[Federal Register Volume 64, Number 219 (Monday, November 15, 1999)]
[Notices]
[Pages 61916-61930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29609]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Federal Drug Testing Custody and Control Form
AGENCY: Substance Abuse and Mental Health Services Administration, HHS.
ACTION: Notice of proposed revision.
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SUMMARY: The Department of Health and Human Services (HHS) establishes
the standards for Federal workplace drug testing programs under
authority of Public Law 100-71 and Executive Order No. 12564. As a
result of the Executive Order and Public Law, HHS published the
Mandatory Guidelines for Federal Workplace Drug Testing Programs in the
Federal Register on April 11, 1988 (53 FR 11979), which were revised on
June 9, 1994 (59 FR 29908), to establish comprehensive standards for
all aspects of the Federal workplace drug testing program. The
Mandatory Guidelines require all urine specimens to be collected using
chain of custody procedures to document the integrity and security of
the specimen from the time of collection until receipt by the
laboratory. To ensure uniformity among all Federal agency workplace
drug testing programs, the Mandatory Guidelines require agencies to use
an Office of Management and Budget (OMB) approved Federal drug testing
custody and control form (Federal CCF) for their programs.
Additionally, the Department of Transportation (DOT) has required its
regulated industries to use the Federal CCF. The current Federal CCF
has been approved for use by OMB until July 31, 2000, for all Federal
agency and federally regulated drug testing programs which must comply
with the HHS Mandatory Guidelines.
The current Federal CCF is a seven-part form that consists of the
following copies: Copy 1 (Original--Must Accompany Specimen to
Laboratory (White)), Copy 2 (Second Original--Must Accompany Specimen
to Laboratory (White)), Copy 3 (Split Specimen--Must Accompany Split
Specimen to Laboratory (White)), Copy 4 (Medical Review Officer Copy
(Pink)), Copy 5 (Donor Copy (Green)), Copy 6 (Collector Copy (Yellow)),
and Copy 7 (Employer Copy (Blue)). The reverse side of copies 1, 2, 3,
4, 5, and 6 have a Paperwork Reduction Act Notice statement, the
reverse side of Copy 5 has a Privacy Act Statement (for Federal
employees only), and the reverse side of Copy 7 has instructions for
completing the CCF. Additionally, the tamper-evident specimen bottle
seal(s)/label(s) are attached to the right side of Copy 1.
This notice provides proposed changes to the current Federal CCF.
It incorporates changes based on the HHS and DOT experiences during the
past several years as well as many of the recommendations developed by
industry representatives (i.e., users and suppliers of the Federal CCF)
at two working group meetings held in January and March 1999. The
Substance Abuse and Mental Health Services Administration (SAMHSA)
believes the proposed changes will make the Federal CCF easier to use
and will more accurately reflect the collection process and how results
are reported by the drug testing laboratories. The proposed form is
provided in Appendix A.
DATES: Written comments on the proposed draft should be submitted by
January 14, 2000.
ADDRESSES: Written comments should be addressed to Robert L. Stephenson
II, M.P.H., Director (Acting), Division of Workplace Programs, CSAP,
5600 Fishers Lane, Rockwall II, Suite 815, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: Walter F. Vogl, Ph.D., Drug Testing
Section, Division of Workplace Programs, CSAP, 5600 Fishers Lane,
Rockwall II, Suite 815, Rockville, Maryland 20857, tel. (301) 443-6014,
fax (301) 443-3031, or email: wvogl@samhsa.gov.
Discussion
SAMHSA is proposing the following major changes to the Federal CCF.
The first major change is to make the revised Federal CCF a six-part
form by eliminating the split specimen copy (current Copy 3). Since the
split specimen copy is used only when the split specimen is tested
(i.e., less than approximately 5 percent of split specimens are
tested), it would be more efficient to have the second laboratory
report the split specimen test result on Copy 1. For those instances
when the split specimen is tested, the primary laboratory will need to
make a photocopy of Copy 1 of the Federal CCF and send it along with
the split specimen to the second laboratory. Although this procedure
requires the primary laboratory to make a photocopy, SAMHSA believes
saving the costs for printing a separate split specimen copy for each
Federal CCF outweighs the costs associated with the few times that Copy
1 will need to be photocopied by the primary laboratory. In addition,
eliminating the split specimen copy will help make the information that
appears on later pages more legible.
