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Inside This Issue:
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FDA Has No Jurisdiction over Workplace, or Other Non-Diagnostic Testing
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The FDA has no jurisdiction over drug testing unless the testing is intended to be used for the diagnosis of disease to treat a disease. Although the definition of the term “device” in the Federal Food, Drug, and Cosmetic Act (the “Act”) is broad, it only applies to products intended for the “diagnosis of disease or other conditions.” Explicit in the definition of device is that the seller must intend that the product be used for medical use. The intended use determines whether these products are medical “devices.”
Congress and the courts agree that drug tests do not diagnose disease. There have been claims made by some individuals who tested positive on employment drug tests that the drug test “diagnoses” them as drug abusers and thereby entitles them to protection as handicapped or disabled persons. The courts have carefully reviewed numerous claims such as these, and do not agree that drug tests provide any basis for a medical evaluation of disability or illness.
Congress has been very explicit in its view on this matter in the language of the Americans With Disabilities Act (ADA) of l990, where it states that “a test to determine the illegal use of drugs shall not be considered a medical examination.”
Although it is in the context of the ADA, it is clear that Congress did not want illegal drug users to be given the protection of the ADA because they were engaging in an illegal activity. Using drugs illegally does not mean that you are ill or an addict. All a drug test does is show drug use, not illness. If the FDA declares that a drug test is a medical examination, this will cause untold complications for employers.
Various non-medical and/or non-diagnostic reasons have been given by employers for drug testing of applicants or employees. The courts have upheld many reasons for employment drug testing, including promoting workplace efficiency and reducing employer costs associated with drug abuse to name a few. None of these reasons include a diagnosis or treatment of disease.
A product that is used by law enforcement to determine compliance with the law will not come under the FDA regulation. For example, alcohol or drug tests for the illegal presence of alcohol or other drugs in the body of a driver of a motor vehicle are not intended to diagnose a disease.
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There are laws administered by the Federal Trade Commission and other federal and state agencies that provide adequate protection against consumer fraud or abuse. Substance Abuse and Mental Health Services Administration (SAMHSA) is about to issue draft regulations that will permit the use of on-site tests for all federal employment drug testing. The Clinical Laboratory Improvement Act (CLIA) may have some jurisdiction over testing, but the Department of Health and Human Services (HHS) has decided that CLIA shall not apply to workplace testing.
Congressman Portman, Co-Chair of the Speaker’s Task Force For A Drug-Free America, and Chairman, Mark Souder and Ranking Member Elijah Cummings of the House Government Reform Subcommittee on Drug Policy and Criminal Justice questioned FDA jurisdiction and called upon the FDA to not regulate on-site tests. He sent letters to HHS Secretary Tommy Thompson and Dr. Bernard A. Schwetz, the acting Principal Deputy Commissioner of the Food and Drug Administration (FDA), questioning the FDA jurisdiction to regulate on-site drug testing and calling upon them to “consider the impact of drastic cost increases on employers before beginning regulation of on-site workplace tests.” David G. Evans, the Executive Director of the National On-site Testing Association (NOTA) provided background on the reason for the letter.
Last January, DATIA sent comments on FDA’s Draft Guidance for “Over the Counter Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications voicing its concerns about FDA equating workplace testing with home testing. DATIA members have stated that they feel the entire draft guidance should not apply to workplace drug testing.
For additional information contact David G. Evans at NOTA at 908-806-0008 or Laura Shelton at DATIA at 703-548-0901 or visit www.datia.org.
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DATIA Joins Anti-Drug Groups to Submit Amicus Brief in School Drug Testing Case
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Recently, DATIA joined a coalition of anti-drug groups in an amicus (friend of the court) brief before the U.S. Supreme Court in a major school drug testing case. Board of Educ. of Independent School Dist. No. 92 of Pottawatomie County v. Earls, 70 USLW 3162 (U.S. Nov 08, 2001) (NO. 01-332).
The current list of participants include:
Drug-Free Schools Coalition; National Institute of Citizen Anti-Drug Policy; Malcolm K. Beyer; Drug-Free Kids: America’s Challenge; Drug-Free America Foundation; National Families In Action; Institute on Global Drug Policy of the Drug Free America Foundation; Legal Foundation Against Illicit Drugs; Drug and Alcohol Testing Industry Association; The Hon. John E. Peterson, Member of Congress.
