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 January 2022 

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 (84 FR 57554) dated 

October 25, 2019 (effective January 1, 2020). 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). 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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..................................................................................................... 11 

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

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

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

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

D. Collection Problems..................................................................................................... 18 

Insufficient Specimen............................................................................................... 18 

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 25, 2019 (84 FR 57554), effective January 1, 2020. 

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Instructions 

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

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

Programs using Oral Fluid (OFMG) published on October 25, 2019 (effective January 1, 2020). 

This Collection Site 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 

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

problem or issue arises during a collection? 

YES NO 

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

serving as a specimen collector? 

YES NO 

If NO, identify the deficient area(s): 

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

alternative and the individual is a trained collector 

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

basis 

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

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

specimen drug test results 

e. Relatives or close personal friends of the donor 

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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: 

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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 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? 

YES NO N/A 

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

the following subjects? 

YES NO 

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

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

device to be used for federal agency specimens 

b. The proper completion and distribution of the Federal CCF 

c. Problem collections 

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

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

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

specimens, and to maintain proper conduct 

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 tamper-evident 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. 

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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 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. 

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 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? 

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: 

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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 

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 

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

YES NO 

If NO, check the deficient step(s): 

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

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

beginning specimen collection

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

colored saliva, or indicates they have “dry mouth”, provide water to the donor

to rinse. Begin 10-minute wait period after donor has rinsed their mouth

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 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

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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 complete the required information in Step 2 of the Federal CCF? 

YES NO 

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

YES NO 

C-19. In the presence of the donor, does the collector place the appropriate tamperevident 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-20. If the tamper-evident label/seal does not adhere to the tube or is damaged, does the 

collector apply the unacceptable label/seal to the tube, and apply a second, separate 

tamper-evident seal to seal the specimen tube? 

YES NO 

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

them on the tubes? 

YES NO 

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

on the tubes? 

YES NO 

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

statement and to fill out the donor portion in Step 5 on Copy 2 of the Federal CCF? 

YES NO 

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

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

YES NO 

C-25. Does the collector place the sealed specimen tubes inside the leak-resistant

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

YES NO 

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

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

YES NO 

C-28. Are the specimen tubes and Federal CCF appropriately safeguarded until they are

retrieved for transport to the HHS-certified laboratory? 

YES NO 

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

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

after the collection? 

YES NO 

C-30. 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-31. 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: 

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D. Collection Problems

Insufficient Specimen – Questions D-1 through D-7 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 in the event the donor states they

are unable to provide a specimen? 

YES NO 

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

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

(e.g., up to 8 ounces of water)? 

YES NO 

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

YES NO 

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

site during the wait period? 

YES NO 

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

Federal CCF? 

YES NO 

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

YES NO 

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

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

of the donor’s first attempt

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

collection procedure and take the following steps? 

YES NO 

If NO, check the deficient area(s): 

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

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

Step 2 of the Federal CCF 

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

alternate specimen or follow the standard protocol from the federal agency 

d. Discard the oral fluid collected (if any) 

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

maintain Copy 3 in the collection records 

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

business day: 

• Send Copy 2 to the MRO 

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

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Refusal to Test 

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

YES NO 

If NO, check the deficient area(s): 

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

reasonable time as determined by the federal agency 

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

(except for leaving before the collection has begun for a pre-employment 

test) 

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

alternate specimen type) 

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

it has been determined through a required medical evaluation that there is no 

legitimate medical explanation for the failure 

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

(e.g., urine) 

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

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

when directed by the collector, refuses to provide a split specimen) 

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

adulterating, substituting, or diluting the specimen 

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

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

their specimen 

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

YES NO 

If NO, check the deficient step(s): 

a. Discard the oral fluid collected (if any) 

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

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

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

in the Remarks line of Step 2 of the Federal CCF 

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

representative 

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Collector Errors 

D-10. When the collector realizes that an incorrect or expired Federal CCF was used prior 

to packaging the specimen tubes, does the collector document on the form that the 

specimen is a federal agency specimen and provide the reason for the incorrect 

form? 

YES NO 

D-11. 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-12. 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: 

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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 

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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: 

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Section

 

 

 

 

 

 

 

 

 

 

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: 

Onsite Inspection by: 

Approved by: 

Position/Title: 

Date 

Date 

Date 

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