashville, TN.
To view the photo gallery of DATIA’s 6th Annual Conference, visit www.datia.org. |
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It’s The Law: FDA’s Regulation of Workplace Drug Testing: Risk Reduction Strategy
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| By Tom Eden & Michael Jackson of Wallace, Jordan, Ratliff & Brandt, L.L.C. |
On June 8, 2001, amendments to the Food and Drug Act became effective that increased the Food and Drug Administration’s (FDA) role in the regulation of workplace drug testing. Under the amended rules (21 CFR£ 864.3260) specimens such as hair, urine, sweat or saliva used outside the medical setting and not on order of a healthcare professional, such as in the home, insurance, sports or workplace setting, are considered over-the-counter (OTC) test sample collection systems by the FDA rule.
These OTC test sample collection systems for testing drugs of abuse are now restricted devices and under the new regulations must be “… performed in a laboratory using screening tests that have been approved, cleared, or otherwise recognized by the Food and Drug Administration as accurate and reliable for the testing of such specimens for identifying drugs of abuse or their metabolites.”
Additionally, under this regulation, the laboratory performing the test must be recognized as having adequate capability to reliably perform the screening and confirmation tests (i.e., the laboratory must be certified or licensed by a recognized agency), and the tests need to be appropriately labeled.
Before these amendments, manufacturers of screening tests for commercial workplace use that wanted to sell those tests to laboratories through interstate commerce needed to have their drug-screening assays submitted to the FDA for review. This review is generally conducted by comparing one cleared device to an earlier cleared or recognized device. (Urine tests that were on the market before the enactment of the initial medical device amendments in 1976 were simply recognized by the FDA and did not need to go through a review process. Subsequent urine tests brought to the commercial market to be sold to laboratories had to demonstrate under this comparison process that they were “substantially equivalent” to products already cleared or recognized.)
To conduct workplace testing, laboratories could either purchase these cleared screening tests from a manufacturer or they could create their own screening tests for internal in-house use that did not have to be cleared through the FDA, the so called “home brew” exception. The FDA has cleared more than 200 drugs-of-abuse testing devices.
The distinction between an in-house test and a test sold over the counter to laboratories has been eliminated with the newer regulations and essentially all testing (there are still exceptions for law enforcement, research and medical purposes) must be approved, cleared or otherwise recognized by the FDA as accurate and reliable. The greatest impact of this regulation will be on newer matrices (e.g., hair, saliva, and sweat) and, to some extent, point of collection (on-site) urine screening through another set of regulations.
Currently, there is only one laboratory provider in each of the newer matrix areas that has FDA clearance on its screening tests. To learn more about laboratory providers, visit the FDA website at www.fda.gov.
“Point of collection” (POC) or “on-site” testing follows a slightly different set of FDA rules because these tests are performed outside of a laboratory and interpreted usually by a non-laboratory person. For these devices there are additional FDA rules requiring that the average person be able to easily understand the labeling and the tests |
results. 21 CFR£ 809.40. On November 14, 2000, the FDA issued the “Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Pre-market Notifications” position paper which recently has been the subject of much controversy. You should also anticipate more governmental guidance from the Department of Health and Human Services regarding the use of POC devices.
Risk Reduction Strategy
As part of their due diligence efforts, employers and all Service Agents need to ensure that the laboratories and device manufactures they are utilizing meet the FDA regulatory requirements. Write a letter today to your lab, device manufacturer or Service Agent, pose that very question, and mention 21 CFR£ 864.3260 or 21 CFR£ 809.40. If you do not get the right answer, my advice is to find someone else.
While generally the impact of an FDA regulation falls on the supplier or manufacturer, 21 CFR£ 809.40 sets forth restrictions on the “sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.” When it comes to lawsuits,” the “defendant” is not a sought after designation. Drug-testing professionals do not want to put themselves in a position to incur liability for testing in violation of federal law, and they should not put their clients in harm’s way or they may become what the law calls a “third-party defendant.”
