Department of Health and Human Services

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Prevention

 

Urine Specimen Collection Handbook

for

Federal Agency Workplace Drug Testing Programs 

EFFECTIVE OCTOBER 1, 2017 

revised January 2022

Note: This manual applies to federal agency drug testing programs that come under 

Executive Order 12564 dated September 15, 1986, section 503 of Public Law 100-71, 5 

U.S.C. section 7301 note dated July 11, 1987, and the Department of Health and 

Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs 

(82 FR 7920) dated January 23, 2017 (effective October 1, 2017).

This manual does not apply to specimens submitted for testing under U.S. 

Department of Transportation (DOT) Procedures for Transportation Workplace Drug 

and Alcohol Testing Programs (49 CFR Part 40).

Previous Versions of this Handbook are Obsolete
Table of Contents

Introduction..................................................................................................................... i

Chapter 1. The Collector............................................................................................ 1

Chapter 2. Collector/Collection Site Records ............................................................. 4

Chapter 3. The Collection Site ................................................................................... 4

Chapter 4. Federal Agency Blind Samples................................................................. 6

Chapter 5. The Federal Drug Testing Custody and Control Form (Federal CCF)....... 7

A. Acceptable Formats for a Federal CCF.......................................................... 7

B. Federal CCF Problems .................................................................................. 9

C. Federal CCF Content Requirements............................................................ 11

D. Federal CCF Instructions for Use with Urine Collections.............................. 12

E. Federal CCF Distribution ............................................................................. 15

Chapter 6. Verification of Donor Identity................................................................... 16

Chapter 7. Urine Specimen Collection .................................................................... 17

A. Collection Site Security................................................................................ 17

B. Collection Supplies ...................................................................................... 17

C. Collection Procedure ................................................................................... 19

Chapter 8. Miscellaneous Collection Issues............................................................. 28

A. Direct Observed Collection .......................................................................... 28

B. Monitored Collection .................................................................................... 29

C. Inability to Provide a Sufficient Specimen .................................................... 30

D. Donor Conduct ............................................................................................ 32

E. Multiple Collectors for a Specimen Collection .............................................. 33

F. Refusal to Test ............................................................................................ 33

G. Problems with Specimen Bottle Labels/Seals .............................................. 34

Chapter 9. Collector Errors and Corrective Actions .................................................. 35

Appendices

Appendix A: Federal CCF Decision Trees for Collectors 

Appendix B: Direct Observed Collection Procedure 

Appendix C: Two Specimens from the Same Collection Event

Appendix D: Insufficient Specimen
Introduction

 

The Substance Abuse and Mental Health Services Administration (SAMHSA) within the U.S. 

Department of Health and Human Services (HHS) establishes the scientific and technical 

guidelines to be used by U.S. federal agencies and drug testing facilities for federally regulated 

drug testing. Testing must be performed at facilities certified by SAMHSA under the National 

Laboratory Certification Program (NLCP). HHS has maintained oversight of federally regulated 

drug testing through this program since it began in 1988. SAMHSA certifies two types of test 

facilities: laboratories and instrumented initial test facilities (IITFs). IITFs are allowed only for 

urine testing, and perform only the initial tests for those specimens. 

The HHS Urine Specimen Collection Handbook provides information and guidance for the 

collection of urine specimens for federal agency workplace drug testing programs, based on the 

HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG).1 

The HHS Oral Fluid Specimen Collection Handbook provides information and guidance for 

the collection of oral fluid specimens for federal agency workplace drug testing programs, based 

on the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral 

Fluid (OFMG).2 

All federally regulated oral fluid specimens must be sent to an HHS-certified laboratory for 

testing. IITFs are not allowed to test oral fluid specimens. 

This document and additional specimen collection resources are available on the SAMHSA 

website: https://www.samhsa.gov/workplace/resources. 

1 Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine, Substance Abuse and 

Mental Health Services Administration, Department of Health and Human Services, 82 FR 7920, effective 

10/01/2017.

2 Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid, Substance Abuse 

and Mental Health Services Administration, Department of Health and Human Services, 84 FR 57554, 

effective 01/01/2020. 

i
1 

Chapter 1. The Collector 

A collector is the person trained to instruct and assist a donor in providing a specimen.

The following restrictions apply: 

1. The immediate supervisor of an employee may only collect that donor’s specimen when no 

other collector is available. A supervisor serving as a collector must be a trained collector.

The supervisor must maintain an explanatory memorandum to explain why they collected 

their employee’s specimen. 

2. The hiring official of a federal agency applicant may only collect that federal agency 

applicant’s specimen when no other collector is available. A hiring official serving as a 

collector must be a trained collector. The hiring official should maintain an explanatory 

memorandum to explain why they collected the applicant’s specimen.

3. A coworker who is in the same testing pool or who works with an employee on a daily basis 

must not serve as a collector when that employee is tested.

4. An applicant or employee must not serve as the collector by collecting their own specimen.

5. An individual working for an HHS-certified test facility may not serve as a collector if that 

individual can link the donor with the specimen drug test result or the report from the test 

facility.

6. An individual who has a personal relationship with the employee (e.g., spouse, ex-spouse, 

relative, close personal friend) must not serve as the collector.

To qualify as a urine specimen collector for a federal agency program, an individual 

must:

1. Be knowledgeable of the collection procedure described in the HHS Mandatory Guidelines 

for Federal Workplace Drug Testing Programs using Urine (UrMG).

2. Be knowledgeable of any guidance provided by the federal agency’s Drug-Free Workplace 

Program and additional information provided by HHS relating to the collection procedure 

described in the UrMG. 

3. Receive training from a qualified trainer for urine specimen collectors on the following topics:

a. All steps to correctly perform a urine specimen collection in accordance with this 

Specimen Collection Handbook. 

b. Completion and distribution of the Federal Custody and Control Form (CCF). (See Note

below.)

c. Problem collections.

d. Fatal and correctable flaws and how to correct problems during collections.
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e. Collector responsibilities to maintain the integrity of the collection process, ensuring the 

privacy of the donor, ensuring the security of the specimen, and avoiding conduct or 

statements that could be viewed as offensive or inappropriate.

4. Demonstrate proficiency in urine collections by successfully completing five consecutive 

error-free mock collections that include: one uneventful scenario, one insufficient specimen 

quantity scenario, one temperature out of range scenario, one scenario in which the donor 

refuses to sign the Federal CCF and one scenario in which the donor refuses to initial the 

specimen bottle tamper-evident bottle seal. 

a. The qualified trainer for collectors must monitor and evaluate the individual being 

trained, in person or by a means that provides real-time observation and interaction 

between the trainer and the trainee, and the trainer must attest in writing that the mock 

collections are error-free.

5. Document their completed training as a collector in accordance with the above requirements 

before collecting any specimens for a federal agency.

6. Maintain training documentation and provide it to a federal agency upon request.

Note: The collector training outlined above must be conducted using a paper Federal CCF. To 

use an electronic Federal CCF (ECCF) for oral fluid collections, a trained collector must 

complete separate additional training from the ECCF system provider. That training should 

address use of the ECCF system for uneventful collections as well as problems that may arise 

during an ECCF collection including, but not limited to, a donor’s refusal to test, a printer 

problem, insufficient specimen, and a donor’s refusal to sign the CCF. See also ECCF 

definitions and requirements in Chapter 5, Section A. 

A trained urine specimen collector must:

1. At least every five years from the date of initial training, complete refresher training that 

includes all initial training items (items 1-5 above).

2. Document training in accordance with the above requirements before collecting any federal 

agency specimens more than five years after initial training.

3. Maintain training documentation and provide it to a federal agency upon request.

To qualify as an observer for a direct observed urine specimen collection for a federal 

agency program, an individual must:

1. Be knowledgeable about the direct observed collection procedure as described in the UrMG. 

2. Be knowledgeable about any guidance provided by the federal agency or by HHS relating to 

the direct observed collection procedure described in the UrMG. 

3. Receive training on the following subjects: 

a. All steps necessary to perform a direct observed collection. 

b. The observer’s responsibility for maintaining the integrity of the collection process.
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c. Ensuring the security of the specimen throughout the collection process by maintaining 

visual contact with the collection container until it is delivered to the collector. 

d. Ensuring the privacy of the donor being tested.

e. Ensuring that the observation is done in a professional manner, to minimize the 

discomfort to the donor. 

f. Avoiding conduct or statements that can be viewed or interpreted as offensive or 

inappropriate. 

4. Be the same gender as the donor’s gender, as determined by the donor’s gender identity. 

There are no exceptions to this requirement. Note: The donor’s gender identity may be the 

same as or different from the donor’s sex assigned at birth.

5. An observer is not required to be a trained collector.

To qualify as a trainer for urine collectors for a federal agency program, an individual 

must:

1. Be qualified as a trained collector and have regularly conducted urine drug test collections 

for a period of at least one year OR have successfully completed a “train the trainer” course 

given by an organization (e.g., manufacturer, private entity, contractor, or federal agency).

2. Complete refresher training in accordance with collector requirements (see above) at least 

every five years from the date of the individual’s initial training.

3. Maintain records documenting trainer qualification (e.g., original records for initial and 

refresher collector training, “train the trainer” course certificate, employment records) and 

provide copies to a federal agency or to a federal agency’s Medical Review Officer (MRO) 

upon request.

Before a collector is permitted to collect a urine specimen for a federal agency, the 

agency must:

1. Ensure that the collector has satisfied the urine specimen collector requirements described 

in the UrMG. 

2. Ensure that the collector, who may be self-employed, or an organization (e.g., third party 

administrator that provides a collection service, collector training organization, federal 

agency that employs its own collectors) maintains a copy of the collector’s training 

documentation.

3. Provide the collector with the name and telephone number of the federal agency’s 

designated representative. 

The collector should have identification with their name and their employer’s name, address, 

and telephone number. The collector is required to provide their identification (employee badge 
4 

or employee list) if requested by the donor. There is no requirement for the collector to have 

identification (ID) with their photo or to provide their driver's license with an address. 

