1 

Department of Health and Human Services

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Prevention

Collection Site Manual

for the

Collection of Oral Fluid Specimens 

for

Federal Agency Workplace Drug Testing Programs

Effective January 2022

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

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

section 7301 note dated July 11, 1987, and the Department of Health and Human Services 

Mandatory Guidelines for Federal Workplace Drug Testing Programs 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).
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Disclaimer

The Department of Health and Human Services (HHS) recommends that each federal agency

use the information contained in this collection site manual to ensure consistency and to 

improve the overall quality of the review process. This collection site manual is for 

informational purposes only and can be modified to reflect the Federal Agency’s Drug-Free 

Workplace Policy. 

If there are questions regarding this manual, please contact Division of Workplace Programs 

staff at 240.276.2600 or see https://www.samhsa.gov/workplace. 

 
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Table of Contents

References ................................................................................................................................................ 4

Introduction................................................................................................................................................ 5

Federal Custody and Control Form (Federal CCF) ................................................................ 5

Collection Site Manual Instructions ....................................................................................................... 6

Guidance and Information .......................................................................................................... 6

Terms and Definitions.................................................................................................................. 6

Checklist ........................................................................................................................................ 6

Section Evaluation ....................................................................................................................... 7

Collection Site Evaluation Form................................................................................................. 7

Inspector/Collection Site Reviewer................................................................................ 7

Federal Agency Reviewer............................................................................................... 8

Definitions.................................................................................................................................................. 9

Section A. Collection Site .................................................................................................................... 11

Section Evaluation ..................................................................................................................... 14

Section B. Personnel ............................................................................................................................ 15

Collectors..................................................................................................................................... 15

Collector Trainers....................................................................................................................... 18

Section Evaluation ..................................................................................................................... 20

Section C. Specimen Collection Procedures ................................................................................ 21

Section Evaluation ..................................................................................................................... 33

Section D. Collection Problems....................................................................................................... 34

Insufficient Specimen – Questions D-1 through D-7 pertain to collections where the 

donor states that they are unable to provide an oral fluid specimen. ................................ 34

Refusal to Test............................................................................................................................ 36

Collector Errors........................................................................................................................... 38

Section Evaluation ..................................................................................................................... 40

Section E. Collection Site Records...................................................................................................... 41

Section Evaluation ..................................................................................................................... 43

Collection Site Evaluation Form........................................................................................................... 44

Attachment 1: OFMG Subparts D-H ................................................................................................... 45

Subpart D - Collectors ........................................................................................................................ 46

Subpart E - Collection Sites.............................................................................................................. 47

Subpart F - Federal Drug Testing Custody and Control Form ................................................ 49

Subpart G – Oral Fluid Specimen Collection Devices ............................................................... 49

Subpart H - Oral Fluid Specimen Collection Procedure............................................................ 50
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References

(available at https://www.samhsa.gov/workplace)

1. Federal Custody and Control Form (Federal CCF)

2. HHS Oral Fluid Specimen Collection Handbook for Federal Agency Workplace Drug 

Testing Programs (HHS Oral Fluid Collection Handbook)

3. Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid

(OFMG). Published October 25, 2019 (84 FR 57554), effective January 1, 2020. 
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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, drug testing facilities, and 

collection sites used for federal workplace drug testing specimens. 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. 

Oral fluid specimens must be collected in accordance with the Mandatory Guidelines for 

Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) published on 

October 25, 2019 (effective January 1, 2020) and must be sent to an HHS-certified 

laboratory for testing. 

This Collection Site Manual provides explanatory comments and references for each 

question included in the Collection Site Checklist for Collection of Oral Fluid Specimens 

for Federal Agency Workplace Drug Testing Programs. SAMHSA developed the 

Collection Site Manual for federal agencies’ use in evaluating collection sites that 

provide specimen collection services to the federal agencies, to verify and document 

compliance with federal requirements. 

Federal Custody and Control Form (Federal CCF)

All oral fluid specimens must be collected using chain of custody procedures. Chain of 

custody is the term used to describe the procedures to account for the integrity of each 

specimen and aliquot (i.e., portion of a specimen used for testing) by tracking handling

and storage from the point of specimen collection to final disposition of the specimen 

and its aliquots. The collector begins the chain of custody at the collection site using the 

Office of Management and Budget (OMB)-approved Federal CCF to document custody 

and control of each federal agency specimen. 

The Federal CCF may be used as a paper (hardcopy) form, an electronic (digital) form, 

or in a combination electronic and paper format. Before an HHS-certified laboratory may 

use an electronic CCF (ECCF: digital form or combination electronic/paper form) for 

federally regulated specimens, the test facility must be approved to use that ECCF 

system by SAMHSA, through the National Laboratory Certification Program (NLCP).

OMB approved the use of the 2020 Federal CCF as of August 17, 2020 for urine and 

oral fluid specimens. SAMHSA’s Division of Workplace Programs (DWP) has released 

guidance associated with the 2020 Federal CCF. 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. OMB extended the use of the expired 

2017 Federal CCF for urine specimens only until August 31, 2023. 

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

Federal CCF must be used for oral fluid specimens. The 2020 Federal CCF is the only

Federal CCF approved for collection of regulated oral fluid specimens. If a regulated

oral fluid specimen is received at a test facility accompanied by the 2017 Federal CCF, 
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the specimen may be rejected. See section 6.2 regarding the use of an incorrect CCF 

for an oral fluid specimen.

Collection Site Manual Instructions

A federal agency must ensure that collectors and collection sites satisfy all requirements 

in subparts D, E, F, G and H of the Mandatory Guidelines for Federal Workplace Drug 

Testing Programs using Oral Fluid (OFMG) published on October 25, 2019 (effective 

January 1, 2020). 

This Collection Site Manual is designed to assist the Drug Program Coordinator or 

designee and collection site personnel in evaluating collection site performance based 

on onsite inspections and self-evaluations. A federal agency is responsible for 

inspecting 5 percent (up to a maximum of 50) collection sites each year, selected 

randomly from those sites used to collect federal agency specimens. A federal agency

must investigate reported collection site deficiencies and take appropriate action, which 

may include an onsite inspection or collection site self-evaluation using the Collection 

Site Checklist for Collection of Oral Fluid Specimens for Federal Agency Workplace 

Drug Testing Programs and the HHS Oral fluid Specimen Collection Handbook. 

Guidance and Information 

To use this manual, you will need: 

• Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral 

Fluid (OFMG) published on October 25, 2019 (effective January 1, 2020) 

• HHS Oral Fluid Specimen Collection Handbook for Federal Agency Workplace 

Drug Testing Programs (HHS Oral Fluid Collection Handbook) 

• Guidance provided by the federal agency’s drug-free workplace program or by 

HHS relating to regulated oral fluid specimen collection 

Terms and Definitions

Before you can begin using this manual, you need to familiarize yourself with the 

checklist questions and comments in each section. This can be done by following these 

easy steps: (1) read each question and the related comments, (2) read the OFMG

section(s) referenced for each question, and (3) understand the federal agency policy. 

Checklist 

Each question in the Collection Site Checklist for Collection of Oral Fluid Specimens for 

Federal Agency Workplace Drug Testing Programs is designed to address the 

requirements in OFMG subparts D, E, F, G and H. The inspector/collection site reviewer 

answers each question based on these requirements and their review of the collection 

site standard operating procedures, practice, and records. The individual completing the 

checklist will:

1. Circle the appropriate YES or NO answer for each checklist question. 

2. If required for a NO answer, check the deficient area(s) for the checklist question.

3. Record comments in the space provided to explain the specific reason for each 

NO answer.
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Section Evaluation

Each checklist section contains a section evaluation page. The inspector/collection site 

reviewer uses the section evaluation to summarize and classify the seriousness of 

identified deficiencies. The individual completing the checklist will:

1. For each checklist question in the section with a NO answer, explain the potential 

problem or identified non-compliance.

2. Mark the overall section evaluation at the top of the page as appropriate:

• Deficiencies require immediate corrective action by the collection site

• Deficiencies were identified but do not require immediate correction action

• No deficiencies were identified.

Collection Site Evaluation Form

The Collection Site Evaluation Form is completed by inspectors (for onsite inspections) 

and by collection site personnel (for self-evaluations) and is used by the federal agency

Drug Program Coordinator (DPC) or designee to determine the inspection outcome. 

 

Inspector/Collection Site Reviewer

1. In the Overall Section Summary, assign a numerical “score” for each checklist 

section, based on the section evaluation: 

• Record a “0” on the evaluation form for each section summary where serious 

deficiencies were identified.

• Record a “1” for each section summary where deficiencies were identified but 

do not require immediate corrective action.

• Record a “2” for each section summary where no deficiencies were identified.

2. In the appropriate “Inspector/Collection Site Reviewer” columns under “Overall 

Summary of Serious Deficiencies,” list the sections identified as having serious 

deficiencies and those with no serious deficiencies.

3. Add the individual section scores to determine the rating and record the total in 

the “Rating” space for “Inspector/Collection Site Reviewer” under “Inspection 

Outcome.” 

4. Sign and date in the appropriate space at the bottom of the form. Inspectors sign 

the “Onsite Inspection by” line; Collection Site Reviewers sign the “SelfEvaluation by” line.
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2. Based on your review, in the appropriate “Federal Agency/Designee” columns 

under “Overall Summary of Serious Deficiencies,” list the sections identified as 

having serious deficiencies and those with no serious deficiencies. 

3. Note (e.g., by circling) any sections with evaluations differing from the 

inspector/collection site reviewer evaluation. If there are differences, calculate a 

final rating based on your individual section scores. 

4. Record the final rating in the “Rating” space for “Federal Agency/Designee” 

under “Inspection Outcome.” 

5. Determine the Inspection Outcome based on the following criteria in each 

section:

 ____ Serious deficiencies were identified (0 points)

 ____ Deficiencies were identified (1 point)

 ____ No deficiencies were identified (2 points)

• Acceptable = A rating of 5 or greater and no more than 1 section with a 

serious deficiency identified. 

• Unacceptable = A rating less than 5 or more than 1 section with a serious 

deficiency identified.

6. Additional comments concerning the inspection outcome should be recorded in 

the space provided. 

Federal Agency Reviewer

1. Review the checklist completed by the inspector (for onsite inspections) or by 

collection site personnel (for self-evaluations).
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Definitions

Adulterated Specimen: A specimen that has been altered, as evidenced by test results 

showing either a substance that is not a normal constituent for that type of specimen or 

showing an abnormal concentration of an endogenous substance.

