SM Professional Ethics & Standards 3 — Questions and Answers
Question 1: A clinical microbiologist receives a subpoena for laboratory records related to a malpractice case. The correct response is to:
- Destroy records older than one year before compliance
- Consult the institution's legal counsel and provide records as directed (Correct answer)
- Release records only to the patient, not the court
- Refuse on the grounds of laboratory confidentiality
Correct answer: Consult the institution's legal counsel and provide records as directed
A valid subpoena is a legal order; the appropriate response is to consult institutional legal counsel and comply in accordance with legal guidance.
Question 2: Which standard-setting body establishes the performance standards for clinical laboratory testing that directly inform ethical quality practice in microbiology?
- FDA Center for Drug Evaluation and Research
- Clinical and Laboratory Standards Institute (CLSI) (Correct answer)
- Environmental Protection Agency (EPA)
- Occupational Safety and Health Administration (OSHA)
Correct answer: Clinical and Laboratory Standards Institute (CLSI)
CLSI develops consensus-based standards for laboratory testing methods and performance, which form the technical and ethical baseline for quality microbiology practice.
Question 3: A microbiologist identifies a critical value (e.g., gram-positive cocci in CSF) but cannot reach the ordering physician. The ethical and regulatory standard requires:
- Documenting the attempt and waiting until morning rounds
- Continuing to attempt contact and escalating through nursing or on-call providers, documenting all steps (Correct answer)
- Contacting the patient directly with the result
- Holding the result until the next shift
Correct answer: Continuing to attempt contact and escalating through nursing or on-call providers, documenting all steps
CLIA and institutional policy require persistent, documented escalation attempts to ensure critical values reach a responsible caregiver promptly.
Question 4: When a laboratory method is validated, which ethical obligation is fulfilled by the validation process?
- Nonmaleficence—ensuring the test does not harm patients through inaccurate results (Correct answer)
- Autonomy—allowing patients to choose their preferred test method
- Justice—ensuring equal access to testing regardless of payer status
- Fidelity—maintaining loyalty to the reagent manufacturer
Correct answer: Nonmaleficence—ensuring the test does not harm patients through inaccurate results
Method validation is rooted in nonmaleficence by confirming that analytical performance meets standards before patient results are reported.
Question 5: A microbiologist is asked to sign off on quality control records they did not personally review. This practice is:
- Acceptable if a supervisor requests it
- A form of record falsification and an ethical violation (Correct answer)
- Standard practice when staffing is short
- Permitted under CLIA's risk-based approach
Correct answer: A form of record falsification and an ethical violation
Signing records for work not personally verified constitutes falsification and violates both professional ethics and CLIA regulatory requirements.
Question 6: A microbiologist working in a BSL-3 facility notices a colleague consistently bypassing decontamination procedures. The FIRST obligation is to:
- Report immediately to the biosafety officer (Correct answer)
- Post a reminder sign in the laboratory
- Ignore it because it is the colleague's personal risk
- Wait to see if an incident occurs before reporting
Correct answer: Report immediately to the biosafety officer
Biosafety violations in high-containment settings pose immediate risk to colleagues, the community, and the environment, requiring immediate reporting to the biosafety officer.
Question 7: A laboratory scientist discovers their employer is billing Medicare for tests not performed. Under federal whistleblower protection, the employee who reports this is protected by:
- The Fair Labor Standards Act (FLSA)
- The False Claims Act (FCA) qui tam provisions (Correct answer)
- HIPAA Security Rule
- The Clinical Laboratory Improvement Act
Correct answer: The False Claims Act (FCA) qui tam provisions
The False Claims Act protects and financially incentivizes employees (relators) who report fraudulent Medicare/Medicaid billing to the federal government.
SM Professional Ethics & Standards 3
A clinical microbiologist receives a subpoena for laboratory records related to a malpractice case.
The correct response is to: