Urine Specimen
Collection Handbook
for Federal Agency Workplace Drug Testing Programs
November 1, 2004 (Effective Date)
This handbook provides additional guidance to
supplement the urine specimen collection requirements contained in the
Mandatory Guidelines for Federal Workplace Drug Testing Programs that were
published in the Federal Register on April 13, 2004 (69 FR 19644), with a
November 1, 2004, implementation date.
Note: This handbook does not apply to
specimens collected under the Department of Transportation Procedures for
Transportation Workplace Drug and Alcohol Testing Programs (49 CFR Part 40).
Previous Versions of this Handbook are Obsolete
Table of Contents
Chapter
Chapter 1: The
Collector
A collector is a trained individual who instructs and
assists a donor at a collection site, and receives the specimen provided by a
donor.
The following restrictions apply:
-
The immediate supervisor of an employee may not serve
as the collector when that employee is tested, unless there is no feasible
alternative;
§
A co-worker who is in the same testing pool or who works with an employee on a
daily basis may not serve as a collector when that employee is tested, unless
there is no feasible alternative;
§
An individual working for an HHS-certified laboratory may not serve as a
collector if that individual can link the donor with the specimen drug test
result or laboratory report;
§
An individual who has a personal relationship with the employee (e.g., spouse,
ex-spouse, relative, close personal friend) may not serve as the collector,
unless there is no feasible alternative.
To qualify as a collector for a Federal agency
program, an individual must:
-
Read and understand the HHS Mandatory Guidelines for
Federal Workplace Drug Testing Programs,
-
Read and understand any guidance provided by the
Federal agency which is consistent with HHS Mandatory Guidelines, and
-
Successfully complete training to perform collections
in accordance with the procedures in this manual.
Thecollector should have identificationwith his/her
name and his/her employer’s name, address, and telephone number. The
collector is required to provide his or her identification (or collection
company identification) if requested by the donor. There is no
requirement for the collector to have a photo ID or to provide his or her
driver's license with an address. Also, the collector is not required to
provide any certification or other documentation to the donor proving the
collector's training in the collection process.
The collector must have the name and telephone number
of the Federal agency’s designated representative to contact in the event that
any problems or issues arise during the collection.
Chapter 2: Collector/Collection
Site Records
Collector training records must be maintained for a
minimum of two years to document a collector’s qualifications for collecting
Federal agency specimens. The collector should maintain the original
training documentation, and provide copies for his/her employer and the Federal
agency. Other collection site records must be stored for a minimum of two
years. This includes the collector copy (Copy 3) of the Federal Drug
Testing Custody and Control Form (Federal CCF) for each specimen.
Collection records must be stored and disposed of in a manner that ensures
donor confidentiality is maintained.
Chapter 3: Collection Site
Security
The collection site must be secure to prevent
unauthorized access to specimens, collection supplies, and collection site
records. A permanent site that is used solely for specimen collections
must be secured at all times. At facilities that are not dedicated
specimen collection sites, the area of the site used for specimen collections
must be secured during the time a specimen is collected.
Chapter 4: Blind Quality
Control Samples
Each Federal agency is required to have blind quality
control (QC) samples (i.e., negative samples, drug positive samples,
adulterated samples, substituted samples) submitted along with the donor
specimens. The blind samples may be purchased by the Federal agency
and supplied to the collector, or purchased by the collector and submitted to a
laboratory with an agency’s specimens. The Mandatory Guidelines specify
the number of blind QC samples a Federal agency must submit based on the ratio
of QC samples to donor specimens and specify the approximate percentage of each
type (i.e., 75% negative, 15% positive for one or more drugs, 10% either
adulterated or substituted).
Each blind QC sample is submitted with a Federal CCF
completed as for a donor specimen, with the following exceptions:
§
Because there is no donor, the collector completes the donor’s section of the
CCF and writes fictitious initials on the specimen bottle label/seal.
§
The collector indicates that the sample is a ‘blind QC sample’ on the Medical
Review Officer (MRO) copy where the donor would normally provide a signature
(Step 5 on Copy 2 of the CCF).
§
The collector may either discard Copy 5 of the CCF (the donor copy) or maintain
it with Copy 3 of the CCF (the collector copy).
If the collector purchases the samples for the Federal
agency’s blind QC program, the collector must send the supplier’s information
to the MRO (e.g., the content and concentration of the blind samples) to enable
the MRO to interpret the results and report them to the agency.
Chapter 5: The Federal Drug
Testing Custody and Control Form
Federal agencies are required to use the Office of
Management and Budget (OMB) approved Federal CCF when collecting urine
specimens for their workplace drug testing programs.
