**Urine Specimen Collection Guidelines**

United States

Department of Transportation

![](media/image1.wmf){width="1.25in" height="1.25in"}

#### Office of Drug and Alcohol Policy and Compliance

Revised December 2006

**DOT Urine Specimen Collection Guidelines\
for the\
U.S. Department of Transportation Workplace**

**Drug Testing Programs\
(49 CFR Part 40)**

These guidelines apply [only]{.underline} to employers and individuals
who come under the regulatory authority of the U.S. Department of
Transportation (DOT) and those individuals who conduct urine specimen
collections under DOT regulations. The term "employee" is used
throughout this document and has the same meaning as "donor" as used on
the Federal Drug Testing Custody and Control Form (CCF).

These guidelines are a [complete revision]{.underline} of the December
1994 (revised in October 1999) DOT Urine Specimen Collection Procedures
Guidelines, 49 CFR Part 40, for Transportation Workplace Drug Testing
Programs. These guidelines contain all of the new requirements and
procedures contained in the DOT rule published in the *[Federal
Register]{.underline}* on December 19, 2000, effective August 1, 2001,
and in the Technical Amendments, published on August 9, 2001. It
contains minimal graphics and formatting to ease transmission and
downloading of the document from the Internet. All previous amendments
and interpretations are superseded and no longer in effect.

All information appearing in these guidelines is in the public domain
and may be used or reproduced without permission from DOT or others.
Citation of the source is appreciated.

**Note: [All]{.underline} DOT-required collections are conducted using
split specimen procedures. There are [no]{.underline} exceptions to this
requirement.**

**Note: If an alcohol test is also required, the alcohol test should be
conducted first, if practicable.**

*This document may be updated or modified based on additional
interpretations or other procedural changes. Collectors and service
agents should check the DOT web site periodically to ensure that they
have the latest version (www.dot.gov/ost/dapc/).*

**Revised December 2006**

Previous editions are obsolete

**INTRODUCTION**

The Department of Transportation\'s (DOT) operating administrations
(Federal Aviation Administration, Federal Motor Carrier Safety
Administration, Federal Railroad Administration, Federal Transit
Administration, Research and Special Programs Administration, and the
United States Coast Guard) have issued regulations requiring anti‑drug
programs in the aviation, highway, railroad, mass transit, pipeline, and
maritime industries. The DOT operating administrations\' rules require
that employers conduct drug testing according to provisions of 49 CFR
Part 40, \"Procedures for Transportation Workplace Drug Testing
Programs,\" Final Rule, published in the Federal Register on December
19, 2000 (65 FR 79462), effective August 1, 2001, together with
subsequent technical amendments. Previously published rules, amendments,
interpretations, and guidelines are no longer in effect.

The procedures for collection of urine under these rules are very
specific and must be followed whenever a DOT-required urine specimen
collection is performed. (The only exception is the Federal Railroad
Administration\'s Post-Accident Toxicological Testing Program in which a
railroad representative will provide the collector specific instructions
and a testing kit.) These procedures, including use of the Federal Drug
Testing Custody and Control Form (CCF), apply only to DOT-required
testing. While employers may use these collection and testing procedures
for testing under [employer or state authority]{.underline}, they must
[not]{.underline} use a Federal CCF nor can they imply that company
tests are conducted using DOT authority.

The collector has a major role in the success of the DOT's drug testing
program. The collector is the one individual in the testing process with
whom all employees have direct, face‑to‑face contact. Without the
collector assuring the integrity of the specimen and collection process,
the test itself may lose validity. Without the collector\'s sensitivity
to an employee\'s privacy, the entire testing program may be subject to
criticism. It is imperative that collectors fully understand and follow
these procedures. These guidelines, together with 49 CFR Part 40 and the
DOT operating administrations\' rules, will provide collectors with the
information needed in the performance of their collection duties.

The information in this document addresses normal collection procedures
and some of the more common problems or situations encountered. However,
information contained in this publication should not be used to
interpret the legal requirements of the actual rule.

**TABLE OF CONTENTS**

Section 1. Collector\
Section 2. Collection Site\
Section 3. Collection Supplies\
Section 4. Federal Drug Testing Custody and Control Form\
Section 5. Employee Identification\
Section 6. Collection Procedures\
Section 7. Shy Bladder Procedures\
Section 8. Directly Observed Collections\
Section 9. Monitored Collections

Section 10. Problem Collections

Section 11. Blind Quality Control Samples

Section 12. Correcting Collection Problems\
Section 13. DOT-regulated and Non-Regulated Employers

Appendix A DOT Standards for Urine Collection Kits

Appendix B Training Requirements for Collectors

Appendix C Questions and Answers

Appendix D Operating Administrations' Rules (Summary)

**SECTION 1. COLLECTOR**\
\
Part 40 defines a collector as a trained person who instructs and
assists employees at a collection site, who receives and makes an
initial inspection of the urine specimen provided by those employees,
and who initiates and completes the Federal Drug Testing Custody and
Control Form (CCF).

> Note: DOT does [not]{.underline} require or provide collector
> certification. Collectors need to have documentation reflecting that
> they have met appropriate training requirements.

Any individual, who has received training specified in 49 CFR Part 40
(40.33) for conducting the required collection procedure, may serve as a
collector except in the following situations:

> 1\. The immediate supervisor of a particular employee may not act as
> the collector when that employee is tested, unless no other collector
> is available and the supervisor is permitted to do so under a DOT
> operating administration's drug and alcohol regulation. (The immediate
> supervisor may act as a monitor or observer (same gender) if there is
> no alternate method at the collection site to conduct a monitored or
> observed collection.);
>
> 2\. An employee who is in a safety-sensitive position and subject to
> the DOT drug testing rules should not be a collector, an observer, or
> a monitor for co-workers who are in the same testing pool or who work
> together with that employee on a daily basis. This is to preclude any
> potential appearance of collusion or impropriety;
>
> 3\. An individual working for an HHS-certified drug testing laboratory
> (e.g., as a technician or accessioner) may not act as a collector if
> that individual can link the employee with the specimen drug test
> result or laboratory report; and,
>
> 4\. The employee may not be the collector of his or her own urine
> specimen.
>
> Note: To avoid a potential conflict of interest, a collector should
> not be someone that is related to the employee (e.g., spouse,
> ex-spouse, relative) or a close personal friend (e.g., fiancée).

A collector should have appropriate identification, which includes the
collector's name and the name of the Collection Company or clinic. The
collector is required to provide his or her identification if requested
by the employee. There is no requirement for the collector to have a
picture I.D. or to provide his or her driver\'s license with an address
or telephone number. Also, the collector is not required to provide any
certification or other documentation to the employee documenting the
collector\'s training. However, the collector must provide this
documentation on request to DOT agency representatives and to employers
and service agents (SA) or Consortia/Third Party Administrators (C/TPAs)
who are using or negotiating to use that collector's services.

As the collector, you must have the name and telephone number of the
appropriate Designated Employee Representative (DER) and of the SA or
C/TPA, where applicable, to contact about any problems or issues that
may arise during the collection process.

**SECTION 2. COLLECTION SITE**\
\
A collection site is a place (permanent or temporary) selected by the
employer where employees present themselves for the purpose of providing
a urine specimen for a DOT-required drug test.

Generally, there are two types of collection facilities:

> 1\. A single-toilet restroom, with a full-length privacy door, or
>
> 2\. A multi-stall restroom, with partial-length doors.

A collection site must have:

> 1\. A restroom or stall with a toilet for the employee to have privacy
> while providing the urine specimen. Whenever available, a single
> toilet restroom, with a full-length privacy door, is preferred. All
> types of restrooms including a mobile facility (e.g., a vehicle with
> an enclosed toilet) are acceptable.\
> \
> 2. A source of water for washing hands that, if practical, is external
> to the restroom where urination occurs. If the only source of water
> available is inside the restroom, the employee may wash his or her
> hands, and then the collector must secure (e.g., use tamper-evident
> tape, cut off the water supply) the water source before the collection
> takes place. If water is not available at the collection site, the
> collector may provide moist towelettes outside the restroom.
>
> 3\. A suitable clean surface for the collector to use as a work area
> and for completing the required paper work.

A second type of facility for urination, which can be used as a
collection site, is a multi-stall restroom. Such a site must provide
substantial visual privacy (e.g., a toilet stall with a partial-length
door) and meet all other requirements listed above (2 and 3).
Additionally, if a multi-stall restroom is used, the collector must
either:

> 1\. Secure all sources of water and other substances that could be
> used for adulteration and substitution (e.g., water faucets, soap
> dispensers) and place bluing agent in all toilets or secure the
> toilets to prevent access; or
>
> 2\. Conduct all collections as monitored collections (See Section 9).

No one but the employee may be present in the multi-stall restroom
during the collection, except the monitor in the event of a monitored
collection or the observer in the event of a directly observed
collection.

> Note: The collector's work area may be located outside the restroom.
> However, if there is no appropriate space available outside the
> restroom to serve as a secure, clean work area and the restroom is
> either a multi-stall facility or a single stall facility with a
> partial door for privacy, and is large enough to accommodate a work
> area, the collector may locate the work area inside the restroom as
> long as all procedures for a monitored collection are met.

All collection sites must meet the following security requirements by
having:

> 1\. Procedures or restrictions to prevent unauthorized access to the
> site during the collection;
>
> 2\. Procedures to prevent the employee or anyone else from gaining
> unauthorized access to the collection materials/supplies. The
> collector must also ensure that the employee does not have access to
> items that could be used to adulterate or dilute the specimen (e.g.,
> soap, disinfectants, cleaning agents, water);
>
> 3\. Procedures to ensure that all authorized persons are under the
> supervision of a collector or appropriate site personnel at all times
> when permitted into the site; and,
>
> 4\. Procedures to provide for the secure handling and storage of
> specimens.
>
> Note: The testing site is that portion of the facility where the
> collector performs the paper work, seals the specimens, and where
> urination occurs. It does not necessarily include the total physical
> facility (e.g., clinic). Additionally, unauthorized personnel are any
> individuals that are [not]{.underline} specifically authorized by the
> regulation, the collector, or employer to be present at the collection
> site.

**SECTION 3. COLLECTION SUPPLIES**\
\
The following items must be available at the collection site in order to
conduct proper collections:

> 1\. For each DOT drug test, a collection kit meeting the requirements
> listed at Appendix A of these guidelines.
>
> 2\. Federal Drug Testing Custody and Control Forms (CCF).
>
> 3\. Bluing (coloring) agent to add to the toilet bowl/water tank to
> prevent an employee from diluting the specimen.\
> *\
> *4. Single use disposable gloves are recommended for use by collectors
> while handling specimens.
>
> 5\. The collector should have available tamper-evident tape for
> securing faucets, toilet tank tops, and other appropriate areas, and
> signs, when necessary, that can be posted to prevent entry into
> collection areas.

