Histocompatibility and Immunogenetics — NABL criteria
NABL 112A, section 7.9 — 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 Histocompatibility and Immunogenetics, 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
- The laboratory shall ensure participation of the laboratory personnel in CEPD programmes.
- The laboratory shall use internal quality control (Negative, Positive or Disease specific) in each run.
- Depending on the test needs, the laboratory shall use donor peripheral blood lymphocytes, separated peripheral B lymphocytes, separated peripheral T lymphocytes, chronic lymphocytic leukemia (CLL) cells, splenic lymphocytes, lymph node lymphocytes or lymphoblastoid cell line.
- CDC cross match test • HLA cross-matching for solid organ transplantation shall use either the standard NIH (CDC) micro lymphocytotoxicity method or its variants utilizing the anti-human lymphocyte globulin.
- For most cases the serological crossmatch test may be performed with Peripheral Blood Lymphocytes (PBL) of the donor or purified donor T and / or B cell populations, such that each cell preparation shall have 80% or higher cell purity.
- Interpretation of Data (HLA) questionable or inconsistent data shall be resolved by either repeating the assay or using an alternative method.
- Reporting of results • In addition to the requirements of the standard, the report shall include the following: -Methodology: Summary of the methods used, Loci/Disease locus tested, test performed.
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
- Flow Cytometry Cl. 7.7
- Molecular Diagnostics Cl. 7.8
- 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.