The following employers are prohibited from
using the Federal CCF:
-
Private-sector companies,
-
States,
-
Department of Justice programs, and
-
Non-DOT testing conducted by DOT-regulated employers.
In the rare instances when the collector, either by
mistake or as the only means to conduct a collection under unusual
circumstances (e.g., post-accident test with insufficient time to obtain the
Federal CCF), uses a non-Federal form for a Federal agency collection:
§
The use of a non-Federal form does not, in and of itself, constitute a reason
for the laboratory to reject the specimen for testing or for the MRO to cancel
the test.
§
The collector must send a signed statement with the specimen stating the reason
why the Federal CCF was not used for the Federal agency collection.
§
If a laboratory or MRO discovers the use of a non-Federal form, the collector
will be notified to provide a memorandum explaining the use of the incorrect
form.
All urine specimens must be collected using chain of
custody. Chain of custody is the term used to describe the process of
documenting the handling and storage of a specimen from the time a donor gives
the specimen to the collector to the final disposition of the specimen.
For specimens collected under the Mandatory Guidelines, the collector begins
the chain of custody documentation at the collection site using the Federal
CCF.
Federal CCFs are available from a number of companies
that print various types of forms. A list of suppliers and a sample of
the Federal CCF (OMB No. 0930-0158) are on the SAMHSA website (http://workplace.samhsa.gov).
A. Federal CCF Description
The Federal CCF consists of the following five pages:
Copy 1 - Laboratory Copy
Copy 2 - MRO Copy
Copy 3 - Collector Copy
Copy 4 - Employer Copy
Copy 5 - Donor Copy
At the top of the Federal CCF, the laboratory must be
identified by one of the following:
§
A specific laboratory name and address,
§
A list of addresses with check boxes to allow the collector to check the box
for the laboratory to which the specimen will be delivered, or
§
A corporate name and telephone number (the laboratory in the corporation that
receives the specimen for testing prints its specific address when accessioning
the specimen).
The bottom area of Copy 1 is reserved for the
tamper-evident specimen bottle seal(s)/label(s). There must be:
§
Two 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, and
§
Each label must have:
-
The same preprinted specimen identification number
that appears at the top of the Federal CCF,
-
A place for the collector to annotate the date of the
collection,
-
A place for the donor to initial each label after it
is placed on the specimen bottle, and
-
If a single specimen collection procedure is used,
the second label (i.e., the “B” label) is discarded by the collector.
B. Federal CCF Instructions for Use
Step 1. To be completed by the collector or
Federal agency representative prior to the donor providing a specimen:
-
The employer and MRO information may be preprinted or
handwritten,
-
The collector enters the donor’s social security
number (SSN) or employee I.D. number after verifying the donor’s identity,
-
The appropriate box is marked to indicate the reason
for the test,
-
The appropriate box is marked for the drug tests to
be performed, and
-
The collection site information may be preprinted or
handwritten.
Step 2. To be completed by the collector after
receiving the specimen from the donor and measuring the temperature of the
specimen. This step requires the collector to mark the appropriate boxes
to indicate that:
§
The temperature of the specimen was or was not within the required temperature
range,
§
The collection was a split specimen or single specimen collection,
§
No specimen was collected and why (if applicable), and
§
A direct observed collection was performed and why (if applicable).
Step 3. To be performed by the collector.
This step instructs the collector to:
-
Seal the specimen container(s) (i.e., bottle, primary
specimen bag, shipping bag),
-
Date the seal(s),
-
Have the donor initial the bottle seal(s) after
placing the seal(s) on the bottle(s), and
-
Have the donor complete step 5 on the MRO copy (Copy
2).
Step 5 (Copy 2). To be completed by the
donor. The collector instructs the donor to:
§
Read the certification statement.
§
Print the following:
-
His or her name,
-
Date of collection,
-
Daytime and evening telephone numbers, and
-
Date of birth.
§
Sign the certification statement.
Step 4. To be initiated by the collector and
completed at the laboratory. The collector is required 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.
-
Print his or her name.
-
Record the following:
-
Time of the collection.
-
The date of collection.
-
The specific name of the delivery service to which
the specimen is released for shipment to the laboratory.
-
There is no requirement for couriers, express
carriers, or postal service personnel to document chain of custody for the
specimens during transit because they do not have access to the specimen
bottle(s) or the Federal CCF.
-
Do not make entries below the bold line in
Step 4, entries in this area are made at the laboratory.
Step 5(a). To be completed by a certifying
scientist to record the test result for the primary specimen.
Step 5(b). To be completed by a certifying
scientist to record the test result for a split (Bottle B) specimen or for an
aliquot of a single specimen tested at a second HHS-certified laboratory, with
the name and address of the testing laboratory.
