Note: This handbook is
essentially the same as the 1996 HHS Urine Specimen Collection Handbook except
for changes related to the new Federal custody and control form. The appendix
has also been deleted since the new
Federal Custody and Control Form is available as a separate file on the
website.
This handbook applies to Federal agency Workplace drug
testing programs that come under Executive Order 12564 and the Department of
Health and Human Services (HHS) Mandatory Guidelines.
Chapter
1.
The Collector
2.
Collection Site
3.
Collection Supplies
4.
Federal Drug Testing Custody and Control Form
5.
Donor Identification
6.
Collection Procedure
7.
Shy Bladder Procedure
8.
Direct Observed Collections
9.
Blind Samples
10.
Documentation Errors/Fatal Flaws
11.
Regulated and Non-Regulated Employers
Chapter 1. The Collector
A collector is a trained individual who instructs and
assists a donor at a collection site, receives and makes an initial inspection
of the urine specimen provided by a donor, and initiates and completes the
Federal Drug Testing Custody and Control Form (CCF).
Any individual, who has received training in
conducting the required collection procedure, may serve as a collector except
in the following situations:
(a) The direct supervisor of a particular employee you
may not act as the collector when that employee is tested, unless there is no
feasible alternative; or
(b) An individual working for an HHS-certified drug
testing laboratory may not act as a collector if that individual can link the
employee with the specimen drug test result or laboratory report (to allow such
an individual to collect such a specimen would compromise the confidentiality
of the employee's test result).
A collector should have appropriate identification.
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 picture I.D. 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.
Note: Although not required, it would benefit the
collector to have the agency representative's name and telephone number to call
if an unusual situation arises during the collection process.
Chapter 2. Collection Site
A collection site is a facility (permanent or
temporary) where a donor provides a specimen for a drug test.
A collection site must have:
(1) A restroom/stall with a toilet for the donor to
have privacy while providing the urine specimen. The presence of a toilet is
not absolutely necessary when a single-use collection container is used that
has sufficient capacity to contain the entire void. Whenever available, a
single toilet restroom 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/stall where urination occurs. If a water
source is not available, providing a moist towelette outside the restroom/stall
is an acceptable alternative.
(3) A suitable clean surface for the collector to use
as a work area.
Note: The collector's work area must 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
large enough to accommodate a work area, the work area may be located inside
the restroom as long as the donor has privacy while providing a urine specimen
and the collector is the same gender as the donor.
(4) Security features to prevent unauthorized access
to the site during the collection.
(5) Features to prevent the donor or anyone else from
gaining unauthorized access to the collection materials/supplies. The collector
must ensure that the donor does not have access to items that could be used to
adulterate or dilute the specimen (e.g., soap, disinfectants, cleaning agents,
water).
(6) Features to provide for the secure
handling/storage of specimens from collection until shipment.
Chapter 3. Collection Supplies
The following items must be available at the
collection site to conduct proper collections:
(1) Single-use plastic collection containers.
Each collection container must be individually sealed using a tamper-evident
system (such as, sealed plastic bag, shrink wrap, or another easily visible
tamper-evident system), be large enough to easily catch and hold at least 55 mL
urine, and have graduated volume markings clearly noting levels of 45 mL and
above.
(2) Single-use plastic specimen bottles. Each
specimen bottle with cap must be sealed using a tamper-evident system (such as,
sealed plastic bag, shrink wrap, or another easily visible tamper-evident
system), be large enough to hold at least 35 mL (or they may be two distinct
sizes of specimen bottles providing 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), have screw-on or snap-on caps that
prevent leakage, have markings clearly indicating the appropriate levels (30 mL
for the primary specimen and 15 mL for the split specimen) of urine to be
poured into each bottle, be designed so that the required tamper-evident bottle
label/seal on the CCF fits with no damage to the seal when the employee
initials it nor with chance that seal overlap would conceal printed
information, and be leak-resistant.
Note: Two specimen bottles with caps may be sealed
together using a single tamper-evident system (such as, shrink wrap) because
two specimen bottles are always needed for split specimen collections.
(3) Temperature strips capable of indicating
temperature readings between 90E-100EF (or 32E-38EC). The temperature strips
may either be affixed to the collection container as supplied or may be affixed
to the collection container after the donor gives the specimen collection
container to the collector.
