Flow Cytometry — NABL criteria
NABL 112A, section 7.7 — Technical Requirements, Discipline Wise
Checked against NABL 112A (Issue 01, 18-Dec-2024) · page updated 23 September 2026
These are the requirements NABL applies specifically to Flow Cytometry, quoted from NABL 112A. They sit on top of the general requirements every accredited laboratory must meet, not instead of them.
What NABL 112A requires of this discipline
- Viability Testing: The laboratory shall have a procedure for evaluation of viability.
- The laboratory shall establish procedures to ensure that viable cells are analyzed.
- If specimen viability is below the laboratory's established minimum criteria, test results may not be reliable, and this shall be noted in the test report.
- Antibody panels: - Comprehensive panel of antibodies that covers common subtypes of hematolymphoid neoplasm shall be available based on the updated manufacturer's recommended volumes or in-house tittered volumes of antibody.
- Antibody titration shall be done to calculate signal to noise (S/N) ratio and concentration with maximum S/N ratio should be used as staining volume for required number of cells in the assay.
- A minimum of “four color” immunophenotyping shall be used for immune • A minimum of “four color” immunophenotyping shall be used for immune cell subset analysis and diagnosis and subtyping of hematolymphoid neoplasms.
- The laboratory shall document cell concentration policy.
- For single platform measurements, manufacturer guidelines shall be followed.
- Gating strategies: Each laboratory shall define appropriate gating strategies for different lesions.
Showing 9 of 16 discipline-specific requirements identified in section 7.7. Read the full section in the official document before an assessment — this page is a guide to it, not a replacement for it.
Verbatim excerpts from NABL 112A - Specific Criteria for Accreditation of Medical Laboratories, Issue 01, 18-Dec-2024, section 7 (Technical Requirements - Discipline Wise). Downloaded from nabl-india.org 2026-09-23. Download the current version from NABL →
Records this discipline still has to produce
The discipline criteria above are additional. Every accredited laboratory, in every discipline, must still maintain the general record set:
- NABL Internal Audit Checklist for Medical Laboratories
- Internal Quality Control (IQC) Record and Levey–Jennings Chart
- EQA / Proficiency Testing Participation Record
- Method Verification Record
- Method Validation Record
- Measurement Uncertainty (MU) Record
- Comparability of Results Record
- Quality Indicators Record
- Sample Rejection Log and Rejection Criteria
- Primary Sample Collection Manual
Other disciplines
- Clinical Biochemistry Cl. 7.1
- Clinical Pathology Cl. 7.2
- Haematology & Immunohaematology Cl. 7.3
- Microbiology & Infectious Disease Serology Cl. 7.4
- Histopathology Cl. 7.5
- Cytopathology Cl. 7.6
- Molecular Diagnostics Cl. 7.8
- Histocompatibility and Immunogenetics Cl. 7.9
- Cytogenetics Cl. 7.10
- Point of Care Testing (POCT) Cl. 7.11
HealthFlow is not NABL accredited and is not an accreditation body. Using it does not make a laboratory accredited or compliant. These pages describe what the standard requires; meeting it is the laboratory's own responsibility.
What the software contributes is evidence produced by normal work: turnaround time measured per test, reports versioned and locked on authorisation with dual signatures, every report access written to an append-only audit trail enforced at the database and retained two years, and full export whenever you want it.