**SECTION 4. FEDERAL DRUG TESTING CUSTODY AND CONTROL FORM**\
\
The Federal Drug Testing Custody and Control Form (CCF OMB No.
0930-0158, Exp. Date: 6/30/2003) must be used to document every urine
collection required by the DOT drug testing program. The CCF must be a
five-part carbonless manifold form. This form may be viewed on the DOT
web site (http://www.dot.gov/ost/dapc/) or the Department of Health and
Human Services (HHS) web site http://workplace.samhsa.gov/. CCFs are
also available from a number of different sources (e.g., laboratories,
service agents) although they are usually part of the urine collection
kits provided by a laboratory.\
\
The CCF consists of the following five copies:\
\
Copy 1. Laboratory Copy - accompanies the specimen to the laboratory\
Copy 2. Medical Review Officer Copy - sent to the MRO\
Copy 3. Collector Copy - retained by the collector\
Copy 4. Employer Copy - sent to the employer\
Copy 5. Employee Copy - given to the employee\
\
The CCF is completed as follows:

Step 1 (Copy 1). This step is completed by the collector or employer
representative prior to the employee providing a urine specimen. The
employer and MRO names, addresses, and telephone and fax numbers may be
preprinted or handwritten. If the employer has designated a service
agent to receive the results from the MRO, the employer's address may be
omitted and the service agent's address may be used. However, in all
cases, the specific employer's name, telephone and fax numbers must be
included. A clinic or collection site name may not be used in lieu of an
employer name. The collector enters the employee's social security
number or employee's ID number after verifying the employee's identity.
The collector also marks the appropriate box to indicate the reason for
the test and the appropriate box for the type of drug tests to be
performed ([all]{.underline} DOT drug tests are for five drugs). The
collector then enters the information required for the collection site
(this information may also be preprinted). The [collector's telephone
number]{.underline} is critical, since the laboratory or the MRO may
need to contact the collector if they have questions related to a
collection.\
\
Step 2 (Copy 1). This step is completed by the collector after receiving
the specimen from the employee and observing the temperature of the
specimen. This step requires the collector to mark the appropriate box
to indicate if the temperature of the specimen was within the required
temperature range. This step also requires the collector to indicate
whether it is a split specimen or single specimen collection, to
indicate if no specimen was collected and why, or to indicate if it was
an observed collection and why.

> Note: All DOT collections are split specimen collections and should
> [never]{.underline} have the single specimen collection box checked.

Step 3 (Copy 1). This step instructs the collector to seal and date the
specimen bottles, have the employee initial the bottle seals
[after]{.underline} placing them on the bottles, and then instruct the
employee to complete step 5 on the MRO copy (Copy 2).

Step 5 ([Copy 2;]{.underline} note this differs from the other steps in
that the collector turns to Copy 2 for the employee to fill out and then
turns [back]{.underline} to Copy 1). This step is completed by the
employee (listed as donor on the CCF). The employee reads the
certification statement, prints his or her name, provides date of birth,
daytime and evening telephone numbers, date of collection, and signs the
form. After the employee completes this portion of the CCF, the
collector reviews it to ensure that all the required information was
provided.\
\
Step 4 (Copy 1). This step is initiated by the collector and then
completed by the laboratory after the laboratory accessions the
specimen. This step requires the collector to sign the form to certify
that the specimen was collected, labeled, sealed, and released for
shipment to the laboratory in accordance with Federal requirements. The
collector is also required to note the time of the collection, the date
of collection, and the specific name of the delivery service to whom the
specimen is released for shipment to the laboratory.

> Note: There is no requirement for couriers, express carriers, or
> postal service personnel to add additional documentation to the chain
> of custody for the specimens during transit because they do not have
> direct access to the specimens or the CCF. Chain of custody
> annotations resume when the shipping container/package is opened and
> accessioned at the laboratory.

Step 5(a) (Copy 1). This step is completed by the laboratory to report
the test result of the primary specimen.\
\
Step 5(b) (Copy 1). This step is completed by the laboratory to report
the test result of the split specimen [if]{.underline} the split
specimen is tested.

Step 6 (Copy 2). This step is completed by the MRO in reporting the
results of the primary specimen to the employer.

Step 7 (Copy 2). This step is completed by the MRO in reporting the
results of the split specimen to the employer.

The bottom area of Copy 1 is reserved for the tamper-evident specimen
bottle seals/labels. There must be two seals/labels (i.e., one marked
with the letter \"A\" to designate the primary specimen and the other
marked with the letter \"B\" to designate the split specimen) to
accommodate collecting split specimens. Each seal/label must have the
same preprinted specimen identification number that appears at the top
of the CCF. Each seal/label must also have a place for the collector to
annotate the date of the collection and a place for the employee to
initial each seal/label [after]{.underline} it is placed on the specimen
bottle.

> Note: No one (including collection site personnel or the collector) is
> permitted to require an employee to sign a consent, release, or waiver
> of liability, or indemnification agreement with respect to any part of
> the drug testing process. Collection sites (clinics) may not use
> "generic" consent forms for DOT-required urine specimen collections,
> even if their clinic policy requires consent from the general patient
> population.

**SECTION 5. EMPLOYEE IDENTIFICATION**\
\
The employee must provide appropriate identification to the collector
upon arrival at the collection site. Acceptable forms of identification
include:

1.  A photo identification (e.g., drivers license, employee badge issued
    by the employer, or any other picture identification issued by a
    Federal, state, or local government agency), or

2.  Identification by an employer or employer representative, or

3.  Any other identification allowed under an operating administration's
    rules.

Unacceptable forms of identification include:

> 1\. Identification by a co-worker,\
> \
> 2. Identification by another safety-sensitive employee,\
> \
> 3. Use of a single non-photo identification card (e.g., social
> security card, credit card, union or other membership cards, pay
> vouchers, voter registration card), or
>
> 4\. Faxed or photocopies of identification document.
>
> Note: If the employee cannot produce positive identification, the
> collector must contact a DER to verify the identity of the employee.
> The collection should not proceed until positive identification is
> obtained. However, if an [owner/operator]{.underline} or other
> [self-employed individual]{.underline} does not have proper
> identification, the collector should record in the remarks section
> that positive identification is not available. The owner/operator must
> be asked to provide [two]{.underline} items of identification bearing
> his/her signature. The collector then proceeds with the collection.
> When the owner/operator signs the certification statement, the
> collector compares the signature on the CCF with signatures on the
> identification presented. If the signatures appear consistent, the
> collection process continues. If the signature does not match
> signatures on the identification presented, the collector makes an
> additional note in remarks section stating \"signature identification
> is unconfirmed.\"

## SECTION 6. COLLECTION PROCEDURES

The collector must do the following [before]{.underline} each collection
to deter potential tampering, adulteration, alteration, or substitution
of the specimens:

> 1\. Secure any water sources or otherwise make them unavailable to
> employees (e.g., turn off water inlet, tape handles to prevent opening
> faucets);
>
> 2\. Ensure that the water in the toilet and tank (if applicable) has
> bluing (coloring) agent in it. Tape or otherwise secure shut any
> movable toilet tank top, or put bluing in the tank;
>
> 3\. Ensure that no soap, disinfectants, cleaning agents, or other
> possible adulterants are present;
>
> 4\. Inspect the site to ensure that no foreign or unauthorized
> substances are present;
>
> 5\. Ensure that undetected access (e.g., through a door not in your
> view) is not possible;
>
> 6\. Secure areas and items (e.g., ledges, trash receptacles, paper
> towel holders, under-sink areas) that appear suitable for concealing
> contaminants; and
>
> 7\. Recheck items (1) through (6) following each collection to ensure
> the site's continued integrity.

If the collection site uses a facility normally used for other purposes,
such as a public restroom or hospital examining room, the collector must
also ensure before the collection that:

> 1\. Access to collection materials and specimens is effectively
> restricted; and
>
> 2\. The facility is secured against access during the procedure to
> ensure privacy to the employee and prevent distraction of the
> collector. Limited-access signs must be posted.

To avoid distraction that could compromise security, the collector is
limited to conducting a collection for only one employee at a time.
However, during the 3 hour time period that an employee is consuming
fluids (shy bladder), the collector may conduct a collection for another
employee. In this case, the employee with the shy bladder must be
properly monitored (see Section 7).

When a specific time for an employee\'s test has been scheduled, or the
collection site is at the employee's work site, and the employee does
not appear at the collection site at the scheduled time, the collector
must contact the DER to determine the appropriate interval within which
the DER has determined the employee is authorized to arrive. If the
employee\'s arrival is delayed beyond that time, the collector must
notify the DER that the employee has not reported for testing.

> Note: For a [pre-employment test]{.underline}, if an employee fails to
> appear, fails to provide a urine specimen, or fails to remain at the
> collection site, this is [not]{.underline} considered a refusal
> provided the employee left the testing site or did not provide a
> specimen [before]{.underline} the testing process commenced (i.e., the
> employee was given the collection kit or cup by the collector).

**The following steps describe a typical urine collection conducted
under the DOT-mandated procedures:**\
\
1. The collector prepares the collection site to collect urine
specimens. All collection supplies must be available, the area properly
secured, water sources secured, and bluing (coloring) agent placed in
all toilets as specified in Sections 2 and 3 of these guidelines.\
\
2. The collector begins the collection without delay after the employee
arrives at the collection site. Do not wait because the employee is not
ready or states he or she is unable to urinate. In most cases, employees
who state they cannot provide a specimen will, in fact, provide
sufficient quantity to complete the testing process. (If an alcohol
breath test is also scheduled, the alcohol test should be conducted
first, if practicable.)\
\
3. The collector requests the employee to present an acceptable form of
identification. If the employee cannot produce positive identification,
the collector must contact the DER to verify the identity of the
employee (see Section 5). If the employee asks the collector to provide
identification, the collector must show the employee some form of
identification. It must include the collector's name and the employer's
(or collection site) name. It does not have to be a picture
identification or include the collector's home address or telephone
number.

4\. The collector explains the basic collection procedures to the
employee and reviews the instructions on the back of the CCF with the
employee.\
\
5. The collector ensures that the required information is provided at
the top of the CCF (the laboratory name and address and a pre-printed
specimen ID number which matches the ID number on the specimen bottle
seals). If the information is not already preprinted, the collector
begins entering the required information in Step 1 of the CCF
(employer\'s name, address, telephone and fax number, and I.D. number
(if applicable); MRO name, address, telephone and fax number; employee
SSN or employee ID number (refusal by the employee to provide a SSN is
not a refusal to test, but requires the collector to annotate this in
the remarks); reason for test; drug test to be performed; and collection
site information).

> Note: Part 40 requires a specific MRO\'s name and address on the CCF
> rather than the name of the clinic or medical facility. An employer
> must provide to the collector the name and telephone number of the
> appropriate DER. This may be part of the CCF information that is
> pre-printed or may be under separate documentation. If there is no
> employer or DER telephone number on the CCF, the collector should
> write in the DER name and telephone number on the CCF (if this
> information is available) so that either the collector or the MRO may
> get in touch with a company representative when any problems arise
> related to that specimen.

6\. The collector asks the employee to remove any unnecessary outer
clothing (e.g., coat, jacket, hat, etc.) and to leave any briefcase,
purse, or other personal belongings he or she is carrying with the outer
clothing. The employee may retain his or her wallet. If the employee
asks for a receipt for any belongings left with the collector, the
collector must provide one.

