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 the first major overhaul of the guidelines since their creation in 1988.

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

a) Executive Agencies as defined in 5 USC 105;

b) The uniformed services as defined in 5 USC 2101 (3) (but excluding the Armed Forces as defined in 5 USC 2101 (2)

c) 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

d) 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.

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 recommends that its members review these areas and provide comment to the Substance Abuse and Mental Health Services Administration by their July 12, 2000 deadline. DATIA will work with its members to provide comprehensive comments on the document. These comments will be reviewed and will have an impact on future drafts of the guidelines.

Outlined below are those items that, upon initial review, DATIA sees as the most significant changes of the draft guidelines.

1. Change in Drugs to be Tested for and Cut-off Levels for Drugs Currently Tested
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.

2. Requirement for Collector Certification
The draft guidelines propose that collectors involved in collecting specimens for federal drug free workplace programs be certified in specimen collection and re-certify 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.

3. HHS Certified Point of Collection Test (POTC) Facility
The rapid response screen tests that have been widely referred to as "on site tests", have been named "Point of Collection tests" 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 POTC 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.

4. MRO and Point of Collection Test Provider Relationship
Under the draft guidelines, an MRO cannot be employed by, be an agent of, or 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.

5. Daily Quality Control on Point of Collection Test Devices
The guidelines 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 practice of performing quality control on each new lot of POCTs.

6. Evaluating the Need for Summary Report from Laboratory to Employer
The guidelines include requirements for the submission of summary reports from the laboratory to the employer, 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".

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