NABL 112 A and NABL 112 B Interpretation and Implementation

Outline clause 4 and 5 of ISO 15189:2022 within Annabel 112A and 112B, focusing on impartiality, confidentiality, governance, risk management, and advisory communications with users.

Explore ISO 15189 2022 clauses six to eight, detailing general and discipline-specific resource, personnel, and facility requirements for accredited laboratories, including auto validation, staffing, and equipment calibration.

Telepathology enables remote interpretation of digital images by referral laboratories and consultants, with guidelines on scope, response times, risk analysis, traceability to patients via lab IDs, and quality assurance.

Ensure pre examination processes include complete clinical data on test requests, proper evacuated tube venipuncture with correct order of draw, and maintain sample integrity through documented handling, transport, and training.

Explain examination processes, including IVD kit usage, open channel verification, and method validation. Outline quality control, measurement uncertainty, reporting, and post-examination processes to ensure accurate results.

Explore alias, the laboratory information system, and laboratory management system, to control data from accession to reporting, ensure confidentiality, verify interfaces, and implement quality indicators, retention, and audits.

Explore the technical requirements for clinical biochemistry, clinical pathology, hematology, and immunohematology. Learn pre-examination precautions, QC, reporting, and verification practices.

Review the requirements for infectious disease serology, including measurement uncertainty and quality control in serology and microbiology. Follow QC guidelines, use ATCC strains, and ensure reporting.

Outline of microbiology laboratory facility and biosafety requirements for infectious samples. Emphasizes biosafety level two or higher, class II biosafety cabinet, two autoclaves, PPE, waste management, and media preparation.

Learn histopathology lab safety, environmental controls, formalin and xylene handling with exhaust and fume hoods, and maintain precise records and ISO 15189 disposal procedures.

Explore the fetal autopsy workflow, including gestational age terms, comprehensive clinical data, and consent requirements. Learn transmission electron microscopy setup and safety, including epoxy handling, one-micron sections, and retention rules.

Explains immunohistochemistry in histopathology, detailing specimen types, fixation times, antibody verification, verification case numbers, controls, equipment harmonization, and reporting standards for predictive and non-predictive markers.

Master digital pathology using whole slide imaging to acquire, manage, and interpret digitized slides for primary diagnosis, telepathology, and frozen sections, with validated workflows and scanner standards.

Learn facility and equipment needs for cytopathology, including a dedicated lab with cyto centrifuge for CSF and urine FNAC, on-site ROSE, and Bethesda system reporting.

Explore technical requirements for flow cytometry, including sample handling, viability testing, immunophenotyping, and antibody panels. Learn quality control, gating strategies, and reporting for hemato lymphoid neoplasms.

Ensure unidirectional workflow and post PCR separation to prevent cross contamination. Guard pre and post amplification guidelines, biosafety, and validation for PCR testing.

Outline molecular genetics within molecular diagnostics by detailing gene-specific DNA sequencing validation, cross-strand verification, HGVS nomenclature, prenatal testing standards, and ACMG/AMP reporting.

Maintain chromosomal microarray standards: probes with coordinates, SNP/CGH platforms, 400 kb resolution, validated software, and ISCN CNV reporting, plus reference DNA documentation.

Outline the end-to-end next generation sequencing workflow—from specimen handling and library preparation to sequence generation and QC—plus bioinformatics pipelines, variant calling, and reporting per ACMG/AMP guidelines.

Master histocompatibility and immunogenetics, covering HLA typing methods (SOP, SSP, SBT, NGS) and HLA crossmatching essential for transplantation. Learn reporting standards, authorization requirements, CPD, and post-examination handling under ISO 15189:2022.