Step 6 (Copy 2). To be completed by the MRO to
record the test result for a primary specimen.
Step 7 (Copy 2). To be completed by the MRO to
record the test result for a split (Bottle B) specimen or second laboratory
test result for a single specimen.
Chapter 6: Verification of
Donor Identity
The donor must provide appropriate identification to
the collector upon arrival at the collection site.
Acceptableforms of identification are:
§ A
photo identification (e.g., driver’s license, employee badge issued by the
employer, any other picture identification issued by a Federal, state, or local
government agency),
§ Identification
by a Federal agency representative, or
§
Other identification allowed under a Federal agency's workplace drug testing
plan.
Unacceptableforms of identification are:
§
Identification by a co-worker,
§
Identification by another donor,
§
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
§
A faxed copy or photocopy of an identification document.
When the donor cannot meet the acceptable
identification criteria listed above, the collector requests the donor to
provide two items of identification bearing his or her signature:
1. If the donor can provide the two items, the
collector will compare the signatures on the items to the donor’s signature on
the donor certification statement of the Federal CCF (Step 5).
-
List on the “Remarks” line the two items of
identification used to identify the donor,
-
Write “signature identification was confirmed,” and
-
Continue with the collection process.
-
Record on the “Remarks” line that “signature
identification is unconfirmed,”
-
Discontinue the collection, and
-
Notify the Federal agency’s designated
representative.
2. If the donor does not have two
items of identification with his or her signature, the collector must proceed
with the collection and record sufficient information on the "Remarks" line of
the Federal CCF to help the MRO and the agency make a determination regarding
the validity of the specimen and the collection process. Note:This
is not considered a refusal to test.
Chapter 7: Urine Specimen
Collection
A. The Collection Site
A collection site is a permanent or temporary facility
selected by the Federal agency where a donor provides a urine specimen for a
drug test. The site must have all necessary personnel, supplies,
equipment, facilities, and supervision to provide for specimen collection,
security, and temporary storage, and have arrangements for the transfer of the
specimens to a certified laboratory.
A urine specimen collection site must:
1. Provide for donor privacy while he or she provides
the urine specimen. An observed collection must only be performed when
required (see Chapter 7, Section D). The following facilities provide
adequate privacy for urine collections:
§ A single-toilet restroom with a full-length
door,
§ A multi-stall restroom with partial-length doors, or
§ A mobile restroom (e.g., a vehicle with an enclosed toilet stall).
-
Secure the water source before the collection (i.e.,
after the donor washes his or her hands), and
-
Restore the water source to allow the donor to wash
his or her hands after the collection.
3. Have a suitable clean surface for the
collector to use as a work area. The collector work area may be located:
-
Unauthorized access to the site during the
collection,
-
Unauthorized access to the collection
materials/supplies,
-
Donor access to items that could be used to
adulterate or dilute the specimen (e.g., soap, disinfectants, cleaning agents,
water),
-
Unauthorized access to the specimen after it is
collected, and
-
Unauthorized access to collection site records.
5. The collector must maintain line-of-sight
custody or provide for the secure storage of specimens from the time the
specimen is collected until it is sealed in a shipping container prior to
transfer to an express carrier or courier for shipment to a laboratory.
B. Collection Supplies
The following items must be available at the
collection site to conduct proper urine collections:
-
Supplied as an individually sealed item using a
tamper-evident system (e.g., in a sealed plastic bag, shrink wrapped, or
another easily visible tamper-evident system),
-
Large enough to easily catch and hold at least 55 mL
urine, and
-
Graduated with volume markings clearly showing the
volume (e.g., 30 mL, 45 mL).
-
Sealed using a tamper-evident system (e.g., sealed
plastic bag, shrink wrap, or another easily visible tamper-evident system),
-
Able to hold at least 35 mL,
-
The split specimen bottle may be the same size or
smaller than the primary specimen bottle, but able to hold at least 20 mL.
-
Leak-resistant (i.e., have screw-on or snap-on caps
that prevent leakage),
-
Marked clearly to indicate the minimum levels of
urine to be poured into each bottle (30 mL for the primary specimen and 15 mL
for the split specimen), and
-
Designed so that the required tamper-evident bottle
label/seal from the Federal CCF is not damaged when the donor initials it and
has no overlap that conceals printed information.
3. Temperature strips. The
temperature strips must be capable of temperature readings between 90°-100°F
(32°-38°C). The temperature strips may be:
5. Tamper-evident seals. The
Federal CCF has two tamper-evident labels/seals that are used to seal a single
specimen bottle or two split specimen bottles. Occasionally, a
tamper-evident label/seal provided with the Federal CCF will not properly
adhere to the specimen bottle (e.g., due to moisture, temperature, or specimen
bottle material). If this occurs, see Chapter 7, Section C, Step 18 for
instructions on using the additional tamper-evident labels/seals.