FDA enforcement aside, in any litigation scenario arising from a wrongful discharge action or union challenge, the issue of regulatory noncompliance would be nearly impossible to overcome in a courtroom, the ultimate drug-testing landmine!
Ask Delta Airlines and LabOne, who last summer ended up on the wrong end of a six-figure verdict in a wrongful-discharge action by a flight attendant based on regulatory noncompliance by the lab in its adulterant testing (since corrected). Imagine hearing the words from the plaintiff’s attorney: “Your Honor, my client was discharged (or not hired) based upon the results of a drug test the federal government has not identified as accurate and reliable.”
It is a simple matter to inquire of the laboratory or on-site device manufacturer to ask for a copy of their FDA clearance letter as part of your due diligence. This is especially important when using alternate matrices, on-site testing, or laboratory urine testing outside the normal five drug screen panel (e.g., testing for oxycontin or ecstasy where clearances may not have been obtained).
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).
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DTAB Update
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| At the recent Drug Testing Advisory Board (DTAB) meeting, the U.S. Department of Health and Human Services (HHS) announced that the final Specimen Validity Testing Guidelines are expected to be printed in the Federal Register in late fall of 2002. After they |
are printed in the Federal Register, employers, consortia, and Third Party Administrators will have six months to comply with the final Specimen Validity Testing Guidelines. DATIA will continue to keep you updated on this process.
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Register Today for Upcoming 2002 DATIA Courses
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January 31, 2003 is fast approaching! Make sure you receive your required specimen collector qualification training and perform your required proficiency demonstrations before the DOT’s deadline.
The schedule for DATIA's upcoming Fall 2002 Nationally Accredited for Administration of Drug and Alcohol Testing Programs (NAADATP) and Certified Professional Collector Trainer (CPCT™) training courses is as follows:
September 13 &14, 2002
Holiday Inn and Suites Downtown – Sears Tower ($135)
(877) 779-7789
Chicago, IL
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October 11 & 12, 2002
Radisson Plaza Hotel – Inner Harbor ($159)
(800) 333-3333
Baltimore, MD
November 8 & 9, 2002
Radisson Hotel Boston ($189)
(800) 333-3333
Boston, MA
Don't miss the opportunity to learn how to develop a collection program and effectively train collection personnel for certification at the CPCT™ course. Register today by calling DATIA at (800) 355-1257 or visiting DATIA’s web site at www.datia.org.
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DATIA Submits Comments Concerning FAA's Antidrug and Alcohol Misuse Prevention Programs
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DATIA submitted comments in reference to the February 28, 2002 Notice of Proposed Rulemaking concerning the Federal Aviation Administration’s antidrug and alcohol misuse prevention programs for personnel engaged in specified aviation activities. Overall, DATIA feels that the changes proposed will enhance the FAA’s antidrug and alcohol misuse prevention programs. Specifically, tightening the pre-employment testing requirements and assurances of contractor participation in antidrug and alcohol misuse prevention programs will assist in ensuring safe air travel.
DATIA’s comments are as follows.
Proposed Principal Changes – Appendix I Section II – Definitions
DATIA approves of the change to clarify that an employer may use a contract employee, who is not part of that employer’s drug and alcohol testing program, to perform safety –sensitive duties only if that contract employee is subject to the requirements of the contractor’s FAA-mandated drug and alcohol testing program and is performing work within the scope of employment with the contractor. DATIA suggests, however, that language be added to the final rule to require documentation that a contract employee is enrolled in the contractor’s FAA mandated drug and alcohol testing program. Similar language occurs in §382.301 (c) (2) of the Federal Motor Carrier Safety Administration regulations.
Section V – Types of Testing Required
DATIA approves the proposal to require a negative pre-employment test result prior to hiring or transferring an individual to a safety-sensitive position.
