Pathlabs in the future will be strongly backed by automation and digital technologies that will enable pathology to become more efficient and scalable
Automated workflows have been regarded as important tools for clinical laboratories to achieve efficiency, accuracy, standardisation, quality and patient data safety. For a variety of reasons, however, many Indian laboratories in the past have been slow to adopt these technologies as a broad strategy. Nevertheless, with an increasing demand for higher levels of performance, the need for automated workflows are becoming more and more essential. Moreover, with increasing clearance by the US Food and Drug Administration and other regulatory agencies in Europe, automated workflows are slowly but steadily becoming a new norm in clinical laboratory practice, ensuring diagnostic accuracy and improved result turnaround time (TAT). When automated workflows are integrated with digital information systems these technologies work wonders for a laboratory, inform experts.
“We have been using automated workflows and have witnessed a considerable difference in capacity and efficiency. We conduct over 25000 tests on a daily basis including routine as well as specialised tests, with routine tests obviously forming a larger chunk. Given the sheer volumes of tests conducted, higher throughput becomes critical. We use the automated workflows for primarily routine clinical chemistry tests followed by specialised chemistry,” shares Dr Ajay Phadke, Centre Head, SRL Dr Avinash Phadke Labs.
Dr Arjun Dang, CEO, DR Dangs Lab explaining how automated workflows are used at their lab says, “Each step in the sample life cycle from collection to dispatch of reports is automated in our laboratory thus, assuring testing of the highest quality. Checks are introduced in the automated workflow so as to ensure the highest diagnostic accuracy and reliability of services provided. Few of these automation tools include use of pneumatic chutes for timely transfer of biological specimens to the lab for analysis, FDA approved/CE marked automated platforms and use of a robust Laboratory Information Management System (LIMS) to effectively manage samples and associated data. We have high throughput, state-of-the art, integrated and modular clinical chemistry and immunochemistry analysers those are interphased to LIMS for direct electronic transcription of test results, hence eliminating even slightest chance of errors due to manual intervention. The samples are bi-directionally bar-coded through LIMS, a major component of automation, where in the bar-coded information on the collection tubes can be accurately read by analysers. These barcodes are generated at the time of registration or sample collection itself where in tests are punched along with demographic details. The overall goal is to improve patient care through accuracy and consistency in laboratory analyses.”
Sharing a perspective from the technology provider point of view, Dr Shravan Subramanyam, Managing Director, Roche Diagnostics India and Neighbouring Markets apprises, “Lab technicians manage an increasing number of samples to continue to provide high-quality results in increasingly shorter span of time. With such time constraints added to finite lab spaces, enhancing lab infrastructure play an important role in managing people productivity in the lab and turnaround times for patients’ test results. To enable a transformation in labs that address these evolving needs, it is important to factor in solutions that enhance operating style, space and quality management. Imagine a lab processing all samples manually on different analysers, tracking sample flow across the floor of the lab and ensuring that all required tests to be performed on the same sample are effectively managed. With timelines and quality standards to meet, especially within the available lab space, this could be a herculean task. In this setting, an automated system that has integrated analysers of different disciplines, enable lab operators to drop samples at one workstation for the workflow to take up the process from thereon, almost independently. Here we are discussing the integration of Serum Work Area, coagulation, urinalysis, haematology and molecular systems – together, with work stations!”
Further citing an example of an automated workflow solution (Serum Work Area Solutions) from Roche explains, “The automated Serum Work Area Solutions provide an interface that is designed to deliver test results to physicians and patients across a number of therapeutic areas, in a simplified and efficient manner. It also enhances operator experience, towards streamlining processes and thereby minimise hands-on time and maximise productivity through automation. The biochemistry and immunoassay testing space has witnessed significant development since the introduction of Serum Work Area (SWA) by Roche for the very first time in the market in 2002. Through the integration of the Clinical Chemistry and Immunoassay analytical modules as part of the SWA solution, labs have moved away from separating the samples to be performed separately on clinical chemistry analysers and immunoassay analysers towards a single supply unit for both chemistry and immunoassays.”
Improving business prospects
While most of these automated workflow solutions aim to improve overall throughput, it eventually creates a positive impact on the business too.
Speaking about a specific automation workflow solution used at his lab, Dr Phadke informs, “The primary benefit of these SWA Automated Solutions- driven modules is the throughput rate that helps achieve shorter turnaround times. For e.g. with an hourly throughput rate of 2000 samples, Cobas 8000, a system we use at our lab can generate results for electrolytes in 15-20 seconds whereas turnaround time for other clinical chemistry tests has been reduced to 5-15 minutes. Another important benefit of these modules is the capability to run multiple tests on a single platform with a single parent sample. This eliminates the need to segregate the sample thereby minimising the room for manual error and further improving accuracy. The larger pack size of testing kits also helps to achieve faster turnaround while reducing costs. These modules require single handlers, which are easy to maintain and don’t require frequent calibrations. The machines do not take too much space, further aiding organised functioning. These attributes have a substantial impact on cost of conducting these tests, especially routine tests, where prices are highly competitive.”
Similarly, Dr Dang records some specific areas where these solutions add value to their laboratories.