6. Leak-resistant plastic bags. The
plastic bag must have two sealable compartments or pouches (i.e., one large
enough to hold two specimen bottles and the other large enough to hold Copy 1
of the Federal CCF).
7. Absorbent material. The
absorbent material is placed with the specimen bottles inside the
leak-resistant plastic bag in case a specimen bottle leaks during
shipment. The U.S. Postal Service and other express carriers require the
use of absorbent material when shipping biological materials.
8. Shipping containers. Boxes or
bags used to transport specimens to a laboratory must be securely sealed to
prevent the possibility of undetected tampering. It is not necessary to
use a shipping container/mailer if a courier hand delivers the sealed
leak-resistant plastic bags containing the specimen bottles directly from the
collection site to the laboratory.
9. Bluing agent. Bluing agent is
added to the toilet bowl and water tank to prevent undetected specimen dilution
by the donor.
10. Secure temporary location. It is the
collector’s responsibility to prevent unauthorized access to the specimen
bottles and Federal CCF. Prior to placement in a shipping container, the
sealed leak-resistant plastic bag containing the specimen bottle(s) and
completed Copy 1 of the Federal CCF must be kept:
-
Within the collector’s line-of-sight, or
-
In a secure temporary location (e.g., locked in a
refrigerator or cabinet).
11. Disposable gloves. HHS recommends
that collectors use single-use disposable gloves while handling
specimens. The Occupational Safety and Health Administration has specific
guidelines addressing protection of employees who are exposed to potentially
infectious body fluids (29 CFR Part 1910.1030).
C. Collection Procedure (Single
Specimen or
Split
Specimen)
-
Assemble supplies,
-
Turn off the water supply or secure water sources,
-
Ensure that there is bluing agent in the toilet,
-
Remove any soap, cleanser, disinfectant, or other
potential adulterants, and
-
Inspect and/or secure areas or items that could be
used to conceal adulterants (e.g., false ceilings, ledges, trash cans, towel
dispensers).
2. Begin the collection without delay after the
donor arrives at the collection site. Do not wait because the donor is
not ready or states that he or she is unable to urinate. See Section E
below for instructions on what to do when a donor is unable to provide a
specimen.
4. Describe the single specimen or split specimen
collection procedure to the donor by reviewing the instructions on the back of
the Federal CCF.
-
Ensure that the pre-printed specimen identification
number on the Federal CCF matches the identification number on the specimen
bottle label(s)/seal(s).
-
Verify any pre-printed urine collection demographic
information in Step 1 of the Federal CCF (i.e., information printed by the form
supplier).
-
If the information is not pre-printed, record the
information in Step 1 of the Federal CCF to include:
-
The employer's name, address, telephone and fax
number, employer ID number as applicable,
-
The specific MRO name, address, telephone and fax
number,
-
Donor SSN or employee ID number,
-
Reason for test,
-
Drug test to be performed, and
-
Collection site information.
-
Remove any unnecessary outer clothing (e.g., coat,
jacket, hat, etc.)
-
The donor must not be asked to remove other
articles of clothing, (e.g., shirts, pants, dresses, undergarments) or to
remove all clothing and wear a hospital or examination gown.
-
It is not necessary for the donor to remove
the following items, unless the collector suspects that they are concealing
something that may be used to adulterate or substitute a specimen:
-
Leave other personal belongings (e.g., briefcase,
purse) with the outer clothing. The donor may retain his/her wallet.
-
To safeguard a donor’s belongings, procedures may be
established to secure the items during the collection. These may include:
-
An itemized receipt for belongings left with the
collector,
-
Storage in a lockable cabinet, or
-
An envelope, box, or container secured with
tamper-evident tape.
-
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 there are no items that can be used to adulterate
a specimen, instruct the donor to return the items to the pockets and continue
the collection procedure. Go to Step 7.
-
If an item is found that appears to have been brought
to the collection site with the intent to adulterate the specimen, use a direct
observed collection procedure (see Chapter 7, Section D).
-
If an item that could be used to adulterate a
specimen appears to have been inadvertently brought to the collection site,
secure the item and continue with the normal collection procedure. Go to
Step 7.
-
If the donor refuses to display the items in his or
her pockets, discontinue the collection. This is considered a refusal to
test (see Chapter 8, Section B).
7. Instruct the donor to wash and dry his or her
hands under your observation and not to wash his or her hands again
until after delivering the specimen to you and watching the single specimen or
split specimens being sealed with the label(s)/seal(s).
