Department of Health and Human Services

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Prevention

 

Oral Fluid Specimen Collection Handbook

for

Federal Agency Workplace Drug Testing Programs 

EFFECTIVE JANUARY 1, 2020

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 

using Oral Fluid (84 FR 57554) dated October 25, 2019 (effective January 1, 2020).

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).
Table of Contents

Introduction.................................................................................................................... 1

Chapter 1. The Collector ............................................................................................ 2

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

Chapter 3. The Collection Site.................................................................................... 5

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.......................................................... 8

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

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

D. Federal CCF Instructions for Use with Oral Fluid Collections....................... 13

E. Federal CCF Distribution ............................................................................. 16

Chapter 6. Verification of Donor Identity ................................................................... 17

Chapter 7. Oral Fluid Specimen Collection............................................................... 18

A. Collection Site Security................................................................................ 18

B. Collection Supplies ...................................................................................... 18

C. Collection Procedure ................................................................................... 20

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

A. Inability to Provide a Sufficient Specimen .................................................... 28

B. Donor Conduct ............................................................................................ 29

C. Specimens with Abnormal Physical Characteristics ..................................... 30

D. Diluent Volume Issues ................................................................................. 30

E. Multiple Collectors for a Specimen Collection .............................................. 30

F. Refusal to Test ............................................................................................ 31

G. Problems with Specimen Tube Labels/Seals ............................................... 32

Chapter 9. Collector Errors and Corrective Actions .................................................. 32

Appendix A: Federal CCF Decision Trees for Collectors.............................................. 34

Appendix B: Oral Fluid Collection Device Requirements.............................................. 38

Appendix C: Abnormal Physical Characteristics Flowcharts......................................... 40

Appendix D: Example Donor Attempts to Subvert an Oral Fluid Collection .................. 43

Appendix E. Insufficient Specimen............................................................................... 44
1 

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. 
2 

Chapter 1. The Collector 

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

The following restrictions apply: 

• 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. 

• 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.

• 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.

• An applicant or employee must not serve as the collector by collecting their own

specimen.

• 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.

• An individual who has a personal relationship with the employee (e.g., spouse, exspouse, relative, close personal friend) must not serve as the collector.

To qualify as an oral fluid 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 Oral Fluid (OFMG).

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 OFMG. 

3. Be knowledgeable of the manufacturer instructions for each oral fluid collection device 

that will be used by the collector for federal agency specimens. See Appendix B

requirements for devices used to collect diluted and undiluted (neat) oral fluid 

specimens. 

4. Receive training from a qualified trainer for oral fluid specimen collectors on the following 

topics for each oral fluid collection device: 

a. All steps to correctly perform an oral fluid specimen collection in accordance with this 

Specimen Collection Handbook and the manufacturer’s instructions for the collection 

device. 
3 

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.

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.

5. Demonstrate proficiency in oral fluid collections by successfully completing five 

consecutive error-free mock collections that include: two uneventful collection scenarios, 

one insufficient specimen quantity 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 tube tamper-evident 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.

b. When training on multiple collection devices, the trainer may revise the proficiency 

demonstration to require two uneventful additional collection scenarios using each 

collection device type and use only one of the device types for the remaining three 

scenarios (i.e., insufficient specimen, donor refusal to sign the Federal CCF, donor 

refusal to initial the tamper-evident seal on the specimen tube). 

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

requirements before collecting any specimens for a federal agency.

7. 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 oral fluid specimen collector must:

1. Before using an additional or revised collection device for a federal agency program, 

complete training that includes initial training in items 4 and 5 above. A minimum of two

mock uneventful collection scenarios using the device is required for the proficiency 

demonstration. The trainer may also choose to require the three additional error-free 

mock collections described in item 5 above. 
4 

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

includes all initial training items (items 1-6 above). 

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

federal agency specimens using the additional/revised collection device or collecting any 

federal agency specimens more than five years after initial training. 

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

To qualify as a trainer for oral fluid collectors to use a specific collection device for a 

federal agency program, an individual must:

1. Be qualified as a trained collector and have regularly conducted oral fluid drug test 

collections using that collection device for a period of at least one year OR have 

successfully completed a “train the trainer” course given by an organization (e.g., oral 

fluid collection device manufacturer, private entity, contractor, 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 an oral fluid specimen for a federal agency, the 

agency must:

1. Ensure that the collector has satisfied the oral fluid specimen collector requirements 

described in the OFMG.

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 

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. 
5 

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, another site may be used for the 

collection. 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 laboratory, and must have arrangements for the 

transfer of the specimens to a certified laboratory.

A facility used as an oral fluid 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.

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

specimen and complete the paperwork. 

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

an HHS-certified 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.
6 

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

time. These conditions may affect the test results of an oral fluid specimen. 

4. Provisions for the donor to wash their hands under the collector’s direct observation. If 

there is not a restroom or a sink within the collection area, the collector must provide 

another means (e.g., hand sanitizer, moist towelette, alcohol-free wipe). 

5. Provisions for the collector to: 

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

b. Store collection site records securely, and

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

specimen, or otherwise adversely affect the oral fluid collection. 

