The quality gap India’s diagnostics boom cannot afford to ignore

India’s diagnostics industry is in the middle of a decade-long expansion. Organised chains, standalone laboratories and collection networks are multiplying across tier-2 and tier-3 cities, bringing testing closer to patients than ever before. The sector’s conversation about quality, however, remains stubbornly fixed on the analytical stage — better analysers, more sensitive assays, tighter internal quality control. That focus, while necessary, leaves the largest source of error almost entirely unaddressed. I write this having recently examined the problem in a peer-reviewed quality-improvement study published in the Archives of Pathology & Laboratory Medicine, the journal of the College of American Pathologists — but the argument that follows is about the sector, not a single laboratory.

The evidence on this is settled and has been for two decades. Between 60% and 70% of all laboratory errors originate not in the analytical phase, but in the pre-analytical one — the sequence of steps from test ordering through specimen collection, labelling, handling and transport, before a sample ever reaches an instrument. Haemolysed samples, insufficient volumes, mislabelled tubes, expired collection devices, temperature excursions in transit: these are ordinary, daily occurrences, and they translate directly into repeat tests, delayed diagnoses, unreliable results and avoidable cost. For a sector built on the promise of accurate, accessible diagnosis, this is the quality frontier that matters most — and the one that receives the least structured attention.

The accreditation paradox

On paper, India has an answer. NABL accreditation has become the recognised benchmark for diagnostic quality, and its uptake is one of the genuine success stories of the sector’s maturation. Accreditation mandates a functioning quality management system, documented standard operating procedures, competency assessment and continuous improvement. These are real safeguards, and they matter.

Yet there is a gap inside the framework. Accreditation standards mandate that laboratories manage quality; they do not prescribe how a laboratory should actually conduct pre-analytical risk assessment, or how it should measure whether its interventions work. The methodology is left to each laboratory to devise. In large hospital and metropolitan reference laboratories, with dedicated quality departments and specialist staff, that latitude is manageable. In the thousands of smaller standalone laboratories now driving the sector’s geographic spread, it often means the pre-analytical phase is managed reactively — a sample is rejected, a recollection is ordered, the incident is logged, and the cycle repeats — rather than assessed and engineered in advance. Accreditation is satisfied; the underlying error rate is not necessarily reduced.

Why smaller laboratories are the most exposed

This gap falls hardest precisely where the sector is growing fastest. A hospital laboratory typically collects specimens within a controlled clinical environment. A standalone laboratory receives samples drawn at scattered collection points, transported across distances and variable temperatures, handled by personnel with differing levels of training. The structural risk is higher, and the specialist infrastructure to manage it is thinner. As diagnostic access expands into smaller cities — an unambiguously good development for patients — the share of the country’s testing that runs through exactly this higher-risk model grows with it.

The business case compounds the clinical one. Every rejected sample is a recollection, a delayed report, an inconvenienced patient and an eroded referral relationship. In a market where laboratories increasingly compete on reliability and turnaround, pre-analytical quality is not a compliance overhead — it is a competitive differentiator that most operators are not yet measuring, let alone managing.

A structured, resource-appropriate answer

The encouraging part is that closing this gap does not require capital most laboratories lack. It requires method. A workable approach begins by making pre-analytical errors visible — classifying and counting them by type and by collection point rather than treating them as background noise — because a problem that is not measured cannot be reduced. From there, each critical process can be scored on two simple axes: the severity of harm if the error occurs, and the probability of its occurrence. Multiplying the two produces a risk ranking that tells a small team, without specialist software, exactly where to intervene first.

The interventions that follow are unglamorous and inexpensive: structured, competency-assessed training for phlebotomists; mandatory expiry verification and first-in-first-out inventory control for collection devices; temperature monitoring and defined acceptance criteria for transported samples; and a non-punitive error-reporting culture in which staff surface problems rather than conceal them. None of this depends on automation. All of it depends on discipline and documentation — much of which accreditation already requires laboratories to maintain.

This is not theoretical. In a peer-reviewed quality-improvement study recently published in the Archives of Pathology & Laboratory Medicine, the journal of the College of American Pathologists, exactly this kind of structured, low-cost approach reduced the pre-analytical error rate at a standalone NABL-accredited laboratory from 1.0% to 0.3% — a statistically significant 70% reduction — without new instrumentation. The point of citing it here is not the single laboratory’s result, but its transferability: the framework was deliberately designed to be reproducible by the thousands of similar laboratories operating under comparable constraints.

Where technology fits

Digitisation has a genuine role here, though not the one usually assumed. The industry’s technology spend flows overwhelmingly toward analysers and information systems built for result reporting; comparatively little is directed at the pre-analytical workflow where most error actually lives. Yet the same laboratory information systems that most laboratories already operate can, with modest configuration, capture rejection reasons at the point of collection, flag expired-device usage, log transport temperatures and surface trend data by collection centre. The barrier is rarely the technology — it is the absence of a structured method telling the laboratory what to capture and why. Technology amplifies a good process; it cannot substitute for the absence of one. Sequencing matters: define the risk-assessment method first, then let digital tools scale and sustain it, rather than expecting a software purchase to deliver quality on its own.

What the sector should do next

If pre-analytical quality is the largest available quality gain in Indian diagnostics, it deserves more than laboratory-by-laboratory improvisation. Three shifts would help. First, accreditation bodies and professional associations could move from mandating that laboratories manage pre-analytical risk to offering practical, standardised, resource-appropriate methodologies for doing so — closing the how gap, not just the whether gap. Second, laboratory owners could reframe pre-analytical quality as a measured business metric, tracked and reported like turnaround time, rather than an invisible cost of doing business. Third, the sector could invest in phlebotomy and collection-network training as a discipline in its own right, given that the single highest-risk step in most laboratories sits at the point of human contact with the patient.

From adopter to contributor

There is a larger shift worth naming. For years, laboratories in settings like ours have looked to internationally published literature to guide our methods and validate our approaches. A publication like this marks a shift worth noting: a laboratory outside the major metros is now contributing original, peer-reviewed methodology back to that same international body of knowledge it once only drew from — evidence that useful quality-improvement approaches can flow in both directions. The hope is that the framework proves useful to laboratories internationally, not only in India. Indian diagnostics has spent this decade proving it can deliver access at scale. The next decade is a chance to prove it can generate the evidence base for how that testing should be done — starting with the phase that matters most, and gets noticed least.

Reference: Chandarana J, Butani K. Risk Assessment and Mitigation of Preanalytical Errors: A Quality Improvement Initiative at a National Accreditation Board for Testing and Calibration Laboratories–Accredited Diagnostic Laboratory. Arch Pathol Lab Med. doi: 10.5858/arpa.2026-0093-OA

https://doi.org/10.5858/arpa.2026-0093-OA