> Note: To safeguard employee's belongings, procedures may be
> established where the belongings are locked (at the collection site or
> in the bathroom) or other alternate methods may be developed. For
> example, if an employee comes to the collection site with his or her
> medications and desires that the collector secure the medication, the
> collector may place the medication in a locked cabinet, if available,
> or alternately, could seal the medication in an envelope, secure the
> envelope with tamper-evident tape and retain the envelope in a secure
> place.
>
> Note: The collector may encourage the employee to also leave, with his
> or her other belongings, any other items that the employee will not
> need or may be prohibited from carrying into the restroom.
>
> Note: The employee must not be asked to remove other articles of
> clothing, such as shirt, pants, dress, or under garments.
> Additionally, the employee must not be requested or required to remove
> all clothing in order to wear a hospital or examination gown. An
> exception may be made, if the employee is also undergoing a physical
> examination authorized by a DOT operating administration's rule, in
> conjunction with the drug test, which normally includes wearing a
> hospital gown. Work boots or cowboy boots do not have to be removed
> unless the collector has a reason to suspect that the employee has
> something in them, which may be used to adulterate or substitute a
> specimen. When an employee is asked to remove his or her hat or head
> covering, and refuses to do so based on religious practice, the
> collector may exempt the employee from removal of the head covering,
> unless the collector has an observable indicator that the employee is
> attempting to hide inside the head covering adulterants or other
> substances which may be used in an attempt to adulterate or substitute
> a specimen.

7\. The collector directs the employee to empty his or her pockets and
display the items to ensure that no items are present that could be used
to adulterate the specimen. If nothing is there that can be used to
adulterate a specimen, the employee places the items back into the
pockets and the collection procedure continues. If the employee refuses
to empty his or her pockets, this is considered a refusal to cooperate
in the testing process.

> Note: If an item is found that appears to have been brought to the
> collection site with the [intent]{.underline} to adulterate the
> specimen, a directly observed collection procedure becomes a
> requirement. If the item appears to be inadvertently brought to the
> collection site, secure the item and continue with the normal
> collection procedure. For example, a bottle of eye drops may have been
> brought inadvertently and would have to be secured by the collector
> and the collection would proceed. However, a bottle of liquid or urine
> would suggest intent to tamper with the specimen and a directly
> observed collection would be required. Whatever the employee brings
> into the collection site, the collector should return it to the
> employee at the end of the collection. Items, such as suspected urine,
> plastic bags with fluid in them, artificial or mechanical objects for
> providing substituted urine, etc., should be fully described in an
> attached memorandum for record, copies of which should be sent to the
> MRO and the employer.

8\. The collector instructs the employee to wash and dry his or her
hands, under the collector\'s observation, and informs the employee not
to wash his or her hands again until after the employee provides the
specimen to the collector. The employee must not be allowed any further
access to water or other materials that could be used to put into the
specimen.

> Note: The employee may use soap and, if practicable, it should be a
> liquid or cream. A solid bar of soap gives the employee the chance to
> conceal soap shavings under his or her fingernails and subsequently
> use them to attempt to adulterate the specimen.

9\. The collector either gives the employee or allows the employee to
select the collection kit or collection container (if it is separate
from the kit) from the available supply. Either the collector or the
employee, with both present, then unwraps or breaks the seal of the kit
or collection container.

> Note: Even if the collection kit is sealed, the collection container
> must still be sealed or individually wrapped in a plastic bag or
> shrink wrapping; or must have a peelable, sealed lid or other easily
> visible tamper-evident system. Do not unwrap or break the seal on any
> specimen bottle at this time. Unwrap only the collection container.\
> \
> Note: Ensure the employee takes only the collection container into the
> room used for urination. The sealed specimen bottles remain with the
> collector.

10\. The collector directs the employee to go into the room used for
urination, provide a specimen of at least 45 mL, [not]{.underline} to
flush the toilet, and return with the specimen as soon as possible after
completing the void. (In many restrooms, a toilet tank into which bluing
agent may be placed is not accessible to the collector. When the
employee flushes the toilet, he or she can use the clear (un-blued)
water to potentially dilute the specimen. Inadvertently flushing the
toilet does not automatically require any corrective action by the
collector or a recollection. However, to guard against this action, the
collector may want to place a card with instructions not to flush by the
toilet handle or tape or otherwise secure the handle with tamper-evident
tape.) The collector may set a reasonable time limit for the employee to
be inside the bathroom and this time frame should be explained to the
employee.

> Note: The collector should also tell the employee that the temperature
> of the specimen is a critical factor and that the employee should
> bring the specimen to the collector as soon as possible after
> urination. The collector should inform the employee that if it is
> longer than 4 minutes from the time the employee urinates into the
> container and the collector takes the specimen temperature, the
> potential exists that the specimen may be out of range and an observed
> collection may be required.
>
> Note: The collector should pay close attention to the employee during
> the entire collection process to note any conduct that clearly
> indicates an attempt to substitute or adulterate a specimen. If the
> collector detects such conduct, and the employee has already provided
> a specimen, the collection process for this specimen is completed, and
> then the collector immediately begins a new collection under direct
> observation using a second CCF and a new kit. The collector then
> provides an appropriate comment on the \"Remarks\" line in Step 2 on
> the first CCF and second CCF indicating that this is the first of two
> or second of two (i.e., 1 of 2, 2 of 2) collections, the specimen ID
> numbers of the first and second CCF, the reason for the second
> collection, and that the second collection was under direct
> observation (check appropriate box in Step 2 of the CCF). This will
> ensure that the laboratory and the MRO know that two separate
> specimens are being submitted for testing; the first one possibly
> being adulterated or substituted. Additionally, the collector must
> inform the collection site supervisor and the DER that a collection
> took place under direct observation and the reason for having done so.

11\. After the employee gives the specimen to the collector, the
collector must check the temperature of the specimen, check the specimen
volume, and inspect the specimen for adulteration or substitution. The
collector should check the temperature of the specimen as soon as the
employee hands over the specimen, but no later than four minutes after
the employee comes out of the restroom. The acceptable temperature range
is 32-38C/ 90-100F. Temperature is determined by reading the temperature
strip originally affixed to or placed on the outside of the collection
container. If the temperature is within the acceptable range, the
\"Yes\" box is marked in Step 2 on the CCF and the collector proceeds
with the collection procedure. (If the temperature is out of range, the
collector marks the "No" box in Step 2 and initiates an observed
collection.) The collector then checks to make sure that the specimen
contains a sufficient amount of urine (a minimum of 45 mL for all DOT
collections). If the volume is sufficient, the collector checks the box
on the CCF (Step 2) indicating that this was a split specimen
collection. (This may be done at the same time that the collector checks
the temperature box.) The collector must inspect the specimen for
unusual color, presence of foreign objects or material, or other signs
of tampering or adulteration. If it is apparent from this inspection
that the employee has adulterated or substituted the specimen (e.g., the
specimen is blue, exhibits excessive foaming when shaken, has smell of
bleach), a second collection using direct observation procedures must be
conducted immediately. If the temperature is outside the acceptable
range, the volume is less than 45 mL, or the specimen may have been
adulterated, the collector follows procedures in Section 10. Problem
Collections.

12\. After the employee hands the collection container to the collector,
the collector unwraps or opens the specimen bottles. (The employee may
be permitted to do this, however, the recommended "best practice" is for
the collector to perform this procedure.) Bottles may be shrink-wrapped
or secured by other easily discernable tamper-evident methodology and
may be wrapped separately or together.

> Note: Both the collector and employee will maintain visual contact of
> the specimen to the greatest extent possible until the labels/seals
> are placed over the specimen bottle caps/lids. If practical, the
> collector may permit the employee to wash his or her hands right after
> the employee gives the collection container to the collector (and the
> collector checked the temperature), provided the employee and the
> collector can still maintain visual control of the specimen collection
> container.

13\. The [collector, not the employee]{.underline}, then pours at least
30 mL of urine from the collection container into a specimen bottle and
places the lid/cap on the bottle. This will be the primary specimen or
\"A\" bottle. The [collector, not the employee]{.underline}, then pours
at least 15 mL into a second bottle and places the lid/cap on the
bottle. This will be the \"B\" bottle used for the split specimen. (The
collector may first pour the requisite amount of specimen into each
bottle and then secure the lids/caps on each bottle.)

> Note: The collector should [not]{.underline} fill the primary or split
> specimen bottle up to the cap because a completely full bottle is more
> likely to leak in transit. Additionally, when a split specimen bottle
> is full and subsequently frozen, it may cause the bottle material to
> crack and then leak during transit as the specimen thaws.

14\. The [collector, not the employee]{.underline}, must then remove the
tamper-evident seals from the CCF and place them on each bottle,
ensuring that the seal labeled as "A" is placed on the primary bottle
with at least 30 mL of urine and that the seal labeled as "B" is placed
on the bottle with 15 mL of urine. The seal must be centered over the
lid/cap and down the sides of the bottle to ensure that the lid/cap
cannot be removed without destroying the seal. The collector, not the
employee, writes the date on the seals. The employee is then requested
to initial the seals. The employee must be present to observe the
sealing of the specimen bottles. If the employee fails or refuses to
initial the seals, the collector must note this in the "Remarks" line of
the CCF and complete the collection process; this is [not]{.underline}
considered a refusal to test.

> Note: The collector must [not]{.underline} ask the employee to initial
> the labels/seals while they are still attached to the CCF; they must
> be initialed after they are placed on the bottles. The collector
> should also inform the employee to use care during the initialing
> process to avoid damaging the labels/seals.
>
> Note: Occasionally, the tamper-evident label/seal provided with the
> CCF will not properly adhere to the specimen bottle because of
> environmental conditions (e.g., moisture, temperature, specimen bottle
> material) or may be damaged or broken during the collection process.
> When this occurs, the collector should use the following corrective
> procedures:
>
> \(a\) If the seal is broken while being removed from the chain of
> custody form or during the application of the first seal on the
> primary bottle, the collector should transfer the information to a new
> CCF and use the seals from the second form.
>
> \(b\) If one seal is already in place on a bottle and the second seal
> is broken while being removed from the CCF [or]{.underline} is broken
> during application on the second bottle [or]{.underline} while the
> employee is initialing either seal, the collector should initiate a
> new CCF and provide an appropriate comment on the "Remarks" line in
> Step 5. The seals from the second CCF should be placed perpendicular
> to the original seals to avoid obscuring information on the original
> seals and must be initialed by the employee (both sets of employee
> initials should match). The collector should draw a line through the
> Specimen ID number and bar code (if present) on the original seals to
> ensure that the laboratory does not use that number for reporting the
> results. The collector should [not]{.underline} pour the specimen into
> new bottles.
>
> \(c\) In both cases, the collector should ensure that all copies of
> the original (first) chain of custody form are destroyed or disposed
> of properly (e.g., shredded, torn into pieces).
>
> \(d\) If the collector inadvertently reverses the seals (i.e., places
> the "A" bottle seal on the split bottle and vise-versa) and the
> collector subsequently notices this, the collector should note this in
> the "Remarks" line and continue the collection process. Laboratories
> have procedures that permit them to "re-designate" the bottles.
>
> Note: There is no corrective procedure available if the seal is broken
> after the employee leaves the collection site.
>
> Note: Since the specimen bottle is now sealed with tamper-evident tape
> and does not have to be under the employee\'s direct observation, the
> employee is allowed to wash his or her hands if he or she desires to
> do so.

15\. The collector directs the employee to read, sign, and date the
certification statement, and provide date of birth, printed name, and
day and evening contact telephone numbers in Step 5 of Copy 2 of the
CCF.

> Note: If the employee refuses to sign the form or provide date of
> birth, printed name, or telephone numbers, the collector must make a
> notation on the \"Remarks\" line to that effect and complete the
> collection. If the employee refuses to fill out any information, the
> collector must, as a minimum, print the employee's name in the
> appropriate place. This does not constitute a refusal to test.

16\. The collector completes the collector's portion of the chain of
custody on the CCF (Copy 1, Step 4) by printing his or her name (the
name may be pre-printed), recording the date and time of the collection,
signing where indicated, and entering the specific name of the delivery
or courier service transferring the specimens to the laboratory.

