DATIA has been active in addressing U.S. Department of Transportation (DOT) regulations and guidance which threaten to interfere with a Consortium's or Third Party Administrator's ability to act as the "agent of the employer" when implementing drug and alcohol testing programs.

Specifically, DATIA is seeking to protect the practice of Consortiums and Third Party Administrators (C/TPA) to receive test results on behalf of its clients from the MRO, and to act in other current capacities. Clients depend on C/TPAs to provide various compliance services as their "agent" and if employers were required to deal directly with MROs, laboratories, and DOT, there would be a significant reduction of the role for C/TPAs.

DATIA has identified conflicting DOT published statements on whether C/TPAs may act as the employer when implementing an employer's drug testing program. It is DATIA's position that DOT drug and alcohol regulations (49 CFR Part 40) clearly state that the definition of an "employer includes an industry consortium", thereby the terms employer and consortium are interchangeable under this definition. For example, this means that the C/TPA may act as an "agent of the employer" by receiving results directly from the Medical Review Officer and transmitting them to the employer.

However, in letters and guidance DOT has said that the C/TPA may not act as the agent of the employer and thereby may not receive results directly from the MRO. DOT's position is that the 1995 Guidance on the Role of the C/TPA clearly states that "it is not appropriate for the MRO or BAT to send the results only to the C/TPA." The guidance, however, also allows "operating administrations to make exceptions to this general rule" and that "C/TPAs may receive from employers or other partiesindividual test results." Clearly, the regulations and the guidance conflict with each other although regulations have the force of law and guidance does not.

Of DATIA's approximately 1,000 members, over 80% provide some sort of consortium or third party administration service. It is estimated that there are as many as 2,500 consortiums in the US helping business to comply with drug testing rules. DATIA conducted a random poll of members providing C/TPA services asking them if they act as the agent of the employer, and 99% of them receive the results directly from the MRO. To get more complete information, DATIA has enclosed a membership survey on this issue.

To clarify this important issue, DATIA held meetings with the DOT, the United States Coast Guard and the Federal Highway Administration. DOT strongly believes that the intent of Part 40 is that the MRO must transmit a copy of the result directly to the employer (company). They did indicate that DATIA made "relevant arguments" as to why the C/TPA should act as the agent of the employer when receiving test results and that DATIA should comment on this issue when the new proposed Part 40 regulations are issued.

This appears to be a misunderstanding on DOT's part, that will have the opposite effect of that intended. The fact is that without the value added services provided by Consortiums or TPAs, many companies, especially small ones, would find it very difficult to comply with the DOT regulations. To ensure that C/TPAs have flexibility in providing employers with the services that they need, DATIA has made this issue a priority and intends to continue to actively work with the DOT, through the Part 40 comment process, to allow the C/TPA to truly act as the agent of the employer. Should it be necessary, we will also take our case to Congress and policymakers in the Executive Branch.

1. Policy and Collection Form
Does your drug-free workplace allow for on-site drug screening in addition to laboratory testing? Is a standardized collection/screening form available and adhered to with every screening collection? Does the collection/screening form require information sufficient to accurately identify the donor, contact person, fax number, etc.? Does the collection/screening form include (a) a participation and consent statement to be signed by the donor; (b) a place to record the particular screening device, identified by drug(s) tested, lot number and expiration date, (c) temperature and control information; and (d) a place to record the screening results, including reporting confirmation?

2. Collection Device
Has the screening device been approved by the FDA for commercial distribution? If the 501(k) (the FDA equivalent notification statement) for the device is in another name, has the manufacturer provided a statement verifying that the product being purchased is identical in test strip components and manufacturing process to the product identified on the 501(k)? Does the screening device detect Health & Human Services/DOT target analytes at HHS/DOT cutoff levels? Are there recent independent studies confirming reliability and accuracy of the device?

3. Security
Is access to collection personnel, specimens, collection materials, supplies, records, and collection sites restricted?

4. Collection Procedures
Is the screening site properly prepared and secured as would be done for a DOT collection? Is the donor required to produce appropriate identification? Does the screening site provide adequate privacy so that visual results cannot be viewed by another donor? Is the screening performed in a manner so that if there is a presumptively positive result, a certified lab test can be conducted on the specimen? Does the screening site have written protocols and checklists for donor, collector and tester?

5. Procedure to Detect Adulterants
Is a procedure available to determine if the specimen has been tampered with or adulterated (temperature strips, built-in controls, visual inspection, adulterant test dipstick, smell, etc.)?

6. Objective Differentiation of Presumptively Positive and Negative
Does the screening device provide an objective discrimination between presumptively positive and negative results (i.e. line or absence of a line, or a digital readout)?

7. Includes Appropriate Controls
Does the on-site screening device have a built-in control which indicates that the test has performed properly? Does the manufacturer provide drug controls and are they used?

8. Training/Certification of On-Site Screening Analysts
Are procedures available to train and certify analysts by the screening device manufacturer?

9. Confidentiality
Is the individual conducting on-site screening unable to determine donor identity (if screening is conducted by fellow employee)? (This will depend on policy of the employer.)