Chapter 4. Federal Agency Blind Samples

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

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 each HHS-certified laboratory that the collector sends the agency’s 

specimens. The OFMG specify the approximate percentage of each type (i.e., 75 percent

negative, 25 percent positive for one or more drugs). 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 oral fluid 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. The samples to be 

validated must be in the specimen tubes for the selected oral fluid collection device(s), 

along with the diluent for that device. 

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. 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. Negative and positive blind samples must be prepared using artificial or human oral fluid 

at the same volume as that collected in the collection device and be added to the 
7 

manufacturer’s specimen tubes with the same pad and volume of diluent that would be 

present in a donor’s specimen. 

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

metabolites listed in the OFMG, and the concentration should be 1.5 to 2 times the initial 

drug test cutoff concentration in “neat” oral fluid prior to any dilution in the collection 

device. 

5. 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.

6. The collector must submit blind samples to the laboratory in the same type of oral fluid 

collection device(s) used by the laboratory for the federal agency’s specimens. 

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 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 tube labels/seals.

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 
8 

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 urine 

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 

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 
9 

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).

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 OMB-approved 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 
10 

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 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 the collector did not 

document that they observed the device volume indicator(s) during the 

collection on the CCF or on a signed MFR sent to the laboratory with the 

specimen, the MRO will cancel the test. 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 
11 

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. 

• 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:
12 

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

• 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 
13 

• 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 Oral Fluid Collections 

Note: Chapter 7, Section C includes step-by-step instructions for oral fluid 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. 

 

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. 
14 

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

email address).

Step 2. To be completed by the collector.

1. Specimen type. Check the ORAL FLUID 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. ORAL FLUID entries:

a. Split Collection Type. Check the appropriate box. 

• Serial: A and B specimens collected one after the other using two devices. 

• Concurrent: A and B specimens collected simultaneously using two devices. 

• Subdivided: A and B specimens collected using one device that directs the oral 

fluid into two separate specimen tubes OR a single specimen collected using a 

single device, that is subsequently divided into A and B specimens. 

b. Expiration Date. Inspect each device to be used for the collection to verify that the 

expiration date has not been exceeded. 

• If each device is within its expiration date, check the YES box in Step 2. If a 

device is outside its expiration date (and no acceptable device is available for 

use), check the NO box and stop the oral fluid collection. 

• Note: the same human-readable expiration date must be on the collection device 

and the specimen tube(s) that will contain the oral fluid collected using that 

device.

• Note: The collector must record the manufacturer’s expiration date on the A 

specimen tube as the Primary/Single Specimen Device Expiration Date in Step 4 

of the Federal CCF and record the manufacturer’s expiration date on the B 

specimen tube as the Split Specimen Device Expiration Date in Step 4 of the 

Federal CCF. For ECCFs: An ECCF system may require the collector to scan or 

type the expiration date for each device into the ECCF system before use, for the 

system to check that the collection device is within its expiration date and to mark 

Step 2 (i.e., when both A and B devices are within date for a split collection). For 

each oral fluid collection, the collector must visually verify the expiration date on 

each tube vs. that recorded on the CCF or in the ECCF system. The laboratory 

accessioner must be able to verify the expiration dates recorded by the collector 

vs. those on the tubes.
15 

c. Volume Indicator(s) Observed. Observe the volume indicator on each device to 

verify that sufficient oral fluid has been collected. After collecting the A and B 

specimens, check the box to document that the volume indicator(s) were observed. 

For devices without a diluent (i.e., neat oral fluid specimens), inspect the volume 

markings on the specimen tubes after the specimen is collected to verify that at least 

1 mL of oral fluid was collected for each of the A and B specimens (i.e., excluding 

any foam or bubbles above the oral fluid). 

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 laboratory 

in accordance with federal requirements. 

2. Include your printed name.
16 

3. Record the following:

a. Date of collection

b. Time of collection

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

for shipment to the HHS-certified laboratory 

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

the HHS-certified laboratory, with one exception. As described under CCF Step 2 entries above 

(i.e., item 3.b), the collector may transcribe the expiration date from each specimen tube (A and 

B) to Step 4 of the Federal CCF. In this case, the laboratory accessioner will verify the recorded 

expiration date vs. that on the specimen tube upon receipt. 

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

separate from the specimen tubes).

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)
17 

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

sends it electronically. 

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 tubes), 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,
18 

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.

Chapter 7. Oral Fluid 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. Note: As time permits, the collector may start 

the collection process for other donors during the 10-minute wait period (see item C.13 

below); however, the collector must reverify the donor’s ID vs. that recorded on the Federal 

CCF prior to resuming the collection process, and must perform each collection one at a 

time, directly observing the donor throughout the collection. 

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 tubes 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 laboratory 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 oral fluid 

collections. Collection supplies should be individually packaged for each collection. Appendix B

describes oral fluid collection device requirements.