17\. The collector then ensures that all copies of the CCF are legible
and complete. The collector removes Copy 5 from the CCF and gives it to
the employee.

> Note: At this time, the collector can suggest that the employee list
> any prescription and over-the-counter medications he or she may be
> taking on the employee's copy (Copy 5) of the CCF, but not on any
> other copy. This information may help the employee remember what
> medications he or she may have taken if a positive result is reported
> by the laboratory to the MRO.

18\. The collector places the specimen bottles and Copy 1 of the CCF
inside the appropriate pouches of the leak-resistant plastic bag, and
seals both pouches. If the employee has not had the opportunity to wash
his or her hands, they may do so now. The collector then informs the
employee that he or she may leave the collection site.

19\. Any urine specimen left over in the collection container after both
specimen bottles have been appropriately filled and sealed should be
discarded at this time. Excess urine may be used to conduct clinical
tests (e.g., protein, glucose) [if]{.underline} the collection was
conducted in conjunction with a physical examination required by a DOT
operating administration's regulation. No further testing (e.g.,
adulteration testing, DNA, additional drugs) may be conducted on this
excess urine and the employee has no right to demand that the excess
urine be turned over to the employee.

20\. The collector places the sealed plastic bag in an appropriate
shipping container (e.g., box, express courier mailer) designed to
minimize the possibility of damage during shipment. More than one sealed
plastic bag can be placed into a single shipping container if there are
multiple collections. The collector seals the shipping container as
appropriate. If a laboratory courier hand-delivers the specimens from
the collection site to the laboratory, the collector prepares the
shipment as directed by the courier service. In this case, the plastic
bag may not need to be placed into a shipping container, but still needs
to be transported by the courier in a manner that protects the bottles
from damage.

> Note: If the laboratory courier does not hand-deliver the specimens to
> the laboratory, but subsequently places the specimens into a
> commercial delivery system, the specimens must be placed into a
> shipping container to minimize damage in transit.

21\. The collector then sends Copy 2 of the CCF to the MRO and Copy 4 to
the DER (or service agent if authorized by the employer). The collector
must fax or otherwise transmit these copies to the MRO and DER within
[24 hours]{.underline} or during the [next business day]{.underline} and
keep Copy 3 for at least 30 days, unless otherwise specified by
applicable DOT operating administration's regulations.

> Note: The MRO copy (Copy 2) may be faxed to the MRO's secure fax
> machine, it may be scanned and the image sent to the MRO's secure
> computer, or it may be mailed or sent by courier to the MRO. (It is
> recommended that the MRO copy be faxed, since it is critical for the
> MRO to have this document to expeditiously conduct the verification
> process.) In the case where the MRO copy (Copy 2) is faxed or the
> scanned image is sent securely to the MRO, the collector or the
> collection site should maintain the MRO copies together with the
> collector's copies for 30 days. Retention is in case the MRO's copy is
> lost in the mail or the faxed or scanned copy is not legible and
> another copy is required by the MRO. The transmission process must be
> coordinated between the collection site and the MRO to ensure that
> transmission procedures meet the MRO's requirements (e.g., MROs must
> provide secure fax numbers to collection sites, some MROs may want
> hard copies mailed; others may want only faxed copies).

22\. The collector or collection site must ensure that each specimen
collected is shipped to a laboratory as quickly as possible, but in any
case within [24 hours]{.underline} or during the [next]{.underline}
[business day]{.underline}.

23\. If the specimen will not be shipped immediately, the collector is
responsible for ensuring its integrity and security. Specimens in
plastic bags, which have not been placed into shipping containers or
which are awaiting a laboratory courier, must be kept in a secure
location. The specimens need not be under lock and key, however,
procedures must exist that would ensure specimens cannot be subject to
tampering.

> Note: After specimens are placed into shipping containers that are
> subsequently sealed, the shipping containers may be placed with other
> containers or packages that the collection site has waiting to be
> picked up by a courier. It is expected that collection sites will use
> reasonable security to ensure that all of their packages are
> relatively secure and not subject to damage, theft, or other actions
> that would potentially raise questions related to the integrity of the
> specimens.
>
> Note: Couriers, postal employees, and other personnel involved in the
> transportation of the sealed shipping container are [not]{.underline}
> required to make, and should not attempt to make, additional chain of
> custody entries on the custody and control form.

[The collection process is now complete]{.underline}.

**SECTION 7. SHY BLADDER PROCEDURES**\
\
The term \"shy bladder\" refers to a situation when the employee does
not provide a sufficient amount of urine (45 mL) for a DOT-required drug
test. If an employee tells the collector, upon arrival at the collection
site, that he or she [cannot provide a specimen]{.underline}, the
collector [must still begin]{.underline} the collection procedure
regardless of the reason given. The collector should tell the employee
that most individuals can provide 45 mL of urine, even when they think
they cannot urinate, and direct the employee to make the attempt to
provide the specimen.\
\
At the point in the collection procedure where the collector and
employee unwrap/open a collection container, the collector does the
following:

> 1\. The collector requests the employee to go into the rest room and
> try to provide a specimen.
>
> Note: The employee demonstrates his or her inability to provide a
> valid specimen when the employee comes out of the rest room with an
> insufficient quantity of specimen or an empty collection container.
>
> 2\. If the employee provided an initial insufficient specimen, the
> collector discards the insufficient specimen. The collector then
> annotates in the "Remarks" line the time when the employee provided
> the insufficient specimen. This is the time when the "shy bladder"
> collection process starts.
>
> Note: If there was actually no specimen provided on an attempt, the
> same collection container may be used for the next attempt (the
> employee may keep possession of the container during the waiting
> period). The collector uses the same CCF and continues to document
> subsequent collections on the same form.
>
> Note: If the insufficient specimen is also out of temperature range
> (assuming there was sufficient specimen to activate the temperature
> strip) or shows evidence of adulteration or tampering, the collector
> completes the collection process, sends the insufficient specimen
> (temperature out of range or adulterated) to the laboratory and
> immediately initiates another collection under direct observation.
>
> 3\. The collector explains to the employee the process for a shy
> bladder collection and urges the employee to drink up to 40 ounces of
> fluids, distributed reasonably through a period of up to three hours,
> or until the individual has provided a sufficient urine specimen,
> whichever occurs first. It is [not a refusal]{.underline} to test if
> the employee [declines]{.underline} to drink.
>
> Note: Collectors should be sensitive to how frequently they should ask
> the employee to provide a specimen. For example, asking the employee
> to provide a specimen every half hour may not produce sufficient
> specimen, although in total, the amount would have been at least 45
> mL. In this case, the collector needs to determine if a longer time is
> needed for the employee to consume fluids and produce a sufficient
> volume of specimen. If the employee refuses to drink fluids, this is
> [not]{.underline} considered a refusal to test, although the collector
> should explain to the employee that not drinking sufficient fluids may
> result in the employee's inability to provide a sufficient specimen
> and would require a medical evaluation. Under [no]{.underline}
> circumstances can a collector "combine" urine collected from separate
> voids to create one specimen of sufficient volume.
>
> 4\. If the employee refuses to make the attempt to provide a new urine
> specimen or leaves the collection site before the collection process
> is completed, the collector must discontinue the collection, note the
> fact on the "Remarks" line of the CCF (Step 2), and immediately notify
> the DER. This is a refusal to test.
>
> 5\. If the employee has not provided a sufficient specimen within
> three hours of the first unsuccessful attempt to provide the specimen,
> the collector must discontinue the collection, note the fact on the
> "Remarks" line of the CCF (Step 2), and immediately notify the DER.
>
> Note: The collector should maintain a record in the "Remarks" line on
> the CCF of the time of each attempt, whether there was any specimen
> provided or the quantity of specimen provided, and the amount of
> fluids that the employee was given to drink. During the waiting time,
> the employee must be monitored by the collector (the one conducting
> the collection or another collector at the site) or by another
> responsible collection site staff member or a company representative.
> The collector must specifically tell the employee that he or she is
> not permitted to leave the collection site and if they do so, that it
> will be considered a refusal to test.
>
> 6\. The collector then sends Copy 2 of the CCF to the MRO and Copy 4
> to the DER. This is done even if the employee did not provide any
> specimen in order to notify the MRO and the employer of the problem.
> The collector must send or fax these copies to the MRO and DER within
> [24 hours]{.underline} or the [next business day]{.underline}.

**SECTION 8. DIRECTLY OBSERVED COLLECTION**\
\
A directly observed collection procedure is the same as a routine
collection procedure with the additional requirement that an observer
physically watches the employee urinate into the collection container.
The observer [must]{.underline} be the same gender as the employee;
there are [no exceptions]{.underline} to this requirement.\
\
[An observed collection is required when]{.underline}:

1\. The employer or DER directs the collector (or collection site) to
conduct a collection under direct observation.

> Note: The employer is [required]{.underline} to conduct a directly
> observed collection when the laboratory reports an invalid specimen
> and the MRO reports that there was not an adequate medical explanation
> for the result, or because the split specimen test could not be
> performed (e.g., split lost, inadequate volume). The employer
> [may]{.underline} direct an observed collection if the test is a
> return-to-duty or follow-up test. An employee may [not]{.underline}
> "volunteer" to have his or her specimen collected under direct
> observation.

2\. The collector observed materials brought to the collection site or
the employee's conduct clearly indicated an attempt to tamper with a
specimen.

3\. The temperature on the original specimen was out of range or the
specimen appeared to have been tampered with.

> Note: The collector may serve as the observer when the collector is
> the same gender as the employee. If not, the collector must call upon
> another individual (who is the same gender as the employee) to act as
> the observer. The collector must verbally instruct the observer as to
> the procedures the observer must follow and specifically inform the
> observer not to take the specimen from the employee, but have the
> employee bring it to the collector. It is recommended that the
> collector have a short written outline of the procedures to be used
> for an observed collection, review these procedures with the observer,
> and provide a copy of the written procedures to the observer, if the
> observer requests it.

[An observed collection is conducted in the following
manner]{.underline}:

> 1\. The collector must explain to the employee why a directly observed
> collection is being conducted. If the directly observed collection is
> requested by the employer, the collector may state the reason (if
> known) or may only state that the employer requested a directly
> observed collection.
>
> 2\. The collector must complete a new CCF for the directly observed
> collection and mark the "reason for test" block (Step 1) the same as
> for the first collection (unless it is a return-to-duty or follow-up
> test).
>
> 3\. The collector then checks the "Observed, (Enter Remark)" box and
> enters the reason in the "Remarks" line (Step 2) and the name of the
> observer if it is someone other than the collector.
>
> 4\. In a case where two sets of specimens are being sent to the
> laboratory because of suspected tampering with the first specimen, the
> collector enters on the "Remarks" line of the CCF (Step 2) for each
> specimen a notation to this effect (e.g., collection 1 of 2, or 2 of
> 2) and the CCF specimen ID number of the other specimen.
>
> 5\. The collector, if the same gender as the employee, or the same
> gender observer enters the restroom or facility where urination occurs
> with the employee. If it is a multi-stall restroom, the
> collector/observer must enter the stall with the employee. The
> collector/observer must watch the employee urinate into the collection
> container. Specifically, the collector/observer must personally and
> directly watch the urine go from the employee's body into the
> collection container (use of mirrors or video cameras is not
> permitted).
>
> 6\. After the employee has completed urinating into the collection
> container, the employee and observer leave the enclosed toilet
> stall/restroom and the employee hands the collection container
> directly to the collector. The observer must maintain visual contact
> of the collection container until the employee hands the container to
> the collector. If the observer is the collector, the collector may
> receive the collection container from the employee while they are both
> in the enclosed toilet stall/restroom.
>
> 7\. If the employee declines to allow a directly observed collection
> required or permitted by Part 40 to occur, the collector discards any
> specimen the employee provided previously and notifies the DER as soon
> as possible. This is considered a refusal to test.
>
> 8\. If the collector learns that a directly observed collection
> [should]{.underline} have taken place, but was not, the collector must
> inform the employer that the employee must be directed to return for
> an immediate recollection under direct observation.