Chapter 2. Collector/Collection Site Records

The collector must maintain their original collector training records (i.e., for initial, additional, and 

refresher training) and provide copies to their employer and, as requested, to the federal 

agency. 

Collection site records must be stored at a secure site designated by the collector or the 

collector’s employer for a minimum of two years. Collection site records include the collector 

copies of the Office of Management and Budget-approved Federal CCF for each specimen.

Both hardcopy and electronic collection records must be stored and disposed of in a manner 

that ensures donor confidentiality is maintained. The collection site may convert hardcopy 

records to electronic records for storage and discard the hardcopy records after 6 months.

Personally identifiable information (PII) is information that can be used to distinguish or trace an 

individual’s identity alone or when combined with other personal identifying information which is 

linked or linkable to a specific individual. PII that may be on the Federal CCF includes the 

donor’s Social Security Number (SSN), name, date of birth, telephone numbers, and 

employment status. All federally regulated employers and drug testing service providers 

(including collectors) must implement procedures and administrative, technical, and physical 

controls to ensure donor privacy by restricting access to PII on hardcopy and electronic 

collection records (e.g., on Federal CCFs, in information entered into a computer system or 

database). Access to donor PII must be limited to those individuals requiring access to fulfill job 

duties. Such individuals must receive training to make them aware of their responsibilities for 

protecting the information. The confidentiality must be maintained from the time the donor PII is 

obtained through transmission/transport of the Federal CCF copies and record handling (i.e., 

storage, retrieval, and final destruction). Both hardcopy and electronic collection records must 

be stored and disposed of in a manner that ensures donor confidentiality is maintained. 

The collector must not solicit or record a donor’s medical information during the collection 

process. 

Chapter 3. The Collection Site 

A collection site may be a permanent or temporary facility, located either at the work site or at a 

remote site, where donors present themselves for the purpose of providing a specimen for a 

drug test. When there is an immediate need to collect a specimen (e.g., a post-accident 

investigation) and there is no agency-designated site available, a public restroom may be used 

for the collection using the procedures for a monitored collection (see Chapter 8, Section B). 

The site must have all necessary personnel, supplies, equipment, facilities, and supervision to 

provide for specimen collection, security, and temporary storage until the specimen is 

transferred to an HHS-certified IITF or laboratory, and must have arrangements for the transfer 

of the specimens to a certified IITF or laboratory.

A facility used as a urine collection site must have:

1. Provisions to ensure donor privacy during the collection. Only authorized personnel and the 

donor may be present in the restricted access area where the collection takes place. The 
5 

collector must give the donor visual privacy while providing the specimen. The following 

facilities provide adequate privacy for urine collections: 

a. An enclosed stall in a multi-stall restroom

b. A single person restroom

c. A partitioned area that allows for individual privacy

d. A mobile restroom (e.g., a vehicle with an enclosed toilet stall).

2. A means for washing hands:

a. If practical, the water source should be external to the restroom where collection occurs. 

If a water source is in the enclosure where the collection occurs, the collector must 

secure it prior to the collection or conduct a monitored collection (see Chapter 8, 

Section B). 

b. If a water source is not available, another means (e.g., waterless cleanser, moist 

towelettes) outside the restroom is an acceptable alternative.

3. A suitable clean surface inaccessible to the donor for the collector to handle the specimen

and complete the paperwork. 

a. If practical, the collector work area should be external to the restroom where collection

occurs. 

b. The collector work area may be inside the restroom only if the donor can have privacy 

while providing the urine specimen. 

4. A secure temporary storage area for maintaining specimens until they are transferred to an 

HHS-certified IITF or laboratory. Specimens must be shipped within 24 hours or no later 

than the next business day. Specimens that will not be shipped within 24 hours (e.g., 

collected on a Friday for shipment on Monday) should be kept in secure refrigerated 

storage.

Note: Specimens should NOT be exposed to high temperatures for an extended time. 

These conditions may affect the test results of a urine specimen. 

5. A restricted access area where only authorized personnel may be present during the 

collection. 

6. Provisions for the collector to:

a. Restrict access to collection supplies before, during, and after collection, 

b. Store collection site records securely, and

c. Restrict donor access to items that could be used to adulterate, substitute, or dilute the 

specimen (e.g., soap, disinfectants, cleaning agents, water). 
6 

Chapter 4. Federal Agency Blind Samples

The UrMG require each federal agency to have blind samples (i.e., negative samples, positive 

samples, adulterated samples, substituted samples) submitted to each HHS-certified laboratory 

that tests donor specimens for its workplace drug testing program. The blind samples may be 

purchased and supplied to the collector by the federal agency or the agency’s external service 

provider, or purchased by the collector and submitted to an HHS-certified IITF or laboratory that 

the collector sends the agency’s specimens. The UrMG specify the approximate percentage of 

each type (i.e., 75 percent negative, 15 percent positive for one or more drugs, 10 percent either 

adulterated or substituted). At a minimum, each federal agency must submit 3 percent blind 

samples with its donor specimens based on the projected total number of donor specimens 

collected per year (up to a maximum of 400 blind samples). Every effort should be made to 

ensure that blind samples are submitted quarterly. The collector should distribute blind samples 

randomly with donor specimens rather than submitting blind samples as one group.

Each urine blind sample must meet the following requirements:

1. Drug-positive and -negative blind samples must be validated by the supplier as to their 

content using appropriate initial and confirmatory drug tests. 

2. The supplier must provide the blind samples as matched A and B pairs, along with 

information on their content, validation, expected results, and stability to the collection 

site/collector that will send the blind samples to the laboratory or IITF. The supplier must 

also provide the information upon request to the MRO, the federal agency for which the 

blind sample was submitted, or the HHS Secretary. If the collector purchases the samples 

for the federal agency’s blind program, the collector must send the supplier’s information 

(e.g., the content and concentration of the blind samples) to the MRO to enable the MRO to 

interpret the results and report them to the agency. The MRO will contact the supplier and/or 

collector as needed when investigating discrepant results.

3. Drug-positive blind samples must be fortified with one or more of the drugs or metabolites 

listed in the UrMG, and the concentration should be 1.5 to 2 times the initial drug test cutoff 

concentration.

4. Drug-negative blind samples (i.e., certified to contain no drugs) must be validated by the 

supplier as negative using the appropriate initial and confirmatory tests.

5. Substituted or adulterated blind samples must be validated by the supplier using appropriate 

initial and confirmatory specimen validity tests, and must be shown to meet substitution or 

adulteration criteria specified in the UrMG at the time of validation. 

Each blind sample must be submitted as a split specimen (specimens A and B) with a current 

Federal CCF (paper or electronic) that the HHS-certified laboratory or IITF uses for donor 

specimens. 

 

1. The collector provides the required information to ensure that the Federal CCF has been 

properly completed, including fictitious donor identification in Step 1c of the Federal CCF 

and fictitious donor initials on the A and B specimen bottle labels/seals.
7 

2. The collector indicates 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 Federal CCF).

3. The collector may either discard Copies 4 and 5 of a paper Federal CCF (the employer copy 

and the donor copy) or maintain them with Copy 3 of the Federal CCF (the collector copy).

Chapter 5. The Federal Drug Testing Custody and Control Form 

(Federal CCF)

Federal agencies are required to use the Office of Management and Budget (OMB)-approved 

Federal CCF when collecting specimens for their workplace drug testing programs. Federal 

CCFs are available from a number of different sources (e.g., laboratories, collectors, third party 

administrators, MROs, ECCF providers). The same Federal CCF is used for urine and oral fluid 

specimens. Note: References to instrumented initial test facilities (IITFs) in this chapter apply to

urine specimens only.

2020 Federal CCF: OMB approved the use of the 2020 Federal CCF as of September 1, 2020, 

for urine and oral fluid specimens. The 2020 Federal CCF may be used as a paper or electronic 

form. Acceptable formats are described in Section A below. 

A proof of the current Federal CCF, guidance for its use, and Instructions for Completing the 

Federal CCF (i.e., separate instructions for urine specimens and for oral fluid specimens) are on 

the SAMHSA website: https://www.samhsa.gov/workplace. 

2017 Federal CCF: OMB originally extended the use of the expired 2017 Federal CCF for 

urine specimens until August 30, 2021 and subsequently extended its use until August 31, 

2023. The 2017 Federal CCF is not authorized for use with oral fluid specimens; the 2020 

Federal CCF should be used for oral fluid specimens. Beginning August 31, 2023, the 2020 

Federal CCF must be used for federally regulated specimens, and the test facility (laboratory or 

IITF) must treat the use of the 2017 Federal CCF for urine specimens as a correctable 

discrepancy. See Section B.1 below regarding use of an incorrect CCF.

Employers are prohibited from using the Federal CCF for:

1. Private-sector employee drug testing, with the exception of transportation industry testing 

conducted under the Department of Transportation (DOT) regulations.

2. State workplace drug testing programs 

3. Department of Justice drug testing programs 

A. Acceptable Formats for a Federal CCF

A federal agency may use the Federal CCF as: 

1. A paper form: a five-part form that is either preprinted or printed at the collection site before 

the collection, or 
8 

2. An electronic form (ECCF): either a digital (paperless) form or a combination electronic and 

paper form. All ECCFs must be the functional equivalent of a paper Federal CCF with 

respect to integrity, accuracy, and accessibility. 

The two types of combination electronic and paper ECCF systems are: 

a. Type 1: The collector uses an ECCF system to document the collection process, then 

prints Copy 1 and Copies 2–5 (without signatures). The donor signs in Step 5 of Copies 

2–5 using a wet-ink signature and the collector signs in Step 4 of Copies 1–5 using a 

wet-ink signature. The electronic form is not signed. 

b. Type 2: The collector uses an ECCF system to document the collection process, the 

collector and donor sign using electronic signatures (the donor uses a digitized 

signature), and the collector prints Copy 1 with his or her electronic signature. The 

printout of ECCF Copy 1 must be designated as the single authoritative copy of the 

ECCF. 

HHS-certified test facilities must receive approval from HHS before accepting regulated 

specimens collected using an ECCF system. SAMHSA maintains the list of HHS-certified 

test facilities (laboratories and IITFs) approved to use an ECCF, with the ECCF system(s) that 

each is authorized to use, on the SAMHSA website: https://www.samhsa.gov/workplace. 

