Cut-off The concentration used to report a specimen as negative or positive.
Dilute Refers to a specimen with less than normal constituents.
( TO BE DETERMINED FOR EACH SPECIMEN )
Donor The individual from whom a specimen is collected.
Failed to Reconfirm The result reported when a laboratory is unable to detect the drug or metabolite that was previously reported from the original analysis.
Federal Custody and Control Form An OMB approved form used to document the collection, security, and test results of the specimen.
Follow-up Test A specimen collected from a donor to ensure that the donor remains drug-free after being returned to a testing designated position.
HHS The Department of Health and Human Services or designee of the Secretary, Department of Health and Human Services.
Initial Test The test used to differentiate a negative specimen from one that requires further testing.
Invalid Result The result reported when a laboratory is unable to obtain a scientifically supportable drug test result.
HHS Certified Instrumented Initial Test Facility A location where initial testing, reporting of results, and recordkeeping is performed under the supervision of a responsible technical (RT).
HHS Certified Laboratory A location where initial and confirmation testing is performed under the supervision of an RP and Certifying Scientists are used for final review and release of drug testing results.
HHS Certified Point of Collection Test Facility A location where specimen collection, initial testing, reporting of results, and record keeping is performed under the supervision of a responsible technician (RT).
Medical Review Officer (MRO) A licensed physician who receives, reviews, verifies, and reports the drug test results.
Negative Result Result for a specimen that either contains no drug or the concentration of the drug is less than the cutoff concentration for that drug or drug class.
Non-Negative Result Result for a specimen from an initial test that must go to confirmation for a final report.
Positive Result Laboratory result for a specimen that contains a drug or metabolite greater than or equal to the cutoff concentration.
Post Accident Test A test performed on a specimen collected from a donor after the donor is involved in a job-related accident.
Pre-employment Test A test performed on a specimen collected from a donor who is applying for a testing designated position.
Quality Control Sample A calibrator, control, and/or blind sample.
Random Test A test performed on a specimen collected from a donor who is selected at random from the individuals working in testing designated positions.
Reasonable Suspicion/Cause Test (TO BE DETERMINED)
Reconfirmed The result reported when a laboratory is able to detect the drug or metabolite that was previously reported from the original analysis.
Rejected for Testing Result for a specimen for which the laboratory or the point of collection test device provider does not perform any tests on the specimen.
Responsible Person (RP) The person who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of the HHS certified laboratory.
Responsible Technician (RT) The person who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of the HHS certified
point of collection test facility or the HHS certified instrumented initial test facility.
Return to Duty Test A test performed on a specimen collected from a donor prior to being reinstated in a testing designated position.
Sample A representative portion of a specimen or quality control material used for testing.
Secretary The Secretary of Health and Human Services or the Secretary’s designee (e.g., Administrator, SAMHSA; Director, Division of Workplace Programs; a contractor; or other recognized organization which acts on behalf of the Secretary in implementing these Guidelines).
Specimen Fluid or material derived from the body and which may be subdivided or concomitantly collected (if a split specimen is required).
Split Specimen A specimen collected at the collection site that is fluid or material derived from the body which has been subdivided or concomitantly collected and independently sealed in the presence of the donor. For urine, one void that is subdivided. For hair, one “harvest” that is subdivided by strands. For oral fluid, one specimen collected that is subdivided or two simultaneously collected specimens. For sweat, a sweat patch that is subdivided or two separate patches that are applied and removed simultaneously.
Standard Reference material of known purity or a solution containing a reference material at a known concentration.
Substituted A specimen that could not have been provided by a donor.
Testing Designated Position An employment position within a Federal agency that has been designated for random testing.
Subpart B – Specimens
2.1 What types of specimens may be collected?
A Federal agency may collect the following types of specimens as part of its workplace drug testing program:
(a) Urine
(b) Oral Fluid (Saliva)
(c) Sweat
(d) Hair
2.2 Under what circumstances can the different types of specimens be collected?
Recommended reasons for specimen type selected are as follows:
Type of Specimen Reason For Test
Urine Pre-employment, random, reasonable suspicion/cause,
post accident, return to duty, follow-up
Oral Fluid reasonable suspicion/cause, post accident
Sweat Return to duty, follow-up
Hair Pre-employment, random, follow-up
Subpart C – Drugs
3.1 For which drugs can a specimen be tested?
The Executive Order 12564 defines “illegal drugs” as those included in Schedule I or II of the Controlled Substances Act (CSA), but not when used pursuant to a valid prescription or when used as otherwise authorized by law. Federal agency drug testing programs must test all specimens for marijuana and cocaine use and may test for use of opiates, amphetamines, and phencyclidine.
