Since the creation of the Department of Transportation's drug and alcohol testing program in 1988, there have been an estimated 2,500 Consortia and Third Party Administrators (C/TPAs) across the United States which have entered the business. Until now, there have been no standards on proper methods and practices for managing a C/TPA. The DATIA C/TPA Management Course and new National Accredited Drug and Alcohol Testing Program (NADATP) represent the first national effort to do so. The educational efforts of the C/TPA Management Course that was initiated in 1999 have grown into a formal program for C/TPA Accreditation.

The goal of the NADATP program is to have a national standards program for companies who provide C/TPA services, to ensure they have company specific standard operating procedures, safeguards, knowledge, and professional practices that keep their clients in compliance with federal drug and alcohol testing regulations. There is clearly a need for standards in C/TPA management and a consensus of opinion that standards need to be adhered to on issues of random notification, DOT notification of positives, liability insurance, pre-employment testing rules, Standard Operating Procedures (SOP) etc.

All of the previous examples of professional management issues are addressed in the C/TPA management course, but until now there has been no formal program to recognize those companies who subscribe to the standards and compliant business and regulatory practices taught at the course. During the C/TPA Management Courses held over the past year, there has been a clearly stated desire among attendees to have an Accreditation program. Many comments on the class questionnaires and calls into the DATIA office inquire whether the C/TPA course will lead to recognition of some sort for their C/TPA.

The NADATP program should not be confused with, nor is in competition with, other industry certification programs, which apply only to individuals. An Accreditation program, such as NADATP, applies to companies, while certification programs apply to individual professionals. Under a certification

program, there is no assurance of company conduct (insurance, standards, and practices) as distinct from the individual. This is an important distinction, and is illustrated by thinking of an educational institution: the professors may have their Ph.D. degrees, but the institution still needs to meet all sorts of other standards in order to be an Accredited College or University.

That is why DATIA initiated the C/TPA Management course and NADATP. C/TPA standards are clearly company based, not dependent on one individual. To achieve NADATP status, the C/TPA must adhere to the C/TPA Standards and Code of Conduct, send a minimum of one principal/manager to the C/TPA Management Course; and have that manager(s) pass an examination on C/TPA management policies and procedures. The DATIA C/TPA Standards and Code of Conduct cover all aspects of C/TPA Management including professional competency, procedural administration, confidentiality, test administration and reporting, accountability, standards of service, and professional conduct.

Program specifics will be sent to all DATIA members and posted on www.datia.org during the first week of September 2000.

The DATIA C/TPA Accreditation Program not only provides guidelines for management of a C/TPA, but also provides employers peace of mind. By utilizing an Accredited C/TPA, employers can rest assured that the services being provided are in full compliance with state and federal regulations. Through the required contract process, employers are made aware of what services they are being provided by the C/TPA. In cases where the client does not have all services provided by the C/TPA, the contract spells out what additional services need to be performed for the employer to be in full compliance with any applicable federal regulations.

The DATIA C/TPA Accreditation program has been formulated over the past year though input from course attendees, and development and review by DATIA's C/TPA Issues Committee and Board of Directors. For complete information on the C/TPA Accreditation Program visit www.datia.org.

On July 24, 2000, the Drug & Alcohol Testing Industry Association (DATIA) certified Ms. Kathy McSweeney, CPC™, as its 1000th professional specimen collector. Ms. McSweeney is employed at Behavior Connections of Wood County in Bowling Green, OH, where she received her specimen collection training from Dottie Lemmerbrock, CPCT™. Ms. Lemmerbrock received her Certified Professional Collector Trainer™ (CPCT™) certification following the DATIA Annual Conference in February 2000.

This milestone stresses the need by specimen collectors for a program offering face to face training and recognition of collectors meeting the professional standards set by the industry. In the midst of debate amongst agency officials on whether or not to require that collectors receive formal training and certification, the response from the industry to this voluntary program has been overwhelming.

Since June 1, 1999 when DATIA's collector certification program was initiated, 450 professional specimen collectors have been certified as a Certified Professional Collector Trainer (CPCT™) and over 550

professional specimen collectors have achieved their Certified Professional Collector (CPC™) certification. To receive certification as a CPCT™, the applicant must meet the minimum experience requirements, attend the DATIA CPCT™ Training Seminar, and pass a 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 program's success is due to the personal instruction on all aspects of the collection process and does not require all collectors to attend an off-site DATIA Training seminar. All collectors receive face to face training on collection procedures including shy bladder, direct observed collections, monitored collections, donor identification, DOT procedures, DHHS Mandatory Guidelines, split and single specimen procedures, completing the Chain of Custody form, etc. For complete program information visit www.datia.org.