(4) Federal Drug Testing Custody and Control Forms
(CCF) approved by the Office of Management and Budget (OMB).
(5) Tamper-evident seals. 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). If this occurs, the collector should
have a separate tamper-evident label/seal that can be used to seal the specimen
bottle.
(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 the 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.
Note: The use of absorbent material is required by the
U.S. Postal Service and other express carriers when shipping biological
materials.
(8) Shipping containers. Boxes or bags that are
used to transport specimens to the laboratory and can be securely sealed to
prevent the possibility of undetected tampering. A shipping container/mailer is
not necessary if a laboratory courier hand-delivers the sealed leak-resistant
plastic bags containing the specimen bottles directly from the collection site
to the laboratory.
(9) Bluing agent. The bluing agent is added to
the toilet bowl/water tank to prevent a donor from diluting the specimen.
(10) Secure temporary location. If the sealed
leak-resistant plastic bag containing the specimen bottles is not immediately
placed in a shipping container, the sealed plastic bag must always be
maintained within the line of sight of the collector to ensure that no one has
access to the specimen until it is placed in a shipping container or it must be
placed in a secured temporary location (e.g., inside a refrigerator that can be
secured, inside a cabinet that can be secured). If the collector always places
the sealed plastic bags immediately into shipping containers, there is no need
to have a secure temporary location available at the collection site.
(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).
Chapter 4. Federal Drug Testing
Custody and Control 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 Office of Management
and Budget (OMB) approved Federal Drug Testing Custody and Control Form (CCF)
must be used to document the collection of a specimen at the collection site.
The CCF is available from a number of different sources (e.g., laboratories,
collectors, MROs) although it is usually provided by the laboratory.
A sample of the CCF (OMB No. 0930-0158, Exp. Date:
6/30/2003) is on the SAMHSA web site (www.health.org/workpl.aspx). All
discussions throughout this revised handbook refer to this version of the CCF
form.
The CCF consists of the following five copies:
Copy 1. Laboratory Copy
Copy 2. Medical Review Officer Copy
Copy 3. Collector Copy
Copy 4. Employer Copy
Copy 5. Donor Copy
Copy 1 accompanies the specimen to the testing
laboratory, Copy 2 is sent to the MRO, Copy 3 is retained by the collector,
Copy 4 is sent to the employer, and Copy 5 is given to the donor.
The CCF is completed as follows:
Step 1. This step is completed by the collector or
employer representative. The employer name and address and the MRO name and
address may be preprinted or handwritten. The collector will normally enter the
donor's social security number after verifying the donor's identity. The
collector also marks the appropriate box to indicate the reason for the test
and the appropriate box for the drug tests to be performed. The collector then
enters the information required for the collection site.
Step 2. This step is 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 box to
indicate if the temperature of the specimen was within the required temperature
range; but 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.
Step 3. This step instructs the collector to seal the
specimen bottle(s), have the donor initial the bottle seal(s), and then
instruct the donor to complete step 5 on the MRO copy (Copy 2).
Step 4. This step is initiated by the collector and
then completed by the laboratory after the specimen is accessioned by the
laboratory. This step requires the collector to only sign the form once 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 document chain of custody for the
specimens during transit because they do not have access to the specimen(s) or
the CCF. Chain of custody annotations resume when the shipping
container/package is opened and an individual at the laboratory has access to
the specimen bottle(s) and the CCF.
At the laboratory, the accessioner is required to
document the condition of the primary specimen bottle seal, sign the CCF, print
his/her name, record the date the specimen was accessioned, and indicate to
whom the specimen was released. The entry for the "Specimen Bottle(s) Released
To" may include transfer to temporary storage or transfer to another
individual. After this transfer, chain of custody of the specimen bottle(s) is
documented by the laboratory on an internal chain of custody form.
Step 5(a). This step is completed by the laboratory to
document the test results on the primary specimen.
Step 5(b). This step is completed by the laboratory to
report the split specimen result if the split specimen is tested.
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 must have the same preprinted
specimen identification number that appears at the top of the CCF. Each label
must also have a place for the collector to annotate the date of the collection
and a place for the donor to initial each label after it is placed on the
specimen bottle. If a single specimen collection procedure is used, the second
label (i.e., the "B" label) is discarded by the collector.