Blind Sample: A sample submitted to an HHS-certified test facility for quality assurance 

purposes, with a fictitious identifier, so that the test facility cannot distinguish it from a 

donor specimen.

Chain of Custody Document: A form used to document the control and security of the 

specimen and all aliquots. The document may account for an individual specimen, 

aliquot, or batch of specimens/aliquots, and must include the name and signature of 

each individual who handled the specimen(s) or aliquot(s), and the date and purpose of 

the handling.

Chain of Custody Procedures: Procedures that document the integrity of each 

specimen or aliquot from the point of collection to final disposition.

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

Administration (FDA) to collect an oral fluid specimen. Devices may include a buffer or 

diluent.

Collection Site: The location where specimens are collected. 

Collector: A person trained to instruct and assist a donor in providing a specimen. 

Federal Custody and Control Form (CCF): The Office of Management and Budget 

(OMB) approved form that is used to document the collection and the chain of custody 

of a specimen from the time the specimen is collected until it is received by the testing 

facility (i.e., HHS-certified laboratory, or for urine, HHS-certified IITF). It may be a paper 

(hardcopy), electronic (digital), or combination electronic and paper format (hybrid). The 

form may also be used to report the test result to the Medical Review Officer (MRO).

Instrumented Initial Test Facility (IITF): A permanent location where (for urine) initial 

testing, reporting of results, and recordkeeping are performed under the supervision of a 

Responsible Technician.

Laboratory: A permanent location where initial and confirmatory testing, reporting of 

results, and recordkeeping are performed under the supervision of a Responsible 

Person.

Medical Review Officer (MRO): A licensed physician who reviews, verifies, and reports 

a specimen test result to the federal agency.

Oral Fluid Specimen: An oral fluid specimen is collected from the donor’s oral cavity 

and is a combination of physiological fluids produced primarily by the salivary glands.

Rejected for Testing: The result reported by an HHS-certified laboratory or (for urine) 

HHS-certified IITF when no tests are performed for a specimen because of a fatal flaw 

or unrecovered correctable error. 
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Specimen: Fluid or material collected from a donor at the collection site for the purpose 

of a drug test.

Split Specimen Collection (for Oral fluid): A collection in which two specimens 

[primary (A) and split (B)] are collected, concurrently or serially, and independently 

sealed in the presence of the donor; or a collection in which a single specimen is 

collected using a single collection device and is subdivided into a primary (A) specimen 

and a split (B) specimen, which are independently sealed in the presence of the donor.
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Section A. Collection Site

Collection Site

Question A-1. Does the collection site have provisions to ensure donor privacy during 

the specimen collection procedure? (YES/NO)

Comment: The collection site must have the ability to ensure donor privacy during 

specimen collections. Only authorized personnel and the donor may be present in the 

restricted access area where the collection takes place. Note: the collector is not 

required to be the same gender as the donor.

Reference: OFMG (subpart E – section 5.2.a; subpart H – section 8.1)

Question A-2. Does the collection site have the following? (YES/NO)

If NO, check the deficient area(s):

____ a. A means for washing hands 

____ b. A suitable clean surface, inaccessible to the donor, for the collector to 

use as a work area 

____ c. A secure temporary storage area for maintaining specimens until they 

are transferred to an HHS-certified laboratory

Comment: The collection site must have a means for the donor to wash his or her 

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). The work area is used by the collector to handle the 

specimens and to complete required paperwork (e.g., Federal CCF). The work area 

must be clean and not accessible to the donor. The collection site must have an 

appropriate secure temporary storage area for maintaining specimens until they are 

transferred to an HHS-certified laboratory. The specimen storage area should not be 

exposed to high temperatures for an extended period of time, as this may affect the test 

results of an oral fluid specimen.

Reference: OFMG (subpart E – section 5.2.b - c and subpart H - section 8.1) and HHS

Oral Fluid Collection Handbook

Question A-3. Does the collection site have procedures or restrictions to prevent the 

following? (YES/NO) 

If NO, check the deficient area(s):

____ a. Unauthorized access to the site during the collection

____ b. Unauthorized access to the collection materials/supplies

____ c. Unauthorized access to collection site records
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____ d. Donor access to items that could be used to adulterate or substitute the 

specimen, or otherwise adversely affect the oral fluid collection 

Comment: To ensure specimen integrity, the collection site must have procedures or 

restrictions in place to prevent unauthorized access as described in this question.

Reference: OFMG (subpart E - section 5.2.d-f) and HHS Oral Fluid Collection 

Handbook

Question A-4. Does the collection site have the required supplies for federal agency

oral fluid specimen collections? (YES/NO)

Comment: The collection site must have all the supplies needed to complete an oral 

fluid split specimen collection such as collection kits (i.e., with single-use collection 

device), Federal CCFs, tamper-evident tape/seals, leak-resistant container (e.g., plastic 

bag) with separate sealable compartments for specimen tubes and CCF, absorbent 

material, shipping containers, and disposable gloves. Collection kits must include an 

FDA-approved, single-use collection device capable of collecting a minimum of 1 mL of 

undiluted (neat) oral fluid. (See Section C, page 21, for types of split oral fluid 

collections that may be used.) If the collection device contains a diluent (or other 

component that modifies the volume), the volume of oral fluid collected by the device 

should be at least 1.0 mL ± 10 percent. Collection devices must not substantially affect 

the composition of drugs and/or metabolites in the specimen collected.

Reference: OFMG (subpart G – section 7.1 through 7.3) and HHS Oral Fluid Collection 

Handbook

Question A-5. Is access to collection supplies restricted to authorized personnel? 

(YES/NO)

Comment: It is the collector’s responsibility to prevent unauthorized access to 

collection supplies. To minimize the chances of tampering, donors must not have 

access to collection site supplies.

Reference: OFMG (subpart E - section 5.5.a.3)

Question A-6. Does the collection site have the name and telephone number of the 

designated representative for each federal agency for which specimens are collected? 

(YES/NO)

If YES, 

a. Is this information readily available to each collector, in the event that a 

problem or issue arises during a collection? (YES/NO)

Comment: The collection site must have the name and telephone number of the 

designated representative for each federal agency readily available, so collectors can 

contact the agency as needed about problems or issues that arise during the specimen 

collection procedure.

Reference: OFMG (subpart D - section 4.5.c) 
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Question A-7. Does the collection site have procedures to prohibit the following 

individuals from serving as a specimen collector? (YES/NO)

If NO, identify the deficient area(s):

____ a. Hiring official or donor’s immediate supervisor unless there is no 

feasible alternative and the individual is a trained collector

____ b. Co-worker in the same testing pool or who works with the donor on a

daily basis 

 

____ c. The applicant or employee (i.e., the specimen donor)

____ d. Employee of an HHS-certified laboratory who can link the donor with 

the specimen drug test results 

____ e. Relatives or close personal friends of the donor

Comment: To avoid a conflict of interest, the collection site must prohibit individuals as 

described in this question from collecting a specimen.

Reference: OFMG (subpart D - section 4.1.b-c, subpart D - section 4.2.a – d)
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Section Evaluation

Question A-8. For the Collection Site Section: 

____ Serious deficiencies were identified (0 points)

____ Deficiencies were identified (1 point)

____ No deficiencies were identified (2 points)

Note: This page is included to facilitate the evaluation of compliance with program 

requirements. The inspector/reviewer should explain the potential problem or identified noncompliance associated with the checklist questions in this section. Serious deficiencies require 

immediate corrective action by the collection site to maintain the integrity of the collection 

process, to maintain the security and integrity of the specimens collected, and to ensure the 

privacy of the donors. 

Describe basis for the above selection:
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Section B. Personnel

Collectors

Question B-1. During interview by the inspection team, did each collector demonstrate a 

working knowledge of the collection procedures described in the OFMG and any other 

guidance provided by the federal agency related to specimen collection procedures? 

(YES/NO)

If NO, identify the individual(s) and deficient area(s) of knowledge.

Comment: Prior to performing specimen collections for a federal agency, each collector 

must demonstrate a working knowledge of the collection procedures described in the 

OFMG, the HHS Oral Fluid Collection Handbook, and any other guidance provided by the 

federal agency related to specimen collection procedures. The extent of knowledge is 

routinely assessed by observing the individual perform a real or mock collection and asking 

questions concerning practices and procedures. To avoid distracting the collector during a 

real collection, inspectors should hold questions until after the collection is completed and 

the donor has left the site.

Reference: OFMG (subpart D - section 4.3.a.1-2)

Question B-2. Was documentation of training for each collector provided for review during 

the inspection? (YES/NO)

If NO, note the collector(s) with missing training documentation.

Comment: The collection site must provide each collector’s training records to the 

inspectors for review. Inspectors should note any collectors with missing training 

documentation.

Reference: OFMG (subpart D - section 4.3.c)

Answer questions B-3 through B-8 for the records provided. 

Question B-3. Does each collector maintain their training documentation? (YES/NO)

Comment: Each collector is required to maintain documentation of current training and 

refresher training and present it to a federal agency upon request. The collection site may 

maintain the originals or maintain copies of the training documents. If the collection site 

provides copies for review, the inspectors may request one or more collectors to provide 

the originals during the inspection. 

Reference: OFMG (subpart D - section 4.3.c and section 4.5.b)

Question B-4. Did each collector complete initial training for each collection device used 

before they began collecting specimens for a federal agency? (YES/NO)

Comment: An individual may not perform specimen collections until his or her training as 
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a collector on that device has been completed and documented. 

Reference: OFMG (subpart D - section 4.3.d)

Question B-5. Has each collector (as applicable) completed refresher training at 

least every five years from the date of initial training? (NA/YES/NO)

Comment: Each collector must complete refresher training every five years.

Reference: OFMG (subpart D - section 4.3.b)

Note: The collector training outlined in Questions B-6 and B-7 below must be conducted 

using a paper Federal CCF. To use an electronic Federal CCF for federal agency 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.