In February of this year, the Fifth Circuit Court of Appeals became the first circuit to address the EEOC's interpretation of the Americans with Disabilities Act (ADA) relative to exclusion of employees who had undergone substance abuse treatment from safety sensitive positions. In EEOC v. Exxon Corp., 203 F.3d 871 (5th Cir. 2000), the Fifth Circuit disagreed with the EEOC's interpretation, holding that "business necessity" is all that must be shown by an employer making a class-wide, across-the-board safety qualification standard.

According to the court, the "direct threat" test used by the EEOC [requiring an employer to prove that an individual poses a "direct threat" to safety] should only be used in cases in which an "employer imposes a special safety standard in an individual case" while the business necessity test should be used to evaluate safety qualifications that are to be applied across-the-board. The issue arose when the EEOC brought suit against Exxon, claiming that Exxon's substance abuse policy violated the ADA. Exxon's policy prohibits any employee who has undergone treatment for substance abuse from occupying certain "safety-sensitive, little-supervised positions." The policy was adopted in response to the 1989 Exxon Valdez incident which resulted in billions of dollars of liability for Exxon. There were concerns that the previously treated alcoholism of the tanker's chief officer contributed to the accident. Exxon justifies its current policy as promoting job safety, environmental protection, the prevention of future tort liability, and, "good corporate citizenship."

The Fifth Circuit held that "[i]n cases where an employer has developed a general safety requirement for a position, safety is a qualification standard no different from other requirements defended under the ADA's business necessity provision." For example, physical requirements are acceptable defenses "as long as the requirements are job-related and consistent with business necessity." The court was also quick to note that the "direct threat" and business necessity tests do not vary in their level of rigor but rather require "different types of proof." The "direct threat" test "focuses on the individual employee, examining the specific risk posed by the employee's disability." The business necessity test addresses "whether the qualification standard can be justified as an across-the-

board requirement." According to the Fifth Circuit, "[i]n evaluating whether the risks addressed by a safety-based qualification standard constitute a business necessity, the court should take into account the magnitude of possible harm as well as the probability of occurrence." The probability of the occurrence is to be discounted by the magnitude of its consequences. Thus, "[t]he acceptable probability of an incident will vary with the potential hazard posed by the particular position." Whichever test is used, "the proofs will ensure that the risks are real and not the product of stereotypical assumptions."

Recommendations

First, if you are attempting to make a blanket drug related disqualification, make sure you can back up your decision with an overwhelming amount of data and can demonstrate the magnitude of possible harm.

Second, if it is an individual drug related disqualification using the "direct threat" standard, seek out an occupational physician/certified medical review officer who can render a medical opinion and an attorney who understands the ADA issues to guide you.

Third, have an interactive meeting with the employee searching out reasonable accommodations before making your disqualification final decision.

Lastly, keep it confidential since you are dealing with medical and drug testing issues.

DISCLAIMER: 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 advises collection sites, TPAs, employers, work comp administrators, and MROs on a variety of drug and alcohol testing issues and risk reduction programs. Tom may be reached at (205) 870-0555 or te@wallacejordan.com. Please visit our Web Site at www.wallacejordan.com (which contains federal drug testing regulations and other drug free workplace resources).

DOT Issues Implementation Guidance for New CCF and Indicates Publication of Final Rule on Part 40 by End of 2000 or First Part of 2001

The U.S. Dept. of Transportation (DOT) has issued a Notice in the Federal Register permitting employers regulated by DOT to begin using the new Federal Drug Testing Custody and Control Form (CCF) on August 1, 2000, providing they follow the guidelines outlined in the Notice. Employers may also continue to use the old seven-part CCF.

The Notice indicates that the changes to the CCF must be followed even though they are not currently required procedures in 49 CFR Part 40 (such as Step 2, check box for Split, Single, or Non Provided, etc.). DOT-regulated employers who choose to use the new CCF must ensure that the form is filled out completely. However, the procedures used in the urine specimen collection process, other than the use of the form, must still conform to the current requirements as directed in 49 CFR Part 40.