## SECTION 9. MONITORED COLLECTIONS

A monitored collection is one that is conducted under less than
completely private conditions, utilizing a multi-stall restroom. If
there is no practicable work place outside of the restroom, the
collector may set up an area within the multi-stall restroom to be used
as a work area and for finalizing the required paper work. (A collection
which is [not]{.underline} monitored may also be conducted in a
multi-stall restroom, provided that the collector secures all of the
stalls (bluing agent, etc.), secures all water sources and other
potential sources of adulterants (soap dispensers) in the restroom, and
posts signs or otherwise secures the restroom from entry by unauthorized
personnel.)

[A monitored collection is conducted in the following
manner]{.underline}:

> 1\. The collector must secure the room being used for the monitored
> collection so that no one except the employee and the monitor can
> enter it until after the collection has been completed.
>
> 2\. The monitor must be the same gender as the employee, unless the
> monitor is a medical professional (e.g., nurse, doctor, physician's
> assistant, technologist or technician licensed or certified to
> practice in the jurisdiction in which the collection takes place). The
> monitor can be a different person from the collector and need not be a
> qualified collector.
>
> 3\. If someone other than the collector is to monitor the collection
> procedure (i.e., the collector is not a medical professional), the
> collector must verbally instruct that person to use the following
> procedures (if the collector is the monitor, the collector must also
> follow these procedures):
>
> \(a\) A monitor stands outside the stall and does [not]{.underline}
> watch the employee urinate. If the monitor hears sounds or makes other
> observations indicating an attempt to tamper with a specimen by the
> employee, there must be an additional collection conducted under
> direct observation.
>
> \(b\) A monitor must ensure that the employee takes the collection
> container directly to the collector as soon as the employee has exited
> the enclosure.
>
> 4\. When someone besides the collector has acted as the monitor, the
> collector must note that person's name in the "Remarks" line of the
> CCF (Step 2).
>
> 5\. If the employee declines to permit a collection authorized under
> Part 40 to be monitored, it is a refusal to test.

**SECTION 10. PROBLEM COLLECTIONS**

[CATHETERIZATION]{.underline}.

If an employee needs medical attention (e.g., an injured employee in an
emergency medical facility who is required to have a post-accident
test), treatment takes priority and should not be delayed to collect a
specimen. If an employee is catheterized as part of a [medical
procedure]{.underline} (following an accident), once the employee's
medical condition is [stabilized]{.underline} and the employee can give
his or her consent to the collection (e.g., understand that a DOT
collection is required, can sign the CCF), a urine specimen should be
obtained from that employee. Procedures similar to those listed below
may be used when an external urine bag is involved. A urine specimen
must [not]{.underline} be collected, by catheterization or other means,
from an unconscious employee to conduct a DOT-required drug test.
Catheterization of a conscious employee to obtain a urine specimen for a
DOT-required test is also [not]{.underline} authorized. However, an
employee who normally voids through intermittent or self-catheterization
is required to provide a specimen in that manner if he or she is
required to produce a specimen for a DOT test. If able to, the employee
may provide the specimen directly from the catheter into the collection
container in the privacy of a restroom. If an employee, who normally
voids through self-catheterization, declines to do so, this would
constitute a refusal to test.

[EXTERNAL URINE BAG]{.underline}.

The following procedures should be used in the collection of a urine
specimen from an employee who has a medical condition requiring an
indwelling catheter or excretion of urine into an external bag. The
urine specimen should be a freshly voided specimen. If an employee with
an indwelling catheter may urinate directly into a collection container.
In the case of an employee with an external bag, the employee should be
asked to empty his or her bag in the privacy of a bathroom, show the
empty bag to the collector, and then drink sufficient fluids at the
collection site to provide 45 mL of urine, which can be subsequently
poured by the employee from the bag into a collection container in the
privacy of a bathroom. In this case, the temperature of the specimen
would not be a critical factor. The collector should be keenly aware of
the potential embarrassment that this type of collection can cause the
employee and should conduct the collection with appropriate decorum.

This procedure would not have to be done in a medical environment/health
clinic or by a collector of the same gender, although the collector may
try to accommodate the employee (e.g., conduct the collection at a
medical facility, have the same gender collector) if the employee
requests this and if it would not significantly delay the collection
process. If the employer is aware of this situation prior to the actual
collection (e.g., because the employee had previously expressed a desire
to provide the specimen in a medical setting, requested a same gender
collector, told the employer about the medical condition and its impact
on urine collection for drug testing), the employer (collection site)
may establish or modify procedures as needed to permit the employee to
provide a specimen in a way consistent with the employee's privacy while
still meeting regulatory requirements. In the case of a collection based
on a post-accident or reasonable suspicion requirement, the collector
may attempt to honor the employee's request (for the collection to be
conducted in a medical setting or for the collector to be the same
gender) if the collection can be accomplished within a reasonable time
frame.

The above scenario assumes that the employee's medical condition is not
one that decreases or completely prohibits renal output, and that the
employee can produce normal amounts of urine that is excreted into an
external bag. Therefore, an employee with this or similar medical
conditions would be subject to the same testing requirements (e.g.,
pre-employment, random) and to the "shy bladder" protocol (three hours
and 40 ounces of fluids) as an employee with no medical condition. If an
employee who normally voids in this manner declines to provide a urine
specimen under these conditions, it would constitute a refusal to test.

[TEMPERATURE]{.underline}. The collector should check the temperature of
the specimen as soon as the employee hands over the specimen, but no
later than four minutes after the employee comes out of the restroom.
The acceptable temperature range is 32-38C/ 90-100F. Temperature is
determined by reading the temperature strip originally affixed to or
placed on the outside of the collection container after the employee
hands the specimen to the collector.

> \(a\) If the temperature is within the acceptable range, the \"Yes\"
> box is marked in Step 2 on the CCF and the collector proceeds with the
> collection procedure.\
> \
> (b) If the temperature is outside the acceptable range, the \"No\" box
> is marked in Step 2 on the CCF and if the temperature was below or
> above the acceptable range should be noted in the "Remarks" line. The
> collector completes the collection process for the "first" specimen
> and immediately begins a "second" collection under direct observation
> using a second CCF and a new kit. The collector then provides an
> appropriate comment on the \"Remarks\" line in Step 2 on the first CCF
> and second CCF indicating that this is the first of two or second of
> two collections, the specimen ID numbers of the first and second CCF,
> the reason for the second collection, and that the second collection
> was under direct observation. This will ensure that the laboratory and
> the MRO know that two separate specimens are being submitted for
> testing; the first one possibly being adulterated or substituted.
> Additionally, the collector must inform the collection site supervisor
> and the DER that a collection took place under direct observation and
> the reason for doing so.
>
> Note: There is no requirement to take the employee's body temperature
> if the specimen temperature is out of range. If the collector suspects
> that the temperature strip was not activated, the collector should
> pour the urine specimen into another collection container with a
> temperature strip or into a specimen bottle which has a temperature
> strip attached, and use this method to determine the specimen
> temperature. Collectors should [not]{.underline} introduce any other
> object (e.g., litmus paper, testing strips, etc.) into the specimen in
> the collection container or the bottles.

[SPECIMEN VOLUME]{.underline}. The collector checks to make sure that
the specimen contains a sufficient amount of urine (a minimum of 45 mL
for all DOT collections). If the volume is sufficient, the collector
checks the box on the CCF (Step 2) indicating that this was a split
specimen collection. (This may be done at the same time that the
collector checks the temperature box.)

If the volume is less than 45 mL, the action taken will depend on
whether the temperature of the specimen is in or outside the acceptable
temperature range.

> \(a\) If the temperature [is]{.underline} in the acceptable range, the
> specimen is discarded and a second specimen is collected. The
> collector may use the original CCF for the second specimen, but should
> annotate in the "Remarks" line the time that the first insufficient
> specimen was provided by the employee and the fact that this is a
> second collection (the time annotation is important since this may
> become a "shy bladder" situation). The collector should use a new
> specimen collection container, if these are available separately or a
> new kit.
>
> \(b\) If the temperature is [outside]{.underline} the acceptable
> range, a second specimen [must]{.underline} be collected under [direct
> observation]{.underline} and both specimens are sent to the laboratory
> for testing. The collector must use a separate CCF and kit for each
> specimen and provide an appropriate comment on each CCF to indicate
> why two specimens were collected.

[ADULTERATION OR SUBSTITUTION]{.underline}. The collector must inspect
the specimen for unusual color, presence of foreign objects or material,
or other signs of tampering or adulteration. If it is apparent from this
inspection that the employee has adulterated or substituted the specimen
(e.g., the specimen is blue, exhibits excessive foaming when shaken, has
smell of bleach), a second collection using direct observation
procedures must be conducted immediately. The first specimen and the
second specimen collected using direct observation are
[both]{.underline} sent to the laboratory for testing. The first
specimen is always sent to the laboratory even though it may have had an
insufficient volume, but showed signs of tampering.\
\
If the employee does not provide the required amount of urine for the
second collection using direct observation, the collector annotates the
time the second specimen was not provided and initiates the shy bladder
procedures. If after 3 hours the employee still cannot provide a
sufficient amount of specimen, the collector ends the collection process
and informs the DER. The collector must send or fax Copy 2 of the CCF to
the MRO and Copy 4 to the DER within 24 hours or the next business day.
The collector [must]{.underline} send the original specimen to the
laboratory with an annotation that the specimen was suspected of being
adulterated or substituted, that a second collection was attempted, but
that a shy bladder prevented collection of a second specimen.

> Note: In a case where the employee refuses to provide another specimen
> or refuses to provide a specimen under direct observation, the
> collector discards any specimen the employee provided previously
> during the collection and then notifies the DER that the employee
> refused to comply with a DOT test.

SECTION 11. BLIND QUALITY CONTROL SAMPLES

An employer or Consortia/Third Party Administrator (C/TPA) with an
aggregate of 2000 or more DOT-covered employees, must send blind quality
control samples to laboratories they use. If the employer or C/TPA have
an aggregate of fewer than 2000 DOT-covered employees, they are not
required to provide blind quality control samples.

To [each laboratory]{.underline} to which an employer or C/TPA sends at
least 100 specimens in a year, they must transmit a number of blind
quality control samples equivalent to one percent of the specimens sent
to that laboratory, up to a maximum of 50 blind quality control samples
in each quarter (i.e., January-March, April-June, July-September,
October-December). A C/TPA must apply this percentage to the total
number of DOT-covered employees\' specimens it sends to the laboratory.
Blind quality control sample submissions must be evenly spread
throughout the year.