10. Result Verification
Is the specimen, at the time of collection and before screening, split for subsequent certified lab testing? Can results, at time of collection, be verified by a second analyst on-site (and possibly preserve visual result through photocopy)? Are all presumptively positive screened specimens confirmed by a certified laboratory before adverse employment action is taken?

*"On-site" screening is intended here to refer exclusively to non-instrumented screening devices.
Special thanks to Mr. James D. Baer, Probation Officer for the United States District Court, Central District of CA for his assistance in refining this Audit.

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 Birmingham, Alabama 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. You may feel free to forward, distribute and copy this DATIA Legal Update if you distribute and copy it without any changes and you include all headers and other identifying information.

DATIA Submits Testimony In Support of Student Drug Testing

DATIA recently submitted testimony to Congress in support of drug-free school legislation. DATIA is supportive of any measure by Congress that targets schools in an effort to curb drug use by children and strongly believes that drug-testing is an important component of any legislation.

DATIA submitted testimony in response to a hearing by the House Subcommittee on Early Childhood, Youth, and Families which is part of the Committee on Education and the Workforce. This Committee is responsible for considering most legislation that affects school drug testing programs.

At a hearing on August 3, 1999, General Barry R. McCaffrey, Director, Office of National Drug Control Policy, testified about the importance of building "more effective Safe and Drug Free Schools and Communities Programs." He spoke about the importance of school-based prevention programs and the need for more schools to adopt them.

In addition to McCaffrey's testimony, five panelists responsible for implementing drug free school programs also testified in support of increased congressional activity and funding for such programs. In fact, Ms. Alyse Booth, Director of Communications, National Center on Addiction and Substance Abuse (CASA) in New York, NY testified that "At schools, teens, teachers and principles believe by whopping majorities that locker searches, drug testing of all students, a police presence and a zero tolerance policy are effective anti-drug measures."
This committee may also consider two bills that have been introduced in the House that create grant programs to fund school drug testing programs.
The first bill, Empowering Parents to Fight Drugs Act of 1999 (HR 1735), is sponsored by Congressman John Peterson (R-PA). This legislation will provide federal matching grants for local school districts to implement random drug testing for students enrolled in grades 7-12. Parents may exclude their children from the random testing program. Each local education agency would have contracting authority with outside sources for implementing drug testing to get rid of this.
The second bill, Parental Consent Drug Testing and Counseling Act (HR 1642) sponsored by Congressman James Rogan (R-CA), would establish a random drug testing program for high school students. This bill differs from Peterson's bill because the program only tests students at the parents' request. Another difference is that Rogan's bill provides $500 to implement the program and does not require matching state grants.

As part of DATIA's testimony to the House of Representatives, they reiterated their support of a good drug testing model for school districts across the country. DATIA will actively work with Congress to positively promote this issue in the House and the Senate.

SBA Grants Still Under Consideration

The Small Business Administration (SBA) is still in the process of reviewing applications for the Drug Free Workplace Grants. According to the SBA, 160 applications were received and they expect to announce the grant recipients in early September. Last year

DATIA worked with Congress to make approximately $3 million dollars in grants available to third party administrators to provide financial and technical assistance to small businesses seeking to establish drug-free workplace programs. The program includes outreach to the small business community and provides additional voluntary education for parents. Drug testing is also a component of the demonstration program.

The SBA has said that they will make up to 30 grants available for approximately $100,000 each, however, the most recent estimate by SBA is that fewer grants will be allocated at higher amounts. They said that most of the applicants submitted proposals in excess of $100,000 for the drug free workplace programs.

DATIA has been told that many of the 160 applicants are DATIA members. As soon as the recipients are announced, DATIA will make that information available. If these programs are successful, Congress may consider additional funding.

DATIA Urges DOT to Seek Assistance with SAP Certification Approval

DATIA recently issued comments to the Department of Transportation in support of their proposal to move their certification approval process for Substance Abuse Professionals (SAP) to the National Commission for Certifying Agencies (NCCA).

Currently, in order to be an approved SAP under the DOT drug and alcohol rules, an individual must be a licensed physician or approved by a DOT approved certification program. DOT has said that they do not have the time or the resources to review all the certification program applicants who want to be included under the DOT rule and have proposed NCCA involvement in the approval process.

The NCCA would review all SAP certification program policies and procedures that want to be included in the DOT's drug and alcohol regulations. DOT would continue to review the content of the program. DATIA believes that the NCCA is uniquely qualified to assist the DOT in approving SAP certification programs for inclusion in DOT's drug and alcohol testing and treatment regulations.

DATIA believes that national standards for SAP certification programs are critical and that since the DOT does not have the time or the resources to "effectively and efficiently examine more than one petitioning organization at a time" that NCCA should be utilized to provide a set of national SAP certification standards. This national approval process will assist employers to identify SAPs who have the experience and training necessary to implement the objectives of DOT's rule. DOT will still have to be involved in the certification approval as they have the necessary content knowledge about what the SAP certification should include.