Clarified is the usage of two documents recently published on the U.S. Dept. of Health and Human Services' web site (http://www.health.org/workpl.htm). The new Urine Specimen Collection Handbook for Federal Workplace Drug Testing Programs and a new Medical Review Officer Manual for Federal Workplace Drug Testing Programs are both intended for use with the new CCF. However, the handbook and the manual are only for Federal agency testing programs and not for DOT-regulated transportation industry programs. Differences between the two new publications and Part 40 are outlined within the Implementation Guidance.

For a complete copy of the July 25 Notice, visit www.thomas.loc.gov or contact DATIA at (800) 355-1257.

Senate Rejects Faith-Based Treatment Bill

A bill that would allow faith-based organizations to receive federal funds to provide services such as drug and alcohol treatment without reducing their religious character, and would supercede state laws regarding education, licensure and certification requirements, was recently defeated by the U.S. Senate. DATIA opposes this legislation, as it would jeopardize public safety and quality of service by reducing or eliminating educational, training, and other standards critical to a program's success.

S. 2779 (American Community Renewal and New Markets Empowerment Act, Santorum, R-PA), states that formal educational qualifications for counselors and other personnel in drug treatment programs may undermine the effectiveness of the programs and may interfere with the provision of needed drug treatment services. Title VI, Section 584 removes programs from compliance under Title VII of the civil rights law by considering financial assistance aid to the beneficiary and not to the organization providing program services. With this provision, religious organizations receiving federal funds would be able to discriminate in their hiring practices.

While the bill failed this time around, Santorum and Democratic co-sponsor Sen. Joseph Lieberman (D-CT), plan to reintroduce it at a later date. For a copy of this bill, visit DATIA's Resource page at www.datia.org/resources resources_mainpage.htm.

Souder Introduces Bill to Negate State Marijuana Legalization Laws

A bill recently introduced by Rep. Mark Souder (R-IN4) would negate state and local medical marijuana legalization laws. H.R. 4802 would clarify congressional intent regarding the relationship between State and Federal law governing controlled substances. This bill would declare that Congress intends to supersede any and all laws of the States and units of local government insofar as they may permit or authorize the use, growing, manufacture, distribution, or importation of marijuana or any controlled substance which differs from the provisions of the Controlled Substances Act and the Controlled Substances Import and Export. Any law, regulation, or ordinance purporting to establish different requirement, prohibition, or standard would be null and void.

This bill would provide the basis for the uniformity and consistency needed to effectively regulate medical marijuana and provide a framework for all areas affected by the legislation of medical marijuana on a national level. Federal guidelines could be set governing how medical marijuana fits into the workplace, providing cut-off levels for medical marijuana use on the job, and outlining the steps employers have to take to accommodate medical marijuana in their workplaces. All of these issues would be addressed on a consistent basis under Rep. Souder's bill.

While the intent of this bill is to ban the use of all medical marijuana, DATIA will work with Rep. Souder to recognize the legitimacy of studies concerning the benefits of medical marijuana, and craft legislation which will establish uniform and consistent federal guidelines for its cultivation, prescription, and use.

H.R. 4802, currently with 10 co-sponsors, was referred to the House Committees on the Judiciary and Commerce.

For a copy of this bill, visit DATIA's Resource page at www.datia.org/resources/resources_mainpage.htm.

NHTSA Amends Conforming List of Breath Alcohol Measuring Devices

The National Highway Transportation Safety Administration (NHTSA) recently updated its Conforming Products List for instruments that conform to the Model Specifications for Evidential Breath Testing Devices. The amendment, effective July 21, 2000, added two instruments, which have been evaluated and found to meet model specifications for mobile and non-mobile testing devices. The Intoxilyzer 400PA, manufactured by CMI, Inc., Owensboro, KY, is a hand-held breath tester with a fuel cell alcohol sensor. Also, the Alco Sensor IV-XL, manufactured by Intoximeters, Inc., St. Louis, MO, is a hand-held breath tester with a fuel cell alcohol sensor that is microprocessor controlled and designed to minimize operator involvement in performing the test and processing the data.

For the complete list visit DATIA's Resource page at www.datia.org/resources/ resources_mainpage.htm.

