DATIA's major recommendations to improve the Federal Drug Testing Custody and Control Form (CCF) have been incorporated into a proposed revision of the CCF. A new CCF is scheduled to replace the form currently in use by July 31, 2000. The proposed changes to the CCF were made in a U.S. Dept. of Health & Human Services (HHS) Substance Abuse and Mental Health Administration (SAMHSA) Notice of Proposed Revision (NPR) published in the November 15, 1999 Federal Register. The NPR incorporates changes based on the HHS and Dept. of Transportation (DOT) experiences during the past several years, as well as many of the recommendations developed by industry representatives, lead by DATIA, at two working group meetings held earlier this year.

The NPR generally recommends the following changes to the current CCF:

*Make the new CCF a six-part form by eliminating the split specimen copy (currently Copy 3). When a split specimen is tested, the NPR requires the primary laboratory to make a photocopy of Copy 1 of the CCF and send it, along with the split specimen, to the secondary laboratory. Eliminating the split specimen copy will save on printing costs, as well as make the information on later pages of the form easier to read.

*Locate the specimen bottle seal(s)/label(s) on the bottom of Copy 1, rather than attaching them to the right side of the form. This eliminates the need for special and expensive wide carriage printers and will standardize the storage and handling requirements to match those of other documents. In addition, the number of printers supplying this form could increase, thereby driving the costs to the user down.

*Simplify the chain of custody step by requiring the collector to only sign the form once. The new certification statement signed by the collector clearly describes that the collector has possessed the specimen from the time it was received from the donor until the collector released it for shipment to the lab.

* Provide additional choices for the lab to report specimen test results that accurately reflect the handling and reporting of a specimen test results, such as "Invalid Result", "Adulterated", "Substituted", or "Rejected for Testing".

* Include a new step on Copy 1 allowing the secondary lab to document a result for the split specimen (Bottle B). This will ensure that the primary and split specimen lab test results are recorded on the same copy that is provided to the MRO if the split specimen is tested.

* Place the MRO steps for the primary and split specimens on Copy 2, thereby allowing the MRO to record the determination for both the primary and split specimen (if tested) on the same copy (Copy 2).

Other changes to the CCF detailed in the NPR, by Copy and Step, include:

* Highlighting data entry/information fields where the collector and donor will provide information and use combs/boxes for the donor's SSN.

* Adding a 1" space on Copy 1 reserved for the form title, name and street address of the receiving and testing lab, specimen identification number, accession number, accounting information, etc.

There is no restriction to the allowable font size for this section.

* Step 1 remains the same, except the collection site information has been moved from Step 5 on the current form to Step 1 on the proposed form. · Step 2 now requires the collector to indicate if it is a single or split

specimen collection, if no specimen was collected (and why), or if it was an observed collection.

* Step 3 remains essentially the same. * Step 4 is a completely revised chain of custody step initiated by the collector and completed by the lab after the specimen is accessioned by the lab.

* Step 5(a) has been expanded upon to more easily report on a specimen for which there may have been an invalid test result, the specimen was adulterated or substituted, or rejected for testing. An additional box has been included for 6-acetylmorphine. Step 5(b) has been added for reporting the split specimen result if the split specimen is tested. This provides the secondary lab a line to indicate the lab name and address, a certification statement, and space for the secondary lab's certifying scientist to sign and date the form.

* As mentioned previously, the bottom of Copy 1 is reserved for the tamper evident bottle label(s)/seal(s). The NPR requires two labels to accommodate collecting split specimens and each must have the same preprinted specimen identification number appearing at the top of the CCF. Each label will also have a place for the collector to note the date of the collection and a place for the donor to initial each label after it is placed on the specimen bottle. If a single specimen is collected, the second label is discarded.

* Copy 2 is similar to Copy 1, except that Step 5(b) and the space where the labels are located has been replaced with Step 6, the MRO step used to make a determination on the split specimen. Step 6 now allows the MRO to record a "Refusal to Test" when the primary specimen is "Adulterated" or "Substituted". Step 7 is used to record the determination for a split specimen if tested.

