Department Of Health And Human Services

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Department of health and human services

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Summary

Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Prevention
Division of Workplace Programs
Subject: Guidance for Using the 2017 Federal Custody and Control Form (CCF)
for Urine Specimens
Date: August 8, 2017
Table of Contents
1. When can a federally regulated program begin using the 2017 Federal CCF? ......... 3
2. What are the allowable formats for the 2017 Federal CCF? ...................................... 3
3. Can the 2014 Federal CCF be used after August 31, 2017? ..................................... 3
4. How does a test facility (laboratory or IITF) report results using the 2017 Federal
CCF during the period of August 8, 2017 to October 1, 2017? .................................. 3
5. How does a test facility (laboratory or IITF) report results using the 2014 Federal
CCF during the period of August 8, 2017 to October 1, 2017? .................................. 3
6. How does a test facility (laboratory or IITF) report results using the 2014 Federal
CCF during the period of October 1, 2017 to July 1, 2018? ....................................... 4
7. Where can a sample proof of the 2017 Federal CCF be viewed? ............................. 4
8. What statements must appear on the 2017 Federal CCF? ........................................ 4
9. Can the 2017 Federal CCF be modified? .................................................................. 4
10. What are the responsibilities of service providers choosing to use an electronic
Federal CCF? ............................................................................................................ 6
11. Has the HHS Urine Specimen Collection Handbook been revised for use with the
2017 Federal CCF? ................................................................................................... 7
12. Has the HHS MRO Manual been revised for use with the 2017 Federal CCF? ......... 7
13. Does a test facility (laboratory or IITF) need to change its Standard Operating
Procedure (SOP) manual for the 2017 Federal CCF? ............................................... 8
14. How does a test facility (laboratory or IITF) document specimen receipt using the
2017 Federal CCF? ................................................................................................... 8
15. How does a test facility (laboratory or IITF) report primary specimen results to MROs
using the 2017 Federal CCF? .................................................................................... 9
1
16. How does a laboratory report split (Bottle B) specimen results to MROs using the
2017 Federal CCF? ................................................................................................... 9
17. What are tamper-evident labels/seals? ...................................................................... 9
18. How does an MRO report a verified result to the employer? ..................................... 9
2
1. When can a federally regulated program begin using the 2017 Federal CCF?
The Office of Management and Budget (OMB) has approved the use of the 2017
Federal CCF as of August 8, 2017. Additional information is available at
www.reginfo.gov (enter the OMB number 0930-0158 in the search area)

2. What are the allowable formats for the 2017 Federal CCF?
The Federal CCF may be used as a paper (hardcopy) or electronic (digital) document,
or in a combination electronic and paper format

A paper Federal CCF may be either 1) a preprinted, multiple-part carbonless form or 2)
a multiple-part CCF that is printed for a specific drug test (i.e., printed “on-demand” for
the collection), usually at the collection site. A paper CCF must conform to the
formatting requirements of the OMB-approved Federal CCF

3. Can the 2014 Federal CCF be used after August 31, 2017?
Yes, OMB has granted an extension for using the 2014 Federal CCF

TERMS OF CLEARANCE: OMB approves the revised Federal Drug Testing Custody
and Control Form (CCF). In addition, the previous version of the CCF (the CCF without
the four new analytes - oxycodone, oxymorphone, hydrocodone, and hydromorphone -
listed in Step 5A) is authorized for use until June 30, 2018. As of July 1, 2018, the 2017
Federal CCF must be used for federally regulated specimens, and the laboratory must
treat the use of the 2014 Federal CCF as a correctable discrepancy

4. How does a test facility (laboratory or IITF) report results using the 2017
Federal CCF during the period of August 8, 2017 to October 1, 2017?
If a specimen is received at the test facility with the 2017 Federal CCF during this period
(i.e., through September 30, 2017), the laboratory or IITF must report the results using
the same procedures as for a specimen received with the 2014 Federal CCF (also see
questions 15 and 16 below). The laboratory or IITF must include the following comment
on the Remarks line in Step 5a of the Federal CCF and on any electronic report: “This
specimen was analyzed and reported in accordance with the HHS Mandatory
Guidelines effective October 1, 2010.” In addition, if the specimen is positive for
methylenedioxyethylamphetamine (MDEA), the laboratory must record “MDEA” and the
concentration on the Remarks line in Step 5a of the Federal CCF