Chapter 5. Donor Identification
The donor 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),
(2) Identification by an agency representative, or
(3) Any other identification allowed under an agency's
Workplace drug testing plan.
Unacceptable forms of identification include:
(1) Identification by a co-worker,
(2) Identification by another donor, or
(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).
Chapter 6. Collection Procedure
The following steps describe a typical urine
collection procedure under the Mandatory Guidelines:
STEP
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 agent placed in all toilets.
Note: If access to a water supply in the restroom
cannot be controlled, the collector may tell the donor that he or she will be
listening at the entrance to the restroom for any sounds associated with the
donor attempting to use the available sources of water. Alternatively, the
collector may enter the restroom with the donor if the collector is the same
gender as the donor, but remains outside the toilet stall.
2. The collector begins the collection without delay
after the donor arrives at the collection site.
Note: Do not wait because the donor is not ready, is
unable to urinate, or an authorized employer or employee representative is
delayed in arriving.
3. The collector requests the donor to present an
acceptable form of identification as described in Chapter 5.
Note: If the donor cannot satisfy the identification
requirement, the collector may proceed with the collection if the donor can
provide two items of identification bearing his or her signature. After
the donor signs the certification statement, the collector should compare the
donor's signature with signatures on the identification that was presented. If
the signatures match, the collector lists on the "Remarks" line the two items
of identification used to identify the donor and states that "signature
identification was confirmed." The collector then continues with the collection
process. If the signature does not match the signatures on the two items of
identification presented, the collector should state on the "Remarks" line that
"signature identification is unconfirmed," discontinue the collection, and
notify the collection site supervisor and the agency.
Note: In situations where the donor does not have
either a photo identification or two other appropriate items of identification
that could be used to verify identity and signature, this should not be
automatically considered a refusal to test. The collector should proceed with
the collection. The collector should provide sufficient information on the
"Remarks" line to help the MRO and the agency make a determination regarding
the validity of the specimen and the collection process.
Note: If the donor asks the collector to provide identification, the collector
must show the donor some form of identification. It must include the
collector's name and the employer's name, address, and telephone number. It
does not have to be a picture identification or include a home address and
telephone number.
4. The collector reviews the instructions on the back
of the CCF with the donor.
5. The collector begins entering information and/or
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) and in Step 1
of the CCF (employer's name, address, and I.D. number (if applicable), MRO
name, address, phone and fax number, donor SSN or employee ID number, reason
for test, drug test to be performed, collection site information).
Note: A specific MRO's name and address must appear on
the form rather than the name of the clinic or medical facility.
6. The collector asks the donor 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 donor may retain his or her wallet.
Note: The donor must not be asked to remove other
articles of clothing, such as, shirts, pants, dresses, or under garments.
Additionally, the donor must not be requested or required to remove all
clothing and wear a hospital or examination gown.
7. The collector directs the donor 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 donor places the items back into the pockets and the
collection procedure continues.
Note: If an item is found that appears to have been
brought to the collection site with the intent to adulterate the specimen, a
direct observed collection procedure is used. If the item appears to be
inadvertently brought to the collection site, secure the item and continue with
the normal collection procedure.
8. The collector instructs the donor to wash and dry
his or her hands, preferably under the collector's observation and must not
wash his or her hands again until after delivering the specimen to the
collector.
Note: The donor must not be allowed any further access
to water or other materials that could be used to adulterate/dilute the
specimen.
9. The collector either gives the donor or allows the
donor to select the collection container from the available supply. Either the
collector or the donor, with both present, then unwraps or breaks the seal of
the collection container.
Note: Do not unwrap or break the seal on any specimen
bottle at this time.
Note: Do not allow the donor to take anything except
the collection container into the room used for urination.
10. The collector directs the donor to go into the
room used for urination, provide a specimen of at least 45 mL (split specimen
collection) or 30 mL (single specimen collection), not to flush the toilet, and
return with the specimen as soon as possible after completing the void.
Note: The donor is always permitted to provide a
specimen in private unless a direct observed collection has been authorized.