* Copy 3 resembles Copy 2 except Step 5(a) has been replaced with Step 5. Step 5 is completed by the donor after the specimen bottle(s) are sealed, initialed and dated. The donor is required to read the certification statement, sign it, print their name, date of collection, daytime and evening phone numbers, and date of birth. Also, Copy 3 will now contain a 1/4" pink border rather than being a pink sheet of paper, to permit easy photocopying, if needed.

* Copies 4, 5 and 6 are identical to Copy 3, except Copy 4 will have a yellow border, Copy 5 a green border, and Copy 6 a blue border.

* The back of Copies 1-5 contain the Paperwork Reduction Act Notice (as required by 5 CFR 1320.21); the back of Copy 6 contains Instructions for Completing the Federal Drug Testing Custody and Control Form.

Mockups of the proposed new forms can be found on pages x-x of the newsletter. To view and/or download a complete copy of the NPR, including the forms, please visit the DATIA website at www.datia.org

The NPR is requesting written comments on the proposed drafts be submitted by January 14, 2000. Comments should be submitted to: Robert L. Stephenson II, M.P.H., Director (Acting), Division of Workplace Programs, CSAP, 5600 Fishers Lane, Rockwall II, Suite 815, Rockville, MD 20857.

DATIA will respond as the industry voice to compliment SAMHSA for incorporating many of DATIA's changes. DATIA will reemphasize its recommendation to make the revised CCF a universal form by including two check boxes at the top of the form to indicate a "Federal" or "Non-Federal Test". To provide support for DATIA's recommendation to make this a universal form, we are asking our members to also request this in their written comments, along with anecdotal evidence on the benefits to be derived from converting the CCF to a universal drug testing form. As always, we would appreciate your sending DATIA a copy of the written comments that you submit.

Government employers (Collectors, Labs and TPAs) must be careful not to violate an employee's freedom from unreasonable searches under the Fourth Amendment to the U.S. Constitution. That issue was raised recently by the Fifth Circuit Court of Appeals in United Teachers v. Orleans Parish School Board, 142 F.3d 853 (5th Cir 1998). Relying upon various Supreme Court, the court held that the school board could not require all teachers who were injured in the course of their employment to submit to a post-accident urine specimen, but required finding a special need for testing. The court questioned the board's right to test all employees injured on the job without regard to circumstances. The teachers were not classified as "safety-sensitive" employees. In the final analysis, the court found "an insufficient nexus between suffering an injury at work and drug impairment" and that to justify testing, the school board needed to show "individualized suspicion" of wrongdoing.

The Fourth Amendment "extends to all government searches, including those conducted by the government while acting as an employer." This restraint requires that the government have either "individualized suspicion" or a "special government need" which outweighs the employee's interest in privacy. Urinalysis, blood tests, and breath tests &emdash; both the collection and the testing of the sample &emdash; are "searches" within the meaning of the Fourth Amendment. Skinner v. Railway Labor Executives Ass'n, 489 U.S. 602, 616-18 (1989). The Fourth Amendment does not generally apply to drug testing conducted in the private sector where there is no "state action."

SPECIAL RULES FOR THE GOVERNMENTAL SAFETY-SENSITIVE EMPLOYEE

However, courts have upheld random and post-accident drug testing of employees who are "safety-sensitive." The rationale is that the government has a substantial interest in preventing drug users from obtaining a safety-sensitive position and in detecting those in such positions who use drugs. Consequently, it is essential for a governmental employer to prepare a list of all positions that are considered "safety-sensitive" and make such list an integral part of the Drug Free Workplace Policy. Safety-sensitive employees are

employees who "discharge duties fraught with risks of injury to others that even a momentary lapse of attention can have disastrous consequences." Skinner, 489 U.S. at 628. Many court cases provide helpful guidance classifying jobs as safety-sensitive. See National Treasury Employees Union v. Von Raab, 489 U.S. 656, 679 (1989); Ford v. Dowd, 930 F.2d 1286, 1290 (8th Cir. 1991). On October 4, 1999 the Supreme Court declined to review a Sixth Circuit Court of Appeals decision [Knox County Education Association v. Knox County Board of Education, 158 F.3d 361 (6th Cir. 1998) ] finding that public school teachers and administrators can be classified as "safety-sensitive." Consequently, the governmental entity should closely document the job duties and responsibilities that render the job "safety-sensitive." Having an outside safety consultant perform or review this analysis may be advisable in the event the classification is challenged. Such employees should be notified in the Drug Free Policy that their positions are considered safety-sensitive and that they will be tested after any accident in which they are involved. Post-accident drug testing and the non-safety-sensitive employee will be discussed in the next issue of "It's the Law." The best protection against a Fourth Amendment violation, and resulting litigation, is a well drafted Fourth Amendment compliant Drug Free Workplace policy with essential forms, notices, and consents.

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. 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.

SBA Awards Grants for Drug-Testing
Development

The Small Business Administration on September 27 awarded grant money to 16 eligible intermediaries to provide financial and technical assistance to small businesses seeking to establish drug-free workplace programs. The SBA awarded an additional 14 grants to small business development centers to provide information and assistance to small businesses relative to establishing drug-free workplace programs. The grants were made possible through an authorization in the Drug-Free Workplace Act, which appropriates $4 million to be used to assist smaller companies set up testing and other anti-drug efforts in the workplace.

The Drug-Free Workplace Act considers a drug-free workplace program to be one with a written policy, training in alcohol or drug prevention, drug testing, some type of an employee assistance program, and education on a continuing basis.

Grant recipients may use the money to financially assist small businesses through lower cost drug-testing or employee assistance programs. In addition, the funds can also be utilized to educate small businesses on the benefits of drug-free workplace programs and to encourage small businesses to establish those programs.

The 16 eligible intermediates awarded grants were: Arizonans for a Drug Free Workplace, Tucson, AZ; Bay Health Systems, Bay City, MI; Centura Health-Profile EAP, Colorado Springs, CO; Council on Alcoholism & Drug Abuse of Northwest Louisiana, Shreveport, LA; Drug-Free America Foundation, St. Petersburg, FL; Drugs Don't Work, Hartford, CT; Drugs Don't Work in Arizona, Phoenix, AZ; Florida Drug Screening, Inc., Palm Bay, FL; Lowell Medical Center-Unity Health of Arkansas, Lowell, AR; National Safety Alliance, Nashville, TN; Occupational Safety Systems, Inc., Corpus Christi, TX; Presbyterian EAP, Charlotte, NC; River Region Human Services, Jacksonville, FL; Straub Clinic & Hospital, Honolulu, HI; Team Fort Collins, Fort Collins, CO; The Walsh Group, Bethesda, MD.

The 14 small business development centers awarded grants were: Arkansas SBDC; Arizona SBDC; Georgia SBDC; Illinois SBDC; Maryland SBDC; Michigan SBDC; North Texas SBDC; Puerto Rico SBDC; Rhode Island SBDC; South Dakota SBDC; South Texas SBDC; West Virginia SBDC, and the Wisconsin SBDC.

For more detailed contact information on the grant recipients, please visit the DATIA website at http://www.datia.org.

Electronic Signatures Bill Passes in House

An important DATIA initiative, which would permit the use of electronic signatures on chain of custody forms, moved closer to reality recently. The House of Representatives passed, on a vote of 356-66, H.R. 1714, the Electronic Signatures in Global and National Commerce Act. The legislation, introduced in May by Rep. Tom Bliley (R-VA), requires that electronic signatures be given the same legal validity as written signatures. The bill also effectively supersedes existing state laws that require written contracts, and invalidates future state laws that do not give equal recognition to electronic signatures. H.R. 1714 exempts state laws or regulations governing health and safety protections and continues to require paper copies for transactions dealing with those issues. The bill also includes "opt-in" language that would require consumers to consent to do their business electronically, rather than on paper.

