Quality Assurance and Quality Control

At GENNext Diagnostics, we adhere to comprehensive quality assurance programs to create the uniform high quality that makes laboratory data reliable. While not infallible, each laboratory quality control program rigorously defines requirements for staff proficiency, equipment maintenance and monitoring and other standards of operations. From the moment a test is ordered, attention to detail becomes an issue critical to the quality of laboratory results. To make it easier to see all the points where quality is monitored - and the areas where the quality of your input is important - we have divided the tasks into three main phases:

  • Pre-Analytical Activities : what happens when the test is ordered and the sample is collected
  • Analytical Activities : what happens in the lab where the test is conducted
  • Post-Analytical Activities : what happens between the time the test is run and the results are reported
Internal Quality Control

A dedicated team of qualified and experienced technicians ensures checking of sample integrity, labelling and bar-coding. To ensure result reliability, acceptance and rejection of samples policies are well defined. The personalized Laboratory Information Management Software generates appropriate number of bar codes for each patient depending on the variety of containers required. The system ensures zero chance of wrong labelling. We have a separate patient services section responsible for sample collection. This section is a group of well-trained experienced phlebotomists working under supervision of our Customer Care department. Quality Control samples are run every day at pre-determined intervals before commencement of testing of actual patient samples. Results are checked for compliance with Westgard rules using LJ charts target CV%. Thereafter, Departmental Heads of the different laboratory sections along with Senior Technicians review Levey Jenning control charts everyday to detect specific areas that require improvement. Each technical Standard Operating Procedure (SOP) includes instructions for the correct use of QC materials. We have established and maintained personnel policies to ensure employees meet or surpass the necessary qualifications and training required to perform their duties.

External Quality Control

The attainment of quality service in a laboratory requires a comprehensive Quality Assurance Program which includes both Internal and External quality control materiel. GENNext Diagnostics is a regular participant in the External Quality Assurance Scheme (EQAS) for Biochemistry, Immunoassay, Hematology, Hematology, Serology and Immunology & Microbiology. Our EQAS agencies are as follows:

  • CMC EQAS, Department of Clinical Biochemistry, Christian Medical College, Vellore under the banner of The Association of Clinical Biochemists of India (ACBI). The Chemistry and Thyroid Hormones program are accredited by NABL in accordance with the standard ISO/IEC 17043:2010.
  • ISHTM-AIIMS EQAS, Department of Hematology, AIIMS, New Delhi. The program is majorly based on WHO international council for standardization in haematology: 2008, ISO/IEC 17043:2010 and ISO/IEC 13528:2015 standard. As Proficiency testing provider (PTP), the goal of the ISHTM-AIIMS- EQAP is to carry out accurate and timely proficiency testing for hemogram for laboratories throughout India. Presently more than 3000 laboratories are registered in the programme with increasing number of applications being received continuously. This programme has recently been accredited as proficiency testing provider (PTP) by NABL (Certificate No. PC- 1002) as per the ISO/IEC 17043:2010 standard.
  • IAMM-EQAS, Department of Clinical Microbiology & Immunology, Sir Ganga Ram Hospital, New Delhi under the aegis of Indian Association of Medical Microbiologists. NABL accreditation as PT provider achieved in October 2018