|Year : 2014 | Volume
| Issue : 2 | Page : 197-198
Laboratory accreditation programme for human immunodeficiency virus testing in India
SA Ganju, AK Kanga
Department of Microbiology, Indira Gandhi Medical College, Shimla 171 001, Himachal Pradesh, India
|Date of Submission||28-Aug-2013|
|Date of Acceptance||28-Sep-2013|
|Date of Web Publication||2-Apr-2014|
S A Ganju
Department of Microbiology, Indira Gandhi Medical College, Shimla 171 001, Himachal Pradesh
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Ganju S A, Kanga A K. Laboratory accreditation programme for human immunodeficiency virus testing in India. Indian J Med Microbiol 2014;32:197-8
|How to cite this URL:|
Ganju S A, Kanga A K. Laboratory accreditation programme for human immunodeficiency virus testing in India. Indian J Med Microbiol [serial online] 2014 [cited 2020 Sep 18];32:197-8. Available from: http://www.ijmm.org/text.asp?2014/32/2/197/129836
Recently accreditation throughout the world is being emphasised. Despite the low numbers of laboratories accredited to date in resource limited settings, accreditation has a potential to improve the quality of healthcare by decreasing testing errors and reducing inappropriate treatment.  In order to meet the rising demand for diagnostics and needs of expanded treatment and prevention programme for human immunodeficiency virus (HIV), significant investment has been made in improving access to testing.  Clinical management of HIV infection is completely dependent on HIV testing. Without a reliable diagnosis, patient will not receive HIV-related services for treatment and prevention. Thus, making reliable tests available at every point of testing, laboratory involves careful implementation of quality control and quality assurance measures. 
National AIDS Control Organisation (NACO) has effectively adopted the accreditation programme as per the International Standard Organisation (ISO) 15189:2007 and the National Accreditation Board for Testing and Calibration Laboratories for HIV testing in National and State reference laboratories (NRLs and SRLs) under the laboratory strengthening program.  The core areas addressed are (i) HIV testing laboratory network upgradation and management; (ii) External assessment; (iii) Capacity building; (iv) Laboratory information and monitoring; (v) Documentation and manuals.
| ~ HIV Testing Laboratory Network up Gradation and Management|| |
NACO has set up a four tiered pyramidal system that supports quality management and mentoring as shown in [Figure 1]. NACO provides funds for quality assurance and quality control (QA/QC) activities through the State AIDS Control Societies (SACS) and has positioned staff at various levels. Recently technical officers have been recruited who have been trained in QA/QC activities. The infrastructure has been improved. The National AIDS Research Institute, Pune has been identified as the apex laboratory. Under the apex laboratory are 12 NRLs. which are in turn linked to 118 SRLs. These SRLs are in turn linked to the integrated counselling and testing centres (ICTCs). The SRLs are located in medical colleges and tertiary level hospitals across the country. 
| ~ External Assessment|| |
NACO in collaboration with Centers of Disease Control and Prevention has carried out two rounds of external assessment using a WHO level II checklist in the 12 Quality System Essentials (QSEs) as defined by Clinical Laboratory Standards and Institutes and is in compliance to ISO 15189:2007.  The baseline assessment was carried out in 2009 by trained laboratory experts and observers in which the existing status of all SRLs across the country was presented. The second round of assessment was carried out in December 2011 using the same check list. The second round of assessment quantified the areas of progress, compliance to ISO 15289:2007 and prioritised key challenges. Simultaneously, the administrative, technical and training needs were addressed during 2009-2011.
| ~ Capacity Building|| |
The quality of laboratory services has been improved by providing financial and technical assistance. The needs of each SRL based on the assessment report were addressed. Trainings for each category of staff positioned in the ICTC/SRL/NRL were carried out. The technical officer, quality manager and the SRL in charge were all trained. The trainings conducted were (i) Calibration, Biosafety and Strategic Information Management System; (ii) Implementation of quality management systems (QMS) based on QSEs and correlation with ISO 15189: 2007 standard; (III) Laboratory Quality Planning and Risk management; (iv) Internal Audit and QMS. The SRL technician undergoes yearly refresher trainings at the linked NRL and the ICTC technicians undergo yearly training at their respective SRL on QA/QC. Besides, the technical officer during the supervisory visits to the ICTCs provides in-house training and supportive supervision. Also performance criteria were established for laboratory technicians. The induction, in-house and refresher trainings for all the staff was carried out using the same format across the country.
| ~ Laboratory Information and Monitoring System|| |
The flow of information is carried out by an effective reporting system between the NRL/SACS/SRL and ICTCs. Each SRL has its own email account and is connected with the NRL/SACS and ICTCs. The monitoring of the SRL is through External Quality Assurance (EQA) and peer group review. Sera panels are prepared by the NRL and sent to the linked SRL for testing. Peer group review is performed by retesting previously tested samples (20% of the positive and 5% of negative) and the discordant results are resolved by the NRL. Regular proficiency testing is carried out. Feedback from monitoring laboratories provides inputs to the peripheral testing sites for improving their performance. 
| ~ Documentation and Manuals|| |
Periodic training, on site mentoring and external assessment has significantly helped to prepare the various levels of documents according to ISO 15189:2007 guidelines. NACO has also published manuals for HIV testing and quality assurance, operational guidelines and training modules, which are available on their website. The training modules have a standardised curriculum that ensures a uniform quality of capacity building program.
Accreditation is voluntary in India, and NACO has addressed to both the managerial and technical requirements as per ISO 15189:2007 guidelines. The private sector laboratories are volunteering for accreditation as it has proved to boost their performance and income.  Though cost and infrastructure development are notable challenges but benefits of accredited diagnostics cannot be underscored. Thus, it is logical to work towards accreditation, which will enable high quality patient care.
| ~ References|| |
|1.||Peter TF, Rotz PD, Blair DH, Khine AA, Freeman RR, Murtagh MM. Impact of laboratory accreditation on patient care and the health system. Am J Clin Pathol 2010;134:550-5. |
|2.||Abimiku AG, Institute of Human Virology, University of Maryland School of Medicine PEPFAR Program (AIDS Care Treatment in Nigeria). Building laboratory infrastructure to support scale-up of HIV/AIDS treatment, care, and prevention: In-country experience. Am J Clin Pathol 2009;131:875-86. |
|3.||Kabra S, Kanungo R. Monitoring quality of HIV testing at point of care facilities in India. Indian J Med Microbiol 2012;30:129-30. |
|4.||Annual Report 2010-11. Department of AIDS Control Ministry of Health and Family Welfare Department of AIDS Control National AIDS Control Organization Ministry of Health and Family Welfare. 2010-11. Available from: http://nacoonline.org/upload/REPORTS/NACOAnnual Report 2010-11.pdf [Last accessed on 2013 Oct 26]. |
|5.||Kapil A. Accreditation of microbiology laboratories: A perspective. Indian J Med Microbiol 2013;31:217-8. |