At the June 6, 2000 meeting of the Drug Testing Advisory Board (DTAB) attended by DATIA, an initial draft of the revised Mandatory Guidelines for Federal Workplace Drug Testing Programs was released. These draft guidelines, which cover testing programs of federal workplaces, represent a major overhaul of the guidelines. DATIA encourages its members to review the guidelines and provide comments to the Substance Abuse and Mental Health Services Administration by the July 12, 2000 deadline. These comments will be reviewed by DATIA and will have an impact on future drafts of the guidelines.

 The draft guidelines will apply to federal drug testing programs including:

Executive Agencies as defined in 5 USC 105; the uniformed services as defined in 5 USC 2101 (3) (but excluding the Armed Forces as defined in 5 USC 2101) (2); any other employing unit or authority of the Federal Government except the United States Postal Services, the Postal Rate Commission, and employing units or authorities in the Judicial and Legislative Branches; and, the Intelligence Community, as defined by Executive Order No. 12333, only to the extent agreed to by the head of the affected Agency.

 These guidelines do not regulate DOT mandated testing programs, however, there are areas of CFR 49 Part 40 that direct these guidelines to be followed, such as the cutoff levels for drugs tested and laboratory certification requirements. In addition, many private sector employers look to the HHS guidelines when developing their own drug testing policies.

 Although the inclusion of alternative specimens and rapid screen urine tests as approved testing methods for federal work place testing is a major advancement for the industry, there are many questionable areas of the draft guidelines. DATIA views the following as the most significant changes of the draft guidelines. The draft guidelines state that a new drug, MDMA (ecstasy) will be included in the drugs to be tested for as part of the test for amphetamines. In addition, the initial cutoff levels for cocaine and amphetamines have been lowered to 150 ng/mL and 500 ng/mL respectively for urine specimen testing. The confirmation cutoff level for cocaine has been lowered to 100 ng/mL and the cutoff levels for amphetamines have been lowered to 150-250 ng/mL for urine specimens. In addition to these changes, cutoff levels have been developed for hair, sweat, and saliva specimens.

 The draft guidelines propose that collectors involved in collecting specimens for federal drug free workplace programs be certified in specimen collection and recertify every two years. HHS has not developed its own formal certification program, but rather is looking to industry organizations to offer the certification program. The guidelines, once finalized, will state who can train and certify collectors.

Rapid response screen tests that have been widely referred to as "on site tests," have been named Point of Collection Tests (POCTs) within the new guidelines and defined as "an initial test conducted at the collection site for either the presence of drugs or to determine specimen validity." In addition, the guidelines define an HHS Certified Point of Collection Test Facility as a "location where specimen collection, initial testing, reporting of results, and record keeping is performed under the supervision of a Responsible Technician (oversees day to day operations of the POCT facility, maintains competency of staff, maintains Standard Operating Procedures, maintains quality assurance program).

 In order to perform point of collection testing for federal drug free workplace testing programs, the facility must apply to be certified by HHS, employ a Responsible Technician, and must be inspected before certification is granted. The guidelines treat a facility that performs POCTs as a lab, and has modeled their certification program after the current CLIA program.

 Also in the draft guidelines, it is stated that an MRO cannot be employed by, be an agent of, nor have any financial interest in a POCT provider. Many of the current providers of POCTs will be in violation of this new guideline. Any Consortium or TPA that offers in house MRO services and POCTs will not be able to provide services for federal drug free workplace programs under the draft guidelines.

 The guidelines for daily quality control on POCT devices treat POCTs just as they treat laboratory devices used for testing samples in that daily quality control is required on POCTs rather than the current standard of performing quality control on each new lot of POCTs.

 Requirements for the submission of summary reports from the laboratory to the employer are included in the guidelines, however, the guidelines state that they are evaluating the need for such reports and the possibility of eliminating this requirement. In addition, the DOT stated in the preamble of the NPRM for CFR 49 Part 40 that "DOT and HHS agree that the laboratory summary reports required by each agency be the same."

 DATIA will post the guidelines on its website once HHS makes them available. For a copy of the guidelines, contact DATIA at info@datia.org or 800-355-1257.

 Please submit your individual comments on the draft guidelines to the Division of Workplace Programs, 5600 Fishers Lane, Rockwall II, Suite 815, Rockville, MD 20857, by fax (301-443-3031), or by email wvogl@samhsa.gov or clodico@samhsa.gov by July 12, 2000. DATIA will work with its legislative and regulatory committee to provide comprehensive comments on the document on behalf of the association.