Question B-6. Do the initial and refresher training records for each collector document 

training on the following subjects? (YES/NO) 

If NO, identify the individual and records and check the deficient area(s):

____ a. The steps to correctly perform a collection using each type of collection 

device to be used for federal agency specimens 

____ b. The proper completion and distribution of the Federal CCF

____ c. Problem collections

____ d. Fatal and correctable flaws and how to correct problems in collections

____ e. Collector responsibilities to maintain the integrity of the collection process, 

to protect the privacy of donors, to ensure the security and integrity of 

specimens, and to maintain proper conduct

Comment: A qualified trainer for collectors must perform training on these topics during 

initial collector training and during refresher training at least every five years. Training 

documentation should clearly indicate these training topics on the certificate or in the 

training manual. Before using an additional or revised collection device for a federal agency 

program, a trained oral fluid collector must complete training by a qualified trainer on the 

topics above and demonstrate proficiency using that device as described under Question 

B-7. 

Reference: OFMG (subpart D - section 4.3.a.3) and HHS Oral Fluid Collection Handbook

Question B-7. Do the initial and refresher training records for each collector document their

proficiency in collections by successful completion of five (5) consecutive error-free mock 
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collections? (YES/NO) 

If NO, identify the individual and records and check the deficient area(s):

____ a. Two uneventful scenarios 

____ b. One insufficient specimen quantity scenario

____ c. One scenario in which the donor refuses to sign the Federal CCF

____d. One scenario in which the donor refuses to initial the tamper-evident tube

label/seal

Comment: Initial and refresher training must include the successful completion of five (5) 

consecutive error-free mock collections (i.e., two uneventful scenarios, one insufficient 

specimen quantity scenario, one in which the donor refuses to sign the Federal CCF, and

one in which the donor refuses to initial the tamper-evident tube label/seal). When training 

for multiple collection devices, the proficiency demonstration must include two uneventful 

collection scenarios for each device. The trainer may require the use of only one device 

type for the other three scenarios (i.e., items b-d above). 

Before using an additional or revised collection device for a federal agency specimen, a 

trained oral fluid collector must demonstrate proficiency by successfully completing at least

two consecutive error-free mock collections using that device. (The trainer may choose to 

require three consecutive error-free mock collections.) 

Reference: OFMG (subpart D - section 4.3.a.4.i) and HHS Oral Fluid Collection Handbook

Question B-8. Do the initial and refresher training records for each collector include the 

following? (YES/NO)

If NO, identify the individual and records and check the deficient area(s):

____ a. Documentation that the training was conducted in person or by means 

allowing real-time observation and interaction between trainer and trainee. 

____ b. Written attestation by the trainer that the mock collections were error-free. 

 

____ c. Documentation of the trainer’s qualifications at the time of the training.

Comment: A qualified trainer for collectors must monitor and evaluate the trainee and must 

attest in writing that all of the required consecutive mock collections were error-free. 

Training records must document that training was either conducted in person by a qualified 

trainer or by a means allowing real-time observation and interaction between trainer and 

trainee. The records should document the trainer’s qualifications at the time of the training 

on the certificate or in the training manual.
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Reference: OFMG (subpart D - section 4.3.a.4.ii, and subpart D - section 4.4.c) and HHS

Oral Fluid Collection Handbook

Collector Trainers

Answer the remaining Section B questions if collection site employees serve as 

collector trainers. 

Question B-9. During interview by the inspection team, did each collector trainer 

demonstrate a working knowledge of the collection procedures described in the OFMG, the 

HHS Oral Fluid Collection Handbook, the manufacturer instructions for the specific 

collection device(s), and any other guidance provided by the federal agency related to the 

collection procedures? (YES/NO)

Comment: Each collector trainer must demonstrate a working knowledge of the collection 

procedures described in the OFMG, the HHS Oral Fluid Collection Handbook, and any 

other guidance provided by the federal agency related to specimen collection procedures 

prior to performing specimen collections. Because collectors must be trained to use one or 

more specific collection devices for federal agency specimens, the trainer must 

demonstrate a working knowledge of the manufacturer instructions for the specific 

device(s). 

Reference: OFMG (subpart D – section 4.3.a.1-2) and HHS Oral Fluid Collection Handbook

Question B-10. Was documentation of training for each trainer provided for review during 

the inspection? (YES/NO)

If NO, note the trainer(s) with missing training documentation.

Comment: For each staff member performing collector training, the collection site must 

provide training records to the inspectors for review. Inspectors should note any trainers 

with missing training documentation. 

Reference: OFMG (subpart D - section 4.4.c) 

Complete the remaining Section B questions for the records provided.

Question B-11. Does each trainer maintain their training documentation? (YES/NO)

Comment: Each trainer is required to maintain documentation of initial and refresher 

training and present it to a federal agency upon request. The collection site may maintain 

the originals or maintain copies of the training documents. If the collection site provides 

copies for review, the inspectors may request one or more trainers to provide the originals 

during the inspection. 

Reference: OFMG (subpart D - section 4.4.c) 

Question B-12. Do the training records for each collector trainer document at least one of 

the following qualifications? (YES/NO) 
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• The trainer is qualified as a collector and has regularly conducted drug test 

collections for a period of at least one year using the specific collection device(s), 

• The trainer successfully completed a “train the trainer” course given by an 

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

including training on the specific collection device(s) 

Comment: To be qualified as a collector trainer, the individual must be qualified as a 

collector and have regularly conducted drug test collections using the specific device(s) for 

at least one year OR must have completed a “train the trainer” course provided by an 

organization (e.g., manufacturer, private entity, contractor, or federal agency). The 

individual must complete device-specific training to be qualified to train collectors on that 

device. 

Reference: OFMG (subpart D - section 4.4.a.1-2) and HHS Oral Fluid Collection Handbook

Question B-13. Has each trainer (as applicable) completed refresher training at least every 

five years from the date of initial training? (YES/NO) 

Comment: Each collector trainer must undergo refresher training at least every five years. 

Reference: OFMG (subpart D - section 4.4.b)
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Section Evaluation

Question B-14. For the Personnel Section: 

____ Serious deficiencies were identified (0 points)

____ Deficiencies were identified (1 point)

____ No deficiencies were identified (2 points)

Note: This page is included to facilitate the evaluation of compliance with program requirements. The 

inspector/reviewer should explain the potential problem or identified non-compliance associated with 

the checklist questions in this section. Serious deficiencies require immediate corrective action by the 

collection site to maintain the integrity of the collection process, to maintain the security and integrity of 

the specimens collected, and to ensure the privacy of the donors. 

Describe basis for the above selection:
21 

Section C. Specimen Collection Procedures

All specimen collections under the OFMG are to be split specimen collections. The 

OFMG require collection of at least 1 mL of undiluted (neat) oral fluid each for the 

primary (A) specimen and split (B), either simultaneously or serially as follows:

• Two specimens collected simultaneously with two separate collection devices;

• Two specimens collected serially with two separate collection devices (i.e., 

collection of the second specimen must begin within two minutes after 

completion of the first collection);

• Two specimens collected simultaneously using a single collection device that 

directs the oral fluid into two separate collection tubes; or

• A single specimen collected using a single collection device, that is subsequently 

divided into two specimens.

Question C-1. Does the collector prepare the collection site to deter the adulteration or 

substitution of a specimen? (YES/NO) 

Comment: Collectors must prepare the collection site prior to specimen collection to 

deter adulteration or substitution of the specimen. 

Reference: HHS Oral Fluid Mandatory Guidelines (subpart H – section 8.2)

Question C-2. Does the collector begin the collection without delay once the donor 

arrives at the collection site? (YES/NO) 

Comment: The collector must begin the collection procedure once the donor arrives at 

the collection site. The collection process must not be delayed because an authorized 

employer or employer representative is late arriving. 

Reference: OFMG (subpart H – section 8.3.b)

Question C-3. When a donor does not arrive at the collection site at the assigned time 

for the drug test, does the collector contact the federal agency representative to obtain 

guidance on the appropriate action to be taken? (YES/NO) 

Comment: If the donor is required to arrive within a window of time and is outside of 

that window specified by the agency, the collector must contact the federal agency 

representative to obtain guidance on the appropriate action to be taken when a donor 

fails to arrive at the collection site on time.

Reference: OFMG (subpart H – section 8.3.a)
22 

Question C-4. Does the collector perform only one specimen collection at a time? 

(YES/NO)

Comment: To ensure specimen integrity, collectors must perform one collection at a 

time.

Reference: OFMG (subpart E - section 5.5.a.2)

Question C-5. Does the collector properly verify donor identity? (YES/NO)

Proper forms of identification include:

• Driver’s license

• Employee badge issued by the employer

• Photo identification issued by a federal, state, or local government agency

Comment: The collector must verify the identity of the donor by requesting photo 

identification (i.e., driver’s license, employee badge issued by the employer, or other 

photo identification issued by federal, state, or local government) from the donor prior to 

specimen collection. If the donor does not have proper photo identification, the collector 

must contact the supervisor of the donor or the federal agency representative who can 

positively identify the donor. If the identity of the donor cannot be established, the 

collector must stop the collection procedure.

Reference: OFMG (subpart H – section 8.3.c)

Question C-6. Does the collector provide identification to the donor when requested? 

(YES/NO) 

Comment: The collector must provide identification (e.g., employee badge, employee 

list) to the donor if requested.

Reference: OFMG (subpart H – section 8.3.e)

Question C-7. Does the collector describe the basic collection procedures to the donor 

and instruct the donor that they may read the instructions for completing the Federal 

CCF? (YES/NO)

Comment: The collector must describe the basic collection procedures to the donor 

and instruct the donor that they may read the Instructions for Completing the Federal 

CCF for an Oral Fluid Collection. These instructions and the collection device-specific 

instructions must be provided to the donor at the time of the collection (i.e., as a 

hardcopy, onscreen, or posted at the collection site). The collector must also inform the 
23 

donor that these instructions are available upon request. 

When the A and B specimens are collected serially, 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. 

Reference: OFMG (subpart H – section 8.3.f - g) and HHS Oral Fluid Collection 

Handbook (special instructions for serial split collections, page 24)

Question C-8. Does the collector answer any reasonable and appropriate questions 

that the donor has about the collection process? (YES/NO)

Comment: The collector must answer any reasonable and appropriate questions that 

the donor has about the collection process.

Reference: OFMG (subpart H – section 8.3.h) 

Question C-9. Does the collector complete the required information in Step 1 of the 

Federal CCF? (YES/NO)

Comment: The collector must ensure that Step 1 of the Federal CCF is completed prior 

to specimen collection. The employer, Medical Review Officer (MRO), collection site, 

and collector information may be preprinted or handwritten. The collector records the 

information if it is not present. The collector enters the donor identification information 

after verifying donor identity and enters a REMARK in Step 2 if the donor refuses to 

provide his or her social security number (SSN) or employee identification number. The 

collector marks the appropriate checkboxes to indicate the testing authority under which 

the specimen is being collected, the reason for testing, and the drug tests to be 

performed. The collector also marks the ORAL FLUID checkbox below Step 1.

Reference: Instructions for Completing the Federal CCF for Oral Fluid Specimen 

Collection and HHS Oral Fluid Collection Handbook

Question C-10. Does the collector take the following steps to deter specimen 

tampering? (YES/NO)

If NO, check the deficient step(s):

____ a. Ask the donor to open their mouth to allow inspection of the oral cavity 

____ b. Begin 10-minute wait period after inspection of the donor oral cavity 

prior to beginning specimen collection 

____ c. If the donor removes an item from their mouth as instructed, has 

abnormally colored saliva, or indicates they have “dry mouth”, provide 
24 

water to the donor to rinse. Begin 10-minute wait period after donor has 

rinsed their mouth

Comment: The collector must take the steps listed in this question to deter specimen 

tampering. 

The donor is required to open their mouth and allow the collector to fully inspect the oral 

cavity. The oral cavity must be free of any items that could impede or interfere with the 

collection, or could be used to adulterate, substitute, or dilute the specimen. If no such 

items are present, the collector starts the 10-minute wait period before collecting the 

specimen.

If an item is found that indicates that the donor intended to adulterate, substitute, or 

dilute the specimen, this is considered a refusal to test. The collector must stop the 

collection and report the refusal to test to the federal agency by a means ensuring 

immediate receipt (e.g., telephone, email, or secure fax) as described in Question D-9. 

If the collector’s inspection of the donor’s oral cavity reveals any items that could 

impede or interfere with the collection (e.g., candy, gum, food, tobacco, abnormally 

colored saliva) or the donor claims to have “dry mouth”, the collector is required to give 

the donor water (e.g., up to 4 oz) for rinsing . The donor may discard or drink the water 

after rinsing. Once the donor has completed rinsing the oral cavity, the collector starts 

the 10-minute wait period before beginning specimen collection. If the donor refuses to 

remove the item or refuses to rinse, this is considered a refusal to test. The collector 

must stop the collection and report the refusal to test to the federal agency by a means 

ensuring immediate receipt (e.g., telephone, email, or secure fax) as described in 

Question D-9. 

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

for inspection, the collector should record the reason for not collecting an oral fluid 

specimen on the Federal CCF, notify the federal agency’s designated representative for 

authorization of an alternate specimen to be collected, and send the Federal CCF to the 

federal agency’s designated representative. 

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. If either requirement is not met, the collector must discard any collected oral 

fluid and recollect A and B specimens. 

Reference: OFMG (subpart H –section 8.3.d.1-3 and 8.6.b.2) and HHS Oral Fluid 

Collection Handbook (special instructions for serial split collections, page 24)

Question C-11. Does the collector note any unusual appearance or behavior of the 

donor on the Federal CCF? (YES/NO)

Comment: The collector must note any unusual appearance or behavior of the donor 
25 

on the Federal CCF. If the collector detects conduct that indicates an attempt to tamper 

with the specimen (e.g., an attempt to bring into the collection site an adulterant or oral 

fluid substitute), this is considered a refusal to test. The collector must stop the 

collection and report the refusal to test to the federal agency as described in Question

D-9. 

Reference: OFMG (subpart H – section 8.4.c)

Question C-12. Does the collector review the procedures for a successful oral fluid 

specimen collection as detailed in the device-specific manufacturer’s instructions?

(YES/NO)

Comment: The collector must go over the instructions for the specific oral fluid device 

with the donor prior to specimen collection. 

Reference: HHS Oral Fluid Mandatory Guidelines (subpart H – section 8.4.b) and HHS

Oral Fluid Collection Handbook (special instructions for serial split collections, page 24)

Question C-13. Are unauthorized personnel prohibited from entering the collection site 

during the collection procedure? (YES/NO) 

Comment: Only authorized personnel and the donor may be present in the restricted 

access area where the collection takes place. 

Reference: OFMG (subpart E - section 5.5.a.1; subpart H – section 8.1.a)

Question C-14. Are only the collector and the donor allowed to handle the unsealed 

specimen? (YES/NO) 

Comment: The collector must ensure that only the collector and donor handle the 

unsealed specimen.

Reference: OFMG (subpart E - section 5.5.a.4)

 

Question C-15. Does the collector remain present and maintain visual contact with the 

donor during the entire collection process? (YES/NO)

If NO, check the deficient area(s):

____ a. Ensure the donor has positioned the specimen collection device 

properly for collection

____ b. Ensure the collection is performed correctly

____ c. Ensure collection device is working properly

 
26 

Comment: The collector must be present and maintain visual contact with the donor 

during the entire procedure for the collection of the oral fluid specimen. 

Under the observation of the collector, the donor is responsible for the proper 

positioning of the specimen collection device for collection. The collector must ensure 

the collection is performed correctly and that the collection device is working as 

intended.

For devices containing a diluent, the collector should visually inspect the volume of the 

diluent in each tube prior to giving it to the donor to ensure the collection device is not 

defective. 

When two specimens are collected serially, collection of the second specimen must 

begin within two minutes of the completion of the first collection. The collector must take 

actions specified in special instructions for serial split collections described in the HHS 

Specimen Oral Fluid Collection Handbook (page 21).

If there is a failure to collect the specimen, the collector must begin the process again, 

using a new specimen collection device (for both A and B specimens) and notes the 

failed collection attempt on the Federal CCF. If the donor states they are unable to 

provide an oral fluid specimen during the collection process or after multiple failures to 

collect the specimen, the collector follows the procedures outlined in Section 8.6 of the 

OFMG. 

The collector and the donor must complete the collection in accordance with the 

manufacturer instructions for the collection device.

Reference: OFMG (subpart H – section 8.5.a) and HHS Oral Fluid Collection Handbook 

(special instructions for serial split collections, page 21)

Question C-16. Does the collector ensure the donor has provided a sufficient volume of 

oral fluid (e.g., 1 mL of undiluted [neat] oral fluid for tube A and 1 mL of undiluted [neat] 

oral fluid for tube B) for the following types of split specimen collections? (YES/NO)

If NO, check the deficient area(s):

____ a. Two specimens collected simultaneously using two separate collection 

devices

____ b. Two specimens collected serially with two separate collection devices

____ c. Two specimens collected simultaneously using a single collection 

 device that splits the specimen into two separate collection tubes
27 

____ d. A single specimen collected using a single collection device that is 

subdivided into two specimen tubes. 

 

Comment: All oral fluid collections are to be collected as a split specimen (see page 

21). Depending on the agency, a variety of methods of collection can be employed to 

ensure a split specimen is collected. 

A volume of at least 1 mL of undiluted (neat) oral fluid is to be collected for the 

specimen designated as “Tube A” and at least 1 mL of undiluted (neat) oral fluid is to be 

collected for the specimen designated as “Tube B”. 

Reference: OFMG (subpart H – section 8.8.a; section 8.8.a.-b) and HHS Oral Fluid 

Collection Handbook

Question C-17. Does the collector complete the required information in Step 2 of the 

Federal CCF? (YES/NO)

Comment: The collector must complete entries in Step 2 of the Federal CCF. This 

includes marking the checkbox for the Collection type: Split, Single, or None provided 

(with explanatory Remarks) and completing subsequent entries specific to oral fluid 

specimens.

• Split Type: check the appropriate box to document the split specimen type 

(serial, concurrent, or subdivided); 

• Expiration Date: inspect each device before use to ensure it is within its 

expiration date. If each device is within date, check the YES box. If a device is 

out of date, check the NO box and stop the oral fluid collection. 

• Volume Indicator(s) Observed: the collector must verify that sufficient oral fluid 

was collected during the collection as described under Question C-16. 

o For devices with a volume indicator, the collector must observe the 

volume indicator for each device during oral fluid collection, and mark the 

box to document this observation after collection of A and B specimens. 

o For devices without a diluent (neat oral fluid specimens), the collector 

must inspect the markings on the specimen tubes after collection to 

ensure that at least 1 mL of oral fluid was collected for each of the A and 

B specimens.

Note: failure to document the Volume Indicator(s) observed box is a fatal flaw, not 

recoverable after shipment of the specimen to the laboratory.

Reference: Instructions for Completing the Federal CCF for Oral Fluid Specimen 

Collection and HHS Oral Fluid Collection Handbook

Completion of a Collection

Question C-18. Does the collector report a refusal if the donor refuses to complete the 

collection? (YES/NO) 
28 

Comment: If the donor fails to remain present through the completion of the collection, 

fails to follow instructions for the collection device, refuses to begin the collection 

process after a failure to collect the specimen as outlined in question C-15 above, 

refuses to provide a split specimen as instructed by the collector, or refuses to provide 

an authorized alternate specimen, the collector stops the collection and reports the 

refusal to test. 

Reference: OFMG (subpart H – section 8.5.b) 

Question C-19. In the presence of the donor, does the collector place the appropriate 

tamper-evident label/seal from the Federal CCF over the lid/cap of each tube to ensure 

that the lid/cap cannot be removed without destroying the label/seal? (YES/NO) 

Comment: The collector must place the tamper-evident label/seal from the Federal 

CCF over the lid/cap of each tube to ensure that the lid/cap cannot be removed without 

destroying the label/seal. This must be performed in the presence of the donor. The 

“A” label is used for the specimen collected first in a serial collection or the tube 

designated as A while the “B” label is used for the specimen collected second in a serial 

collection or the tube designated as B. 

The label/seal must be positioned such that the expiration date on the tube is not 

covered by the seal and will allow visual assessment of the contents of the tube.

