Module 6 HTS Quality Assurance.pptx bbbbbbbbbbb

Cholera

1. HTS Quality Assurance

2. Module 6 Contents – HIV Quality Control Understanding HTS Quality Systems in South Sudan Basic Terms Used in HIV Quality Assurance Internal Quality Control Protocol External Quality Control Protocol Re-testing Review & Exercise

3. Overview of Quality in HTS Quality HIV testing is central in any counselling and testing programme . Effective HTS services need quality approaches in HIV rapid testing. In order for clients to receive accurate test results within a reasonable time frame, quality in testing must be maintained. HTS Quality control is essential for monitoring the quality of the HIV test in our facilities. HTS quality program includes procedures and strategies (from within and outside the facility) which we put in place in our respective health facilities in order for our clients to receive accurate test results within a reasonable time frame

4. Overview of Quality in HTS… cnt ’ Quality is everyone’s responsibility and should not be compromised. Laboratory management and HTS supervisors have a key role in ensuring that all test site personnel implementing the procedures adhere to highest quality standards and use test kits approved by the MOH-RSS in all centers Effective HTS services need quality approaches in HIV rapid testing. Test kits should be the right type and in correct quantities and specimen should be handled using acceptable standards. Standard test procedures, recording, and correct interpretation are important components of quality assurance.

5. Reasons for Testing Errors No written standard operating procedures Unclear individual responsibilities Lack or poor training Poor quality products Improper handling of specimens Poor transportation and storage conditions Poor maintenance of equipment Absence of Quality Control procedures

6. Quality of HIV testing Behind any test result is a client who is depending on us for right HIV test status Implication of starting a negative client on life long ART Implication of sending a way a positive client because of a wrong negative result

7. Retesting in HIV testing Retesting to verify HIV-positive diagnoses before initiating ART To ensure that individuals are not needlessly placed on life-long ART (with potential side-effects, waste of resources, psychological impact of misdiagnosis), M OH recommends that all individuals be retested to verify their HIV status prior to enrolling in care and/or starting ART. Retesting N ew specimen A different provider S ame testing algorithm

8. Which facilities are doing Retesting to verify HIV-positive diagnoses before initiating care or ART? How ?

9. Overview cont’d Quality Assurance components in HTS Targets the following program areas at facility level Following national HTS guidelines: Algorithm and Testing SOP, HTS Registers, linkage and proper documentation Participating in semi-annual National HIV/PT Program from NRL Participating in Semi-annual Facility Internal Quality Control HIV Test kits quality: storage and proper use, expiry, temperature Following Standard test procedures, recording, and correct interpretation are important components of quality assurance. Testing personnel proficiency : training and supervision Testing period/ window period Follow up of Inconclusive results clients

10. Schemes for HTS quality in our facilities Include Internal quality control scheme/ blind samples at facility level (Internal Quality Assurance) Training, use of SOP, performance review, and following national testing algorithm (Internal Quality assurance) National proficiency testing panels from NRF (External Quality assurance)

11. Module 6 Contents – HIV Quality Control Understanding HTS Quality Systems in South Sudan Basic Terms Used in HIV Quality Assurance Internal Quality Control Protocol External Quality Control Protocol Re-testing & its SOP Inconclusive Results & its SOP Review & Exercise

12. a. Internal Quality Control (IQC) IQC refers to operational techniques that must be included in testing procedure to verify that the requirements for quality are met. The aim of IQC is simply to ensure that the HIV test results generated by the test are correct for the right person at right time. Internal quality control includes: evaluation of Testing personnel, test kits, & documentation/HTS Register It considers the following: Pre-analytical (specimen collection), Analytical (results accuracy) and Post analytical (documentation) process to the actual test All IQC test results should be recorded in IQC worksheet and HTS register. The IQC worksheet will be reviewed by supervisor, and filed in the facility.

13. Key Points Quality Control Each testing personnel is to receive 4 blind samples per testing cycle Ensuring high quality standards is everyone’s responsibility Proper transportation and storage of HIV test kits/commodities key to quality results QC should be conducted regularly as specified in the HTS protocols Invalid QC results should be investigated, reported and responded to timely HIV Testing Window period

14. When a test can be used/ window period Average time after exposure to detect HIV antigens and antibodies (window period)

15. Module 6 Contents – HIV Quality Control Understanding HTS Quality Systems in South Sudan Basic Terms Used in HIV Quality Assurance Internal Quality Control Protocol External Quality Control Protocol Re-testing Review & Exercise

16. b. External Quality assessment (EQA) External quality assessment is important to ensure that all the testing points are performing to an external standard Its an evaluation of a test site by an outside agency or personnel using proficiency panels (Dry tube sample) In S outh Sudan, National Reference Laboratory (NRL) semi-annually distributes 6 DTS samples per site

17. Performing EQA/ NRL- PT Key Roles and responsibilities for QC in DTS include the following: Verifying DTS components upon receipt, Rehydrating DTS, Testing according to SOPs, Recording QC results in the QC form (to be submitted back) and in the HTS register. Supervisor must review the form before submission Implementing corrective actions in case of failure.

18. Performing MOH EQA Quality Controls Steps when performing Quality Controls

19. QC Evaluation Evaluation of Results and Improvement Plan Evaluation of the results is based on: correctness of actual test results and documentation based on SOP and algorithm. Acceptable result/evaluation is all the PT test results are correct Any wrong result from any of the PT samples provided is considered unacceptable result If a report contains unacceptable results, immediate review of the results is necessary as per IQC SOP

20. HTS QC Facility Roles and Responsibilities Facility laboratory/ HTS Internal Quality focal person (IQC) Semi- annully prepare blind samples for all the testing points in their respective facilities Distribute the blind samples to the either HTS supervisor or different testers Receive the completed IQC worksheet and check for correctness Review and provide appropriate feedback to all the different testers For testers with identified performance challenge, support the counselors to do root cause analysis and develop improvement plan Supports implementation of improvement plan Facility points of test/ test providers: Receive the samples and store them appropriately (4 degree Celsius refrigeration). Whenever possible, the PT samples are run immediately upon receipt Where immediate run is not possible, store appropriately and run PT not more than two days Document test results in the Internal quality worksheet (see attached) Return the results to the HTS quality focal person Receive feedback and where necessary develop and implement the improvement plan agreed upon.

21. What is expected of the facility Laboratory IQC Focal person Internal IQC Prepare semi-annual blind samples for each tester in the respective facilities Prepare 4 blind samples for each tester Analyse the performance of IQC results and provide feedback to the respective testers External QA/PT Receive PT panels from the reference lab as per SOP Distribute PT panels to respective testers Submit back PT results to the NRL Testing Point/ Testers Semi- annually test all blind samples given to them as per national algorithm and test SOP Submit back IQC test results to the laboratory IQC focal person

22. Roles and Responsibilities Facility management/ HTS In-Charge Supervise HIV testing and linkage of patients at facility level Review testing data in the facility Make consumption summary data for ordering of test kits Coordination of the different testing points: quality testing and ordering of test kits Support & coordinate all HIV test kits consumption at all testing points: Ordering of testing and management of consumption Laboratory Personnel: Semi-annually prepare IQC/blind samples to different testing points and give results feedback for improvement Provide technical support to all testing points