> Note: In general, the employer determines who will conduct the
> regulatory requirement for the employer to submit blind quality
> control samples. It may be the employer itself, the collection site,
> MRO, or the C/TPA. However, regardless of who purchases the blind
> quality control samples, they must be submitted through the normal
> collection procedures used by the employer and must be
> indistinguishable by the laboratory from normal specimens sent by the
> collection site for DOT testing.

The collector always submits the blind quality control sample using the
same CCF as that used for an employee specimen. The collector provides
the required information to ensure that the CCF has been properly
completed as well as providing fictitious initials on the specimen
bottle labels/seals. Since there is no employee, the collector must
indicate that the sample is a \"blind quality control\" on the MRO copy
where the employee would normally provide a signature (Step 5 on Copy 2
of the CCF).

> Note: For a blind quality control sample, Copies 4 and 5 of the CCF
> (the employer and employee copy) may be discarded by the collector,
> unless the employer or the service agent requires the employer copy
> (in this case, the collector must ensure that the employer copy has
> the same "blind quality control" annotation as the MRO copy). All
> blind quality control samples must be submitted as DOT split specimen
> collections. Blind quality control samples may be obtained from
> companies listed on the HHS Internet web site
> (http://workplace.samhsa.gov/).

**SECTION 12. CORRECTING COLLECTION PROBLEMS\
\
**When an HHS certified laboratory receives specimen bottles and the
associated CCF, it checks to see if the specimen ID number on the
specimen bottle labels/seals matches the number on the CCF, that the
specimen bottle seals are intact, that there is sufficient specimen
volume, and that the CCF has been properly completed by the collector.
If there is any discrepancy and/or error of omission (i.e., the
collector did not sign the chain of custody, the collector did not check
the temperature box), the laboratory will contact the collector to
determine if the discrepancy and/or missing information can be
recovered. That is, the collector can provide a written memorandum
attesting to the fact that he or she inadvertently forgot to properly
document the CCF.

> Note: If a fatal flaw exists in the collection process or a memorandum
> for record or other written statement cannot be provided by the
> collector to related to a correctable flaw, the laboratory will report
> \"Rejected for Testing\" to the MRO and provide an appropriate comment
> as to why the specimen was not tested. If the reason for rejecting the
> test was a collector error, when a test is cancelled by the MRO, the
> collector who collected the specimen will need to go through an error
> correction training process within 30 days addressing the specific
> problem that caused the specimen to be cancelled.\
> \
> Note: Once contacted by the laboratory or the MRO, the collector
> should immediately provide a statement or memorandum to recover the
> discrepancy and/or error of omission. Laboratories are required by HHS
> to retain these specimens for a minimum of 5 business days before they
> may be discarded; therefore, it is critical that the collector respond
> immediately to the laboratory's request for corrective action.

The collector has the responsibility of trying to successfully complete
a collection procedure for each employee.

> 1\. If, during or shortly after the collection process, the collector
> becomes aware of any event that prevents the completion of a valid
> test or collection (e.g., a procedural or paperwork error), the
> collector must try to correct the problem promptly, if doing so is
> practicable. The collector may initiate another collection as part of
> this effort. However, the collector [must not]{.underline} recall an
> employee for another collection once the employee has left the
> collection site. There is one [exception]{.underline}: when the
> collector learns that a directly observed collection should have been
> conducted, but was not, the collector must notify the employer to
> direct the employee to return for an immediate recollection under
> direct observation.
>
> 2\. If another collection is necessary, the collector must begin the
> new collection procedure as soon as possible, using a new CCF and a
> new collection kit.
>
> Note: If the collector becomes aware of a problem that can be
> corrected, but which has not already been corrected, the collector
> must take all practicable actions to correct the problem so that the
> test is not cancelled.
>
> 3\. If the problem resulted from the omission of required information,
> the collector must, as the person responsible for providing that
> information, supply in writing the missing information and a statement
> that it is true and accurate. For example, suppose the collector
> forgot to make a notation on the "Remarks" line of the CCF that the
> employee did not sign the certification. The collector would, when the
> problem is called to his or her attention, supply a signed statement
> that the employee failed or refused to sign the certification and that
> the collector's statement is true and accurate. The collector must
> supply this information on the same business day on which he or she is
> notified of the problem, transmitting it by fax or courier.
>
> Note: If the problem is the use of a non-Federal form, the collector
> must, as the person responsible for the use of the incorrect form,
> provide a signed statement that the incorrect form contains all the
> information needed for a valid DOT drug test, that the incorrect form
> was used inadvertently or as the only means of conducting a test, in
> circumstances beyond the collector's control. The statement must also
> list the steps the collector has taken to prevent future use of
> non-Federal forms for DOT tests. For this flaw to have been corrected,
> the test of the specimen must have occurred at a HHS-certified
> laboratory where it was tested using the testing protocol in this
> part. The collector must supply this information to the laboratory on
> the same business day on which he or she is notified of the problem,
> transmitting it by fax or courier.
>
> 4\. If the problem is the use of a non-Federal CCF or an expired
> Federal form, the collector must provide a signed statement (e.g., a
> memorandum for record). The documentation must state that the
> incorrect form contains all the information needed for a valid DOT
> drug test, and that the incorrect CCF was used inadvertently or as the
> only means of conducting a test, in circumstances beyond the
> collector's control. The memorandum must also list the steps the
> collector took to prevent future use of non-Federal or expired Federal
> CCFs for DOT tests. This information must be supplied to the
> laboratory on the same business day that the collector is notified of
> the problem, and may be transmitted by fax or courier.
>
> 5\. The collector must maintain a copy of the written and dated
> documentation of correction with the appropriate CCF. The collector
> must also mark the CCF in such a way (e.g., stamp noting correction,
> written notation) that it would be obvious on the face of the CCF that
> the corrected (missing) information was supplied.

## SECTION 13. DOT-REGULATED AND NON-REGULATED EMPLOYERS

Employers regulated by the Department of Transportation (as well as
Federal agencies) are required to use the OMB approved Federal Drug
Testing Custody and Control Form for their workplace drug testing
programs. All other employers or private sector companies and non-DOT
testing conducted by DOT-regulated employers are
[prohibited]{.underline} from using the Federal CCF. (The Federal
Railroad Administration has specific CCFs, which must be used for
post-accident testing in the railroad industry.)\
\
In the rare instance where the collector, either by mistake or as the
only means to conduct a test under difficult circumstances (e.g.,
post-accident test with insufficient time to obtain the CCF), uses a
non-Federal form for a regulated collection, the use of a non-Federal
form does not, in and of itself, present a reason for the laboratory to
reject the specimen for testing or for the MRO to cancel the test.
However, if the laboratory or the MRO discovers the use of the incorrect
form, a signed statement must be obtained from the collector stating the
reason why the Federal CCF was not used for the regulated collection.

**APPENDIX A - DOT STANDARDS FOR URINE COLLECTION KITS**

1\. [Collection Container]{.underline}

a\. Single-use container, made of plastic, large enough to easily catch
and hold at least 55 mL of urine voided from the body.

b\. Must have graduated volume markings clearly noting levels of 45 mL
and above.

c\. Must have a temperature strip providing graduated temperature
readings 32-38 º C / 90-100 º F, that is affixed or can be affixed at a
proper level on the outside of the collection container. Other
methodologies (e.g., temperature device built into the wall of the
container) are acceptable provided the temperature measurement is
accurate and such that there is no potential for contamination of the
specimen.

d\. Must be individually wrapped in a sealed plastic bag or shrink
wrapping; or must have a peelable, sealed lid or other easily visible
tamper-evident system.

e\. May be made available separately at collection sites to address shy
bladder situations when several voids may be required to complete the
testing process.

2\. [Plastic Specimen Bottles]{.underline}

a\. Each bottle must be large enough to hold at least 35 mL; or
alternatively, they may be two distinct sizes of specimen bottles
provided that the bottle designed to hold the primary specimen holds at
least 35 mL of urine and the bottle designed to hold the split specimen
holds at least 20 mL.

b\. Must have screw-on or snap-on caps that prevent seepage of the urine
from the bottles during shipment.

c\. Must have markings clearly indicating the appropriate levels (30 mL
for the primary specimen and 15 mL for the split) of urine that must be
poured into the bottles.

d\. Must be designed so that the required tamper-evident bottle seals
made available on the CCF fit with no damage to the seal when the
employee initials it nor with the chance that the seal overlap would
conceal printed information.

e\. Must be wrapped (with caps) together in a sealed plastic bag or
shrink wrapping separate from the collection container; or must be
wrapped (with cap) individually in sealed plastic bags or shrink
wrapping; or must have peelable, sealed lid or other easily visible
tamper-evident system.

f\. Plastic material must be leach resistant.

3\. [Leak-resistant Plastic Bag]{.underline}

a\. Must have two sealable compartments or pouches which are
leak-resistant; one large enough to hold two specimen bottles and the
other large enough to hold the CCF paperwork.

b\. The sealing methodology must be such that once the compartments are
sealed, any tampering or attempts to open either compartment will be
evident.

4\. [Absorbent material]{.underline}

Each kit must contain enough absorbent material to absorb the entire
contents of both specimen bottles. Absorbent material must be designed
to fit inside the leak-resistant plastic bag pouch into which the
specimen bottles are placed.

5\. [Shipping Container]{.underline}

a\. Must be designed to adequately protect the specimen bottles from
shipment damage in the transport of specimens from the collection site
to the laboratory (e.g., standard courier box, small cardboard box,
plastic container).

b\. May be made available separately at collection sites rather than
being part of an actual kit sent to collection sites.

c\. A shipping container is not necessary if a laboratory courier
hand-delivers the specimen bottles in the plastic leak-proof bags from
the collection site to the laboratory.

**APPENDIX B - TRAINING REQUIREMENTS FOR COLLECTORS**

To be permitted to act as a collector in the DOT drug testing program,
you must meet the following requirements:

\(a\) [Basic information]{.underline}. You must be knowledgeable about
49 CFR Part 40, the current "DOT Urine Specimen Collection Procedures
Guidelines," and DOT agency regulations applicable to the employers for
whom you perform collections, and you must keep current on any changes
to these materials. The DOT Urine Specimen Collection Procedures
Guidelines document is available from ODAPC (Department of
Transportation, 400 7th Street, S.W., Room 10403, Washington DC, 20590,
202-366-3784, or on the ODAPC web site (http://www.dot.gov/ost/dapc).

\(b\) [Qualification training]{.underline}. You must receive
qualification training which provides instruction on the following
subjects:

\(1\) All steps necessary to complete a collection correctly and the
proper completion and transmission of the CCF;

\(2\) "Problem" collections (e.g., situations like "shy bladder" and
attempts to tamper with a specimen);

\(3\) Fatal flaws, correctable flaws, and how to correct problems in
collections; and

\(4\) The collector's responsibility for maintaining the integrity of
the collection process, ensuring the privacy of employees being tested,
ensuring the security of the specimen, and avoiding conduct or
statements that could be viewed as offensive or inappropriate;

(c[) Initial Proficiency Demonstration]{.underline}. Following your
completion of qualification training under paragraph (b) above, you must
demonstrate proficiency in collections by completing five consecutive
error-free mock collections.

\(1\) The five mock collections must include two uneventful collection
scenarios, one insufficient quantity of urine scenario, one temperature
out of range scenario, and one scenario in which the employee refuses to
sign the CCF and initial the specimen bottle tamper-evident seal.