On July 12, 2000, DATIA submitted comments on the Draft Mandatory Guidelines for Workplace Drug Testing Programs on behalf of its constituency, based on input from DATIA's members and the Legislative & Regulatory Committee.

DATIA believes the inclusion of alternative testing methods is much needed and appreciated by professionals in the drug and alcohol testing industry. DATIA is concerned, however, that requirements appropriately applied to laboratories are inappropriately applied to Point of Collection Test (POCT) Providers in the draft guidelines.

Under the draft guidelines, it appears that a POCT Provider is considered to be a laboratory. Many of the responsibilities addressed in the draft guidelines do not appear to apply to a POCT Provider. For example, the draft guidelines read "(a)…even where another individual has overall responsibility for an entire multi-specialty laboratory and (d)...monitor analytical performance of all controls and standards; document the validity, reliability, accuracy, precision, and performance characteristics of each device/system used at that testing facility." These responsibilities are identical to the responsibilities listed for a laboratory's Responsible Person. Since their responsibilities are identical, will a Responsible Technician also be required to adhere to the qualifications for a Responsible Person (Ph.D., experience in analytical forensic toxicology, etc.)?

DATIA cannot emphasize enough that a POCT provider is not a laboratory. The toxicology and science behind the POCTs is developed by the manufacturer and approved by the FDA and SAMHSA/HHS. The certified collectors who perform the POCT do not have a laboratory/toxicology background, nor do they need to. They simply need to understand and be proficient in specimen collection and how to operate/read the POCT device. No quantitative results are obtained at the POCT Provider, nor does the POCT Provider report any positive results. This is information that is provided by the laboratory once a non-negative is sent to the laboratory for confirmation.

In the section addressing application requirements for a POCT Provider, these requirements are again identical to those required for laboratories. DATIA does not see the reason for or positive effects of requiring POCT Providers to be inspected and certified by SAMHSA/HHS. Both FDA and SAMHSA/HHS have approved the test devices that POCT Providers use, and a SAMHSA/HHS approved program has certified the persons performing the screens. Why then must a facility that utilizes these approved products and employs these approved collectors be required to be certified as well? This seems like an extra burden, for both the POCT Provider and SAMHSA/HHS, that is not necessary.

The draft guidelines examine the performance test requirements for a POCT Provider. DATIA believes that with the use of FDA and SAMHSA/HHS approved POCT devices that are quality control tested both at the lab and at the POCT provider, these requirements (which are identical to those for a lab, with the exception of the concentration of drugs in the sample) seem unnecessary and inappropriate for the POCT provider.

The draft guidelines state the inspection requirements for a POCT Provider. DATIA does not see the value or feasibility in inspecting the thousands of potential POCT Providers. What will the inspection consist of? Storage of the POCTs? Paperwork? How does SAMHSA/HHS plan to inspect mobile POCT Providers who collect the specimens at the employer's place of business? Again, this is a requirement appropriate for laboratories that is being inappropriately applied to POCT Providers. If monitoring of the facilities and their protocols is deemed necessary, this could be done in other ways including submission of Standard Operating Procedures and Collector Certifications to SAMHSA/HHS. To view the full text of DATIA's comments on the Draft Mandatory Guidelines for Federal Workplace Drug Testing Programs, visit www.datia.org.

The DATIA Collector Certification Program is an industry-developed program designed to certify specimen collectors who have attained the industry standard for proficiency in collections. As such, the program has guidelines and rules that must be adhered to by participants in order to maintain the program's integrity.

One such guideline sets the number of attempts that a person has to pass the examination. Each certification candidate has two attempts at the exam per each certification year. Should a candidate fail the exam twice, they will need to wait until the next certification year (June 1-May 31) to apply for certification. This guideline ensures that the candidates do not simply "learn" the answers to questions on the DATIA exams. In addition, there are multiple exams consisting of questions on the same subject matter but with different questions and answers. This means that no candidate will take the same exam twice in the same year.

The second major guideline that candidates need to consider is that cheating will not be permitted on the DATIA collector certification exam. Candidates are required to sign an affidavit that they have not received help from any other person in completing the exam.

This help includes using another person's answer sheet from the current exam or a previous exam, referring to a previous exam and its answers for completing the current exam, or asking another person for the answer to a question. In cases of suspected cheating, the candidate is given the reason why such activity is suspected and given the opportunity to explain the reason for the suspicious activity. This information is then forwarded to the Specimen Collection Issues Committee for a vote. Should a person be found to have cheated on the certification exam, they will be unable to retake the certification exam until the following certification year.

