Statistical Quality Control and Method Validation/Verification (QCMV²) This course has been updated to align to ISO 15189:2022

Course Description

The Statistical Quality Control and Method Validation/Verification (QCMV²) course is focused on quantitative testing, including CD4 testing, with examples of biochemistry and hematology. This course provides participants with the crucial knowledge and tools to evaluate and monitor their quantitative tests.

With lecture recordings on the Moodle platform and Zoom-based interactive live webinars, participants will learn to:

• Select new methods and instruments with performance specifications that relate to "the intended use" of the procedure (ISO15189:2022, 7.3)
• Introduce new methods and instruments into laboratories by properly evaluating the procedures for "the intended use" (ISO15189:2022, 7.3.1)
• Design a robust internal QC program for all the tests (ISO15189:2022, 7.3.7.2)
• Assess on-going laboratory's accuracy through External Quality Assessment Schemes (EQAS) (ISO15189:2022, 7.3.7.3)

Course Objectives

Participants will learn to:

• Translate the clauses of ISO 15189 into daily laboratory practice
• Understand the QMS as a whole and its interconnected processes
• Design and implement those processes for a cost-effective QMS that meets the requirements of ISO 15189
• Establish a practical QMS that enables laboratories to achieve and maintain accreditation status

Target Audience

The target audience includes:

• Laboratory directors, managers, supervisors, or QC officers involved with conducting quantitative QC and method validation/verification.
• Senior laboratory staff involved in quantitative testing and method validation/verification.
• Quality managers, project managers and mentors who are implementing QMS in laboratories.
• Auditors and assessors who have a technical background in clinical pathology.
• Those who conduct QMS training including statistical QC and validation/verification or involved in pre-service curriculum.

Course Format

This course contains 10-week online learning followed by 4 ECHO sessions delivered over 2 weeks. This eLearning course uses a “flipped classroom” model (definition). Participants engage in self-study, learning from 100+ online lecture videos and completing weekly assignments, before they attend live Zoom-based sessions for debrief, discussion, and Q&A. The ECHO sessions allow the participants to work on their own laboratory's data and get mentoring from the facilitators.

Table of Contents

QMS 1 — MANAGEMENT RESPONSIBILITY

• 0.0 – Workshop Overview
• 1.0 – QMS 1 Overview
• 1.1 – Introduction to Management Responsibility
• 1.2 – Management Tools
• 1.3 – Quality Management System
• 1.4 – Documents and Records
• 1.5 – Planning and Conducting a Staff Meeting

QMS 2 — RESOURCE MANAGEMENT

• 2.0 – QMS 2 Overview
• 2.1 – Personnel
• 2.2 – Infrastructure and Safety
• 2.3 – Purchasing and Inventory
• 2.4 – Equipment

QMS 3 — WORKFLOW PATHWAY

• 3.0 – QMS 3 Overview
• 3.1 – Pre-analytical Phase
• 3.2 – Analytical Phase
• 3.3 – Post-analytical Phase

QMS 4 — EVALUATION AND CONTINUAL IMPROVEMENT

• 4.0 – QMS 4 Overview
• 4.1 – Occurrence Management
• 4.2 – Internal Audit
• 4.3 – Management Review Process

Launch QCMV Course Content