For compliance officers, lab managers, and assessors evaluating AyusLab, this is the full mapping of NABL 112 (Specific Criteria for Medical Laboratories) to where each requirement is implemented in the platform.
Total: 57 mapped specifications. “Not lab-software scope” covers requirements that are operational responsibilities of the lab (e.g. equipment calibration, staff training) where AyusLab provides supporting documentation features.
| Section | Specification | Status | AyusLab implementation |
|---|---|---|---|
| 4.5 p.4 |
Examination by referral laboratories Documented policy for selecting and referring tests to other accredited labs. Accredited lab must specify the name of the referral lab in the report. |
Part compliant | Outsourced-lab list with per-report tracking |
| 4.6 p.5 |
External services and supplies Each lot of reagents checked against earlier in-use lots before service. Antibiotic sensitivity discs checked for activity / potency. |
Part compliant | Inventory module — reagent + lot tracked against each test |
| 4.12 p.5 |
Continual improvement Comprehensive quality improvement program with quality indicators: sample collection, transport, analysis, TAT, complaints, equipment downtime, MU, EQAS performance. |
Part compliant | TAT module, Sample module, QC module, Equipment / analyzer module |
| 4.13 p.6 |
Quality and technical records Minimum retention: 5 years for Histopathology / Cytopathology, 1 year for other disciplines. |
Compliant | Cloud storage with retention policy |
| 5.1.1.2 p.7 |
Qualification norms for authorized signatories Authorized signatories list maintained with qualifications and authorisation rules. |
Part compliant | Signatures master with authorisation rules per report print |
| 5.3 p.11 |
Laboratory equipment Many equipment types calibrated in-house using reference materials or comparative techniques. |
Not implemented | Lab equipment master maintained; calibration is the lab’s responsibility |
| 5.4 p.18 |
Pre-examination procedures Sample collection and handling instructions documented. Guidelines for rejection (under-fill / over-fill, coagulation tubes). Reasons for rejection stated in writing. |
Compliant | Sample module with rejection workflow |
| 5.6 p.28 |
Quality of examination procedures Daily QC values documented with %CV from monthly QC data. Control charts maintained for stability of analytical measuring systems. |
Compliant | Quality Check (QC) module |
| 5.6 p.29 |
Haematology — variation limits Day-to-day variation in MCV, MCH should be between the 2SD limits determined on 400 samples. |
Compliant | Quality Check (QC) |
| 5.6 p.31 |
Cytopathology — follow-up records Review all previous slides for a patient. Match previously reported abnormal smears with histopathology sections. Compare cytological findings with colposcopy / biopsy. |
Compliant | Patient historical records maintained |
| 5.8 p.33 |
Reporting — critical limits Establish critical limits for tests requiring immediate attention. Communicate critical results with proper documentation. |
Compliant | Critical-value alert feature |
| 5.8 p.33 |
Biological reference intervals Age- and sex-specific reference intervals established by the lab for the method used. Documentation retained. |
Compliant | Normal range — age and gender specific |
| 5.8 p.34 |
Authorizing and issuing reports Reports checked for accuracy by a pathologist before authorising printed or electronic reports. |
Compliant | Multi-level approval workflow per department |
| 5.8 p.34 |
TAT for issue of reports TAT for issue of reports should not exceed 4 days. Interim reports for special procedures. |
Part compliant | Interim Report (IR) with marked IR label |
| 5.8 p.34 |
Cytopathology — explanatory notes Explanatory notes shall accompany any unsatisfactory or equivocal report. |
Compliant | Report master with notes provision |
| 6 p.35 |
Guidelines for collection centres Guidelines for operating collection centres. |
Compliant | SOP document upload provision |
| 6 p.36 |
Sample condition on receipt Record of temperature and condition of sample on receipt at the lab. |
Part compliant | Sample quality recorded with approve / reject option |
| 6 p.36 |
Collection-centre staff training Adequate training including policies, hygiene, methodology, processing, packaging, transport, first aid, safety, waste disposal. |
Not relevant | Document repository for SOP reference |
| 6 p.36 |
Collection centre name in reports Include the name and address of the collection centre in the test report. |
Compliant | Reference center provision in report |
| 6 p.37 |
Assessment plan for collection centres Sampling-based assessment of collection centres. |
Not relevant | Collection centers maintained separately for assessment |
| 6 p.38 |
Collection centre audit checklist Additional requirements for accreditation of labs operating collection centres. |
Not relevant | Compliance checklist module |
| Annex 1 p.42 |
List of routine and special tests Routine and special test list maintained. |
Compliant | Comprehensive report master |
| 4 p.12 |
Service agreements Users explicitly informed about non-accredited status of requested tests. |
Compliant | Report master flags NABL vs non-NABL tests |
| 4 p.13 |
Records — referral laboratories Records of referred tests and referral labs with signatory details. Information kept in referral file and patient file. |
Compliant | Outsourced labs list maintained |
| 4 p.13 |
Referring laboratory — prior intimation Prior intimation to users about referred tests. Produce original referral lab report or transcribe without altering clinical interpretation. |
Compliant | Provision to upload referral lab report as-is |
| 5.5 p.25 |
Measurement uncertainty Run controls for each analyte; derive SD and %CV from lab mean (not manufacturer’s target). %CV to first decimal place. |
Compliant | Quality Check (QC) module |
| 5.6 p.28 |
