Laboratory Service
MIZORAM STATE AIDS CONTROL SOCIETY: LABORATORY SERVICE DIVISION FUNCTIONAL
- Mizoram SACS Laboratory services Division major activities is to deals with the Quality assurance which ensures that the final result reported are correct, reliable and accurate as per the limitations of the test system employed and are achieved in a standard, reproducible and traceable manner.
- The HIV testing laboratories Assurance Programme are arranged in a tiered manner with Apex laboratory (NARI, Pune) at the top that supervise the National Reference Laboratory (NICED, Kolkata) and NRL evaluates the quality of the HIV testing of State Reference Laboratory (Dept. Of Microbiology, Civil Hospital Aizawl) and SRL supervised the quality testing of HIV in all peripheral testing centers (37 ICTC’s and 10 Blood Bank).
(Note: The above Cascade is produced only for Mizoram State)
- To achieve such reassurance and to ensure quality of HIV testing, quality assessment programmed has been ruled out known as “External Quality Assessment Schemes” (EQAS) which determine the quality of results generated by the laboratory.
- All 37 Stand alone ICTC’s and 10 Blood Bank participate in an External Quality Assessment Scheme (EQAS) programmed monitored under Lab Service Division, Mizoram SACS. Under EQAS programmes, quality assessment has been carried out in 3 different ways:
1) Known as “Rechecking or Retesting”. This rechecking is carried out four times annually.
All 37 ICTC’s should send samples to “State Reference Laboratory”; Department of Microbiology, Civil Hospital Aizawl, which include 20% of all positive samples and 5% of all negative samples collected in the 7 working days of the first week of every quarter i.e. January, April, July and October; for cross checking to the SRL.
SRL send the feedback to the participating laboratories (37 stand alone ICTC) and this scheme is used to detect error in HIV testing results whether the ICTC’s is generating false positive and false negative result or not. Hence, it is extremely important to avoid the occurrence of inaccurate result as the false results are associated with social, medical, ethical and legal implication.
2) Called as Proficiency testing which involves sending “coded” samples or “Unknown” samples of Panel sera from the National Reference laboratories (NRL, NICED Kolkata) to the SRL- Civil Hospital Aizawl twice a year i.e. May and October for standard testing.
SRL distribute the panel sera to the participating laboratories (37 stand alone ICTC and 10 Blood Banks) to check the testing device, testing quality, and personnel performance. Results indicate quality of personnel performance and test site operations.
SRL then analyzed the result of Proficiency testing and the feedback has been send to participating laboratories and does the troubleshooting in case of default. If necessary, corrective action has been taken to resolve the same by locating the problem.
- Result of panel sera and Retesting FY 2014-2015, 2015-2016, 2016-2017, 2017-2018, 2018-2019 shows 100% matching results which indicate that the HIV testing quality is upto standardization until today.
3) Lastly, the quality assessment called On Site Evaluation is included, in that the Technical Officer of Mizoram SACS supervised the HIV testing laboratory of all 37 Stand Alone ICTC’s.
▣ This programme for assuring the quality carried out under Laboratory Service Division are used for:
- Allowing comparison of performance and results among different test sites.
- Provide early warning for systematic problems associated with HIV testing kits or operations.
- Provide objective evidence of testing quality.
- Indicate areas that need improvement.
- Identifies training needs.
Others important activities under Lab Service Division:
1. CD4 EQAS which has been done twice a year in the month of May and October for CD4 count testing laboratories such as Aizawl ART center, Lunglei ART center and Champhai ART center where the coded samples has been send over to each center from Apex Laboratory (NARI Pune) directly and the EQAS test results has been convey back by each ART centers within the timeline and feedback is to be received from Apex Laboratory to cross check with the CD4 testing centers whether the CD4 Counting machine falls under the normal range of the test result produced. This programme is mainly to check the errors in CD4 Counting machine and the performance of the personnel who do the CD4 testing.
Moreover, newly CD4 testing centers such as Kulikawn ART centre, Mamit ART centre and Kolasib ART centre will soon be included later on for CD4 EQAS programme.
2. Quality Management System of ISO 9000:2007 has been taken up by Laboratory Service Division which is integrated in 28 Stand Alone ICTC excluding Mobile ICTC to attain and retain the quality in HIV testing Laboratory.
QMS is a set of essential building blocks for a laboratory’s work operation to fulfill stated quality objectives. Such a system provides the means to direct and control the laboratory with regard to quality. QMS is not limited to only testing but extends much beyond the testing process and is divided into 3 phases: pre-analytical (Pre Examination), analytical (Examination) and post analytical (Post Examination).
3. NABL (National Accreditation Board for Testing and calibration Laboratories) of ISO 15189:2012 has been applied for SRL, Civil Hospital Aizawl commence by Laboratory Service Division and NABL accreditation certificate has been received on November 2016 and the accreditation cycle is 2 years and is once expired on November 2018.
Reaccreditation is for a second time achieved on 10th January 2019 which is valid upto 9th January 2021. Hence, SRL, Department of microbiology, Civil Hospital Aizawl is NABL Accredited Laboratory in HIV and CD4 testing area.
NABL provide accreditation services to “General requirements for the competence of testing and calibration Laboratories”; “Requirement for quality and competence “and “Conformity assessment – General requirement for proficiency testing”.