Regulatory Compliance, Ethics, and Professional Conduct
Core concepts
Regulatory compliance includes accreditation standards, personnel requirements, competency assessment, and record retention. Candidates should understand the roles of the laboratory director, supervisor, and testing personnel, and the distinction between waived, moderate, and high-complexity testing.
Ethics and conduct
Know patient confidentiality, informed consent, conflict of interest, and research ethics. Understand the obligation to report errors and near-misses, and the prohibition on altering results or falsifying records. Recognize that competency assessment and continuing education are professional obligations.
Traps in questions
- Assuming confidentiality ends when a patient is discharged.
- Confusing the roles of director and supervisor.
- Overlooking the requirement to document competency assessment.
- Treating waived testing as exempt from quality oversight.
Worked rule of thumb
When a question describes pressure to release an unverified result, the correct action is to follow the established reporting procedure and escalate through the chain of command. When in doubt, document and report rather than conceal.
Study guidance
Map each regulation to the responsible role and the required documentation. Most items test whether you can identify the correct authority or record.