Synopsis of Major Changes in SAMHSA Regulations Issued April 13, 2004

Federal Workplace Drug Testing Program; Proposed Mandatory Guidelines: Hair, sweat, oral fluid, and urine specimens testing; scientific and technical guidelines

Subpart A – proposes to add or revise several of the definitions

Subpart B –

Section 2.1 Proposes to expand the urine drug-testing program for Federal agencies to permit head hair, oral fluid, and sweat specimens.

Section 2.2 Proposes to allow head hair for pre-employment, random, return to duty, and follow-up testing; oral fluid for pre-employment, random, reasonable suspicion/cause, and post-accident testing; sweat for return to duty and follow-up testing; and urine for pre-employment, random, reasonable suspicion/cause, post-accident testing, return to duty, and follow-up testing.

Section 2.3 Proposes that a urine specimen must also be collected from a donor when an oral fluid specimen is collected. Proposes that when a problem occurs in the collection of one type of specimen, a second type of specimen can be collected after receiving permission from the Federal agency.

Section 2.4 Proposes that all specimens, regardless of specimen type, be collected as a split specimen.

Subpart C – Proposes to lower cutoff concentrations for cocaine and amphetamines. Proposes validity testing requirements for all types of specimens, as well as how and when to report the various types of specimens as adulterated, dilute, or invalid.

Subpart D – Proposes that collectors must be trained for each type of specimen they will collect. Proposes that collectors complete a training course by an established organization for each type of specimen they will collect and perform proficiency demonstrations for each type of specimen they will collect.

Subpart E – Proposes that head hair is the only type of hair to collect for a hair specimen, and that the back and upper arm are the only areas to place a sweat patch. Proposes privacy requirements for donors providing each type of specimen.

Subpart F – Proposes that there is a separate Federal CCF for each type of specimen.

Subpart G – Describes collection devices for each type of specimen.

Subpart H – Proposes collection procedures for each specimen type. Proposes that Federal agencies must conduct annual inspections of each collection site used to collect agency specimens.

Subpart I – Proposes major changes to HHS Certification of Laboratories and IITFs.

Subpart J – Proposes to decrease blind sample reduction. Proposes guidelines for submission of hair, sweat, and oral fluid blind specimens.

Subpart K – Proposes major changes to laboratory procedures including new policies when the Responsible Person leaves, requiring laboratories to be certified separately for each type of specimen that it wants to test for a Federal Agency, allowing the use of additional analytical procedures for confirmatory drug tests, and how to report test results for each type of specimen to an MRO.

Subpart L – Proposes guidelines for use of point-of-collection tests (POCT). Proposes that POCTs be FDA cleared, and approved by the Secretary and placed on a list of SAMHSA certified POCTs. Proposes how to have POCTs reviewed and placed on list of approved devices.

Subpart M - Proposes requirements for a new type of facility called an Instrumented Initial Test Facility (IIFT). An IIFT is essentially a laboratory that only conducts initial tests for drugs and validity tests; it is at a permanent location and uses instrumented initial tests.

Subpart N – Proposes requirement for MRO training, and requires MROs to complete an examination administered by a nationally recognized entity approved by the Secretary. Proposes requirements for MROs in reviewing alternative specimen results.

Subpart O – Proposes new split specimen guidelines including guidelines for hair, sweat, and oral fluid specimens.

Subpart P – Proposes guidelines for handling errors or discrepancies that arise with the use of the Federal CCF.

Subpart Q – Proposes to expand laboratory suspension/revocation guidelines to include IITFs.

Federal Workplace Drug Testing Program; Mandatory Guidelines: Urine specimen validity determination standards

1. Definitions

The proposed revisions added definitions specifically associated with specimen validity testing. These include the definitions for adulterated specimen, confirmatory validity test, dilute specimen, initial validity test, invalid result, non-negative specimen, oxidizing adulterant, and substituted specimen.

2. SVT Requirement

The proposed revisions require each Federal agency to have specimen validity tests conducted on all urine specimens collected under the Mandatory Guidelines.

3. Split Specimen Testing

The proposed revisions grant the donor the right to request that a split (Bottle B) specimen be tested to confirm an adulteration or substitution result that was reported by the primary laboratory on the primary (Bottle A) specimen.

4. SVT Reporting Criteria

The proposed revisions add a new section, entitled ``Validity Testing,'' to the Mandatory Guidelines. The new section requires a laboratory to conduct validity testing and establishes the criteria that must be used by a laboratory to report a specimen as adulterated, substituted, invalid, or dilute.

5. Cutoff Levels

The proposed revisions establish a pH cutoff for reporting a specimen as adulterated and establish a creatinine cutoff and a specific gravity cutoff for reporting a specimen as substituted. The creatinine concentration cutoff is proposed to be less than 2 mg/dL.

The specific gravity cutoff is proposed to be less than 1.0010. The pH cutoff is proposed to be less than 3.

6. Retesting

The proposed revisions require a second laboratory to conduct validity tests when it is unable to reconfirm the drug or drug metabolite that was originally reported positive in a single specimen or primary (Bottle A) specimen. The proposed revisions also add criteria for retesting a specimen for adulterants and substitution.

7. Quality Control

The proposed revisions establish specific quality control criteria and other procedural and test requirements for performing each individual validity test.

8. MRO Qualifications and Duties

The proposed revisions clarify the qualifications and responsibilities of the MRO and expand the MRO's duties to review adulteration, substitution, and invalid test results reported by a laboratory.

9. Donor's Right To Challenge Results

The proposed revisions provide that a donor has the same right to challenge the accuracy of a positive, adulterated, or substituted result reported for a single specimen collection as for a split specimen collection.

10. HHS Notification of Results

The proposed revisions state that an MRO will notify the designated regulatory office that is responsible for the laboratory certification program when a second laboratory fails to reconfirm a positive, adulterated, or substituted result reported by a first laboratory.

11. Performance Testing and Laboratory Inspection Programs

The proposed revisions expand the performance testing program and the laboratory inspection program. The performance-testing program will include performance-testing samples to challenge each certified laboratory's ability to correctly perform validity tests. The inspection program will include inspecting and evaluating the SVT procedures used by the laboratories in a manner similar to that for all other laboratory operations.

12. List of Adulterants

HHS will begin to include a list of known adulterants in the monthly Federal Register notice that lists certified laboratories.