Collection Site
Monitoring Toolkit
FTA Drug and Alcohol Program Compliance
September, 2004
Diana Byrnes
Substance Abuse Management Specialist
Center for Urban Transportation Research
University of South Florida
4202 E. Fowler Ave CUT 100
Tampa, Florida 33620
byrnes@cutr.usf.edu
Introduction
This Collection Site Monitoring Toolkit is designed to assist the Drug and
Alcohol Program Manager (DAPM) in identifying collection facilities that
are not in compliance with DOT regulations regarding specimen collection
procedures.
The collection of urine drug specimens is the single most common area of
potential error in the drug and alcohol testing process, therefore monitoring
the compliance of the collection facilities utilized is vital to a compliant
Substance Abuse Management program.
Although a collection facility may be deemed approved for use by a Third
Party Administrator (TPA); frequent employee turnover or the inability for
the TPA to conduct on-site monitoring could lead to improperly trained
collectors or collection sites that are not observing proper security measures
to avoid employee tampering of the specimens. It is ultimately the
responsibility of the agency to monitor the collection facilities and collection
personnel being utilized.
This toolkit includes the following:
49 CFR Part 40.33- Collector Training Requirements
2
Custody and Control Form Checklist
5
Collector “Red Flags”
7
Correctable Flaws
8
Fatal Flaws
9
Collection Site Auditing Checklist
10
Introduction to Undercover Auditing
12
Undercover Auditing Report Cover Page
13
Undercover Auditing Report Form
14
Subpart C - Urine Collection Personnel
49 CFR § 40.33 What training requirements must a collector meet?
To be permitted to act as a collector in the DOT drug testing program,
you must meet each of the requirements of this section:
(a) Basic information. You must be knowledgeable about this part, 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, SW.,
Room 10403, Washington DC, 20590, 202–366–3784, or on the ODAPC
web site (http://www.dot.gov/ost/dapc).
(b) Qualification training. You must receive qualification training
meeting the requirements of this paragraph. Qualification training must
provide 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. Following your completion of
qualification training under paragraph
(b) of this section, you must
demonstrate proficiency in collections under this part 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. 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. No less frequently than every five years from
the date on which you satisfactorily complete the requirements of paragraphs
(b) and (c) of this section, you must complete refresher training that meets
all the requirements of paragraphs (b) and (c) of this section.
(f) Error Correction Training. 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.
(1) Error correction training must be provided and your proficiency
documented in writing by a person who meets the requirements of paragraph
(c)(2) of this section.
(2) 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.
(3) 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. 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.
[65 FR 79526, Dec 19, 2000; 66 FR 3885, Jan. 17, 2001, as amended at 66
FR 41950, Aug. 9, 2001]
Federal Drug Testing Custody and Control Form Checklist
Step 1 on the Federal Drug Testing Custody and Control Form:
 Employer Name and Address is pre-printed or hand written clearly,
including a phone and fax number
 The Medical Review Officer’s name, address, phone and fax numbers are
pre-printed or hand written clearly.
 The donor’s (employee’s) social security number or employee ID are written
clearly and are recorded correctly
 The reason for test is indicated, and agrees with the testing notification form
provided by the DAPM
 Drug test performed: either the box indicating THC, COC, PCP, OPI, AMP
is marked, or the box “Other/NIDA” is marked instead
 Collection site address, phone and fax numbers are pre-printed or hand
written clearly
Step 2 on the Federal Drug Testing Custody and Control Form:
 Box indicating specimen temperature is within range is checked. (If the
“no” box is checked, remarks should be provided.)
 The specimen collection is marked as SPLIT.
 The “observed” box should be checked and remarks provided in this space
only if a directly observed collection took place.
Step 3 takes place at the collection facility.
 Collector affixes bottle seals to bottles, dates seals; donor initials seals.
Step 4 on the Federal Drug Testing Custody and Control Form:
 The signature of the collector and printed name are provided as well as the
date and time of the collection.

The time of the collection falls within the acceptable time range that the
employee was given to arrive at the collection facility
 The specific name of the delivery service transferring the specimen to the lab
is indicated in the “Specimen Bottles Released to:” box.
(E.g. Federal Express, LabCorp Courier; Note: the word “Courier” only is
not acceptable)
Step 5 on the Federal Drug Testing Custody and Control Form:

The donor (employee) has provided their signature, printed name and
date of birth. Donor is not required to provide day and evening telephone
numbers.
Errors noted on this form must be brought to the attention of the collector,
TPA and/or Medical Review Officer in writing; to provide the necessary
error correction or documentation pursuant to 49 CFR Part 40.275(a)
Collector “Red Flags”
The following are hints that could indicate that the collector or collection
facility is not observing proper DOT Specimen Collection Guidelines or that
the collection personnel are not properly trained.
 Employer copies of the custody and control forms are not promptly
delivered to the attention of the DAPM
 Test type is frequently marked incorrectly
 Employees are reporting that collections are conducted hastily or that
there are extraordinary delays in testing
 An increase in the turn around time for result reporting is noted
 An increase in the number of correctable flaws are noted
 The DAPM is not notified when a shy lung or shy bladder situation
occurs
 The information provided by the collector on the CCF is not written
legibly
Correctable Flaws
Correctable flaws are errors that occur in the testing process that do not
impact the accuracy of the test; therefore they can be corrected. When the
laboratory identifies a correctable flaw, every attempt must be made to
correct the problem following the procedures outlined in 49 CFR Part
40.205.
A correctable flaw that is not corrected will result in a canceled test.
Correctable flaws cause delays in result reporting. If the DAPM can identify
a correctable flaw prior to the specimen reaching the laboratory, the error
correction process can begin immediately and delays can be minimized. A
review of the employer copy of Custody and Control form upon receipt can
be a valuable tool in expediting the process.
The following are common correctable flaws that can be noted by review of
the employer copy of the custody and control form:
 The collector’s signature is omitted on the certification statement on
the CCF
 The employee’s signature is omitted from the certification statement
and the “employee refused to sign” is not stated in the remarks section
 A non-DOT or expired DOT custody and control form was used for a
DOT collection when otherwise the testing process followed is in
accordance with the DOT procedures (specimen may be “upgraded”
to a DOT result)
As soon as a correctable flaw is noted, your third party administrator should
be contacted and given the specimen ID number indicated on the CCF.
They will obtain the necessary documentation from the collector and the
laboratory to ensure timely release of the result.
Fatal Flaws
The following four errors cannot be corrected if they occur, and are not
followed by a retest. DOT has identified these errors as “fatal flaws” that
result in a specimen being rejected for testing by the laboratory, per 49 CFR
Part 40.199.
1. Specimen ID number on the specimen bottle does not match the
specimen ID on the custody and control form
2. The collector’s printed name AND signature are both missing from
the custody and control form
3. The primary specimen volume is less than 30ml and the split
specimen cannot be re-designated as the primary specimen
4. The specimen bottle seal is broken or shows evidence of tampering
and the split specimen cannot be re-designated as the primary
specimen
Collection Site Audit Checklist
This checklist can be utilized when making unannounced inspections of
collection facilities.
The following elements are necessary to conduct a urine specimen collection
in accordance with 49 CFR Part 40 U.S. Department of Transportation
Workplace Drug Testing Specimen Collection Guidelines:









A privacy enclosure for urination, preferably a single toilet room
with full length door
A suitable clean writing surface
A water source for hand washing that is located outside of the
privacy enclosure
If a water source is available within the privacy enclosure, it must
be secured with tamper evident tape
The absence of substances that could be used to adulterate or
substitute urine specimens (cleaning agents, hand soap, etc.)
A bluing agent has been added to the toilet water to prevent
substitution/adulteration of the specimen
Areas and items that are suitable for concealing contaminants must
be secured and inspected prior to the collection (e.g.; trash
receptacles, paper towel holders, under sink cabinets)
Restricted access to the privacy enclosure to ensure the donor’s
privacy and to prevent the collector from becoming distracted
Restricted access to the collection materials and specimens must be
maintained at all times, signs should be posted indicating restricted
areas




All collectors must meet the minimum requirements to collect
DOT urine specimens, and must be able to provide documentation
of training, proficiency demonstration, refresher training and error
correction training to DOT representatives, employers or TPAs
upon request.
Split specimen collection kits must be used for all DOT testing
Federal Drug testing custody and control forms must be used for
all DOT required testing
Collector must require proper identification of the employee before
the collection procedure commences. (Use of driver’s license,
employee ID badge or other government issued photo
identification is acceptable as well as the identification from a
DER when donor is accompanied by such)
Introduction to “Undercover” Urine Collection Site Auditing
The term “undercover audit” refers to the auditing of a collection facility, its
personnel and urine collection procedures, without supplying notification of
the review to the facility. A representative from your agency; preferably the
DAPM, alternate or a supervisor who has knowledge of the DOT drug
testing regulations, submits to a urine drug test with the intent to record and
document the facility’s collection procedures and the efforts taken to ensure
a DOT compliant collection.
Prior to conducting an undercover audit of a collection facility, carefully
review the checklist of potential areas of non-compliance. It is also
beneficial to familiarize yourself with the DOT specimen collection
guidelines which can be found at the following web address:
http://transitsafety.volpe.dot.gov/Publications/substance/DOTurine/PDF/urine.pdf
In addition to monitoring the regulatory requirements of the collection
facility, it may be helpful to document the wait time, the disposition of the
personnel, and the cleanliness of the facility. These factors play a significant
role in the employee perception of the drug and alcohol testing program.
When the audit process is complete, record your findings and document any
additional notes on the form provided on the following pages. Submit your
report using the contact information provided to guarantee that any findings
of non-compliance are addressed. You will receive copies of all
correspondence related to the audit, the corrective action required and the
follow-up procedures taken by FDOT.
Undercover Audit Report
Cover page
Agency Name:
_____________________________________________________________
Drug and Alcohol Program Manger:
_____________________________________________________________
Collection facility name:
_____________________________________________________________
Collection facility address:
_____________________________________________________________
Collector name:
_____________________________________________________________
Date of collection:
_____________________________________________________________
Third Party Administrator (name and telephone number):
_____________________________________________________________
Undercover Audit Report Form
Instructions:
Use the following checklist as a guide to monitoring the procedures of a
DOT urine specimen collection. If you agree with the statement, check the
box provided. If the statement is inaccurate as it relates to your collection
experience, record your notes in the space provided.

