Quality in diagnostics: Price of getting it right

This article is authored by Dr Navin Dang, founder & chairman, Dr Dangs Lab and board member, NABL; Member of NATHEALTH.

A missed or incorrect diagnosis can have consequences far beyond a laboratory report. Imagine a woman wrongly diagnosed with tuberculosis, undergoing months of treatment while her actual illness progresses unchecked. Such cases underscore a fundamental truth: Accurate diagnosis is the foundation of effective treatment. Yet, diagnostic errors remain an often-overlooked contributor to the global disease burden, and India is no exception.

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Medical diagnostics plays a critical role in clinical decision-making. Nearly 70% of treatment decisions are estimated to be influenced by diagnostic tests, making diagnostic quality a patient safety imperative. An inaccurate report can lead to unnecessary medication, delayed treatment, avoidable complications and substantial financial hardship.

Quality in diagnostics is not a certificate on the wall; it is a continuous commitment to excellence. It begins with preparing patients correctly and collecting, labelling, handling and transporting samples appropriately. It extends to accurate testing, validation of results and timely communication of reports. Even sophisticated equipment cannot compensate for errors in sample collection or inadequate quality controls.

Technology is an important enabler, but qualified professionals remain at the heart of reliable diagnostics. Skilled pathologists, microbiologists, biochemists and laboratory technologists must work with calibrated equipment, dependable reagents and robust quality management systems. Regular training, equipment maintenance and internal and external quality checks are equally essential.

Equally important is ensuring that diagnostic laboratories are operated by appropriately qualified personnel. Many laboratories are run by individuals without formal training in medicine or laboratory science. Diagnostic testing and report validation require specialised knowledge, technical competence and professional oversight. India needs clear, strictly enforced regulations defining who can operate laboratories, supervise testing and authorise reports. Accountability is essential to ensure accurate results and protect patients from inappropriate treatment.

Despite advances in India's organised diagnostic sector, quality standards remain uneven. The country has an estimated 300,000 diagnostic laboratories, but only around 2,500 are NABL-accredited, according to industry estimates. The National Accreditation Board for Testing and Calibration Laboratories (NABL), through standards aligned with ISO 15189, provides a framework for assessing medical laboratory competence. However, accreditation remains voluntary for much of the sector, while implementation of minimum standards under the Clinical Establishments Act, 2010, varies across states.

India needs a nationally recognised, government-backed accreditation framework establishing clear and uniform quality benchmarks. While NABL provides an established accreditation mechanism, consistent regulatory oversight is necessary to strengthen public confidence. Accreditation and minimum regulatory compliance must work together to ensure laboratories, regardless of size or location, are accountable for testing and reporting quality. This disparity creates a significant quality gap. Established laboratories have invested in automation, quality management systems and external quality assessment, while smaller facilities often face financial and operational barriers. Accreditation requires investment in infrastructure, documentation, trained personnel and continuous monitoring. Limited availability of qualified specialists further complicates professional oversight, particularly across decentralised collection networks and underserved regions.

The pre-analytical phase is especially vulnerable. Inadequate patient preparation, incorrect sample collection, improper labelling and transportation delays can compromise results before testing begins. As diagnostic services expand into tier-II and tier-III cities, standardised protocols and continuous training across collection centres become increasingly important. Quality must be consistent across the entire testing network.

Delivering reliable diagnostics requires sustained investment in qualified personnel, modern equipment, calibration, quality-assured reagents, proficiency testing and infrastructure. These are essential safeguards against diagnostic errors. Consequently, unrealistic caps on diagnostic test prices can have unintended consequences. When rates fall below the cost of maintaining quality, laboratories may be pressured to use cheaper reagents, reduce quality checks or defer equipment upgrades. This can lead to inaccurate reports, repeat investigations, inappropriate treatment and higher costs for patients and the health care system.

India must pursue a balanced approach that makes quality both mandatory and achievable. Accreditation processes should be simplified through digital documentation, technical guidance and financial incentives for smaller laboratories. A phased, risk-based regulatory framework can establish minimum standards while enabling laboratories to strengthen their capabilities. Effective enforcement must address facilities operating without appropriately qualified personnel or adequate safeguards.

Medical education also has a crucial role to play. Quality, patient safety and accurate diagnostics must be embedded in medical curriculums, building a culture in which clinicians and laboratory professionals recognise the value of reliable testing. India has the expertise, technology and institutional capability to become a global hub for quality diagnostics. Realising this ambition requires consistent standards across standalone laboratories, hospital-based facilities, corporate diagnostic chains and government laboratories.

Ultimately, the price of quality must be measured against the cost of getting a diagnosis wrong. Investing in accurate diagnostics is investing in patient safety, better treatment outcomes and trust in health care. We must pay for quality and never allow short-term cost savings to come at the expense of a patient's health.

(The views expressed are personal)

This article is authored by Dr Navin Dang, founder & chairman, Dr Dangs Lab and board member, NABL; Member of NATHEALTH.