Note: Pay close attention to the donor during the
entire collection process to note any conduct that clearly indicates an attempt
to substitute or adulterate a specimen. If you detect such conduct, immediately
begin a new direct observed collection using a second CCF. Provide an
appropriate comment on the "Remarks" line in Step 2 on the first CCF and submit
it along with the specimen to the laboratory for testing. This will ensure that
the laboratory knows that two separate specimens are being submitted for
testing; the first one possibly being adulterated or substituted. Additionally,
inform a supervisor that a collection took place under direct observation and
the reason for doing so.
11. After the donor hands the specimen to the
collector, the collector must measure the temperature of the specimen, check
the specimen volume, and inspect the specimen for adulteration or substitution.
Temperature. Check the temperature of the
specimen within four minutes after the donor hands you the specimen. The
acceptable temperature range is 32E-38EC/ 90E-100EF. Temperature is determined
by reading the temperature strip originally affixed to or placed on the outside
of the collection container after the donor hands you the specimen.
1. 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.
2. If the temperature is outside the acceptable range,
the "No" box is marked in Step 2 on the CCF and the collector immediately
begins a direct observed collection procedure using a second CCF. The original
specimen is sealed and sent with the first CCF to the laboratory with an
appropriate comment on the "Remarks" line to indicate that a direct observed
specimen was also being collected and submitted to the laboratory.
Specimen Volume. Check to make sure that the
specimen contains a sufficient amount of urine (i.e., 30 mL for a single
specimen collection, 45 mL for a split specimen collection).
A. Single specimen collection. If the volume is
less than 30 mL, the action taken will depend on whether the temperature of the
specimen is in or outside the acceptable range.
1. If the temperature is in the acceptable range, the
specimen is discarded and a second specimen is collected. The collector may use
the same CCF for the second specimen, but must use a new specimen collection
container. If the donor fails for any reason to provide 30 mL of urine for the
second specimen collected, the collector will contact the agency to obtain
guidance on the action to be taken.
2. If the temperature is outside the acceptable
range, a second specimen is collected under direct observation and both
specimens are sent to the laboratory for testing. The collector must use a
separate CCF for each specimen and provide an appropriate comment on each CCF
to indicate why two specimens were collected. If the donor fails for any reason
to provide 30 mL of urine for the second specimen collected, the collector will
contact the agency to obtain guidance on the action to be taken.
Note: In either case when a second specimen is to be
collected, HHS permits giving the donor a reasonable amount of fluid to drink
to provide a second specimen distributed reasonably through a period of up to 3
hours, or until the donor has provided a new sufficient amount of urine,
whichever occurs first.
B. Split specimen collection. If the volume is
less than 30 mL, the action taken will depend on whether the temperature of the
specimen is in or outside the acceptable temperature range.
1. If the temperature is 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 use a new specimen
collection container.
If the donor fails to provide 45 mL for the second specimen collected, the
donor forfeits the right to the use of a split specimen collection procedure
and the collector submits the second specimen as a single specimen collection
with an appropriate comment on the "Remarks" line on the CCF.
2. If the temperature is outside the acceptable
range, a second specimen is collected under direct observation and both
specimens are sent to the laboratory for testing. The collector must use a
separate CCF for each specimen and provide an appropriate comment on each CCF
to indicate why two specimens were collected.
If the donor fails to provide 45 mL for the second
specimen collected, the donor forfeits the right to the use of a split specimen
collection procedure and the collector submits the second specimen as a single
specimen collection (regardless of the volume collected) with an appropriate
comment on the "Remarks" line on the CCF.
Note: In either case when a second specimen is to be
collected, HHS permits giving the donor a reasonable amount of fluid to drink
to provide a second specimen distributed reasonably through a period of up to 3
hours, or until the donor has provided a new sufficient amount of urine,
whichever occurs first.
C. Split specimen collection. If the volume is
between 30 and 45 mL, the action taken will depend on whether the temperature
of the specimen is in or outside the acceptable temperature range.
1. If the temperature is in the acceptable range, all
of the urine should be poured into one specimen bottle (Bottle A). Bottle A is
sent to the laboratory along with the CCF. The collector should provide an
appropriate comment on the "Remarks" line on the CCF that the donor did not
provide a sufficient volume of urine for the split (Bottle B) specimen. The
donor forfeits the use of a split specimen collection procedure.
2. If the temperature is outside the acceptable
range, a second specimen is collected under direct observation and both
specimens are sent to the laboratory for testing. The collector must use a
separate CCF for each specimen and provide an appropriate comment on each CCF
to indicate why two specimens were collected.
If the donor fails to provide 45 mL for the second
collection, the second specimen is submitted as a single specimen collection
and the collector should provide an appropriate comment on the "Remarks" line
on the CCF that the donor did not provide a sufficient volume of urine for the
split (Bottle B) specimen. The donor forfeits the use of a split specimen
collection procedure.
Note: HHS permits giving the donor a reasonable amount
of fluid to drink to provide a second specimen distributed reasonably through a
period of up to 3 hours, or until the donor has provided a new sufficient
amount of urine, whichever occurs first.
Adulteration or Substitution. Inspect the
specimen for unusual color, presence of foreign objects or material, or other
signs of adulteration (e.g., if you notice any unusual odor). If it is apparent
from this inspection that the donor 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 is
conducted. The first specimen and the specimen collected using direct
observation are both sent to the laboratory for testing. The first specimen is
always sent to the laboratory even though it may have had an insufficient
volume for either a single or split specimen collection.
If the donor does not provide the required amount of
urine for the second collection using direct observation, the collector submits
the second specimen as a single specimen collection (regardless of the volume)
and provides appropriate comments on the "Remarks" line on both CCFs.
Note: When a second specimen is to be collected, HHS
permits giving the donor a reasonable amount of fluid to drink to provide a
second specimen distributed reasonably through a period of up to 3 hours, or
until the donor has provided a new sufficient amount of urine, whichever occurs
first.
Note: Under no circumstance is the collector permitted
to collect and add or combine urine from two separate voids.
12. The sealed specimen bottle is then
unwrapped/opened in the donor's presence after the donor gives the specimen in
the collection container to the collector. The collector or the donor may
unwrap/open the specimen bottle.
Note: There will be two specimen bottles to be
unwrapped/opened if a split specimen was collected.
Note: Both the collector and donor will maintain
visual contact of the specimen until the label/seal is placed over the specimen
bottle cap/lid.
13. The collector pours the specimen from the
collection container into a specimen bottle, places the lid/cap on the bottle,
and uses the "A" bottle tamper-evident label/seal. The "B" bottle label is
discarded. If a split specimen collection procedure is used, the collector
pours 30 mL of urine into a specimen bottle, places the lid/cap on the bottle
and uses the "A" bottle label/seal. The collector then pours the remaining
urine (at least 15 mL) into a second bottle, places the lid/cap on the bottle,
and uses the "B" bottle label/seal.
Note: The tamper-evident label/seal must be placed
over the lid/cap to ensure that the lid/cap cannot be removed without
destroying the label/seal. The donor must be present to observe the sealing of
the specimen bottle(s).
14. The collector writes the date on the
tamper-evident label(s)/seal(s). The donor is requested to initial the
tamper-evident label(s)/seal(s).
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). When this occurs, the collector should still apply the
tamper-evident label/seal provided with the CCF and then apply a second,
separate tamper-evident seal to seal the specimen bottle. This second seal
should be placed perpendicular to the CCF label/seal to avoid obscuring
information on the CCF label/seal. This second seal must be initialed and dated
by the collector and should be initialed by the donor (i.e., if the donor is
still present when it is apparent that the CCF label/seal is not properly
adhering to the specimen bottle; however, a label/seal may appear to adhere
when initially placed on the bottle, but after several minutes the label/seal
begins to lift off along the edges). The collector must also provide an
appropriate comment on the "Remarks" line (CCF, Step 2) stating why the second
seal was used.
Note: If while sealing and initialing the CCF
label/seal the collector or donor accidentally breaks/damages the seal, the
collector must apply a second, separate tamper-evident seal to seal the
specimen bottle. This second seal should be placed perpendicular to the CCF
label/seal to avoid obscuring information on the CCF label/seal. This second
seal must be initialed and dated by the collector and initialed by the donor.
The collector must also provide an appropriate comment on the "Remarks" line
(CCF, Step 2) stating why the second seal was used.