\(2\) Another person must monitor and evaluate your performance, in
person or by a means that provides real-time observation and interaction
between the instructor and trainee, and attest in writing that the mock
collections are "error-free." This person must be a qualified collector
who has demonstrated necessary knowledge, skills, and abilities by \--

\(i\) Regularly conducting DOT drug test collections for a period of at
least a year;

\(ii\) Conducting collector training under this part for a year; or

\(iii\) Successfully completing a \"train the trainer\" course.

\(d\) [Schedule for qualification training and initial proficiency
demonstration.]{.underline} The following is the schedule for
qualification training and the initial proficiency demonstration you
must meet:

\(1\) If you became a collector before August 1, 2001, and you have
already met the requirements of paragraphs (b) and (c) of this section,
you do not have to meet them again.

\(2\) If you became a collector before August 1, 2001, and have yet to
meet the requirements of paragraphs (b) and (c) of this section, you
must do so no later than January 31, 2003.

\(3\) If you become a collector on or after August 1, 2001, you must
meet the requirements of paragraphs (b) and (c) of this section before
you begin to perform collector functions.

\(e\) [Refresher training]{.underline}. No less frequently than every
five years from the date on which you satisfactorily complete the
requirements of paragraphs (b) and (c) above, you must complete
refresher training that meets all the requirements of paragraphs (b) and
(c).

\(f\) [Error Correction Training.]{.underline} If you make a mistake in
the collection process that causes a test to be cancelled (i.e., a fatal
or uncorrected flaw), you must undergo error correction training. This
training must occur within 30 days of the date you are notified of the
error that led to the need for retraining.

\(i\) Error correction training must be provided and your proficiency
documented in writing by a person who meets the requirements of
paragraph (c)(2) above.

\(ii\) Error correction training is required to cover only the subject
matter area(s) in which the error that caused the test to be cancelled
occurred.

\(iii\) As part of the error correction training, you must demonstrate
your proficiency in the collection procedures of this part by completing
three consecutive error-free mock collections. The mock collections must
include one uneventful scenario and two scenarios related to the area(s)
in which your error(s) occurred. The person providing the training must
monitor and evaluate your performance and attest in writing that the
mock collections were "error-free."

\(g\) [Documentation]{.underline}. You must maintain documentation
showing that you currently meet all requirements of this section. You
must provide this documentation on request to DOT agency representatives
and to employers and C/TPAs who are using or negotiating to use your
services.

**APPENDIX C -- QUESTIONS AND ANSWERS**

Periodically, DOT will publish questions and answers specific to the
collector and the collection process. These will be posted on the DOT
Internet web site
([www.dot.gov/ost/dapc/](http://www.dot.gov/ost/dapc/)). All collectors
are encouraged to check the site to ensure that they have the most
current information to help them conduct DOT-required specimen
collections appropriately. Collectors who do not have access to the
Internet may obtain copies of the questions and answers from a
fax-on-demand system by calling 1-(800)-225-3784. Collectors who do not
have access to the Internet may obtain copies of the Questions and
Answers from a fax-on-demand system by calling 1-(800)-225-3784.

**APPENDIX D -- OPERATING ADMINISTRATIONS' RULES (SUMMARY)**

49 CFR Part 40 (40.33(a)) states that collectors must be knowledgeable
about the DOT agency regulations applicable to the employers for whom
the collectors conduct urine specimen collections. The following is a
list of regulations which govern an employer's implementation of the DOT
drug and alcohol testing rules:

The FMCSA regulation is 49 CFR Part 382.

The FRA regulation is 49 CFR Part 219.

The FAA regulation is 14 CFR Part 121.

The FTA regulation is 49 CFR Part 655.

The PHMSA regulation is 49 CFR Part 199.

The USCG regulation is 46 CFR Parts 4, 5, and 16.

Drug and alcohol testing (including SAP) procedures are 49 CFR Part 40.

The following pages contain a short summary of some of the operating
administrations' requirements. Copies of the complete rule texts are
available on the DOT Internet web site
([www.dot.gov/ost/dapc/](http://www.dot.gov/ost/dapc/)).

**Federal Motor Carrier Safety Administration**

(FMCSA)

**Covered employee**: A person who ***operates (i.e., drives)*** a
Commercial Motor Vehicle(CMV) with a gross vehicle weight rating (gvwr)
of 26,001 or more pounds; or is designed to transport 16 or more
occupants (to include the driver); or is of any size and is used in the
transport of hazardous materials that require the vehicle to be
placarded.

**Types of tests for drugs**: Pre-employment, random, reasonable
suspicion, post-accident, return-to-duty, and follow-up.

**Types of tests for alcohol**: Pre-employment (optional), random,
reasonable suspicion, post-accident, return-to-duty, and follow-up.

**Definition of accident requiring testing**: Any accident involving a
fatality requires testing. Testing is also required in accidents in
which one or more motor vehicles are towed from the scene or in which
someone is treated medically away from the scene; ***and*** a citation
is issued to the CMV driver.

**Reasonable-suspicion determination**: One trained supervisor or
company official can make the decision based upon specific,
contemporaneous, articulable observations concerning the appearance,
behavior, speech, or body odors of the employee.

**Pre-duty alcohol use prohibitions**: Four (4) hours prior to
performance of duty.

**Actions for BACs 0.02 -- 0.039**: The employee cannot be returned to
duty until the next day or the start of the employee's next regularly
scheduled duty period, but not less than 24 hours following the test.

**Employee training**: Employer must provide educational materials
explaining drug and alcohol regulatory requirements and employer's
policies and procedures for meeting regulation requirements.
Distribution to each employee of these educational materials and the
employer's policy regarding the use of drugs and alcohol is mandatory.

**Supervisor training**: One-hour of training is required on the
specific, contemporaneous physical, behavioral, and performance
indicators of probable drug use. One-hour of training is also required
on the specific, contemporaneous physical, behavioral, and performance
indicators of probable alcohol use.

**Reportable employee drug and alcohol violations**: No requirements to
report violations to FMCSA.

### Other: Drivers are prohibited from using alcohol for eight hours following an accident (as described above) or until they have undergone a post-accident alcohol test, whichever occurs first. 

## Federal Railroad Administration

## (FRA)

Covered employee: A person who performs *hours of service* functions at
a rate sufficient to be placed into the railroad's random testing
program. Categories of personnel who normally perform these functions
are *locomotive engineers, trainmen, conductors, switchmen, locomotive
hostlers/helpers, utility employees, signalmen, operators,* and *train
dispatchers.*

**Types of tests for drugs**: Pre-employment, random, reasonable
suspicion, reasonable cause, post-accident, return-to-duty, and
follow-up.

**Types of tests for alcohol**: Pre-employment (optional), random,
reasonable suspicion, reasonable cause, post-accident, return-to-duty,
and follow-up.

**Definition of accident requiring testing**: FRA's post-accident
testing rule requires urine and blood specimen collection from surviving
employees and also tissue from deceased employees (these collection
procedures go well beyond the normal Part 40 procedures). For surviving
employees, these specimens are collected at an independent medical
facility. FRA regulation, 49 CFR Part 219 Subpart C, stipulates the
level of events requiring testing and who has to be tested. The
collected specimens are analyzed only at FRA's contract laboratory.
Post-accident testing provides FRA with accident investigation and usage
data.

**Reasonable-suspicion determination**: One trained supervisor can make
the decision for alcohol testing based upon specific, contemporaneous,
articulable observations concerning the appearance, behavior, speech, or
body odors of the employee. A decision to conduct a drug test requires
two supervisors (only the on-site supervisor must be trained).

**Reasonable-cause determination**: Employers are authorized to use
federal authority to test covered employees after specific operating
rule violations or accidents/incidents which meet the criteria in 49 CFR
Part 219 Subpart D.

**Pre-duty alcohol use prohibitions**: Four (4) hours prior to
performance of duty or after receiving notice to report for covered
service, whichever is the shorter period.

**Actions for BACs 0.02 -- 0.039**: The employee cannot be returned to
duty until the start of the employee's next regularly scheduled duty
period, but not less than 8 hours following the test. Railroads are
prohibited from taking further disciplinary action under their own
authority.

**Employee training**: Employer must provide education materials that
explain the requirements of the FRA rules as well as railroad policies
and procedures with respect to meeting these requirements.

**Supervisor training**: A total of three hours of training is required:
one-hour on the specific, contemporaneous physical, behavioral, and
performance indicators of probable drug use; one-hour of similar
training on probable indicators of alcohol use; and one-hour of training
on how to determine if an accident qualifies for post-accident testing.

FRA (continued)

**Reportable employee drug and alcohol violations**: No requirements to
report violations to FRA. Engineers, who are the only certificate
holders in the rail industry, will have their certificates reviewed for
suspension or revocation by the employer when a FRA violation occurs.
Note that a FRA alcohol violation occurs at 0.04 percent or greater.
When a locomotive engineer is in a voluntary referral program, the
counseling professional must report the engineer's refusal to cooperate
in the recommended course of counseling or treatment.

**Other**:

Anyone with direct or immediate supervisory authority over an employee
may not collect that person's urine, saliva, or breath.

Refusal to test results in a mandatory minimum nine-month removal from
covered service. During this nine-month period, there is no prohibition
against the employee working a non-covered service position if agreeable
to the employer.

Locomotive engineers (or other employees certified as a locomotive
engineer at the time of the alcohol or drug violation) required both
alcohol and drug return-to-duty tests; and both alcohol and drug
follow-up tests.

Locomotive engineers who have a DUI are required by Part 240 to be
evaluated to determine whether they have an active substance abuse
disorder. A DUI is not considered to be a violation of FRA regulations
if it occurred during the employee's off-duty time; therefore, any
testing would be conducted under employer authority.

Employers must provide a ***voluntary referral program*** which allows
an employee to self-refer for treatment, and a ***co-worker report
program*** which allows one employee to refer another for treatment
before the employer identifies a problem. Both of these ***employee
assistance programs*** guarantee that employees will retain their jobs
if they cooperate and complete the required rehabilitation program. For
an engineer who is in a voluntary referral program, the counseling
professional must report the engineer's refusal to cooperate in the
recommended course of counseling or treatment to the employer.

## Federal Aviation Administration

## (FAA)

**Covered employee**: A person who performs ***flight crewmember
duties***, ***flight attendant duties***, ***flight instruction
duties***, ***aircraft dispatch duties***, ***aircraft maintenance*** or
***preventive maintenance duties***; ***ground security coordinator
duties***; ***aviation screening duties***; and ***air traffic control
duties***. Note: Anyone who performs the above duties directly or by
contract for part 121 or 135 certificate holders, ***sightseeing
operations*** as defined in 135.1(c), and ***air traffic control***
facilities not operated by the Government are considered covered
employees.

**Types of tests for drugs**: Pre-employment, random, reasonable cause,
post-accident, return to duty, and follow-up.

**Types of tests for alcohol**: Pre-employment (optional), random,
reasonable suspicion, post-accident, return to duty, and follow-up.

**Definition of accident requiring testing**: Accident means an
occurrence associated with the operation of an aircraft which takes
place between the time any person boards the aircraft with the intention
of flight and all such persons have disembarked, and in which any person
suffers death or serious injury, or in which the aircraft receives
substantial damage. Testing must occur if employee\'s performance either
contributed to the accident or cannot be completely discounted as a
contributing factor of the accident. The decision not to test an
employee must be based on a determination, using the best information
available at the time of the determination, that the employee\'s
performance could not have contributed to the accident.

