Recently, the Drug and Alcohol Testing Industry Association (DATIA) submitted comments to the Food and Drug Administration (FDA) on their draft guidance “Over the Counter Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications.” DATIA's comments on behalf of its constituency were based on member input, including a survey of the membership.

The main concern that DATIA has with the draft guidance is that it equates workplace testing with home testing. DATIA members overwhelmingly indicated that workplace drugs of abuse screening tests should not be subject to FDA over-the-counter approval. Experienced and trained specimen collectors/testers conduct workplace drugs of abuse screening tests, not an amateur or layperson as in home testing.

The Department of Health and Human Services (HHS), Department of Transportation (DOT), and an increasing number of state laws specifically address who can perform a drug test specimen collection and/or on-site drugs of abuse test. Although not licensed medical personnel, the persons performing these tests are required to have been trained and will soon be required to be certified.

In addition to the distinction between who performs workplace on-site drugs of abuse screening tests, the proposed over-the-counter guidance would significantly hamper scientific and technological advancements in on-site testing. Since any change in the product, drugs tested for, or cutoff levels would result in a new product that would need to go through the over-the-counter approval process, this would slow down the introduction of new and more reliable tests into the market.

FDA over-the-counter approval costs significantly more and takes much longer than the current premarket clearance that the tests must currently go through. It is for these reasons that only a handful of manufacturers have attempted to get over-the-counter clearance for home drugs of abuse screening tests. To apply these over-the-counter guidelines to workplace drug testing would possibly result in only a handful of manufacturers attempting to complete the approval process – a significant step back for the industry.

DATIA members have stated that they feel the entire draft guidance should not apply to workplace drug testing. However, one specific requirement contained in

the draft guidance causes concern. DATIA members indicated that they oppose the requirement for all workplace drugs of abuse urine screening tests to include the fee for a laboratory confirmation test whether or not the confirmation test is performed.

The FDA’s reason for this requirement appears to be to ensure that all non-negative results are sent for laboratory confirmation, but the inclusion of the laboratory testing fee into all screening tests does not offer this assurance. This requirement will most likely have the opposite effect of lowering the amount of drugs of abuse screening tests performed since the barrier to entry will be high. Many employers request that their drug testing program use these quick response tests for their ability to provide a near immediate negative result. This saves the employer time and money. For the FDA to require a fee for confirmation testing on all drugs of abuse screening tests would be the same as the DOT requiring that all laboratory drug testing fees also include a fee for testing of the split specimen.

The majority of DATIA members who completed the survey on this issue indicated that the fee for confirmation testing should not be included in the fee for on-site drugs of abuse screening tests, but rather the confirmation fee should be paid only when a confirmation test is required and performed.

It is current practice, and included in the HHS draft “Mandatory Guidelines for Federal Workplace Drug Testing Programs,” that all non-negative results are sent to a laboratory for confirmation testing. In addition, states and employers commonly base their drug free workplace programs on the HHS guidelines thereby ensuring that the majority of drug free workplace policies incorporating point of collection screening tests will include protocols for sending non-negative results for confirmation testing.

The majority of DATIA members do not see how the draft guidelines will result in more accurate and reliable drugs of abuse screening tests. In addition, important questions have been raised by DATIA members as to the jurisdiction of the FDA in issuing the draft guidelines for over-the-counter clearance of workplace drugs of abuse screening tests. DATIA encouraged the FDA and the Executive Branch to seriously look at the above issues. DATIA will follow this issue closely and keep its members up to date on the proposed regulation status.

Regarding the new 49 CFR Part 40 collector training requirements, the Drug and Alcohol Testing Industry Association (DATIA) wants to answer your Frequently Asked Questions (FAQs) on the New DOT Regulations and their impact on urine specimen collectors.

When do the specimen collector training requirements go into effect?

The new CFR 49 Part 40 regulations concerning collector training go into effect August 1, 2001. Persons who have been performing collections prior to August 1, 2001 will need to meet the qualification training and proficiency demonstration requirements by January 31, 2003.

If a collector has met the qualification training and proficiency demonstration requirements prior to August 1, 2001, he/she does not need to meet the requirements again after August 1, 2001. Persons who become a collector on or after August 1, 2001 will need to meet the qualification training and proficiency demonstration requirements before performing specimen collections.

What are the qualification training and proficiency demonstration requirements for specimen collectors?

