Audit by the DOT here is what you need to prep…
DOT Collector Documentation Auditors Will Request
Auditors almost always begin by verifying that everyone who collects DOT specimens is properly trained and documented. Be prepared to provide DOT training certificates for all current collectors and any former collectors who worked in the lab within the past five years. This includes paper or digital copies that can be produced immediately upon request.
In addition to certificates, auditors commonly ask for collector qualification files, including initial training records, refresher training documentation (if applicable), and any remedial or error-correction training completed after an incident. If a collector has undergone corrective training, auditors may request an affidavit confirming completion of that training, so be sure these affidavits are stored and easy to retrieve.
Auditors may also ask for a current collector roster listing each collector’s name, hire date, DOT status, and role. If your lab uses contract or third-party collectors, their documentation must be available as well.
Random Testing Program Review
Auditors frequently inquire about your random testing program. They are not only checking whether a program exists, but whether it is scientifically valid and properly documented. Be ready to explain your selection method, how names are generated, and how you prevent supervisor or client bias in selections.
They may request proof that random testing rates and annual coverage requirements are met, and they may ask to review recent random selection records. This can include selection lists, notification dates, completion dates, and documentation of any missed or delayed tests along with your follow-up actions. Detailed information and standard expectations for random programs are available in the Fastest Labs University knowledge base, and staff should know how to access it quickly.
Policies, Procedures, and Reference Materials
Auditors want to confirm your lab is operating from current DOT guidance and that collectors know how to apply it. Your lab should have access to up-to-date DOT regulations (Part 40) either in printed form or digitally, and staff should be able to show where they would verify requirements if asked.
Your lab’s DOT Standard Operating Procedures should be current, controlled, and clearly available to collectors. Auditors often review SOPs related to:
- Standard DOT urine collections
- Shy bladder / insufficient specimen procedures
- Refusal to test handling
- Out-of-temperature specimens
- Suspected tampering or adulteration
- Fatal flaw vs. correctable flaw scenarios
- Specimen packaging and shipping
They may also check your document control process to ensure collectors are always using the most recent SOP versions.
Facility Walkthrough and Site Compliance Checks
Auditors conduct a physical walkthrough to ensure your facility matches DOT requirements. This includes inspection of the collection station, restroom, specimen storage areas, and shipping workspace.
Restrooms are a key focus. Auditors verify that privacy standards are met while also confirming the restroom is secured against opportunities for adulteration or substitution. They may check for access to water sources, soap availability (as allowed by protocol), bluing agents placed correctly where required, and removal or securing of items that could compromise specimen integrity. Expect them to note any inconsistency between the restroom setup and your written SOPs.
They also review specimen security. This includes evaluating locked storage, limited access controls, and clear accountability for specimen handling. If you refrigerate specimens, they may ask for temperature logs and incident documentation tied to any out-of-range event.
Inventory and Supply Spot Checks
Auditors often perform spot checks of your collection materials. They verify that you have the correct and current DOT Chain of Custody (COC) forms onsite and that older or expired versions are not being used.
They will also check expiration dates on collection cups, seals, temperature strips, adulterant strips (if applicable), and shipping supplies. Non-DOT rapid test devices should be clearly separated from DOT materials to avoid any risk of misuse.
Chain-of-Custody and Record Sampling
A major part of every audit is traceability. Auditors will pull random COCs from different dates and verify that each collection was documented correctly. They usually review:
- Required fields fully completed
- Proper donor and collector signatures
- Accurate times and temperature readings
- No unapproved alterations
- Correct correction method used when errors occur
- Collector ID matching your roster
- Specimens tied to shipping records properly
They may ask what your lab does during fatal flaw or correctable flaw situations and then look for real examples in your records. Record retention practices are also reviewed, including security, accessibility, and retention timelines.
DOT Collection Demonstrations and Live Observation
Auditors commonly require a full DOT collection demonstration. This might be a standard start-to-finish collection or a more complex scenario involving refusal to test, shy bladder procedures, tampering indicators, or an out-of-temperature specimen.
During demonstrations, auditors focus on both steps and judgment. They observe whether collectors provide correct donor instructions, follow temperature and timing protocols precisely, maintain appropriate privacy boundaries, avoid coaching or leading the donor, and correctly document the process.
Collectors should be prepared for “show me” questions such as where supplies are stored, how to package a specimen, or how to document an unusual event on the COC.