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Molecular pathology quality Assurance Program  

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INTRODUCTION:

The Molecular Pathology Quality Assurance Program (MP-QAP) is designed to achieve uniformity in every aspect of molecular diagnostics right from sample selection toperforming the tests to analytical interpretation by offering the proficiency testing in Molecular diagnostics. At present no External Quality Assurance (EQA) program exists for solid tumor molecular diagnostics. Hence the need of the hour is to create a National forum for providing Quality assurance in molecular pathology diagnostics. MP-QAP offers adequate infrastructure and expertise to establish EQAS for molecular diagnostics across country and also to the neighbouring countries.

BACKGROUND:

Method-based proficiency testing (MBPT) refers to an EQA approach that is based on method, rather than based on each individual analyte tested. MBPT testing can assess proficiency much more efficiently and effectively. The MP-QAP follows the MBPT based approach. The ability of laboratories to detect different types of genetic alterations and to recognize technical reasons for false positive or false negative results can systematically be tested by a Methods-based proficiency testing (MBPT) program. At present, there are several providers for EQA schemes for mutation detection in solid tumors at international level.However at national level challenges have been identified to participate in inter laboratory performance evaluation; such as lack of appropriate samples, availability of control/reference material and exorbitant cost of participation in CAP Accreditation program.

AIM:

MP-QAP provides a forum for on-going standardization of molecular pathology services across the country and address critical issues, aims to build national guideline data base. It looks forward to become exemplary accredited PT provider across the country, also extending the services at both national and international level.

POLICY:

Ours is a non-profit scientific organization without economic or political interests. All the protocols provided are as per the standardization carried out at our laboratory. This program is presently being run by and in the Tata Memorial Hospital. Participating laboratories can avail the benefit of participation in EQAS modules and use the Confidential Assessment Report for their quality management documentation and for NABL accreditation purposes.

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