1. Collection Device: a single-use device that has been cleared by the Food and Drug 

Administration (FDA) and validated by an HHS-certified laboratory as acceptable to collect 

federal agency oral fluid specimens. Many current devices consist of a stick with a pad that 
19 

is placed in the donor’s oral cavity to collect oral fluid. However, oral fluid may also be 

collected without a pad, by expectoration into a device. 

a. If the device contains a diluent, the device must have an indicator that signals when a 

sufficient volume of oral fluid has been collected.

b. If the collection device does not contain a diluent:

• The volume of undiluted (i.e., neat) oral fluid collected should be at least 1 mL for 

each primary (A) and split (B) specimen; and

• The A and B specimen tubes (defined below) must each have a volume marking 

clearly noting 1 mL.

2. Specimen Tube: a sealable, non-leaking container to hold the collected oral fluid specimen 

[i.e., one tube for the (A) primary specimen and one tube for the (B) split specimen]. 

3. Collection Device Instructions: Device-specific instructions for the collection must be 

available at the time of the collection. The instructions may be provided to the donor as a 

hardcopy, displayed onscreen, or posted at the collection site. The collector may also offer a

copy of the instructions to the donor at the end of the collection (e.g., a hardcopy, an

electronic file, a website link sent via email). 

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 tubes containing the primary (A) and split (B) specimens. Occasionally, a tamperevident label/seal will not properly adhere to the specimen tube (e.g., due to moisture, 

temperature, or specimen tube 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 tubes.

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

contains the specimen tube(s) and Federal CCF from an oral fluid drug test collection. Note:

When an electronic Federal CCF was used for the collection, 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.

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

with the specimen tubes in case a specimen tube leaks during shipment. The U.S. Postal 

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

biological materials.
20 

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

or more specimen packages for transport to a 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 laboratory.

C. Collection Procedure 

1. Prepare the collection site to collect oral fluid specimens. 

2. Assemble supplies.

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). 

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 

representative is late in arriving.

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 tube 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 tube 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. To deter adulteration or substitution of the specimen:
21 

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 oral fluid 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. 

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).

 If the donor will be under your direct observation from this point until the end of the 

collection, skip to Step 11. 

 If the donor will not be under your direct observation from this point until the end of the 

collection (including the entire 10-minute wait period described in Step 12 below), continue 

with item c below. 

Note: If the donor fails to follow any of the instructions in item c below, skip to Step 11 and keep 

the donor under your direct observation until the end of the collection.

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 

8). 

• If an item is present that appears to have been brought to the collection site for the 

purpose of adulterating, substituting, or diluting the specimen or otherwise affecting 

the collection (e.g., a commercial drug culture product; a collection device, pad, or 

stick that mimics that to be used for an oral fluid collection; 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 a 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 or substitute a specimen (e.g., common 

personal care products such as mouthwash, lozenges, capsules, breath mints, 

breath spray) appears to have been inadvertently brought to the collection site, 
22 

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 8). 

11. Ask the donor to open their mouth, so you can inspect the oral cavity.

a. If the donor claims that they have a medical condition that prevents opening their mouth 

for inspection, follow the federal agency policy or contact the federal agency 

representative for authorization to collect another authorized specimen matrix (e.g., 

urine).

b. When you inspect the donor’s oral cavity:

• If an item in the donor’s oral cavity is present for the purpose of adulterating, 

substituting, or diluting the specimen or otherwise affecting the collection, 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). 

 Create an MFR to document the item (e.g., written description, photograph), and 

sign and date the MFR. 

• If an item (e.g. candy, gum, food, tobacco) is present that could be used to

adulterate, substitute, or dilute the specimen, but may not be present for that 

purpose, instruct the donor to remove the item. 

 If the donor removes the item(s), give the donor water (e.g., up to 4 oz.) to rinse 

their mouth. The donor may drink the water.

 If the donor refuses to remove an item or refuses to rinse their mouth, this is 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). 

• If the donor’s oral fluid is abnormally colored or if the donor claims to have “dry 

mouth,” give the donor water (e.g., up to 4 oz.) to rinse their mouth. The donor may 

drink the water.

 If the donor refuses to rinse their mouth, this is 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). 

• The donor is not required to remove a dental appliance (e.g., a retainer). 

12. Start the 10-minute wait period. During the wait period:

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

collection device-specific instructions and Instructions for Completing the Federal 

Custody and Control Form for an Oral Fluid Collection are available upon request. Note:

You may allow the donor to review these documents during the 10-minute wait period.
23 

b. Answer any reasonable and appropriate questions that the donor has about the 

collection process. 

c. Inform the donor that they must remain at the collection site (i.e., in the area that you 

designate) during the wait period. If the donor fails to follow these instructions, you must 

report a refusal to test to the federal agency (see Chapter 8, Section F). 

If the donor will not be under your direct observation from this point until the end of the 

collection, as time permits, you may start the collection process for other donors during the 

remainder of the 10-minute wait period. 

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.

13. Prepare for the collection:

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

• After washing their hands, the donor must remain in your presence. 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.

b. Provide or allow the donor to select the packaged collection device(s) to be used for the 

collection. 

• Only you (the collector) may open the package. 

• Once you have opened a package, both you and the donor must keep the 

unwrapped device in view at all times until the donor’s specimen collected using the 

device has been sealed and labeled. 

c. Review the device manufacturer’s instructions for the collection with the donor.

d. Inspect each device for obvious defects prior to starting the collection. You must discard 

a defective device and replace it with a compliant device for the collection.

