TRAINER GUIDE Module 11 Assessment — Norms And Accreditation

trainer guide module 11: assessment — norms and accreditation purpose to provide the participants with information on labo

TRAINER GUIDE
Module 11: Assessment — Norms and Accreditation
Purpose
To provide the participants with information on laboratory
standards, the organizations that develop them, and how the
processes of accreditation and certification are conducted.
Module Time
(suggested)
65 minutes: 55 minutes for presentation
10 minutes for activity
Learning Objectives
At the end of this module, participants will be able to:
*
compare and contrast accreditation, certification and
licensure;
*
describe the process involved in the development of
standards;
*
discuss the need for laboratory norms and standards.
Test Questions
(suggested)
Suggested test questions (with answers bolded) for this module
include:
1.
Which of the following statements is true?
a.
standards organizations can never serve as accrediting
bodies
b.
certification is the procedure by which an independent
body gives written assurance that a product, process or
service conforms to specific requirements
c.
most standards for laboratory practice are developed by
local government agencies
d.
only one international standards organization is
recognized by all countries for quality management of
laboratories
2.
In order to be accredited, a laboratory must do all of the
following EXCEPT:
a.
be visited by representatives of the accrediting body
which observes the laboratory’s policies and practices
b.
be enrolled in a proficiency testing or other EQA
program
c.
pay a fee for the accreditation process
d.
adhere to international standards rather than local
standards
3.
The main focus of ISO 15189 standard is
a.
improving the quality of medical laboratories
b.
minimizing the harmful effects of the environment
c.
addressing laboratory safety issues
d.
improving the status of the quality manager
Module Overview
(suggested)
The following table suggests an agenda for organizing the
module. Each trainer can modify it, as well as select and
customize the available resources.
Step
Time
Topics
Contents
Available resources
1
15 min
Introduction
Presentation 11, Slides 1-3
Activity sheet 11-1
2
5 min
Overview of norms and accreditation
Content sheet 11-1
Presentation 11, Slides 4-6
3
10 min
International standards and standardization bodies
Content sheet 11-2
Presentation 11, Slides 7-13
4
5 min
National standards and technical guidelines
Content sheet 11-3
Presentation 11, Slides 14-15
5
15 min
Certification and accreditation
Content sheet 11-4
Presentation 11, Slides 16-23
6
5 min
Process of accreditation
Content sheet 11-5
Annex 11-A
Presentation 11, Slides 24-27
7
5 min
Benefits of accreditation
Content sheet 11-6
Presentation 11, Slides 28-31
8
5 min
Summary
Content sheet 11-7
Presentation 11, Slides 32-34
Material/Equipment Checklist
*
PowerPoint slides or transparencies
*
Overhead projector or computer with an LCD projector
*
Prepared flipchart, white board, or chalk board
*
Paper cards, markers, and tape
*
Additional handouts as required.
2
Norms and Accreditation ● Module 11 ● Cover Sheet