Qualification training must include instruction on (1) all steps necessary to complete a collection correctly and the proper completion and transmission of the Custody and Control Form (CCF); (2) problem collections such as shy bladder and attempts to adulterate a specimen; (3) fatal flaws, correctable flaws, and how to correct problems in collections; and (4) the collector’s responsibility for maintaining the integrity of the collection process, ensuring the privacy of employees being tested, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate.

Proficiency demonstration consists of completing five consecutive error-free mock collections. The five mock collections must include two uneventful collection scenarios, one insufficient quantity of specimen scenario, one temperature out of range scenario, and one scenario where the donor refuses to sign the CCF and initial the specimen bottle tamper evident seal. These mock collections must be monitored and evaluated by a person that meets the DOT requirements to do so (see #3). This person must attest in writing that the mock collections were error-free.
What qualifications must a collector meet to be able to monitor and evaluate a collector’s proficiency demonstration?

This person must have demonstrated the necessary knowledge, skills, and abilities by (1) regularly conducting DOT drug test collections for a period of at least one year; (2) conducting collector training under part 40 for at least one year; or (3) successfully completing a “train the trainer” course.

What should you look for in a training course?

Nationally Recognized Certification. The DATIA collector training program has been in existence since 1997. Since its transition to a formal certification program in June of 1999, the program has certified over 1500 collectors. These certified collectors receive and are able to use the professional designation of either CPCT™ (Certified Professional Collector Trainer™) or CPC™ (Certified Professional Collector). DATIA’s program is currently the only collector certification program offering National Recognition. In addition, although not in the DOT requirements, the Department of Health and Human Services (HHS) is in the process of preparing requirements for collector certification as part of their Mandatory Guidelines for Federal Drug Testing Programs.

Small Class Size. Specimen collections, although they appear simple, can be very complex. A small class size allows attendees to receive special attention from the instructor during class. This attention ensures that attendees do not leave the course with outstanding questions or misinterpretations of the information. DATIA has limited its course size to 25 persons to ensure that all attendees have the opportunity to have questions answered and information clarified.

Experienced Instructors. The information taught in a course can only be as good as the person presenting the material. Be sure that the instructor has enough experience to answer questions on even very obscure collection scenarios. A person experienced not only in performing collections, but also in presenting a training course will be better equipped to present the material in a way that allows attendees to get the most out of the course. Sherri Vogler and John Corpus have been presenting DATIA’s collector training programs since 1998 and continue to receive near perfect ratings for their effective delivery, ability to answer questions, and ability to clarify even the most difficult information.

Thorough Coverage of all Information. Be sure that the course allows ample time to thoroughly cover all aspects of the collection process and to pay particular attention to problem collection scenarios such as shy bladder and specimen adulteration. Adequate time should also be allotted for question and answer periods. These are often the most enlightening segments of the course as everyone can learn from the experiences of others. DATIA’s course is offered only as a full day course providing 7 hours of intense instruction and question and answer periods.

Comprehensive Course Development. A good training course is developed by those with extensive experience with the information being taught. By knowing first hand what skills tend to cause the most difficulties for collectors, a course can be developed to overcome these difficulties and ensure that proficiency is attained in all areas of specimen collections. DATIA’s course is the only peer developed and industry reviewed course currently available. A committee of industry professionals spent over a year preparing the agenda and materials for the DATIA collector training program. This program was reviewed multiple times by DATIA’s committee and finally reviewed by the DOT for accuracy.

Follow-up Materials. A good training course doesn’t end when the attendee walks out of the door at 5:00 pm. Be sure that you receive reference materials to refer to when questions arise and/or information on how to contact your instructor for questions. In addition, be sure that you can be easily updated on changes to the information that you were taught. Good training occurs daily.

DATIA provides its attendees with a comprehensive manual on the collection procedures and problem scenarios along with copies of the regulations concerning specimen collections. Through the DATIA website, emails, and letters, DATIA alerts its CPCTs™ to changes in specimen collection procedures and standards. Most recently, DATIA alerted its CPCTs™ to new information concerning the new 5-part CCF and how to correctly complete the form.

DATIA will be offering its training courses regionally across the nation, review information on our 2001 courses at www.datia.org. Additional courses for 2002 will be announced during the summer of 2001. Make plans now to attend a course in your area….remember you do not need to rush to attend the first course offered.

Drug and alcohol testing professionals looking for a convenient and informative way to get answers to their most pressing questions, can now look to DATIA’s website. In addition to the wealth of information on the pages, DATIA has just launched its Industry Forum.