Note: Since the specimen bottle is now sealed with
tamper-evident tape and does not have to be under the donor's direct
observation, the donor is allowed to wash his or her hands if he or she desires
to do so.
15. The donor reads the certification statement on
Copy 2 of the CCF (Step 5), signs and dates the certification statement,
provides date of birth, printed name, and day and evening contact phone
numbers.
Note: If the donor refuses to sign the form, the
collector must make a notation on the "Remarks" line to that effect. Otherwise,
without the collector's comment, a CCF without the donor's signature could
result in a canceled test. The same procedure should be followed if the donor
refuses to initial the label(s).
16. The collector completes the chain of custody on
the CCF (Step 4) by printing his or her name, signing where indicated,
recording the date and time of the collection, and indicating the specific name
of the delivery service to whom the specimen bottle(s) are being released.
17. The collector removes Copy 5 from the CCF and
gives it to the donor. The donor may now leave the collection site.
Note: At this time, the collector can tell the donor
to list any prescription and over-the-counter medications he or she may have
recently taken on the back of the donor copy (Copy 5) of the CCF, but not on
any other copy. This information will help the donor 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 bottle(s) and
Copy1 of the CCF inside the appropriate pouches of the leak-resistant plastic
bag, seals the pouches, and initials and dates the seal.
19. The collector places the sealed plastic bag in an
appropriate shipping container (e.g., express carrier mailer) and seals the
shipping container as appropriate.
Note: If a collector is collecting several specimens
within a short period of time, the sealed plastic bags may be placed into a
single shipping container. The collector must maintain visual contact of the
sealed plastic bags until all plastic bags are sealed in the single shipping
container.
Note: The collector must ensure that each specimen is
shipped to a laboratory as expeditiously as possible, the same day
preferably.
20. The collector sends Copy 2 to the MRO and Copy 4
to the employer. Copy 3 is retained by the collector.
The collection procedure is now complete.
Chapter 7. Shy Bladder Procedure
When a donor is unable to provide a urine specimen,
the donor may have intentionally urinated prior to arriving at the collection
site, could not provide a specimen as directed by the collector, has a physical
disability making it impossible to provide a specimen, or has a "shy bladder."
The term "shy bladder" usually refers to an individual who is unable to provide
a specimen either upon demand or when someone is nearby during the attempted
urination.
If a donor tells the collector, upon arrival at the
collection site, that he or she cannot provide a specimen, the collector
must begin the collection procedure regardless of the reason given.
At the point in the collection procedure where the
collector and donor unwrap/open a collection container, the collector does the
following:
(1) Requests the donor to try to provide a specimen.
Note: The donor demonstrates his or her inability to
provide a valid specimen when the donor comes out of the enclosed toilet stall
with an empty collection container.
(2) Directs the donor to drink some fluids.
Note: 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 new sufficient amount of urine, whichever occurs first.
Note: The donor must remain under the direct
observation of the collector or an agency representative to prevent the donor
from possibly compromising the collection process.
Note: If the donor refuses to drink fluids as directed
or refuses to attempt to provide a urine specimen, the collection procedure is
discontinued and a "refusal to test" is noted on the "Remarks" line of the CCF.
(3) Instructs the donor to let you know when he or she
is able to provide a sufficient quantity of specimen. The collector uses the
CCF from the first attempt.
Note: It is recommended that the collector allow
sufficient time to have only one additional attempt rather than having to
document several unsuccessful attempts.
(4) Maintains a record of the time of each attempt,
whether there was no specimen provided or the quantity of specimen provided,
and the total ounces of fluid given to the donor.
(5) Discards any inadequate specimen and the
collection container that was used for the void, but retains the CCF.
Note: If there was actually no specimen provided on an
attempt, the collection container may be used for the next attempt.
(6) Discontinues the collection procedure and notifies
the agency of a potential "shy bladder" situation if after a period of three
hours (i.e., from the time the donor first demonstrated that he or she was
unable to provide a sufficient quantity of specimen) the donor is still unable
to provide an adequate specimen.
(7) Indicates "Shy Bladder" on the "Remarks" line of
the CCF and attaches a copy of the record documenting the attempts to collect a
specimen. Copy 1 is discarded since no valid specimen was collected and the
other copies of the CCF are distributed as appropriate.
