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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 Urine Specimens for

Federal Agency Workplace Drug Testing Programs

Effective February 2024

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 (88 FR 70768) dated

October 12, 2023 (effective February 1, 2024). This manual does not apply to specimens 

submitted for testing under U.S. Department of Transportation (DOT) Procedures for 

Transportation Workplace Drug and Alcohol Testing Programs (49 CFR Part 40).

Previous Versions of this Manual are Obsolete
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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............................................................................................................................................ 5

Introduction ........................................................................................................................................... 6

Federal Custody and Control Form (Federal CCF).................................................................. 6

Collection Site Manual Instructions ...................................................................................................... 7

Guidance and Information ........................................................................................................ 7

Terms and Definitions............................................................................................................... 8

Checklist.................................................................................................................................... 8

Section Evaluation .................................................................................................................... 8

Collection Site Evaluation Form ............................................................................................... 8

Inspector/Collection Site Reviewer........................................................................................... 9

Federal Agency Reviewer....................................................................................................... 10

Definitions ........................................................................................................................................... 11

Section A. Collection Site ................................................................................................................... 13

Collection Site ......................................................................................................................... 13

Section Evaluation .................................................................................................................. 17

Section B. Personnel .......................................................................................................................... 18

Collectors ................................................................................................................................ 18

Collector Trainers.................................................................................................................... 21

Section Evaluation .................................................................................................................. 23

Section C. Specimen Collection Procedures...................................................................................... 24

Section Evaluation .................................................................................................................. 38

Section D. Collection Problems .......................................................................................................... 39

Direct Observed Collections ................................................................................................... 39

Monitored Collections ............................................................................................................. 42

Insufficient Specimen.............................................................................................................. 43

Refusal to Test........................................................................................................................ 46

Collector Errors ....................................................................................................................... 48

Section Evaluation .................................................................................................................. 49

Section E. Collection Site Records..................................................................................................... 50

Section Evaluation .................................................................................................................. 52

Collection Site Evaluation Form ......................................................................................................... 53

Attachment 1: UrMG Subparts D-H .................................................................................................... 54

Subpart D - Collectors ............................................................................................................ 54

Subpart E - Collection Sites.................................................................................................... 54

Subpart F - Federal Drug Testing Custody and Control Form............................................... 54

Subpart G – Urine Specimen Collection Containers and Bottles .......................................... 54

Subpart H - Urine Specimen Collection Procedure................................................................ 54

Subpart D - Collectors ............................................................................................................ 55

Section 4.1 Who may collect a specimen? .............................................................. 55

Section 4.2 Who may not collect a specimen? ........................................................ 56

Section 4.3 What are the requirements to be a collector?....................................... 56

Section 4.4 What are the requirements to be an observer for a direct 

observed collection? ....................................................................................... 57

Section 4.5 What are the requirements to be a trainer for collectors? .................... 58

Section 4.6 What must a Federal agency do before a collector is permitted 

to collect a specimen? .................................................................................... 58

Subpart E - Collection Sites.................................................................................................... 58

Section 5.1 Where can a collection for a drug test take place?............................... 58

Section 5.2 What are the requirements for a collection site? .................................. 59

Section 5.3 Where must collection site records be stored?..................................... 59
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Section 5.4 How long must collection site records be stored? ................................ 59

Section 5.5 How does the collector ensure the security and integrity of a 

specimen at the collection site?...................................................................... 59

Section 5.6 What are the privacy requirements when collecting a urine 

specimen?....................................................................................................... 60

Subpart F - Federal Drug Testing Custody and Control Form............................................... 60

Section 6.1 What Federal form is used to document custody and control?............ 60

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

available or is not used?................................................................................. 60

Subpart G – Urine Specimen Collection Containers and Bottles .......................................... 61

Section 7.1 What is used to collect a urine specimen? ........................................... 61

Section 7.2 What are the requirements for a urine collection container and 

specimen bottles?........................................................................................... 61

Section 7.3 What are the minimum performance requirements for a urine 

collection container and specimen bottles? ................................................... 61

Subpart H - Urine Specimen Collection Procedure................................................................ 62

Section 8.1 What privacy must the donor be given when providing a urine 

specimen?....................................................................................................... 62

Section 8.2 What must the collector ensure at the collection site before 

starting a urine specimen collection? ............................................................. 62

Section 8.3 What are the preliminary steps in the urine specimen collection 

procedure?...................................................................................................... 63

Section 8.4 What steps does the collector take in the collection procedure 

before the donor provides a urine specimen?................................................ 64

Section 8.5 What steps does the collector take during and after the urine 

specimen collection procedure?..................................................................... 65

Section 8.6 What procedure is used when the donor states that they are 

unable to provide a urine specimen? ............................................................. 67

Section 8.7 If the donor is unable to provide a urine specimen, may another 

specimen type be collected for testing? ......................................................... 68

Section 8.8 How does the collector prepare the urine specimens?....................... 68

Section 8.9 When is a direct observed collection conducted? .............................. 69

Section 8.10 How is a direct observed collection conducted?................................. 70

Section 8.11 When is a monitored collection conducted? ....................................... 71

Section 8.12 How is a monitored collection conducted? ......................................... 71

Section 8.13 How does the collector report a donor’s refusal to test?.................... 72

Section 8.14 What are a Federal agency’s responsibilities for a collection 

site?................................................................................................................. 73
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References

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

1. Federal Custody and Control Form (Federal CCF)

2. HHS Urine Specimen Collection Handbook for Federal Agency Workplace 

Drug Testing Programs (HHS Urine Collection Handbook)

3. Mandatory Guidelines for Federal Workplace Drug Testing Programs (UrMG). 

Published October 12, 2023 (88 FR 70768), effective February 1, 2024. 
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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 federally regulated workplace drug testing. SAMHSA certifies two 

types of test facilities: laboratories and instrumented initial test facilities (IITFs). IITFs are 

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

Urine specimens must be collected in accordance with the Mandatory Guidelines for 

Federal Workplace Drug Testing Programs (UrMG) published on October 12, 2023

(effective February 1, 2024) and must be tested at an HHS-certified laboratory or an HHScertified IITF. 

This Collection Site Manual provides explanatory comments and references for each 

question included in the Collection Site Checklist for Collection of Urine 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 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 documentation 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, a digital form, or in a 

combination electronic and paper format. Before an HHS-certified test facility may use an 

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

specimens, the test facility must be approved to use that ECCF system by SAMHSA, 

through the National Laboratory Certification Program (NLCP).
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OMB approved the use of the 2023 Federal CCF as of May 1, 2023, for urine and oral fluid 

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

associated with the 2023 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 oral fluid specimens) are on the SAMHSA website: 

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

 

Notes for Expired CCFs for Urine Specimens: 

• The 2023 Federal CCF is the same as the expired 2020 Federal CCF. Therefore, 

use of the 2020 Federal CCF is approved for federally regulated specimens.

If a regulated urine specimen is received at a laboratory accompanied by the 2017 Federal 

CCF, the specimen may be rejected. See UrMG section 6.2 regarding the use of an 

incorrect CCF for a urine 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 (UrMG) published on October 12, 2023 (effective February 1, 2024). 

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 Urine Specimens for Federal Agency Workplace Drug Testing Programs and 

the HHS Urine Specimen Collection Handbook. 

Guidance and Information 

To use this manual, you will need: 

• Mandatory Guidelines for Federal Workplace Drug Testing Programs (UrMG) 

published on October 12, 2023 (effective February 1, 2024) 

• HHS Urine Specimen Collection Handbook for Federal Agency Workplace Drug 

Testing Programs (HHS Urine Collection Handbook) 
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• Guidance provided by the Federal agency’s drug-free workplace program or by 

HHS relating to regulated urine 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 UrMG section(s) referenced 

for each question, and (3) understand the Federal agency policy. 

