Medical Ethics, Health Law, and Clinical Practice Standards
This domain tests informed consent, confidentiality, record keeping, prescribing, infection control, licensure and professional conduct under Chinese law and clinical standards.
Consent and communication
Valid informed consent requires capacity, adequate information (nature, risks, alternatives, consequences of refusal) and voluntariness, with documentation in the record. Minors and patients lacking capacity require a legal guardian. Emergency treatment may proceed without consent when the patient cannot consent and delay would endanger life. Confidentiality is a duty, not an absolute one: statutory reporting, court order and risk to third parties are recognised exceptions.
Records, prescribing, infection control
- Under 《医疗机构病历管理规定》, outpatient records are kept at least 15 years and inpatient records at least 30 years; the record is the practitioner's legal evidence.
- Prescribing follows 《处方管理办法》: narcotics and psychotropics require special prescription forms with strict quantity limits and mandated retention periods.
- Sterilisation: autoclave at 121 °C for 15–20 minutes or 134 °C for 4 minutes, with biological spore monitoring; handpieces are sterilised between patients; standard precautions apply to every patient.
Worked example
A dental nurse sustains a needlestick from a patient known to be HBsAg-positive. Her records show full vaccination with anti-HBs above 10 mIU/mL. A protective titre means no post-exposure prophylaxis is needed; take a baseline sample and document. If she were unvaccinated or a non-responder, give hepatitis B immunoglobulin plus a vaccine course. HIV exposure requires antiretroviral prophylaxis started within about two hours.
Traps
Assuming confidentiality overrides a lawful public health or police request; treating a minor without a guardian; quoting 15 years for inpatient records; relying on an unmonitored autoclave cycle.