A New Democrat amendment, offered by Jay Inslee (D-WA), enhances the "opt-in" language requiring it to be "conspicuous and visually separate" from other terms of the transaction in order to be binding. The amendment also requires that consumers be able to review, save and print electronic records and would specifically state that the bill does not change substantive provisions of federal and state consumer protection laws.

The codification of the legitimacy of electronic signatures is an important first step toward DATIA's goal of permitting the use of e-signatures on federal and non-federal chain of custody forms. However, DATIA still has its work cut out for it convincing federal agencies and others to accept the optional use of

electronic forms and, thus, electronic signatures. As this issue continues to evolve, DATIA will keep you updated on its progress.

NMCSA Legislation Could Change Way MROs & C/TPAs Report Driver Test Results

Legislation to Form National Motor Carrier Safety Administration Could Change the Way MROs and C/TPAs Report Positive Driver Test Results

Legislation (H.R. 2679), sponsored by Rep. Bud Shuster (R-PA) establishing the National Motor Carrier Safety Administration within the U.S. Dept. of Transportation, improving the safety of commercial motor vehicle operators and carriers, and strengthen commercial driver's licenses, recently passed the House of Representatives. Currently, it is pending in the Senate Committee on Commerce, Science and Transportation. Section 219 of the legislation is of particular interest to medical review officers and C/TPAs.

Section 219 requires the Secretary of Transportation to complete, within 2 years of the bill's passage, a study on the necessity of requiring medical review officers to report all verified positive controlled substances test results on any driver required to be tested under 49 CFR 382 to the state which issued the driver's commercial drivers license. Reporting requirements include the identity of each person tested and each controlled substance found. The section also requires all perspective employers, prior to hiring any driver, contact the state that issued the driver's CDL to determine if the driver has any verified positive controlled substance tests results on record.

In conducting this study, DOT will take under consideration the methods for safeguarding the confidentiality of verified positive controlled substance test results, along with the costs, benefits and safety impacts of requiring states to maintain the records of positive test results. In addition, the study will examine whether there should be a process that would allow drivers to correct errors in their records, and eliminate positive test result information from their records within a certain period of time.

As of this writing, the Senate Commerce Committee hasn't scheduled action on the bill. DATIA will continue to follow the legislation, and keep you informed of its progress.

Supreme Court Lets Stand Teacher Drug Test

The U.S. Supreme Court last month declined to consider a challenge to the Knox County, LA, teacher drug testing requirement. The Sixth U.S. Circuit Court of Appeals previously upheld the Knox County Board of Education's policy of pre-employment, pre-promotion and for-cause drug testing of teachers, finding that teachers, principals and other positions identified for drug testing are safety-sensitive employees as defined by the U.S. Supreme Court in Skinner vs. Railway Labor Executives. Safety sensitive employees are workers who "discharge duties fraught with risks of injury to others that even a momentary lapse of attention can have disastrous consequences." The Sixth Circuit ruled in Knox County Education Association vs. Knox County Board of Education that while a school teacher may not seem to fit the profile of a safety sensitive employee, there is a strong desire to keep school personnel drug free "so that they can satisfy their statutory obligation to insure the safety and welfare of the children."

The challenge by the Knox County Education Association revolved around reasonable suspicion testing and questioned, along with other issues, the constitutionality of the policy, as it requires testing for drugs that are not included in the federal government's drug testing program. The federal government tests for five illicit drugs; the Knox County testing program tests for 18.

While there is no concrete evidence that drug abuse is a problem for the teachers of Knox County, LA, the court determined that this issue alone does not mean suspicionless testing is unconstitutional. In making their decision, the Sixth Circuit noted that the testing program is warranted by the role that teachers play in the lives of their students.

