Welcome to the ISO 15189:2012 course!

Medical laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients. Such services include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.

The international organisation for standardisation, under its technical committee developed an accreditation standard for medical laboratories, ISO 15189:2015 as a requirement for medical laboratories to exhibit quality and competence in the services they offer. The ministry of health MOH under UNHLS has also adopted the ISO 15189:2012 as the accreditation standard for all its medical public laboratories.

This is a modular course that targets both the managerial and technical requirements of the standard and how they are inter linked with the pre-examination, examination ,post examination and support processes in the lab These will be delivered through various methods that include live video conferencing sessions, recorded lectures and self-paced online learning modules, quizzes, facility based projects and group discussion via the moodle course website/learning management system.

Purpose of the course

This course aims to build the capacity of Laboratory personnel to correctly interpret the managerial and technical requirements of the standard and then utilize the standard to develop, improve and audit Laboratory Quality Management Systems in their Laboratories.

Specific course objectives

After successful completion of this course, trainees will be able to:

  • Develop a quality policy and objectives for their laboratories
  • Develop, control and archive documents and records used in their QMS
  • Implement Continual improvement activities in the Laboratory
  • Develop and implement reagent and equipment procedures

Target Audience

This course targets Laboratory personnel in Laboratories implementing Quality management systems.

Course Evaluation:

The ISO 15189:2012 evaluation will be in three parts; Modular quizzes, weekly discussion forum and participation in course sessions as shown below:

  • Discussion Forum (10% to final score): Discussion questions allow students to reflect on the unit topic and learn from other students. Posting a response to the question and to a student in your discussion group is required by Sunday. Each discussion post is worth 1.5 points.
  • Quizzes (70% to final score): weekly quizzes will be conducted at the end of each module consisting of 10 multiple-choice questions (1 mark each) Quizzes are due by Sunday each week. The quiz has two attempts and the highest score will be recorded.
  • Attendance/Active Participation: (20%) Attendance of the weekly live video conferencing sessions and review of the online materials.

Certification:

Certificates of completion will be awarded to trainees who participate in at least 80% of the online sessions and have a final score of 70% or more in the course assessments. This certificate will be downloaded on the course website upon successful completion of the course. Hard copies of the certificate can be picked from IDI Makerere 2 weeks after completion of the course.

Course Instrucrors and Developers:

Mrs Mirembe Violet: Medical Laboratory Technologist: Laboratory Technical Trainer. IDI Training Department.

Mr. Ivan Patrick Walwema: Laboratory Service Specialist , Kampala & Wakiso HIV Project.

Mr. Paul Oboth: Malaria Diagnostics Specialist USAID's Malaria Action Program for Districts (MAPD).

Mr. Derrick Kitwe: Medical Laboratory Technologist: Laboratory Service Specialist, Western Region Western and West Nile HIV Project.

Mr. Tusiime James: Medical Laboratory Technologist: Laboratory Service Specialist, West Nile Western and West Nile HIV Project.

Mrs Mutua Diana: Medical Laboratory Technologist: Laboratory Service Specialist, Kampala & Wakiso HIV Project.

Week 0

Orientation to the eLearning platform

Week 1

Module 1: Organisation and Management Requirements

Module 2: Documents and Records Control

Module 3: Services and Supplies

Week 2

Module 4: Identification and control of Non Conformities

Module 5: Evaluation of the Quality Management System

Week 3

Follow up on the Management Requirement Project and its integration in the Lab

Week 4

Module 6: Personnel Management

Module 7: Facilities and safety

Module 8: Equipment and Reagent management

Week 5

Module 9: Pre- Examination and Examination processes

Module 10: Post Examination Processes

Week 6

Follow up on the Management Requirement Project and its integration in the Lab

Acknowledgements

This course curriculum and content has been adapted from the classroom version to suit online delivery and support the management of Laboratory Quality Management systems as recommended by the standard. This course is sponsored by the Western and West Nile HIV Project (Accelerating Comprehensive HIV/AIDS Service Delivery through Health System Capacity Building and Technical Assistance to District Health Teams and Health Facilities in Western and West-Nile Regions in the Republic of Uganda under the President's emergency Plan for AIDS Relief) funded by CDC-PEPFAR through cooperative agreement number 6NU2GGH001294.

Click here to access course content.