Chapter 8. Direct Observed Collection
A direct observed collection procedure is the same as
a routine collection procedure with the additional requirement that an observer
physically watches the donor urinate into the collection container.
The use of an observer may occur only when:
(1) A previous drug test was reported either positive
for a drug, dilute, adulterated, substituted, unsuitable for testing, or
canceled because the split specimen was not tested;
(2) The drug test is a return-to-duty or a follow-up
test;
(3) The agency/employer believes that the donor may
alter or substitute the specimen to be provided; or
(4) During a routine collection, the temperature of
the specimen collected is outside the acceptable range, the collector observed
materials brought to the collection site or donor conduct indicated a possible
attempt to adulterate or substitute a specimen, or the collector believes that
the specimen has been adulterated (e.g., the specimen is blue, exhibits
excessive foaming when shaken, has smell of bleach).
Note: The observer must be the same gender as the
donor even if the observer has a medical background/training.
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.
Note: With regard to chain of custody, the observer
must never touch/handle the collection container.
After the donor has completed urinating into the
collection container, the donor and observer leave the enclosed toilet
stall/restroom and the donor hands the collection container directly to the
collector.
Note: The observer must maintain visual contact of the
collection container until the donor hands the container to the collector.
Note: If the observer and collector are one and the
same, the collector may receive the collection container from the donor while
they are both in the enclosed toilet stall/restroom.
The collector continues with the collection procedure,
checks the box for an observed collection in Step 2 on the CCF, and provides
the name of the observer and the reason for an observed collection on the
"Remarks" line in Step 2 on the CCF. A separate sheet explaining the use of an
observed collection may be attached to the CCF if there is insufficient room on
the "Remarks" line.
Chapter 9. Blind Samples
Each Federal agency is required to have some blind
samples (negative and positive spiked samples) submitted along with the donor
specimens.
The blind samples are either purchased by the agency
and given to the collector or the collector, third party administrator, or MRO
purchases the blind samples from a supplier and submits the blind samples along
with agency's donor specimens.
A blind sample is always submitted using the same CCF
as that used for a donor 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 label/seal. Since there is
no donor, the collector must indicate that the sample is a "blind sample" on
the MRO copy where the donor would normally provide a signature (Step 5 on Copy
2 of the CCF).
Note: For a blind sample, Copy 5 of the CCF (the donor
copy) may be discarded by the collector.
Note: If a Federal agency/employer collects "split
specimens" for its Workplace drug testing program, the blind samples must also
be submitted as "split specimens."
Chapter 10. Documentation
Errors/Fatal Flaws
When an HHS certified laboratory receives a specimen
bottle(s) and its associated CCF, it checks to see if the specimen ID number on
the specimen bottle label/seal matches the number on the CCF, that the specimen
bottle seal is intact, and that the CCF has been properly completed by the
collector. If there is any discrepancy and/or error of omission (e.g., the
collector did not sign the chain of custody, the collector did not check one of
the specimen temperature boxes), 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 did actually carry out the required action but inadvertently forgot
to properly document the CCF.
Note: If a memorandum cannot be provided by the
collector to recover the discrepancy or error of omission, the laboratory will
report "Rejected for Testing" to the MRO and provide an appropriate comment as
to why the specimen was not tested.
Note: Once contacted by the laboratory, the collector
should immediately respond to the laboratory indicating whether it can or
cannot provide a memorandum to recover the discrepancy and/or error of
omission. HHS recommends that laboratories retain these specimens for a minimum
of 5 business days before they may be discarded.
Chapter 11. Regulated and
Non-Regulated Employers
Federal agencies and employers regulated by the
Department of Transportation (DOT) are required to use the OMB approved Federal
Drug Testing Custody and Control Form for their Workplace drug testing
programs. All other employers, private sector companies, States, Department of
Justice programs, and the non-DOT testing conducted by DOT regulated employers
are considered "non-regulated" with respect to complying with the HHS Mandatory
Guidelines for Federal Workplace Drug Testing Programs or the DOT Workplace
Drug and Alcohol Testing Programs and are prohibited from using the
Federal CCF.
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.