Checklist 

Each question in the Collection Site Checklist for Collection of Urine Specimens for Federal 

Agency Workplace Drug Testing Programs is designed to address the requirements in HHS 

Mandatory Guidelines 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.

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. 
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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 “Self-Evaluation by” 

line.
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Federal Agency Reviewer

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

site personnel (for self-evaluations). 

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. 
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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 a normal constituent (e.g., nitrite in urine). 

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 Documents: Forms 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 site: The location where specimens are collected. 

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

Dilute Specimen: A urine specimen with creatinine and specific gravity values that are 

lower than expected but are still within the physiologically producible ranges of human 

urine.

Federal Drug Testing Custody and Control Form (Federal 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).

Gender Identity: Gender identity means an individual’s internal sense of being male or 

female, which may be different from an individual’s sex assigned at birth.

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.
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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. 

Specimen: Fluid or material collected from a donor at the collection site for the purpose of 

a drug test.

Split Specimen Collection (for Urine): A collection in which the specimen collected is 

divided into a primary (A) specimen and a split (B) specimen, which are independently 

sealed in the presence of the donor.

Substituted Specimen: A specimen that has been submitted in place of the donor’s urine, 

as evidenced by the absence of a biomarker or a biomarker concentration inconsistent with 

that established for a human specimen, as indicated in the biomarker testing panel, or (for 

urine) creatinine and specific gravity values that are outside the physiologically producible 

ranges of human urine. 
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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 provisions to ensure donor privacy during 

specimen collections. This may be in the form of an enclosed stall in a multi-stall restroom, 

a single person restroom, a partitioned area that allows for individual privacy, or a mobile 

restroom. 

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

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 test facility 

Comment: The collection site must have a means for the donor to wash their hands prior 

to and after urination. The work area is used by the collector to handle the specimens and 

to complete required paperwork (e.g., Federal CCF). The collector work area should be 

external to the restroom where the collection occurs; however, it may be inside the 

restroom, if the donor still has privacy while providing the urine specimen. 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 test facility. 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 a urine specimen.

Reference: UrMG (subpart E – section 5.2.b - c and subpart H - section 8.3.j) and HHS

Urine Collection Handbook
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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

____ d. Donor access to items that could be used to adulterate, substitute, or dilute 

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

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: UrMG (subpart E - section 5.2.d-f) and HHS Urine Collection Handbook

Question A-4. Does the collection site have the required supplies for federally regulated 

urine specimen collections? (YES/NO)

Comment: The collection site must have all the supplies needed to complete a urine 

specimen collection such as collection kits (i.e., single-use collection container with a 

means to measure the urine temperature and two specimen bottles), Federal CCFs, 

tamper-evident tape/seals, leak-resistant container (e.g., plastic bag) with separate 

sealable compartments for specimen bottles and CCF, absorbent material, shipping 

containers, bluing agent, and disposable gloves. Collection kits must include a single-use 

collection container able to hold at least 55 mL, one specimen bottle able to hold at least 35 

mL, and one specimen bottle able to hold at least 20 mL. Collection containers and 

specimen bottles must not substantially affect the composition of drugs and/or metabolites 

in the specimen collected.

The collection site must maintain a supply of paper Federal CCFs, to be used in the event 

of a software/hardware problem preventing collections using an ECCF. In addition, 

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

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

completion of a collection using an ECCF (e.g., allowing for handwritten collector and donor 
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signatures in the event of a problem with the electronic signature system or when a donor 

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

Reference: UrMG (subpart G – section 7.1 through 7.3) and HHS Urine 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: UrMG (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: UrMG (subpart D - section 4.6.c)

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
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____ 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 Instrumented Test Facility (IITF) or HHScertified laboratory who can link the donor with the specimen drug test 

results 

____ e. Relatives or 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: UrMG (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 

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:
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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 UrMG, the HHS Urine 

Specimen Collection Handbook, 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 

UrMG, the HHS Urine Specimen 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: UrMG (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: UrMG (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 
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provides copies for review, the inspectors may request one or more collectors to provide 

their original training records during the inspection. 

Reference: UrMG (subpart D - section 4.3.c and section 4.6.b)

Question B-4. Did each collector complete initial training before they began collecting 

specimens for a Federal agency? (YES/NO)

Comment: An individual may not perform specimen collections until their training as a 

collector has been completed and documented. 

Reference: UrMG (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: UrMG (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 urine 

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 for Federal agency specimens

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

____ c. Problem collections

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

collections
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____ 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. 

Reference: UrMG (subpart D - section 4.3.a.3)

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 

collections? (YES/NO) 

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

____ a. One uneventful scenario 

____ b. One insufficient specimen quantity scenario

____ c. One temperature is out of range scenario

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

____ e. One scenario in which the donor refuses to initial the tamper-evident bottle 

label/seal

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

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

specimen quantity scenario, one where the temperature is out of range, one in which the 

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

tamper-evident bottle label/seal). 

Reference: UrMG (subpart D - section 4.3.a.4.i) and HHS Urine 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 
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____ 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 the five (5) 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.

Reference: UrMG (subpart D - section 4.3.a.4.ii, and subpart D - section 4.5.c) and HHS 

Urine 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 UrMG, the 

HHS Urine Collection Handbook, and any other guidance provided by the Federal agency 

related to the collection procedures? (YES/NO)

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

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

procedures described in the UrMG, the HHS Urine Specimen Collection Handbook, and 

any other guidance provided by the Federal agency related to specimen collection 

procedures prior to performing specimen collections.

Reference: UrMG (subpart D – section 4.3.a.1-2) and HHS Urine 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.
22

Reference: UrMG (subpart D - section 4.5.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 their original

training records during the inspection. 

Reference: UrMG (subpart D - section 4.5.c)

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

the following qualifications? (YES/NO)

• The trainer is qualified as a collector and has regularly conducted drug test 

collections for a period of at least one year, 

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

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

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

collector and have regularly conducted drug test collections 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). 

Reference: UrMG (subpart D - section 4.5.a.1 - 2) and HHS Urine Collection Handbook

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

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

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

Reference: UrMG (subpart D - section 4.5.b)
23

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:
24

Section C. Specimen Collection Procedures

Question C-1. Does the collector prepare the restroom to deter the dilution or substitution 

of a specimen? (YES/NO) 

Required steps:

• Placing bluing agent in the toilet or turning off the water supply and flushing the 

toilet 

• Securing any other water source in the enclosure where urination occurs 

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

dilution or substitution of the specimen. The collector must ensure that there is bluing agent 

in the toilet or toilet tank so that water always remains blue. If bluing agent is not available 

or the toilet has an automated flushing system, the collector must turn off the water supply 

and flush the toilet to remove any water in the toilet. The collector must also turn off or 

secure other water supply inside the restroom where the collection is taking place. If the 

water supply cannot be secured or turned off, the collector must perform a monitored 

collection as described in Questions D-6 through D-8.

Reference: UrMG (subpart H – section 8.2.a-b)

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 or because the donor indicates that 

they are not able to urinate. 

Reference: UrMG (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) 
25

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

outside of that window, the collector must contact the Federal agency representative to 

obtain guidance on the appropriate action to be taken.

Reference: UrMG (subpart H – section 8.3.a)

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

(YES/NO) 

Comment: To ensure specimen integrity, the collector must perform only one donor 

collection at a time.

Reference: UrMG (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: UrMG (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.
26

Reference: UrMG (subpart H – section 8.3.d)

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. 

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

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

donor that these instructions are available upon request. 

Reference: UrMG (subpart H – section 8.3.e - f)

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: UrMG (subpart H – section 8.3.g)

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 their

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 URINE checkbox below Step 1.
27

Reference: Instructions for Completing the Federal CCF for Urine Specimen Collection and 

HHS Urine 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 remove any unnecessary outer clothing (e.g., coat, jacket, 

hat, etc.)