When I arrived at the collection facility, I was asked to “sign in” and
the time of my arrival was recorded.
________________________________________________________
________________________________________________________

I was not asked to sign a consent, release, or waiver of liability.
________________________________________________________
________________________________________________________

I was asked to provide photo identification
________________________________________________________
________________________________________________________

I provided the collection personnel with a testing notification form,
indicating the reason for test and the type of testing required
(the testing notification form is not a regulatory requirement, but is a
“Best Practice”)
________________________________________________________
________________________________________________________

The collector explained the basic collection procedures and reviewed
the instructions on the back of the Federal Drug Testing Custody and
Control Form
________________________________________________________
________________________________________________________

The collector ensured that the pre-printed information in Step 1 of the
CCF was accurate (the employer name, address, telephone and fax
number, the MRO information)
________________________________________________________
________________________________________________________

The collector recorded my social security number or employee ID
number correctly on the CCF.
________________________________________________________
________________________________________________________

The collector indicated the correct test type (reason for test) on the
CCF.
________________________________________________________
________________________________________________________

The collector instructed me to remove any unnecessary outer clothing
and to leave my briefcase, purse or any other belongings outside of
the privacy enclosure, with the outer clothing.
________________________________________________________
________________________________________________________

The collector instructed me to remove and display any items that were
in my pockets, to determine if I was concealing an item that could be
used to adulterate my specimen
________________________________________________________
________________________________________________________

The collector instructed me to wash and dry my hands and to not do
so again until the specimen collection had taken place
________________________________________________________
________________________________________________________

I was not given access to any other water source at this point
________________________________________________________
________________________________________________________

The collector unwrapped a DOT Split Specimen collection kit in my
presence
________________________________________________________
________________________________________________________

The collector handed me the specimen collection container and
directed me to supply a minimum of 45mL, and not to flush the toilet.
The collector mentioned that the temperature of my specimen is a
critical factor and I should return promptly with my specimen
________________________________________________________
________________________________________________________

The privacy enclosure had:
 Bluing agent in the toilet
 Secured ceiling tiles
 No water source
 No cleaning agents or other contaminants present
 No trash receptacles
 No paper towel holders
 No functional soap dispenser
 No access from the outside
________________________________________________________
________________________________________________________

After inspecting the sample for temperature, discoloration and
volume, the collector unwrapped the split specimen bottles and
transferred the urine into the A and B bottles in my presence
________________________________________________________
________________________________________________________

The collector removed the tamper evident seals from the CCF and
placed the appropriate seal on each of the two specimen bottles (A and
B)
________________________________________________________
________________________________________________________


The collector instructed me to initial the seals at this point. (Note:
seals should never be initialed prior to being affixed to the A and B
bottles)
________________________________________________________
________________________________________________________
I was instructed that I was able to wash my hands at this time
________________________________________________________
________________________________________________________

The collector instructed me to read, sign and date the certification
statement
and provide date of birth, printed name and day and evening telephone
numbers in Step 5 of Copy 2 (Medical Review Officer’s copy) of the
CCF.
________________________________________________________
________________________________________________________

The collector completed Step 4 of Copy 1 by printing his or her name,
recording the date and time of the collection, signing where indicated
and entering the specific name of the delivery or courier service that
will be transporting the specimen to the lab.
________________________________________________________
________________________________________________________

The collector ensured that all copies were legible and complete. I was
given the employee copy (Copy 5) of the CCF and told that the
collection process was complete.
________________________________________________________
________________________________________________________

The employer copy of the CCF was received in a timely manner
________________________________________________________
________________________________________________________

A review of the CCF, using the “Custody and Control Form
Checklist” revealed no correctable flaws
________________________________________________________
________________________________________________________
Fax or e-mail completed report, including cover page to:
Diana Byrnes
Substance Abuse Management Specialist
Center for Urban Transportation Research
University of South Florida
4202 E. Fowler Avenue CUT 100
Tampa, Florida 33620
E-mail: byrnes@cutr.usf.edu
Phone: 813-426-6980
Fax: 727-859-4346