Reference: OFMG (subpart H – section 8.8.c) and HHS Oral Fluid Collection Handbook

Question C-20. If the tamper-evident label/seal does not adhere to the tube or is 

damaged, does the collector apply the unacceptable label/seal to the tube, and apply a 

second, separate tamper-evident seal to seal the specimen tube? (YES/NO)

Comment: In some cases, the tamper-evident label/seal may not adhere to the tube or 

the label/seal may be accidentally broken or damaged during the collection process. In 

these instances, the collector must apply the original (unacceptable) labels/seals and 

apply a second separate tamper-evident seal to each specimen tube. The additional 

seal should be placed perpendicular to the original label/seal to avoid obscuring 

information on the label/seal (e.g., specimen ID number associated with the Federal 

CCF) and avoid obscuring the expiration date on the tubes while allowing visual 

assessment of the tubes’ contents. The collector must initial and date the second seal, 

and request that the donor initial the second seal. If the donor refuses to initial the 

second seal, the collector should note this refusal on the Remarks line in Step 2 and 

continue with the collection process. This is not considered a refusal to test.

The collector should provide a comment on the Remarks line in Step 2 of the Federal 

CCF explaining why a second seal was used.

Reference: HHS Oral Fluid Collection Handbook
29 

Question C-21. Does the collector record the date of the collection on the tube seals 

after placing them on the tubes? (YES/NO)

Comment: The collector must write the date of the collection on the labels/seals after 

placing them on the specimen tubes (i.e., Tube A and Tube B). 

Reference: OFMG (subpart H – section 8.8.c)

Question C-22. Does the collector ask the donor to initial the specimen tube seals after 

placing them on the tubes? (YES/NO) 

Comment: After placing the labels/seals on the tubes, the collector must direct the 

donor to initial the labels/seals taking care to avoid damage. If the donor refuses to 

initial the labels/seals, the collector should note this refusal on the Remarks line in Step 

2 and continue with the collection process. This is not considered a refusal to test.

Reference: OFMG (subpart H – section 8.8.d)

Question C-23. Does the collector instruct the donor to read and sign the donor 

certification statement and to fill out the donor portion in Step 5 on Copy 2 of the 

Federal CCF? (YES/NO) 

Comment: The collector requests that the donor fill out the donor portion in Step 5 on 

Copy 2 of the Federal CCF by printing their name, and providing their email address, 

day and evening telephone numbers, and date of birth. If the donor refuses to provide 

the information, the collector should print the donor’s name where indicated. 

The collector requests that the donor read, sign, and date the donor statement certifying 

that the specimen identified was collected from him or her. If the donor refuses to sign 

the certification statement, the collector should note this refusal on the Remarks line in 

Step 2 of the Federal CCF and continue with the collection process. This is not 

considered a refusal to test. 

For electronic (digital) CCFs or combination electronic and paper CCFs: Some of the 

items (i.e., date of birth, printed name, and telephone numbers) may already have been 

entered in to the ECCF system prior to the collection. If the donor refuses to sign 

electronically, but is willing to sign a paper CCF with a wet signature, the collector must 

print the ECCF, Copies 1-5. The donor must sign in Step 5 of Copies 2-5 using a wet 

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

Reference: OFMG (subpart H – section 8.8.f) and HHS Oral Fluid Collection Handbook

Question C-24. Does the collector complete the collector chain of custody section and 

document device expiration dates (as applicable) in Step 4 on Copy 1 of the Federal 

CCF? (YES/NO)
30 

Comment: The collector must complete Step 4 on Copy 1 of the Federal CCF by 

signing and printing their name, recording the date and time of the collection, and 

indicating the delivery service to which the specimen tubes and CCF will be released. 

The collector must record the manufacturer’s expiration date on each specimen tube in 

Step 4 (i.e., the A specimen tube expiration date as the Primary/Single Specimen 

Device Expiration Date, the B specimen tube expiration date as the Split Specimen 

Device Expiration Date). 

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.

Reference: OFMG (subpart H – section 8.8.g) and HHS Oral Fluid Collection Handbook

Question C-25. Does the collector place the sealed specimen tubes inside the leakresistant container, seal the container, and include Copy 1 in the package with the 

specimen (i.e., in a compartment separate from the specimen tubes)? (YES/NO)

Comment: The collector places both specimen tubes inside the leak-resistant container

and seals the container. 

For paper CCFs and combination electronic and paper CCFs: the collector places Copy 

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

Note: 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 signature.

For electronic (digital) Federal CCFs: the collector must either include a printed copy of 

Copy 1 with the specimen OR must apply a label to the outside of the specimen 

package with the specimen identification number, test facility name and contact 

information, and the collection site name and contact information.

Reference: OFMG (subpart H – section 8.8.h) and HHS Oral Fluid Collection Handbook 

Question C-26. Does the collector provide Copy 5 of the Federal CCF to the donor? 

(YES/NO) 

Comment: The collector gives Copy 5 of the Federal CCF to the donor. This may be a 
31 

printed copy or a copy provided electronically after the collection. The collector reminds 

the donor that they may list any prescription medications on the back of Copy 5 or on a 

separate sheet of paper. This information may help the donor remember which 

medications they may have taken near the time of the collection, if contacted later by 

the MRO. This information must not be recorded on any other copy of the Federal CCF 

or other record maintained or distributed by the collector. 

Reference: HHS Oral Fluid Collection Handbook 

Question C-27. Does the collector prepare the sealed tamper-resistant package

containing the specimen tubes and Federal CCF for transport to the HHS-certified

laboratory? (YES/NO)

Comment: The collector places the sealed specimen package into a shipping container 

(e.g., box or express carrier mailer). Several specimen packages may be placed in one 

shipping container. The collector then seals the container. It is not necessary to use a 

shipping container if the specimen packages are to be hand-delivered to the laboratory. 

Reference: HHS Oral Fluid Collection Handbook

Question C-28. Are the specimen tubes and Federal CCF appropriately safeguarded 

until they are retrieved for transport to the HHS-certified laboratory? (YES/NO) 

Comment: If the specimens are not shipped immediately, the collector is responsible 

for ensuring specimen security. For specimens not in a shipping container, the collector 

must take necessary steps to prevent any possible tampering or access by 

unauthorized personnel. Specimen packages in a sealed shipping container should be 

protected against theft or damage prior to pick-up by the designated delivery service.

Reference: OFMG (subpart E – section 5.2.c and subpart H - section 8.8.i) and HHS

Oral Fluid Collection Handbook 

Question C-29. Does the collector send Copy 2 of the Federal CCF to the Medical 

Review Officer (MRO) and Copy 4 of the Federal CCF to the agency’s designated 

representative after the collection? (YES/NO) 

Comment: The collector must send Copy 2 of the Federal CCF to the MRO and Copy 4 

to the federal agency’s representative as soon as possible once the collection is 

complete (e.g., within 24 hours of the collection or during the next business day). 

Acceptable methods of transmitting the Federal CCF include faxing to a secure fax 

machine, sending a scanned image to a secure computer, or sending by mail or courier.

Reference: HHS Oral Fluid Collection Handbook

Question C-30. Are specimens submitted to an HHS-certified laboratory within 24 

hours after the collection or during the next business day? (YES/NO) 
32 

Comment: Specimens must be submitted to the laboratory within 24 hours after the 

collection or during the next business day.

Reference: OFMG (subpart H – section 8.8.h) and HHS Oral Fluid Collection Handbook
33 

Section Evaluation

Question C-31. For the Specimen Collection Procedures Section: 

____ Serious deficiencies were identified (0 points)

____ Deficiencies were identified (1 point)

____ No deficiencies were identified (2 points)

Note: This page is included to facilitate the evaluation of compliance with program 

requirements. The inspector/reviewer should explain the potential problem or identified noncompliance associated with the checklist questions in this section. Serious deficiencies require 

immediate corrective action by the collection site to maintain the integrity of the collection 

process, to maintain the security and integrity of the specimens collected, and to ensure the 

privacy of the donors. 

Describe basis for the above selection:
34 

Section D. Collection Problems

Insufficient Specimen – Questions D-1 through D-7 pertain to collections where 

the donor states that they are unable to provide an oral fluid specimen.

Question D-1. Does the collector attempt an oral fluid collection in the event the donor 

states they are unable to provide a specimen? (YES/NO) 

Comment: If the donor states they are unable to provide an oral fluid specimen, the 

collector requests that the donor follow the instructions for the specific collection device 

and attempt to provide an oral fluid specimen. 

Reference: OFMG (subpart H – section 8.6.a) 

Question D-2. When the donor has demonstrated that they are unable to provide a 

sufficient specimen, does the collector offer the donor a reasonable amount of fluid to 

drink (e.g., up to 8 ounces of water)? (YES/NO) 

Comment: The collector must begin the collection regardless of whether the donor 

states that they cannot provide a specimen. The collector requests that the donor follow 

the collector instructions and attempt to provide an oral fluid specimen. The donor 

demonstrates their inability to provide a specimen when after 15 minutes of using the 

collection device, there is insufficient volume or no oral fluid collected using the device. 

If the donor indicates that they may be able to provide a specimen if given more time, 

the collector should offer the donor a reasonable amount of fluid to drink (e.g., up to 8 

ounces). The donor is not required to drink fluids during this time period. The collector 

must wait 10 minutes from the time the donor drinks fluids before beginning specimen 

collection. 

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

before the process is completed, this is considered a refusal to test. The collector 

reports the refusal to test as outlined in Question D-9. 

Special instructions for serial split collections: When A and B specimens are 

collected serially, the donor is not allowed to drink or rinse their mouth between the two 

collections. Collection of the second specimen must begin within two minutes of the 

completion of the first collection. See special instructions for serial split collections on 

page 21 of the HHS Oral Fluid Collection Handbook

Reference: OFMG (subpart H – section 8.6.a-b) and HHS Oral Fluid Collection 

Handbook

Question D-3. Does the collector allow the donor up to one hour to provide a sufficient 

specimen? (YES/NO) 
35 

Comment: The collector must allow up to one hour for the donor to provide a sufficient 

specimen. The collector should be sensitive to how frequently the donor is asked to 

provide a specimen. It is recommended that the collector allow sufficient time to only 

have one additional attempt rather than documenting several unsuccessful attempts. 

Reference: OFMG (subpart H – section 8.6.b.1) and HHS Oral Fluid Collection 

Handbook

Question D-4. Does the collector direct the donor to remain in a designated area at the 

collection site during the wait period? (YES/NO)

Comment: During the wait period between collection attempts, the donor must remain

in a designated area at the collection site to prevent the donor from possibly 

compromising the collection process. At a minimum, the donor must remain under the 

direct observation of the collector during the final 10 minutes of the wait period before 

the collection attempt.

