CSC Legal & Ethical Standards in Specimen Collection 3 — Questions and Answers
Question 1: A donor refuses to sign the chain of custody form after providing a specimen. The collector should:
- Discard the specimen and reschedule
- Note the refusal on the form, sign as witness, and proceed with the collection (Correct answer)
- Refuse to process the specimen until the donor signs
- Contact law enforcement immediately
Correct answer: Note the refusal on the form, sign as witness, and proceed with the collection
If a donor refuses to sign the CCF, the collector notes the refusal, signs as a witness, and continues processing the specimen.
Question 2: Under ADA considerations, a collector who refuses to accommodate a donor's documented disability during specimen collection may be exposing the employer to:
- OSHA citations only
- Criminal fraud charges
- Discrimination liability under the Americans with Disabilities Act (Correct answer)
- CLIA non-compliance penalties
Correct answer: Discrimination liability under the Americans with Disabilities Act
Failure to provide reasonable accommodations for a donor with a documented disability can constitute discrimination under the ADA.
Question 3: Which ethical principle is violated when a collector shares a donor's test result at a social gathering?
- Autonomy
- Beneficence
- Confidentiality (Correct answer)
- Justice
Correct answer: Confidentiality
Confidentiality requires that health-related information obtained during professional activities not be disclosed outside authorized channels.
Question 4: A collection site must retain CCF copies for a minimum of how many years under DOT regulations?
- 1 year
- 2 years
- 5 years (Correct answer)
- 10 years
Correct answer: 5 years
DOT 49 CFR Part 40 requires collection sites to retain copies of the CCF for a minimum of two years — but employers must keep MRO-reported results for five years.
Question 5: A donor asks the collector to backdate the collection time on the CCF to avoid a late positive result. The collector should:
- Comply if the donor provides a medical reason
- Refuse and document the request (Correct answer)
- Alter the time and report it to the MRO privately
- Leave the time blank to avoid conflict
Correct answer: Refuse and document the request
Falsifying any information on the CCF is illegal; the collector must refuse and document the donor's request.
Question 6: The concept of "chain of custody" in specimen collection primarily ensures:
- The specimen was collected in a sterile environment
- The specimen's integrity and identity are legally defensible from collection through reporting (Correct answer)
- The donor paid for the test
- The laboratory used certified equipment
Correct answer: The specimen's integrity and identity are legally defensible from collection through reporting
Chain of custody provides a documented record that the specimen was not tampered with and belongs to the identified donor.
Question 7: A non-DOT employer asks a collector to conduct an observed collection without a valid reason. The collector should:
- Comply because the employer pays for the service
- Refuse and explain that observation requires specific justification (Correct answer)
- Conduct the observed collection and document the employer's verbal instruction
- Conduct the observation only if the donor consents
Correct answer: Refuse and explain that observation requires specific justification
Observed collections require specific valid reasons (e.g., prior substitution or adulteration); conducting observation without cause violates donor dignity and applicable guidelines.
A donor refuses to sign the chain of custody form after providing a specimen.
The collector should: