Barnali Das
Lead Consultant at the Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Mumbai, and Chair, Association for Diagnostics & Laboratory Medicine, India Section, India
Biggest challenge in pathology? Harmonization and standardization of laboratory testing is the need of the hour. Clinical chemistry and immunoassay tests form a very important set of tests in a pathology laboratory, a tool that clinicians and patients alike depend on to pin down the symptoms for treatment and relief. However, this very set of tests has come into question as the acceptable ranges for biomarkers can change in relation to other biochemicals, biomolecules and hormones, which themselves vary considerably with race, gender, age, different physiological conditions (like pregnancy, new-born) and other illnesses & interfering substances. Individual variations in thyroid-stimulating hormone (TSH), for example, can be so pronounced that each person may seem to have their own set-point. In addition, clinicians and diagnosticians have to grapple with the variability of test results. Even a broadly similar set of instruments and methods can provide different results, to as much as 40 percent, for example, in case of TSH values.
As an executive committee member of the International Federation of Clinical Chemistry and Laboratory Medicine scientific division and chair of the ADLM India section, I have a bigger role to play to incorporate quality competence in healthcare, implement standardization and harmonization of laboratory testing, bridge the gap between diagnosticians and clinicians and connect with professionals in clinical chemistry, pathology, molecular diagnostics and the IVD industry.
The roadmap for laboratory medicine, therefore, will involve strategies for harmonizing, communicating and integrating with all stakeholders to formulate guidelines for assisting in correct measurement, diagnosis and management of diseases.
Solving problems… I have encountered several problems in providing reports with proper reference intervals so I decided to establish my own to address the issue. My involvement with organizations such as ICMR TERIIP, IFCC C-RIDL, IFCC C-STFT and ADLM also encouraged me to pursue reference interval studies. A few examples include:
i) Ethnicity-specific cut offs for TSH are important for accurate test results. We established an in-house reference interval for TSH and FT4. The reference interval (90 percent confidence interval) for TSH by non-parametric procedure (bootstrap) is 0.48-4.52, and by parametric (after data transformation) is 0.45-4.27 for the adult population, which is slightly different from manufacturer’s guidelines.
ii) High-sensitivity cardiac troponin assays (hs-cTnI or T) have improved rapid risk assessment of myocardial infarction in acute coronary syndrome (ACS). However, using a single, universal cut-off for both men and women raised concerns about underdiagnosis in women, who typically have lower troponin thresholds. Our study found that around 14 percent of women were underdiagnosed with ACS when using gender specific cut off. Implementing gender-specific thresholds helped in identifying more women at risk of ACS or death, than a generic threshold.
Exciting developments and trends? Automation, integration and digital transformation are the keys to achieving the 2030 United Nations Sustainable Development Goals (SDGs) Agenda in Healthcare.
Rapid changes in the diagnostic sector coupled with parallel advances in laboratory automation and digital transformation technology in diagnostic platforms have stimulated the evolution of approaches for AI and robotic elements in routine laboratory process flow. Laboratory processes are streamlined to ensure provision of reliable and timely test results enhancing quality of care and patient safety.
The implementation of lab automation, middleware, AI-assisted clinical decision making and adoption of paperless workflows are instrumental in the transformation of the laboratory, specifically influencing clinical validation, procedure efficiency, data handling, data analysis, and more.
Laboratory IT functionalities help us in sample tracking, sample archiving, accounting of tests, audit trails, autovalidation, critical result reporting, data export, generation of monthly statistics reports, inventory management, moving averages, etc. AI helps in computing risk stratification scores of laboratory data and clinical data using expert systems and evidence-based guidelines. Increasing cost containment pressures make the application of this technology highly approachable.
There is a strong need to create a sustained technology policy and supply chain policy framework through a thrust on innovation and allocation of resources for fast-pacing the development of the IVD sector. A strong diagnosis technology model needs to be formulated which will ensure that technologically advanced healthcare is available to all sections of the population.
We also need to bridge the supply–demand gap by digitization. The challenges during the COVID pandemic suggested focusing on opportunities and bridging the supply–demand gap. Diagnosticians, laboratory staff and other key stakeholders responded with initiatives to standardize and harmonize inventory management, resource allocation, cost of ownership and codification, with the help of digital technology to drive supply chain efficiency during the pandemic. Efficiently managing these pressures is critical to the sustainability of laboratory management and requires new strategies to reduce cost burden, while maintaining quality. Increasing cost-containment pressures make the application of this technology highly approachable.
Hospitals can benefit from digital and technology transformation both operationally and clinically. Lab automation and digitization can help our hospitals and laboratories deliver greater outcomes, increase stakeholder collaboration and enhance communication between lab and administration. Timely reporting of diagnostic test results to clinicians and all stakeholders is essential for effective disease and public health management.