If a laboratory or IITF receives a specimen that was collected using an ECCF system whose use 

has not been approved by SAMHSA for that test facility, they will reject the specimen. 

All collection sites must maintain a supply of paper Federal CCFs. A paper Federal CCF must 

be used in the event of a software/hardware problem preventing collections using an ECCF. In 

addition, collection sites must have the ability to print the Federal ECCF on demand. This 

capability allows the collector to print the Federal CCF in the event of a problem preventing 

completion of a collection using an ECCF (e.g., allowing for handwritten collector and donor 

signatures in the event of a problem with the electronic signature system or when a donor 

refuses to sign electronically but agrees to sign using a wet-ink signature). 

Federally regulated employers and drug testing service providers (e.g., collectors, test facilities, 

MROs) who use an ECCF must implement procedures and administrative, technical, and 

physical 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:

1. System validation. 

2. 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). 

3. Protection of records to enable accurate and ready retrieval throughout the records retention 

period. 

4. Limiting system access to authorized individuals (e.g., trained collectors). Procedures must 

be in place for managing the user authentication system (e.g., assignment, review, 

revocation).
9 

5. 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). 

6. 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.

B. Federal CCF Problems 

See also Appendix A: Federal CCF Decision Trees for Collectors. 

1. Use of an Incorrect CCF

a. As noted above, if a laboratory or IITF receives a specimen that was collected using an 

ECCF system whose use has not been approved by SAMHSA for that test facility, they 

must reject the specimen. 

b. In rare cases, a collector may use a non-federal CCF or an expired Federal CCF for a 

federal agency collection by mistake or as the only means to conduct a collection under 

unusual circumstances (e.g., post-accident test with insufficient time to obtain an OMBapproved Federal CCF). 

• If the collector realizes an incorrect CCF was used, they must include remarks on the 

CCF noting that it is a federal agency specimen or that an expired Federal CCF was 

used, provide the reason that the incorrect form was used, and include all collection 

information required on the current Federal CCF for that specimen type (urine or oral 

fluid). (Instructions for using the current Federal CCF are in Section D below.) 

 If the CCF used for the collection does not include space for all collection 

information required on the current Federal CCF, the collector must include the 

missing information in a signed memorandum for the record (MFR) sent to the 

test facility with the specimen. 

 If a laboratory or IITF discovers or is notified that a federal agency specimen was 

collected using an incorrect CCF and the collector did not provide explanatory 

collector remarks and required 2020 Federal CCF information on the CCF or on 

a signed MFR sent with the specimen, the test facility will contact the collector for 

an MFR to recover the missing information, with the following exception. 

- For an oral fluid collection device with diluent, if a laboratory receives an 

oral fluid specimen with an incorrect CCF and no collector documentation that 

they observed the device volume indicator(s) during the collection (i.e., on the 

CCF or a signed MFR sent with the specimen), the laboratory will reject the 

specimen. An MFR cannot be used to recover this missing information 

after the collection. 

 If an MRO discovers the use of a non-federal or expired Federal CCF, the 

collector is notified to provide an MFR to the MRO with the reason for using the 
10 

incorrect form and with other information required on the 2020 Federal CCF, with 

the following exception. 

- For an oral fluid collection device with diluent, if a laboratory receives an 

oral fluid specimen with an incorrect CCF and no collector documentation that 

they observed the device volume indicator(s) during the collection (i.e., on the 

CCF or a signed MFR sent with the specimen), the laboratory will reject the 

specimen. An MFR cannot be used to recover this missing information 

after the collection. 

c. The collector must take immediate steps to provide an MFR when notified. A laboratory

or IITF holds specimens for a short time (i.e., a minimum of five business days) after 

notifying the collector, before reporting a “rejected for testing” result to the MRO, who will 

cancel the test. 

• In the case of an expired (urine-only) CCF for a urine specimen, if the collector is not 

available, the collection site supervisor may sign the MFR.

2. Incorrect CCF Copy

Section E below describes proper distribution of Federal CCF Copies 1–5. The collector 

sends the Test Facility Copy (Copy 1) with the specimen to the laboratory or IITF. 

a. If the collector sends an incorrect CCF copy (i.e., Copy 2–5) with the specimen, the 

laboratory or IITF will not test the specimen until the collector provides documents to 

recover the error. The collector must send a signed explanatory MFR and the original 

Federal CCF Copy 1 signed by the collector using a wet-ink signature. The collector 

must send the Federal CCF Copy 1 with their wet-ink signature by courier or mail to the 

test facility (i.e., it is not acceptable to send a fax or pdf copy). 

b. The collector must take immediate steps to provide an MFR when notified. In the case 

of an ECCF reprint error, if the collector no longer works at the collection site, the 

collection site supervisor may sign the MFR. A laboratory or IITF holds specimens for a 

short time (i.e., a minimum of five business days) after notifying the collector, before 

reporting a rejected for testing result to the MRO, who will cancel the test. 

3. Reprint ECCF Copy 1 

For a Combination Electronic and Paper Federal CCF that has been signed by the collector 

and donor using electronic signatures, the collector must send the printout of Copy 1 

designated as the single authoritative copy of the ECCF with the specimen. 

a. The ECCF system will distinguish the authoritative copy from subsequent printed copies 

of Copy 1 (e.g., identifying subsequent copies as “Reprint”). If there is a problem with 

printing the authoritative copy (e.g., a printer error): 

• The collector must sign the reprinted Copy 1 (in the presence of the donor) using a 

wet-ink signature in Step 4 (near their printed name and electronic signature) to

designate this copy as the single authoritative copy. 
11 

• The collector (or the ECCF system) must include a remark in Step 2 of the ECCF 

reprint noting the reason for reprinting Copy 1. Alternatively, the collector must send 

a signed MFR to the laboratory or IITF with the specimen, including the reason that a 

reprinted Copy 1 was sent with the specimen. 

• If the collector fails to sign the ECCF reprint using a wet-ink signature and/or fails to 

provide an explanatory remark or an MFR, the laboratory or ITTF will not test the 

specimen, but will hold the specimen pending receipt of collector documents to 

recover the error(s). The collector must reprint the ECCF Copy 1 for the specimen, 

sign using a wet-ink signature, and provide an explanatory MFR. The collector must 

send the reprint ECCF with their wet-ink signature by courier or mail to the test 

facility (i.e., it is not acceptable to send a fax or pdf copy). 

b. The collector must take immediate steps to provide an MFR when notified. In the case 

of an ECCF reprint error, if the collector no longer works at the collection site, the 

collection site supervisor may sign the MFR. A laboratory or IITF holds specimens for a 

short time (i.e., a minimum of five business days) after notifying the collector, before 

reporting a rejected for testing result to the MRO, who will cancel the test. 

C. Federal CCF Content Requirements

1. Test Facility Identification

At the top of the Federal CCF, the test facility (i.e., HHS-certified laboratory or IITF) must be 

identified by one of the following:

a. The name and address of the specific test facility, 

b. A list of addresses with checkboxes to allow the collector to check the box for the 

specific laboratory or IITF to which the specimen will be shipped, or

c. A corporation name and telephone number. Note: Either the collector will annotate the 

address of the specific test facility within the corporation to which the specimen will be 

shipped, or the test facility that receives the specimen for testing will annotate its 

address. 

2. Labels/Seals

The tamper-evident labels/seals for the specimen bottles/tubes may be at the bottom of 

Copy 1 or may be separate from the form:

a. There must be two labels/seals: one marked with the letter “A” to designate the primary 

specimen and the other marked with the letter “B” to designate the split specimen. 

b. Each label/seal must have:

• The same specimen ID number that is at the top of the Federal CCF,

• A place for the collector to annotate the date of the collection, and
12 

• A place for the donor to initial the label/seal after it is placed on the specimen 

bottle/tube. 

 For oral fluid specimens: The label/seal must not cover the expiration date on 

the oral fluid specimen tube and must allow visual assessment of the contents of 

the tube.

3. Required Statements and Instructions

Wording of required statements must be identical to that on the OMB-approved Federal 

CCF. Instructions and statements must be provided as follows:

a. Instructions for Completing the Federal Drug Testing Custody and Control Form 

for Urine and Oral Fluid Specimen Collections 

• Separate Instructions for Completing the Federal CCF (for urine specimens and for 

oral fluid specimens) are available for downloading on the SAMHSA website: 

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

• The collector must provide the instructions to the donor (e.g., hardcopy, onscreen, 

posted at the collection site). 

b. Public Burden Statement 

• Paper Federal CCF: The Public Burden Statement is printed on each Federal CCF 

copy (i.e., on the back of Copies 1 through 5).

• Electronic CCF or Combination Electronic and Paper Federal CCF: The Public 

Burden Statement is provided to employers and donors on the printed or 

electronically transmitted ECCF (Copies 4 and 5) and to collectors on the ECCF 

(Copy 3) maintained in collector/collection site records. The statement must be 

provided to test facilities and MROs on a separate page (hardcopy or electronic). 

c. Privacy Act Statement (For Federal Employees Only) 

• Paper Federal CCF: The Privacy Act Statement is printed on the back of the donor 

copy (Copy 5). 

• Electronic CCF or Combination Electronic and Paper Federal CCF: The Privacy Act 

Statement is provided to donors on the printed or electronically transmitted Federal 

CCF (Copy 5). 

D. Federal CCF Instructions for Use with Urine Collections 

Note: Chapter 7, Section C includes step-by-step instructions for urine collections, including 

instructions for collector and donor entries on the Federal CCF.

Step 1. To be completed by the collector or federal agency representative prior to the donor 

providing a specimen. 

 
13 

1. The employer's name, address, telephone and fax numbers, and employer ID number (if 

applicable). 

2. The specific MRO name, address, telephone number, and fax number. 

3. Donor identification (e.g., SSN, employee ID number, or commercial driver’s license number

and state). The collector enters the donor identification after verifying the donor’s identity. If 

the donor refuses to provide their SSN or ID number, the collector enters a remark in Step 2

on Copy 1. 

