Risk Management in the Clinical Laboratory

Identify, prioritise and control risk across the pre-analytical, analytical and post-analytical stages of testing, using FMEA, root cause analysis and CAPA.

3 days in person / 4 weeks online (24 hours) In-personVirtual (live online) Next: 1 to 3 Feb 2027 USD 1,050
Hand holding laboratory tools

Overview

Level
Open to all experience levels
Delivery format
In-person, Virtual (live online)
Teaching language
English
Duration
3 days in person / 4 weeks online
Prerequisites
None stated

ISO 31000 defines risk as the effect of uncertainty on objectives. In a laboratory, risk touches operations, technical work, liability and the business itself, and it always combines two things: how likely an event is and how severe its impact would be. A risk management framework gives the laboratory a structured way to identify risks, reduce unanticipated adverse events and protect patients, staff and visitors.

For laboratory professionals and directors, risk management is an essential discipline. It is their responsibility to understand and monitor the many guidelines and rules that govern laboratory testing. This course gives participants a complete understanding of risk management from a clinical laboratory viewpoint and shows how it improves the quality of care patients receive.

Risk-based thinking is required by ISO 15189:2022 and expected by CAP and JCI assessors. Individualized Quality Control Plans (IQCP), covered on day three, are accepted by CAP as a risk-based approach to quality control.

Who this course is for

  • Laboratory directors, managers and quality managers
  • Medical laboratory scientists, technologists and technicians
  • Pathology residents and practising pathologists
  • Medical laboratory science students and interns

How it is delivered

Competency-based sessions using interactive teaching methods that take laboratory personnel through identifying risks and applying precise control measures across the pre-analytical, analytical and post-analytical processes. Every quarter we run one in-person cohort in Nairobi and one live online cohort, each of 5 to 30 participants.

What you will learn

  • Define risk and explain why risk management matters in healthcare
  • Identify the accrediting bodies and regulations that shape laboratory risk management
  • Recognise risk in the pre-analytical, analytical and post-analytical stages of testing
  • Apply the main tools of risk management, including FMEA, root cause analysis and hazard vulnerability analysis
  • Build a risk-based quality control plan and a CAPA process that leads to continual improvement

Syllabus

Day 1

  1. Introduction to risk management
  2. The risk management processPlanning, identifying, handling and monitoring risk
  3. Conformance to consensus standards

Day 2

  1. Failure Mode and Effects Analysis (FMEA)
  2. Root Cause Analysis (RCA)
  3. Hazard Vulnerability Analysis (HVA)
  4. A systems approach to error reduction

Day 3

  1. Corrective and preventive action (CAPA) and continual improvement
  2. Human factors: error detection and reporting
  3. Performance monitoring and the quality control plan

Materials included

  • Participant guide and training materials

Duration and schedule

Total duration
3 days in person / 4 weeks online
Learning hours
24
Session frequency
In person: 3 consecutive days, 08:00 to 16:00 EAT. Online: 12 two-hour sessions, Mon, Wed and Fri 18:00 to 20:00 EAT, over 4 weeks.
Cohort size
Cohort of 5 to 30 participants
IntakeSessionsFormat and venueDeadlineAvailability
1 to 3 Feb 2027 Mon to Wed, 08:00 to 16:00 EAT (UTC+3) In-person
Nairobi, Kenya
Until the intake is full Open
8 Feb to 5 Mar 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
26 to 28 Apr 2027 Mon to Wed, 08:00 to 16:00 EAT (UTC+3) In-person
Nairobi, Kenya
Until the intake is full Open
3 to 31 May 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
26 to 28 Jul 2027 Mon to Wed, 08:00 to 16:00 EAT (UTC+3) In-person
Nairobi, Kenya
Until the intake is full Open
2 to 27 Aug 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
1 Oct to 1 Nov 2027 Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3) Virtual (live online)
Zoom
Until the intake is full Open
1 to 3 Nov 2027 Mon to Wed, 08:00 to 16:00 EAT (UTC+3) In-person
Nairobi, Kenya
Until the intake is full Open

Times are shown in the timezone of the venue. Where your browser can work it out, your local time appears underneath.

Need a different date or your whole team trained? Every course can be delivered in-house or virtually on dates that suit you. Mention this in the notes when you register.

Fees and payment

USD 1,050 per participant

Group and in-house rates on request.

How payment works

We invoice after registration. Pay by bank transfer or M-Pesa at least one week before the course starts. Your place is confirmed once payment is received.

Cancellation and refund terms

The fee includes

  • Facilitation and training materials
  • Two tea breaks and buffet lunch each day (in-person sessions)
  • Certificate of completion
  • First month of Elmenta Lab Pro mentorship, free

Instructors and certificate

Facilitators are experienced medical laboratory experts who work as practitioners and trainers in the field. Named facilitators are confirmed in the joining instructions.

Certificate

Certificate of completion issued by Elmenta Consulting on successful completion of the training. A certificate of completion records attendance and completion; it is not a professional certification and does not confer laboratory accreditation.

Free guides on this topic

Common questions

Does this course cover IQCP?

Yes. Individualised Quality Control Plans are covered as part of risk-based quality control on day three.

Can this course be run at our laboratory?

Yes. In-house delivery for a team is available at any time. Choose the in-house option on the registration form.

Is this relevant to CAP or JCI accreditation?

Yes. Both expect laboratories to identify and control risk, and CAP accepts IQCP, which is covered on day three, as a risk-based approach to quality control.

How is payment made?

After you register we send a pro forma invoice. Payment is due at least one week before the course starts, by bank transfer or M-Pesa.

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