The second major change is locating the specimen bottle seal(s)/
label(s) on the bottom of Copy 1 rather than attaching them to the
right side of the form. This change will eliminate the need to have
special and expensive wide carriage printers and equipment to handle
the automatic processing of the Federal CCF and will standardize the
storage and handling requirements to match those for other documents.
We believe this change will increase the number of suppliers printing
the Federal CCF, will reduce the cost to print the Federal CCF, and
reduce the cost of the forms for the user.
The third major change involves simplifying the chain of custody
step by requiring the collector to only sign the form once. SAMHSA
believes the current requirement for the collector to sign the form
three times can be replaced by using one signature because the
certification statement signed by the collector clearly describes that
the collector had possession of the specimen from the time collector
received the specimen from the donor until the collector released the
specimen for shipment to the laboratory.
The fourth major change is to provide additional choices for the
laboratory to report specimen test results. The current form uses
``Test Not Performed'' to report anything other than a negative or
positive result. SAMHSA believes it is more appropriate to provide
choices on the form that accurately reflect the handling and reporting
of specimen test results, such as, invalid result, adulterated,
substituted, or rejected for testing.
The fifth major change is to include a new step on Copy 1 to allow
the secondary laboratory to document a result for the split specimen
(Bottle B). This change ensures that the primary specimen and split
specimen laboratory test results are recorded on the same copy that is
provided to the Medical Review Officer if the split specimen is tested.
The sixth major change is placing the Medical Review Officer steps
for the primary and split specimens on Copy 2. This change permits the
MRO to record the determination for both the primary specimen and the
split specimen (if tested) on the same copy (Copy 2).
Appendix A presents the required format and appearance for each
copy of
[[Page 61917]]
the Federal CCF. SAMHSA recognizes that suppliers use different
hardware and software to print forms and minor differences in
appearance will occur. For example, the size of each ``check'' box
appearing on the form may be different, the font sizes and styles used
for letters may be different, or the ``exact'' location of an item on a
printed form varies slightly from the location indicated on the sample
provided in Appendix A. These minor changes in appearance are permitted
since they do not impact on the required format. Other changes
permitted on the printed copies include highlighting data entry/
information fields where the collector and donor would be providing
information and using combs/boxes (rather than a single line) for the
donor's SSN to facilitate using optical readers for transferring that
information. The colors used to highlight the fields may be different
for different fields, but must not prevent making clear photocopies of
the information that is printed or handwritten in these highlighted
fields. Other required information (e.g., the name and address of the
testing laboratory, the specimen identification number appearing on the
top of the form and on the specimen bottle seal(s)/label(s)) may be
printed on the Federal CCF during the original printing and assembly
process or added by ``overprinting'' the six-part printed form after it
is assembled.
A detailed discussion of other proposed changes is as follows:
Copy 1
Copy 1 (Laboratory Copy) has a one inch space at the top of the
page reserved for the title of the form (Federal Custody and Control
Form) that must be printed along the top edge, the OMB Number that must
appear in the upper right hand corner (the OMB Number may be placed
vertical or horizontal), the name and street address of the laboratory
that will receive and test the specimen, a unique preprinted specimen
identification number (it may be a bar code with an associated human
readable number or only a human readable number), space for the
laboratory to assign an accession number after the specimen is
received, and any other information (e.g., accounting) the laboratory
or user of the form may want to document on the form. There are no
restrictions on the font size used for the information appearing in
this one inch space.
Step 1 is completed by the collector or employer representative.
The employer name and address, the acronym of the Federal Agency under
which the specimen is being collected and tested (e.g., DOD, DOI, FRA,
FAA), 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. This step is essentially
the same as for the current Federal CCF except the collection site
information has been moved from step 5 on the current form to step 1 on
this proposed form.
