NABL

Pathoshine Diagnostics has accreditation from ISO 9001-2015. We are following guidelines of National Accreditation Board for Testing and Calibration Laboratories for its Laboratory. (NABL), which is a constituent board of Quality Council of India and is a leading accreditation body to provide formal recognition of technical competence for specific tests.

 

The laboratory accreditation services to testing and calibration laboratories are provided in accordance with ISO:9001- 2005 ‘General Requirements for the Competence of Testing and Calibration Laboratories’ and ISO     9001-2015 ‘Medical laboratories — Requirements for quality and competence’. The accreditation to Proficiency testing providers is based on ISO/IEC 17043: 2010 “Conformity assessment — General requirements for proficiency testing” and to reference material producers based on ISO Guide 34:2009 “General requirements for the competence of reference material producers”.

 

Quality Control and Standardization of  procedures in all aspects of Laboratory testing is of prime importance at our center for provision of quality results in the interest of patient care. It covers all aspects of laboratory functioning i.e. pre-analytical, analytical and post-analytical, turnaround time, maintenance of equipment, selection of tests & reagents, standardization & validation of tests before they are introduced and training of personnel Proficiency Testing.

1  Internal quality control (IQC) is useful to detect, reduce and correct deficiencies in the laboratory`s analytical process prior to the release of patient results. Stringent practice of quality control helps our laboratory to  achieve better performance goals. In addition to the daily routine, IQC material is run after an instrument is serviced, after reagents are changed, after calibration and when patient results seem inappropriate. Quality control data is interpreted by both graphical and statistical methods using the Levey Jennings(LJ) chart. The control values are plotted against their respective dates. The mean value and one, two and three standard deviation limits are also marked. The pattern of plotted points provides information of random error, shifts or trends in the control runs. The internal quality control system helps in immediate intervention during the release of patients results. The laboratory personnel performing this exercise determines the appropriate corrective action to be taken for QC data that fall outside the tolerance limits. The daily control values are documented along with calculation of % CV from the monthly quality control data and the control charts are maintained.

 

2. External Quality Assessment is used to identify the degree of agreement between our laboratory`s results and those obtained by others. EQAS provides information concerning the relative performance of analytical procedures, including the method principle, reagents, and instruments. Continued participation in EQA schemes has been linked to improvement in our  laboratory performance.