4. The testing authority box indicating under which federal agency the specimen is being 

collected. The HHS box is checked for a federal agency employee or pre-employment 

specimen.

5. The appropriate box indicating the reason for the drug test. If the test is to be performed for 

a reason other than those listed on the Federal CCF, the “Other” box is checked and the 

specific reason is recorded.

6. The appropriate box for the drug tests to be performed. If the test is to be performed for a 

drug other than those listed on the Federal CCF, the “Other” box is checked and each 

specific drug is recorded. 

7. The collection site address. 

8. Collector contact information including telephone number, fax number, and other (e.g., email 

address).

Step 2. To be completed by the collector after receiving the specimen from the donor and 

measuring the temperature of the specimen within 4 minutes. This step requires the 

collector to mark the appropriate boxes to indicate: 

1. Specimen type. Check the URINE checkbox at the top of Step 2.

2. Collection type: Check the appropriate box to indicate whether the collection was a split 

specimen or single specimen collection. Note: Split specimens are required for all federal 

agency collections. If no specimen was provided, check the None Provided box and enter a 

remark and print your name in Step 2. You may, but are not required to, sign the Step 2 

Remarks.

3. URINE entries:

a. Temperature. Check the appropriate box to indicate whether the temperature of the 

specimen was or was not within the required temperature range. If temperature was 

outside the acceptable range, the collector enters a remark in Step 2 and takes action as 

required. 

b. Observed. If a direct observed collection was performed, check the Observed box and 

enter the following information on the Remarks line in Step 2. 

• Ask the donor to write the donor’s gender and initial it.
14 

• Write the name and gender of the observer and the reason for an observed collection. 

Note: If there is insufficient room on the Remarks line, the collector may provide a 

separate MFR explaining the use of an observed collection. The collector must send 

the MFR to the test facility. 

 

4. Remarks: Enter collector remarks and take action as needed (e.g., unusual behavior or 

appearance of the donor; failed collection attempts; unusual color, presence of foreign 

objects or material in the specimen). 

Step 3. This section lists actions to be performed by the collector and donor at the end of the 

collection, after the primary (A) and split (B) specimens have been collected. The collector 

assists the donor with completing the donor section of the Federal CCF in Step 5 on Copy 2. 

1. Record or instruct the donor to record the donor’s information: 

a. Printed name

b. Date of collection

c. Email address, daytime, and evening telephone numbers

d. Date of birth

2. Instruct the donor to: 

a. Review information transcribed by the collector on the CCF 

b. Read the donor certification statement and information in Step 5 on possible MRO 

requests for donor medication information (i.e., based on MRO review of test results) 

c. Sign and date the certification statement 

3. If the donor refuses to provide their information or to sign the certification statement, enter a 

remark in Step 2 on Copy 1. 

 

For ECCFs: if the donor refuses to sign electronically but is willing to sign a paper CCF with 

a wet-ink signature, print the ECCF, Copies 1–5. The donor must sign in Step 5 of Copies 

2–5 using a wet-ink signature and the collector must sign in Step 4 of Copies 1–5 using a 

wet-ink signature.

Step 4. To be initiated by the collector and completed at the test facility. 

1. Sign the collector certification statement in Step 4 on Copy 1 to certify that the specimen 

was collected, labeled, sealed, and released for shipment to the HHS-certified IITF or

laboratory in accordance with federal requirements. 

2. Include your printed name.

3. Record the following:
15 

a. Date of collection

b. Time of collection

c. The specific name of the delivery service to which the specimen bottles are released for 

shipment to the HHS-certified IITF or laboratory 

Note: Copy 1 entries in Step 4 below the first bold line and in the subsequent steps are 

made at the HHS-certified IITF or laboratory. 

E. Federal CCF Distribution

Note: Employers, collectors, test facilities, and MROs who send or receive CCFs electronically 

are responsible for ensuring the security of data transmissions and limiting access to any data 

transmission, storage, and retrieval systems. 

Paper CCFs and Combination Electronic and Paper CCFs 

1. Copy 1 (Test Facility Copy) 

The collector sends the signed Copy 1 with the specimen to the HHS-certified laboratory or 

IITF. Copy 1 is placed in the package with the specimen (i.e., in a compartment separate 

from the specimen bottles).

For Combination Electronic and Paper CCFs: Copy 1 sent with the specimen must be either 

the single authoritative copy, or a reprint of Copy 1 that has been signed by the collector 

using a wet-ink signature.

2. Copy 2 (MRO Copy)

 

The collector sends Copy 2 signed by the donor to the MRO via courier, mail, fax, or other 

electronic transmission method. 

For a Paper Federal CCF: If a copy of Copy 2 is sent to the MRO via fax or provided 

electronically, the collector maintains the original Copy 2 in the collection site records.

3. Copy 3 (Collector Copy) 

Copy 3 is maintained in the collection site records.

4. Copy 4 (Employer Copy) 

The collector sends Copy 4 to the federal agency employer via courier, mail, fax, or other 

electronic transmission method.

5. Copy 5 (Donor Copy)

The collector gives Copy 5 to the donor as a hardcopy after the collection is complete or

sends it electronically. 
16 

Digital Federal CCFs 

1. Copy 1 (Test Facility Copy) 

a. Copy 1 signed by the collector is electronically provided to the HHS-certified laboratory. 

b. In addition, the collector must either:

• Include a printed copy of the Test Facility Copy (Copy 1) in the package with the 

specimen (i.e., in a compartment separate from the specimen bottles), or

• Apply a label to the outside of the specimen package, with the specimen ID number, 

test facility name and contact information, and collection site name and contact 

information. 

2. Copies 2 through 5 

a. Copy 2 signed by the donor is electronically provided to the MRO.

b. Copy 3 is maintained in the collection site records. 

c. Copy 4 is provided electronically to the employer.

d. Copy 5 is provided to the donor as a hardcopy or electronically.

Chapter 6. Verification of Donor Identity

The donor must provide appropriate identification to the collector upon arrival at the collection 

site. 

Acceptable forms of identification are:

1. A photo ID (e.g., driver’s license, employee badge issued by the employer, or an alternative 

photo ID issued by a federal, state, or local government agency), or

2. Positive identification by the supervisor of the donor or by a federal agency representative.

If the identity of the donor cannot be established, the collector must not proceed with the 

collection.

Unacceptable forms of identification are:

1. Identification by a co-worker,

2. Identification by another donor,

3. Non-photo ID (e.g., social security card, credit card, union or other membership cards, pay 

vouchers, voter registration card), or

4. A faxed copy or photocopy of an identification document.
17 

Chapter 7. Urine Specimen Collection

A. Collection Site Security

The collection site must have a restricted access area to prevent unauthorized access to 

specimens, collection supplies, and collection site records. A permanent site that is used solely 

for specimen collections must be secured at all times. At facilities that are not dedicated 

specimen collection sites, the area of the site used for specimen collections must be secured as 

a restricted access area during the time a specimen is collected.

A collector must:

1. Prohibit unauthorized personnel from entering the collection site during the collection. 

2. Ensure the privacy of the donor. 

3. Perform only one donor collection at a time. 

4. Restrict access to collection supplies before, during, and after the collection. 

5. Ensure that only the collector and the donor are allowed to handle the unsealed specimen. 

6. Ensure that chain of custody is maintained and documented from the time of collection until 

the labeled and sealed specimen bottles are sealed in the specimen package for transport 

to the laboratory. 

7. Ensure that the Federal CCF is completed and CCF Copies 1–5 are distributed as required. 

8. Ensure that specimens are transported to the test facility in a sealed and secure transport 

container to minimize the possibility of damage during shipment and to prevent undetected 

tampering.

B. Collection Supplies

The following items must be available at the collection site to conduct proper urine collections:

1. Single-use plastic collection containers: Each collection container must not substantially 

affect the composition of drugs and/or metabolites in the urine specimen collected and must 

be:

a. Supplied as an individually sealed item using a tamper-evident system (e.g., in a sealed 

plastic bag, shrink wrapped, with a peelable or sealed lid, or another easily visible 

tamper-evident system), 

b. Large enough to easily catch and hold at least 55 mL of urine, and

c. Graduated with volume markings clearly showing the volume (e.g., 45 mL).
18 

2. Single-use plastic specimen bottles: Each specimen bottle with cap must not 

substantially affect the composition of drugs and/or metabolites in the urine specimen 

collected and must be:

 

a. Supplied as individually sealed bottles with a tamper-evident system (e.g., using plastic 

bag, shrink wrap, with a peelable or sealed lid, or another easily visible tamper-evident 

system), 

b. Able to hold at least 35 mL,

 

• The split specimen bottle may be the same size as or smaller than the primary 

specimen bottle, but must be able to hold at least 20 mL. 

c. Leak-resistant (i.e., have a screw-on or snap-on cap that prevents leakage),

d. Marked clearly to indicate the minimum levels of urine to be poured into each bottle (30 

mL for the primary specimen and 15 mL for the split specimen), 

e. Designed so that the required tamper-evident bottle label/seal from the Federal CCF is 

not damaged when the donor initials it and has no overlap that conceals printed 

information, and

f. Sufficiently transparent to enable an objective assessment of the urine specimen 

appearance and identification of abnormal physical characteristics without opening the 

bottle.

3. Thermometer: The thermometer must be capable of temperature readings between 

90°-100°F (32°-38°C). The thermometer must accurately measure the temperature of the 

specimen and not contaminate the specimen. The thermometer may be affixed to or built 

into the collection container as supplied or placed on the collection container after the donor 

gives the collection container with the specimen to the collector. Alternately, the collector 

may use another technology to measure the specimen temperature (e.g., thermal radiation 

scanning), providing the thermometer does not come into contact with the specimen.

4. Federal CCFs: An OMB-approved Federal CCF as described in Chapter 5 must be used 

for the collection. All collection sites, including those using ECCFs (digital and/or

combination electronic and paper Federal CCFs), should maintain a supply of paper Federal 

CCFs. 