Reference: HHS Oral Fluid Collection Handbook

 

Question D-5. Does the collector record each failed collection attempt on the Remarks 

line of the Federal CCF? (YES/NO) 

Comment: The collector must record each collection attempt made by the donor to 

provide a sufficient volume of specimen (e.g., on the Remarks line of the Federal CCF). 

Reference: HHS Oral Fluid Collection Handbook

Question D-6. Does the collector discontinue the collection procedure in the following 

situations? (YES/NO) 

• The donor states that they are unable to provide a specimen

• The donor has not provided sufficient volume of specimen in one hour from 

the time of the donor’s first attempt 

Comment: If the donor states they are unable to provide a specimen or if the donor has 

not provided a sufficient specimen after a one hour wait period from the first attempt, the 

collector is to discontinue the collection. 

Reference: OFMG (subpart H –8.6.b.2) and HHS Oral Fluid Collection Handbook

Question D-7. When the donor has not provided a sufficient specimen, does the 

collector end the collection procedure and take the following steps? (YES/NO) 

If NO, check the deficient area(s):
36 

____ a. Mark the “None Provided” checkbox in Step 2 of the Federal CCF

____ b. Record the reason for not collecting the specimen on the Remarks line 

in Step 2 of the Federal CCF

____ c. Notify the agency’s designated representative for authorization to 

collect an alternate specimen or follow the standard protocol from the 

federal agency

____ d. Discard the oral fluid collected (if any)

____ e. Discard Copy 1 of the Federal CCF (no valid specimen was collected) 

and maintain Copy 3 in the collection records

____ f. Distribute the remaining Federal CCF copies within 24 hours or the next 

business day:

• Send Copy 2 to the MRO

• Send Copy 4 to the federal agency’s designated representative 

Comment: When a donor has not provided a sufficient specimen, the collector must 

follow all steps listed above. If an alternate specimen is authorized, the collector may 

begin the collection procedure for the alternate specimen in accordance with the 

Mandatory Guidelines for Federal Workplace Drug Testing Programs using the alternate 

specimen (i.e., urine). The federal agency may choose to provide the collection site with 

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

designated representative for authorization in each case.

Reference: OFMG (subpart H –8.6.b.1-2) and HHS Oral Fluid Collection Handbook

Refusal to Test

Question D-8. Does the collector report a “refusal to test” in the following situations? 

(YES/NO) 

If NO, check the deficient area(s):

____ a. The donor fails to appear for any test (except a pre-employment test) 

within a reasonable time as determined by the federal agency

____ b. The donor leaves the collection site before completion of the collection 

(except for leaving before the collection has begun for a preemployment test)
37 

____ c. The donor fails to provide a specimen (e.g., oral fluid or another 

authorized alternate specimen type)

____ d. The donor fails to provide a sufficient amount of oral fluid when directed 

and it has been determined through a required medical evaluation that

there is no legitimate medical explanation for the failure 

____ e. The donor fails or declines to participate in an alternate specimen 

collection (e.g., urine) 

____ f. The donor fails to cooperate with any part of the testing process (e.g., 

refuses to empty pockets, disrupts the collection process, fails to rinse 

mouth when directed by the collector, refuses to provide a split 

specimen) 

____ g. The donor brings materials to the collection site for the purpose of 

adulterating, substituting, or diluting the specimen

____ h. The donor attempts to adulterate, substitute, or dilute the specimen 

____ i. The donor admits to the collector that they have adulterated or 

substituted their specimen

Comment: A federal agency will take adverse action against an employee whose drug 

test specimen is reported as a refusal to test. The collector must report a refusal to test 

in the situations listed above. 

Reference: OFMG (subpart A – section 1.7.a.1-10, subpart H – section 8.5b) and HHS 

Oral Fluid Collection Handbook

Question D-9. When reporting a “refusal to test,” does the collector take the following 

steps? (YES/NO) 

If NO, check the deficient step(s):

____ a. Discard the oral fluid collected (if any)

____b. Immediately notify the agency’s designated representative of the refusal 

(e.g., by telephone, secure fax machine, e-mail)

____ c. Document the refusal to test with appropriate comments, signature, and 

date in the Remarks line of Step 2 of the Federal CCF

____ d. Send all copies of the Federal CCF to the federal agency’s designated 

representative
38 

Comment: When reporting a refusal to test, the collector must discard all oral fluid

collected (if any). The collector must immediately notify the federal agency’s designated 

representative by a means (e.g., by telephone, secure fax machine, e-mail) that ensures 

immediate receipt of the refusal notification. The collector must document the refusal to 

test with appropriate comments, signature, and date in the Remarks line of Step 2 of the 

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

representative.

Reference: OFMG (subpart A Section 1.8.b, subpart H - section 8.9)

Collector Errors

Question D-10. When the collector realizes that an incorrect or expired Federal CCF 

was used prior to packaging the specimen tubes, does the collector document on the 

form that the specimen is a federal agency specimen and provide the reason for the 

incorrect form? (YES/NO)

Comment: If an incorrect or expired Federal CCF is used, the collector must document 

on the form that the specimen is a federal agency specimen and provide the reason for 

the incorrect form. The collector must include all collection information required on the 

current Federal CCF for that specimen type (e.g., observation of volume indicators for 

an oral fluid collection device with diluent). Based on the documentation provided by the

collector, the testing facility will handle and test the specimen as a federal agency 

specimen.

Note: The collector may document the reason for using the incorrect form on an MFR 

attached to the form.

Reference: OFMG (subpart E – section 6.2.a-b) and HHS Oral Fluid Collection 

Handbook

Question D-11. Does the collector provide a memorandum for the record (MFR) when 

requested by the HHS-certified laboratory or MRO? (YES/NO)

Comment: The collector must take immediate steps to provide an MFR to the

laboratory, or MRO when notified of an error. 

There are three categories of collector errors:

• Fatal flaws that result in a laboratory rejecting a specimen or an MRO cancelling a 

test, 

• Correctable flaws that result in a laboratory rejecting a specimen or an MRO 

cancelling a test unless the flaw is corrected by an MFR from the collector, or 

• Omissions and discrepancies on the Federal CCF that do not require rejection by 

the laboratory or cancellation by the MRO 
39 

Note: Federal agencies will investigate reported collection site deficiencies (e.g., 

specimens rejected for testing due to collector errors).

Reference: OFMG (subpart E – section 6.2.c) and HHS Oral Fluid Collection Handbook 
40 

Section Evaluation

Question D-12. For the Collection Problems Section:

____ Serious deficiencies were identified (0 points)

____ Deficiencies were identified (1 point)

____ No deficiencies were identified (2 points)

Note: This page is included to facilitate the evaluation of compliance with program 

requirements. The inspector/reviewer should explain the potential problem or identified noncompliance associated with the checklist questions in this section. Serious deficiencies require 

immediate corrective action by the collection site to maintain the integrity of the collection 

process, to maintain the security and integrity of the specimens collected, and to ensure the 

privacy of the donors. 

Describe basis for the above selection:
41 

Section E. Collection Site Records

Question E-1. Are collection site records including Copy 3 of the Federal Custody and 

Control Form (Federal CCF) stored for a minimum of two years? (YES/NO) 

Comment: The collector or collector’s employer must maintain collection site records 

(e.g., Copy 3 of the Federal CCF) for a minimum of two years. 

Reference: OFMG (subpart E - section 5.4)

Question E-2. Are collection site records stored and disposed of in a manner that 

ensures donor confidentiality? (YES/NO) 

Comment: The collection site must have the ability to store records securely. Records 

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

Reference: OFMG (subpart E - section 5.3) and HHS Oral Fluid Collection Handbook 

Question E-3. Have collectors properly completed the Federal CCF? (YES/NO)

Comment: The collector is responsible for completing Steps 1, 2, and 4 on the Federal 

CCF. 

Reference: HHS Oral Fluid Collection Handbook

Question E-4. Are edits to the Federal CCF properly made, initialed, and dated? 

(YES/NO)

Comment: The Federal CCF is a forensic document and will be part of the litigation 

package if a specimen comes under legal challenge. 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 identification 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 single line through the erroneous information, leaving the 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 cross 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.
42 

Reference: HHS Oral Fluid Collection Handbook
43 

Section Evaluation

E-5. For the Collection Site Records Section:

____ Serious deficiencies were identified (0 points)

____ Deficiencies were identified (1 point)

____ No deficiencies were identified (2 points)

Note: This page is included to facilitate the evaluation of compliance with program 

requirements. The inspector/reviewer should explain the potential problem or identified noncompliance associated with the checklist questions in this section. Serious deficiencies require 

immediate corrective action by the collection site to maintain the integrity of the collection 

process, to maintain the security and integrity of the specimens collected, and to ensure the 

privacy of the donors. 

Describe basis for the above selection:
44 

Collection Site Evaluation Form

Overall Section Summary

Checklist Sections

Serious 

Deficiencies 

Identified (0)

Deficiencies 

Identified (1)

No 

Deficiencies 

Identified (2)

A. Collection Site

B. Personnel

C. Specimen Collection

Procedures

D. Collection Problems

E. Collection Site

Records

Overall Summary of Serious Deficiencies

(List Sections)

Section

Serious Deficiencies 

were identified

No Serious Deficiencies 

were identified

Inspector / Collection 

Site Reviewer

Federal Agency/ 

Designee 

Inspection Outcome

Rating (out of 10) Acceptable: rating ≥ 5 and no more than one section 

with serious deficiencies

Unacceptable: rating < 5 or more than one section with 

serious deficiencies

Inspector / Collection 

Site Reviewer /10

Federal Agency/ 

Designee /10 Outcome:

Additional Comments:

Acceptable Outcome for Inspection: Yes ______ No _______

Self-Evaluation by: Date:

Onsite Inspection by: Date:

Approved by: Date:

Position/Title:
45 

Attachment 1: OFMG Subparts D-H 

Subpart D—Collectors

4.1 Who may collect a specimen?

4.2 Who may not collect a specimen?

4.3 What are the requirements to be a collector?

4.4 What are the requirements to be a trainer for collectors?

4.5 What must a federal agency do before an individual is permitted to collect a 

specimen?

Subpart E—Collection Sites

5.1 Where can a collection for a drug test take place?

5.2 What are the requirements for a collection site?

5.3 Where must collection site records be stored?

5.4 How long must collection site records be stored?

5.5 How does the collector ensure the security and integrity of a specimen at the 

collection site?