This case is important because it will decide how much of a drug problem a school has to have in order to drug test students. The school in this case had minimal drug use and so the court did not allow testing, however, this is not the situation with many schools in the US. The ACLU has taken the position that a school has to be “out of control” with drugs before testing can take place. The ACLU position accepts the status quo of substantial drug use in most schools and asserts that the school must be in a state of rebellion before testing can take place. |
Over one-third of secondary school students use illegal drugs leading to poor school performance, addiction, overdose deaths and accidents in schools. For the last six years school children have listed drugs as the most important problem they face. Based on experience in the military, professional athletics, and business, drug testing substantially reduces drug use.
The U.S. Supreme Court will hear a case in which the federal Court of Appeals for the 10th Circuit concluded that a public school district’s policy of suspicionless urinalysis drug testing of students participating in competitive extracurricular activities was not reasonable, and thus violated the students’ Fourth Amendment rights. Pursuant to the district’s policy, each student seeking to participate in extracurricular activities was required to sign a written consent agreeing to submit to drug testing prior to participating in the activity and random testing during the year while participating.
For more information, contact David G. Evans, Esq. at 908-788-7077, or at thinkon908@aol.com or Laura Shelton at DATIA at 703-548-0901.
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It’s The Law: Supreme Court to Again Weigh Expanded School Drug Testing
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| By Tom Eden, Esq., Wallace, Jordan,
Ratliff & Brandt, L.L.C. |
The United States Supreme Court agreed on November 8, 2001, to decide whether all high school students who participate in extra-curricular activities beyond sports can be forced to undergo random drug tests. An expected ruling by next spring should clarify how far public school officials can go in requiring drug tests of students.
The justices have ruled that students have lesser privacy rights than adults. [For a comprehensive review of public sector drug testing see the DATIA archived three part series “It’s the Law” on “Post Accident Drug Testing of the Public Employee: Walking the 4th Amendment Tightrope”]. Six years ago, they upheld an Oregon school district’s policy of testing school athletes for drug use. In that case school officials in the town of Vernonia, OR, argued they had a serious drug problem and that athletes serve as role models and must be seen as drug-free. Additionally, young athletes would risk serious injury if they were using drugs while playing sports.
The Supreme Court accepted the school officials position and approved the school’s drug-testing policy. They rejected the claim that it violated the 4th Amendment’s ban on unreasonable searches and seizures.
Since then, school officials in some communities across the country have sought to extend mandatory drug testing to all students who participate in extracurricular activities, not just athletes. In 1998, the Tecumseh School District in Oklahoma decided to require random urine tests of high school students who participated in such activities as band, choir, cheerleading and Future Farmers of America. Their urine specimens were tested for such illegal drugs as cocaine, marijuana and amphetamines, but not alcohol. Students testing positive were counseled to quit using drugs. Two students—Lindsay Earls, who was in the choir, and Daniel James, who was on the academic team—challenged the policy as unconstitutional and won before the Tenth U.S. Court of Appeals in Denver who ruled that the drug problem in Tecumseh was “negligible” in general and that nothing regarding choir members and cheerleaders indicated a “special need” to test them for drugs.
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The Supreme Court voted to take up the school district’s appeal in the case, Board of Education v. Earls. It is expected that the justices will devise a clear rule on when the government can impose mandatory drug testing of high school students. Typically, the 4th Amendment requires governmental officers to have specific evidence before they can search someone. However, in 1989, the high court ruled that this rule of individualized suspicion can be waived if the government has a “special need” for drug testing. On that basis, the court upheld a federal regulation requiring urine testing of railroad crews after an accident. Separately, the justices also upheld the drug testing of U.S. Customs agents who carry guns and inspect for narcotics. There are no such restrictions on drug testing of private school students. However, in 1997, the court drew back striking down a requirement by the state of Georgia that candidates for high state offices undergo drug tests. Any public school conducting drug testing of students, other than in athletics, should follow this case closely and keep in mind the concepts set forth below when establishing a program.
The Comprehensive Drug-Free School Program is composed of the following elements: Community Task Force, written policy and procedures, drug testing, student assistance program, and student, parent, teacher education. For additional information on establishing a school based program see: Drug Testing Law Tech & Practice 1998 Cumulative Supplement, by David Evans, Esq.
DISCLAIMER & ACKNOWLEDGMENTS: 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 is a management labor attorney 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 may be reached by telephone at (205) 870-0555 or by e-mail at te@wallacejordan.com. Please visit his 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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DATIA’s New R-CPCT Program
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In an effort to maintain the recognition afforded to professional specimen collectors that meet DATIA’s stringent requirements for certification and the integrity of its Collector Certification Program, DATIA has clarified the guidelines of the Certified Professional Collector Trainer (CPCT) program that has always limited CPCTs to training and certifying only individuals who work for their company and/or a company owned facility.
DATIA members have expressed strong interest in creating a regional trainer model to meet the demand for courses and training in general. DATIA’s program has grown by over 100% per year; the number of yearly classes held has doubled from last year. This growth and success has made DATIA’s course the industry standard, and demand is expected to continue as DOT, federal agencies and employers demand more accuracy in the drug testing process |
and qualifications from collectors. To meet the increased demand for DATIA certification, we need to partner with key professionals to expand the reach of the non-profit CPCT training courses to reach those in rural areas, smaller cities, and in the situations where a regional training is more appropriate.
These courses will be taught by Regional Trainers (R-CPCT) who must undergo a rigorous selection process. Once the R-CPCT’s are selected, they will be assigned regions and will be able to conduct DATIA CPC courses within that region of the United States. DATIA and the Specimen Collection Issues Committee have been working on this expansion of the program and anticipate finalizing the details shortly so that DATIA can begin the selection process. If you are a CPCT, please be on the look out for your application packet!
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Mock Collections Included in CPCT Course
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As you know, the Department of Transportation has a new requirement that all collectors perform proficiency demonstrations.
At the upcoming 2002 Certified Professional Collector Trainer™ (CPCT) courses, DATIA will offer an optional mock collections opportunity where |
attendees who elect to participate will be able to fulfill the DOT requirement of performing five consecutive error free mock collections. The mock collection segment will be offered at the end of the day-long instructional session. For registration information, please visit www.datia.org.
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DATIA’s 2002 Annual Conference
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The DATIA 2002 Annual Conference to be held May 2-4, 2002 will once again feature top notch speakers within the drug and alcohol testing industry.
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Don’t let this opportunity to meet with key legislative and regulatory officials, industry experts, and leaders in the advancement of drug and alcohol testing pass you by. We look forward to seeing you at our celebration in San Antonio, Texas. Stay tuned for more conference details. For more information or to register online visit www.datia.org. |
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DATIA’s CPCT Program Tops 2000
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In November 2001, DATIA certified its 2000th Certified Professional Collector Trainer™. This milestone stresses the desire and need for a program offering face-to-face training in drug testing specimen collections and recognition of collectors meeting the professional standards set by the industry.
While federal drug and alcohol testing regulations require only training and not certification, the response from the industry to this voluntary program has been overwhelming. Most recently, the DATIA program has been selected by the American Association of Occupational Health Nurses as a pre-conference workshop for the 2002 American Occupational Health Conference, and DATIA has learned that numerous state agencies use the CPC and CPCT designations as criteria when selecting vendors to provide drug and alcohol testing services.
Since June 1, 1999 when DATIA’s collector certification program was initiated, 927 professional specimen collectors have been certified as a Certified Professional Collector Trainer™ (CPCT) and over 1200 professional specimen collectors have achieved their Certified Professional Collector™ (CPC) certification. To receive certification as a CPCT, the applicant must establish that they meet the minimum experience requirements, successfully complete the DATIA CPCT Training Seminar held nationally, and pass a
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rigorous examination covering all aspects of the collection process. CPC certification requires receiving comprehensive training from a DATIA CPCT, and passing the collector certification examination. The course has also been modified to include the required Department of Transportation (DOT) proficiency demonstrations of five mock collections consisting of normal and abnormal collection scenarios.