5. Tamper-evident labels/seals: Tamper-evident labels/seals are used to identify and seal 

the specimen bottles containing the primary (A) and split (B) specimens. Occasionally, a 

tamper-evident label/seal will not properly adhere to the specimen bottle (e.g., due to 

moisture, temperature, or specimen bottle material). If this occurs, follow instructions in 

Chapter 8, Section G for using another tamper-evident seal.

6. Leak-resistant container: A container (e.g., plastic bag) that is leak-resistant and large 

enough to hold two specimen bottles.

7. Specimen package: The sealed, tamper-resistant container (e.g., plastic bag, box) that 

contains the specimen bottle(s) and Federal CCF from a urine drug test collection. Note: 

When an electronic Federal CCF was used for the collection, the collector must either 
19 

(1) include a printed copy of the Federal CCF (for informational purposes only) in the 

specimen package or (2) apply 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.

8. Absorbent material: The absorbent material is placed inside the leak-resistant container 

with the specimen bottles in case a specimen bottle leaks during shipment. The U.S. Postal 

Service and other express carriers require the use of absorbent material when shipping 

biological materials.

9. Shipping container: The container (e.g., box, mailer, bag) in which the collector places one 

or more specimen packages for transport to an IITF or laboratory. The shipping container 

must be securely sealed to prevent loss of a specimen during transport. It is not necessary 

to use a shipping container if a courier hand-delivers the specimen package directly from the 

collection site to the IITF or laboratory.

10. Bluing agent: Bluing agent is added to the toilet bowl and water tank to prevent undetected 

specimen dilution by the donor.

11. Disposable gloves: HHS recommends that collectors use single-use disposable gloves 

while handling specimens. The Occupational Safety and Health Administration has specific 

standards addressing protection of employees who are exposed to potentially infectious 

body fluids (29 CFR Part 1910.1030).

C. Collection Procedure 

1. Prepare the collection site to collect urine specimens. 

2. Assemble supplies.

a. Ensure that there is bluing agent in the toilet. If no bluing agent is available or if there is 

an automatic flushing system, turn off the water supply and flush the toilet to remove any 

water in the toilet when possible.

b. Turn off the water supply or secure water sources inside the restroom. 

3. Provide a means for the donor to wash their hands under your direct observation. If there is 

not a restroom or a sink within the collection area, provide another means (e.g., waterless 

cleanser, moist towelette). 

a. If a water source inside the restroom cannot be turned off or secured, you must perform 

a monitored collection as described in Chapter 8, Section B. 

b. Remove any soap, cleanser, disinfectant, or other potential adulterants, and

c. Inspect and/or secure areas or items that could be used to conceal adulterants (e.g., 

false ceilings, ledges, trash cans, towel dispensers).

4. Begin the collection process without delay when the donor arrives at the collection site. For 

example, the collection should not be delayed because an authorized employer or employer 
20 

representative is late in arriving. If the donor states that they are unable to provide a 

urine specimen, continue with the collection procedure through Step 13 below.

a. If a donor fails to arrive at the collection site at the assigned time for the drug test, follow 

the federal agency policy or contact the federal agency representative to obtain 

guidance on the appropriate action to be taken. 

5. Verify the donor’s identity with a photo identification (see Chapter 6). If the donor requests, 

you must provide identification (e.g., employee badge, employee list).

See Chapter 5, Section D for step-by-step instructions for completing the Federal CCF. 

Instructions below apply to all Federal CCF formats (see ECCF definitions and requirements in 

Chapter 5, Section A). 

 

6. Obtain the paper Federal CCF or log onto the Federal ECCF system for the collection. 

7. Ensure that the specimen identification number on the Federal CCF matches the 

identification number printed on each specimen bottle label/seal and on the specimen 

package label (if any). 

Note: Some ECCF systems require the collector to scan the barcoded specimen ID number 

on each bottle label/seal and add that specimen ID number to the ECCF. This step may be 

later in the collection process (as directed by the ECCF system). 

8. Verify the preprinted laboratory information (e.g., name and address) at the top of the 

Federal CCF, including the laboratory account number (if applicable).

9. Record and verify the information in Step 1 of the Federal CCF. Edit entries as needed. For 

a paper CCF, line through incorrect information, handwrite the correct information and initial 

and date the change.

10. Describe the basic collection procedure to the donor and inform the donor that the 

Instructions for Completing the Federal Custody and Control Form for a Urine Collection are 

available upon request. Answer any reasonable and appropriate questions that the donor 

has about the collection process.

11. To deter adulteration or substitution of the specimen:

a. Ask the donor to remove any unnecessary outer clothing (e.g., coat, jacket, hat) that 

could be used to conceal items or substances that could be used to adulterate or 

substitute the urine specimen.

• It is not necessary for the donor to remove a hat or head covering that the donor 

refuses to remove based on religious practice. 

• It is not necessary for the donor to remove their footwear, unless you suspect that 

they are concealing something that may be used to adulterate or substitute the 

specimen. 
21 

b. Take steps to safeguard the donor’s outer clothing and other personal belongings (e.g., 

briefcase, purse). The donor may retain their wallet. 

• The belongings may be left unsecured if they remain within the line of sight of the 

collector and the donor, and out of the donor’s reach, until the end of the collection, 

or

• The belongings may be secured (e.g., in a lockable cabinet with access controlled by

the donor, in a sealed bag with a tamper-evident seal).

c. Ask the donor to empty their pockets and display the items.

• If there are no items that can be used to adulterate a specimen, instruct the donor to 

return the items to their pockets and continue the collection procedure (i.e., with Step 

12). 

• If an item is present whose purpose is to adulterate, substitute or dilute the specimen

(e.g., a commercial drug culture product or other substance for which the donor has 

no reasonable explanation), this is considered a refusal to test. You must stop the 

collection and report the refusal to test to the federal agency to ensure immediate 

notification is received (see Chapter 8, Section F). Create an MFR to document the 

item (e.g., written description, photograph), and sign and date the MFR. 

• If an item that could be used to adulterate, substitute, or dilute a specimen (e.g., 

common personal care products such as eyedrops, mouthwash, or hand sanitizer) 

appears to have been inadvertently brought to the collection site, document the item 

in an MFR (e.g., written description, photograph), sign and date the MFR, safeguard 

the item with the donor’s belongings, and continue the collection procedure (i.e., with 

Step 12). 

• If the donor refuses to display the items in their pockets, this is considered a refusal 

to test. Stop the collection and report the refusal to test to the federal agency to 

ensure immediate notification is received (see Chapter 8, Section F). 

Note: The collector must work with only one donor at a time and must protect each donor’s

privacy. Only authorized personnel and the donor may be present in the restricted access area 

where the collection takes place. In addition, the collector must maintain the security and 

confidentiality of donor information on the Federal CCF for each donor.

12. Prepare for the collection:

a. Instruct the donor to wash and dry their hands under your observation. 

• Liquid soap is preferred over bar soap because bar soap gives the donor the 

opportunity to conceal soap shavings under their fingernails in an attempt to 

adulterate the specimen. 

b. After washing their hands, the donor must remain in your presence and not be allowed 

access to any water fountain, faucet, soap dispenser, cleaning agent, or other materials 
22 

which could be used to adulterate, substitute, or dilute a specimen. Instruct the donor to 

keep their hands within view and avoid touching items or surfaces. 

• If the donor refuses to wash their hands when instructed, this is considered a refusal 

to test. You must stop the collection and report the refusal to test to the federal 

agency.

c. Provide or allow the donor to select the collection kit or packaged collection container (if 

it is separate from the kit) from the available supply. 

d. Unwrap or break the seal of the kit or collection container in view of the donor. You may 

allow the donor to perform this step.

• Both the collector and the donor must be present. 

• Only the seal on the collection container is broken at this time (i.e., the specimen 

bottles remain sealed/wrapped).

Note: If the donor has stated that they are unable to provide a specimen, at this point in the 

collection, request that the donor enter the restroom and attempt to provide a specimen. If the 

donor comes out of the stall with an empty collection container, they have demonstrated the 

inability to provide a specimen. Follow the Insufficient Specimen procedure in Chapter 8, 

Section C, and Appendix D. 

13. Direct the donor to: 

a. Provide the specimen in the privacy of the restroom/stall/partitioned area to be used for 

the collection, 

b. Provide a specimen of at least 45 mL,

c. Not flush the toilet, and

d. Return with the specimen as soon as they have finished completing the void. 

 

• You may inform the donor that the temperature of the urine specimen must be read 

within 4 minutes after the void to be valid. Longer wait periods may cause the 

temperature to be out of range and necessitate an observed collection.

• A reasonable time limit may be set for completing the void.

Note: Neither the collector nor anyone else may go into the restroom with the donor, except in 

the case of a direct observed collection (see Chapter 8, Section A) or a monitored collection

(see Chapter 8, Section B).

Note: You must note any unusual behavior or appearance of the donor on the Federal CCF. If 

you detect any conduct that clearly indicates an attempt to tamper with a specimen, you must 

report a refusal to test immediately to the federal agency.
23 

Note: Both you and the donor must maintain visual contact with the specimen from the time the 

specimen is transferred to you until specimen bottles have been sealed for shipment to the IITF 

or laboratory. 

Note: After receiving the specimen from the donor, whenever practical, you may allow the donor 

to wash their hands and to flush the toilet. (The collector may inspect the toilet for any materials 

indicative of specimen tampering prior to flushing.)

14. After you receive the specimen from the donor, read the temperature. 

a. Do this within 4 minutes after the void. 

b. Mark the appropriate box in Step 2 of the Federal CCF:

• If the temperature is within the acceptable range (32° - 38°C; 90o-100oF), mark 

“Yes” and proceed with the collection procedure. Go to Step 15. 

• If the temperature is outside the acceptable range, mark “No.” You will perform a 

second, direct observed collection, and send both specimens to an HHS-certified 

laboratory (not an IITF) for testing. (See exception in first Note below.) 

 Record an appropriate comment on the Remarks line in Step 2 of the Federal 

CCF for the first specimen to identify this as the first of two specimens collected 

and the reason why two specimens were collected.

 Complete the first collection before initiating the second collection, including Step 

15 (examining the physical characteristics of the urine). 

