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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