3.2 Can a specimen be tested for additional drugs?
(a) Reasonable suspicion/cause, or post accident specimens may be tested for any drug listed in Schedule I or II of the CSA.
(b) A Federal agency covered by these Guidelines must petition the Secretary in writing for approval to routinely test for any drug class not listed in section 3.1. Such approval shall be limited to the use of the appropriate science and technology and shall not otherwise limit agency discretion to test for any drug tested under paragraph (a) of this section.
3.3 Can a specimen be used for other purposes?
(a) Specimens collected pursuant to these Guidelines may be used to test only for those drugs included in the Agency workplace drug testing program. They may not be used to conduct any other analysis or test unless otherwise authorized by the Guidelines.
(b) A specimen that tests negative by initial or confirmatory testing may, however, be pooled for use in a laboratory’s internal quality control program.
(c) These Guidelines are not intended to prohibit any Federal agency specifically authorized by law to test for additional classes of drugs in its workplace drug testing program.
3.4What is the cutoff concentration for each drug by type of specimen collected?
Urine
Initial Test Cutoff Concentration
(ng/mL)
Marijuana metabolites………..50
Cocaine metabolites…………..150
Opiate metabolites……………..2000
Phencyclidine……………………25
Amphetamines………………….500 Screening must significantly cross-react w/MDMA (Roughly equal cross-reactivity)
Confirmatory Test Cutoff Concentration
(ng/mL)
Marijuana metabolite1…………..15
Cocaine metabolite2……………..100
Opiates
Morphine……………………….?..2000
Codeine…………………………?…2000
6-acetylmorphine ……………?..10
Phencyclidine………………….?..25
Amphetamines
d-Amphetamine………………..150 – 250
d-Methamphetamine3………..150 – 250
MDMA…………………..????..150 – 250
MDA………………………….???..150 – 250
MDEA………………………..???.150 – 250
1 Delta-9-tetrahydrocannabinol-9-carboxylic acid
2 Benzoylecgonine
3 Specimen must also contain Amphetamine at a concentration * 100 ng/mL
Hair
Initial Test Cutoff Concentration
(pg/mg)
Marijuana metabolites…………1.0
Cocaine metabolites……………500
Opiate metabolites……………..200
Phencyclidine…………………….300
Amphetamines……………………500 Screening must cross-react w/MDMA
Confirmatory Test Cutoff Concentration
(pg/mg)
Marijuana metabolite1……………0.05
Cocaine metabolite2………………100
Cocaine……………………………….1000
BE/COC ratio *= 0.1
Opiates
Morphine………………………….200
Codeine……………………………200
6-acetylmorphine ……………..200
Hair 6-AM rule (TO BE DETERMINED)
Phencyclidine…………………..300
Amphetamines
d-Amphetamine…………….?300
d-Methamphetamine…..??300
Hair amp rule………????50
MDMA
MDA
MDEA
1 Delta-9-tetrahydrocannabinol-9-carboxylic acid
2 Benzoylecgonine
Sweat
Initial Test Cutoff Concentration Target Analyte
(ng/ 2.5 mL eluate)
Marijuana metabolites…………1.5THC
Cocaine metabolites……………10Benzoylecgonine
Opiate metabolites……………..10Morphine
Phencyclidine……………………7.5Phencyclidine
Amphetamines………………….10d-Methamphetamine
(Amp screening must cross-react w/MDMA)
Confirmatory Test Cutoff Concentration
(ng/2.5 mL eluate)
THC parent drug……………………..0.5
Cocaine parent drug……………..?10
Cocaine metabolite2……………?.10
Opiates
Morphine………………………….10
Codeine……………………………10
6-acetylmorphine ……………..10
Phencyclidine……………………..7.5
Amphetamines
d-Amphetamine…………………10
d-Methamphetamine3…………10
MDMA
MDA
MDEA
2 Benzoylecgonine
3 Specimen must also contain Amphetamine at a
concentration * (TO BE DETERMINED) ng/mL
Oral Fluid
Initial Test Cutoff Concentration
(ng/mL)
Marijuana metabolites…………4
Cocaine metabolites……………20
Opiate metabolites……………..40
Phencyclidine………………….?4
Amphetamines………………….160 Screening must cross-react w/MDMA
Confirmatory Test Cutoff Concentration
(ng/mL)
THC Parent drug………….???2
Cocaine metabolite2…………?….8
Opiates
Morphine………………………..?40
Codeine………………………….?40
6-acetylmorphine ……………?..4
Phencyclidine……………………?..2
Amphetamines
d-Amphetamine…………………160
d-Methamphetamine3…………160
MDMA
MDA
MDEA
2 Benzoylecgonine
3 Specimen must also contain Amphetamine at a
concentration * (TO BE DETERMINED) ng/mL
Subpart D – Collectors
4.1 Who may collect a specimen?
(a) An individual trained or certified to collect specimens.
(b) The direct supervisor of donor may not act as the collector when that donor is tested, unless no other collector is available.
4.2 What training and certification must a collector have?
(a) HHS has not established a formal certification program for collectors. However, private sector organizations are encouraged to develop the required certification program. This will help to ensure that collectors have, in fact, been properly trained and certified to collect specimens as required by the Guidelines.
(b) To be a collector, you must do the following:
(1) Read and become familiar with the collection procedures in these Guidelines;
(2) Read and become familiar with the HHS Specimen Collection Handbook for the specimen being collected; and
(3) Attain certification through a recognized collector certification program for the type(s) of specimen(s) you are going to collect.
(c) As a collector, you must be recertified once every two years to ensure that you are familiar with current HHS specimen collection policies and procedures.
(d) As a collector, you must maintain all documentation of certification/recertification as long as you serve as a collector.
4.3 Who can train and certify collectors?
(TO BE DETERMINED)
4.4 Under what circumstances must a collector be retrained?
(a) A collector needs to be retrained when:
(1) The collection procedure changes significantly (e.g., a new CCF is used); or
(2) The collector makes mistakes that cause tests to be canceled. This will lead to a “collector?s cancellation rate” being an index of performance.
(b) The required retraining:
(1) Must be focused in the specific area of collection procedures that caused the tests to be canceled; and
(2) Be documented in writing by a trainer.
4.5 What are the collector monitoring and support requirements for organizations employing collectors?
An organization (e.g., Federal agency, contractor, health clinic) employing the collector must do the following:
(a) Have an official certification statement documenting that the collector is certified;
(b) Retain these official certification statements as long as the person performs collector functions and for 2 years after the collector leaves the organization; and
(c) Provide to a collector the name and telephone number of the Federal agency?s representative to contact about problems or issues that may arise during a specimen collection procedure.
Subpart E – Collection Sites
5.1 Where can a collection for a drug test take place?
(a) A collection site may be a permanent or temporary facility located either at the work site or at a remote site.
(b) The selection of an appropriate collection site will depend on the type of specimen being collected.
5.2 What are the requirements for a collection site?
A collection site must have the following:
(a) A suitable clean surface for handling the specimen and completing the required paperwork;
(b) A secure temporary storage capability to maintain a specimen until it is tested or shipped to the laboratory;
(c) Ability to restrict access to only authorized personnel during the collection;
(d) Ability to restrict access to collection supplies; and
(e) Ability to store records securely.
5.3 How long must collection site records be stored?
Collection site records must be stored for a minimum of 2 years.
5.4 How does the collector ensure the security of a specimen at the collection site?
A collector must do the following to maintain the security of a specimen:
(a) Do not allow unauthorized personnel to enter the collection site during the collection;
(b) Perform only one specimen collection at a time;
(c) Restrict access to collection supplies before and during the collection;
(d) Ensure that you are the only person other than the donor to handle the specimen; and
(e) Immediately seal the specimen.
5.5 What are the privacy considerations when collecting a specimen?
The requirements for specimen collection are as follows depending on the type of specimen being collected:
(a) For urine, the donor must have visual privacy while providing the specimen unless:
(1) There is a reason to believe that the donor may alter or substitute the specimen to be provided; or
(2) A direct observed collection was authorized.
(b) For hair, head hair is collected unless it is not available. Collection of hair from other areas of the body must be approved in accordance with Agency procedures before the collection and must be collected using appropriate privacy.
(c) For sweat, the sweat patch will be applied by the collector to the donor?s upper arm, chest, or back. The donor must be allowed privacy during the application and removal of the patch by the collector.
(d) For oral fluid, the collection device must be inserted into and removed from the donor?s mouth by the donor in the presence of the collector. The donor will be observed by the collector during this entire process.
(e) A complete description of collection procedures for each specimen are in the HHS Specimen Collection Handbook for Federal Workplace Drug Testing Programs.
5.6 What supplies are needed at the collection site?
(a) A complete list of the supplies needed to collect each type of specimen is in the HHS Specimen Collection Handbook for Federal Workplace Drug Testing Programs.
(b) The handbook is available on the following website:
Subpart F – Federal Drug Testing Custody and Control Forms