____ b. Ask the donor to leave all other personal belongings (e.g., briefcase, purse) 

with the outer clothing 

____ c. Direct the donor to empty their pockets and display the items for inspection 

____ d. Secure any items that could be used to adulterate a specimen that appear

to have been inadvertently brought by the donor to the collection site 

____ e. Direct the donor to wash and dry their hands under the collector’s 

supervision 

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

tampering. 

Steps a and b: The donor is not required to remove any items worn for faith-based reasons. 

The collector must ensure that all personal belongings (e.g., briefcase, purse) remain with 

the outer clothing. The donor may retain their wallet. The collection site may have 

procedures to ensure security of the donors’ belongings (e.g., itemized receipt; storage in a 

lockable cabinet; envelope, box, or container sealed with tamper-evident tape 

initialed/signed by the donor). 

Steps c and d: The collector takes the following action based upon their inspection of items 

from the donor’s pockets.

• If the collector sees no items from the donor’s pockets that could be used to 

adulterate or substitute the specimen, the donor is instructed to place those items 

back in their pockets and continue with the collection procedure.

• If items are present that could be used to adulterate or substitute a specimen 

(e.g., common personal care products such as eyedrops, mouthwash, or hand 

sanitizer), but may have been inadvertently brought by the donor to the collection 

site, the collector secures the items and proceeds with the collection. 

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

this is considered a refusal to test. The collector must stop the collection and 

report the refusal to test to the Federal as outlined in Question D-16. 
28

Step g: The collector must direct the donor to wash and dry their hands under the 

collector’s supervision. Liquid soap is preferred over bar soap as the donor may conceal 

soap shavings under their fingernails in an attempt to adulterate the specimen. After 

washing their hands, the donor must remain in the collector’s presence and not be allowed 

access to any water fountain, faucet, soap, cleaning agent, or any other items that could be 

used to adulterate or substitute the specimen. 

Reference: UrMG (subpart H –section 8.3.h-j 

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 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 urine 

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-16. 

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

Question C-12. Does the collector give the donor the following collection instructions? 

(YES/NO) 

If NO, check the deficient area(s):

____ a. Provide at least 45 mL of urine

____ b. Do not flush the toilet 

____ c. Provide the specimen in a reasonable time (set by the collector)

 

____ d. Return with the specimen as soon as they have finished providing the 

specimen 

Comment: The collector must give the donor the instructions listed in this question. The 

collector may set a reasonable time limit for voiding. The collector may inform the donor 

that the specimen temperature must be read within four minutes after completing the void, 

and that longer wait periods may cause the specimen to be out of range and may 

necessitate an observed collection. 
29

Reference: UrMG (subpart H – section 8.4.b)

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

during the collection procedure? (YES/NO) 

Comment: Except in the case of an observed specimen collection, neither the collector nor 

anyone else may enter the restroom with the donor. In the case of a monitored collection, 

the monitor may enter a multi-stall restroom, but must stay outside the stall.

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

Question C-15. Do both the collector and the donor maintain visual contact with the 

specimen from the time the specimen is transferred to the collector until specimen bottles 

have been sealed for shipment? (YES/NO)

Comment: Both the collector and the donor must maintain visual contact with the 

specimen from the time the specimen is transferred from the donor to the collector until the 

specimen bottles have been sealed for shipment to the testing facility.

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

Completion of a Collection

Question C-16. After receiving the specimen from the donor, whenever practical, does the 

collector allow the donor to wash their hands and to flush the toilet? (YES/NO) 
30

Comment: After the collector has received the specimen from the donor, the donor may be 

allowed to wash their hands and to flush the toilet. Prior to flushing the toilet, the collector 

may inspect the toilet for any materials indicative of specimen tampering.

Reference: UrMG (subpart H – section 8.5.c)

Question C-17. Does the collector check the specimen temperature within four minutes 

after receiving the specimen from the donor and check the appropriate box in Step 2 of the 

Federal CCF? (YES/NO) 

Comment: The collector must check the temperature of the specimen within four minutes 

after receiving the specimen from the donor. The temperature measuring device must be 

able to accurately read the temperature and must not contaminate the specimen. The 

collector must indicate on the CCF whether the specimen was within the acceptable 

temperature range (i.e., 90° - 100°F; 32° – 38°C). If the specimen is outside the acceptable 

range, this is reason to believe that the donor may have adulterated or substituted the 

specimen, and another specimen must be collected under direct observation as described 

in Questions D-1 through D-5. If the donor refuses to attempt to provide a second specimen 

or leaves the collection site before the collection process is completed, this is considered 

as a refusal to test. The collector reports a refusal to test as outlined in Question D-16. 

Note: The second collection using the direct observed collection procedure must be 

performed using a new collection kit (i.e., new collection container and Federal CCF). Prior 

to beginning the direct observed collection, the collector completes the first collection. The 

collector must record a comment on the Remarks line in Step 2 of both Federal CCF’s (i.e., 

from the first and second specimens) indicating why two specimens were collected and 

including a cross-reference to the first specimen identification number on the Federal CCF 

for the second specimen. The specimen with unacceptable temperature must be forwarded 

to an HHS-certified laboratory (not an IITF) regardless of the specimen volume. 

Exception: If the unacceptable temperature is due to a measurement problem (e.g., no 

reading due to extremely low volume, temperature strip failure), the collector must discard 

the urine collected.] The collector must begin a second collection using the same Federal 

CCF and the same procedures (not directly observed) and use a new collection container 

for the second collection. If the donor provides less than 45 mL for the second specimen, 
31

the collector must follow the insufficient specimen procedures, as applicable. The second

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

Reference: UrMG (subpart H – section 8.5.d.1-2) 

Question C-18. Does the collector inspect the specimen for adulteration or substitution by 

examining the physical characteristics of the urine? (YES/NO)

Comment: The collector must inspect the specimen for signs of adulteration or substitution 

by examining the physical characteristics of the urine. The collector should note any 

unusual color, foreign objects, unusual odor, or other signs of adulteration (e.g., excessive 

foaming when shaken). Any unusual finding must be noted on the Federal CCF. 

Any specimen suspected of not being a valid urine specimen is forwarded to the testing 

facility. When there is reason to believe the donor has adulterated or substituted the 

specimen, another specimen must be collected under direct observation as described in 

Questions D-1 through D-5. If the donor refuses to attempt to provide a second specimen 

or leaves the collection site before the collection process is completed, this is considered 

as a refusal to test. The collector reports a refusal to test as outlined in Question D-16. 

Note: The second collection using the direct observed collection procedure must be 

performed using a new collection kit (i.e., new collection container and Federal CCF). Prior 

to beginning the direct observed collection, the collector completes the first collection. The 

collector must record a comment on the Remarks line in Step 2 of both Federal CCF’s (i.e., 

from the first and second specimens) indicating why two specimens were collected and 

including a cross-reference to the first specimen identification number on the Federal CCF 

for the second specimen. The specimen with abnormal physical characteristics and its 

Federal CCF must be forwarded to an HHS-certified laboratory (not an IITF), regardless of 

the specimen volume. If the donor provides less than 45 mL for the second specimen, the 

collector must follow the insufficient specimen procedures, as applicable. The second

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

Reference: UrMG (subpart H – section 8.5.e.1-2) 
32

Question C-19. Does the collector check the specimen volume to ensure that the 

specimen contains at least 45 mL of urine? (YES/NO) 

Comment: The collector must verify that the specimen volume is at least 45 mL. If the 

specimen volume is sufficient, the collector should continue with the collection procedure. 

If the specimen volume is not at least 45 mL, the collector must discard the specimen and 

immediately collect another specimen using a new collection container and the same 

Federal CCF. The collector must never combine urine collected from separate voids 

to create a sufficient specimen. 