Saving time: From sample collection to transferring those to the laboratory via pneumatic chutes, to automated critical callout for emergency lab values, thus empowering physicians to take timely decisions.
Accuracy of results: The seamless automation at each step including analysis and data transfer through LIMS in line with process excellence and efficiency. Direct aspiration from bi-directional bar-coded primary collection tubes mitigates any risk of secondary labelling errors. The electronic data transfer from these modular analyser to the LIMS ensure no transcription error, whatsoever.
Space management: The compact desktop or floor random access models occupy minimal footprints and with abundant options of modular analysis equipment, combining clinical chemistry and immunoassays space management is increasingly better compared to the past decade.
Team empowerment: A single-trained technician can operate multiple analysers and better outputs are achieved and with state-of-the-art track systems human intervention has been drastically reduced
Increased efficiency: Significant improvements in workflow and efficiency; multiple analytes can be estimated from a single sample resulting in efficient sample management; shorter TAT allows early diagnosis/treatment options. The bar-coded containers can be directly loaded on to the analysers without the need for human workforce required to aliquot.
Adding to this, Dr Subramanyam chips in, “Integrating and consolidation of different workstreams diagnostic areas within a single lab space comes with clear organisational and technical benefits. From allowing to define larger, more complex and accurate auto-validation criteria to providing the laboratory personnel a view into a broader picture of the patient’s results, integration and automation can help detect potential errors and identify critical patient test situations that need timely communication to the clinicians. Such integration may work for labs that operate on very high workloads. It is thereby important for labs to identify their current and future needs for a customised solution that addresses their specific requirements, especially in the light of quality and maintenance protocols that need to be followed.”
While quality, standardisation and efficiencies are the ultimate objectives of automated workflow solutions, maintaining those improvements is also an important element to be considered. How do automated workflow solutions maintain consistency? What happens if automation fails?
How do laboratories prepare themselves to handle such situations?
Handling automation failure
As per some experts, automated workflow solutions are robust and have enough firewalls to avoid system failures. “These systems have an automated alarm system in event of any breakdowns. There are multiple alarms and each signifies a particular issue. There are remedies given for every issue which are mostly manageable by the in-house staff. We rope in the customer support centre in case we need help in resolving the issue. As a back-up, we have spare machines that can be used in case of breakdowns, thereby ensuring turnaround time of reports is not impacted,” informs Dr Phadke.
Dr Subramanyam adds, “With an increasing number of patients and increasing diagnostic sample workloads, a manual system can quickly become complex and difficult to manage. Automated systems, if modular by design, can be scaled up by adding a variety of modules to handle more and more samples. Thus, the advantages of automation are maintained. If an automation system fails, there are ways to keep the laboratory operational. In modular automation, if one module fails, it can be masked while other modules continue to work. All modules failing at one time is highly unlikely and labs generally have backup systems.”
Explaining how laboratories can build a fail-proof system within, Dr Dang cites, “In case of a breakdown, we have an identical automated system to run the parameters. Also, quick intervention by the support /service team greatly helps to get the equipment running within a few hours. Highly unlikely but in a situation where both fail, manual processes shall be initiated right from test request registration to analysis and entry into the LIMS which may lead to a much higher than committed TAT. In such cases, the stringent checks are introduced for all processes and human interventions thus curtailing any potential source of error.”
Although automated workflow solutions so far have been proved to be extremely beneficial to laboratories, its true potential should be measured by successful patient outcomes. “The benefits of automated workflows definitely get extended to patients by way of higher accuracy and faster turnaround. These technologies require lesser manpower and reduce manual errors, thereby reducing the need for repeat tests. More importantly, these technologies aid large set-ups like ours, helping us achieve economies of scale. The cost-benefit that we receive can be passed on to customers by offering affordable rates on routine tests,” says Dr Phadke. Similarly, Subramanyam says that Roche believes in ‘Doing now what patients need next.’
“Especially in a complex and evolving market like India, with its out-of-pocket spends model, this could not be any more relevant. Our innovation is aimed at addressing the future needs of people and patients. All our technologies in India stand the test of ‘innovation’ and ‘patient benefit’. From a scale perspective, approximately, every minute 475 diagnostic tests are performed on Roche Diagnostics systems in India! This, I believe provides us with a robust foundation to build diagnostic capabilities in India, for today and the future needs of people and patients. I specifically would like to call out on the need for India to enhance preventive healthcare reach in India, so ‘people’ do not have to become ‘patients’ at least in those disease areas where it is possible. This can impact allocation of healthcare spends and hospital bedtime to those patients that crucially need it and provide people and the system the benefit of economies arising out of this model,” he sums up.
Going forward, Dr Dang sums up saying that with healthcare diagnostics at crossroads the ‘lab in a chip’ concept has gained a lot of attention. Wearables and artificial intelligence have been predicted to play a major role in labs of the future where healthcare is going to be integrated providing maximum convenience to both diagnosed patients, as well as those opting to get preventive checks.
As rightly pointed out by Dr Dang, labs in the future will be strongly backed by automation and digital technologies that will enable pathology into becoming more efficient and more scalable field in medical sciences.