QUALITY ASSURANCE QUALITY ASSURANCE GUIDELINESGUIDELINES

HONWANI F.JHONWANI F.J

Q.A ON RAPID HIV TESTINGQ.A ON RAPID HIV TESTING

10 AUGUST 2010 10 AUGUST 2010

PURPOSE OF THE GUIDELINESPURPOSE OF THE GUIDELINES

Most of the rapid HIV tests used today are single-Most of the rapid HIV tests used today are single-use, disposable devices that may be used to use, disposable devices that may be used to directly test whole blood, serum/plasma samples. directly test whole blood, serum/plasma samples. These simple HIV tests present unique These simple HIV tests present unique challenges – testing is often performed by challenges – testing is often performed by persons without formal laboratory training, there persons without formal laboratory training, there is no residual sample that can be checked or re-is no residual sample that can be checked or re-tested, conventional quality control methods tested, conventional quality control methods cannot be used, and there are special problems cannot be used, and there are special problems associated with efforts to provide conventional associated with efforts to provide conventional external quality assessments (e.g. proficiency external quality assessments (e.g. proficiency testing testing

CONT.CONT.

The purpose of these guidelines is to facilitate The purpose of these guidelines is to facilitate adoption of a quality system approach that adoption of a quality system approach that encompasses all aspects essential to assuring encompasses all aspects essential to assuring accurate and reliable rapid HIV testing. accurate and reliable rapid HIV testing.

It is intended to provide assistance to all persons It is intended to provide assistance to all persons involved in rapid HIV testing service (quality involved in rapid HIV testing service (quality planners/managers, planners/managers, programmeprogramme managers, managers, trainers and testerstrainers and testers). ).

CONT.CONT.

With the expansion of rapid HIV testing to large With the expansion of rapid HIV testing to large numbers of testing sites, it will be very important numbers of testing sites, it will be very important to implement these guidelines, and monitor the to implement these guidelines, and monitor the processes to assure quality and reliability of the processes to assure quality and reliability of the rapid HIV test results. rapid HIV test results.

April 2010- June 2011 target of 15 MilApril 2010- June 2011 target of 15 Mil

there is need to make sure the results issued are there is need to make sure the results issued are accurate.accurate.

Challenges and the need for Challenges and the need for guidelinesguidelines

Discordant resultsDiscordant results Test taking longer than 30 minutes to give Test taking longer than 30 minutes to give results.results.No line on the control bend.No line on the control bend.Reaction bend always faint/ weak but stronger Reaction bend always faint/ weak but stronger with the other test kit.with the other test kit. No migration of sample on the reaction window.No migration of sample on the reaction window.Test has to be repeated in most occasion to get Test has to be repeated in most occasion to get a resulta result

Poor quality HIV rapid test kitsPoor quality HIV rapid test kits

Q.A guidelines & programQ.A guidelines & program

Aims Aims

The aim of this guideline is:The aim of this guideline is:

To provide a framework for the implementation To provide a framework for the implementation of a quality assurance program around the HIV of a quality assurance program around the HIV rapid testing process. rapid testing process.

The aim of the QAThe aim of the QA programme programme is: is:

To ensure that the process of HIV rapid testing To ensure that the process of HIV rapid testing is performed accurately and reliably in a safe is performed accurately and reliably in a safe and professional manner.and professional manner.

BASIC CONCEPTS APPLIEDBASIC CONCEPTS APPLIED

Quality systemsQuality systemsOrganizational structures ( NDOH, NICD, PROV etc)Organizational structures ( NDOH, NICD, PROV etc)

Responsibilities Responsibilities

ResourcesResources

Processes and procedures needed to implementProcesses and procedures needed to implement

QC and EQAQC and EQA

QCQCA set of procedures used internally to validate test A set of procedures used internally to validate test

performance and reagents stability.performance and reagents stability. Facilities will have to analyze samples with known Facilities will have to analyze samples with known

controls. Just completed a pilot in Limpopo. controls. Just completed a pilot in Limpopo. This will be a requirement to all facilities implementing This will be a requirement to all facilities implementing

HCT.HCT. EQAEQADefined as a set of activities performed through an external Defined as a set of activities performed through an external

source to evaluate testing site operations. To follow once source to evaluate testing site operations. To follow once the QC is rolled out in all provinces.the QC is rolled out in all provinces.

QC and EQA CONT.QC and EQA CONT.

Proficiency testing (PT)Proficiency testing (PT)

Re- testingRe- testing

On-site assessmentOn-site assessment

THE OVERALL GOALTHE OVERALL GOAL

Improvement inImprovement in• Occurrence managementOccurrence management• Process improvementProcess improvement• Information managementInformation management• InventoryInventory• Safety in all facilitiesSafety in all facilities• Eventually service and satisfactionEventually service and satisfaction

CONCLUSSIONCONCLUSSION

IdentifyProblemsIdentify

ProblemsTake

Corrective Action

Take Corrective

Action