If the donor is unable to provide a second urine specimen, the collector follows the 

Insufficient Specimen procedures described in Questions D-9 through D-14. If the donor 

refuses to attempt to provide a second specimen or leaves the collection site before the 

collection process is completed, this is considered as a refusal to test. The collector reports 

a refusal to test as outlined in Question D-16. 

Reference: UrMG (subpart H – section 8.5.f.1-2) 

Question C-20. In the presence of the donor, does the collector pour at least 30 mL into 

“Bottle A” and at least 15 mL into “Bottle B”? (YES/NO)

Comment: The collector should unwrap the specimen bottles (i.e., Bottle A and Bottle B) in 

the donor’s presence. The collector must pour the urine from the collection container into 

each specimen bottle and cap each bottle in the presence of the donor. At least 30 mL 

must be poured into Bottle A and at least 15 mL into Bottle B. 

Reference: UrMG (subpart H – section 8.8.b)

Question C-21. Does the collector discard excess urine (unless it is used for a clinical test 

as part of a physical examination required by a Federal agency)? (YES/NO) 

Comment: After the specimen bottles have been appropriately filled, the collector must 

discard excess urine left in the collection container. No further testing may be done with the 

excess urine (e.g., specimen validity testing). The only exception is if the collection was 

conducted in conjunction with a physical examination required by the Federal agency. In 

this case, the excess urine may be used for the clinical tests.
33

Reference: UrMG (subpart H – section 8.8.j) 

Question C-22. 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 bottle 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 bottle 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 bottle containing the larger volume (i.e., at least 30 mL urine) and the 

“B” label is used for the bottle containing the smaller volume (i.e., at least 15 mL).

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

Question C-23. If the tamper-evident label/seal does not adhere to the bottle or is 

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

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

Comment: In some cases, the tamper-evident label/seal may not adhere to the bottle, 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 bottle. 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). 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 Urine Collection Handbook
34

Question C-24. Does the collector record the date of the collection on the bottle seals after 

placing them on the bottles? (YES/NO) 

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

placing them on the specimen bottles (i.e., Bottle A and Bottle B). 

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

Question C-25. Does the collector instruct the donor to initial the specimen bottle seals 

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

Comment: After placing the labels/seals on the bottles, 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: UrMG (subpart H – section 8.8.d)

Question C-26. 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, 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 the donor. 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 ECCFs (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, 
35

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: UrMG (subpart H – section 8.8.f) and HHS Urine Collection Handbook

Question C-27. Does the collector complete the collector chain of custody section in Step 

4 on Copy 1 of the Federal CCF? (YES/NO) 

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 bottles and CCF will be released. 

Reference: UrMG (subpart H – section 8.8.g) 

Question C-28. Does the collector place the sealed specimen bottles 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 bottles)? (YES/NO) 

Comment: The collector places both specimen bottles 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 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: UrMG (subpart H – section 8.8.h) and HHS Urine Collection Handbook 

Question C-29. Does the collector provide Copy 5 of the Federal CCF to the donor? 

(YES/NO) 
36

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

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 Urine Collection Handbook 

Question C-30. Does the collector prepare the sealed tamper-resistant package containing 

the specimen bottles and Federal CCF for transport to the HHS-certified test facility (i.e.,

IITF or 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 testing facility. 

Note: If the tamper-evident label/seal from the Federal CCF is broken on the specimen 

bottle after the donor leaves the collection site, the collection must be cancelled. The 

collector notifies the Federal agency’s designated representative that the label/seal was 

broken on the specimen bottle(s).

Reference: HHS Urine Collection Handbook

Question C-31. Are the specimen bottles and Federal CCF appropriately safeguarded until 

they are retrieved for transport to the HHS-certified test facility (i.e., IITF or 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.
37

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

Collection Handbook 

Question C-32. 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 

within 24 hours after the collection or during the next business day? (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 a paper 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 Urine Collection Handbook

Question C-33. Are specimens submitted to an HHS-certified test facility (i.e., IITF or 

laboratory) within 24 hours after the collection or during the next business day? (YES/NO) 

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

collection or during the next business day.

Reference: UrMG (subpart H – section 8.8.h) and HHS Urine Collection Handbook
38

Section Evaluation

Question C-34. 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 

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:
39

Section D. Collection Problems

Direct Observed Collections

Question D-1. Does the collector initiate a direct observed collection in the following 

situations? (YES/NO) 

If NO, check the deficient area(s):

____ a. Specimen temperature is outside the acceptable range

____ b. Specimen appearance indicative of tampering (abnormal physical 

characteristic such as unusual color, excessive foaming when shaken, 

unusual odor)

____ c. Donor conduct indicates an attempt to adulterate or substitute the 

specimen, and the donor has already provided a specimen 

Comment: The collector initiates a direct observed specimen for the reasons listed above. 

Reference: UrMG (subpart H – section 8.9.b)

Question D-2. Does the collector take the following steps before conducting a direct 

observed collection? (YES/NO) 

If NO, check the deficient step(s):

____ a. Contact a collection site supervisor for concurrence with the collector’s 

decision for a direct observed collection 

____ b. Explain to the donor why a direct observed collection is being conducted 

____c. Inform the donor that the gender of the observer will match the donor’s 

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

Comment: If a direct observed collection is warranted for one or more of the reasons listed 

in Question D-1, the collector must contact the collection site supervisor for concurrence in 

advance of any decision to obtain a specimen under direct observation. Once the decision 

for an observed collection has been made, the collector must explain to the donor why a 

direct observed collection is being conducted. The collector informs the donor that the 

gender of the observer will be the same as the donor’s gender, which is determined by the 

donor’s gender identity. 
40

Reference: UrMG (subpart H – section 8.9.c and 8.10.a-b) and HHS Urine Collection 

Handbook 

Question D-3. Before an individual is allowed to serve as the observer for a direct 

observed collection, does a collector/collection site supervisor provide training on the 

following subjects? (YES/NO) 

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

____ a. The steps necessary to perform a direct observed collection correctly

____ b. Maintaining visual contact with the collection container throughout the 

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

____ c. Ensuring the privacy of the donor

____ d. Observing the collection in a professional manner, to minimize 

discomfort of the donor

____ e. Avoiding conduct that could be interpreted as offensive or 

inappropriate

Comment: In direct observed specimen collections, an observer who is the same gender 

as the donor must accompany the donor into the restroom during the specimen collection. 

The observer must directly watch the urine exit from the donor’s body into the collection 

container. The use of mirrors or video cameras is not permitted. 

The collector asks the donor to identify the donor’s gender on the Federal CCF and initial it. 

The donor will then be provided an observer whose gender matches the donor’s gender.

The collector documents the observer’s name and gender on the Federal CCF. 

Before an individual is allowed to serve as an observer for a direct observed specimen 

collection, a collector/collection site supervisor must provide training on all items listed in 

this question. The observer is not required to be a trained collector.

Note: If the donor fails to follow the observer’s instructions related to the direct observed 

collection, this is considered a refusal to test. The collector reports the refusal to test as 

outlined in Question D-16. 

After the donor has completed urinating into the collection container, the donor and 

observer leave the restroom together and the donor hands the collection container directly 
41

to the collector. The observer must never touch or handle the collection container unless 

the observer is also serving as the collector. The observer must maintain visual contact 

with the collection container until the donor hands the container to the collector. If the 

collector serves as the observer, the collector may receive the collection container from the 

donor inside the restroom.

Reference: UrMG (subpart D - section 4.4.a-c and subpart H - section 8.10.a-d)

Question D-4. Does the collector ensure that the observer for each direct observed 

collection meets the following requirements? (YES/NO)

• Trained in direct observed specimen collection procedures

• Same gender as the donor 

Comment: The collector must ensure that the observer has received training in direct 

observed specimen collection procedures training (i.e., on all items listed in Question D-3). 