Other quality assurance procedures Review of daily mean, delta check, clinical correlation, correlation with other lab results, in addition to IQC. |
Compliant | Quality Check (QC) — delta check, daily mean review |
| 5.9 p.29 |
Release of reports Reports released per signature / department workflow. |
Compliant | Signature and department-based workflow |
| 5.9 p.30 |
Revised reports Hard or soft copy of original and revised reports retained with reason for revision. |
Compliant | Result entry with revision history |
| 5.1 p.31 |
Information system management All functions from accession to reporting verified after installation. |
Compliant | Validation and help file documentation |
| 5.1 p.31 |
Rule-based systems Rule-based systems for automated selection and reporting verified. |
Compliant | Auto-dispatch with rule verification |
| 5.1 p.32 |
Security and confidentiality Role-based authenticated access. Procedures to inactivate users no longer authorised. Audit trail of user actions on patient data. |
Compliant | User role management + full audit trail |
| 5.6 p.33 |
Ensuring quality of examination results Two levels of QC at least once per day. For 24x7 ops: two levels at peak hour, one level every 8 hours. Daily QC values documented; LJ charts plotted daily. |
Compliant | Quality Check (QC) with LJ charts |
| 5.6 p.33 |
Monthly mean / SD / %CV Calculate monthly mean, SD, %CV. Maintain control charts to demonstrate stability of analytical measuring systems. |
Compliant | Quality Check (QC) — automated monthly stats |
| 5.6 p.34 |
Reporting with interpretation Reports should have interpretation where relevant. |
Compliant | Report master with interpretation field |
| 5.4 p.35 |
Sample rejection guidelines Under-fill or over-fill for coagulation tests rejected. Reasons stated in writing to collection staff. |
Compliant | Sample module with rejection workflow |
| 5.6 p.38 |
Duplicate tests for precision Duplicate tests on patient samples. Day-to-day variation in MCV / MCH / MCHC analysed using Bull’s algorithm. |
Compliant | Quality Check (QC) — duplicate testing support |
| 5.3 p.43 |
Stains, reagents, kits — labelling Labelled, dated, stored properly. Not used past expiry or showing signs of deterioration. |
Compliant | Inventory module with expiry tracking |
| 5.5 p.45 |
Informed consent Written informed consent before blood sample collection. Consent form in commonly used vernacular language. |
Compliant | Consent upload provision |
| 5.5 p.45 |
Dengue rapid test disclaimer Dengue rapid test reports include disclaimer that results are provisional; confirm with IgM capture ELISA. |
Compliant | Report master with disclaimers |
| 5.6 p.46 |
Quality indicators Specimen rejection rate, transit time, blood culture contamination rate, TAT. |
Part compliant | Sample + TAT tracking |
| 5.8 p.47 |
Reporting — infectious diseases Serological tests for infectious diseases reported with comments on interpretation and limitations. |
Compliant | Report summary with interpretation |
| 5.3 p.55 |
Equipment maintenance log All equipment installed, operated, maintained per manufacturer guidelines. Daily / weekly / monthly / semi-annual / annual maintenance log maintained. |
Not relevant | Equipment master with full equipment list |
| 5.3 p.55 |
Reagent expiration assignment Assign expiration date to reagents without manufacturer date, based on stability, use frequency, storage, deterioration risk. |
Compliant | Inventory module |
| 5.4 p.56 |
Sample acceptance / rejection policy Documented policy for acceptance, rejection, anticoagulant, collection time, transport temperature, processing, storage. |
Compliant | Sample policy module |
| 5.6 p.60 |
Instrument set-up & QC Instrument optimised for optical alignment, electronic standardisation, sensitivity / linearity, compensation. Documented function checks before daily run. |
Compliant | Equipment master with policy document upload |
| 5.6 p.60 |
Cross-instrument performance If more than one instrument for the same test, verify concordance at least twice a year. |
Compliant | Equipment master |
| 5.8 p.61 |
Flow cytometry reports Report includes instrument name / type, software used, cell preparation method, gating strategies, % of gated cells examined. |
Compliant | Report master |
| 6 p.85 |
No testing at collection centre Testing at collection centre in same city = satellite laboratory (multiple location). Different city = separate laboratory. |
Compliant | Reference center with location tracking |
| 6 p.86 |
Sample transport time Lab runs pilot studies to determine sample transport time by chosen route / mode. |
Not relevant | Collection Center module |
| 6 p.87 |
Collection centre staff training Adequate training on policies, hygiene, methodology, processing, packaging, transport, first aid, safety, waste disposal. |
Not relevant | SOP reference repository |
| 6 p.88 |
Internal audit of collection centres Annual internal audit of each collection centre. Discussed in management review. |
Not relevant | Collection Center module |
| Annex 1a p.92 |
Scope preparation guidelines Guidelines for scope preparation. |
Not implemented | Sample module |
| Annex 1b p.98 |
Point of Care Testing (POCT) Guidelines regarding POCT. |
Not implemented | Equipment master |
| Annex 3 p.103 |
Lot verification / parallel testing Lot verification or parallel testing of controls. |
Not implemented | Quality Check (QC) |
| Annex 5 p.107 |
EQAS (External Quality Assessment) External proficiency testing services to enable labs to compare with peer groups on accuracy. |
Not relevant | EQAS module |
| Annex 6 p.112 |
Auto-selection and reporting algorithm Guidelines algorithm for automated selection and reporting of results. |
Compliant | Auto-approval rules configurable |
Source: NABL 112 — Specific Criteria for Medical Laboratories (NABL India). For the official document, see nabl-india.org. For platform-specific compliance documentation or audit support, contact the AyusLab team.
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