Department of Health and Human Services

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Prevention

Division of Workplace Programs

Guidance for Using the 2014 Federal Custody and Control Form (CCF) for Urine 

Specimens 

Date: May 31, 2014

Table of Contents

1. When can a federally regulated program begin using the 2014 Federal CCF? ......... 2

2. What are the allowable formats for the 2014 Federal CCF?...................................... 2

3. Can the 2010 Federal CCF be used after May 31, 2014? ......................................... 2

4. Where can a sample proof of the 2014 Federal CCF be viewed?.............................. 2

5. What statements must appear on the 2014 Federal CCF?........................................ 2

6. Can the 2014 Federal CCF be modified? .................................................................. 3

7. What are the responsibilities of service providers choosing to use an electronic

Federal CCF? ............................................................................................................ 4

8. Has the HHS Urine Specimen Collection Handbook been revised for use with the

2014 Federal CCF? ................................................................................................... 5

9. Has the HHS MRO Manual been revised for use with the 2014 Federal CCF?......... 5

10.Does a test facility (IITF or laboratory) need to change its Standard Operating

Procedure (SOP) manual for the 2014 Federal CCF? ............................................... 5

11.How does a test facility (IITF or laboratory) document specimen receipt using the

2014 Federal CCF? ................................................................................................... 6

12. How does a test facility (IITF or laboratory) report primary specimen results to

MROs using the 2014 Federal CCF?......................................................................... 7

13.How does a laboratory report split (Bottle B) specimen results to MROs using the

2014 Federal CCF? ................................................................................................... 7

14.What are tamper-evident labels/seals?...................................................................... 7

15.How does an MRO report a verified result to the employer? ..................................... 7

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1. When can a federally regulated program begin using the 2014 Federal CCF?

The Office of Management and Budget (OMB) has approved the use of the 2014

Federal Drug Testing Custody and Control Form (Federal CCF) beginning May 31, 

2014. 

2. What are the allowable formats for the 2014 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 2010 Federal CCF be used after May 31, 2014?

Yes. The content of the 2014 Federal CCF and the 2010 Federal CCF (75 FR 41488, 

July 16, 2010) are the same; only minor changes were made to the required statements 

(see question 5 below). Because the form content has not changed, service providers 

may continue to use preprinted 2010 Federal CCFs until supplies are depleted. The test 

facility will accept and process the specimen using the same procedures as for a 

specimen received with a paper 2014 Federal CCF.

4. Where can a sample proof of the 2014 Federal CCF be viewed?

A sample of the Federal CCF is available on the SAMHSA drug testing website. 

The website (currently under construction) is available at: 

https://www.beta.samhsa.gov/workplace. 

5. What statements must appear on the 2014 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 OMBapproved Federal CCF.

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6. Can the 2014 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

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.

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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.

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 3⁄4 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. 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.

7. 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

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• 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

• 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 provide 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, 

SOPs, staff training records, and practices associated with the electronic Federal CCF 

will be part of the NLCP inspection process. 

8. Has the HHS Urine Specimen Collection Handbook been revised for use with

the 2014 Federal CCF?

Yes. The HHS Collection Handbook has been revised to reflect the use of an electronic 

Federal CCF and how the collector completes the form. The revised handbook is 

available on the SAMHSA website (http://www.workplace.samhsa.gov).

9. Has the HHS MRO Manual been revised for use with the 2014 Federal CCF?

Yes. The HHS MRO Manual has been revised to reflect the use of an electronic Federal 

CCF and how test facilities will be reporting results. The revised manual is available on 

the SAMHSA website (http://www.workplace.samhsa.gov).

10. Does a test facility (IITF or laboratory) need to change its Standard Operating

Procedure (SOP) manual for the 2014 Federal CCF?

Yes. A certified IITF or laboratory will continue to use its current procedures for 

regulated specimens collected using a paper CCF. However, the test facility must revise 

its SOP (e.g., accessioning, chain of custody, reporting, and records handling

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procedures) if it will use electronic Federal CCFs for regulated specimens. The 

procedures must be reviewed and approved by SAMHSA (through SAMHSA’s 

National Laboratory Certification Program, NLCP) prior to implementation.

11. How does a test facility (IITF or laboratory) document specimen receipt using

the 2014 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). 

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. 

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. 

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12. How does a test facility (IITF or laboratory) report primary specimen results to

MROs using the 2014 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.

13. How does a laboratory report split (Bottle B) specimen results to MROs using

the 2014 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. 

14. 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. Tamper-evident specimen bottle 

labels/seals must be at least 3⁄4-inch wide. 

15. 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

primary specimen and Step 7 for the split specimen) are formatted in accordance with 

MRO reporting requirements in the HHS Mandatory Guidelines and in DOT Regulations 

(49 CFR Part 40). 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.

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