• For devices with a diluent: the collector must check that the diluent volume in each 

device is not visibly different from the standard volume for that device. Note: It is 

suggested that the collector/collection site maintain an unopened device/tube to use 

for this comparison.

 

• When two devices with a diluent are to be used for the A and B specimens, the 

collector must visually compare the volume of fluid in the two devices before they are 
24 

used to collect the donor’s oral fluid. A visible difference in diluent volumes is 

evidence of a defective product that can affect the test. 

e. Check that each collection device is within its expiration date and mark the checkbox in 

Step 2 of the Federal CCF. 

Special instructions for serial split collections: 

Note: The B specimen collection must begin within two minutes after the A specimen 

has been collected.

a. Instruct the donor to place the A specimen device into the tube (with diluent)

immediately when you direct them to remove the device from their mouth.

b. When the donor removes the A specimen device from their mouth, record the 

time on the Federal CCF (Step 4). 

c. The donor is not allowed to drink or rinse their mouth between the two 

collections.

d. Cap the A specimen tube, then give the collection device for the B specimen to 

the donor and instruct them to position the device in their mouth while you record 

the start time on the Federal CCF (Step 4). 

If the time between the end of the A specimen collection and the beginning of the B 

specimen collection is within two minutes: proceed to label and seal the A specimen

tube in the presence of the donor.

If the time between the end of the A specimen collection and the beginning of the B 

specimen collection exceeds two minutes: 

a. Discard the first specimen collected, and continue to collect the second 

specimen as the A specimen. 

b. Follow the specimen collection instructions above to collect a third specimen as 

the B specimen. 

Using the same Federal CCF, document disposal of the first specimen and reason in 

the Remarks line in Step 2. Line through the original collection time and record the 

new collection time in Step 4, and initial the edit.

Note: If the donor refuses to provide a specimen, delays providing the B specimen 

within 2 minutes of the A specimen, or leaves the collection site before the collection 

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

Discard any collected oral fluid and unpackaged devices, document the refusal to test 

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

designated representative.
25 

14. Perform the oral fluid collection: 

a. You must be present and maintain visual contact with the donor for the entire 

collection. Follow the device-specific instructions provided by the collection device 

manufacturer for the proper use of the device. 

Note: The following instructions are written for collection devices that are placed in the 

donor’s mouth. For oral fluid specimens collected by expectoration, follow the same/similar 

steps as applicable. See Special Instructions for Serial Split Collections above for 

routine specimen collection and A and/or B recollection. 

b. Give the collection device to the donor. The donor is responsible for positioning the 

collection device in their mouth as you watch. Verify the positioning and provide further 

instructions as needed. The device must stay in the donor’s mouth for the 

manufacturer’s specified time or until a sufficient volume of oral fluid has been collected 

as shown by the device volume indicator or by the volume markings on the specimen 

tubes.

• For specimen tubes with 1 mL volume markings: if a specimen has air bubbles or 

froth, ensure that at least 1 mL of oral fluid was collected by requiring the donor to 

provide oral fluid above the 1 mL mark for each of the A and B specimens. 

c. If there is a failure to collect a specimen, discard the collection device with the 

insufficient specimen and begin the process again, using a new collection device (see 

Chapter 8, Section A, and Appendix E). Note the failed collection attempt on the 

Remarks line in Step 2 of the Federal CCF. If multiple devices fail to collect an oral fluid 

specimen, record the lot number(s) of the devices separately (not on the Federal CCF) 

for troubleshooting purposes and report the problem to the HHS-certified oral fluid 

laboratory. (If the laboratory is not the form supplier, also notify the supplier and obtain

additional devices/different lots as needed). 

d. Once the required volume of oral fluid has been collected, receive the device from the 

donor, inspect the condition of the device for any abnormal appearance (e.g., abnormal 

color, foreign material, evidence of chewing on collection pad or stick). If a device’s 

appearance is abnormal, take actions as described in Chapter 8, Section C and/or

Appendix C. If there are no abnormal characteristics, follow the manufacturer’s 

instructions for completing the collection (e.g., inserting the pad into the specimen tube, 

capping the specimen tube). Carefully handle all open tubes containing diluent. If 

any diluent is spilled (i.e., before or after combining with the collected oral fluid), recollect 

the specimen using a new device.

e. Mark the checkbox in Step 2 of the Federal CCF to document that you observed the 

volume indicator(s) during the collection. 

f. For collection devices with a diluent, visually compare the volumes (i.e., oral fluid plus 

diluent) of the A and B specimens. A visible difference in volumes could be evidence of a 

problem with the collection or with a device. If A and B volumes are different, take action 

as described in Chapter 8, Section D and/or Appendix C. 

g. Inspect the specimen for any abnormal appearance (e.g., unusual color, presence of 

foreign objects or material). If there are no abnormal characteristics, proceed with the 
26 

collection. If a specimen’s appearance is abnormal, take actions as described in 

Chapter 8, Section C and/or Appendix C. 

