Unit 1: Ethics, GLP and safety
Medical Laboratory Management notes · PTU syllabus (BMLS503-18)
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Unit summary
A medical laboratory serves patients ethically, follows good laboratory practice and protects its staff. This unit covers ethical principles for laboratory professionals, Good Laboratory Practice and accreditation, general safety, HIV and hepatitis B and C pre- and post-exposure guidelines, and drug-resistant tuberculosis.
After this unit you can
- Apply ethical principles towards patients, colleagues and society
- Explain GLP and laboratory accreditation
- Follow safety and post-exposure prophylaxis guidelines
- Handle drug-resistant tuberculosis samples safely
PTU syllabus topics
- Ethical principles and standards for clinical laboratory professionals (duty to patient, colleagues, society)
- Good Laboratory Practice and accreditation — aims
- advantages and national/international accrediting agencies
- general safety precautions
- HIV and Hepatitis B/C pre- and post-exposure guidelines
- drug-resistant tuberculosis
NABL (India)
Accredits medical labs
ISO 15189
Quality and competence of medical labs
GLP
Good Laboratory Practice principles
CAP
International accreditation (USA)
Topic 1
Ethical principles and standards
To the patient
Accurate, timely results; confidentiality; respect and consent
Never disclose HIV results without authorisation
To colleagues and the profession
Honesty, cooperation, sharing knowledge, maintaining competence
Report errors; mentor juniors
To society
Public health reporting, responsible use of resources, research integrity
Notify dengue, TB, cholera to authorities
- Core principles: beneficence, non-maleficence, autonomy (consent), justice (equal service), confidentiality and integrity.
Topic 2
Good Laboratory Practice and accreditation
- GLP: a quality system covering organisation, processes and conditions under which studies and tests are planned, performed, monitored, recorded and reported — ensuring reliable, reproducible results.
- Quality
- Standardised, reliable results
- Confidence
- Trust of doctors, patients and insurers
- Competence
- Third-party assessment of staff and methods
- Improvement
- Continuous audits and corrective actions
- Recognition
- Required for empanelment (CGHS, insurers) and international acceptance
NABL (National Accreditation Board for Testing and Calibration Laboratories)
Medical laboratories to ISO 15189
India (under QCI)
NABH
Hospitals, including their labs
India
CAP (College of American Pathologists)
Laboratory accreditation
International
ISO 15189
International standard for medical laboratories
Global
ILAC
Mutual recognition of accreditation bodies
International
Topic 3
General safety precautions
- Universal precautions; PPE; vaccination; no eating, drinking or smoking in the lab; biosafety cabinets for aerosols; chemical safety with MSDS; fire safety drills; electrical safety; safe sharps handling; incident reporting.
Topic 4
HIV and hepatitis B and C: pre- and post-exposure guidelines
Hepatitis B
Three-dose vaccine; check anti-HBs (protective 10 mIU/mL or more)
If not immune: hepatitis B immunoglobulin and vaccine within 24 hours (up to 7 days)
HIV
Standard precautions; no vaccine
First aid; risk assessment; PEP — tenofovir + lamivudine + dolutegravir for 28 days, started within 2 hours (up to 72 hours); HIV tests at baseline, 6 weeks, 3 and 6 months
Hepatitis C
Standard precautions; no vaccine
Baseline and follow-up anti-HCV and HCV RNA; early treatment if infection occurs
- 1
Let it bleed; wash with soap and water
- 2
Do not squeeze or use bleach on skin
- 3
Report to the in-charge immediately
- 4
Assess source status (HIV, HBsAg, HCV)
- 5
Start PEP as indicated
- 6
Document and follow up
Topic 5
Drug-resistant tuberculosis
- Rifampicin-resistant TB (RR-TB)
- Resistant to rifampicin
- MDR-TB
- Resistant to isoniazid and rifampicin
- Pre-XDR TB
- MDR/RR-TB plus resistance to a fluoroquinolone
- XDR-TB
- Pre-XDR plus resistance to bedaquiline or linezolid
- Laboratory role: CBNAAT and Truenat for rifampicin resistance, line probe assays (first- and second-line), liquid culture and drug susceptibility testing in BSL-3 laboratories (NTEP's certified labs).
- Safety: process sputum in a class II biosafety cabinet; N95 respirators; minimise aerosols; decontaminate with 5% phenol or hypochlorite.
Key terms
- GLP
- Quality system for planning, performing and reporting laboratory work
- Accreditation
- Formal recognition of a laboratory's competence
- ISO 15189
- International standard for medical laboratories
- PEP
- Post-exposure prophylaxis
- MDR-TB
- TB resistant to isoniazid and rifampicin
Quick revision
- Duties to patients, colleagues and society; ethical principles.
- GLP; aims and advantages of accreditation; NABL, NABH, CAP, ISO 15189.
- General safety precautions.
- Hepatitis B vaccine and HBIG; HIV PEP regimen and timing; HCV follow-up.
- RR, MDR, pre-XDR, XDR-TB; lab tests; biosafety.
Important exam questions
Practice questions written to the PTU exam pattern for this unit's syllabus: short answers (Section A style) and long answers (Sections B and C style).
Short-answer questions
- Q1.State two duties of a lab professional towards society.
- Q2.What is GLP?
- Q3.Which standard does NABL use for medical laboratories?
- Q4.When should HIV PEP be started?
- Q5.What is the protective anti-HBs level?
- Q6.Define MDR-TB.
Long-answer questions
- Q1.Explain ethical principles for laboratory professionals.
- Q2.Explain GLP and laboratory accreditation.
- Q3.Describe pre- and post-exposure guidelines for HIV and hepatitis.
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