 Begin the collection of a second specimen using a direct observed collection 

procedure (see Chapter 8, Section A) and a new collection kit (i.e., a new 

collection container and a new Federal CCF).

 Record an appropriate comment on the Remarks line in Step 2 of the Federal

CCF for the second specimen to indicate why two specimens were collected, 

including a cross reference to the specimen identification number of the first 

specimen. 

Note: The specimen with unacceptable temperature and its Federal CCF are sent to an HHScertified laboratory regardless of the specimen volume. Exception: If the unacceptable 

temperature is due to a measurement problem (e.g., no reading due to extremely low volume, 

temperature strip failure) discard the urine collected and immediately begin a second collection 

using the same Federal CCF and the same procedures (not directly observed). Use a new 

collection container for the second collection.

Note: If the donor provides less than 45 mL for the second specimen, follow the Insufficient 

Specimen procedures in Chapter 8, Section C. Discard the second specimen. Do not send the 

second specimen for testing if the volume is less than 45 mL.

Note: If the donor refuses to provide a second specimen or leaves the collection site before the 

collection process is completed, this is considered a refusal to test (see Chapter 8, Section F). 
24 

Discard any urine, document the refusal to test on the Federal CCF and send all copies of the 

Federal CCF to the federal agency’s designated representative.

15. Inspect the specimen for adulteration or substitution by examining the physical 

characteristics of the urine. 

a. Note any abnormal characteristics such as:

• Unusual color (e.g., specimen is blue),

• Presence of foreign objects or material, 

• Unusual odor (e.g., bleach), or

• Signs of adulteration (e.g., excessive foaming when shaken).

b. If there are no abnormal characteristics indicative of adulteration or substitution by the 

donor, proceed with the collection procedure. Go to Step 16. 

c. If you observe any abnormal characteristic(s) that appears to be due to adulteration or 

substitution by the donor, you will perform a second, direct observed collection and send 

both specimens to an HHS-certified laboratory (not an IITF) for testing: 

• Record an appropriate comment on the Remarks line in Step 2 of the Federal CCF 

for the first specimen to identify this as the first of two specimens collected and the 

reason why two specimens were collected. 

• Complete the first collection before initiating the second collection by continuing with 

the procedure in Step 17. 

 

• Begin the second specimen collection using a direct observed collection procedure 

(see Chapter 8, Section A) and a new collection kit (i.e., a new collection container 

and a new Federal CCF).

• Record an appropriate comment on the Remarks line in Step 2 of the Federal CCF 

for the second specimen to indicate why two specimens were collected, including a 

cross reference to the specimen identification number of the first specimen.

d. Follow the additional instructions below (also see Appendix C, Two Specimens from 

the Same Collection Event).

• The specimen with abnormal physical characteristics and its Federal CCF are sent to 

an HHS-certified laboratory regardless of the specimen volume. 

• If the donor provides less than 45 mL for the second specimen, follow the Insufficient 

Specimen procedures in Chapter 8, Section C. Discard the second specimen. Do 

not send the second specimen for testing if the volume is less than 45 mL.

• If the donor refuses to provide a second specimen or leaves the collection site before 

the collection process is completed, this is considered a refusal to test (see
25 

Chapter 8, Section F). Discard any urine, document the refusal to test on the 

Federal CCF and send all copies of the Federal CCF to the federal agency’s 

designated representative.

16. Check the specimen volume to ensure that the specimen contains at least 45 mL of urine.

a. If the specimen volume is at least 45 mL, complete the specimen collection procedure 

continuing with Step 17. 

b. If the specimen volume is less than 45 mL, discard the specimen and immediately begin 

a second collection using the same procedures and the same Federal CCF. Use a new 

collection container for the second collection. 

Note: If the donor refuses to attempt to provide a second specimen or leaves the collection site 

before the collection process is completed, this is considered a refusal to test (see Chapter 8, 

Section F).

c. When a second specimen must be collected, follow the Insufficient Specimen procedure 

in Chapter 8, Section C. 

• When the donor hands you the second specimen, continue with the collection 

procedure, including Step 14 (checking specimen temperature) and Step 15 

(examining physical characteristics of the urine). 

• If the donor is unable to provide at least 45 mL for the second specimen after a 

period of three hours, stop the collection procedure. Record the reason for not 

collecting a urine specimen on the Federal CCF, and notify the federal agency’s 

designated representative for authorization of an alternate specimen to be collected. 

The federal agency may choose to provide the collection site with a standard 

protocol to follow in lieu of requiring the collector to notify the agency’s designated 

representative for authorization in each case. You must send the appropriate copies 

of the Federal CCF to the MRO and to the federal agency’s designated 

representative (see Chapter 8, Section C). 

• If an alternate specimen is authorized, the collector may begin the collection 

procedure for the alternate specimen in accordance with the UrMG. If the donor

refuses to provide an alternate specimen, the collector stops the collection and 

reports the refusal to test (see Chapter 8, Section F). 

 

17. Unwrap the sealed specimen bottles in the donor’s presence. 

18. In the donor’s presence, pour the urine from the specimen collection container into the two 

specimen bottles labeled “A” and “B”. 

a. Pour at least 30 mL into the “A” Bottle and at least 15 mL into the “B” bottle. 

b. Secure the lid/cap on each bottle.
26 

19. Seal the A and B specimen bottles while the donor watches, positioning the appropriate 

label/seal over the lid/cap of each bottle to ensure that the lid/cap cannot be removed 

without breaking the label/seal. 

20. Discard any excess urine remaining in the collection container after the bottles have been 

filled with the appropriate volumes of urine.

a. The only exception is when the excess urine is being used to conduct clinical tests in 

conjunction with a physical examination that is required by the federal agency. No further 

tests may be conducted on the excess urine. 

21. Write the date on the tamper-evident labels/seals. 

22. Ask the donor to initial the label/seal on each bottle, using care to avoid damage. 

• If the donor fails or refuses to initial the seals, note this on the Remarks line in Step 2 of 

the Federal CCF and complete the collection process. This is not considered a refusal to 

test.

23. Inform the donor that it is not necessary for them to continue observing the collection

procedure after the bottles have been sealed, and that they are allowed to wash their hands.

24. Complete the Federal CCF. 

See Chapter 5, Section D for step-by-step instructions for completing the Federal CCF. 

Instructions below apply to all Federal CCF formats (see ECCF definitions and 

requirements in Chapter 5, Section A). 

a. Assist the donor in completing the donor section of the Federal CCF (Copy 2, Step 5)

• Record (or instruct the donor to record) donor information indicated on the CCF. The 

collector must not solicit any donor medical information, and medical information 

must not be recorded on the Federal CCF or other record maintained or distributed 

by the collector. See Step 26 regarding a donor-recorded list of medications. 

• Instruct the donor to read the donor certification statement, and to sign and date the 

certification statement. 

 If the donor refuses to provide their information or to sign the form, make a 

comment on the Remarks line in Step 2 of the Federal CCF to that effect. This is 

not considered a refusal to test.

b. Complete the collector chain of custody portion in Step 4 on Copy 1 of the Federal CCF.

25. Prepare the specimen package for shipment.

a. Place the sealed specimen bottles in a leak-resistant container (e.g., plastic bag)

including the absorbent material. 

b. Place the Test Facility Copy (Copy 1) and any collector MFRs in the container with the 

specimen (i.e., in a compartment separate from the specimen bottles). 
27 

Note: For a digital Federal CCF, the collector must either (1) include a printed copy of the 

Federal CCF (for informational purposes only) in the specimen package or (2) apply 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. Any 

collector MFRs for the specimen must be included in the package (i.e., in a compartment 

separate from the specimen tubes) or sent electronically to the laboratory using established 

procedures (e.g., secure fax, email).

c. Seal the bag so both compartments are sealed. 

26. Provide the Donor Copy of the Federal CCF to the donor. 

a. Remind the donor that they may list any prescription and over-the-counter medications 

on a separate sheet or on the back of the donor’s copy of the Federal CCF. This 

information may help the donor to remember what medications they may have taken if 

they are contacted by the MRO. 

Note: This information must not be recorded on any other copy of the Federal CCF or other 

record maintained or distributed by the collector. 

27. Inform the donor that they may leave the collection site.

 Send the specimen package to the IITF or to the HHS-certified laboratory within 24 hours 

after the collection or during the next business day. Specimens that will not be shipped 

within 24 hours (e.g., collected on a Friday for shipment on Monday) should be kept in secure 

refrigerated storage. If the specimen package is not shipped immediately, the collector is 

responsible for ensuring its security: 

a. For specimens in a sealed specimen package that has not been placed in a shipping 

container, take necessary steps to prevent tampering or access by unauthorized 

personnel.

b. For specimen packages in a sealed shipping container, take necessary steps to protect 

the container from damage or theft prior to pick-up by the designated delivery service. 

c. If the tamper-evident label/seal is broken on a specimen bottle after the donor leaves the 

collection site, the collection must be cancelled.

• Notify the agency’s designated representative that the label/seal was broken on the 

specimen bottle, and send all copies of the Federal CCF to the federal agency’s 

designated representative. 

29. Distribute the MRO and employer copies of the Federal CCF. Chapter 5, Section E

describes proper distribution of Federal CCF Copies 1–5.

a. The collection site and the MRO must coordinate the Federal CCF distribution process 

to ensure that procedures meet the MRO’s and federal agency’s requirements. 

b. The collection site or the MRO must maintain the original Copy 2 with the donor’s 

signature (i.e., paper Copy 2 with the donor’s wet-ink signature, if signed).
28 

Chapter 8. Miscellaneous Collection Issues

A. Direct Observed Collection

See also Appendix B: Direct Observed Collection Procedure

A direct observed collection procedure may only be used when:

1. A federal agency has authorized a direct observed collection because a donor’s previous 

drug test result was reported by an MRO as drug positive, adulterated, substituted, invalid

without a legitimate medical reason, or cancelled because the split specimen failed to 

reconfirm the primary specimen results or could not be tested, or

2. At the collection site, an immediate collection of a second urine specimen is required in one 

of the following situations:

a. The temperature of the specimen collected during a routine collection is outside the 

acceptable temperature range.

b. There is an indication that the donor has tampered with the specimen (e.g., abnormal 

physical characteristic such as unusual color, excessive foaming when shaken, unusual 

odor).