15. Seal the A and B specimen tubes one at a time while the donor watches, using the tamperevident A and B specimen labels/seals with the same specimen ID number as the Federal 

CCF. For each specimen:

 

a. Place the label/seal on the tube and over the cap. The label/seal must be positioned to:

• Provide a tamper-evident seal (i.e., the lid/cap cannot be removed without breaking 

the label/seal); 

• Not cover the expiration date on the tube; and

• Allow visual assessment of the contents of the tube. 

b. Date the label/seal on each tube.

c. Instruct the donor to verify that the specimen ID number on A and B tubes match that on 

the Federal CCF, and to initial the two labels.

• 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.

16. 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 18 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.
27 

17. Prepare the specimen package for shipment.

a. Place the sealed specimen tubes 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 tubes). 

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. 

18. 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. 

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

 

20. Send the specimen package 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 tube 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 tube, and send all copies of the Federal CCF to the federal agency’s 

designated representative. 
28 

21. 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).

Chapter 8. Miscellaneous Collection Issues

A. Inability to Provide a Sufficient Specimen

If the donor states that they are unable to provide an oral fluid specimen during the collection 

process, request that the donor follow the device instructions and attempt to collect a specimen. 

The donor demonstrates their inability to provide a specimen when there is insufficient oral fluid 

after 15 minutes of using the device or after multiple failures to collect the specimen. Appendix 

E provides flowcharts for collector actions. 

Note: For serially collected A and B specimens, the donor is not allowed to rinse their mouth or 

drink water between A and B specimen collections, and time between the end of Specimen A 

collection and beginning of Specimen B collection must not exceed two minutes. (See Special 

Instructions for Serial Split Collections in Chapter 7, Section C.) 

1. If the donor states that they may be able to provide a specimen after drinking some fluids, 

give the donor a drink (up to 8 oz.) and wait an additional 10 minutes before the next 

collection attempt. 

a. You must provide a period of up to 1 hour for the donor to attempt to provide a sufficient 

oral fluid specimen. 

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

designate) during the wait period.

c. The donor is not required to drink any fluids between collection attempts. 

d. At a minimum, the donor must be under your observation during the final 10 minutes of 

the wait period before the collection attempt. 

2. If the donor is unable to provide a specimen: 

a. Record the reason for not collecting an oral fluid specimen on the Federal CCF. 

b. Follow the federal agency policy or contact the federal agency representative for 

authorization to collect another authorized specimen matrix (e.g., urine). 

c. Send the appropriate copies of the Federal CCF to the MRO and to the federal agency 

representative.
29 

B. 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. 

a. If the conduct or an abnormal specimen characteristic clearly indicates an attempt to 

tamper with a specimen, report a refusal to test immediately to the federal agency in 

accordance with Section F below. 

b. If the donor’s actions may have affected a collected oral fluid specimen but do not clearly 

indicate an attempt to tamper with a specimen (e.g., possible misunderstanding of 

collection instructions), stop the collection procedure, discard that specimen, and 

perform a second split oral fluid specimen collection using the same Federal CCF. 

• Note the incident in the Remarks line in Step 2 of the Federal CCF.

• Proceed with the second split specimen collection as described in Chapter 7, 

Section C. 

o If you did not follow Step 7 (i.e., instructing the donor to remove unnecessary 

outer clothing and display their pocket contents) prior to the first collection, start 

with Step 7 to deter adulteration or substitution of the specimen.

o If you followed Step 7 prior to the first collection, start with Step 8. 

Note: If the donor refuses to provide an additional specimen or leaves the collection site 

before the split specimen collection process is completed, this is considered a refusal to test 

(see Section F below). 

2. 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.

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 packaged 

collection device as described in the Collection Procedure, Chapter 7, Section C, 

Step 10). If the donor for a pre-employment test leaves after that step, before the 

collection is complete, the collector reports a refusal to test.
30 

C. Specimens with Abnormal Physical Characteristics

The collector must inspect each oral fluid specimen for abnormal physical characteristics that 

may interfere with testing and/or be indicative of the donor’s attempt to adulterate or substitute 

the specimen. Supporting evidence of donor tampering includes, but is not limited to, an item in 

the donor’s oral cavity that could have affected the collection; evidence of chewing on the 

collection pad or stick; foreign material in the tube that could have been introduced only by the 

donor; and a donor admission to tampering with the specimen. Appendix C provides flowcharts 

for collector actions for specimens with abnormal color and for specimens with abnormal 

physical characteristics other than color (e.g., foam, chemical smell, foreign material in the 

tube). Appendix D provides some Example Donor Attempts to Subvert an Oral Fluid Collection.

D. Diluent Volume Issues

The collector must evaluate the volume of diluent present in the tube(s) to be used before 

beginning a collection. The collector must check that the diluent volume in each device is not 

visibly different from the standard volume for that device (e.g., using an unopened tube for 

comparison). The collector must also compare the volumes (i.e., oral fluid plus diluent) of the A 

and B specimens after collection. If A and B volumes are different, take action as described in 

Appendix C.

