Clinical laboratory automation is growing in India, however, its impact on patient care is yet to be felt as only a small percentage of laboratories are fully automated. How will automation shape-up in the coming years? Will automation be a key factor in the survival of clinical laboratories as they compete for their share of the diagnostics market? An analysis By M Neelam Kachhap
One of the major challenges faced by the new Indian government is to provide affordable healthcare to all. Healthcare in India, as elsewhere in the world, is
facing unprecedented challenges, including the economic burdens associated with rising costs, chronic diseases, and caring for ageing populations. The need for efficient systems to deliver quality healthcare is much more intensified today and healthcare providers face the challenging mandate of doing more with less.
Medical diagnostics is at the centre of healthcare delivery and is facing its own challenges. With increasing demand for tests, focus on quality and accuracy by physicians as well as changing economic paradigm, laboratories are forced to think out-of-the-box to keep functioning.
An estimated 70 per cent of medical decisions are based on laboratory test results. However, diagnostic laboratories in India are limited by means and resources. The thought of investing in an automation system feels like a daunting task, let alone expanding a laboratory or replacing existing systems. But the need for quality and reproducibility as well as the increasing demand for tests with less turn-around-time have only fuelled the need for adoption and use of laboratory automation.
The key challenge for the diagnostic industry is to find innovative and cost-effective ways to improve testing efficiency and eliminate errors. Given the variation of power supply in India, equipment manufacturers must have a clear vision of how to best enhance a laboratory’s capability with their automated equipment. The question the industry is asking today is how do laboratories adopt automation and how do they positively impact patient care?
According to a report published by RNCOS Industry Research Solutions in June 2012, the Indian diagnostic services market is estimated to have generated Rs 97.3 billion in revenue during 2011 and is expected to grow at a compound annual growth rate (CAGR) of around 26 per cent to Rs 235.8 billion by 2015.
The market in India is highly fragmented. It is not surprising given its healthcare delivery structure, but of the estimated one lakh laboratories in India many have just basic facilities and only three to four laboratories are state-of-the-art multidisciplinary core labs. The hierarchy has specialised laboratories on the top, followed by laboratories in hospitals and nursing homes, and finally by small testing centres. All specialised laboratories operate in the private sector. The government at the best has semi-automated laboratories.
Test volumes range from 50 to 100 samples per day for one laboratory located in a small town to several thousand samples per day for a major laboratory.
“Test samples processed per day in a laboratory attached to a tertiary care hospital ranges from 500-1000,” informs Dr Arathi Prakash, Consultant, Clinical Bio Chemistry & Quality Manager, BGS Global Hospitals. The quality of services provided by these laboratories also varies widely.
“The National Accreditation Board for Testing and Calibration Laboratories (NABL) was established to accredit the laboratories; however, the number of accredited laboratories remains low since accreditation, so far, is voluntary,” informs Dr Vandana Lal, Executive Director, Dr Lal Pathlabs.
Currently, only about 10 per cent of the market is organised and composed of laboratories with proper accreditation.
Today, diagnostic laboratories are facing many challenges in order to remain competitive but the most important consideration is error. “Mistakes occur primarily due to human error, but there are also chances of random error,” says Dr Arathi Prakash, Consultant, Clinical Bio Chemistry and Quality Manager, BGS Global Hospitals.
As a result, quality control has gained immense importance in a clinical laboratory. But maintaining a good team of quality managers is again a challenge.
“A strong requirement for quality managers who are properly trained and have proper standard operating procedures in place is challenging,” says Dr Suvarna Ravindranath, General Manager Karnataka, SRL Diagnostics.
In fact, it is necessary to train and retain competent staff, which is equally challenging. Precision and accuracy are the mark of a good laboratory. Medical laboratories, through their systems, have to generate results that can be replicated or reproduced in different diagnostic centres.
“The hallmark of a good medical laboratory is accurate analysis and reporting of diagnostic tests carried out by them thereby helping the medical fraternity to recommend proper dosages of medicines to cure the patient. A high degree of quality control in testing therefore instils trust and confidence in the patients. Challenges include, but are not restricted to trained and skilled manpower in proper analysis, and use of test equipment,” explains V Ramakrishnan, Marketing Manager, Remi Elekrotechnik.
Since automation for clinical laboratories came into existence equipment manufacturers have been promoting the benefits of stand-alone and total laboratory automation systems. The crux of their marketing lies in the fact that these equipment save time, reduce manual steps and above all, remove the human element from testing to lower the risk of errors. So it does, but is automation really beneficial?
“Automation makes the process very easy, makes the process and manpower requirement less. Even with less manpower more tasks can be accomplished more efficiently,” says Dr Ravindranath. “Even the turnaround time will scale up to significant improvements and the chances of error is minimised to a large extent,” she adds.
Talking about the benefits, Ramakrishnan says, “Lab automation ensures reduction of human errors in diagnosis and reporting of test results.
It ensures consistent and reproducible results of same samples across different centres. It enhances the patients’ and doctors’ confidence on the test reports generated by the diagnostic centres.”
“Automation provide laboratories the ability to establish sustainable processes,” says Dr Lal. Giving an example, she says that if a mid-level laboratory wants to increase productivity and deliver faster testing results they can consider installing a new automation system. While automation decreases turn-around time from five days to less than two days it also helps the lab slash material cost since the test uses less sample and hence the number of tubes collected from each patient gets cut in half. It also helps to decrease water use, and produces less waste. As a result, overall lab costs reduce by 30 per cent. Thus, it creates a sustainable process for the lab.
Although automation seems highly beneficial it also comes with considerable expense. “The cost of automation is huge. Be it a hospital or stand-alone laboratory, investments are considerable and so there should be much thought given to the type of automation to opt for,” says Dr Prakash.
“Test assays are constantly evolving. The flexibility and adaptability of an automation system needs a lot of consideration. The system should have the ability to meet current testing needs and also be easily reconfigured to handle future demands,” she explains.
Automation and quality
Leveraging the full capability of automation to drive quality and productivity improvement is the aim of all laboratories. “Laboratory automation primarily is a means to improve efficiency and reduce human errors in all steps of testing. There is also an enhanced use of informatics continuum where there is a continuous recording o