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Mandatory Guidelines for Federal Workplace Drug Testing Programs
Substance Abuse and Mental Health Services Administration (SAMHSA)

The basic purpose of the Mandatory Guidelines is to establish scientific and technical guidelines for Federal agencies' Workplace drug testing programs and to establish a certification program for laboratories engaged in urine drug testing for Federal agencies.

These Mandatory Guidelines and the revisions are developed in accordance with Executive Order No. 12564 dated September 15, 1986, and section 503 of Pub. L. 100-71. Executive Order No. 12564 was signed by former President Ronald Reagan.

Originally Published: April 11, 1988
The Department of Health and Human Services (HHS) revises some of the scientific and technical guidelines for Federal drug testing programs and revises certain standards for certification of laboratories engaged in urine drug testing for Federal agencies. The revisions to the Mandatory Guidelines incorporate changes based on the comments submitted and the Department's first 5 years of experience in implementing and administering these Guidelines.
Revision Published: January 25, 1993

Subpart A - General
1.1 Applicability.
1.2 Definitions.
1.3 Future Revisions.

Subpart B - Scientific and Technical Requirements
2.1 The Drugs.
2.2 Specimen Collection Procedures.
2.3 Laboratory Personnel.
2.4 Laboratory Analysis Procedures.
2.5 Quality Assurance and Quality Control.
2.6 Reporting and Review of Results.
2.7 Protection of Employee Records.
2.8 Individual Access to Test and Laboratory Certification Results.

Subpart C - Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies
3.1 Introduction.
3.2 Goals and Objectives of Certification.
3.3 General Certification Requirements.
3.4 Capability to Test for Five Classes of Drugs.
3.5 Initial and Confirmatory Capability at Same Site.
3.6 Personnel.
3.7 Quality Assurance and Quality Control.
3.8 Security and Chain of Custody.
3.9 One-Year Storage for Confirmed Positives.
3.10 Documentation.
3.11 Reports.
3.12 Certification.
3.13 Revocation.
3.14 Suspension.
3.15 Notice.
3.16 Recertification.
3.17 Performance Testing (PT) Requirement for Certification.
3.18 Performance Test Samples Composition.
3.19 Evaluation of Performance Testing.
3.20 Inspections.
3.21 Results of Inadequate Performance.
3.22 Listing of Certified Laboratories.

Subpart D - Procedures for Review of Suspension or Proposed Revocation of a Certified Laboratory
4.1 Applicability.
4.2 Definitions.
4.3 Limitations on Issues Subject to Review.
4.4 Specifying Who Represents the Parties.
4.5 The Request for Informal Review and the Reviewing Official's Response.
4.6 Abeyance Agreement.
4.7 Preparation of the Review File and Written Argument.
4.8 Opportunity for Oral Presentation.
4.9 Expedited Procedures for Review of Immediate Suspension.
4.10 Ex Parte Communications.
4.11 Transmission of Written Communications by Reviewing Official and Calculation of Deadlines.
4.12 Authority and Responsibilities of Reviewing Official.
4.13 Administrative Record.
4.14 Written Decision.
4.15 Court Review of Final Administrative Action; Exhaustion of Administrative Remedies.

Authority: E.O. 12564 and Sec. 503 of Pub. L. 100-71.

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