Guide to the Federal Drug Testing Custody and Control Form (CCF)

Overview

The Federal Drug Testing Custody and Control Form (CCF) is a critical document in the DOT drug testing process. It ensures the accurate documentation, handling, and chain of custody for oral fluid specimens collected for DOT-regulated drug testing. This article outlines the proper use, completion, and handling of the CCF to maintain compliance with 49 CFR Part 40 requirements.

Purpose of the CCF

The CCF serves to:

• Document the collection process from start to finish.
• Maintain the integrity of the specimen through a secure chain of custody.
• Ensure accurate communication between collectors, laboratories, Medical Review Officers (MROs), and employers.
• Prevent tampering or misidentification of specimens.

Formats of the CCF

1. Paper CCF

• A five-part carbonless form with designated copies for each party involved in the testing process.

2. Electronic CCF (eCCF)

• A digital version approved by HHS and used by participating laboratories and employers.
• Provides electronic signatures and data entry to reduce errors and streamline the process.

CCF Components and Copies

The CCF consists of five parts, each serving a specific function:

1. Copy 1 - Test Facility: Sent to the laboratory with the specimen.
2. Copy 2 - Medical Review Officer (MRO): Sent to the MRO for review.
3. Copy 3 - Collector: Retained by the collector for recordkeeping.
4. Copy 4 - Employer: Provided to the employer for their records.
5. Copy 5 - Employee: Given to the employee (donor) as a record of the collection.

Completing the CCF

Step 1: Employer and Employee Information

• Employer Details: Name, address, phone number, and fax number (can be pre-printed).
• Employee Details: Full name, ID number or CDL number (for FMCSA-regulated employees), and reason for the test (e.g., pre-employment, random, post-accident).
• Laboratory and MRO Information: Lab name, address, and MRO contact details (can be pre-printed).

Step 2: Collector Actions

• Specimen Type: Mark the correct box for "Oral Fluid."
• Collection Device Expiration Date: Verify and document the expiration date of the collection device.
• Observations: Note any unusual behavior or issues during collection.
• Volume Indicator: Check that the specimen meets the required volume.

Step 3: Specimen Handling

• Tamper-Evident Seals: Apply seals to specimen containers and record the specimen ID number.
• Packaging: Place specimens in a leak-resistant bag with Copy 1 of the CCF.

Step 4: Collector Certification

• Signature and Date: The collector must print and sign their name and record the date and time of collection.
• Courier Service: Document the name of the delivery service handling specimen transport to the lab.

Step 5: Employee Certification

• Employee Acknowledgement: The employee must print and sign their name, provide date of birth, and contact details.
• Refusals: If the employee refuses to sign, the collector must note this in the Remarks section.

Handling Errors on the CCF

• Fatal Flaws: Errors that invalidate the test (e.g., missing signatures, mismatched specimen IDs). The test must be canceled.
• Correctable Flaws: Minor errors that can be resolved (e.g., missing information in the Remarks section). Collectors must correct and document these flaws promptly.

Handling the CCF During Collection

• Ensure all entries are legible and complete before distributing copies.
• Verify that specimen ID numbers on the seals match those on the CCF.
• Avoid making corrections after distributing the CCF copies.

Best Practices for CCF Management

• Double-Check Entries: Review the form before completing the collection to avoid errors.
• Backup Copies: Keep extra paper CCFs available in case of electronic system failures.
• Secure Storage: Store Copy 3 securely for at least 30 days or as required by DOT regulations.

Conclusion

Proper completion and handling of the Federal Drug Testing Custody and Control Form (CCF) are essential to maintaining the integrity of the DOT oral fluid testing process. Collectors must follow detailed procedures to ensure accurate documentation, secure specimen handling, and regulatory compliance. Attention to detail throughout this process is critical to preserving the validity of test results and protecting all parties involved.