-
Liquid soap is preferable. The donor may use
bar soap, but bar soap gives the donor the opportunity to conceal soap shavings
under his or her fingernails that may be used to attempt to adulterate the
specimen.
8. Allow the donor to select the collection kit
or collection container (if it is separate from the kit) from the available
supply.
9. Unwrap or break the seal of the kit or
collection container. You may allow the donor to perform this step.
-
Both the collector and the donor must
be present.
-
Only the seal on the collection container is broken
at this time (i.e., the single specimen bottle or split specimen bottles remain
sealed/wrapped).
-
To enter the restroom used for urine specimen
collection with the collection container,
-
To provide a specimen of at least 30 mL for a single
specimen collection or at least 45 mL for a split specimen collection,
-
Not to flush the toilet, and
-
To return with the specimen within approximately 4
minutes of completing the void (i.e., longer wait periods may cause the
temperature to be out of range and necessitate a direct observed collection).
Note: Both the collector and the donor
must maintain visual contact of the specimen from the time the specimen is
transferred to the collector until the single specimen bottle or split specimen
bottles have been sealed for shipment to the laboratory.
11. When you receive the specimen from the
donor, read the temperature strip affixed to or placed on the outside of the
collection container.
-
Do this within 4 minutes after the void.
-
Mark the appropriate box in Step 2 of the Federal
CCF:
-
If the temperature is within the acceptable range
(32E‑38EC/ 90E‑100EF), mark “Yes” and proceed with the single
specimen or split specimen collection procedure. Go to Step 12.
-
If the temperature is outside the acceptable range,
mark “No” and immediately begin to collect a second specimen using a direct
observed collection procedure (see Chapter 7, Section D) and a new collection
kit (i.e., a new collection container and a new Federal CCF).
- Record an appropriate
comment on the “Remarks” line of both Federal CCFs (i.e., for the first and
second specimens) to indicate why two specimens were collected including a
cross reference to the associated specimen identification number.
- Complete the first specimen collection and send the
first specimen and its Federal CCF to the laboratory.
12. Check the specimen volume to ensure that
the specimen contains the required volume of urine (at least 30 mL for a single
specimen or 45 mL for a split specimen).
-
Single Specimen Collection Procedure
-
When the specimen volume is more than 30 mL and the
temperature is within the acceptable range, complete the single specimen
collection procedure. Go to Step 13.
-
When the specimen volume is less than 30 mL and the
temperature is within the acceptable range, begin a second single specimen
collection procedure using either the original or a new Federal CCF. Go
to Step 9.
-
When the temperature is outside the acceptable range,
submit the first specimen collected and begin a second single specimen
collection procedure using a direct observed collection procedure (see Chapter
7, Section D). Then proceed with Step 11.
-
Split Specimen Collection Procedure
-
When the specimen volume is more than 45 mL and the
temperature is within the acceptable range, complete the split specimen
collection procedure. Go to Step 13.
-
When the specimen volume is between 30 mL and 45 mL
and the temperature is within the acceptable range, complete the collection
procedure as a single specimen collection procedure (i.e., the donor forfeits
the right to a split specimen collection. Go to Step 13.
-
When the specimen volume is less than 30 mL and the
temperature is within the acceptable range, begin a second split specimen
collection procedure using either the original or a new Federal CCF. Go
to Step 9.
-
hen the temperature is outside the acceptable range,
submit the first specimen collected and begin a second split specimen
collection procedure using a direct observed collection procedure (see Chapter
7, Section D). Then proceed with Step 11.
-
When a second specimen must be collected
-
Record an appropriate comment on the “Remarks” line
of both Federal CCFs (i.e., for the first and second specimens) to indicate why
two specimens were collected including a cross reference to the associated
specimen identification number.
-
You may give the donor a reasonable amount of fluid
to drink prior to the second collection. The fluid is to be distributed
reasonably through a period of up to three hours or until the donor has
provided a sufficient amount of urine for the second specimen, whichever occurs
first.
-
You are not permitted under any circumstances
to collect and add or combine urine from two separate voids.
-
If the donor refuses to provide a second specimen,
this is considered a refusal to test (see Chapter 8, Section B).
13. Inspect the specimen for adulteration or
substitution by examining the physical characteristics of the urine.
-
Note any abnormal characteristics such as:
-
Unusual color (e.g., specimen is blue),
-
Presence of foreign objects or material,
-
Unusual odor (e.g., bleach), or
-
Signs of adulteration (e.g., excessive foaming when
shaken).
-
If you observe any abnormal characteristic(s) that
appear to be due to adulteration or substitution by the donor, immediately
begin a second specimen collection using a direct observed collection procedure
(see Chapter 7, Section D).
