Chief of Quality, Senior Consultant- Pathology,
Suraksha Diagnostic Pvt. Ltd., Kolkata
Nobel laureate Niels Bohr once said “Prediction is difficult, especially about the future”. Hence it is vital to know and understand our present as that will define our future. Laboratory medicine has seen a paradigm shift from manual processing and handling of reagents and patients’ samples to a so called software driven, robotic lab equipped with fully automated analyzers requiring minimal human intervention. The shift is basically driven by need for accurate, error free and faster reports, in order to get precise therapy. Gone are the days of traditional trial and error method of care which is no longer acceptable for obvious reasons. Today the expectation from a modern medical laboratory is not only limited to accuracy and reliability of test results but a faster turnaround time (TAT), state-of-the-art technology with global quality standard, affordable cost and reports carrying simple and useful information preferably with a direction to therapy.
To meet such ever increasing demands, modern medical laboratories have adopted several ways and no doubt automation, robotics and use of artificial intelligence (AI) are cornerstones of this attempt.
Where the world is going?
The modern days’ autoanalyzers with bidirectional interfacing improve productivity, measure and standardize performance, reduce manual errors and deliver faster reports with more consistent turnaround time. Some manufacturers have even come up with integrated systems where two analyzers working on different principles (e.g. spectrophotometry with chemiluminescence) can be combined to improve operational efficiency, TAT and to save manpower. Now automation in laboratories is not only restricted in adopting standalone analyzers but also integrating the analyzers into larger systems namely task-targeted automation (TTA) and total lab automation (TLA).
The concept of TTA and TLA saw daylight when Dr Masahide Sasaki, the father of clinical laboratory automation presented the implementation of automation in his own laboratory in the 1989 AACC meeting. Following the amazing presentation of his work, many vendors started designing and constructing automated systems for commercial sale and trading purposes.
Task-targeted automation (TTA) can either perform a single task or can combine multiple tasks into a multifunction workstation. A TTA system can significantly improve productivity, quality and TAT. Such systems can automate centrifugation, decapping, recapping, aliquoting, sorting urgent samples from routine samples or sample archiving for post analysis storage purpose. The multifunction TTA may be ideal for laboratories who don’t have necessary budget or floor space for commissioning of a total lab automation (TLA) system. A lab with 500-1500 daily sample volume with autoanalyzers from different vendors can justify the installation of multifunction TTA systems.
The concept of total lab automation (TLA) includes preanalytical, analytical and post analytical components which supports quality control, inventory management, control of autoanalyzers and TAT. With robust IT and quality controls in place, the TLA has truly proved itself to be a game changer and can be an idiot proof system which listens only to barcodes and thereby ensures almost zero chance of errors. Preanalytical automation commonly includes auto barcoding, barcode reader, transport system (conveyors), sample aliquoting, centrifugation, sorting (de-capping) whereas analytical automation brings in specimen identification, auto loading, dispatching to right technology and right analyzer, processing the sample, reagent/controls handling, delivery and storage, autostainer etc. Auto-verification/auto approval, vial recapping, storage and archival in right location, in right cold room are parts of post analytical automation. The introduction of AI enabled robotic track (track-based automation solution) which effectively combines and integrates different clinical disciplines, test methodologies and analyzers has turned into an unified and complete solution to high volume, ultra-modern laboratory’s expanding need. Simultaneous STAT and routine testing on the same, single track with provision for manual loading of urgent samples directly to defined instrument makes it very easy to deal with critical deadlines. Some TLA systems are closed allowing analyzers only of that particular vendor, whereas systems with open design allow interfacing of analyzers from different vendors. However, as TLA systems are very costly, laboratories should carefully analyse the expected benefits (e.g. potential labour, man-hours, TAT saving) from it before investment. Workload of minimum 2000-3000 per day may justify its procurement especially if there is a scarcity of trained and efficient manpower.
In hematology, integration of autoanalyzers with auto slide makers, autostainers and even automated image analysis system are being introduced to characterize and pre-classify various types of blood cells in peripheral blood smears.
Use of point of care testing (POCT) is also on the rise for labs especially in critical care setting to monitor blood gas levels, measure electrolytes, glucose, lactate, creatinine, haemoglobin, haematocrit, PT, APTT etc. Many reputed manufacturers are coming up with pocket size, user friendly, cost effective POCT devices which ensure prompt analysis of samples at the bedside of such critically ill patients.
Machine vision technology is another interesting aspect which is replacing human inspection and automatically check of height and diameters of vacutainers, volume of serum in centrifuged tubes, look for haemolysis, lipemia or icterus etc. thereby facilitating better and rational use of laboratory workforce in other skilful tasks.
Attempt to interface analyzers and automate pre-analytic sample preparation in highly specialized domains like mass spectrometry, PCR, next generation sequencing are on the way and going to be the next big thing in laboratory automation.
Current status in India
India’s diagnostic healthcare market is a mix of large diagnostic chains, standalone laboratories, hospital based laboratories with variable infrastructure, capacities and workload. Moreover, there is an asymmetry in distribution of laboratories between rural and urban areas in India. Most of the big, good quality, better equipped private and public laboratories are situated in urban areas whereas rural people are mostly dependent either on small public facilities or unregulated, small, standalone private laboratories.
The large corporate chains and even standalone laboratories in urban areas have already adopted automation to a large extent with high throughput modern automated analyzers interfaced with laboratory information system (LIS). Many are taking advantage of integrated systems whereas some of them have already introduced TTA and are even exploring the option of commissioning TLA system. However, the picture is not so bright everywhere, especially in rural areas and small towns where laboratory diagnosis is still largely dependent on mostly manual, time consuming activities with high chance of imprecision. The initial investment and the running cost for automation is currently a setback for such small laboratories to adopt automation. If we aspire for better quality laboratories and a good standard in laboratory medicine in India, at least a basic level of automation is mandatory for all laboratories.
Hence it is high time that, we think about customized and commercially viable automation for these small but important players also. Thanks to instrument manufacturers and the recent Make in India initiative which has made launch of smaller but fully automated compact and robust benchtop systems with wider test menu conceivable. Such automation has made possible to reduce outsourcing of important test parameters (e.g. hormones, tumour markers etc.) by these small labs and rather process them in-house with better confidence and lesser cost. This has also made such tests easily available and affordable even in remote areas which was beyond the imagination even a few years back.
With such an encouraging picture, emerging, it is expected that, government would consider investing more in all types of laboratory equipment and reagent kit manufacturing units so that, the cost of automation in a laboratory can be drastically reduced. Automation under supervision of a trained laboratory medicine practitioner has already proved to be a game changer and can significantly reduce errors in a laboratory.
With every passing day, cost of manpower is increasing in India. The laboratories will have to spend more to attract and retain efficient manpower. With slow but steady increase in number of diagnostic chains in India, even smaller laboratories need to spend more on automation and cutting edge technology to stay competitive.
Peer pressure on laboratories to consistently deliver accurate and timely reports will go on increasing and judicious use of automation, robotics and AI can be the laboratory’s response to all these challenges. However, we need to remember that, automation comes with a price.
The balance between revenue generated from the workload of a laboratory and cost of automation must be carefully balanced. The cost saving, in terms of reagent cost as well as reduction of man hours, works only when the laboratory caters to a substantial sample volume. As reiterated earlier, government also has a big role to play here. Reducing the cost of automation, some sort of regulation on analyser and reagent cost will help laboratories, irrespective of their size and location to adopt at least the base level automation and ensure faster, cost effective and reliable service to their customers.