Before conducting a direct observed collection under Item 2 above, the collector must contact a

collection site supervisor for concurrence with the collector’s decision for a direct observed 

collection. The collector must explain to the donor why a direct observed collection is being 

conducted. If the donor declines to allow a direct observed collection it is considered a refusal to 

test (see Chapter 8, Section F). 

 

The procedure for a direct observed collection is the same as that for a routine collection except 

an observer watches the donor urinate into the collection container. The observer’s gender must 

be the same as the donor’s gender, which is determined by the donor’s gender identity. There 

are no exceptions to this requirement. The donor’s gender identity may be the same as or 

different from the donor’s sex assigned at birth. At the point in a routine collection where the 

donor enters the restroom with the collection container (see Chapter 7, Section C, Step 13), a 

direct observed collection includes the following additional steps:

1. The collector informs the donor that the gender of the observer will match the donor’s 

gender, which is determined by the donor’s gender identity.

a. The collector asks the donor to identify the donor’s gender on the Remarks line in 

Step 2 of the Federal CCF and initial it.

b. The donor is provided an observer whose gender matches the donor’s gender.

c. The collector documents the observer’s name and gender on the Remarks line in 

Step 2 of the Federal CCF. 

d. If there is no collector of the same gender as the donor’s gender, the collector or

collection site supervisor must select another individual trained in direct observed 
29 

specimen collections. The individual must meet the UrMG qualifications for an 

observer (see Chapter 1). 

Note: If there is insufficient room on the Remarks line, the collector may send a separate 

explanatory MFR.

2. The observer enters the restroom with the donor. 

3. The observer must directly watch the urine go from the donor’s body into the collection 

container. The use of mirrors or video cameras is not permitted. If the donor fails to follow 

the observer’s instructions related to the direct observed collection, this is considered a 

refusal to test (see Chapter 8, Section F). 

4. With regard to chain of custody, the observer must never touch or handle the collection 

container unless the observer is also serving as the collector.

5. The observer must maintain visual contact with the collection container until the donor 

hands the container to the collector

6. After the donor has completed urinating into the collection container:

a. The donor and observer leave the restroom.

 

• The observer must ensure that the employee hands the collection container directly

to the collector as soon as the employee has exited the enclosure, or 

• If the same individual serves as both observer and collector, the collector may 

receive the collection container from the donor while they are both in the restroom.

7. The collector checks the box for an observed collection in Step 2 of the Federal CCF. 

8. The collector continues with the routine collection procedures (see Chapter 7, Section C, 

Step 14). 

B. Monitored Collection

A monitored collection procedure must be used when:

1. The collection is being conducted in a public restroom (e.g., when the federal agency’s 

designated collection site is not available and there is an immediate need for a collection), or

2. The restroom used for the collection has a water source that cannot be disabled or secured. 

If the donor declines to allow a monitored collection when one of the above circumstances has 

occurred, it is considered a refusal to test (see Chapter 8, Section F). 

The procedure for a monitored collection is the same as that for a routine collection except a

monitor accompanies the donor into the restroom to check for signs that the donor may be 

tampering with the specimen. At the point in a routine collection where the donor enters the 

restroom with the collection container (see Chapter 7, Section C, Step 13), a monitored 

collection includes the following additional steps:
30 

1. The monitor accompanies the donor into the restroom and secures the restroom to ensure 

that no one else can enter during the collection process. The monitor remains in the 

restroom, but outside the stall, while the donor is providing the specimen.

a. The monitor must be the same gender as the donor’s gender, unless the monitor is a 

trained medical professional (e.g., nurse, doctor, physician’s assistant, technologist or 

technician) who is licensed or certified to practice where the collection occurs. 

b. The monitor may be an individual other than the collector and is not required to be a 

trained collector.

2. The monitor listens for signs of tampering with the specimen. The monitor must not watch 

the donor urinate into the specimen container.

3. If there is evidence of specimen tampering, the monitor notifies the collector to immediately 

begin to collect a second specimen using a direct observed collection procedure (see 

Chapter 8, Section A).

4. With regard to chain of custody, the monitor must never touch or handle the collection 

container unless the monitor is also serving as the collector.

5. After the donor has completed urinating into the collection container:

a. The donor and monitor leave the restroom. 

• The monitor must ensure that the employee hands the collection container directly to 

the collector as soon as the employee has exited the enclosure, or 

• If the same individual serves as both monitor and collector, the collector may receive 

the collection container from the donor while they are both in the restroom.

6. The collector provides the name of the monitor (if applicable) on the Remarks line in Step 2 

on Copy 1 of the Federal CCF. 

7. The collector continues with the routine collection procedures (see Chapter 7, Section C, 

Step 14). 

C. Inability to Provide a Sufficient Specimen

If a donor states that they are unable to provide a urine specimen during the collection process, 

the collector must begin the collection procedure regardless of the reason given. The donor 

demonstrates their inability to provide a valid specimen when they come out of the restroom 

with an empty collection container. Immediately begin a second collection using the same 

procedures, the same collection container (i.e., if no specimen was provided upon the first 

attempt), and the same Federal CCF. Appendix D provides flowcharts for collector actions. 

1. If the donor states that they may be able to provide a specimen if given more time:
31 

a. You must provide a period of up to 3 hours for the donor to attempt to provide a 

sufficient urine specimen. 

b. Inform the donor that they must remain at the collection site (in the area that you 

designate) during the wait period. The donor must be monitored to prevent the donor 

from possibly compromising the collection process. 

c. Offer the donor a reasonable amount of fluid to drink distributed reasonably through a 

period of up to 3 hours (e.g., an 8 ounce glass of water every 30 minutes, not to exceed

40 ounces over a period of 3 hours) or until the donor has provided a sufficient amount 

of urine, whichever occurs first. The donor is not required to drink fluids during the 

waiting period. 

d. Instruct the donor to let you know when they are able to provide a sufficient quantity of 

specimen. It is recommended that you allow sufficient time to have only one additional 

attempt rather than having to document several unsuccessful attempts. Be sensitive to 

how frequently you ask a donor to attempt to provide a specimen. 

e. Record the time of the attempt to provide a sufficient volume of specimen (e.g., on the 

Remarks line in Step 2 of the Federal CCF). 

Note: The collector must NOT under any circumstances combine urine collected from 

separate voids to create one specimen of sufficient volume.

2. If the donor states that they are unable to provide a specimen, or if the donor has not 

provided sufficient volume of specimen in three hours from the time of the donor’s first 

attempt, discontinue the collection and:

a. Record the reason for not collecting the specimen on the Remarks line and mark the 

“None Provided” box in Step 2 of the Federal CCF.

b. Notify the agency’s designated representative for authorization to collect an alternate 

specimen. The federal agency may provide the collection site with a standard protocol to 

follow instead of requiring the collector to notify the agency’s designated representative 

for authorization in each case. If an alternate specimen is authorized by the federal 

agency, begin the alternate specimen collection procedure. 

c. Discard the urine collected (if any). 

d. Provide a copy of the Federal CCF (as described in the Collection Procedure in Chapter 

7, Section C, Step 26) to the donor. Request that the donor leave the collection site or, 

if authorized, proceed with the alternate specimen collection. 

e. Discard Copy 1 of the Federal CCF (no valid specimen was collected). 

f. Provide a copy of the Federal CCF to the MRO and to the federal agency’s designated 

representative within 24 hours or the next business day (as described in the Collection 

Procedure in Chapter 7, Section C, Step 29). 

3. If the donor refuses to attempt to provide a specimen, refuses to provide a second 

specimen, leaves the collection site before the collection process is completed, refuses a 
32 

direct observed collection, or refuses to provide an alternate specimen, these are 

considered a refusal to test. The collector must follow the procedure in Chapter 8, 

Section F. 

D. Donor Conduct

The collector should pay close attention to the donor’s conduct during the entire collection 

process and take the following actions as necessary:

1. Note any unusual behavior or appearance of the donor in the Remarks line in Step 2 of the 

Federal CCF. 

2. If donor conduct clearly indicates an attempt to tamper with the specimen (e.g., substitute 

urine in plain view or an attempt to bring into the collection site an adulterant or urine 

substitute), report a refusal to test immediately to the federal agency in accordance with

Section F below. 

3. If there is reason to believe the donor may have adulterated or substituted a collected 

specimen (based on donor actions or an abnormal specimen characteristic including 

temperature outside of range), complete the collection procedure for the first specimen; 

perform a second, direct observed collection; and send both specimens to an HHS-certified 

laboratory (not to an IITF) for testing. 

4. Record an appropriate comment on the Remarks line in Step 2 of the Federal CCF for the 

first specimen to identify this as the first of two specimens collected and the reason why two 

specimens were collected.

5. Complete the first collection using the procedures in Chapter 7, Section C, before initiating 

the second collection. 

6. Begin the second specimen collection using a direct observed collection procedure (see 

Chapter 8, Section A) and a new collection kit (i.e., a new collection container and a new 

Federal CCF).

7. Record an appropriate comment on the Remarks line in Step 2 of the Federal CCF for the 

second specimen to indicate why two specimens were collected, including a cross reference 

to the specimen identification number of the first specimen.

Note: The first specimen and its Federal CCF are sent to an HHS-certified laboratory 

regardless of the specimen volume.

Note: If the donor refuses to provide a second specimen or leaves the collection site before 

the collection process is completed, this is considered a refusal to test (see Section F 

below). Discard any urine, document the refusal to test on the Federal CCF, and send 

all copies of the Federal CCF to the federal agency’s designated representative.

8. If the donor fails to arrive at the assigned time within a reasonable time, as determined by 

the federal agency:

a. Contact the federal agency’s designated representative to obtain guidance on the action 

to be taken.
33 

b. This is considered a refusal to test except for: 

• A donor who fails to appear for a pre-employment test; or

• A donor for a pre-employment test who leaves the collection site before the collection 

begins (i.e., before the collector provides or the donor selects the collection kit or 

packaged collection container as described in the Collection Procedure, Chapter 7,

Section C, Step 12). If the donor for a pre-employment test leaves after that step, 

before the collection is complete, the collector reports a refusal to test.