-
Record an appropriate comment on the “Remarks” line
of both Federal CCFs (i.e., for the first and second specimens) to indicate why
two specimens were collected including a cross reference to the associated
specimen identification number.
-
Complete the first collection as described below and
send the first specimen and its Federal CCF to the laboratory regardless of
whether the first specimen had insufficient volume for either a single or split
specimen collection.
-
If the donor fails to provide at least 45 mL for the
second specimen collected, submit the second specimen as a single specimen
collection regardless of the volume.
14. Unwrap the sealed specimen bottle(s) in the
donor’s presence. (There will be two specimen bottles to be unwrapped/opened
for a split specimen collection.)
-
For a split specimen collection, pour at least 30 mL
into the “A” Bottle and at least 15 mL into the “B” bottle), and
-
Discard any excess urine remaining in the collection
container after the bottle(s) have been filled with the appropriate volumes of
urine.
16. Place the appropriate tamper-evident
label/seal over the lid/cap of each bottle to ensure that the lid/cap cannot be
removed without destroying the label/seal.
-
The donor must observe the sealing of the specimen
bottle(s).
18. Ask the donor to initial the bottle
label(s)/seal(s), using care to avoid damaging them.
-
If the donor fails or refuses to initial the seal(s),
note this on the “Remarks” line of the Federal CCF and complete the collection
process. This is not considered a refusal to test.
-
If the tamper-evident label/seal from the Federal CCF
does not adhere properly to the specimen bottle (e.g., due to moisture,
temperature, specimen bottle material) or is accidentally broken or damaged
during the collection process:
-
Apply the unacceptable label/seal to the bottle, and
-
Apply a second, separate tamper-evident label/seal to
seal the specimen bottle.
- Place the additional
label/seal perpendicular to the Federal CCF label/seal, to avoid obscuring
information on the Federal CCF label/seal,
- Initial and date the seal,
- Ask the donor to initial the seal, and
- Provide a comment on the “Remarks” line of the
Federal CCF explaining why the second seal was used.
-
If the tamper-evident label/seal from the Federal CCF
is broken on the specimen bottle after the donor leaves the collection site, the
collection must be cancelled.
-
Notify the agency’s designated representative that
the seal was broken on the specimen bottle.
19. Inform the donor that it is not necessary for
him or her to continue observing the collection procedure after the bottle(s)
have been sealed, and that he or she is allowed to wash his or her hands.
-
Instruct the donor to read the donor certification
statement in Step 5 (Copy 2) of the Federal CCF.
-
Instruct the donor to complete the donor portion of
the Federal CCF,
-
Sign and date the certification statement,
-
Provide his or her date of birth,
-
Print his or her name, and
-
Provide day and evening contact telephone numbers.
-
If the donor refuses to sign the form or to provide
the other information, make a comment on the "Remarks" line of the Federal CCF
to that effect. At a minimum, print the donor’s name in the appropriate
place. Note: This does not constitute a refusal to test.
21. Complete the collector chain of custody
portion of the Federal CCF (Copy 1, Step 4):
-
Print your name,
-
Sign where indicated,
-
Record the date and time of the collection, and
-
Record the specific name of the delivery service to
which the specimen bottle(s) are being released.
22. Separate Copy 1 of the Federal CCF from the other
four copies and place it and the specimen bottle(s) inside the appropriate
pouches of the leak-resistant plastic bag and seal the bag.
-
Suggest that the donor list any prescription and
over-the-counter medications he or she may be taking on the back of the donor’s
copy (Copy 5) of the Federal CCF. This information may help the donor to
remember what medications he or she may have taken if a positive result is
reported by the laboratory to the MRO. This information must not be
recorded on any other copy of the Federal CCF or on the “Remarks” line of the
Federal CCF.
25. Prepare the sealed tamper-resistant plastic
bag containing the specimen bottle(s) and Federal CCF for transport to the
laboratory.
-
Place specimens that are to be shipped into a
shipping container (e.g., box, express carrier mailer). Several specimen
bags may be placed into one shipping container.
-
For specimens that will be hand-delivered from the
collection site to the laboratory, it is not necessary to use a sealed shipping
container. The courier must handle the specimen bags in a manner that
protects the specimens from damage.
26. Send Copy 2 of the Federal CCF to the MRO
and Copy 4 of the Federal CCF to the agency’s designated representative within
24 hours or during the next business day.
-
Acceptable transmission methods include:
-
Faxing to a secure fax machine,
-
Scanning the image and sending it to a secure
computer, and
-
Mailing or transporting by courier.