5. How does a test facility (laboratory or IITF) report results using the 2014
Federal CCF during the period of August 8, 2017 to October 1, 2017?
If a specimen is received at the test facility with the 2014 Federal CCF during this period
(i.e., through September 30, 2017), the laboratory or IITF must report the results using
the same procedures used prior to the CCF’s extended date

3
6. How does a test facility (laboratory or IITF) report results using the 2014
Federal CCF during the period of October 1, 2017 to July 1, 2018?
If a specimen is received at the test facility with the 2014 Federal CCF during this
period, the laboratory or IITF must report the results on the 2014 Federal CCF using the
same procedures as for a specimen received with the 2017 Federal CCF (also see
questions 15 and 16 below). The laboratory or IITF must include the following comment
on the Remarks line in Step 5a of the Federal CCF and on any electronic report: “This
urine specimen was analyzed and reported in accordance with the HHS Mandatory
Guidelines effective October 1, 2017.” In addition, if the specimen is positive for an
opioid analyte that is not listed on the CCF, the laboratory must record the analyte name
and concentration on the Remarks line in Step 5a of the Federal CCF. (As noted under
question 3 above, as of July 1, 2018, the test facility must treat the use of the 2014
Federal CCF as a correctable discrepancy.)
7. Where can a sample proof of the 2017 Federal CCF be viewed?
A sample of the Federal CCF is available on the SAMHSA drug testing website
www.samhsa.gov/workplace and at www.reginfo.gov

8. What statements must appear on the 2017 Federal CCF?
• The Public Burden Statement must appear on all Federal Government forms
that place a reporting burden on gathering information. This statement must be
included on the back of each paper copy of the Federal CCF (i.e., Copies 1
through 4). If an electronic Federal CCF is used, this statement must be provided
as a separate page. Wording must be identical to that on the OMB-approved
Federal CCF

• The following must be printed on the back of the donor copy (Copy 5) of a paper
Federal CCF or, if an electronic Federal CCF is used, be provided as a separate
page: Instructions for Completing the Federal Drug Testing Custody and
Control Form for Urine Specimen Collection, Privacy Act Statement (For
Federal Employees Only), and Public Burden Statement. Wording must be
identical to that on the OMB-approved Federal CCF

9. Can the 2017 Federal CCF be modified?
Yes. SAMHSA recognizes that suppliers use different hardware and software for paper
and for electronic forms. Minor differences in appearance from SAMHSA’s Federal CCF
proof are permitted provided that they do not significantly impact the required format

The following lists some acceptable differences and modifications:
General
4
1. The OMB number may appear either vertically or horizontally in the upper right
hand corner of the form

2. The unique specimen identification number at the top of the form may be either a
bar code with an associated human-readable number or a human-readable
number only

3. The data entry/information fields may be highlighted using different colors to
show where the collector, donor, and test facility will provide information. The
colors used to highlight the fields may be different for different fields but must not
prevent making clear facsimiles and photocopies of the information that is printed
or handwritten in those fields

4. If a test facility uses the unique specimen identification number to track
specimens after receipt and does not assign a separate accession number, the
words ACCESSION NO. are not required on the top of the form

5. The spaces for the employer name and address, MRO name and address, and
the collection site address may have lines

6. The space for the donor’s SSN or Employee I.D. No. may have combs, boxes, or
a single line

7. The size of each checkbox may vary slightly

8. The font size and style used for letters may vary to enhance readability

9. The form may include a designated space for a collector identification number
(e.g., as assigned by a collector training organization) in Step 4 beside the
collector’s signature or printed name

Paper Federal CCF
1. For preprinted paper CCFs, the name and address of the test facility and the
unique specimen identification number at the top of the form may be printed
during the original printing process or added by overprinting after the form is
assembled

2. For individually printed (“on-demand”) paper CCFs, the unique specimen
identification number must be printed on the form to irrevocably link the same
specimen identification number on the form and the labels/seals (i.e., it is not
sufficient to place a label on the printed Federal CCF)

3. Preprinting and/or overprinting the employer name and address, MRO name and
address, and collection site information is permitted

4. The exact location for each item on the printed form may vary slightly from the
location indicated on the OMB-approved Federal CCF

5. The legend (i.e., copy number and name) at the bottom of Copies 2 through 5
may be printed using different colors, or a different color stripe may be printed at
the bottom of Copies 2 through 5. To ensure consistency and correct distribution
of the copies, if different color stripes or legends are used at the bottom of each
copy, the following colors must be used: MRO Copy - pink, Collector Copy -
yellow, Employer Copy - blue, Donor Copy - green