5.6 What are the privacy requirements when collecting an oral fluid specimen?

Subpart F—Federal Drug Testing Custody and Control Form

6.1 What federal form is used to document custody and control? 

6.2 What happens if the correct OMB-approved Federal CCF is not available or is 

not used?

Subpart G—Oral Fluid Specimen Collection Devices

7.1 What is used to collect an oral fluid specimen?

7.2 What are the requirements for an oral fluid collection device?

7.3 What are minimum performance requirements for a collection device? 

Subpart H—Oral Fluid Specimen Collection Procedure

8.1 What privacy must the donor be given when providing an oral fluid specimen?

8.2 What must the collector ensure at the collection site before starting an oral fluid

specimen collection?

8.3 What are the preliminary steps in the oral fluid specimen collection procedure? 

8.4 What steps does the collector take in the collection procedure before the donor 

provides an oral fluid specimen?

8.5 What steps does the collector take during and after the oral fluid specimen 

collection procedure?

8.6 What procedure is used when the donor states that they are unable to provide an 

oral fluid specimen?

8.7 If the donor is unable to provide an oral fluid specimen, may another specimen 

type be collected for testing? 

8.8 How does the collector prepare the oral fluid specimens?

8.9 How does the collector report a donor's refusal to test?

8.10 What are a federal agency's responsibilities for a collection site?
46 

Subpart D - Collectors

Section 4.1 Who may collect a specimen?

(a) A collector who has been trained to collect oral fluid specimens in accordance 

with these Guidelines and the manufacturer’s procedures for the collection device.

(b) The immediate supervisor of a federal employee donor may only collect that 

donor’s specimen when no other collector is available. The supervisor must be a trained 

collector.

(c) The hiring official of a federal agency applicant may only collect that federal

agency applicant’s specimen when no other collector is available. The hiring official 

must be a trained collector.

Section 4.2 Who may not collect a specimen?

(a) A federal agency employee who is in a testing designated position and 

subject to the federal agency drug testing rules must not be a collector for co-workers in 

the same testing pool or who work together with that employee on a daily basis.

(b) A federal agency applicant or employee must not collect their own drug 

testing specimen. 

(c) An employee working for an HHS-certified laboratory must not act as a 

collector if the employee could link the identity of the donor to the donor’s drug test 

result.

(d) To avoid a potential conflict of interest, a collector must not be related to the 

employee (e.g., spouse, ex-spouse, relative) or a close personal friend (e.g., fiancée). 

Section 4.3 What are the requirements to be a collector?

(a) An individual may serve as a collector if they fulfill the following conditions: 

(1) Is knowledgeable about the collection procedure described in these 

Guidelines;

(2) Is knowledgeable about any guidance provided by the federal agency’s DrugFree Workplace Program and additional information provided by the Secretary relating 

to these Guidelines;

(3) Is trained and qualified to use the specific oral fluid collection device. Training 

must include the following: 

(i) All steps necessary to complete an oral fluid collection; 

(ii) Completion and distribution of the Federal CCF;

(iii) Problem collections;

(iv) Fatal flaws, correctable flaws, and how to correct problems in collections; and

(v) The collector’s responsibility for maintaining the integrity of the collection 

process, ensuring the privacy of the donor, ensuring the security of the specimen, and 

avoiding conduct or statements that could be viewed as offensive or inappropriate.

(4) Has demonstrated proficiency in collections by completing five consecutive 

error-free mock collections.

(i) The five mock collections must 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.

(ii) A qualified trainer for collectors must monitor and evaluate the individual 
47 

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) A trained collector must complete refresher training at least every five years 

that includes the requirements in paragraph (a) of this section. 

(c) The collector must maintain the documentation of their training and provide 

that documentation to a federal agency when requested.

(d) An individual may not collect specimens for a federal agency until the 

individual’s training as a collector has been properly documented.

Section 4.4 What are the requirements to be a trainer for collectors?

(a) Individuals are considered qualified trainers for collectors for a specific oral 

fluid collection device and may train others to collect oral fluid specimens using that 

collection device when they have completed the following: 

(1) Qualified as a trained collector and regularly conducted oral fluid drug test 

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

(2) Completed a “train the trainer” course given by an organization (e.g., 

manufacturer, private entity, contractor, federal agency).

(b) A qualified trainer for collectors must complete refresher training at least 

every five years in accordance with the collector requirements in Section 4.3(a). 

(c) A qualified trainer for collectors must maintain the documentation of the 

trainer’s training and provide that documentation to a federal agency when requested.

Section 4.5 What must a federal agency do before a collector is permitted to collect a 

specimen?

A federal agency must ensure the following: 

(a) The collector has satisfied the requirements described in Section 4.3;

(b) The collector, who may be self-employed, or an organization (e.g., third party 

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

agency that employs its own collectors) maintains a copy of the training record(s); and 

(c) The collector has been provided the name and telephone number of the 

federal agency representative.

Subpart E - Collection Sites

Section 5.1 Where can a collection for a drug test take place?

(a) A collection site may be a permanent or temporary facility located either at the 

work site or at a remote site.

(b) In the event that an agency-designated collection site is not accessible and 

there is an immediate requirement to collect an oral fluid specimen (e.g., an accident 

investigation), another site may be used for the collection, providing the collection is 

performed by the collector who has been trained to collect oral fluid specimens in 

accordance with these Guidelines and the manufacturer’s procedures for the collection 

device. 

Section 5.2 What are the requirements for a collection site?
48 

The facility used as a collection site must have the following:

(a) Provisions to ensure donor privacy during the collection (as described in 

Section 8.1);

(b) A suitable and clean surface area that is not accessible to the donor for 

handling the specimens and completing the required paperwork;

(c) A secure temporary storage area to maintain specimens until the specimen is 

transferred to an HHS-certified laboratory;

(d) A restricted access area where only authorized personnel may be present 

during the collection;

(e) A restricted access area for the storage of collection supplies; and

(f) The ability to store records securely. 

Section 5.3 Where must collection site records be stored?

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

or the collector’s employer.

Section 5.4 How long must collection site records be stored?

Collection site records (e.g., collector copies of the OMB-approved Federal CCF) 

must be stored securely for a minimum of 2 years. The collection site may convert 

hardcopy records to electronic records for storage and discard the hardcopy records 

after 6 months. 

 

Section 5.5 How does the collector ensure the security and integrity of a specimen at 

the collection site?

(a) A collector must do the following to maintain the security and integrity of a 

specimen:

(1) Not allow unauthorized personnel to enter the collection area during the 

collection procedure;

(2) Perform only one donor collection at a time;

(3) Restrict access to collection supplies before, during and after collection;

(4) Ensure that only the collector and the donor are allowed to handle the 

unsealed specimen;

(5) Ensure the chain of custody process is maintained and documented 

throughout the entire collection, storage, and transport procedures; 

(6) Ensure that the Federal CCF is completed and distributed as required; and

(7) Ensure that specimens transported to an HHS-certified laboratory are sealed 

and placed in transport containers designed to minimize the possibility of damage 

during shipment (e.g., specimen boxes, padded mailers, or other suitable shipping 

container), and those containers are securely sealed to eliminate the possibility of 

undetected tampering;

(b) Couriers, express carriers, and postal service personnel are not required to 

document chain of custody since specimens are sealed in packages that would indicate 

tampering during transit to the HHS-certified laboratory. 

Section 5.6 What are the privacy requirements when collecting an oral fluid specimen?

Collections must be performed at a site that provides reasonable privacy (as 

described in Section 8.1).
49 

Subpart F - Federal Drug Testing Custody and Control Form

Section 6.1 What federal form is used to document custody and control? 

The OMB-approved Federal CCF must be used to document custody and control

of each specimen at the collection site.

Section 6.2 What happens if the correct OMB-approved Federal CCF is not available 

or is not used?

(a) The use of a non-federal CCF or an expired Federal CCF is not, by itself, a 

reason for the HHS-certified laboratory to automatically reject the specimen for testing 

or for the MRO to cancel the test. 

(b) If the collector does not use the correct OMB-approved Federal CCF, the 

collector must document that it is a federal agency specimen collection and provide the 

reason that the incorrect form was used. Based on the information provided by the 

collector, the HHS-certified laboratory or IITF must handle and test the specimen as a 

federal agency specimen. 

(c) If the HHS-certified laboratory or MRO discovers that the collector used an 

incorrect form, the laboratory or MRO must obtain a memorandum for the record from 

the collector describing the reason the incorrect form was used. If a memorandum for 

the record cannot be obtained, the laboratory or IITF reports a rejected for testing result 

to the MRO and the MRO cancels the test. The HHS-certified laboratory or IITF must 

wait at least 5 business days while attempting to obtain the memorandum before 

reporting a rejected for testing result to the MRO. 

Subpart G – Oral Fluid Specimen Collection Devices

Section 7.1 What is used to collect an oral fluid specimen?

An FDA-cleared single-use collection device intended to collect an oral fluid 

specimen must be used. This collection device must maintain the integrity of such 

specimens during storage and transport so that the specimen contained therein can be 

tested in an HHS-certified laboratory for the presence of drugs or their metabolites. 

Section 7.2 What are the requirements for an oral fluid collection device? 

An oral fluid specimen collection device must provide: 

(a) An indicator that demonstrates the adequacy of the volume of oral fluid 

specimen collected;

(b) A sealable, non-leaking container that maintains the integrity of the specimen 

during storage and transport so that the specimen contained therein can be tested in an 

HHS-certified laboratory for the presence of drugs or their metabolites; 

(c) Components that ensure pre-analytical drug and/or drug metabolite stability; 

and

(d) Components that do not substantially affect the composition of drugs and/or 

drug metabolites in the oral fluid specimen. 

Section 7.3 What are the minimum performance requirements for a collection device? 
50 

An oral fluid collection device must meet the following minimum performance 

requirements:

(a) Reliable collection of a minimum of 1 mL of undiluted (neat) oral fluid;

(b) If the collection device contains a diluent (or other component, process, or 

method that modifies the volume of the testable specimen): 

(1) The volume of oral fluid collected should be at least 1.0 mL±10 percent, and

(2) The volume of diluent in the device should be within ±2.5 percent of the 

diluent target volume;

(c) 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

(d) Recover ≥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 (see Section 

3.4)

Subpart H - Oral Fluid Specimen Collection Procedure

Section 8.1 What privacy must the donor be given when providing an oral fluid

specimen?

