The National Accreditation Board for Testing and Calibration Laboratories (NABL), on November 4, 2025, issued an amendment (Amendment No: 01) to its guidance document NABL 112B for medical laboratories. This document provides essential guidance on various aspects of laboratory operation, including the operation of sample collection centers (SCFs), scope of accreditation preparation, lot verification, and the use of automated result reporting algorithms.
The primary goal of NABL 112B is to ensure the reliability of test results by guiding medical laboratories on maintaining sample integrity during collection, handling, and transportation, particularly concerning temperature-sensitive parameters. It details requirements for quality systems, staff training, and compliance with waste disposal regulations for SCFs.
The document further provides model scopes of accreditation for various disciplines—Histopathology, Cytopathology, Microbiology & Infectious Disease Serology, Clinical Biochemistry, Clinical Pathology, and Haematology & Immunohaematology—detailing the component tested, test method, range of testing, and the required %CV/MU. It also specifies that calculated parameters must have their primary parameters included in the scope and require evaluation for QC performance.
[Notification No. NABL 112B]