The program’s success, as indicated by participants, is that the focus is on personal instruction on all aspects of the collection process and that the program operates so as not to require all collectors to attend an off-site DATIA training seminar. All collectors, whether trained by DATIA or by a CPCT, receive face to face training on collection procedures including shy bladder, direct observed collections, monitored collections, donor identification, DOT procedures, HHS Mandatory Guidelines, split and single specimen procedures, completing the Chain of Custody form, and fatal flaws to name a few. Participants in the program have indicated that their participation has resulted in fewer rejected specimens and fatal flaws, fewer affidavits required from collectors, and an increased sense of client satisfaction.
The upcoming 2002 CPCT seminar schedule is as follows:
- February 8 & 9, 2002 in Portland, OR
- March 15 & 16, 2002 in Jacksonville, FL
- May 2 & 5, 2002 in San Antonio, TX
- September 13 & 14, 2002 in Chicago, IL
- October 11 & 12, 2002 in Baltimore, MD
- November 8 & 9, 2002 in Boston, MA
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It’s Time to Tune Your Random Pools!
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By Eric Quilter, Compliance Information Systems
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Contrary to popular belief, it is actually possible (and even desirable) to review how you go about the administration of your random testing program at least once a year. Since most employers and Third Party Administrators (TPAs) manage their pools on a calendar year basis, this is the perfect time to make sure your pool group configuration is meeting your objective.
Knowing the primary objective of your random program is the first step. Many random programs have the simple objective of regulatory compliance. Others are more interested in maximizing deterrence. Still others want to conduct a certain amount of tests each year to fit within budgetary constraints. If you know which objective is most important, you can tailor your pool setup accordingly.
The second step in your evaluation is gathering data about your current random efforts. How many tests below or above your target percentage did you conduct? How many selections did you have to perform in order to accomplish those tests? Do certain employee groups (or companies in a consortium) bear a disproportionate amount of the actual testing? How frequently do you select individuals that are not actually eligible for testing? Do you’“carry over” selections into the next period? If so, why?
Now that you’ve got some history in front of you and know your primary objective, you can look at the three principal components of the selection process and tune accordingly.
The first is the method used for the selection process. The method is composed of the mathematical equation (algorithm) used for generating random numbers, and the manner is which it is used. If you are regulated by DOT, you are required to use a method that gives every pool member the same chance of being selected for testing for each selection period. This approach is called “replacement.” While the use of computerized random generators is preferred, the actual methods are easiest to illustrate using a couple of decks of playing cards:
Let’s assume you have a company with 52 people and a need to choose five people at random for drug testing each month.
At the beginning of each month, you gather everyone in a room. You have two identical decks of playing cards. You shuffle one of the decks, and hand out a card to each person in the room. The second deck of cards is then shuffled.
Option 1. You pick five cards right off the top of the deck. Whoever holds a matching card submits to a test. Five different people will be picked for testing that month.
Option 2. You pick one card off the top of the deck. Whoever holds the matching card must submit to a test. You then reinsert the card in the deck, shuffle again, pick a card, and match it. You repeat this process 5 times. It is possible in this scenario to pick the same person more than once for testing that month.
At the beginning of the next month you repeat the process.
In Option 1 and 2, everyone’s odds are equal at the beginning of each month, ensuring that being picked for testing in previous selections does not impact the odds of being picked in subsequent selections. However, the two approaches differ significantly in determining whether or not an individual can be picked for more than one test in a given selection or “draw.” While improbable, it is possible that one person could be picked for five tests in the same month in the Option 2 approach. Conversely, Option 1 guarantees that five different people would be picked for testing in any given selection or draw.
The overwhelming majority of random pool managers choose Option 1 because of the labor relations and scheduling problems inherent in Option 2. Notwithstanding, both methods are available and it is left up to the end-user to decide which approach is utilized.
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If you are not mandated by DOT, you have more flexibility in method selection. “Weighted” sampling methods are available that produce a better distribution of testing throughout the pool membership over time. For example, if you used simple random sampling with replacement on a pool of 100 people with a goal of each member being tested once, it is probable that you would have to perform more than 400 selections in order to meet your objective. A weighted method, however, increases the odds of selection for pool members that haven’t experienced a test in relation to those that have. Weighted methods are advantageous if you test at annual percentages at or above 75%. More pool members will be tested over time with less repeat testing. Spreading the testing out in this fashion, while maintaining a measure of repeat testing, increases deterrence and decreases employee complaints.