-
The transmission process must be coordinated between
the collection site and the MRO to ensure that transmission procedures meet the
MRO’s or Federal agency’s requirements.
27. Submit the specimen to the laboratory as
soon as possible (i.e., no later than 24 hours after the collection or during
the next business day).
-
If the specimen is not shipped immediately, the
collector is responsible for ensuring its security.
-
For specimens that are in a sealed plastic bag that
have not been placed in a shipping container, take necessary steps to prevent
any possible tampering or access by unauthorized personnel.
-
For specimens in a sealed shipping container, take
necessary steps to protect the container from any possible damage or theft
prior to pick-up by the designated delivery service.
D. Direct Observed
Collection
A direct observed collection procedure may only
be used when:
1. A Federal agency has authorized a direct
observed collection because a donor’s previous drug test result was reported by
an MRO as drug positive, negative and dilute, adulterated, substituted, or
invalid, or
2. An immediate collection of a second urine
specimen is required in one of the following situations:
-
The temperature of the specimen collected during a
routine collection is outside the acceptable temperature range.
-
There is an indication that the donor has tampered
with the specimen (e.g., abnormal physical characteristic such as unusual
color, excessive foaming when shaken, unusual odor).
-
The donor has intentionally brought to the collection
site an item that could be used to:
-
Adulterate (e.g., a small vial containing a
suspicious liquid),
-
Substitute (e.g., a small vial containing water or
other liquid), or
-
Dilute a urine specimen.
Before conducting a direct observed collection, the
collector must make the agency representative aware that a situation
exists warranting a direct observed collection and explain to the donor why a
direct observed collection is being conducted. If the donor declines to
allow a direct observed collection when one of the above circumstances has
occurred, it is considered a refusal to test (see Chapter 8, Section B).
The procedure for a direct observed collection is the
same as that for a routine collection except an observer watches the donor
urinate into the collection container. At the point in a routine
collection where the donor enters the restroom with the collection container
(see Section C, Step 10), a direct observed collection includes the following
additional steps:
§ The observer must be the same gender as the
donor. There are no exceptions to this requirement. The
individual serving as the direct observer enters the restroom with the donor.
§ The observer must directly watch the urine go
from the donor’s body into the collection container. The use of mirrors
or video cameras is not permitted.
§ With regard to chain of custody, the observer
must never touch or handle the collection container unless the observer is also
serving as the collector.
-
The collector may serve as the observer when the
collector is the same gender as the donor. If not, the collector must
call upon another individual (who is the same gender as the donor) to act as
the observer.
-
The donor and observer leave the restroom and the
donor hands the collection container directly to the collector,
-
The observer must maintain visual contact of the
collection container until the donor hands the container to the collector, and
-
If the same individual serves as direct observer and
collector, he or she may receive the collection container from the donor while
they are both in the restroom.
§ The collector checks the box for an observed
collection in Step 2 on the Federal CCF, and provides the name of the observer
and the reason for an observed collection on the "Remarks" line in Step 2 of
the Federal CCF. A separate sheet explaining the use of an observed
collection may be attached to the Federal CCF if there is insufficient room on
the “Remarks” line.
§ The collector continues with the routine
collection procedures (see Section C, Step 11).
E. Shy Bladder
The term “shy bladder” is used when an individual is
unable to provide a specimen either upon demand or when someone is nearby
during the attempted urination. The HHS Guidelines specify procedures to
follow when a donor claims he or she cannot provide a specimen. If a
donor tells the collector, upon arrival at the collection site, that he or she cannot
provide a specimen, the collector must still begin the collection
procedure regardless of the reason given.
At the point in the collection procedure where the
collector and donor unwrap/open the collection container (see Section C, Step
9), the collector does the following:
1. Request that the donor go into the restroom
and try to provide a specimen. The donor demonstrates his or her inability to
provide a valid specimen when he or she comes out of the restroom with an empty
collection container.
2. Begin a “Shy Bladder” collection procedure:
-
The donor is given a reasonable amount of fluid to
drink distributed reasonably through a period of up to 3 hours, or until the
donor has provided a sufficient amount of urine, whichever occurs first.
-
The donor must remain under the direct observation of
the collector to prevent the donor from possibly compromising the collection
process.
-
If the donor refuses to attempt to provide a specimen
or leaves the collection site before the collection process is completed, the
collector must discontinue the collection, record a “refusal to test” on the
“Remarks” line of the Federal CCF, and immediately notify the agency’s
designated representative of the situation.
-
If the donor declines to drink fluids, it is not a
refusal to test.
-
Under no circumstances can a collector combine
specimens collected from separate voids to create one specimen of sufficient
volume.
