Drug Laws Essay, Research Paper
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: wvogl@samhsa.gov *mailto:wvogl@samhsa.gov* or clodico@samhsa.gov *mailto:clodico@samhsa.gov*
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 are the quality control requirements when conducting an initial test?
11.12 What is a confirmatory test?
11.13 What must a laboratory do to validate a confirmatory test method?
11.14 Why must the confirmatory test be calibrated?
11.15 What are the quality control requirements when conducting a confirmatory test?
11.16 Is a laboratory allowed to conduct any additional tests on a specimen?
11.17 What are the requirements for a laboratory to report the test result for a specimen?
11.18 How long must a laboratory retain a specimen?
11.19 How long must a laboratory retain records?
11.20 Can a laboratory store records electronically?
11.21 What summary report must a laboratory provide to a Federal agency?
11.22 What information is available to the donor?
11.23 What type of relationship is prohibited between a laboratory and an MRO?
11.24 What information must a certified laboratory provide to its private sector clients?
Subpart L – Point of Collection Test (POCT)
12.1 What is a point of collection test?
12.2 What types of POCT devices are there?
12.3 What are the requirements for a POCT device?
12.4 Who may conduct a POCT?
12.5 What are the qualifications for the person who performs a POCT?
12.6 What are the responsibilities of a responsible technician?
12.7 Which specimen types may be tested using a POCT?
12.8 What are the cutoff concentrations when using a POCT?
12.9 May the donor observe the POCT being performed?
12.10 What are the requirements for conducting a POCT?
12.11 What are the quality control requirements when conducting a POCT?
12.12 What are the application requirements for a POCT provider?
12.13 What are the qualitative and quantitative specifications for PT samples that are used to evaluate a POCT provider?
12.14 What are the inspection requirements for a POCT provider?
12.15 Who may inspect a POCT provider?
12.16 What happens if a POCT provider does not satisfy the minimum inspection requirements?
12.17 Where is a list of “recognized” POCT providers published?
12.18 Is a POCT provider allowed to conduct any additional tests on a specimen?
12.19 How long must a POCT provider retain a specimen?
12.20 How long must a POCT provider retain records?
12.21 Can a POCT provider store records electronically?
12.22 What summary report must a Federal agency receive from a POCT provider?
12.23 What type of relationship is prohibited between a POCT provider and a Medical Review Officer?
12.24 What type of relationship can exist between a POCT provider and an HHS certified laboratory?
12.25 What security measures must a POCT provider maintain?
12.26 What information is available to the donor?
12.27 What is the minimum specimen volume for a POCT?
12.28 What action may a Federal agency take when a POCT is positive?
12.29 How is the POCT result reported to the Medical Review Officer?
Subpart M -Instrumented Initial Test Facility
13.1 What is an instrumented initial test facility?
13.2 Are laboratories that perform only initial tests allowed?
13.3 What is an instrumented initial test?
13.4 What types of initial tests are there?
13.5 What are the requirements for an instrumented initial test facility?
13.6 Why must the instrumented initial test device be calibrated?
13.7 Who may conduct an instrumented initial test?
13.8 What are the qualifications for the person who performs an instrumented initial test?
13.9 What are the responsibilities of a responsible technician?
13.10 Which specimen types may be tested using an instrumented initial test?
13.11 What are the cutoff concentrations when using an instrumented initial test?
13.12 What are the quality control requirements when conducting an instrumented initial test?
13.13 What are the application requirements for an instrumented initial test facility?
13.14 What are the qualitative and quantitative specifications for PT samples that are used to evaluate an instrumented initial test facility?
13.15 What are the inspection requirements for an instrumented initial test facility?
13.16 Who may inspect an instrumented initial test facility?
13.17 What happens if an instrumented initial test facility does not satisfy the minimum inspection requirements?
13.18 Where is a list of “recognized” instrumented initial test facilities published?
13.19 Is an instrumented initial test facility allowed to conduct any additional tests on a specimen?
13.20 How long must an instrumented initial test facility retain a specimen?
13.21 How long must an instrumented initial test facility retain records?
13.22 Can an instrumented initial test facility store records electronically?
13.23 What summary report must a Federal agency receive from an instrumented initial test facility?
13.24 What type of relationship is prohibited between an instrumented initial test facility and a Medical Review Officer?
13.25 What type of relationship can exist between an instrumented initial test facility and an HHS certified laboratory?
13.26 What security measures must an instrumented initial test facility maintain?
13.27 What is the minimum specimen volume collected for an instrumented initial test?
13.28 What action may a Federal agency take when an instrumented initial test is reported as a non-negative?
13.29 How is the instrumented initial test result reported to the Medical Review Officer?
Subpart N – Medical Review Officer (MRO)
14.1 Who may serve as an MRO?
14.2 What are the responsibilities of an MRO?
14.3 What type of relationship is prohibited between an MRO and a laboratory, POCT provider, or an instrumented initial test facility?