In its next term, which begins in October 2000, the U.S. Supreme Court will decide a case concerning an employee who was fired twice after testing positive for marijuana and was reinstated by an arbitrator both times. In Eastern Associated Coal Co. v. United Mine Workers of America, District 17, No. 98-2527, 1999 U.S. App. Lexis 19944, 140 Lab. Cas. (CCH) ¶ 10,684 (4th Cir. Aug. 20, 1999), James Smith, a mobile equipment operator, tested positive for cannabinoids on March 25, 1996, as part of a random drug test. He was discharged. He filed a grievance under the collective bargaining agreement between his employer, Eastern Associated Coal Company, and his union, United Mine Workers of America (UMWA). The grievance was arbitrated, and the arbitrator issued an order returning Mr. Smith to work after a 30-day suspension without back pay. Mr. Smith was also required to take part in a substance abuse program and to be subject to random drug testing at the discretion of either Eastern or a substance abuse professional over a five-year period.

Mr. Smith tested negative for illegal drugs on three subsequent occasions, but tested positive for cannabinoids again on June 27, 1997. He was discharged, and he again filed a grievance. The arbitrator found that Mr. Smith's lapse in abstinence from recreational drug use was an isolated occurrence instigated by a family problem. The arbitrator ordered Mr. Smith to be reinstated after a suspension through October 27, 1997, subject to the conditions that he would receive no back pay, that he would reimburse Eastern and UMWA for the costs of both arbitrations, and that he would provide a signed, undated letter of resignation which would be dated and accepted if he tested positive for any illegal drug, or refused to submit to a drug test, in the following five years.

Eastern sought to have the award vacated in federal court, arguing that the arbitrator's decision does not "draw its essence" from the collective bargaining agreement and that it violates public policy against the use of illegal drugs by persons in safety-sensitive positions. The federal district court refused to vacate the award, as did the court of appeals, stating that because neither the collective bargaining agreement nor the employer's substance abuse policy mandated discharge as the punishment for testing positive for illegal drugs, the arbitrator rationally could have concluded that there was not just cause for discharge. The courts also ruled that the arbitrator's decision was not contrary to "a well-defined and dominant public policy because although there is a public policy against the use of illegal drugs by those in safety-sensitive positions, there is no such public policy against the reinstatement of employees who have used illegal drugs in the past."

The questions likely to be addressed by the U.S. Supreme Court in this case (Supreme Court Docket No. 99-1038) are (1) whether, as the First, Third, Fifth, Eighth, and Eleventh Circuits have held, there is a well defined and dominant public policy that prohibits enforcement of arbitration awards requiring reinstatement to safety sensitive positions of employees who test positive for illegal drugs, or whether, as the Second, Ninth, Tenth, and now Fourth Circuits have held, no such policy exists and courts must therefore uphold reinstatement to safety sensitive positions of those who test positive for illegal drugs; and (2) whether, as the Fourth, Ninth, and District of Columbia have held, an arbitration award should be vacated on public policy grounds only when the award itself violates positive law or requires unlawful conduct by the employer, or whether, as the First, Third, Fifth, Seventh, Eighth, and Eleventh Circuits have held, such an award need not violate positive law to violate public policy.

Until the decision is announced by the Supreme Court, it is advised that all form last chance agreements be strengthened to provide for immediate termination (or automatic resignation) upon a positive test result or refusal to be tested. The value of a well drafted last chance agreement when allowing an employee who has tested positive to return to work is significant. A poorly drafted agreement is similar to hanging a valuable watercolor painting in your shower. It looks great until some water splashes up on it, and then it becomes worthless.

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).

A Look at Drug and Alcohol Testing Legislation in the 106TH Congress

While Congress may be locked in a battle to pass the most politically pleasing legislation prior to Election Day, the issue of substance abuse testing, both drug and alcohol, has not escaped the interest of many in Congress. DATIA took a look at all of the bills that have been introduced during this Congress, which began in January 1999, and found dozens relating in some way to substance abuse testing. What follows is a list of the most relevant bills concerning substance abuse testing introduced during this Congress that DATIA has been following, and the current status of each. While the motivation behind each bill may be different, what is clear is that all demonstrate a continued interest by Congress to improve upon public safety and confidence through the expanded availability and use of drug and alcohol testing.