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), a second trained collector may assume 

responsibility for the collection at certain specific steps during the collection, as follows:

1. At any step up to the end of the 10-minute wait period prior to the collection (see 

Chapter 7, Oral Fluid Specimen Collection, Step 10); or

2. When there is an issue that requires the collector to restart the split collection (e.g., 

insufficient specimen volume, one or more specimens with an abnormal physical 

characteristic).

Note: The same collector must collect both A and B specimens from the donor and complete 

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: 
31 

• 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).

• Verify the donor ID number recorded on the Federal CCF. 

• Ensure that Step 1 of the Federal CCF is complete. 

• 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 B above). 

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 B above). 

3. The donor admits to the collector that they have adulterated or substituted their 

specimen. 

4. The donor fails to cooperate with any part of the testing process or disrupts the collection 

process. Examples include, but are not limited to:

a. Failing to open their mouth for inspection when directed 

b. Failing to remove a foreign object from their mouth when directed

c. Failing to rinse their mouth when directed

d. Refusing to wash their hands

e. Failing to provide a specimen (i.e., oral fluid or other authorized alternate specimen 

type) for a drug test required by the Mandatory Guidelines or federal agency 

regulations (except for a donor who leaves the collection site before the collection 

begins for a pre-employment test as noted in Section B.5 above)

f. Failing or declining to participate in an alternate specimen collection (e.g., urine) as 

directed by the federal agency or collector

g. Bringing materials to the collection site for the purpose of adulterating, substituting, 

or diluting their specimen, or otherwise affecting the collection. 
32 

h. Delaying more than two minutes between collection of the A and B specimens during 

a serial specimen collection 

i. Conduct that clearly indicates an attempt to adulterate, substitute, or dilute the 

specimen, or otherwise prevent collection of a sufficient oral fluid specimen as 

described in item B above. Examples of donor attempts to subvert an oral fluid 

collection are included in Appendix D. 

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 oral fluid, and

3. Send all copies of the Federal CCF to the federal agency’s designated representative. 

G. Problems with Specimen Tube Labels/Seals

 

If the tamper-evident label/seal does not adhere properly to the specimen tube (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 specimen identification 

number as the Federal CCF) to the tube, and 

2. Apply a second, separate tamper-evident seal to seal the specimen tube.

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 or the expiration date on the tube, 

and will allow visual assessment of the tube contents.

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).
33 

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, 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 laboratory rejecting a specimen or an MRO 

canceling a test, 

2. Correctable flaws that result in an HHS-certified 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 laboratory or cancellation by the MRO. 

The collector should not access the Federal CCF or the specimen tubes after the package has 

been sealed in the presence of the donor. If the collector realizes they have made a correctable 

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 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 laboratory or 

the MRO when notified of an error. A 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.
34 

Appendix A: Federal CCF Decision Trees for Collectors
35 

Appendix A: Federal CCF Decision Trees for Collectors
36 

Appendix A: Federal CCF Decision Trees for Collectors
37 

Appendix A: Federal CCF Decision Trees for Collectors
38 

Appendix B: Oral Fluid Collection Device Requirements

Collection Device: a single-use device that has been cleared by the Food and Drug 

Administration (FDA) and validated by an HHS-certified laboratory as acceptable to collect 

federal agency oral fluid specimens. Many current devices consist of a stick with a pad that is 

placed in the donor’s oral cavity to collect oral fluid; however, oral fluid may be collected by 

(unstimulated) expectoration into the device. The FDA-approved collection device must be used 

in accordance with manufacturer instructions and program requirements. No modification of 

the FDA-cleared device is allowed. 

1. A collection device must not substantially affect the composition of drugs and/or drug 

metabolites in the oral fluid specimen, and must:

 

a. Ensure pre-analytical drug and drug metabolite stability, and

b. Include an indicator that demonstrates to the collector the adequacy of the volume of 

the oral fluid specimen collected.

2. If the device contains a diluent (or other component, process, or method that modifies the 

volume of the collected specimen):

a. The volume of undiluted oral fluid collected should be at least 1 mL ±10 percent of 

the target volume for each primary (A) and split (B) specimen; 

b. The volume of diluent in the device should be within ±2.5 percent of the diluent target 

volume; and

c. The device must have a volume indicator visible to the collector, that demonstrates 

when an adequate volume of oral fluid has been collected.

3. If the collection device does not contain a diluent (or other component, process, or method 

that modifies the volume of the collected specimen):

a. The volume of undiluted (neat) oral fluid collected should be at least 1 mL for each 

primary (A) and split (B) specimen; and

b. The A and B specimen tubes (defined below) must each have a volume marking 

clearly noting 1 mL.

Specimen Tube: a sealable, non-leaking container approved by FDA with the collection device, 

used to hold the collected oral fluid specimen (i.e., one tube for the primary specimen and one 

tube for the split specimen). 

1. A specimen tube must not substantially affect the composition of drugs and/or drug 

metabolites in the oral fluid specimen, and must:

 

• Ensure pre-analytical drug and drug metabolite stability,
39 

• Maintain the integrity of the specimen during storage and transport so that the 

specimen can be tested for drugs and drug metabolites,

• Display device expiration date: 

◦ The manufacturer must include the expiration date on the tube (i.e., the 

expiration date cannot be printed or transcribed on the label/seal applied by 

the collector);

◦ The expiration date must be the date of the key component (i.e., the diluent 

expiration date if a diluent is used); and

◦ The expiration date must be human-readable and readily visible to the 

collector and laboratory staff.