The observer’s gender must be the same as the donor’s gender, which is determined by 

the donor’s gender identity. There are no exceptions to this requirement.

Reference: UrMG (subpart D - section 4.4.a-c and subpart H – section 8.10.a)

Question D-5. Does the collector properly document the direct observed collection in Step 

2 of the Federal CCF? (YES/NO) 

If NO, check the deficient step(s):

____ a. Mark the checkbox for an observed collection

____ b. Record the name and gender of the observer on the Remarks line

____ c. Record the reason for the observed collection on the Remarks line

Comment: The collector documents the direct observed collection on the Federal CCF as 

listed above: marking the checkbox for an observed collection, recording the observer’s 

name and gender, and recording the reason for the observed collection. 

Reference: UrMG (subpart H – section 8.10.d)
42

Monitored Collections

 

Question D-6. Does the collector initiate a monitored collection in the following situations? 

(YES/NO) 

• The collection is being conducted in a public restroom

• The restroom used for the collection has a water source that cannot be disabled 

or secured

Comment: Monitored collections are performed when the Federal agency’s designated 

collection site is not available and there is an immediate need to collect a specimen (e.g., 

accident investigation). A monitored collection must be performed if a public restroom is 

being used for the collection or if the restroom has a water source that cannot be disabled 

or secured.

Note: If a donor refuses to permit a monitored collection, the collector must report a refusal 

to test as outlined in Question D-16. 

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

individual monitors the collection by checking for signs that the donor may be tampering 

with the specimen. The monitor must accompany the donor into the restroom and secure 

the restroom to ensure that no one else can enter during the collection process. The 

monitor must remain in the restroom, but outside the stall, while the donor is providing the 

specimen and must listen for signs of tampering. The monitor must not watch the donor 

urinate into the specimen container. After the donor has completed urinating in the 

collection container, the donor and monitor leave the restroom together and the donor 

hands the collection container to the collector. The monitor must never handle or touch the 

collection container unless the monitor also serves as the collector. The monitor must 

maintain visual contact with the collection container until the donor has handed the 

container to the collector. If the collector serves as the monitor, the collector may receive 

the collection container from the donor inside the restroom.

Note: If there are signs of tampering, the monitor must immediately report this to the 

collector so that the collector can begin to collect a second specimen using the direct 

observed specimen collection procedures described under Questions D-1 through D-5. 

Reference: UrMG (subpart H – section 8.12)
43

Question D-7. Does the collector ensure that the monitor for each monitored collection 

meets at least one of the following requirements? (YES/NO) 

• Same gender as the donor

• A trained medical professional (e.g., nurse, doctor, physician’s assistant, 

technologist, or technician) who is licensed or certified to practice where the 

collection occurs 

Comment: The collector must ensure that the monitor’s gender is the same as the donor’s

gender, which is determined by the donor’s gender identity, unless the monitor is a trained 

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

who is licensed or certified to practice where the collection occurs. The monitor may be an 

individual other than the collector and does not need to be a trained collector.

Reference: UrMG (subpart H – section 8.12) 

Question D-8. Does the collector record the name of the monitor (if not the collector) on 

the Remarks line in Step 2 on Copy 1 of the Federal CCF? (YES/NO)

Comment: If the collector is not serving as the monitor, the collector must record the name 

of the monitor on the Remarks line in Step 2 on Copy 1 of the Federal CCF.

Reference: UrMG (subpart H – section 8.12.f)

Insufficient Specimen

Question D-9. Does the collector attempt a urine collection when the donor has 

demonstrated that they are unable to provide a sufficient specimen? (YES/NO) 

If NO, check the deficient step(s):

____ a. Requests that the donor attempt to provide a urine specimen

____ b. Offers a drink (e.g., 8 oz. of water every 30 minutes; no more than 40 oz. 

over 3 hours) when the donor indicates they may provide a specimen after 

drinking fluids

____ c. Allows a wait period up to 3 hours for the donor to provide a sufficient urine

specimen 

 

____ d. Directs the donor to remain at the collection site (in an area designated by 

the collector) during the wait period
44

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 enter the 

restroom and attempt to provide a specimen. The donor demonstrates their inability to 

provide a specimen by returning from the restroom with an empty specimen collection 

container. 

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 distributed reasonably 

over three hours (e.g., an 8-ounce glass of water every 30 minutes, not to exceed 40 

ounces over a period of 3 hours). The donor is not required to drink fluids during this time 

period. It is recommended that the collector allow sufficient time to only have one additional 

attempt rather than documenting several unsuccessful attempts. 

The collector must allow three hours for the donor to provide a sufficient specimen. The 

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

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-16. 

Reference: UrMG (subpart H – section 8.5.f.2.i and subpart H – section 8.6) and HHS Urine 

Collection Handbook

Question D-10. Do collection procedures prohibit combining urine collected from separate 

voids to create a specimen of sufficient volume? (YES/NO) 

Comment: The collector must not, under any circumstances, combine urine collected from 

separate voids to create one specimen of sufficient volume.

Reference: UrMG (subpart H – section 8.5.f)

Question D-11. Does the donor remain under the direct observation of the collector to 

prevent the donor from possibly compromising the collection process? (YES/NO)

Comment: The donor must remain under the direct observation of the collector to prevent 

the donor from possibly compromising the collection process.
45

Reference: HHS Urine Collection Handbook

 

Question D-12. Does the collector record the time of each attempt to provide a sufficient 

volume of specimen (e.g., on the Remarks line of the Federal CCF)? (YES/NO) 

Comment: The collector must record the time of each attempt by the donor to provide a 

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

Reference: HHS Urine Collection Handbook

Question D-13. Does the collector discontinue the collection procedure in the following 

situations? (YES/NO) 

• The donor has demonstrated that they are unable to provide a specimen

• The donor has not provided sufficient volume of specimen in three hours from the 

time of the donor’s first attempt 

Comment: If the donor states they are unable to provide a specimen after attempting to 

provide a specimen or if the donor has not provided a sufficient specimen in three hours 

from the first attempt, the collector is to discontinue the collection and direct the donor to 

leave the collection site. 

Reference: UrMG (subpart H – section 8.5.f.2.iii and 8.6.b.2) and HHS Urine Collection 

Handbook

Question D-14. When discontinuing a collection, does the collector take the following 

steps? (YES/NO) 

If NO, check the deficient area(s):

____ 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 urine collected (if any)
46

____ 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:

o Send Copy 2 to the MRO

o 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., oral fluid). 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: UrMG (subpart H – section 8.5.f.2.iii and 8.6.b.1-2) and HHS Urine Collection 

Handbook

Refusal to Test

Question D-15. 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 within a reasonable time as 

determined by the Federal agency

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

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

alternate specimen type) 

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

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

hands when directed by the collector)

____ e. The donor fails to allow a direct observed collection when required

____ f. The donor fails to follow the observer’s instructions related to the direct 

observed collection
47

____ g. The donor fails to allow a monitored collection when required

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

adulterating, substituting, or diluting the specimen

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

____ j. The donor possesses or wears a prosthetic or other device that could be 

used to interfere with the collection process

____ k. 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: UrMG (subpart A – section 1.7and subpart H – section 8.5g) and HHS Urine 

Collection Handbook

Question D-16. 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 urine 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

Comment: When reporting a refusal to test, the collector must discard all urine 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.
48

Reference: UrMG (subpart A Section 1.8.b –subpart H section 8.13)

Collector Errors

Question D-17. When the collector realizes that an incorrect or expired Federal CCF is 

used prior to packaging the specimen bottles, 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. 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 a 

memorandum for the record (MFR) attached to the form.

