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 Oral Fluid Specimens 

for

Federal Agency Workplace Drug Testing Programs

Effective October 10, 2023

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 using Oral Fluid (88 FR 

70814) dated October 12, 2023 (effective October 10, 2023). 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).
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Table of Contents

Instructions........................................................................................................................... 4 

Checklist .................................................................................................................... 4 

Section Evaluation..................................................................................................... 4 

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

A. Collection Site................................................................................................................. 6 

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

B. Personnel......................................................................................................................... 9 

Collectors .................................................................................................................. 9 

Collector Trainers .................................................................................................... 10

Section Evaluation................................................................................................... 12

C. Specimen Collection Procedures ................................................................................ 13

Completion of a Collection....................................................................................... 15

Section Evaluation................................................................................................... 18

D. Collection Problems .................................................................................................... 19

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

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

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

Section Evaluation................................................................................................... 22

E. Collection Site Records.................................................................................................. 23

Section Evaluation................................................................................................... 24

Collection Site Evaluation Form ......................................................................................... 25
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References

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

1. Federal Custody and Control Form (Federal CCF)

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

Testing Programs (HHS Oral Fluid Collection Handbook)

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

(OFMG). Published October 12, 2023 (88 FR 70814), effective October 10, 2023. 
4

Instructions

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

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

Programs using Oral Fluid (OFMG) published on October 12, 2023 (effective October 10, 

2023). 

This Collection Site Checklist is designed to assist the Drug Program Coordinator (DPC) 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 an HHScertified laboratory) and take appropriate action, which may include an onsite or virtual

inspection or collection site self-evaluation using the Collection Site Checklist for Collection of 

Oral Fluid Specimens for Federal Agency Workplace Drug Testing Programs and the HHS 

Oral Fluid Specimen Collection Handbook for Federal Agency Workplace Drug Testing 

Programs. 

Checklist 

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

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

OFMG subparts D, E, F, G and H. 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.
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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.
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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 laboratory 

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 or 

substitute the specimen, or otherwise adversely affect the 

oral fluid collection 

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

agency oral fluid 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

 
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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 laboratory who can link the 

donor with the specimen drug test results 

____ e. Relatives or personal friends of the donor
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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:

 
9

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 OFMG, the manufacturer instructions for each oral 

fluid collection device that will be used by the collector for the 

Federal agency specimens, 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 for each collection device used

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 using each type of 

collection device to be used for Federal agency specimens

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

____ c. Problem collections

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

collections
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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

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. Two uneventful scenarios 

____ b. One insufficient specimen quantity scenario

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

CCF 

____ d. One scenario in which the donor refuses to initial the tamperevident tube 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 OFMG, the HHS Oral Fluid Collection Handbook, the 

manufacturer instructions for the specific collection device(s) and any 
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other guidance 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.

 

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 using the 

specific collection device(s), 

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

by an organization (e.g., manufacturer, private entity, contractor, or 

Federal agency), including training on the specific collection 

device(s)

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

every five years from the date of initial training? NA YES NO
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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:
13

C. Specimen Collection Procedures

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

or substitution of a specimen? YES NO

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
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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)

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

briefcase, purse) with the outer clothing 

If the collector will not keep the donor under direct observation until the 

end of the collection:

 

____ 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 

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

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

cavity prior to beginning specimen collection 

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

has abnormally colored saliva, or indicates they have “dry 

mouth”, provide water to the donor to rinse. Begin 10-minute 

wait period after donor has rinsed their mouth

____ g. 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 review the procedures for a successful oral fluid 

specimen collection as detailed in the device-specific manufacturer’s 
15

instructions? YES NO

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. Does the collector remain present and maintain visual contact with the 

donor during the entire collection process? YES NO

If NO, check the deficient area(s):

____ a. Ensure the donor has positioned the specimen collection 

device properly for collection

____ b. Ensure the collection is performed correctly

____ c. Ensure collection device is working properly

Completion of a Collection

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

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

of undiluted [neat] oral fluid for tube B) for the following types of split 

specimen collections? YES NO

If NO, check the deficient area(s):

____ a. Two specimens collected simultaneously using two separate collection 

devices

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

____ c. Two specimens collected simultaneously using a single collection device 

that splits the specimen into two separate collection tubes

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

subdivided into two specimen tubes. 