Step 2 is completed by the collector after receiving the specimen
from the donor and measuring the temperature of the specimen. As on the
current form, 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 single or split specimen collection, to indicate if no
specimen was collected and why, or to indicate if it was an observed
collection and why. SAMHSA believes the additional information is
needed to ensure that the collector documents why a specimen was not
collected or the reason an observed collection was conducted.
Step 3, as on the current form, 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 3). This is
essentially the same instruction that appears on the current form.
Step 4 is a totally revised chain of custody step that 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. SAMHSA believes that one
collector signature is sufficient to document the chain of custody from
the time the collector receives the specimen from the donor and
prepares the specimen bottle(s) and Federal CCF for shipment to the
laboratory. 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. This is the same information that is required on the
current Federal CCF, but the format has changed. Since 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 Federal 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 Federal CCF. We consider this individual to be the
accessioner, and he or she is required to document the condition of the
primary specimen bottle seal, sign the Federal CCF, print his/her name,
the date the specimen was accessioned, and then 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) is completed by the laboratory to document the test
results on the primary specimen. This step has been expanded compared
to the current Federal CCF to allow the laboratory to more easily
report a specimen for which there may have been an invalid result, the
specimen was adulterated or substituted, or rejected for testing. An
additional box has been included for 6-acetylmorphine since the
required testing for this analyte began December 1, 1998.
Step 5(b) has been added for reporting the split specimen result if
the split specimen is tested. This new step gives the secondary
laboratory an area to report the result for the split specimen, a line
to indicate the laboratory's name and address, a certification
statement, and a space for the secondary laboratory's certifying
scientist to sign and date the form.
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 Federal 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.
Copy 2
Copy 2 (Laboratory Copy) is similar to Copy 1 except that step 5(b)
and the
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space where the labels are located has been replaced with step 6
(Medical Officer Review step used to make a determination on the
primary specimen) and step 7 (Medical Officer Review step used to make
a determination on the split specimen). Step 6 has been changed from
the current Federal CCF to allow the MRO to record a ``Refusal To
Test'' when the primary specimen is ``Adulterated'' or ``Substituted.''
Step 7 is used to record the determination for the split specimen (if
tested).
Copy 3
Copy 3 (Medical Review Officer Copy) is the same format as Copy 2
except that step 5(a) has been replaced with step 5. This step 5 on
Copy 3 is completed by the donor after the specimen bottle(s) are
sealed, initialed by the donor, and dated. The donor is required to
read the certification statement, provide a signature, printed name,
date of collection, daytime phone number, evening phone number, and
date of birth. This information will be used by the Medical Review
Officer to contact the donor for results that require donor contact
before making a determination. Additionally, Copy 3 must have a pink
border (approximately \1/4\ inch width) rather than using a pink sheet
of paper to allow easy photocopying, if needed.
Copy 4, Copy 5, Copy 6
Copy 4 (Collector Copy), Copy 5 (Donor Copy), and Copy 6 (Employer
Copy) are exactly the same as Copy 3 with the following exceptions.
Copy 4 must have a yellow border, Copy 5 must have a green border, and
Copy 6 must have a blue border. These borders will allow photocopying,
if necessary. As with Copy 3, the color borders should be approximately
\1/4\ inch width.
Paperwork Reduction Act Notice
The Paperwork Reduction Act Notice in Appendix A must appear on all
Federal government forms that place a reporting burden on gathering
information. This notice is the same as that appearing on the current
OMB approved Federal CCF; however, SAMHSA is specifically interested in
receiving comments for the estimated average times it will take the
collector to complete the form, the donor to complete the form, the
laboratory to complete the form, and the Medical Review Officer to
complete the form. Please assume that completing the form will include
reviewing printed information and/or reading certification statements.
Privacy Act Statement
The Privacy Act Statement in Appendix A must appear on the back of
the donor copy (Copy 4). It applies to all donors who are Federal
employees. It is the same statement that appears on the current Federal
CCF.