Reference: UrMG (subpart E – section 6.2.b) and HHS Urine Collection Handbook

Question D-18. Does the collector provide a memorandum for the record (MFR) when 

requested by the HHS-certified test facility (i.e., laboratory, IITF) or MRO? (YES/NO)

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

facility (i.e., IITF or laboratory), or MRO when notified of an error. 

There are three categories of collector errors:

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

cancelling a test, 

• Correctable flaws that result in an IITF or 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 are considered 

insignificant and do not cause rejection by the IITF or laboratory or cancellation 

by the MRO 

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

specimens rejected for testing due to collector errors).

Reference: UrMG (subpart E – section 6.2.c) and HHS Urine Collection Handbook
49

Section Evaluation

Question D-19. 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 

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:
50

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. The collection site may convert 

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

months.

Reference: UrMG (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: UrMG (subpart E - section 5.3) and HHS Urine 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 Urine 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. 
51

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, IITF, laboratory, or employer 

information). The collector must use the procedures described above for changing the 

information on the form. This may be necessary in the event of unexpected collections 

(e.g., accident investigation) or when Federal CCFs at the collection site have outdated 

information.

Reference: HHS Urine Collection Handbook
52

Section Evaluation

Question 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 

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:
53

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)

Reviewer

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: __________________________________________________________
54

Attachment 1: UrMG 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 an observer for a direct observed collection?

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

4.6 What must a Federal agency do before a collector 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 a urine 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 – Urine Specimen Collection Containers and Bottles

7.1 What is used to collect a urine specimen?

7.2 What are the requirements for a urine collection container and specimen bottles?

7.3 What are the minimum performance requirements for a urine collection container 

and specimen bottles?

Subpart H - Urine Specimen Collection Procedure

8.1 What privacy must the donor be given when providing a urine specimen?
55

8.2 What must the collector ensure at the collection site before starting a urine specimen 

collection?

8.3 What are the preliminary steps in the urine specimen collection procedure?

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

provides a urine specimen?

8.5 What steps does the collector take during and after the urine specimen collection 

procedure?

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

urine specimen?

8.7 If the donor is unable to provide a urine specimen, may another specimen type be 

collected for testing?

8.8 How does the collector prepare the urine specimens?

8.9 When is a direct observed collection conducted?

8.10 How is a direct observed collection conducted?

8.11 When is a monitored collection conducted?

8.12 How is a monitored collection conducted?

8.13 How does the collector report a donor’s refusal to test?

8.14 What are a Federal agency’s responsibilities for a collection site?

Subpart D - Collectors

Section 4.1 Who may collect a specimen?

(a) A collector who has been trained to collect urine specimens in accordance with 

these Guidelines.

(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.
56

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 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 or IITF 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 be a personal friend of the employee (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 

the collection procedure described in these Guidelines;

(3) Is trained and qualified to collect a urine specimen. Training must include the 

following: 

(i) All steps necessary to complete a urine 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 errorfree mock collections.
57

(i) The five mock collections must include one uneventful collection scenario, one 

insufficient specimen quantity scenario, one temperature out of range scenario, one 

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

donor refuses to initial the specimen bottle tamper-evident seal.

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

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

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

collections are error-free.

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

includes the requirements in Section 4.3(a). 

(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 an observer for a direct observed 

collection?

(a) An individual may serve as an observer for a direct observed collection when the 

individual has satisfied the requirements: 

(1) Is knowledgeable about the direct observed collection procedure described in 

Section 8.9;

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

direct observed collection procedure described in these Guidelines;

(3) Has received training on the following subjects:

(i) All steps necessary to perform a direct observed collection; and

(ii) The observer’s responsibility for maintaining the integrity of the collection 

process, ensuring the privacy of individuals being tested, ensuring that the observation is 

done in a professional manner that minimizes the discomfort to the employee so observed, 

ensuring the security of the specimen by maintaining visual contact with the collection 
58

container until it is delivered to the collector, and avoiding conduct or statements that could 

be viewed as offensive or inappropriate.

(b) The gender of the observer must be the same as the donor’s gender, which is 

determined by the donor’s gender identity. The observer selection process is described in

Section 8.10(b).

(c) The observer is not required to be a trained collector.

Section 4.5 What are the requirements to be a trainer for collectors?

(a) Individuals are considered qualified trainers for collectors and may train others to 

collect urine specimens when they have completed the following: 

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

collections 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 4.6 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.
59

(b) In the event that an agency-designated collection site is not accessible and there 

is an immediate requirement to collect a urine specimen (e.g., an accident investigation), a 

public restroom may be used for the collection, using the procedures for a monitored 

collection described in Section 8.12.

Section 5.2 What are the requirements for a collection site?

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 or IITF;

(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;

(f) A restricted access area for the secure storage of records; and

(g) The ability to restrict the donor access to potential diluents in accordance with 

Section 8.2.

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:
60

(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 or IITF 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 or IITF. 

Section 5.6 What are the privacy requirements when collecting a urine specimen?

Collections must be performed at a site that provides reasonable privacy (as described in 

Section 8.1).

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 or IITF to automatically reject the specimen for 

testing or for the MRO to cancel the test. 
61

(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, HHS-certified IITF, or MRO discovers that the 

collector used an incorrect form, the laboratory, IITF, 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 – Urine Specimen Collection Containers and Bottles

Section 7.1 What is used to collect a urine specimen?

A single-use collection container with a means (i.e., thermometer) to measure urine 

temperature and two specimen bottles must be used. 

Section 7.2 What are the requirements for a urine collection container and 

specimen bottles?

(a) The collection container, the thermometer, and the specimen bottles must not 

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

(b) The two specimen bottles must be sealable and non-leaking, and must maintain 

the integrity of the specimen during storage and transport so that the specimen contained 

therein can be tested in an HHS-certified laboratory or IITF for the presence of drugs or 

their metabolites.

(c) The two specimen bottles must be sufficiently transparent (e.g., translucent) to 

enable an objective assessment of specimen appearance and identification of abnormal 

physical characteristics without opening the bottle. 

Section 7.3 What are the minimum performance requirements for a urine collection 

container and specimen bottles?

(a) The collection container must be capable of holding at least 55 mL and have a 

volume marking clearly noting a level of 45 mL.
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(b) One of the two specimen bottles must be capable of holding at least 35 mL and 

the other at least 20 mL, and each must have a volume marking clearly noting the 

appropriate level (30 mL for the primary specimen and 15 mL for the split specimen).

(c) The thermometer may be affixed to or built into the collection container and must 

provide graduated temperature readings from 32–38 °C/90–100 °F. Alternatively, the 

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

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

specimen.

Subpart H - Urine Specimen Collection Procedure

Section 8.1 What privacy must the donor be given when providing a urine 

specimen?

The following privacy requirements apply when a donor is providing a urine 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. The gender of 

the observer for purposes of a direct observed collection (i.e., as described in Section 8.10) 

must be the same as the donor’s gender, which is determined by the donor’s gender 

identity. The gender of the monitor for a monitored collection (i.e., as described in Section 

8.12) must be the same as the donor’s gender, unless the monitor is a medical professional 

(e.g., nurse, doctor, physician's assistant, technologist, or technician licensed or certified to 

practice in the jurisdiction in which the collection takes place). 

(c) The collector must give the donor visual privacy while providing the specimen. 

The donor is allowed to provide a urine specimen in an enclosed stall within a multi-stall 

restroom or in a single person restroom during a monitored collection.

Section 8.2 What must the collector ensure at the collection site before starting a 

urine specimen collection?

The collector must deter the dilution or substitution of a specimen at the collection site by:

(a) Placing a toilet bluing agent in a toilet bowl or toilet tank, so the reservoir of water 

in the toilet bowl always remains blue. If no bluing agent is available or if the toilet has an 

automatic flushing system, the collector shall turn the water supply off to the toilet and flush 

the toilet to remove the water in the toilet when possible. 
63

(b) Secure other sources of water (e.g., shower or sink) in the enclosure where 

urination occurs. If the enclosure has a source of water that cannot be disabled or secured, 

a monitored collection must be conducted in accordance with Section 8.11.