With the many new industry regulations, the forum could not have been launched at a better time. Visitors to the forum will have the opportunity to join discussions on the new Part 40 regulations, Medical Review Officer functions, specimen collections, alcohol testing, and much more. The forum’s easy to navigate appearance makes it simple for visitors to get answers to their

questions and learn about what others in the industry are concerned about. Advanced functions of the forum allow registered users to search the forum for keywords, and to have answers to their questions emailed directly to them. This allows users to get the answer to their question without having to check back each day to see if anyone has replied to their question.

DATIA is confident that its members will find substantial benefit in the forum and we encourage all members to register and start using the forum today (http://www.datia.org/forum). If you have any questions on the forum, please contact DATIA at info@datia.org.

On December 1, 2000, Wienhoff and Associates, Inc. of Boise, ID, become the first company to meet the requirements of the Nationally Accredited for Administration of Drug and Alcohol Testing Programs (NAADATP) program, and on January 5, 2001 C.J. Cooper and Associates, Inc. of Marion, IA joined the NAADATP ranks. Ms. Colleen Wienhoff and Ms. C.J. Copper are to be commended for their dedication and commitment to meeting the program’s standards.

To receive such recognition, a principal of the company must first attend the Drug and Alcohol Testing Program Management Training Course. That person is then qualified to take the NAADATP exam, and submit the NAADAPT application. Both the application and the exam, require the applicant to demonstrate that their company’s policies and procedures adhere to strict standards for drug and alcohol testing program management. The standards of the program were based on items contained in the Department of Transportation’s Drug and Alcohol Testing Regulations, and formulated by industry experts with years of trial and error experience in the areas not covered by the regulations.

Such company standards include ensuring that pre-employment test requirements are met before adding an employee to the random pool, using secure means to notify employees of random tests, using secure means to identify the designated employer representative (DER) before delivering confidential information over the phone, and using secure means to transmit confidential information between the DER and the program manager.

The NAADATP program was first announced in September of 2000. Since that date, over 100 program managers have attended the Drug and Alcohol Testing Program Management Training Course. Of these, two have received NAADATP status and there are currently 13 companies with NAADATP applications pending.

Most attendees of the course leave with an abundance of new information, and a list of policies and procedures that they need to implement in order to meet the program’s standards. Attendees have indicated that the course and standards program will be a great benefit to the business. Not only does the company receive industry recognition for their efforts, but NAADATP status is also a great marketing tool when bidding for new business. For complete program information, visit DATIA’s website at www.datia.org and click on the NAADAPT logo.

DATIA is pleased to report that on January 12, 2001, at the DATIA Executive Committee meeting in Alexandria, VA, DATIA announced that it is now formally and legally incorporated.

The DATIA Executive Committee also discussed DATIA’s accomplishments, strategic plan, and regional conference for 2001. DATIA’s Chairman Dean Klassy, Vice Chairman Colleen Weinhoff, Secretary Theresa Nones, and Treasurer Karen Rapchick along with Executive Director Laura Norfolk were in attendance for the meeting. Other DATIA staff participating at the meeting included DATIA’s Membership Assistant Alicia Williams, Managing Director Jeffrey Smith, and DATIA’s Editor Erin Broekhuysen.

Among DATIA’s many successes in 2000 are: the new Nationally Accredited for Administration of Drug and Alcohol Testing Programs (NAADATP) Program; DATIA’s constantly improving Certified Professional Collector™(CPC™) and Certified Professional Collector Trainer (CPCT™) programs; the substantial impact DATIA had regarding changes to the new Chain of Custody Form and the New 49 CFR Part 40.

DATIA has approved its strategic plan for 2001. Some important aspects of the plan include strengthening regulatory and legislative advocacy and enhancing DATIA’s educational programs and seminars. DATIA also strives to produce the most informative DATIA conference ever this year for its 5th Annual Conference in May 2001.

The Drug and Alcohol Testing Industry Association (DATIA) would like to encourage its members to be more active in the Member Get A Member Campaign. DATIA will recognize sponsoring members in each issue of DATIA News and during the 2001 Annual Conference. Plus, for every company that you recruit for DATIA membership between now and April 27, 2001, your name will be entered into a drawing for valuable prizes. The more members you recruit, the greater your chances of winning prizes.

In addition, the DATIA member who recruits the most members will be awarded the Grand Prize of roundtrip airfare and conference registration to DATIA’s 2001 Annual Conference to be held May 31-June 2 in Phoenix, AZ!

Remember that your name must be listed on the new member’s application as the referring member in order for you to be eligible to receive recognition and awards. Good luck and start recruiting! For more information access www.datia.org.