C-17. Does the collector inspect the collected specimen for signs that it may 

not be a valid oral fluid specimen? YES NO
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C-18. Does the collector complete the required information in Step 2 of the 

Federal CCF? YES NO

C-19. Does the collector report a refusal if the donor refuses to complete the 

collection? YES NO

C-20. In the presence of the donor, does the collector place the appropriate 

tamper-evident label/seal from the Federal CCF over the lid/cap of 

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

destroying the label/seal? YES NO

C-21. If the tamper-evident label/seal does not adhere to the tube or is 

damaged, does the collector apply the unacceptable label/seal to the 

tube, and apply a second, separate tamper-evident seal to seal the 

specimen tube? YES NO

C-22. Does the collector record the date of the collection on the tube seals 

after placing them on the tubes? YES NO

C-23. Does the collector instruct the donor to initial the specimen tube seals 

after placing them on the tubes? YES NO

C-24. 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-25. Does the collector complete the collector chain of custody section and 

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

of the Federal CCF? YES NO

C-26. Does the collector place the sealed specimen tubes inside the leakresistant container, seal the container, and include Copy 1 in the 

package with the specimen (i.e., in a compartment separate from the 

specimen tubes)? YES NO

C-27. Does the collector provide Copy 5 of the Federal CCF to the donor? YES NO

C-28. Does the collector prepare the sealed tamper-resistant package

containing the specimen tubes and Federal CCF for transport to the
17

HHS-certified laboratory? YES NO

C-29. Are the specimen tubes and Federal CCF appropriately safeguarded 

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

 

C-30. Does the collector send Copy 2 of the Federal CCF to the Medical 

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

designated representative after the collection? YES NO

 

C-31. Are specimens submitted to an HHS-certified laboratory within 24 

hours after the collection or during the next business day? YES NO
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Section Evaluation

C-32. 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:
19

D. Collection Problems

Insufficient Specimen – Questions D-1 through D-4 pertain to collections where the 

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

D-1. Does the collector attempt an oral fluid collection when the donor 

states they are unable to provide a specimen? YES NO

 

If NO, check the deficient step(s):

____ a. Requests that the donor follow the instructions for the specific 

collection device and attempt to provide an oral fluid 

specimen

____ b. Provides a drink (up to 8 oz.) when the donor indicates they 

may provide a specimen after drinking fluids

____ c. Allows a wait period up to 1 hour for the donor to provide a 

sufficient oral fluid specimen

 

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

designated by the collector) during the wait period

D-2. Does the collector record each failed collection attempt on the 

Remarks line of the Federal CCF? YES NO

D-3. 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 one

hour from the time of the donor’s first attempt 

D-4. 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
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____ c. Notify the agency’s designated representative for

authorization to collect an alternate specimen or follow the

standard protocol from the Federal agency

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

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

collected) and maintain Copy 3 in the collection records

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

or the next business day:

• Send Copy 2 to the MRO

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

Refusal to Test

D-5. 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., oral fluid 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 rinse mouth when directed by the 

collector, refuses to provide a split specimen) 

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

purpose of adulterating, substituting, or diluting the specimen 

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

specimen 

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

or substituted their specimen
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D-6. When reporting a “refusal to test,” does the collector take the following 

steps? YES NO

If NO, check the deficient step(s):

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

____ b. Immediately notify the agency’s designated representative of 

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

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

signature, and date in the Remarks line of Step 2 of the 

Federal CCF

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

designated representative

Collector Errors

D-7. When the collector realizes that an incorrect or expired Federal 

CCF was used prior to packaging the specimen tubes, does the 

collector document on the form that the specimen is a Federal

agency specimen and provide the reason for the incorrect form? YES NO

D-8. Does the collector provide a memorandum for the record (MFR) 

when requested by the HHS-certified laboratory or MRO? YES NO

 
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Section Evaluation

D-9. 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:
23

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
24

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:
25

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: __________________________________________________________