• Be designed so that the required tamper-evident label/seal from the Federal CCF is 

not damaged when initialed by the donor, and

• Be sufficiently transparent to enable a visual assessment of the contents (i.e., oral 

fluid, diluent, collection pad) for identification of abnormal physical characteristics 

without opening the tube.

 

2. Specimen tubes must be supplied as:

a. An individual tube for a single oral fluid specimen (i.e., primary or split specimen) 

collected using a single collection device (i.e., two collection devices are used 

simultaneously or serially for a split specimen collection), or

b. Paired tubes for the primary and split specimens, when one collection device is used 

to collect a single oral fluid specimen that is subdivided into primary and split 

specimens.

Analyte Stability and Recovery 

Stability: (recoverable concentrations ≥80 percent of the concentration at the time of collection) 

of the drugs and/or drug metabolites for five days at room temperature (64-77 °F/18-25 °C) and 

under the manufacturer’s intended shipping and storage conditions; and

Recovery: ≥80 percent (but no more than 120 percent) of drug and/or drug metabolite in the 

undiluted (neat) oral fluid at (or near) the initial test cutoff.
40 

Appendix C: Abnormal Physical Characteristics Flowcharts

Abnormal Color

of Specimen A and/or Specimen B

Abnormal color other than red Red

Collector gives donor water 

(e.g., up to 4 oz.) to rinse their 

mouth. Donor may drink the 

water.*

Collector keeps donor under 

direct observation for 10 

minutes before recollecting 

the specimen

Collector checks the donor’s mouth for oral 

ulcerations (“mouth sores”)

No ulcerations, donor used colored 

product (e.g., mouthwash, candy, 

throat lozenge), or source of red 

color not identified

Oral ulcerations 

Collector contacts federal agency 

representative or refers to agency's 

established policy for authorization 

to collect an alternate specimen

Collector documents abnormal 

color and actions in Collector 

Remarks on CCF, completes 

the OF collection, and sends 

A and B specimens to the 

laboratory 

Alternative 

specimen 

collected

Yes No

Collector discards oral fluid 

collected and collects alternate 

specimen in accordance with 

HHS Collection Handbook for 

that specimen type

*Serial split collections: Donor is not allowed to rinse or drink water between A and B specimen collection. If time between the end 

of Specimen A collection and beginning of Specimen B collection exceeds two minutes, discard all collected oral fluid and 

recollect both A and B specimens.

 Recollection: If donor states that they are unable to provide an oral fluid specimen during the collection process, follow the 

procedure in Appendix E, Insufficient Specimen.

Refusal to test: Stop the collection and report a refusal to test when donor fails to follow instructions (e.g., refuses to remove an 

item from their mouth, refuses to rinse), admits that they have adulterated or substituted their specimen, or donor conduct clearly 

indicates an attempt to subvert the collection. See Appendix D, Example Donor Attempts to Subvert an Oral Fluid Collection.

 
41 

Abnormal Volume

of Specimen A and/or Specimen B

Neat oral fluid (no diluent) Device containing a diluent*

Collector discards 

the device with less 

than the required 

volume (at least 1 

mL) and recollects 

the specimen.

Volume (A and/or B) 

lower than expected 

A specimen volume 

that is visibly lower 

than expected for the 

device could indicate 

a collection problem 

or defective device. 

A and B volumes 

visibly different 

Visible differences 

in A and B 

specimen volumes 

could indicate a 

collection problem 

or defective device.

Volume (A and/or B) 

higher than expected

A specimen volume 

that is incompatible 

with the collection 

time (e.g., a full 

collection tube) could 

indicate addition of 

other liquids to 

attempt dilution.

Collector discards the device with abnormal 

volume and recollects the specimen**

* The collector should have checked diluent volumes for A and B devices during device selection. If any diluent is spilled (before or after 

combining collected specimen with diluent): discard the device and use a new device to collect/recollect the specimen.

**Serial split collections: Donor is not allowed to rinse or drink water between A and B specimen collection. If time between the end of 

Specimen A collection and beginning of Specimen B collection exceeds two minutes, discard all collected oral fluid and recollect both A 

and B specimens.

If multiple devices appear defective (e.g., fail to collect any oral fluid, device particles indicative of defect): record the lot number(s) of the 

devices separately (not on the CCF) and report the problem to the HHS-certified oral fluid laboratory. If the laboratory is not the form 

supplier, also notify the supplier and obtain additional devices/different lots as needed.

Recollection: If donor states that they are unable to provide an oral fluid specimen during the collection process, follow the procedure in 

Appendix E, Insufficient Specimen.

Refusal to test: Stop the collection and report a refusal to test when donor fails to follow instructions (e.g., refuses to remove an item 

from their mouth, refuses to rinse), admits that they have adulterated or substituted their specimen, or donor conduct clearly indicates an 

attempt to subvert the collection. See Appendix D, Example Donor Attempts to Subvert an Oral Fluid Collection. 

