CSC Legal & Ethical Standards in Specimen Collection 2 — Questions and Answers
Question 1: Under HIPAA, which action by a specimen collector constitutes a privacy breach?
- Sharing a donor's test result with their employer without written authorization (Correct answer)
- Recording a donor's name in a chain of custody document
- Asking a donor to show a photo ID before collection
- Logging specimen temperature during transport
Correct answer: Sharing a donor's test result with their employer without written authorization
HIPAA prohibits disclosing protected health information, including test results, to employers without the donor's written authorization.
Question 2: A collector discovers a colleague has been accepting gifts from donors in exchange for not witnessing a urine collection. This is best described as:
- A minor procedural deviation
- Specimen adulteration conspiracy
- Fraudulent activity that must be reported (Correct answer)
- An acceptable accommodation if documented
Correct answer: Fraudulent activity that must be reported
Accepting gifts to bypass required observation constitutes fraud and must be reported to supervisors or the appropriate regulatory body.
Question 3: Which federal regulation specifically governs workplace drug testing procedures for DOT-regulated industries?
- OSHA 29 CFR 1910
- DOT 49 CFR Part 40 (Correct answer)
- CLIA 42 CFR Part 493
- HIPAA 45 CFR Part 164
Correct answer: DOT 49 CFR Part 40
DOT 49 CFR Part 40 establishes procedures for transportation workplace drug and alcohol testing programs.
Question 4: A donor claims a medical condition prevents them from providing the required urine volume. The collector should:
- Waive the collection and mark the form complete
- Follow the "shy bladder" protocol outlined in 49 CFR Part 40 (Correct answer)
- Accept any volume the donor can produce without documentation
- Immediately report the donor for refusal
Correct answer: Follow the "shy bladder" protocol outlined in 49 CFR Part 40
When a donor cannot produce sufficient volume, the collector must follow the shy bladder protocol, allowing up to three hours for the donor to try again.
Question 5: Informed consent in specimen collection means the donor has been told:
- Only the collection site address and hours of operation
- The purpose of the test, what substances are being tested, and how results will be used (Correct answer)
- The identity of the laboratory analyzing the specimen
- The names of all staff present during collection
Correct answer: The purpose of the test, what substances are being tested, and how results will be used
Informed consent requires disclosure of the test's purpose, the substances being screened, and how the results will be used.
Question 6: A collector notices a donor attempting to substitute a specimen with a synthetic urine product. The correct action is to:
- Allow the collection to proceed and note suspicions privately
- Confiscate the product and dismiss the donor
- Document the observed tampering and report it as a refusal to test (Correct answer)
- Test the synthetic urine and report results normally
Correct answer: Document the observed tampering and report it as a refusal to test
Attempted substitution is treated as a refusal to test under federal guidelines and must be documented on the chain of custody form.
Question 7: Which document serves as the primary legal record linking a specimen to a specific donor throughout the testing process?
- Laboratory accreditation certificate
- Collector training certificate
- Federal Drug Testing Custody and Control Form (CCF) (Correct answer)
- Employer drug policy handbook
Correct answer: Federal Drug Testing Custody and Control Form (CCF)
The CCF is the legal document that tracks specimen identity and integrity from collection through laboratory analysis.
Under HIPAA, which action by a specimen collector constitutes a privacy breach?