The second variable in pool group configuration is the frequency of selection. You choice of frequency can greatly impact deterrence, compliance, cost, and ease of administration. While, some DOT modes have established frequency requirements for specific employer situations, the choice is typically left to the program administrator. The basic rule of thumb is to use the highest number of selection periods you can effectively manage. This improves deterrence and gives you more opportunity to adjust the number of selections to hit your target more precisely.
To determine the frequency that fits your pool(s), consider first how you go about scheduling and performing collections once the random list is generated. If you can accomplish collections quickly and easily, then you can probably take advantage of more frequent selections. This would be the case with a large, confined population, such as a nuclear power plant or large factory with an on-site clinic for collections. A large, geographically dispersed workforce generally requires more logistical coordination to perform collections, resulting in fewer selection periods.
Another consideration for frequency is your access to updated pool membership information. Running a random selection without updating the pool membership can do more harm than good. Accurate pool membership means fewer excused tests and less chasing around. If updated pool membership information is easily obtained (e.g. through a payroll system import), then you can select with greater frequency.
The final variable for pool group tuning is administration. Generating a random list with accurate pool information is half the battle. What you do with it is just as important and usually subject to greater scrutiny. You should review the circumstances that caused you to excuse selected employees from testing. If you find that certain employee groups (or certain companies in the case of a consortium) are being excused from testing more frequently than others, you may want to make a change. One way to remedy this problem is to isolate the “unavailable” population in a separate pool. In fact, as a general rule, you should group employees of similar “availability” in a pool group. While maintaining more than one random pool has an associated administrative burden, it will decrease the overall burden of the program and reduce the exposure to bias complaints.
Yet another common administrative practice that gets administrators into trouble is “carrying over” tests from one selection period to the next. Remember, your goal is to achieve a certain number of tests rather than test a given number of individuals. If you constantly remind yourself that you are hunting tests and not people, you’ll avoid sticky labor situations. If an individual is unavailable for testing during the selection period in accordance with your excuse policy (which should be strict), then dismiss the test. If your pool group is properly tuned, it’s no big deal to pick a few more people than you need each period and you’ll hit your annual goal within a couple of percentage points.
So take the time to review your pool group configuration on an annual basis. A little tuning can make a big difference in the level of deterrence, administrative ease, and expense of your random testing program.
Eric Quilter is President & CEO of Compliance Information Systems (CIS) in Salt Lake City, UT. CIS is a provider of software and information services for managing workplace drug and alcohol programs. Eric is a member of DATIA’s Board of Directors and CIS is a Sustaining Member of DATIA. |
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At the Drug Testing Advisory Board Meeting on December 4, 2001, Robert L. Stephenson II, Director, Division of Workplace Programs, Center for Substance Abuse Prevention, announced that comments submitted in response to the August 21, 2001 Notice of Proposed Revisions to the Mandatory Guidelines for Federal Drug Testing Programs incorporating specimen validity testing have been posted on the agency’s website and can be viewed at www.workplace.samhsa.gov.
His office must make any changes in response to the comments. From there, the final revisions will be published in the Federal Register in their entirety, and will include previous revisions to the guidelines since 1994 to include the change in the opiate cutoff level. Once the revised guidelines are officially released in 2002, there will be an implementation date several months later to allow service agents time to conform to the new guidelines.
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The Division of Workplace Programs is also preparing the revised guidelines incorporating alternative specimen testing to be printed in the Federal Register for public comment. The document must first clear the Office of General Counsel, the office of the Secretary of HHS, and the Office of Management and Budget. Any changes made as a result of the review process will be incorporated and the final proposed revisions will be published in the Federal Register as a Notice of Proposed Revision. This notice is expected to be published in the summer of 2002. Two noteworthy changes that have already been made to draft four (www.workplace.samhsa.gov) of the guidelines concerning collector and medical review officer training.
Rather than requiring certification for these service agents, the proposed Mandatory Guidelines for Federal Drug Testing Programs have been changed to mirror the requirements for collectors and MROs in the Department of Transportation CFR 49 Part 40 regulations. Stephenson indicated that this change was to better standardize the two programs and make training requirements more consistent for the industry. As these two issues move forward, DATIA will keep its members informed. |
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