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Clinical Quality GovernanceNABL • ISO 15189:2022 • ICMR Guidelines

Diagnostic Quality & Clinical Compliance Framework

How HealthSetu enforces stringent quality standards from doorstep phlebotomy to automated digital pathology verification.

1

100% NABL (ISO 15189:2022) Partner Mandate

HealthSetu exclusively partners with laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) under the international ISO 15189:2022 standard for medical laboratories. Unaccredited or makeshift diagnostic setups are strictly disqualified from our partner routing network.

2

Monitored 2°C – 8°C Cold-Chain Logistics

Biological specimens (serum, plasma, whole blood) degrade rapidly when exposed to tropical Indian ambient temperatures. Our phlebotomy fleet carries insulated bio-carriers equipped with phase-change cold gel packs and digital temperature indicators, ensuring specimens stay strictly within 2°C to 8°C until lab accessioning.

3

Zero Sample Mix-Up (On-Site Barcoding)

Sample tubes are labeled with machine-readable alphanumeric barcodes (e.g. SPEC-XXXX-A) at the patient's home immediately after venipuncture. Hand-written marker labels are strictly prohibited to eliminate human clerical error and sample mix-up.

4

Mandatory Pathologist Sign-Off & Tamper-Evident SHA-256 Digest

Technicians can enter raw analyzer values, but reports are only released once an authorized MD/DNB Pathologist reviews the quality control checks, delta checks, and signs off. Each PDF is cryptographically hashed with a unique SHA-256 digest so patients and treating physicians can verify authentic lab results.