3. Instruct the donor to let you know when he or
she is able to provide a sufficient quantity of specimen. It is
recommended that you allow sufficient time to have only one additional attempt
rather than having to document several unsuccessful attempts. Be
sensitive to how frequently you ask a donor to attempt to provide a specimen.
5. If the donor is unable to provide a
sufficient volume of specimen in three hours from the time the donor
first demonstrated that he or she was unable to provide a sufficient volume of
specimen, discontinue the collection and:
-
Notify the agency’s designated representative of a
potential “shy bladder” situation,
-
Write "Shy Bladder" on the "Remarks" line of the
Federal CCF,
-
Attach a copy of the record documenting the attempts
to collect a specimen, and
-
Distribute the copies of the Federal CCF as required.
-
Give Copy 5 to the donor,
-
Discard Copy 1 (no valid specimen was collected), and
-
Send Copy 2 to the MRO and Copy 4 to the agency
designated representative within 24 hours or the next business day.
Chapter 8: Miscellaneous
Collection Issues
A. Donor Conduct
The collector should pay close attention to the
donor’s conduct during the entire collection process and take the following
actions as necessary:
1. If the donor’s actions or items on his/her
person clearly indicate an attempt to substitute or adulterate a specimen
conduct a direct observed collection and document the reason on the “Remarks”
line of the CCF.
2. If the donor’s actions clearly indicate an
attempt to substitute or adulterate a specimen and the donor has already
provided a specimen:
-
Complete the collection procedure for that specimen
and immediately begin a new collection using a direct observed collection
procedure, a second Federal CCF, and a new collection kit.
-
Provide appropriate comments in Step 2 on both
Federal CCFs (i.e., for the first and second specimens):
-
Note on the "Remarks" line whether the specimen is
the first or the second of the two collections for the donor,
-
Write on the "Remarks" line the specimen ID number of
the associated specimen,
-
Note on the "Remarks" line the reason for the second
collection (i.e., the observed conduct or found items indicative of attempted
adulteration/substitution), and
-
Document that the second collection was under direct
observation by checking appropriate box.
-
Inform the agencys designated representative that a
collection took place under direct observation and the reason for having done
so.
3. If the donor fails to arrive at the assigned
time or if the donor fails to remain present through the completion of the
collection:
-
Contact the agencys designated representative to
obtain guidance on the action to be taken.
-
This is not considered a refusal to
test.
B. Refusal to Test
A Federal agency will take adverse action against an
employee whose drug test specimen is reported as a refusal to test.@ The
collector reports a “refusal to test” when:
1. The donor refuses to display the items in his
or her pockets at the beginning of the inspection,
2. The donor declines to allow a direct observed
collection when required, or
3. The donor declines to
continue the collection process when his or her first specimen has insufficient
volume.
When reporting a “refusal to test,” the collector
must:
1. Notify the agencys designated representative
by telephone as soon as possible,
2. Document the refusal to test on the Federal
CCF, and
3. Send all copies of the Federal CCF to the
Federal agency's designated representative.
Chapter 9: Collector Errors
The Federal CCF is a forensic document and will be
part of the litigation package if a specimen comes under legal challenge.
The collector should never overwrite or scribble out information
recorded or printed on the Federal CCF. Unclear or improper edits to
Federal CCF information (e.g., donor identification numbers, signatures) could
compromise the legal defensibility of the document.
If the collector makes an error on a CCF, he or she
should:
1. Make a line through the erroneous
information, leaving the original information legible,
2. Write the correct information near (e.g.,
beside) the original annotation, and
3. Initial and date the change.
It is acceptable for the collector to cross out
preprinted information on the Federal CCF that is incorrect or inapplicable
(e.g., collection site, MRO, laboratory, or employer information). The
collector must use the procedures described above for editing the form.
This may be necessary in the event of unexpected collections (e.g.,
post-accident) or when Federal CCFs at the collection site have outdated
information (i.e., the collection site has not yet received Federal CCFs with
updated information).
There are three categories of collector errors:
1. Fatal flaws that result in a laboratory
rejecting a specimen for testing or that result in an MRO canceling a test,
2. Correctable flaws that result in a laboratory
rejecting a specimen for testing or an MRO canceling a test unless the flaw is
corrected by a memorandum from the collector, or
3. Omissions and discrepancies on the Federal
CCF that are considered insignificant and do not cause rejection by the
laboratory or cancellation by the MRO when they are infrequent (i.e., when a
collector does not make the error more than once a month).
The collector must take immediate steps to
provide a memorandum for the record to the laboratory or MRO when notified of
an error. A laboratory holds specimens for a short time (i.e., a minimum
of 5 business days) after the collector has been notified, before reporting the
specimen as rejected and discarding the specimen.
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