Tamper-Evident Labels
The size of the two tamper-evident seal(s)/label(s) may vary, but
must be placed within the space provided at the bottom of Copy 1. It is
also the responsibility of the supplier of the specimen bottle seal(s)/
label(s) to ensure that they are tamper-evident. Tamper-evident is
defined as a seal/label that cannot be removed from the specimen bottle
after 5 minutes contact with the specimen bottle. SAMHSA believes this
single requirement is sufficient to ensure that the seal(s)/label(s)
provided with the Federal CCF are tamper-evident; however, we invite
comments to recommend other specifications/requirements that should be
considered.
Availability of CCF
The proposed Federal CCF, once approved by OMB, will be available
on the SAMHSA website as an electronic file (using several different
formats) that can be downloaded. Photocopies will also be available
from the Division of Workplace Programs. SAMHSA believes making the
Federal CCF available using this approach will ensure that the form is
readily available from different sources.
Richard Kopanda,
Executive Officer, Substance Abuse and Mental Health Services
Administration.
BILLING CODE 4162-20-P
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Appendix A
[GRAPHIC] [TIFF OMITTED] TN15NO99.016
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Back of Copy 1
Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)
Public reporting burden for this collection of information,
including the time for reviewing instructions, gathering and
maintaining the data needed, and completing and reviewing the
collection of information is estimated for each respondent to average:
5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3
minutes/Medical Review Officer. Federal employees may send comments
regarding these burden estimates, or any other aspect of this
collection of information, including suggestions for reducing the
burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction
Project (0930-0158), Room 16-106, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control number
for this project is 0930-0158.
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[GRAPHIC] [TIFF OMITTED] TN15NO99.017
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Back of Copy 2
Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)
Public reporting burden for this collection of information,
including the time for reviewing instructions, gathering and
maintaining the data needed, and completing and reviewing the
collection of information is estimated for each respondent to average:
5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3
minutes/Medical Review Officer. Federal employees may send comments
regarding these burden estimates, or any other aspect of this
collection of information, including suggestions for reducing the
burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction
Project (0930-0158), Room 16-106, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control number
for this project is 0930-0158.
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[GRAPHIC] [TIFF OMITTED] TN15NO99.018
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Back of Copy 3
Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)
Public reporting burden for this collection of information,
including the time for reviewing instructions, gathering and
maintaining the data needed, and completing and reviewing the
collection of information is estimated for each respondent to average:
5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3
minutes/Medical Review Officer. Federal employees may send comments
regarding these burden estimates, or any other aspect of this
collection of information, including suggestions for reducing the
burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction
Project (0930-0158), Room 16-106, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control number
for this project is 0930-0158.
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[GRAPHIC] [TIFF OMITTED] TN15NO99.019
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Back of Copy 4
Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)
Public reporting burden for this collection of information,
including the time for reviewing instructions, gathering and
maintaining the data needed, and completing and reviewing the
collection of information is estimated for each respondent to average:
5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3
minutes/Medical Review Officer. Federal employees may send comments
regarding these burden estimates, or any other aspect of this
collection of information, including suggestions for reducing the
burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction
Project (0930-0158), Room 16-106, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control number
for this project is 0930-0158.
Privacy Act Statement (For Federal Employees Only)
Submission of the information on the attached form is voluntary.
However, incomplete submission of the information, refusal to provide a
urine specimen, or substitution or adulteration of a specimen may
result in delay or denial of your application for employment/
appointment or may result in your removal from Federal service or other
disciplinary action.
The authority for obtaining the urine specimen and identifying
information contained herein is Executive Order 12564 (``Drug-Free
Federal Workplace''), 5 U.S. C. Sec. 3301 (2), 5 U.S.C. Sec. 7301 and
Section 503 of Public Law 100-71, 5 U.S.C. Sec. 7301 note. Under
provisions of Executive Order 12564 and U.S.C. 7301, test results may
only be disclosed to agency officials on a need-to-know basis. This may
include the agency Medical Review Officer, the administrator of the
Employee Assistance Program, and a supervisor with authority to take
adverse personnel action. This information may also be disclosed to a
court where necessary to defend against a challenge to an adverse
personnel action.