**Reasonable cause determination (drugs)**: Two of the employee\'s
supervisors, one of whom is trained, shall substantiate and concur in
the decision to test the employee. If the employer is not an air carrier
operating under 14 CFR part 121 and has 50 or fewer employees, a single
trained supervisor can make the determination. A trained supervisor
makes the determination based upon specific contemporaneous physical,
behavioral or performance indicators of probable drug use.

**Reasonable suspicion determination (alcohol)**: One trained supervisor
makes the determination based upon specific, contemporaneous,
articulable observations concerning the employee\'s appearance,
behavior, speech, or body orders.

**Pre-duty alcohol use prohibitions**: Eight (8) hours prior to
performance of flight crewmember duties, flight attendant duties, and
air traffic controller duties. Four (4) hours prior to performance of
other duties.

**Actions for BACs 0.02 - 0.039**: If the employer chooses to return the
employee to covered services within 8 hours, the BAC retest must be
below 0.02.

**Employee training (drugs)**: An employer must train all employees who
perform safety-sensitive duties on the effects and consequences of
prohibited drug use on personal health, safety, and work environment,
and on the manifestations and behavioral cues that

FAA (continued)

may indicate drug use and abuse. Employers must also implement an
education program for safety-sensitive employees by displaying and
distributing informational materials, a community service hot-line
telephone number for employee assistance and the employer\'s policy
regarding drug use in the work place which must include information
regarding the consequences under the rule of using drugs while
performing safety-sensitive functions, receiving a verified positive
drug test result, or refusing to submit to a drug test required under
the rule.

**Employee training (alcohol)**: Employers must provide covered
employees with educational materials that explain the alcohol misuse
requirements and the employer\'s policies and procedures with respect to
meeting those requirements. The information must be distributed to each
covered employees and must include such information as the effects of
alcohol misuse on an individual\'s health work, personal life, signs and
symptoms of an alcohol problem; and the consequences for covered
employees found to have violated the regulatory prohibitions.

**Supervisor training (drugs)**: One-hour of training is required on the
specific, contemporaneous physical, behavioral, and performance
indicators of probable drug use. In addition, supervisors must receive
employee training as defined above. Reasonable recurrent training is
also required.

**Supervisor training (alcohol)**: One-hour of training is required on
the physical, behavioral, speech, and performance indicators of probable
alcohol misuse.

**Reportable employee drug and alcohol violations**:

Each employer must notify the FAA about any covered employee who holds a
certificate issued under 14 CFR Parts 61 (pilots and flight and ground
instructors), 63 (flight engineers and navigators), or 65 (air traffic
control tower operators, aircraft dispatchers, airframe or power plant
mechanics, and repairmen) who has refused to take a drug or alcohol
test. The MRO may report a positive or refusal (i.e. adulterated,
substituted results or no medical explanation for providing an
insufficient specimen) on behalf of the employer.

Each employer must notify the FAA about any safety-sensitive employee
who is required to hold an airman medical certificate issued under 14
CFR Part 67 who has a positive drug test result, an alcohol test result
of 0.04 or greater, or who has refused to submit to testing. The MRO may
report a positive or refusal (i.e. adulterated, substituted results or
no medical explanation for providing an insufficient specimen) on behalf
of the employer.

Each employer must not permit an employee who is required to hold a
medical certificate under part 67 to perform a safety-sensitive function
to resume that duty until the employee has received a new medical
certificate issued by the FAA Federal Air Surgeon ***and*** the employer
has ensured that the employee meets the return to duty requirements of
Part 40. (Medical certificates are not operating certificates but
employees cannot continue to perform airman duties without a medical
certificate.)

FAA (continued)

According to FAA's regulation 14 CFR part 121 Appendix I, Section
VII.C.1 & 2, when a MRO verifies a drug test result or a SAP performs
the initial evaluation, they must ask the employee whether he or she
holds or would be required to hold an airman medical certificate issued
under 14 CFR part 67 of this chapter to perform a safety-sensitive
function for the employer. \[[This requirement only applies to MROs and
SAPs who provide services for FAA regulated employers.]{.underline}\] If
the employee answers in the affirmative, the employee must obtain an
airman medical certificate issued by the Federal Air Surgeon dated after
the drug and/or alcohol violation date.

The SAP must wait until the employee obtains their airman medical
certificate before reporting to an employer that the employee
demonstrated successful compliance with the SAP\'s treatment and/or
education recommendations.

## Federal Transit Administration

## (FTA)

**Covered employee**: A person who performs a ***revenue vehicle***
***operation***; ***revenue vehicle and equipment maintenance; revenue
vehicle control or dispatch (optional); Commercial Drivers License
non-revenue vehicle operation;*** or ***armed security duties.***

**Types of tests for drugs**: Pre-employment, random, reasonable
suspicion, post-accident, return-to-duty, and follow-up.

**Types of tests for alcohol**: Pre-employment (optional), random,
reasonable suspicion, post-accident, return-to-duty, and follow-up.

**Definition of accident requiring testing**: Any accident involving a
fatality requires testing. Testing following a non-fatal accident is
discretionary: If the employer can show the employee's performance could
not have contributed to the accident, no test is needed. Non-fatal
accidents that may require testing must have disabling damage to any
vehicle or immediate medical attention away from the scene to meet the
testing threshold.

**Reasonable-suspicion determination**: One trained supervisor or
company official can make the decision based upon specific,
contemporaneous, articulable observations concerning the appearance,
behavior, speech, or body odors of the employee.

**Pre-duty alcohol use prohibitions**: Four (4) hours prior to
performance of duty.

**Actions for BACs 0.02 -- 0.039**: If the employer chooses to return
the employee to covered service within 8 hours, the BAC re-test must be
below 0.02.

**Employee training**: Employer must provide education with display and
distribution of informational materials and a community service hot-line
telephone number, if available.

One-hour of training on the effects and consequence of prohibited drug
use on personal health, safety, and the work environment, and on the
signs and symptoms that may indicate prohibited drug use. Distribution
to each employee of the employer's policy regarding the use of drugs and
alcohol with signed receipt is mandatory.

**Supervisor training**: One-hour of training is required on the
specific, contemporaneous physical, behavioral, and performance
indicators of probable drug use. One-hour of training is also required
on the specific, contemporaneous physical, behavioral, and performance
indicators of probable alcohol use.

**Reportable employee drug and alcohol violations**: No requirements to
report violations to FTA.

### 

### Other: Anyone with direct or immediate supervisory authority over an employee may

### not collect that person's urine, saliva, or breath. 

### 

## Pipeline and Hazardous Materials Safety Administration

## (PHMSA)

**Covered employee**: A person who performs on a pipeline or liquefied
natural gas (LNG) facility an ***operation, maintenance, or
emergency-response*** function.

**Types of tests for drugs**: Pre-employment, random, reasonable cause,
post-accident, return-to-duty, and follow-up.

**Types of tests for alcohol**: Post-accident, reasonable suspicion,
return-to-duty, and follow-up.

**Definition of *accident* requiring testing**: An accident is one
involving gas pipeline facilities or LNG facilities or involving
hazardous liquid or carbon dioxide pipeline facilities.

**Reasonable-suspicion determination**: One trained supervisor can make
the decision based upon signs and symptoms.

**Reasonable-cause determination**: One trained supervisor can make the
decision based upon reasonable and articulable belief that the employee
is using prohibited drugs on the basis of specific, contemporaneous
physical, behavioral, or performance indicators of probable drug use.

**Pre-duty alcohol use prohibitions**: Four (4) hours prior to
performance of duty.

**Actions for BACs 0.02 -- 0.039**: If the employer chooses to return
the employee to covered service within 8 hours, the BAC retest must be
below 0.02.

**Employee training (Drugs)**: Employer must provide EAP education with
display and distribution of informational materials; display and
distribution of a community service hot-line telephone number; and
display and distribution of the employer's policy regarding the use of
prohibited drugs.

**Employee Training (Alcohol)**: Employer must develop materials that
explain policies and procedures (as well as names of those who can
answer questions about the program) and distribute them to each covered
employee.

**Supervisor training**: One-hour of training is required on the
specific, contemporaneous physical, behavioral, and performance
indicators of probable drug use. One-hour of training is also required
on the specific, contemporaneous physical, behavioral, and performance
indicators of probable alcohol use.

### Reportable employee drug and alcohol violations: No requirements to report violations to PHMSA. 

### 

## United States Coast Guard

## (USCG)

**Covered employee**: A person who is ***on board a vessel*** acting
under the authority of a ***license***, ***certificate of registry***,
or ***merchant mariner\'s document***. Also, a person ***engaged*** or
***employed on board a U.S. owned vessel*** and such vessel is required
to engage, employ or be operated by a person holding a license,
certificate of registry, or merchant mariner\'s document.

**Types of tests for drugs**: Pre-employment, periodic, random,
reasonable cause, and post-serious marine incident (SMI),
return-to-duty, and follow-up.

**Types of tests for alcohol**: 49 CFR Part 40 alcohol-testing
requirements do not apply to the Maritime Industry. 46 CFR Part 4.06
requires post-SMI chemical testing for alcohol use. 33 CFR Part 95.035
allows for a marine employer or a law enforcement officer to direct an
individual to undergo a chemical test for intoxicants when reasonable
cause exists or a marine casualty has occurred.

**Definition of incident requiring testing**: An SMI is defined in 46
CFR 4.03-2. In general, an SMI is: A discharge of 10,000 gallons or more
of oil into the navigable waters of the United States, whether or not
resulting from a marine casualty; a discharge of a reportable quantity
of a hazardous substance into the navigable waters or into the
environment of the United States, whether or not resulting from a marine
casualty; or a marine casualty or accident required to be reported to
the Coast Guard, involving a vessel in commercial service, and resulting
in any of the following: One or more deaths; an injury to any person
(including passengers) which requires professional medical treatment
beyond first aid, and, in the case of a person employed on board a
commercial vessel, which renders the person unable to perform routine
vessel duties; damage to property in excess of \$100,000; actual or
constructive total loss of any inspected vessel; or actual or
constructive total loss of any uninspected, self-propelled vessel of 100
gross tons or more.

**Reasonable-cause determination (drugs)**: The marine employer must
have a reasonable and articulable belief that the individual has used a
dangerous drug. This belief should be based on the direct observation of
specific, contemporaneous physical, behavioral, or performance
indicators of probable use and where practicable based on the
observation of two persons in supervisory positions.

**Reasonable-cause determination (alcohol)**: The employee was directly
involved in the occurrence of a marine casualty or the individual
operated a vessel and the effect of the intoxicant(s) consumed by the
individual on the person\'s manner, disposition, speech, muscular
movement, general appearance or behavior is apparent by observation.

**Pre-duty alcohol use prohibitions**: Four (4) hours prior to
performance of scheduled duty.

USCG (continued)

**Employee training**: Employer must provide education with display and
distribution of informational materials and a community service hot-line
telephone number. Distribution to each employee of the employer's policy
regarding the use of drugs and alcohol is mandatory. Training must
include the effects of drugs and alcohol on personal heath, safety, and
work environment; and manifestations and behavioral cues that may
indicate drug and alcohol use and abuse.

**Supervisor training**: One-hour of training is required on the effects
of drugs and alcohol on personal heath, safety, and work environment;
and manifestations and behavioral cues that may indicate drug and
alcohol use and abuse.

**Reportable employee drug and alcohol violations**: Results of all
post-SMI tests and positive drug test results for all mariners who hold
a license, certificate of registry or merchant mariner\'s document must
be reported to the nearest Coast Guard Officer in Charge, Marine
Inspection.