Unit 3: Quality management, calibration and audit
Medical Laboratory Management notes · PTU syllabus (BMLS503-18)
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Unit summary
A laboratory runs on quality systems, calibrated instruments, information systems, sound finances and audits. This unit covers quality management systems, internal and external QC, biomedical waste management, calibration and validation of instruments, laboratory information systems, financial management, ethics across the testing process and laboratory audits.
After this unit you can
- Describe a quality management system
- Calibrate and validate laboratory instruments
- Explain LIS and financial management
- Plan and document laboratory audits
PTU syllabus topics
- Quality management systems — quality assurance and control
- internal and external QC
- biomedical waste management
- calibration and validation of clinical laboratory instruments
- laboratory information systems and financial management
- ethics across the pre-examination
- examination
- reporting and records-access stages
- laboratory audit — types
- frequency
- responsibility and documentation
- 1. Plan: Set quality goals
- 2. Do: Run the process
- 3. Check: QC, audits, indicators
- 4. Act: Correct and improve
Topic 1
Quality management systems
Plan
Quality policy, objectives, SOPs, quality manual
Do
Trained staff, controlled documents, QC in every run
Check
Internal audits, EQAS, quality indicators, complaints
Act
Corrective and preventive actions, management review
- Quality indicators: sample rejection rate, TAT, EQAS performance, critical value notification time, customer satisfaction. Internal QC checks daily precision; external QC checks accuracy against peers.
Topic 2
Biomedical waste management
Yellow
Anatomical waste, soiled waste, expired medicines, lab cultures after pre-treatment
Incineration
Red
Contaminated recyclable plastics
Autoclaving, shredding, recycling
White
Sharps
Autoclaving, shredding, sharps pit
Blue
Glassware, metallic implants
Disinfection, recycling
- Liquid chemical waste neutralised before drainage; bar-coded bags; records and annual reports to the State Pollution Control Board.
Topic 3
Calibration and validation of instruments
Meaning
Adjusting an instrument against standards of known value
Proving a method or instrument performs to specification in your lab
When
At installation, as scheduled, after maintenance or QC failure
Before routine use of a new method or analyser
Includes
Traceable calibrators; pipettes, balances, thermometers, centrifuges
Precision, accuracy (bias), linearity, reportable range, carry-over, reference interval check, method comparison with the existing method
- Keep calibration certificates traceable to national standards (NPL) and records of intervals.
Topic 4
Laboratory information systems
- Registration and barcoding
- Unique sample IDs
- Worklists and interfacing
- Analyser connection — fewer transcription errors
- Result validation
- Auto-verification rules, delta checks
- Reporting
- Electronic reports, SMS and portals
- Data management
- QC, TAT, billing, inventory
- Security
- User roles, audit trail, backups, privacy (DPDP Act)
Topic 5
Financial management
- Budgeting (capital — equipment; operational — reagents, salaries), cost per test (reagents + consumables + labour + overheads ÷ tests), pricing, inventory control (stock levels, first-expiry-first-out), equipment purchase vs reagent rental, and reducing waste through test utilisation reviews.
Example
Monthly costs ₹3,00,000 for 10,000 glucose tests = ₹30 per test; pricing must cover this plus a margin.
Topic 6
Ethics across the testing process
- Pre-examination
- Informed consent, privacy during collection, accurate identification
- Examination
- Valid methods; no testing beyond consent; honest QC
- Reporting
- Accurate, timely, understandable reports; confidential delivery
- Records access and storage
- Only authorised access; secure retention; sharing only with consent or legal requirement
Topic 7
Laboratory audits
Internal audit
By trained staff of the lab against standards
At least yearly; quality manager
External (accreditation) audit
By NABL or other assessors
At accreditation and surveillance visits
Vertical audit
Follows one sample through all steps
Periodic
Horizontal audit
One process across sections
Periodic
Clinical audit
Test use and outcomes with clinicians
As planned
- 1
Plan scope and checklist
- 2
Collect evidence — records, observation, interviews
- 3
Identify non-conformities
- 4
Report findings
- 5
Corrective and preventive actions with deadlines
- 6
Follow-up to verify effectiveness
- 7
Document everything
Key terms
- Quality management system
- Organised framework of quality policies and processes
- Calibration
- Adjusting an instrument against known standards
- Method validation
- Showing a method performs as intended
- LIS
- Software managing laboratory data and workflow
- Non-conformity
- Failure to meet a requirement
Quick revision
- PDCA in QMS; quality indicators; internal and external QC.
- BMW categories and disposal.
- Calibration vs validation; validation parameters; traceability.
- LIS functions; budgeting; cost per test; inventory.
- Ethics at each stage; audit types; audit cycle.
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.Name three quality indicators.
- Q2.Distinguish calibration and validation.
- Q3.What is auto-verification?
- Q4.How is cost per test calculated?
- Q5.Distinguish vertical and horizontal audits.
- Q6.What is a non-conformity?
Long-answer questions
- Q1.Describe a quality management system for a medical laboratory.
- Q2.Describe calibration and validation of laboratory instruments.
- Q3.Describe laboratory information systems and financial management.
- Q4.Describe the types and process of laboratory audits.
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