DATIA also suggests that DOT considers requiring NCCA approval for C/TPAs, MROs and collection site certification programs so that there are uniform national standards developed to evaluate these programs as well. By requiring NCCA approval of these programs, DOT will ensure that there will be national standards for ensuring the quality of these programs.

One principal distinction between DATIA and any other drug and alcohol testing industry group is that we spend much of our time and resources to provide the industry active involvement with federal policymakers and Congress. I believe that this lobbying activity is crucial to the industry's growth and survival. Legislators created the Consortium/TPA industry, so they could also end it with a misguided law or rulemaking. It is therefore imperative that we make it our agenda to have our industry's voice heard by those in government who make the decisions.

In fact, providing the drug testing industry an active voice in Washington with Congress, agencies, and the executive branch was the single most important void that this organization was formed to fill back in September 1995. Then, in September 1998, when we found that other segments of our membership including Consortiums and laboratories were not represented with an effective lobbying voice here in Washington, the organization changed its name to DATIA from NACS and expanded our agenda further.

As the founder of a consortium myself, I found the lack of lobbying clout by the drug and alcohol testing industry before 1995, very surprising given the realities in Washington. The alcohol industry, transportation unions, ACLU, truckers groups, drug legalization advocates, and many others all have major lobby groups that oppose many or most elements of drug and alcohol testing, and certainly don't want our member's businesses to be expanded.

DATIA attends and monitors Congressional hearings on drug testing issues, meets regularly with executive branch officials, and pursues a legislative and regulatory agenda on issues impacting the industry and our 1,000 members.

The emphasis that DATIA places on its lobbying activity is due to the recognition of the fact that Congress created most drug testing industry providers by a law in 1986 and subsequent regulations, including the DOT and DHHS rules. Congress has created many industries such as ours, but has also put many others out of businesses, or severely hampered their operations.

At DATIA, we have worked closely with Congress to pass legislation, most recently the drug free workplace bill, and have impacted federal rulemakings on drug and alcohol testing regulations. Review of the past six rulemakings of federal agencies on drug and alcohol testing rules reveals that DATIA provided written input in the docket in all six, and that our input was reflected in the final rules. That means our members' voice is being put on the record at every opportunity, and they are having an impact outside of just DOT.

To guide DATIA's lobbying activity, we have a comprehensive legislative and regulatory agenda (http://www.datia.org/legislative/legis_agenda.htm). Right now there are major items on this agenda that will have a major impact on the growing drug and alcohol testing industry. As you can see from reading the front page of this newsletter there is a crucial issue now before us: we are seeking to ensure that re-written Department of Transportation rules do not interfere with the role of 'agent of the employer' for consortiums/TPAs and expand the laws to better allow drug testing in small businesses and schools. In my opinion, this issue of the consortium's role is actually the most crucial issue now facing the industry.

We report on our lobbying progress, and the latest legislative and regulatory developments from Washington in our bimonthly newsletter, legislative alerts, and the monthly President's message. Members can run their businesses more effectively knowing that DATIA is diligently watching out for their interests in Washington with the people who make laws and regulations. And we are unique in doing this for you.

DATIA is proud to welcome Ms. Diane Schwimmer, Executive Vice President of Doctors Review Service, Inc, as one of DATIA's newest Sustaining Members. Ms. Schwimmer states that she decided to join DATIA since she saw that we were the industry association working for the benefit of the industry with strength behind it.

Founded in 1986, Doctors Review Service, Inc., provides over 18,000 clients with comprehensive drug and alcohol testing services, including the New York Taxi and Limousine Commission, who themselves account for over 100,000 tests a year.

In addition to full medical review services, Doctors Review Service also provides clients with the full gamut of services including policy development, training management, collection site management, and in-house collectors for their local area. As far as services are concerned, Ms. Schwimmer tells her clients, "If you need it, we do it!" As a testament to her company's dedication to providing exceptional services to its clients, Doctors Review Service employs in-house MROs, as well as 7 MROs located across the country to provide clients in different time zones with MROs available when they need them.

DATIA asked Ms. Schwimmer how she saw the potential Consortium/TPA issue (see page 1) affecting MROs and her thoughts represent those of the industry's majority. As she sees it, it is the

Consortiums and the companies whose drug and alcohol testing programs they are administering and managing that will suffer should the DOT define that consortiums cannot act as the agent of the employer. Ms. Schwimmer feels, however, that the DOT will not take this position thus eliminating the industry that it created in 1988. She feels it would be impractical to get results to the companies in a timely and effective manner by eliminating the provider who administers and manages the drug and alcohol testing programs. Most MROs simply do not have time or resources to get results to each and every employer.

Ms. Schwimmer feels that the industry needs to work as a team to keep the industry alive and growing by fighting to keep the regulations. She sees that the industry's goals today need to be focused on preventing the dissolution of regulations and encouraging professionalism. While she sees the professionalism of the industry increasing, she also feels that, as with any industry, there will never be 100% of the industry's professionals performing at the same level of professionalism.

DATIA is exceptionally glad to have active members such as Doctors Review Service involved in the association. Although, she only joined recently, Ms. Schwimmer will be serving as a member of DATIA's Government Relations Committee.