6. Reference mark(s) may be used to position the form in a printer to overprint
information in the correct location or to optically scan the information in the
various fields

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Electronic Federal CCF
1. The legend (i.e., copy number and name) at the bottom of Copies 2 through 5
may be omitted

Labels/Seals
1. The unique specimen identification number on the tamper-evident label(s)/seal(s)
may be either a bar code with an associated human-readable number or a
human-readable number only

2. The size of the two tamper-evident labels/seals may vary, but each must be at
least ¾ inch wide

3. The color of the preprinted information on the “A” specimen bottle label/seal may
be different than the color of the preprinted information on the “B” specimen
bottle label/seal

4. The unique specimen identification number must be preprinted on labels/seals
for a paper Federal CCF. If the labels/seals are attached at the bottom of the
paper Federal CCF, the specimen identification number may be preprinted during
the original printing and form assembly process, or added by overprinting after
the form is assembled. For a combination electronic/paper CCF: The unique
specimen identification number may be preprinted or may be printed on the
labels/seals when the collector prints Copy 1 to be sent to the test facility with the
specimen

10. What are the responsibilities of service providers choosing to use an
electronic Federal CCF?
An electronic Federal CCF must be the functional equivalent of a paper Federal CCF
with respect to integrity, accuracy, and accessibility. Federally regulated employers and
drug testing service providers (e.g., collectors, test facilities, MROs) who use electronic
or combination electronic and paper Federal CCFs must implement procedures and
controls to ensure the authenticity, integrity, and confidentiality of electronic records,
and to ensure that electronic signatures are the legally binding equivalent of traditional
handwritten signatures. These procedures and controls include, but are not limited to:
• System validation
• The ability to generate accurate and complete copies of records in both human
readable and electronic form suitable for inspection, review, and copying upon
request of authorized parties (e.g., the MRO, federal agency, or SAMHSA)
• Protection of records to enable accurate and ready retrieval through the records
retention period
• Limiting system access to authorized individuals
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• Secure, computer-generated, time-stamped audit trails to independently record
the date and time of operator entries and actions that create, modify, or delete
records from the time of initiation of the Federal CCF (changes should be evident
when reviewing the original record, and any electronic or paper copy of the
original record)
• Use of authority checks to ensure that only authorized individuals can use the
system, electronically sign a record, access the operation or computer system
input or output device, alter a record, or perform the operation at hand

Before implementing an electronic Federal CCF, HHS-certified IITFs and laboratories
must submit information including a detailed plan and proposed standard operating
procedures (SOPs) for SAMHSA review and approval (i.e., through SAMHSA’s National
Laboratory Certification Program, NLCP). The review of validation records, specimen
records, the collection process, SOPs, staff training records, and practices associated
with the electronic Federal CCF will be part of the NLCP inspection process

For test facilities approved to use an ECCF system: Before implementing the revised
2017 ECCF, the test facility must submit updated ECCF information to the NLCP
including the Process Overview, Topic Outline of Proposed SOP Revisions, the 2017
ECCF, Training Plans for Federal ECCF Users, and System Validation Plan

11. Has the HHS Urine Specimen Collection Handbook been revised for use with
the 2017 Federal CCF?
Yes. The HHS Urine Specimen Collection Handbook has been revised to reflect the
HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine
and how the collector completes the CCF. The revised handbook is available on the
SAMHSA website (www.samhsa.gov/workplace)

12. Has the HHS MRO Manual been revised for use with the 2017 Federal CCF?
Yes. The HHS MRO Manual has been revised to reflect the HHS Mandatory Guidelines
for Federal Workplace Drug Testing Programs using Urine and how test facilities will be
reporting results. The revised manual is available on the SAMHSA website
(www.samhsa.gov/workplace)

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13. Does a test facility (laboratory or IITF) need to change its Standard Operating
Procedure (SOP) manual for the 2017 Federal CCF?
Yes. A certified laboratory or IITF must revise all SOP sections, where appropriate, to
address the 2017 Federal CCF (e.g., accessioning, chain of custody, and reporting
procedures). Since the laboratory may continue receiving 2014 Federal CCF, the SOP
manual will need to have procedures applicable to both forms until July 1, 2018, when
the 2014 Federal CCF is no longer approved for use. At that time, the laboratory must
have procedures to handle specimens submitted with the 2014 Federal CCF as having
a recoverable discrepancy