The following privacy requirements apply when a donor is providing an oral fluid

specimen:

(a) Only authorized personnel and the donor may be present in the restricted 

access area where the collection takes place. 

(b) The collector is not required to be the same gender as the donor. 

Section 8.2 What must the collector ensure at the collection site before starting an oral 

fluid specimen collection?

The collector must deter the adulteration or substitution of an oral fluid specimen 

at the collection site. 

 

Section 8.3 What are the preliminary steps in the oral fluid specimen collection 

procedure? 

The collector must take the following steps before beginning an oral fluid

specimen collection: 

(a) If a donor fails to arrive at the collection site at the assigned time, the collector 

must follow the federal agency policy or contact the federal agency representative to 

obtain guidance on action to be taken. 

(b) When the donor arrives at the collection site, the collector should begin the 

collection procedure without undue delay. For example, the collection should not be

delayed because an authorized employer or employer representative is late in arriving. 

(c) The collector requests the donor to present photo identification (e.g., driver’s

license; employee badge issued by the employer; an alternative photo identification 

issued by a federal, state, or local government agency). If the donor does not have 

proper photo identification, the collector shall contact the supervisor of the donor or the 

federal agency representative who can positively identify the donor. If the donor’s

identity cannot be established, the collector must not proceed with the collection.

 (d) The collector requests that the donor open the donor’s mouth, and the 
51 

collector inspects the oral cavity to ensure that it is free of any items that could impede 

or interfere with the collection of an oral fluid specimen (e.g., candy, gum, food, 

tobacco) or could be used to adulterate, substitute, or dilute the specimen. If an item is 

present that appears to have been brought to the collection site with the intent to 

adulterate, substitute, or dilute the specimen, this is considered a refusal to test. The 

collector must stop the collection and report the refusal to test as described in Section 

8.9. 

(1) At this time, the collector starts the 10-minute wait period and proceeds with 

the steps below before beginning the specimen collection as described in Section 8.5.

(2) If the collector’s inspection of the donor’s oral cavity reveals any items that 

could impede or interfere with the collection of an oral fluid specimen (including 

abnormally colored saliva), or the donor claims to have “dry mouth,” the collector gives 

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

The collector must then wait 10 minutes before beginning the specimen collection. If the 

donor refuses to remove the item or refuses to rinse, this is a refusal to test.

(3) If the donor claims that they have a medical condition that prevents opening 

their mouth for inspection, the collector follows the procedure in Section 8.6(b)(2).

 (e) The collector must provide identification (e.g., employee badge, employee 

list) if requested by the donor. 

(f) The collector explains the basic collection procedure to the donor.

(g) The collector informs the donor that the instructions for completing the 

Federal Custody and Control Form are located on the back of the Federal CCF or 

available upon request. 

(h) The collector answers any reasonable and appropriate questions the donor 

may have regarding the collection procedure. 

Section 8.4 What steps does the collector take in the collection procedure before the 

donor provides an oral fluid specimen? 

(a) The collector will provide or the donor may select a specimen collection 

device that is clean, unused, and wrapped/sealed in original packaging. The specimen 

collection device will be opened in view of the donor. 

(1) Both the donor and the collector must keep the unwrapped collection devices 

in view at all times until each collection device containing the donor’s oral fluid specimen 

has been sealed and labeled. 

(b)The collector reviews with the donor the procedures required for a successful 

oral fluid specimen collection as stated in the manufacturer’s instructions for the 

specimen collection device.

(c) The collector notes any unusual behavior or appearance of the donor on the 

Federal CCF. If the collector detects any conduct that clearly indicates an attempt to 

tamper with a specimen (e.g., an attempt to bring into the collection site an adulterant or 

oral fluid substitute), the collector must report a refusal to test in accordance with 

Section 8.9.

 

Section 8.5 What steps does the collector take during and after the oral fluid specimen

collection procedure? 

Integrity and Identity of the Specimen. The collector must take the following steps 

during and after the donor provides the oral fluid specimen: 

(a) The collector shall be present and maintain visual contact with the donor 

during the procedures outlined in this section.
52 

(1) Under the observation of the collector, the donor is responsible for

positioning the specimen collection device for collection. The collector must ensure the

collection is performed correctly and that the collection device is working properly. If 

there is a failure to collect the specimen, the collector must begin the process again, 

beginning with Step 8.4(b), using a new specimen collection device (for both A and B 

specimens) and notes the failed collection attempt on the Federal CCF. If the donor 

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

process or after multiple failures to collect the specimen, the collector follows the 

procedure in Section 8.6.

(2) The donor and collector must complete the collection in accordance with the 

manufacturer instructions for the collection device.

(b) If the donor fails to remain present through the completion of the collection, 

fails to follow instructions for the collection device, refuses to begin the collection 

process after a failure to collect the specimen as required in step (a)(1) above, refuses 

to provide a split specimen as instructed by the collector, or refuses to provide an 

alternate specimen as authorized in Section 8.6, the collector stops the collection and 

reports the refusal to test in accordance with Section 8.9. 

Section 8.6 What procedure is used when the donor states that they are unable to 

provide an oral fluid specimen?

(a) If the donor states that they are unable to provide an oral fluid specimen 

during the collection process, the collector requests that the donor follow the collector 

instructions and attempt to provide an oral fluid specimen. 

(b) The donor demonstrates their inability to provide a specimen when after 15 

minutes of using the collection device, there is insufficient volume or no oral fluid 

collected using the device. 

(1) If the donor states that they could provide a specimen after drinking some 

fluids, the collector gives the donor a drink (up to 8 oz) and waits an additional 10 

minutes before beginning the specimen collection (a period of 1 hour must be provided 

or until the donor has provided a sufficient oral fluid specimen). If the donor simply 

needs more time before attempting to provide an oral fluid specimen, the donor is not 

required to drink any fluids during the 1 hour wait time. The collector must inform the 

donor that the donor must remain at the collection site (i.e., in an area designated by the 

collector) during the wait period. 

(2) If the donor states that they are unable to provide an oral fluid specimen, the 

collector records the reason for not collecting an oral fluid specimen on the Federal 

CCF, notifies the federal agency’s designated representative for authorization of an 

alternate specimen to be collected, and sends the appropriate copies of the Federal 

CCF to the MRO and to the federal agency’s designated representative. The federal 

agency may choose to provide the collection site with a standard protocol to follow in 

lieu of requiring the collector to notify the agency’s designated representative for 

authorization in each case. If an alternate specimen is authorized, the collector may 

begin the collection procedure for the alternate specimen (see Section 8.7) in 

accordance with the Mandatory Guidelines for Federal Workplace Drug Testing 

Programs using the alternative specimen.

Section 8.7 If the donor is unable to provide an oral fluid specimen, may another 

specimen type be collected for testing?
53 

Yes, if the alternate specimen type is authorized by Mandatory Guidelines for 

Federal Workplace Drug Testing Programs and specifically authorized by the federal 

agency. 

Section 8.8 How does the collector prepare the oral fluid specimens?

(a) All federal agency collections are to be split specimen collections. 

An oral fluid split specimen collection may be: 

(1) Two specimens collected simultaneously with two separate collection 

devices;

(2) Two specimens collected serially with two separate collection devices. The 

donor is not allowed to drink or rinse their mouth between the two collections. Collection 

of the second specimen must begin within two minutes after the completion of the first 

collection and recorded on the Federal CCF;

(3) Two specimens collected simultaneously using a single collection device that 

directs the oral fluid into two separate collection tubes; or

(4) A single specimen collected using a single collection device, that is 

subsequently subdivided into two specimens. 

(b) A volume of at least 1 mL of undiluted (neat) oral fluid is collected for the 

specimen designated as “Tube A” and a volume of at least 1 mL of undiluted (neat) oral 

fluid is collected for the specimen designated as “Tube B”. 

(c) In the presence of the donor, the collector places a tamper-evident label/seal 

from the Federal CCF over the cap of each specimen tube. The collector records the 

date of the collection on the tamper-evident labels/seals.

(d) The collector instructs the donor to initial the tamper-evident labels/seals on 

each specimen tube. If the donor refuses to initial the labels/seals, the collector notes 

the refusal on the Federal CCF and continues with the collection process.

(e) The collector must ensure that all the information required on the Federal 

CCF is provided.

 (f) The collector asks the donor to read and sign a statement on the Federal CCF 

certifying that the specimens identified were collected from the donor. If the donor 

refuses to sign the certification statement, the collector notes the refusal on the Federal 

CCF and continues with the collection process.

(g) The collector signs and prints their name on the Federal CCF, completes the 

Federal CCF, and distributes the copies of the Federal CCF as required.

(h) The collector seals the specimens (Tube A and Tube B) in a package and, 

within 24 hours or during the next business day, sends them to the HHS-certified 

laboratory that will be testing the Tube A oral fluid specimen. 

(i) If the specimen and Federal CCF are not immediately transported to an HHScertified laboratory, they must remain under direct control of the collector or be 

appropriately secured under proper specimen storage conditions until transported. 

Section 8.9 How does the collector report a donor’s refusal to test?

If there is a refusal to test as defined in Section 1.7, the collector stops the 

collection, discards any oral fluid specimen collected and reports the refusal to test by:

(a) Notifying the federal agency by means (e.g., telephone, e-mail, or secure fax) 

that ensures that the notification is immediately received,

(b) Documenting the refusal to test on the Federal CCF, and

(c) Sending all copies of the Federal CCF to the federal agency’s designated 

representative.
54 

Section 8.10 What are a federal agency’s responsibilities for a collection site?

(a) A federal agency must ensure that collectors and collection sites satisfy all 

requirements in subparts D, E, F, G, and H.

(b) A federal agency (or only one federal agency when several agencies are 

using the same collection site) must inspect 5 percent or up to a maximum of 50 

collection sites each year, selected randomly from those sites used to collect agency 

specimens (e.g., virtual, onsite, or self-evaluation).

(c) A federal agency must investigate reported collection site deficiencies (e.g., 

specimens reported “rejected for testing” by an HHS-certified laboratory) and take

appropriate action which may include a collection site self-assessment (i.e., using the 

Collection Site Checklist for the Collection of Oral Fluid Specimens for Federal Agency 

Workplace Drug Testing Programs) or an inspection of the collection site. The 

inspections of these additional collection sites may be included in the 5 percent or 

maximum of 50 collection sites inspected annually.