NABL accreditation records: what your lab software must produce

NABL accredits medical laboratories against ISO 15189:2022, and its specific criteria document for Indian labs, NABL 112A, spells out what an assessor expects to see. A large part of that evidence is records: who authorised each report, what the daily quality control showed, how long each sample took, and what was done when something went wrong. Lab software that cannot produce these records on demand makes accreditation harder than it needs to be.

What does NABL expect from the lab's information system?

NABL 112A, issued in December 2024 and available from nabl-india.org, has a section on control of data and information management. In plain terms it asks for the following.

• Results, manual or from an analyser, reach users through an information system that manages workflow, quality and the audit trail for every sample.
• A computerised system is verified after installation by entering patient data, retrieving it and comparing it with the source, and the check is repeated every six months on at least ten sample or test types.
• Analyser-to-LIS and LIS-to-HIS interfaces are verified so that results are not misfiled or misformatted.
• Access is role based and authenticated, users who leave are inactivated, and the system can show an audit trail linking each action to a user and to the patient data or software change involved.

The audit trail is the item that separates lab software from a billing tool. Every result entry, edit, rerun, authorisation and reprint has to be attributable to a named user with a timestamp. Pathixio records this by default, and the interface verification asked for above is part of our analyser setup.

Which records must the software keep, and for how long?

NABL 112A says the lab decides retention in line with national, state and local regulations, and then sets minimums of its own. The table shows the entries most relevant to a general pathology lab, from Table 2 of that document.

Note two things. These are minimums, and the document allows records to be kept physically or electronically. In practice a cloud LIMS keeps every report, so what matters is that QC data, EQA data and authorisation records are retrievable for the assessor. Retention required under the Clinical Establishments Act rules in your state may be longer, so check the MoHFW clinical establishments portal as well.

What does authorisation look like on a report?

NABL 112A requires test reports to include identification, by name or signature, of the person authorising release. It also asks the lab to establish and display critical limits for tests needing immediate attention, and to communicate such results to the treating doctor after proper documentation. Where results are released automatically under rules, those reports must be marked auto verified and the rules must be traceable to an authorised person, with the system reviewed once a year.

For most labs the practical setup is a pathologist queue in the software, a digital signature applied on authorisation, the authoriser's name and time printed on the report, and a critical-value alert that records who was informed and when. Where a preliminary report is released overnight by trained technical staff, as NABL 112A permits for urgent care, the authorised person reviews it on the next working day and the software keeps both versions.

What about QC logs, TAT and corrective actions?

Internal quality control. NABL 112A asks for two levels of QC on the day a test is performed and one level every shift or eight hours after that, daily documentation of QC values, Levey-Jennings charts plotted and reviewed daily, the lab's own mean and SD from at least twenty data points, and monthly mean, SD and CV. Out-of-control runs must be analysed and corrective action taken. A LIMS that receives QC results from the analyser and draws the chart removes most of the manual work here.

External quality assessment. Labs participate in EQA or proficiency testing for each discipline before accreditation and document corrective actions taken on the EQA evaluation report.

Turnaround time. NABL 112A defines TAT as the elapsed time between two specified points through the pre-examination, examination and post-examination processes, and lists it among the quality indicators a lab must monitor, alongside sample identification, transport, complaints, downtime and EQA performance. Internal audits covering all three phases must be conducted at least once in twelve months. Our guide to improving turnaround time covers that.

Corrective actions. Every nonconformity, whether an EQA outlier, a mislabelled sample or a late report, needs a record of what happened, the root cause and what changed. The register can live in the LIMS or in a quality document, but it must link back to the event the LIMS recorded.

How to prepare: a checklist

1. Read NABL 112A and NABL 112B, the guidance document, from the NABL site, and map each clause to a screen or report in your software.
2. Turn on and test the audit log. Change a result, authorise a report, reprint it, and confirm each action shows the user and time.
3. Set up QC levels per analyser, receive QC runs into the LIMS and check that LJ charts draw correctly.
4. Enrol in an EQA programme for each discipline and file the reports with the corrective actions.
5. Define TAT targets per test and check the TAT report weekly for a month before the assessment.
6. Run the half-yearly information system verification and file the signed screen prints.
7. Conduct an internal audit covering pre-examination, examination and post-examination, and record the findings.

Accreditation is granted for four years with annual surveillance, according to the NABL FAQ. NABL also announced in October 2025 on its news page that accredited medical laboratories would receive 15 percent higher rates than non-accredited ones under CGHS. The records above are what keep the certificate through each surveillance visit, not only what earns it.

Frequently asked questions

Does NABL require a specific brand of lab software?

No. NABL 112A describes what the information system must do, including workflow, quality and audit trail management, verification after installation, verified interfaces and role-based access. Any system that meets those requirements and can demonstrate them to an assessor is acceptable. A cloud system is fine; the document itself refers to cloud-based systems.

Can a small lab get NABL accreditation?

Yes. NABL 112A states that the criteria apply to laboratories applying for accreditation regardless of the level at which they function. The scope can be limited to the tests the lab actually performs. The main investments are a qualified authorised signatory, QC materials and EQA enrolment, documented procedures, and software that produces the records.

How long should we keep signed reports?

NABL's stated minimum for reports and worksheets is one month, but that is a floor, not a recommendation. State rules under the Clinical Establishments Act, medico-legal needs and the lab's own patient-history service all argue for keeping reports far longer. A cloud LIMS keeps every authorised report with its audit trail, so there is no reason to delete.