Standard Operating Procedures for On-Site Testing

When performing traditional specimen collections, there are clear-cut policies and procedures that must be adhered to. No matter where or when the collection is performed, collectors understand that these procedures are a must. In these instances, however, the collector is not involved in the actual testing process. Once this process is added to the collector's responsibilities many new factors arise along with many questions.

For this reason, the National On-Site Testing Association (NOTA) has initiated the development of Standard Operating Procedures for performing on-site tests. As DATIA has been instrumental in educating and training collectors on the procedures for traditional specimen collections, NOTA has elicited DATIA's assistance in developing these procedures to ensure that standards are met.

Although on-site testing is not included in mandated testing regulations, on-site tests are of great benefit to many employers. As the Drug Testing Advisory Board (DTAB) studies the use of on-site tests, the possibility exists hat this form of testing may be included in regulated testing once the industry has shown that it is an accurate and viable form of drug testing.

Many concerns of the industry are specifically addressed in the draft form of the on-site testing standard operating procedures. Some items addressed include:

What if the on-site test produces a positive result? A positive result from an on-site test should not be considered a true positive until a laboratory using GC/MS testing has confirmed the specimen.

How can I be sure that the test worked correctly? Each FDA approved on-site test has its own built in quality control device, and on-site test technicians are to be trained by the manufacturer of the test device on how to determine if the test worked correctly. In addition, when the collector receives a new lot of devices, both a positive and negative test should be performed to ensure that the new lot of devices work properly. These two levels of quality control will ensure that the testing devices are working as they are intended.

What about donor confrontation when receiving test results? Testing should not be performed in front of the donor. Rather, there should be separate area for testing away from the collection and paperwork area. The employer, as in traditional testing, should report test results to the donor.

This represents only a small portion of the issues addressed in the draft Standard Operating Procedures. DATIA is excited about the interest from the industry in establishing these guidelines and welcomes your comments or suggestions. If there is a particular question or area of concern that you would like to see addressed, please forward it to DATIA at www.datia.org.

DATIA's 4th Annual Conference will be the drug and alcohol testing industry's premier event of the year, providing attendees insight, information, and advocacy on issues that impact providers of drug and alcohol testing services. Foremost among these issues are important legislative and regulatory policies that promise change for the drug and alcohol testing industry, both on the state and federal levels. The effects of new technologies and testing methodologies are part of this pending change, and will also be part of the conference agenda.

Top level speakers from Federal Agencies, Congress and industry will address the conference and interact with attendees to discuss the impact of proposed changes in drug and alcohol testing policy. Session topics include the Top Ten Tips for Influencing Your Local, State, and Federal Legislation, Advances in Donor Practices and Techniques for Specimen Adulteration, Preparing Your Company for an Audit, and Evaluating Current Alternative Specimen Technologies. As DATIA's Keynote address, the Office of National Drug Control Policy has been invited to speak on Testing as a Key Component of a Drug Free Workplace.

The DATIA conference will also provide the opportunity for individuals to take a pro-active involvement with pending state and federal legislative and regulatory issues. DATIA's unique and needed role as the lobbyist and advocate for the industry ensures that the conference will be the first of its type with an agenda that promotes action.

This conference will provide attendees with comprehensive information on the technological advancements being made within the industry and what they mean for both providers and end-users of drug and alcohol testing.

As a drug and alcohol-testing provider, this is the one conference that can't be missed. Don't let this opportunity to meet with key legislative and regulatory officials, industry experts, and leaders in the advancement of drug and alcohol testing pass you by. We're positive that every attendee of DATIA's 4th Annual Conference will have a monumental experience while at the conference and take with them concrete information that can immediately be applied to their specific operation. We look forward to seeing you in Washington, DC! Look for your conference brochure in the mail, or visit DATIA's website at www.datia.org.