drug laws



NOTE:This draft document represents a joint effort by the SAMHSA/CSAP Division of Workplace Programs and members of the SAMHSA Drug Testing Advisory Board (DTAB). It has not been reviewed by all members of the DTAB, by industry working groups, or by other Federal agencies. This draft document is the first release to a wider audience. It will serve as the basis for developing the guidelines for Federal Workplace Drug Testing Programs.

All interested parties are invited to comment on the draft document. Comments may be mailed to the Division of Workplace Programs, 5600 Fishers Lane, Rockwall II, Suite 815, Rockville, Maryland 20857, by fax (301-443-3031), or by email: [email protected] *mailto:[email protected]* or [email protected] *mailto:[email protected]*

Please submit your comments by July 12, 2000, to ensure they are considered prior to the September Drug Testing Advisory Board meeting.

MANDATORY GUIDELINES
for
FEDERAL WORKPLACE DRUG TESTING PROGRAMS

Subpart A - Applicability
Sec.
1.1 Whom do these Guidelines cover?
1.2 Who is responsible for developing and issuing authoritative interpretations of the Guidelines?
1.3 How is an exemption granted from these Guidelines?
1.4 How are these Guidelines revised?
1.5 What do the terms used in these Guidelines mean?

Subpart B - Specimens
2.1 What types of specimens may be collected?
2.2 Under what circumstances can the different types of specimens be collected?

Subpart C - Drugs
3.1 For which drugs can a specimen be tested?
3.2 Can a specimen be tested for other drugs?
3.3 Can a specimen be used for other purposes?
3.4 What is the cutoff concentration for each drug by type of specimen collected?

Subpart D - Collectors
4.1 Who may collect a specimen?
4.2 What training and certification must a collector have?
4.3 Who can train and certify a collector?
4.4 Under what circumstances must a collector be retrained?
4.5 What are the collector monitoring and support requirements for organizations employing collectors?

Subpart E - Collection Sites
5.1 Where can a collection for a drug test take place?
5.2 What are the requirements for a collection site?
5.3 How long must collection site records be stored?
5.4 How does the collector ensure the security of a specimen at the collection site?
5.5 What are the privacy considerations when collecting a specimen?
5.6 What supplies are needed at the collection site?
5.7 How do you protect the privacy of a donor at the collection site?

Subpart F - Federal Drug Testing Custody and Control Forms
6.1 What form is used to document collecting a specimen?
6.2 What happens if an approved form is not available or is not used?

Subpart G - Collection Device
7.1 What is a collection device?
7.2 Must the collection device be cleared by the FDA?

Subpart H - Specimen Collection Procedure
8.1 What must the collector do before starting the collection procedure?
8.2 What are the basic requirements for collecting any type of specimen?
8.3 Where can I find the collection procedure for each type of specimen?

Subpart I - National Laboratory Certification Program
9.1 What is the National Laboratory Certification Program (NLCP)?
9.2 How does a laboratory apply to the NLCP?
9.3 What is a performance testing (PT) sample?
9.4 What are the performance testing requirements for an applicant laboratory?
9.5 What are the performance testing requirements for a certified laboratory?
9.6 What are the inspection requirements for an applicant laboratory?
9.7 What are the inspection requirements for a certified laboratory?
9.8 Who may inspect a laboratory participating in the NLCP?
9.9 What happens if a laboratory does not satisfy the minimum requirements for either the PT program or the inspection program?
9.10 Where is a list of certified laboratories published?

Subpart J - Blind Samples Submitted by an Agency
10.1 What are the requirements for a blind sample?
10.2 What are the requirements for Federal agencies to submit blind samples?
10.3 How is a blind sample submitted to the laboratory?
10.4 What happens if an inconsistent result is reported on a blind sample?

Subpart K - Laboratory Requirements
11.1 What is a Standard Operating Procedure Manual?
11.2 What qualifications must the laboratory’s responsible person (RP) have?
11.3 What are the responsibilities of the RP?
11.4 What qualifications and training must an individual have to certify a drug test result that is reported by a laboratory?
11.5 What qualifications and training must other laboratory personnel have?
11.6 What security measures must a laboratory maintain?
11.7 How must a laboratory handle a specimen or an aliquot?
11.8 What is an initial test?
11.9 What must a laboratory do to validate an initial test method?
11.10 Why must the initial test be calibrated?
11.11 What