Subpart O – Single Specimen Retests and Split Specimen Tests
15.1 When may a single specimen or primary specimen be retested?
15.2 When may a split specimen be tested?
15.3 How does a laboratory handle the retesting of a single specimen or the testing of a split specimen?
15.4 Who receives the single specimen retest result or the split specimen result?
15.5 What happens when a single specimen retest or split specimen result does not reconfirm the original test result?
15.6 How long must a laboratory retain a split specimen?
Subpart P – Problems with Drug Tests
16.1 What problems will always result in a laboratory not testing a specimen?
16.2 What problems will result in a laboratory not reporting a drug test result unless the problem is corrected?
Subpart Q – Laboratory Suspension/Revocation Procedures
17.1 When may a certified laboratory be suspended?
17.2 When may a laboratory?s certification be revoked?
17.3 What is the procedure when a laboratory is suspended?
17.4 What is the procedure when there is a proposal to revoke a laboratory?s certification?
17.5 Where are notices of laboratory actions published?
Authority:
Subpart A – Applicability
1.1 Whom do these Guidelines cover?
These guidelines apply to:
(a) Executive Agencies as defined in 5 U.S.C. 105;
(b) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but excluding the Armed Forces as defined in 5 U.S.C. 2101(2));
(c) Any other employing unit or authority of the Federal Government except the United States Postal Service, 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.
1.2 Who is responsible for developing and issuing authoritative interpretations of the Guidelines?
(a) Executive Order 12564 and Public Law 100-71 require the Department of Health and Human Services (HHS) to establish a Drug-Free Federal Workplace Program.
(b) Within HHS, the Division of Workplace Programs (DWP) in the Center for Substance of Abuse Prevention, Substance Abuse and Mental Health Services Administration (SAMHSA), has been delegated the responsibility of providing:
(1) The day-to-day oversight of the Drug-Free Federal Workplace Program; and
(2) The development of comprehensive procedural and scientific standards for all aspects of a drug testing program.
(c) The Division of Workplace Programs provides written interpretations of the provisions in these Guidelines as written or electronic program documents, handbooks, manuals, and Federal Register notices. These interpretations are the only official and authoritative interpretations that are valid and binding.
1.3 How is an exemption granted from these Guidelines?
(a) A Federal agency may not deviate from the provisions of these Guidelines without the written approval of the Secretary of Health and Human Services.
(b) In requesting approval for a deviation, a Federal agency must petition the Secretary in writing and describe the specific provision or provisions for which a deviation is sought and the rationale for the deviation.
1.4 How are these Guidelines revised?
(a) The Secretary of Health and Human Services is responsible for approving and publishing in the Federal Register major changes to these Guidelines. Examples of major changes include, but are not limited to, changes in cutoff concentrations, drugs tested, and scientific methods used.
(b) The Division of Workplace Programs is responsible for making minor changes as a result of improvements in the available science and technology. These minor changes are published as program documents or as Federal Register notices.
1.5 What do the terms used in these Guidelines mean?
The following definitions are adopted:
Aliquot A fractional part of a specimen used for testing. It is taken as a sample representing the whole specimen.
Adulterated A specimen is considered to be adulterated if it either contains a substance that is not a normal constituent for that type of specimen or contains an endogenous substance at a concentration that is not a normal physiological concentration.
Batch A set of specimens being tested as a group.
Blind Sample A blind sample is a sample with a known drug concentration or a negative sample used to evaluate the ability of a laboratory to test a specimen for drugs and/or metabolites. The laboratory does not know either the concentration of the drug or that it is a blind sample
Calibrator A solution of known concentration that is used to define a measurement procedure or to compare the response obtained with the response of a test specimen aliquot/sample. The concentration of the analyte of interest in the calibrator is known within limits ascertained during its preparation. Calibrators may be used to establish a calibration curve over a range of interest.
Canceled test The MRO determines that the result reported by the laboratory or the POCT provider cannot support reporting either a positive nor a negative test to the employer.
Certifying Scientist The individual who is responsible for verifying the forensic and scientific supportability of a test result.
Chain of Custody Procedures to account for the integrity of each specimen or aliquot by tracking its handling and storage from point of specimen collection to final disposition of the specimen.
Chain of Custody Document The form(s) used by the laboratory to document the security of the specimen and all aliquots of the specimens during testing and storage by the laboratory. The form, which may account for an entire test batch, shall include the names and signatures of all individuals who accessed the specimens or aliquots and the date and purpose of the access.
Collection Site A place where donors present themselves for the purpose of providing a specimen to be analyzed for the presence of drugs.
Collector A person who instructs and assists donors at a collection site and receives the specimen provided by the donor.
Confirmatory Test An analytical procedure performed on a separate aliquot of the specimen to identify the presence of a specific drug or metabolite.
Control A sample used to evaluate whether or not the analytical procedure is operating within predefined tolerance limits.