Overview
The oral fluid specimen collection process is a critical component of the DOT drug testing program. It must be conducted in strict compliance with 49 CFR Part 40 to ensure the integrity, accuracy, and security of the drug testing process. This article provides a detailed, step-by-step guide for collectors to properly perform oral fluid collections.
Pre-Collection Preparation
1. Secure the Collection Site
- Ensure the site meets DOT security and privacy requirements.
- Restrict access to authorized personnel only.
- Verify that all necessary supplies are available, including:
- Approved oral fluid collection devices
- Custody and Control Forms (CCFs)
- Tamper-evident seals
- Disposable gloves
- Leak-proof specimen transport bags
2. Review Employer Instructions
- Confirm the employer's standing orders regarding specimen type.
- Verify the designated laboratory and Medical Review Officer (MRO) information.
Collection Process
3. Employee Verification
- Request a valid, government-issued photo ID from the employee.
- If no valid ID is available, contact the DER for verification.
4. Explain the Collection Procedure
- Clearly explain the collection process to the employee.
- Provide instructions for completing the CCF.
5. Pre-Collection Employee Preparation
- Instruct the employee to:
- Remove unnecessary outer clothing (e.g., jackets, hats).
- Leave personal items in a secure area (retain their wallet).
- Wash or sanitize their hands.
- Empty their mouth of any items (e.g., gum, candy).
6. Inspect the Oral Cavity
- Ask the employee to open their mouth.
- Use a flashlight if necessary to check for foreign objects.
- If foreign items are present, provide water for rinsing and wait 10 minutes before starting.
7. Select and Inspect the Collection Device
- Choose an approved, non-expired collection device.
- Show the expiration date to the employee.
8. Collect the Specimen
- Follow the manufacturer’s instructions for using the device.
- Ensure the employee properly positions the collection device.
- Monitor the collection until a sufficient volume of oral fluid is collected.
9. Handle Insufficient Specimen Volume
- If the initial collection is insufficient, provide up to 8 oz. of water and wait 10 minutes before reattempting.
- If the employee cannot provide a sufficient specimen after the second attempt, follow employer instructions or contact the DER for further action.
10. Secure the Specimen
- Apply tamper-evident seals over the specimen container lids.
- Have the employee initial the seals.
11. Complete the Custody and Control Form (CCF)
- Confirm the following sections are completed:
- Employee and employer information (Step 1)
- Collector details and specimen information (Step 2 & Step 4)
- Employee certification and signature (Step 5)
- Document any issues in the Remarks section.
12. Prepare the Specimen for Shipment
- Place the specimen and Copy 1 of the CCF into a leak-proof transport bag.
- Seal the bag and prepare it for shipment to the designated laboratory within 24 hours.
13. Distribute CCF Copies
- Copy 1: Laboratory (with the specimen)
- Copy 2: Medical Review Officer (MRO)
- Copy 3: Collector (retain for at least 30 days)
- Copy 4: Employer
- Copy 5: Employee
Post-Collection Procedures
14. Employee Departure
- Once the specimen is secured and documentation is complete, inform the employee that the collection is finished and they may leave.
15. Specimen Transport
- Ensure the specimen is shipped promptly to the correct laboratory.
- Use a secure courier or delivery service.
Best Practices
- Double-check all documentation before the employee leaves.
- Maintain direct observation of the specimen until it is sealed.
- Store all collector copies of the CCF securely.
- Follow manufacturer instructions carefully for each collection device.
Conclusion
By following these step-by-step oral fluid collection procedures, collectors can ensure compliance with DOT regulations and maintain the integrity of the drug testing process. Proper execution of each step helps protect the safety, fairness, and accuracy of DOT-regulated drug testing programs.
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