Submission of your SSN is not required by law and is voluntary.
Your refusal to furnish your number will not result in the denial of
any right, benefit, or privilege provided by law. Your SSN is
solicited, pursuant to Executive Order 9397, for purposes of
associating information in agency files relating to you and for
purposes of identifying the specimen provided for urinalysis testing
for illegal drugs. If you refuse to indicate your SSN, a substitute
number or other identifier will be assigned, as required, to process
the specimen.
In the event laboratory analysis determines the presence of one or
more illegal drugs in the specimen you provide, you will be contacted
by an agency Medical Review Officer (MRO). The MRO will determine
whether there is a legitimate medical explanation for the drug(s)
identified by urinalysis.
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[GRAPHIC] [TIFF OMITTED] TN15NO99.020
[[Page 61928]]
Back of Copy 5
Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)
Public reporting burden for this collection of information,
including the time for reviewing instructions, gathering and
maintaining the data needed, and completing and reviewing the
collection of information is estimated for each respondent to average:
5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3
minutes/Medical Review Officer. Federal employees may send comments
regarding these burden estimates, or any other aspect of this
collection of information, including suggestions for reducing the
burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction
Project (0930-0158), Room 16-106, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control number
for this project is 0930-0158.
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[GRAPHIC] [TIFF OMITTED] TN15NO99.021
BILLING CODE 4162-20-C
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Back of Copy 6
Instructions for Completing the Federal Drug Testing Custody and
Control Form
Note: Use ballpoint pen, press hard, and check all copies for
legibility.
Procedure:
1. Collector ensures that the name and address of the drug testing
laboratory appear on the top of the form and that the preprinted
Specimen I.D. number on the top of the form is identical to the
preprinted Specimen I.D. number appearing on the specimen bottle
labels/seals.
2. Collector ensures the required information is provided in STEP 1
on the CCF.
Note: If the donor refuses to provide his/her SSN or Employee
I.D. number, the collector must provide an appropriate comment on
the REMARKS line in STEP 4.
3. Collector gives the collection container/specimen bottle to the
donor for providing a specimen.
4. Upon receiving the specimen from the donor, the collector checks
the temperature of specimen within 4 minutes.
5. Collector marks appropriate temperature box (if outside the
temperature range, provides a remark in STEP 4).
6. Collector marks the appropriate box to indicate whether it is a
single or split specimen collection. If no specimen is collected, the
box is checked and a remark is provided in STEP 4. If it is an observed
collection, the box is checked and a remark is provided in STEP 4.
Note: If no specimen is collected, Copies 1 and 2 are discarded,
but the remaining copies are distributed as indicated below.
7. Collector secures cap(s) on specimen bottle(s) and affixes
seal(s).
8. Collector dates the specimen bottle label(s).
9. Donor initials the specimen bottle label(s) after the label(s)
have been placed on the specimen bottle(s).
10. Collector turns to Copy 3 (MRO Copy--pink border) and instructs
the donor to read the certification statement in STEP 5 (Copy 3) and to
sign, print name, date, provide phone numbers, and date of birth after
reading the certification statement.
Note: If the donor refuses to sign the certification statement,
the collector must provide an appropriate comment on the REMARKS
line in STEP 4 on Copy 1.
11. Collector completes STEP 4 (i.e., provides signature, printed
name, date, time of collection, and specific name of delivery service).
Note: Collector records any comments concerning the collection
on the REMARKS line in STEP 4.
12. Collector immediately places and seals the specimen bottle(s)
and Copy 1 and Copy 2 of the CCF in an appropriate leak-proof plastic
bag.
Note: If the plastic bag containing the specimen bottle(s) is
not immediately placed in a shipping container and sealed because
several collections will be placed in the same shipping container,
the Collector must maintain visual control of the specimens or place
them in secured temporary storage.
13. Collector sends Copy 3 to the MRO, gives Copy 4 to the donor,
retains Copy 5, and sends Copy 6 to the Employer.
[FR Doc. 99-29609 Filed 11-12-99; 8:45 am]
BILLING CODE 4162-20-P
