1 

Department of Health and Human Services

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Prevention

Collection Site Checklist

For the

Collection of Urine Specimens for

Federal Agency Workplace Drug Testing Programs

Effective October 1, 2017

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

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

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

Mandatory Guidelines for Federal Workplace Drug Testing Programs (82 FR 7920) dated 

January 23, 2017 (effective October 1, 2017). 

This checklist 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).
2 

Table of Contents

Instructions........................................................................................................................... 3

Checklist.................................................................................................................... 3

Section Evaluation..................................................................................................... 3

Collection Site Evaluation Form................................................................................. 4

A. Collection Site................................................................................................................. 5

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

B. Personnel......................................................................................................................... 8

Collectors .................................................................................................................. 8

Collector Trainers ...................................................................................................... 9

Section Evaluation................................................................................................... 11

C. Specimen Collection Procedures............................................................................. 12

Completion of a Collection....................................................................................... 14

Section Evaluation................................................................................................... 16

D. Collection Problems................................................................................................. 17

Direct Observed Collections .................................................................................... 17

Monitored Collections .............................................................................................. 18

Insufficient Specimen .............................................................................................. 19

Refusal to Test ........................................................................................................ 20

Collector Errors........................................................................................................ 21

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

E. Collection Site Records.................................................................................................. 24

Section Evaluation................................................................................................... 25

Collection Site Evaluation Form ......................................................................................... 26
3 

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 (HHS Mandatory Guidelines) published on January 23, 2017 (effective October 1, 

2017). 

This Collection Site Checklist 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 (e.g. specimens reported as “rejected for testing” by a HHS-certified testing 

facility) and take appropriate action, which may include an onsite inspection, or virtual, 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. 

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. Answer each question based on these 

requirements and your review of the collection site standard operating procedures, practice, 

and records. 

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. Use the section evaluation to 

summarize and classify the seriousness of identified deficiencies. 

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.
4 

Collection Site Evaluation Form

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.
5 

A. Collection Site

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

the specimen collection procedure? YES NO

 

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 

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)

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

regulated urine specimen collections? YES NO

A-5. Is access to collection supplies restricted to authorized personnel? YES NO

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

 
6 

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

A-7. Does the collection site have procedures to prohibit the following 

individuals from serving as a specimen collector? YES NO

If NO, identify the deficient area(s):

____ a. Hiring official or donor’s immediate supervisor unless there is 

no feasible alternative and the individual is a trained collector

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

donor on a daily basis

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

____ d. Employee of an HHS-certified Instrumented Initial Test 

Facility (IITF) or HHS-certified laboratory who can link the 

donor with the specimen drug test results 

____ e. Relatives or close personal friends of the donor
7 

Section Evaluation

A-8. For the Collection Site Section: 

____ Serious deficiencies were identified

____ Deficiencies were identified

____ No deficiencies were identified

Note: 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:

 
8 

B. Personnel

Collectors

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

demonstrate a working knowledge of the collection procedures 

described in the HHS Mandatory Guidelines 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.

 

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.

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

B-3. Does each collector maintain their training documentation? YES NO

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

specimens for a federal agency? YES NO

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

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

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

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

____ c. Problem collections

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

collections
9 

____ 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

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 tamperevident bottle label/seal

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

following? YES NO

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

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

by means allowing real-time observation and interaction 

between trainer and trainee. 

____ b. Written attestation by the trainer that the mock collections 

were error-free. 

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

training.

Collector Trainers

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

collector trainers.

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

demonstrate a working knowledge of the collection procedures 

described in the HHS Mandatory Guidelines and any other guidance 
10 

provided by the federal agency related to the collection procedures? YES NO

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.

 

Complete the remaining Section B questions for the records provided.

B-11. Does each trainer maintain their training documentation? YES NO

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)

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

every five years from the date of initial training? YES NO
11 

Section Evaluation

B-14. For the Personnel Section: 

____ Serious deficiencies were identified

____ Deficiencies were identified

____ No deficiencies were identified

Note: 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:
12 

C. Specimen Collection Procedures

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

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

arrives at the collection site? YES NO

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

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

time? YES NO

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

C-6. Does the collector provide identification to the donor when requested? YES NO

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
13 

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

that the donor has about the collection process? YES NO

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

Federal CCF? YES NO

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 or in another secured 

location 

____ 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 appears 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 

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

donor on the Federal CCF? YES NO

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 
14 

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

during the collection procedure? YES NO

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

specimen? YES NO

 

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

Completion of a Collection

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

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

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

by examining the physical characteristics of the urine? YES NO

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

specimen contains at least 45 mL of urine? YES NO

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

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

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

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

collector apply the unacceptable label/seal to the bottle, and apply a 
15 

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

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

after placing them on the bottles? YES NO

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

after placing them on the bottles? YES NO

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

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

Step 4 on Copy 1 of the Federal CCF? YES NO

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

C-29. Does the collector provide Copy 5 of the Federal CCF to the donor? YES NO

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

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

 

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

 

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 
16 

Section Evaluation

C-34. For the Specimen Collection Procedures Section: 

____ Serious deficiencies were identified

____ Deficiencies were identified

____ No deficiencies were identified

Note: 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:
17 

D. Collection Problems

Direct Observed Collections

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

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

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 
18 

____ 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

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 

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

Monitored Collections

 

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

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
19 

• 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 

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

Insufficient Specimen

D-9. When the donor has demonstrated that they are unable to provide 

a sufficient specimen, does the collector offer the donor a 

reasonable amount of fluid to drink (e.g., an 8 ounce glass of water 

every 30 minutes, not to exceed 40 ounces over a period of 3 

hours)? YES NO

 

D-10. Does the collector allow the donor up to three hours to provide a 

sufficient specimen? YES NO 

 

D-11. Do collection procedures prohibit combining urine collected from 

separate voids to create a specimen of sufficient volume? YES NO

 

D-12. Does the donor remain under the direct observation of the collector to 

prevent the donor from possibly compromising the collection process? YES NO

 

D-13. 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

D-14. Does the collector discontinue the collection procedure in the following 

situations? YES NO 

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

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

hours from the time of the donor’s first attempt 

D-15. When the donor has not provided a sufficient specimen, does the 

collector end the collection procedure and take the following steps? YES NO 
20 

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)

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

collected) and maintain Copy 3 in the collection records

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

or the next business day:

• Send Copy 2 to the MRO

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

Refusal to Test

D-16. Does the collector report a “refusal to test” in the following situations? YES NO

If NO, check the deficient area(s):

____ a. The donor fails to appear for any test (except a preemployment test) within a reasonable time as determined by 

the federal agency 

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

authorized alternate specimen type)

____ c. 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)

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

required
21 

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

the direct observed collection

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

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

purpose of adulterating, substituting, or diluting the specimen

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

specimen

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

collection (except for leaving before the collection has begun 

for a pre-employment test)

____ 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

D-17. 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

Collector Errors

D-18. 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
22 

D-19. 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

 
23 

Section Evaluation

D-20. For the Collection Problems Section: 

____ Serious deficiencies were identified

____ Deficiencies were identified

____ No deficiencies were identified

Note: 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 

E. Collection Site Records

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

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

ensures donor confidentiality? YES NO

E-3. Have collectors properly completed the Federal CCF? YES NO

E-4. Are edits to the Federal CCF properly made, initialed and dated? YES NO
25 

Section Evaluation

E-5. For the Collection Site Records Section:

____ Serious deficiencies were identified

____ Deficiencies were identified

____ No deficiencies were identified

Note: 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:
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)

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: __________________________________________________________

26