1. H.R. 1642, Parental Consent Drug Testing and Counseling Act, by Rep. James E. Rogan (R-CA27)

Purpose: Would require local educational agencies to develop and implement a random drug testing and counseling program for students in grades 9 through 12.

Status: No co-sponsors, pending in the Subcommittee on Early Childhood, Youth and Families of the House Education and the Workforce Committee.

2. H.R. 1735, Empowering Parents to Fight Drugs Act of 1999, by Rep. John E. Peterson (R-PA5)

Purpose: Would authorize the Secretary of Education to make grants to state educational agencies to enable each local educational agency to develop and implement a random drug testing program for students in grades 7 through 12. The bill also provides for parental notification of results, substance abuse treatment availability notification, and possible school disciplinary action.

Status: One co-sponsor; referred to the Subcommittee on Early Childhood, Youth and Families of the House Committee on Education and the Workforce.

3. H. RES. 331, Mandatory Drug Testing of Members, Officers, and Employees of the House of Representatives, by Rep. Joe Barton (R-TX6)

Purpose: Would provide for the mandatory drug testing of Members, officers, and employees of the House of Representatives.

Status: 7 co-sponsors, referred to the House Committee on Rules.

4. H.R. 279, Federal Employment Applicant Drug Testing Act, by Rep. John E. Sweeney (R-NY22)

Purpose: Would require pre-employment drug testing for all applicants for Federal employment.

Status: No co-sponsors, referred to the Subcommittee on Civil Service of the House Committee on Government Reform.

5. S. 2008, A bill to require the pre-release drug testing of Federal prisoners, by Sen. John Ashcroft (R-MO)

Purpose: Would require the Attorney General to direct the Bureau of Prisons to establish and implement a mandatory drug testing program under which: each prisoner would be required to submit to a drug test not less than 30 nor more than 60 days prior to their release; the Bureau would notify the Attorney General if a prisoner tests positive, and the Attorney General would, not later than the scheduled date of the prisoner's release, issue an arrest warrant for the prisoner if the Attorney General believes, based on the test results, that the prisoner has violated the law against providing or possessing contraband in prison.

Status: No co-sponsors, referred to the Senate Judiciary Committee.

6. S. 906, Drug Testing and Treatment for Welfare Recipients Act of 1999, by Sen. Spencer Abraham (R-MI)

Purpose: Would authorize the Secretary of Health and Human Services to award grants to up to five states to establish and maintain pilot drug testing programs and drug treatment programs for welfare recipients.

Status: One co-sponsor, referred to the Senate Finance Committee.

7. S. 2267, Amateur Sports Integrity Act, by Sen. John McCain (R-AZ)

Purpose: Would direct the National Institute of Standards and Technology (NIST) to establish a program to support research and training in methods of detecting the use of performance-enhancing substances by athletes.

Status: Two co-sponsors, reported to the Senate by the Committee on Commerce, Science and Transportation, and placed on the Senate Calendar.

8. S. 5, Drug-Free Century Act, by Sen. Michael DeWine (R-OH)

Purpose: Generally to reduce the transportation and distribution of illegal drugs and strengthen domestic demand reduction. Specifically, Section 3003 would direct the NIST to conduct a study of drug testing technologies that may be used as alternatives or complements to urinalysis.

Status: 14 co-sponsors, referred to the Senate Judiciary Committee.

For additional information on these or any bills being considered by Congress, visit http://thomas.loc.gov.

Policies and Activities at NIAAA

On June 8, DATIA attended the Ninety-Fourth Meeting of the National Advisory Council on Alcohol Abuse and Alcoholism in Bethesda, Maryland. The Council provided advice and recommendations on the award of research grants, directions in research, and issues of policy and program development. To read the Council minutes visit http://www.niaaa.nih.gov.

Congress Passes E-Signature Bill

The House and Senate recently passed the much anticipated Electronic Signatures in Global and National Commerce Act, S. 761 (Sen. Spencer Abraham, R-MI). The bill, which President Clinton indicated he will sign into law, extends to electronic signatures the same legal validity and protections as those signatures executed with pen and ink.

The bill allows consumers to "opt in" to electronic signature agreements, and must consent to receiving documents electronically, rather than on paper. Businesses must be certain that their customers have the necessary hardware and software support to receive electronic documents. Some documents, such as notices of service termination, are still required to be delivered in paper form. In addition, legal and commercial documents excluded from the act include: certain testamentary instruments, family law documents, certain instruments under the Uniform Commercial Code, certain judicial documents, certain credit-related proceedings, the Uniform Anatomical Gift Act, and the Uniform Health-Care Decisions Act.

