Laboratory Quality Systems in HIV (LaQSH)
SHARE INDIA’s Project LaQSH and the U.S. Centers for Disease Control and Prevention (CDC) provided technical assistance (TA) to the National AIDS Control Organization (NACO), Government of India (GoI), for implementing Quality Management Systems (QMS) and Viral Load (VL) testing in India’s National AIDS Control Programme (NACP) laboratories through the President’s Emergency Plan for AIDS Relief (PEPFAR). We are working in the Focused Districts of Andhra Pradesh, Maharashtra, Nagaland, Manipur and Mizoram to provide Free Access to Quality HIV-1 Viral Load Testing.
64 Public Sector Viral Load Laboratories 499 CD4 Laboratories
264 HIV Counseling & Testing Services
What we Deliver
Technical Assistance for National Scale-Up of Routine Viral Load Testing
The project facilitated development of the national guidelines for HIV-1 viral load laboratory testing in 2018, which was launched by the Honorable Union Minister of Health and Family Welfare Shri Jagat Prakash Nadda, Government of India.This immunological monitoring is for utilization by 540 ART centres and 64 viral load laboratories and to guide treatment options for nearly 1.3 million people living with HIV (PLHIV) in India.
- Collaborated with APSACS for a one-day review and orientation workshop for nodal officers of the viral load laboratories, in-charge medical officers of the State Referral Laboratories, technical officers of SRLs and District HCTS supervisors from DAPCU.There were 50 participants. The status of the refurbishment of the 10 viral load laboratories was reviewed and the operational challenges were discussed and solutions provided.
- Laboratory – Clinical Interface (LCI) training was organized for 173 laboratory and clinical staff to orient and equip them to support viral load testing in the public sector viral load laboratories across India.
- Commenced 11 e-Learning sessions to provide TA to 10 viral load laboratories to support accelerated operationalization of HIV-1 viral load laboratories in Andhra Pradesh.
Laboratory Clinical Interface (LCI) Training
As per the directive of NACO, the Laboratory Clinical Interface (LCI) training was facilitated by SHARE INDIA’s Project LaQSH in collaboration with CDC and APSACS in Andhra Pradesh for the staff of Viral Load (VL) laboratories and linked ART centres. The training was conducted on a virtual platform from 15th to 22nd July 2020. The twenty-seven participants included the VL In-charges, Medical Officer, Technical Officers, Laboratory Technicians of Viral Load Laboratories, the Linked ART centres and Laboratory Service Division (LSD) of APSACS.
The objective of the LCI training was to orient the clinicians and laboratorians:
- On the aspects of VL testing
- To get acquainted with HIV 1 VL testing workflow (patient selection to report uptake)
- To utilize VL test result and understand enhanced adherence counselling
- To understand the Principles of Abbott equipment for molecular methods in HIV VL testing
- To understand the use of checklists in different aspects of VL testing and the Quality System Essentials (QSEs) in VL laboratories
- To understand the Monitoring and Evaluation process in both ARTC and VL testing laboratories
- Orchestrated a network of viral load laboratories in the public sector by coordinating extensively between multi-lateral and host-government counterparts to scale-up from 10 viral load laboratories in the country to 64 viral load laboratories.
- Developed and implemented the appropriate evidence-based tools to inform the functionality of the viral load laboratories in the public sector.
- Facilitated development of an in-country Proficiency Test (PT) program for 10 viral load laboratories in the public sector laboratories through technology transfer from CDC Atlanta and on-going technical assistance. The Proficiency Test will cater to 24 viral load laboratories.
Introduction of standard QMS implementation tools resulted in the accreditation of 5 out of the 10 regional referral Laboratories in the public sector.
- We demonstrated that a vaccine carrier could be used as a transportation container to maintain 2-8°C up to 65 hours at external temperature of 35°C. Validation of plasma preparation tubes (PPT) decreased the amount of time required to process specimens, eliminated a potential source of transcriptional error in specimen labelling and reduced the risk of HIV exposure to healthcare workers. The pilot activity showed that PPT could be preferred to the EDTA tube for collection of specimen and transportation of plasma in situ for HIV-1 viral load testing in the national program. Additionally, PPT has an advantage over EDTA: it is user-friendly, relatively cheaper (unit cost of PPT is ₹23 while EDTA with other accessories costs₹24.02) and saves time in processing of specimens.
- Under the Undetected = Untransmittable (U=U) campaign, Project LaQSH demonstrated a fast-track model to enhance access to viral load testing in hard-to-reach terrains of cluster districts in North-Eastern states, which served to identify the viral load count of 2111 Key populations for the very First time.
Forerunner in Quality Management Systems (QMS) for HIV Counselling and Testing Services (HCTS) Facilities
Developed capacity building modules and Training Programs
- The QMS Checklist and Facilitator’s Manual was designed in the year 2016 to implement QMS in HCTS laboratories, which was approved by NACO.The modules are also being used for blended training.