As you can see, the DATIA Collector Certification program underwent thorough development to ensure that all possible situations to call the program's integrity into question were addressed. By doing so, DATIA can ensure that Certified Professional Collectors (CPCs™) and Certified Professional Collector Trainer™s (CPCTs™) possess the highest proficiency in specimen collection. For complete program policies and procedures visit www.datia.org.

Effective September 22, 2000, the DATIA Certified Professional Collector Trainer™ Training Course and all subsequent Collector Certification Examinations will emphasize the new procedures involving the use of the recently approved Federal Chain of Custody Form. The form which was approved for use effective August 1, 2000, will be phased in by most providers over the course of the coming year.

In using the new form for Department of Transportation (DOT) mandated testing, collectors must be sure that current CFR 49 Part 40 requirements are adhered to even though the current regulations were written for the 7 part form that is being phased out of use. The Department of Health and Human Services (HHS) has issued guidance on procedures for using the new form, however, these often contradict current DOT procedures (see Washington Update). Regulations incorporating the new chain of custody form will be included in the rewrite of CFR 49 Part 40 due out later this year or in early 2001.

The DATIA Certified Professional Collector™training program will work to direct collectors on the correct procedures to follow amongst these differing requirements. New and varying requirements include

whether or not to require donors to empty pockets, initiating a direct observed collection immediately upon receiving a specimen that is out of temperature, declaring a refusal to test when the donor refuses to drink liquids, etc. The DATIA Certified Professional Collector program will focus on the new 5 part Chain of Custody form, and specifically the many changes in procedures from the 7-part form. Since many companies will be using the 7-part form for many months to come, the course will cover both forms until August 2001 when the 7-part form is completely phased out.

For collectors that have already been through the certification process, new CPCT™ and CPC™ manuals can be purchased which will include information on the new procedures. Although not required to attend a refresher course, all collectors currently certified by DATIA will be tested on the new CCF procedures and will need to take all necessary measures to ensure their proficiency before taking their certification renewal examination.

Complete information on DATIA's training programs and manuals, and the new chain of custody form can be found at www.datia.org.

The draft of mandatory guidelines for federal workplace drug testing programs stated that a new drug, Methylenedioxymethamphetamine (MDMA) also known as Ecstasy, would be included as a drug to be tested for as part of the test for amphetamines.

Psychemedics Corporation and the Associated Pathologists Laboratories (APL) have begun testing for Ecstasy in hair specimens submitted for drugs of abuse testing. Ecstasy, a hybrid of the hallucinogen mescaline and the stimulant amphetamine, has become a popular drug of abuse in the all-night dance club scene or rave parties.

According to the National Institute on Drug Abuse (NIDA), people may use Ecstasy to improve their moods or get energy, however, chronic use of Ecstasy appears to cause death or damage to the brain's ability to regulate emotion, memory, sleep and pain. MDMA can be extremely dangerous in high doses. It can cause a marked increase in body temperature (malignant hyperthermia) leading to the muscle breakdown and kidney and cardiovascular system failure reported in some fatal cases at raves. MDMA use may also lead to

heart attacks, strokes, and seizures in some users. NIDA has issued an alert to aid communities in identifying and responding to this threat as a result of an alarming increase in the popularity of dangerous substances known collectively as "club drugs."

Corporate clients, schools, parents, and even the federal government, strongly encouraged and requested drug testing companies to research and develop an effective test for Ecstasy.

Currently, Psychemedics Corporation and the Associated Pathologists Laboratories provide hair testing screens for the presence of marijuana, cocaine (as well as crack cocaine), opiates (heroin), methamphetamine (speed and uppers), and PCP (angel dust), and additionally screening for Ecstasy. Hair testing can detect drug use for the past 90 days . The test for Ecstasy will be a very significant research tool for the important work that needs to be conducted on the long-term health impact of Ecstasy.

Learn more about Ecstasy and drug testing for Ecstasy by visiting www.drugtestingnews.com.

DATIA is pleased to announce that drugtestingnews.com continues to reach more drug and alcohol industry professionals, as well as the general public. Since DATIA added sponsorship logos and advertisements to drugtestingnews.com in June 2000, the visitor traffic has more than doubled.