DATIA has supported this legislation as a first step toward the optional use of electronic signatures and electronic forms in the mandated drug and alcohol testing programs. Use of e-signatures and e-forms has the potential to simplify the testing process, increase security, reduce costs, and speed up processing. Now that this legislation is passed, DATIA's next step is to work with the U.S. Dept. of Health and Human Services (HHS) and the U.S. Dept. of Transportation to move toward the option of using e-signatures and e-forms in mandated drug and alcohol testing programs. The approval of which is under the purview of HHS. For additional information on S. 761, visit http://thomas.loc.gov.

OMB Information Initiative: Collecting Information on the Information Age

On June 12, 2000, DATIA participated in the roundtable for workplace drug testing programs and the "paperless laboratory," hosted by the Office of Management and Budget (OMB), the Department of Transportation (DOT) and Department of Health and Human Services (HHS). The round table focused on the idea of the paperless laboratory, and developing working groups to address setting industry standards with the assistance of the drug and alcohol industry. This brainstorming session addressed how laboratories, medical review officers (MRO), and employers can electronically transmit data efficiently and accurately in a cost-effective manner. Industry professionals propose that the federal government needs to establish regulations in certain areas as to the procedures, standards, and uniform software necessary to regulate the transmission of data for federally mandated drug testing. The notion of biometrics or a smartcard to replace the donor signature could be options used to allow for electronic transmission.

All government agencies present were receptive to developing a collection site process where data would be entered electronically using a software application that requires completion of each step on the collection form. If a typing or procedural error occurs during the data entry process, the computer program would not allow the process to continue until the problem was remedied. All fields would have to be completed correctly before the data could be sent. This could substantially decrease errors and allow for more accuracy.

Many industry professionals voiced their concerns and problems with paper storage of drug testing results and how moving to a paperless laboratory would reduce storage in their facilities. DATIA will continue to keep you updated on further information regarding the "paperless laboratory."

New CCF Has Been Approved By OMB

On June 12, 2000 at the Office of Management and Budget (OMB) Information Initiative, Walter Vogl from the Division of Workplace Programs, Substance Abuse and Mental Health Services Administration announced that the new Chain of Custody Form (CCF) has received OMB approval and effective August 2000, will be available for use. The Federal Register announcement and a copy of the form are available at www.datia.org.

The draft of mandatory guidelines for federal workplace drug testing programs state that a new drug, Methylenedioxymethamphetamine (MDMA) also known as Ecstasy, will be included as a drug to be tested for as part of the test for amphetamines. The initial cutoff levels for amphetamines has been lowered to 500 ng/mL for urine specimen testing. The confirmation cutoff level for amphetamines has been lowered to 150-250 ng/mL for urine specimens.

The alterations in testing levels of amphetamines and adding MDMA as a drug to be tested for could have a significant impact on onsite drug testing kits. New onsite testing kits would have to be made in order to test for MDMA. Even though MDMA is an amphetamine, the current immunoassay kit used in detecting amphetamines in not sensitive to MDMA. Therefore, another assay must be used. This would require a new testing kit and FDA approval and could cost the manufacturers of onsite testing kits substantially.

The Division of Workplace Programs at the Center for Substance Abuse Prevention (CSAP), part of the Substance Abuse and Mental Health Services Administration (SAMHSA) is focused on maximizing deterrence and detection of MDMA while managing cost. CSAP is currently examining the availability of MDMA immunoassay kits specificity and sensitivity to MDMA and MDA as to methamphetamine and amphetamine. During the review process, CSAP will consider the comprehensive GC/MS procedures for single runs to include methamphetamine, amphetamine, MDMA, and MDA.

DATIA will continue to keep you updated on the draft of mandatory guidelines for

federal workplace drug testing programs as new developments unfold.

In a recent survey of 500 Drug & Alcohol Testing Industry Association Members (DATIA), problems in the drug and alcohol collection process were outlined in order to provide substantial insight into ways to rectify problematic areas. Such problems have received more attention in recent years due to the increased number of legal cases challenging drug test results and those results overturned due to technicalities. In the drug testing industry, technicalities overwhelmingly correspond to administrative errors in the collection, laboratory, or medical review process.