Section 8.3 What are the preliminary steps in the urine specimen collection 

procedure?

The collector must take the following steps before beginning a urine 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 the donor states that they are unable to urinate or 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 must provide identification (e.g., employee badge, employee list) if 

requested by the donor.

(e) The collector explains the basic collection procedure to the donor.

(f) The collector provides the instructions for completing the Federal CCF for the 

donor’s review, and informs the donor that the instructions are available upon request.

(g) The collector answers any reasonable and appropriate questions the donor may 

have regarding the collection procedure.

(h) The collector asks the donor to remove any unnecessary outer garments (e.g., 

coat, jacket) that might conceal items or substances that could be used to adulterate or 

substitute the urine specimen. The collector must ensure that all personal belongings (e.g., 

purse or briefcase) remain with the outer garments. The donor may retain the donor’s 

wallet. The donor is not required to remove any items worn for faith-based reasons.
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(i) The collector asks the donor to empty the donor’s pockets and display the 

contents to ensure no items are present that could be used to adulterate or substitute the 

specimen. 

(1) If no items are present that can be used to adulterate, substitute, or dilute the 

specimen, the collector instructs the donor to return the items to their pockets and 

continues the collection procedure.

(2) If an item is present whose purpose is to adulterate, substitute, or dilute the 

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

has no reasonable explanation), this is considered a refusal to test. The collector must stop 

the collection and report the refusal to test as described in Section 8.13. 

(3) If an item that could be used to adulterate, substitute, or dilute the specimen 

(e.g., common personal care products such as eyedrops, mouthwash, or hand sanitizer) 

appears to have been inadvertently brought to the collection site, the collector must secure 

the item and continue with the normal collection procedure.

(4) If the donor refuses to show the collector the items in their pockets, this is 

considered a refusal to test. The collector must stop the collection and report the refusal to 

test as described in Section 8.13.

(j) The collector shall instruct the donor to wash and dry the donor’s hands prior to 

urination. After washing the donor’s hands, the donor must remain in the presence of the 

collector and must not have access to any water fountain, faucet, soap dispenser, cleaning 

agent, or any other materials which could be used to adulterate or substitute the specimen. 

(k) If the donor refuses to wash their hands when instructed by the collector, this is 

considered a “refusal to test.” The collector must stop the collection and report the refusal 

to test as described in Section 8.13.

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

the donor provides a urine specimen? 

(a) The collector will provide or the donor may select a specimen collection container 

that is clean, unused, wrapped/sealed in original packaging and compliant with subpart G 

of these Guidelines. The specimen collection container package will be opened in view of 

the donor. 
65

(b)The collector instructs the donor to provide the specimen in the privacy of a stall 

or otherwise partitioned area that allows for individual privacy. The collector directs the 

donor to provide a specimen of at least 45 mL, to not flush the toilet, and to return with the 

specimen as soon as the donor has completed the void.

(1) Except in the case of a direct observed collection (i.e., as described in Section 

8.10) or a monitored collection (i.e., as described in Section 8.12), neither the collector nor 

anyone else may go into the room with the donor. 

(2) The collector may set a reasonable time limit for specimen collection. 

(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., substitute urine in plain view or an attempt to bring into the 

collection site an adulterant or urine substitute), the collector must report a refusal to test in 

accordance with Section 8.13.

Section 8.5 What steps does the collector take during and after the urine specimen

collection procedure?

Integrity and Identity of the Specimen. The collector must take the following steps during 

and after the donor provides the urine specimen: 

(a) The collector must inform the donor that, once the collection procedure has 

begun, the donor must remain at the collection site (i.e., in an area designated by the 

collector) until the collection is complete and that failure to follow these instructions will be 

reported as a refusal to test. This includes the wait period (i.e., up to 3 hours) if needed to 

provide a sufficient specimen as described in Sections 8.5(f)(2) and 8.6. 

(b) After providing the specimen, the donor gives the specimen collection container 

to the collector. Both the donor and the collector must keep the specimen container in view 

at all times until the collector seals the specimen bottles as described in Section 8.8.

(c) After the donor has given the specimen to the collector, whenever practical, the 

donor shall be allowed to wash the donor’s hands and the donor may flush the toilet.

(d) The collector must measure the temperature of the specimen within 4 minutes of 

receiving the specimen from the donor. The collector records on the Federal CCF whether 

or not the temperature is in the acceptable range of 32°-38°C/90°-100°F.
66

(1) The temperature measuring device must accurately reflect the temperature of the 

specimen and not contaminate the specimen.

(2) If the temperature of the specimen is outside the range of 32°-38°C/90°-100°F, 

that is a reason to believe that the donor may have adulterated or substituted the 

specimen. Another specimen must be collected under direct observation in accordance 

with Section 8.9. The collector must forward both specimens (i.e., from the first and second 

collections) to an HHS-certified laboratory for testing and record a comment on the Federal 

CCF for each specimen. 

(e) The collector must inspect the specimen to determine if there is any sign 

indicating that the specimen may not be a valid urine specimen (e.g., unusual color, 

presence of foreign objects or material, unusual odor). 

(1) The collector notes any unusual finding on the Federal CCF. A specimen 

suspected of not being a valid urine specimen must be forwarded to an HHS-certified 

laboratory for testing. 

(2) When there is any reason to believe that a donor may have adulterated or 

substituted the specimen, another specimen must be obtained as soon as possible under 

direct observation in accordance with Section 8.10. The collector must forward both 

specimens (i.e., from the first and second collections) to an HHS-certified laboratory for 

testing and record a comment on the Federal CCF for each specimen.

(f) The collector must determine the volume of urine in the specimen container. The 

collector must never combine urine collected from separate voids to create a specimen.

(1) If the volume is at least 45 mL, the collector will proceed with steps described in 

Section 8.8.

(2) If the volume is less than 45 mL, the collector discards the specimen and 

immediately collects a second specimen using the same procedures as for the first 

specimen (including steps in Section 8.5(c) and (d)). 

(i) The collector may give the donor a reasonable amount of liquid to drink for this 

purpose (e.g., an 8-ounce glass of water every 30 minutes, but not to exceed a maximum 

of 40 ounces over a period of 3 hours or until the donor has provided a sufficient urine 

specimen). However, the donor is not required to drink any fluids during this waiting time.
67

(ii) If the donor provides a sufficient urine specimen (i.e., at least 45 mL), the 

collector proceeds with steps described in Section 8.8.

(iii) If the employee has not provided a sufficient specimen (i.e., at least 45 mL) 

within three hours of the first unsuccessful attempt to provide the specimen, the collector 

records the reason for not collecting a urine specimen on the Federal CCF, notifies the 

Federal agency’s designated representative for authorization to collect an alternate 

specimen, 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 alternate specimen.

(g) If the donor fails to remain present through the completion of the collection, 

declines to have a direct observed collection as required in Section 8.5(d)(2) or (e)(2), 

refuses to provide a second specimen as required in Section 8.5(f)(2), or refuses to provide 

an alternate specimen as authorized in Section 8.5(f)(2)(iii), the collector stops the 

collection and reports the refusal to test in accordance with Section 8.13.

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

provide a urine specimen?

(a) If the donor states that they are unable to provide a urine specimen during the 

collection process, the collector requests that the donor enter the restroom (stall) and 

attempt to provide a urine specimen. 

(b) The donor demonstrates their inability to provide a specimen when he or she 

comes out of the stall with an empty collection container. 