DATIA supports the proposal to require another pre-employment drug test if more than 60 days have elapsed between the time of the drug test and placement in a safety-sensitive position. DATIA shows that the majority of positive drug test results occur as a result of pre-employment testing, and DATIA feels that this type of test is the most effective in detecting users of drugs of abuse.
DATIA supports the removal of the periodic drug-testing requirement.
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DATIA supports the proposal to allow employers of contract employees to make reasonable cause determinations on contract employees who are performing safety-sensitive duties on the employer’s premises and under the supervision of the employer.
Section IX – Implementing an Antidrug Program
DATIA approves the proposal to eliminate the requirement for antidrug plan approval, and replace it with the Antidrug and Alcohol Misuse Prevention Program Operations Specification.
DATIA supports the proposal to eliminate the 60-day timeframe for employers to ensure that contractors who perform safety-sensitive duties are subject to an antidrug program. This should be done before contracting with the contractor.
DATIA feels that the table format of this section is easier to understand.
Proposed Principal Changes – Appendix J
Section III – Tests Required
DATIA supports the proposal to allow employers of contract employees to make reasonable cause determinations on contract employees who are performing safety-sensitive duties on the employer’s premises and under the supervision of the employer.
Section VII – Implementing an Antidrug Program
DATIA approves the proposal to eliminate the Alcohol Misuse Prevention Certification Statement, and replace it with the Antidrug and Alcohol Misuse Prevention Program Operations Specification.
DATIA supports the proposal to eliminate the 180-day timeframe for employers to ensure that contractors who perform safety-sensitive duties are subject to an antidrug program. This should be done before contracting with the contractor.
DATIA feels that the table format of this section is easier to understand.
FAA has extended its comment period for this Notice of Proposed Rule Making until July 29, 2002.
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R-CPCT Database Developed to Assist Collectors
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DATIA has posted its newly devel-
oped Regional Certified Professional Collector Trainer™ (R-CPCT) database on the website, replacing the previous listing of R-CPCTs. The new database allows collectors needing to receive qualification training a simple way to find the qualified trainer closest to them. Collectors interested in receiving training
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need only to enter in their zip code, hit search, and are supplied with the contact information of the trainer closest to them along with an approximate distance. With January 31, 2003 closer than imagined, DATIA is optimistic that our R-CPCTs will be able to provide a viable training option for many collectors needing training. |
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DATIA Members Appointed to DOT Advisory Committee
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The Secretary of Transportation recently established the Department of Transportation (DOT) Electronic Transmission and Storage of Drug Testing Information Advisory Committee. The purpose of the committee is to recommend to DOT the type and level of electronic security that should be used for the transmission and storage of drug testing information generated as part of the DOT drug and alcohol testing program regulated by 40 CFR part 40 (65 FR 79462). Of those appointed, one-third of the committee members are DATIA member companies
The Committee will examine and provide advice to the DOT related to the format and methodology used in transmitting this type of information as well as the levels and procedures to use in implementing electronic signature technology within the context of the drug and alcohol program.
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The purpose of the Committee is to recommend to DOT the type and level of electronic security that should be used for the transmission and storage of drug testing information, to assess the type of format and methodology that would be appropriate, and to recommend the level and type of electronic signature technology that would support the procedures used in the DOT drug and alcohol program.
DATIA members appointed to the DOT Electronic Transmission and Storage of Drug Testing Information Advisory Committee are as follows: Barry Sample (Chairperson) from Quest Diagnostics Incorporated, Atlanta, GA; Karam Bedros from MedTox Laboratories, St. Paul, MN; Michael Feldman from Northwest Toxicology, Inc., Salt Lake City, UT; Neil Fortner from PharmChem, Inc., Fort Worth, TX; Eric A. Hess from U.S. Investigative Services, Annandale, PA; Eric Quilter from Compliance Information Systems, Salt Lake City, UT; Lisa D. Tarnai from Scientific Testing Laboratories, Richmond, VA.
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