Of the 500 random DATIA members surveyed by Moore North America, over 42% responded and indicated that the majority of collection errors are due to incomplete chain of custody forms, missing collector signatures, usage of the wrong form, and donor errors such as missing donor signatures or identification numbers. DATIA members took it one step further by recommending the best ways to eliminate or decrease these errors was to develop a universal chain of custody form with shaded highlighted areas and standardized collector training. The universal Chain of Custody form would be used for both Department of Transportation (mandated) and private business (non-mandated) testing. Currently, the federal chain of custody form can only be used for mandated testing. The industry and DATIA members have been lobbying for a universal form since DATIA's inception in 1995, but no such form is foreseeable any time soon even though the creation of one would require only a check box to indicate mandated or non-mandated.

In DOT's recent CFR 49 Part 40 proposed revision, comments were solicited on whether they should consider such a form. The majority of the comments received on this issue were in favor of such a form. The need for such a universal form is even more enumerated by the fact that of those surveyed, 58% of the collections performed are non-mandated and 42% are mandated. Even more significant is that: 51.4% of those surveyed use up to 20 different chain of custody forms; 21.5% use 21-40 different forms; and, 27.2% utilize over 40 different chain of custody forms. These large

numbers of forms is attributed to the fact that one form is to be used by employees mandated to be federally tested, and a different form is to be used by each employer for employees not mandated to be federally tested. Clearly the industry numbers indicate the need for a universal form.

Another solution to decreasing errors includes highlighted areas for collector and donor fulfillment areas on the chain of custody form. Highlighted areas are included in the new Federal Chain of Custody Form. This change will significantly increase the completeness of both collectors and donors filling out the appropriate areas of the chain of custody form.

Finally, respondents indicated that errors could be reduced through standardized collector training. This is exactly the purpose of DATIA's Professional Collector Certification program. Over 65% of the survey respondents indicated that they had worked for their company for over 3 years, while 34% have worked for less than 2 years. For this reason the DATIA Professional Collector Certification program aims at training the Certified Professional Collector Trainer™ (CPCT™), the more experienced collector, and having them train the facility's collectors. DATIA's program ensures that there is a person qualified to train new collectors on proper collection procedures despite the facility's turnover rate for first time collection employees.

Other areas of concern indicated by the DATIA respondents included shy bladder situations and adulterated specimens, both of which are focal points of the DATIA Certified Professional Collector™Training Course. These areas have been an emphasis of the DATIA Certified Professional Collector™Training Course since its inception. For further information on the survey visit www.datia.org.

Methylenedioxymethamphetamine (MDMA), also known as Ecstasy, was developed and patented in the early 1900's as a chemical precursor in the synthesis of pharmaceuticals. Chemically, MDMA is similar to the stimulant amphetamine and the hallucinogen mescaline. MDMA can produce both stimulant and psychedelic effects.

 MDMA is taken orally, usually in a tablet or a capsule. MDMA's effects last approximately 3 to 6 hours, though confusion, depression, sleep problems, anxiety, and paranoia have been reported to occur even weeks after the drug is taken. MDMA can produce a significant increase in heart rate and blood pressure and a sense of alertness like that associated with amphetamine use. The stimulant effects of MDMA, which enable users to dance for extended periods, may also lead to dehydration, hypertension, and heart or kidney failure.

 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. MDMA is neurotoxic. Chronic use of MDMA was found, first in laboratory animals and more recently in humans, to produce long-lasting, perhaps permanent, damage to the neurons that release serotonin, and consequent memory impairment

DATIA is pleased to welcome Ann De Michele, as the new Membership Assistant. Ann will be assisting with all of the Certification results and exams, as well as welcoming the newly accredited facilities.

Ann is a graduate of Mary Washington College, where she completed her Bachelor of Arts degree in History.

A. Since SAP referrals to treatment programs must not give the impression of a conflict of interest, the rules do state that a SAP can't refer an employee to a program in which the SAP has a financial interest. The regulations provide exceptions to this rule, however, for situations similar to the one above. The situations which allow the rule to be waived include when a SAP refers an employee for assistance through: A public agency; the employer of a person under contract to provide treatment on behalf of the employer; the sole source of therapeutically appropriate treatment under the employee's health insurance program; or, the sole source of therapeutically appropriate treatment reasonably accessible to the employee.

These exceptions allow the employee to receive the assistance needed, as financially feasible and convenient as possible.