E. Multiple Collectors for a Specimen Collection

The procedures for collecting a federal agency drug testing specimen, as required by the HHS 

Mandatory Guidelines and detailed in this Specimen Collection Handbook, are designed to be 

performed from start to finish by one trained collector. Collection sites and federal agencies are 

expected to schedule collections accordingly. 

In the rare event when the collector who began a collection cannot complete all steps (e.g., 

when a collection coincides with a shift change, shy bladder, insufficient specimen), a second 

trained collector may assume responsibility for the collection. 

Prior to changing collectors:

1. The first collector must document their name, the time, and the reason for the change in 

Step 2 of the Federal CCF. The first collector may, but is not required to, sign in addition to 

printing their name in Step 2.

2. Before assuming responsibility for the collection, the second collector must:

a. Verify the donor’s identity with a photo identification (see Chapter 6). If the donor 

requests, you must provide identification (e.g., employee badge, employee list).

b. Verify the donor ID number recorded on the Federal CCF.

c. Ensure that Step 1 of the Federal CCF is complete.

d. Review and verify any information in Step 2 of the CCF recorded by the first collector.

F. Refusal to Test

A federal agency will take adverse action against an employee whose drug test specimen is 

reported as a refusal to test. The collector reports a “refusal to test” when:

1. The donor fails to appear for a collection within a reasonable time as determined by the 

federal agency, consistent with federal agency regulations (except for a donor who leaves 

the collection site before the collection begins for a pre-employment test as noted in 

Chapter 8, Section D, Step 8 above). 
34 

2. The donor fails to remain at the collection site until the collection is complete (except for a 

donor who leaves the collection site before the collection begins for a pre-employment test 

as noted in Chapter 8, Section D, Step 8 above).

3. The donor fails to cooperate with any part of the testing process (e.g., refuses to provide a 

specimen, refuses to display the items in their pockets at the beginning of the collection, 

disrupts the collection process, refuses to wash their hands at the beginning of the 

collection, or exhibits conduct that clearly indicates an attempt to adulterate, substitute, or 

dilute the specimen or otherwise prevent collection of a urine specimen), 

4. The donor declines to allow a direct observed collection when required, or fails to follow the 

observer’s instructions related to the direct observed collection, 

5. The donor declines to allow a monitored collection when required,

6. The donor declines to continue the collection process when their first specimen has 

insufficient volume,

7. The donor fails or declines to participate in an alternate specimen collection (e.g., oral fluid) 

as directed by the federal agency or collector, 

8. The donor admits to the collector that they have adulterated or substituted their specimen. 

9. The donor brings materials to the collection site whose purpose is to adulterate, substitute or 

dilute their specimen

When reporting a “refusal to test,” the collector must:

1. Notify the agency’s designated representative by a means (e.g., telephone, secure fax, 

email) that ensures immediate receipt of the refusal notification,

2. Document the refusal to test on the Federal CCF with appropriate comments, signature, and 

date in the Remarks line of Step 2 of the Federal CCF, discards any urine, and

3. Send all copies of the Federal CCF to the federal agency’s designated representative.

G. Problems with Specimen Bottle Labels/Seals

 

If the tamper-evident label/seal does not adhere properly to the specimen bottle (e.g., due to 

moisture, temperature, specimen tube material) or is accidentally broken or damaged during the 

collection process:

1. Apply the unacceptable label/seal (i.e., printed with the same identification number as the 

Federal CCF) to the bottle, and 

2. Apply a second, separate tamper-evident seal to seal the specimen bottle. 

a. Place the additional seal perpendicular to the original label/seal. Position the seal so 

it does not cover information on the original label/seal and will allow visual 

assessment of the bottle contents.
35 

b. Initial and date the second seal.

 

c. Ask the donor to initial the second seal.

d. Provide a comment on the Remarks line in Step 2 of the Federal CCF explaining why 

the second seal was used. 

Note: If the donor refuses to initial the second seal, the collector should note this on the 

Remarks line in Step 2 and continue with the collection process. This is not considered a 

refusal to test.

Chapter 9. Collector Errors and Corrective Actions

The Federal CCF is a forensic, legal document and will be part of the litigation package if a 

specimen comes under legal challenge. Federal agencies will investigate reported collection site 

deficiencies (e.g., specimens rejected for testing due to collector/collection errors).

The collector should never use correction fluid on the Federal CCF and should never overwrite 

or obscure information recorded or printed on the Federal CCF. Unclear or improper edits to 

Federal CCF information (e.g., donor ID numbers, signatures) could compromise the legal 

defensibility of the document. 

If the collector makes an error on a Federal CCF, they should:

1. Make a line through the erroneous information, leaving the original information legible,

2. Write the correct information near (e.g., beside or above) the original annotation, and

3. Initial and date the change.

It is acceptable for the collector to line out preprinted information on the Federal CCF that is 

incorrect or inapplicable (e.g., collection site, MRO, IITF, laboratory, or employer information). 

The collector must use the procedures described above for changing the information on the 

form. This may be necessary in the event of unexpected collections (e.g., accident investigation) 

or when Federal CCFs at the collection site have outdated information. 

There are three categories of collector errors:

1. Fatal flaws that result in an HHS-certified IITF or laboratory rejecting a specimen or an MRO 

canceling a test, 

2. Correctable flaws that result in an HHS-certified IITF or laboratory rejecting a specimen or 

an MRO canceling a test unless the flaw is corrected by an MFR from the collector, and 

3. Omissions and discrepancies on the Federal CCF that do not require rejection by the HHScertified IITF or laboratory or cancellation by the MRO. 

The collector should not access the Federal CCF or the specimen bottles after the package has 

been sealed in the presence of the donor. If the collector realizes they have made a correctable 
36 

flaw or omission after the Federal CCF Copy 1 has been sealed in the specimen package, the 

collector should proactively send an explanatory MFR to the HHS-certified IITF or laboratory. 

Chapter 5 includes instructions for when an incorrect CCF is used for a federal agency 

specimen or an incorrect CCF copy is sent with the specimen. See also Appendix A: 

Federal CCF Decision Trees for Collectors.

The collector must take immediate steps to provide an MFR to the HHS-certified IITF,

laboratory, or the MRO when notified of an error. An IITF or laboratory holds specimens for a 

short time (i.e., a minimum of five business days) after the collector has been notified, before 

reporting the specimen as rejected for testing and discarding the specimen.
Appendix A: Federal CCF Decision Trees for Collectors
Appendix A: Federal CCF Decision Trees for Collectors
Appendix A: Federal CCF Decision Trees for Collectors
Appendix A: Federal CCF Decision Trees for Collectors
1 Collector informs the donor that the gender of the 

observer will match the donor’s gender (determined by the 

donor’s gender identity).

• Collector asks the donor to identify the donor’s gender on the Remarks 

line in Step 2 of the Federal CCF and initial it.

• Donor is provided an observer (gender matches the donor’s gender).

• Collector documents the observer’s name and gender on the Remarks 

line in Step 2 of the Federal CCF.

If there is no collector of the same gender as the donor to serve as the 

observer, the collector or collection site supervisor selects another 

individual trained in direct observed specimen collections. 

2

Observer enters the restroom with the donor.

• Observer must directly watch the urine go from the donor’s body into 

the collection container.

If the donor fails to follow the observer’s instructions related to the direct 

observed collection, this is considered a refusal to test (see Chapter 8, 

Section B). 

• Observer must never touch or handle the collection container unless 

the observer is also the collector.

• Observer must maintain visual contact with the collection container 

until the donor hands the container to the collector

3 After the donor has completed urinating into the 

collection container:

• Donor and observer leave the restroom and the donor hands the 

collection container directly to the collector OR

• If the same individual serves as both observer and collector, the 

collector may receive the collection container from the donor while 

they are both in the restroom.

4 Collector checks the box for an observed collection in Step 2 

of the Federal CCF.

• Collector provides the reason for an observed collection on the 

Remarks line in Step 2 of the Federal CCF.

• Collector continues with the routine collection procedures (see 

Chapter 7, Section C, Step 13). 

Appendix B: Direct Observed Collection Procedure

General Note: 

For observed collections decided at the collection site - collector contacts a collection site 

supervisor for concurrence and explains to the donor why a direct observed collection 

is being conducted. If the donor declines to allow a direct observed collection, it is 

considered a refusal to test (see Chapter 8, Section B).
NO MRO Reports

“Refusal to Test”

Legitimate YES

Medical 

Condition?

2

1

1st Specimen 

Sent to Lab to be Tested

2nd Specimen 

Discarded

Collector Rejects – 

Insufficient Specimen

MRO Directs Medical 

Evaluation

NO*

Appendix C: Two Specimens from the Same Collection Event

1 2

1st and 2nd Specimens 

Sent to Lab to be Tested

1st Specimen Suspect =

2nd Specimen Direct Observed Recollection

1 2

2nd Specimen 

> 45 mL?

YES

MRO Reports

“Test Canceled”

* Collector follows routine

procedures for specimens

with insufficient volume,

including a wait period if

donor states that they could

provide a specimen if given

more time and/or after

drinking fluids.
Appendix D: Insufficient Specimen 

Request that the donor 

attempt to follow instructions 

and provide a specimen

Donor refuses to attempt 

collection

• Discard any collected 

urine and report a 

refusal to test

Donor agrees to attempt collection

• Allow the donor up to 3 hours to provide a 

sufficient specimen

• Instruct the donor to remain in a collectordesignated area at the collection site during the 

wait period (donor must be monitored)

• Provide water (8 oz every 30 minutes, up to a 

maximum of 40 oz) upon donor request*

• Instruct the donor to let you know when they 

can provide a specimen

• Record the time of the collection attempt(s) on 

the CCF

Unsuccessful collection

• Donor demonstrates the inability to 

provide a sufficient specimen

• Discard any urine collected

• Contact federal agency representative or 

follow federal agency’s policy for 

authorization to collect an alternate

specimen

*Donor is not required to drink any fluids.