(1) If the donor states that they could provide a specimen after drinking some fluids, 

the collector gives the donor a reasonable amount of liquid to drink for this purpose (e.g., 

an 8 ounce glass of water every 30 minutes, but not to exceed a maximum of 40 ounces 

over a period of 3 hours or until the donor has provided a sufficient urine specimen). If the 

donor simply needs more time before attempting to provide a urine specimen, the donor 

may choose not to drink any fluids during the 3 hour wait time.
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(2) If the donor states that they are unable to provide a urine specimen, the collector 

records the reason for not collecting a urine specimen on the Federal CCF, notifies the 

Federal agency’s designated representative for authorization to collect an alternate 

specimen, 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 alternate specimen.

Section 8.7 If the donor is unable to provide a urine specimen, may another

specimen type be collected for testing?

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 urine specimens?

(a) All Federal agency collections are to be split specimen collections. 

(b) The collector, in the presence of the donor, pours the urine from the collection 

container into two specimen bottles to be labeled “A” and “B.” The collector pours at least 

30 mL of urine into Bottle A and at least 15 mL into Bottle B, and caps each bottle.

(c) In the presence of the donor, the collector places a tamper-evident label/seal 

from the Federal CCF over each specimen bottle cap. 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 bottle. 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 required information is included on the Federal 

CCF.

(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.
69

(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 (Bottle A and Bottle B) in a package and, 

within 24 hours or during the next business day, sends them to the HHS-certified laboratory 

or IITF that will be testing the Bottle A urine specimen. 

(i) If the specimen and Federal CCF are not immediately transported to an HHScertified laboratory or IITF, they must remain under direct control of the collector or be 

appropriately secured under proper specimen storage conditions until transported. 

(j) The collector must discard any urine left over in the collection container after both 

specimen bottles have been appropriately filled and sealed. There is one exception to this 

requirement: the collector may use excess urine to conduct clinical tests (e.g., protein, 

glucose) if the collection was conducted in conjunction with a physical examination required 

by Federal agency regulation. Neither the collector nor anyone else may conduct further 

testing (such as specimen validity testing) on the excess urine. 

Section 8.9 When is a direct observed collection conducted?

A direct observed collection procedure must be conducted when:

(a) The agency has authorized a direct observed collection because:

(1) The donor’s previous drug test result was reported by an MRO as positive, 

adulterated, or substituted; or

(2) The HHS-certified laboratory reports to the MRO that a specimen is invalid, and 

the MRO reported to the agency that there was not a legitimate medical explanation for the 

result; or 

(3) The MRO reported to the agency that the primary (A) specimen was positive, 

adulterated, or substituted but the test was cancelled because the split (B) specimen could 

not be tested or the split specimen failed to reconfirm the primary specimen result; or

(b) At the collection site, an immediate collection of a second urine specimen is 

required because:

(1) The temperature of the specimen collected during a routine collection is outside 

the acceptable temperature range; or
70

(2) The collector suspects that the donor has tampered with the specimen during a 

routine collection (e.g., abnormal physical characteristic such as unusual color and/or odor, 

and/or excessive foaming when shaken). 

(c) The collector must contact a collection site supervisor to review and concur in 

advance with any decision by the collector to obtain a specimen under direct observation. 

(d) If the donor declines to have a direct observed collection, the collector reports a 

refusal to test (i.e., as described in Section 8.13).

Section 8.10 How is a direct observed collection conducted?

(a) A direct observed collection procedure is the same as that for a routine 

collection, except an observer watches the donor urinate into the collection container. The 

observer’s gender must be the same as the donor’s gender, which is determined by the 

donor’s gender identity, with no exception to this requirement. 

(b) Before an observer is selected, the collector informs the donor that the gender of 

the observer will match the donor’s gender, which is determined by the donor’s gender 

identity (as defined in Section 1.5). The collector then selects the observer to conduct the 

observation:

(i) The collector asks the donor to identify the donor’s gender on the Federal CCF 

and initial it. 

(ii) The donor will then be provided an observer whose gender matches the donor’s 

gender. 

(iii) The collector documents the observer’s name and gender on the Federal CCF.

(c) If there is no collector available of the same gender as the donor’s gender, the 

collector or collection site supervisor shall select an observer trained in direct observed 

specimen collection as described in Section 4.4. The observer may be an individual that is 

not a trained collector.

(d) At the point in a routine collection where the donor enters the restroom with the 

collection container, a direct observed collection includes the following additional steps:

(1) The observer enters the restroom with the donor;

(2) The observer must directly watch the urine go from the donor’s body into the 

collection container (the use of mirrors or video cameras is not permitted);
71

(3) The observer must not touch or handle the collection container unless the 

observer is also serving as the collector;

(4) After the donor has completed urinating into the collection container:

(i) If the same person serves as the observer and collector, that person may receive 

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

(ii) If the observer is not serving as the collector, the donor and observer leave the 

restroom and the donor hands the collection container directly to the collector. The 

observer must maintain visual contact of the collection container until the donor hands the 

container to the collector.

(5) The collector checks the box for an observed collection on the Federal CCF and 

writes the name of the observer and the reason for an observed collection on the Federal 

CCF; and

(6) The collector then continues with the routine collection procedure in Section 8.3.

Section 8.11 When is a monitored collection conducted?

(a) In the event that an agency-designated collection site is not available and there is 

an immediate requirement to collect a specimen (e.g., an accident investigation), a public 

restroom may be used for the collection, using the procedures for a monitored collection 

described in Section 8.12.

(b) If the enclosure used by the donor to provide a specimen has a source of water 

that cannot be disabled or secured, a monitored collection must be conducted. 

(c) If the donor declines to permit a collection to be monitored when required, the 

collector reports a refusal to test (i.e., as described in Section 8.13).

Section 8.12 How is a monitored collection conducted?

A monitored collection is the same as that for a routine collection, except that a monitor 

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

tampering with the specimen. The monitor remains in the restroom, but outside the stall, 

while the donor is providing the specimen. A person of the same gender as the donor shall 

serve as the monitor, unless the monitor is a medical professional (e.g., nurse, doctor, 

physician's assistant, technologist, or technician licensed or certified to practice in the 

jurisdiction in which the collection takes place). The same procedures used for selecting an 
72

observer of the appropriate gender in Section 8.10(b) must be used to select the monitor 

for the purposes of Section 8.12, unless the monitor is a medical professional as described 

above. The monitor may be an individual other than the collector and need not be a 

qualified collector. 

(a) The collector secures the restroom being used for the monitored collection so 

that no one except the employee and the monitor can enter the restroom until after the 

collection has been completed.

(b) The monitor enters the restroom with the donor.

(c) The monitor must not watch the employee urinate into the collection container. If 

the monitor hears sounds or makes other observations indicating an attempt by the donor 

to tamper with a specimen, there must be an additional collection under direct observation 

in accordance with Section 8.9. 

(d) The monitor must not touch or handle the collection container unless the monitor 

is also the collector.

(e) After the donor has completed urinating into the collection container:

(1) If the same person serves as the monitor and collector, that person may receive 

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

(2) If the monitor is not serving as the collector, the donor and monitor leave the 

restroom and the donor hands the collection container directly to the collector. The monitor 

must ensure that the employee takes the collection container directly to the collector as 

soon as the employee has exited the enclosure.

(f) If the monitor is not serving as the collector, the collector writes the name of the 

monitor on the Federal CCF.

(g) The collector then continues with the routine collection procedure in Section 8.3.

Section 8.13 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 urine 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, 
73

(b) Documenting the refusal to test including the reason on the Federal CCF, and

(c) Sending all copies of the Federal CCF to the Federal agency’s designated 

representative.

Section 8.14 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 of these Guidelines.

(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 or IITF) and take 

appropriate action which may include a collection site self-assessment (i.e., using the 

Collection Site Checklist for the Collection of Urine 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.