 If the donor states 

that they are unable to 

provide an oral fluid 

specimen during the 

collection process, 

follow the procedure in 

Chapter 8, Section A.
42 

Foreign Material

in Specimen A and/or Specimen B

If the material appears to 

be part of the device (e.g., 

plastic particles)

If the material could have 

been introduced only by 

the donor (i.e., an attempt 

to subvert the test)

If the material appears to 

be food particles, tobacco, 

or smokeless tobacco 

products (i.e., dip, snuff, 

snus, chewing tobacco)

Miscellaneous foreign 

material (i.e., not 

consistent with items to 

the left)

Option 1: If donor agrees 

with recollection, discard 

collected oral fluid. 

Document observation 

(specify foreign material) 

and recollection in 

Collector Remarks on 

CCF, give donor water to 

rinse mouth. Keep donor 

under direct observation 

for 10 minutes before 

recollecting specimen*

Option 2: If donor objects 

to recollection, document 

observation (specify 

foreign material) in 

Collector Remarks on 

CCF, and send specimen 

(A and B) to laboratory

 *Serial split collections: Donor is not allowed to rinse or drink water between A and B specimen collection. If time between the end of Specimen A 

collection and beginning of Specimen B collection exceeds two minutes, discard all collected oral fluid and recollect both A and B specimens.

**If multiple devices appear defective (e.g., fail to collect any oral fluid, device particles indicative of defect): record the lot number(s) of the devices 

separately (not on the CCF) and report the problem to the HHS-certified oral fluid laboratory. If the laboratory is not the form supplier, also notify the 

supplier and obtain additional devices/different lots as needed.

Recollection: If donor states that they are unable to provide an oral fluid specimen during the collection process, follow the procedure in Appendix E, 

Insufficient Specimen.

Refusal to test: Stop the collection and report a refusal to test when donor fails to follow instructions (e.g., refuses to remove an item from their mouth, 

refuses to rinse), admits that they have adulterated or substituted their specimen, or donor conduct clearly indicates an attempt to subvert the 

collection. See Appendix D, Example Donor Attempts to Subvert an Oral Fluid Collection. 

Option 1: Defective 

device** or collector error 

(e.g., overtightening cap). 

Discard collected oral 

fluid, document 

observation (specify 

foreign material) and 

recollection in Collector 

Remarks on CCF, and 

recollect specimen.*

Option 2: Device 

damaged by donor (e.g., 

chewing or biting on pad 

or stick). Discard 

collected oral fluid and 

report a refusal to test. 

Discard collected oral 

fluid and report a refusal 

to test. 

Discard collected oral 

fluid, recollect 

specimen, document 

observation (describe 

foreign material) and 

recollection in Collector 

Remarks on CCF. Give 

donor water to rinse 

mouth and keep donor 

under direct 

observation for 10 

minutes before 

recollecting specimen.*
43 

• Attempting to rinse their mouth or gargle with mouthwash or other liquid (e.g., 

detox products, hydrogen peroxide, lemon juice, vinegar) immediately before or 

during the collection

• Chewing gum, using dental products (e.g., dental floss), or holding items (e.g., 

lozenges, capsules) in their mouth before collection 

• Attempting to hold a portion of collector-provided water in their mouth to dilute 

their specimen

• Attempting to cause bleeding (e.g., biting/chewing their cheek)

• Biting/chewing the collection device

• Sucking the fluid out of the collection device, attempting to direct oral fluid away 

from collection pad, or swallowing excessively during collection process.

• Not positioning the collection device correctly in their mouth

• Attempting to conceal a foreign object (e.g., mint, breath strip, toothpaste, ice, 

liquid capsule, cough drop) in their mouth 

• Attempting to detach, rip, eat, swallow, or destroy the collection pad while in the 

mouth

Appendix D: Example Donor Attempts to Subvert an Oral Fluid 

Collection
44 

Appendix E. Insufficient Specimen

Request that donor attempt to follow 

instructions and collect the specimen

Donor agrees to attempt collection

• Allow the donor up to 1 hour to provide a 

sufficient specimen

• Instruct donor to remain in collectordesignated area at the collection site 

during the wait period 

• Provide water (up to 8 oz) upon donor 

request** 

• At a minimum, keep donor under your 

direct observation for the 10 minutes 

immediately before each collection attempt

Donor refuses to attempt collection

• Discard any collected oral fluid and 

report a refusal to test. 

Unsuccessful collection

• Donor demonstrates the inability to 

provide a sufficient specimen 

• After a 15-minute collection attempt (i.e., 

no device indicator response, less than 1 

mL neat oral fluid expectorated), or 

• After multiple collection attempts 

• Contact federal agency representative or 

follow federal agency’s policy for 

authorization to collect an alternate 

specimen.

*Serial split collection. If time between the end of Specimen A collection and beginning of Specimen B collection exceeds two minutes, discard all 

collected oral fluid and recollect both A and B specimens.

**Donor is not required to drink any fluids. For serial split collections, donor is not allowed to rinse mouth or drink water between A and B specimen 

collection.