- A cascade training model was used effectively to deliver training through a pool of master trainers trained centrally to reach trainees at the local level.
- Regional Training of Masters Trainers were organised at 9 locations—Mumbai, Pune, Bangalore, Delhi, Kolkata, Hyderabad, Chennai, Dimapur and Lucknow and 274 personnel were trained to be part of the Resource Pool (Master Trainers); 124 belonged to the focused states of Andhra Pradesh, Maharashtra and Nagaland.
- The Training of Master Trainers aimed to build the capacity and orient officers of State Referral Laboratories (SRLs), State AIDS Control Society (SACS) and District AIDS Prevention Control Unit (DAPCUs) on the mentoring and monitoring tool for stand-alone HCTS laboratories and SACS personnel, on the principles of SA-HCTS laboratory mentoring, and to create an environment for strengthening SA-HCTS mentoring through SRLs.
- 896 personnel from 264 HCTS laboratories were trained in 15 batches on QMS across the focused districts. The state and SA-HCTS laboratories were trained, mentored and monitored by the SRL/NRL (resource pool), with support from the national team comprising members of NACO, CDC and SHARE INDIA.
Technical assistance for step-wise quality management systems
- Distinct mentoring, monitoring and advocacy initiatives were provided to the HCTS laboratories in the focused districts that preceded through baseline assessments.
- Baseline assessments of 264 SA-HCTS laboratories were organized between October and November 2016.District- and state-level stakeholders were closely involved in the baseline assessments and in the review of action taken.
- Dissemination workshops were organized at administrative headquarters of all focused districts and drew participation of 785 representatives from all laboratories in that particular district, district health officials, DAPCUs as well as officials from NACO, SACS and SRLs.
- The HCTS QMS Checklist was designed as a desktop-based application SA-HCT QMS E-Tool. The front-end user interface of this tool was designed in Microsoft-Excel using Visual Basic, and the SQL server 2014 was used for the back-end data storage. Stakeholders such as the District AIDS Prevention and Control Units (DAPCUs), SRLs, State AIDS Control Societies (SACSs) and NACO can use the dashboard view to understand the status of QMS performance in their district, state or nationally. As an outcome of the QMS a standardized web-based NEQAS data management tool was developed to collect the Proficiency and Reverse testing data from all the HCTS, SRLs and aggregated data is reported at APEX lab, NARI and NACO.
- A differential technical assistance and mentoring plan was developed to focus amongst laboratories requiring greater improvement. On-site hand-holding and capacity building were slotted for all laboratories with a rating of Grades 1, 2 and 3. In line with this, a domain-wise performance of laboratories rated Grade 4 was reviewed and those performing poorly were visited for on-site support and the rest were provided virtual assistance. The objective of both forms of technical assistance was to focus on improving the HCTS laboratories QMS performance and achieve a Certificate of Excellence. Among the total 264 HCTS in Andhra Pradesh, Maharashtra, Nagaland, Manipur and Mizoram,160 HCTS laboratories received on-site support and 104 HCTS laboratories received virtual assistance.
The project developed two tools that help generate error-free data from the laboratories and help the SRLs and SACS to analyse the data and provide timely feedback to HCTS laboratories to improve quality:
HCTS QMS assessment tool: The HCTS QMS assessment tool is designed in Microsoft-Excel. This tool consists of five sheets that generate a site-wise assessment score, site-wise summary, site- and domain-wise final scores with star rating. It provides analysis tables for decision-making and for initiating action.
PT/RT data management system: This is a web-based tool to capture the data of PT-RT from the HCTS laboratories and transmit it to SRLs and feedback from SRLs to HCTS. Through this tool the SRLs, NRLs, SACS and NACO will be able to view and assess data on the status of PT-RT participation from the HCTS laboratories to understand whether issues of discordance are addressed and generate aggregated information in the dashboard.
- An HCTS laboratory is selected for an external audit only after it scores over 90 per cent in its self-assessment and the findings are verified virtually.
- Implemented QMS in 264 laboratories in the focused districts to ensure quality in the HIV Counseling and Testing Services. 118 laboratories have received the national award of Certificate of Excellence from NACO, assuring quality HIV testing for nearly 5 crore PLHIV per year.
- Supported NACO to scale-up QMS in >5500 HCTS laboratories through phased implementation approach and provided refresher training to DAPCU and SRL staff in implementation of QMS in non-focused districts. Baseline assessments were conducted in Vizianagaram, Visakhapatnam, Nellore and Chittoor. The training in implementation of QMS in HCTS in non-focused districts was conducted in Telangana in 3 SRLs. It was provided to 163 Laboratory Technicians (LTs) in 10 districts across Telangana.