14. How does a test facility (laboratory or IITF) document specimen receipt using
the 2017 Federal CCF?
Specimens received from a collection site
Paper CCF: The test facility that receives the specimen package from the collection site
continues the specimen’s chain of custody by completing the appropriate chain of
custody entries in Step 4 (i.e., “Received at Lab or IITF).” In addition to signing and
printing his or her name, the accessioner records the receipt date, marks the
appropriate checkbox to document the condition of the primary specimen seal, and
releases custody of the specimen (e.g., to a storage area). This process is also used for
Combination (electronic/paper) ECCFs

Electronic CCF: To facilitate linkage of the specimen package to the electronic Federal
CCF sent to the test facility, the collector either 1) includes a printed copy of the Test
Facility copy (i.e., Copy 1) of the Federal CCF with the specimen; or 2) applies a label to
the outside of the specimen package, with the specimen identification number, test
facility name and contact information, and collection site name and contact information

The test facility that receives the specimen package from the collection site continues
the specimen chain of custody on the electronic Federal CCF. In addition to
documenting receipt of the specimen using an electronic signature, the accessioner
documents the condition of the primary specimen seal and releases custody of the
specimen (e.g., to a storage area). Note: If a printed copy of Copy 1 is included in the
specimen package, the accessioner may, but is not required to, annotate this form. This
is only a replica of the Federal CCF which contains the collector’s electronic signature
and is not the chain of custody for the specimen

Specimens received from an IITF
When forwarding a specimen to a laboratory, an IITF sends both the original Federal
CCF (Copy 1) and an IITF Supplemental CCF with the specimen. The laboratory that
receives the specimen package from the IITF continues the specimen chain of custody
on the IITF Supplemental CCF. This may be a paper or electronic form

8
Specimens or aliquots received from another certified laboratory for retesting
When forwarding a specimen or aliquot to another laboratory for retesting, the
laboratory that tested and reported the primary specimen (Lab A) sends both a copy of
the Federal CCF (copy of Copy 1) and the transmittal chain of custody form with the
specimen or aliquot. The laboratory that receives the specimen package continues the
specimen chain of custody on the transmittal chain of custody form. This may be a
paper or electronic form

15. How does a test facility (laboratory or IITF) report primary specimen results to
MROs using the 2017 Federal CCF?
A test facility must fax, courier, mail, or electronically transmit the completed Federal
CCF (copy of Copy 1) to the MRO, with one exception. The test facility may report
specimens that were received with a paper Federal CCF as negative using only a
computer-generated electronic report, provided that the report contains sufficient
information to ensure that the test result is properly associated with the MRO copy
(Copy 2) of the Federal CCF

Specimens forwarded by an IITF: A laboratory must also send a copy of the completed
IITF Supplemental CCF to the MRO for all results. The laboratory may fax, courier, mail,
or electronically transmit a legible image or copy of this form

16. How does a laboratory report split (Bottle B) specimen results to MROs using
the 2017 Federal CCF?
For all split specimen results, the split testing laboratory must fax, courier, mail, or
electronically transmit the completed Federal CCF (i.e., the copy of Copy 1) to the
MRO. For “Failed to Reconfirm” results, the laboratory must also complete and send a
laboratory Split Specimen Report Form to the MRO and include a reference to this
separate laboratory report in the “Reason” line in Step 5b of the Federal CCF

17. What are tamper-evident labels/seals?
Once applied, tamper-evident labels/seals cannot be removed and replaced without
visible evidence that tampering has occurred. It is the responsibility of the supplier of the
labels/seals to ensure that they are tamper-evident. However, HHS-certified test
facilities must perform a study to verify that the labels/seals are tamper-evident

Tamper-evident specimen bottle labels/seals must be at least ¾-inch wide

18. How does an MRO report a verified result to the employer?
For all verified results, an MRO may fax, courier, mail, or electronically transmit a legible
image or copy of the report to the agency/employer

The result sections on the MRO Copy (Copy 2) of the Federal CCF (Step 6 for the
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primary specimen and Step 7 for the split specimen) are formatted in accordance with
MRO reporting requirements in the HHS Mandatory Guidelines. To complete the
Federal CCF, the MRO marks the appropriate checkbox(es) for the verified result and
records information in the designated spaces to specify the test results (i.e., drug
analytes, substitution, adulteration). The MRO includes any explanatory comments on
the “Remarks” line and signs and dates the CCF

Paper Federal CCF may be either 1) a preprinted, multiple-part carbonless form or 2) a multiple-part CCF that is printed for a specific drug test (i.e., printed “on-demand” for …

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