Transcript QUALITY ASSURANCE GUIDELINES

QUALITY ASSURANCE
GUIDELINES
HONWANI F.J
Q.A ON RAPID HIV TESTING
10 AUGUST 2010
PURPOSE OF THE GUIDELINES
Most of the rapid HIV tests used today are
single-use, disposable devices that may be used
to directly test whole blood, serum/plasma
samples.
These simple HIV tests present unique
challenges – testing is often performed by
persons without formal laboratory training, there
is no residual sample that can be checked or retested, conventional quality control methods
cannot be used, and there are special problems
associated with efforts to provide conventional
external quality assessments (e.g. proficiency
testing
CONT.
The purpose of these guidelines is to facilitate
adoption of a quality system approach that
encompasses all aspects essential to assuring
accurate and reliable rapid HIV testing.
It is intended to provide assistance to all persons
involved in rapid HIV testing service (quality
planners/managers, programme managers,
trainers and testers).
CONT.
With the expansion of rapid HIV testing to large
numbers of testing sites, it will be very important
to implement these guidelines, and monitor the
processes to assure quality and reliability of the
rapid HIV test results.
April 2010- June 2011 target of 15 Mil
there is need to make sure the results issued are
accurate.
Challenges and the need for
guidelines
Discordant results
Test taking longer than 30 minutes to give
results.
No line on the control bend.
Reaction bend always faint/ weak but stronger
with the other test kit.
No migration of sample on the reaction window.
Test has to be repeated in most occasion to get
a result
Poor quality HIV rapid test kits
Q.A guidelines & program

Aims
The aim of this guideline is:
To provide a framework for the implementation
of a quality assurance program around the HIV
rapid testing process.
The aim of the QA programme is:
To ensure that the process of HIV rapid testing
is performed accurately and reliably in a safe
and professional manner.
BASIC CONCEPTS APPLIED
Quality systems
Organizational structures ( NDOH, NICD, PROV etc)
Responsibilities
Resources
Processes and procedures needed to implement
QC and EQA
 QC
A set of procedures used internally to validate test
performance and reagents stability.
 Facilities will have to analyze samples with known
controls. Just completed a pilot in Limpopo.
 This will be a requirement to all facilities implementing
HCT.
 EQA
Defined as a set of activities performed through an external
source to evaluate testing site operations. To follow once
the QC is rolled out in all provinces.
QC and EQA CONT.
Proficiency testing (PT)
Re- testing
On-site assessment
THE OVERALL GOAL
Improvement in
•
•
•
•
•
•
Occurrence management
Process improvement
Information management
Inventory
Safety in all facilities
Eventually service and satisfaction
CONCLUSSION
Identify
Problems