Clinical laboratories in the era of the 4.0 industrial revolutionClinical laboratories in the era of the 4.0 industrial revolution

Looking at industrial development eras in the history of humanity, the world experienced four industrial revolutions starting with the industry 1.0 revolution by the end of the 18th century where we saw the use of water and steam-powered mechanical production facilities. It was the era of power generation, mechanical production, and railroads driven by the advancements in engineering sciences.

The beginning of the 20th century introduced the use of electrical power, which enabled work-sharing mass production and the advent of the assembly line paved the road for the industry revolution 2.0. With 100 years of electronics, production improvements and information technology leaps, automated production became the norm and computers became predominant in shaping industry revolution 3.0.

The advancement milestones in medicine started to appear on the horizon in the 1960s when the hidden secrets of human DNA data began to reveal useful information in understanding the human genome and causes of diseases at the cellular levels. This led to fast jumps in advancing diseases and syndromes’ diagnostic testing, predictions of infections, as well as advanced treatment regimes.

Trilogy matrix of healthcare

The acceleration of digital technology and discoveries of the human genome project in 2000, it became evident that six characters 0, 1, A, T, C, and G are rebooting medicine and health in modern medicine today to enhance the quality of life. Personally, I strongly believe that human DNA discoveries, combined with Information Technology (IT) and quality are forming the new “Trilogy Matrix” for the upcoming generations, where diseases, cancers, and syndromes could be prevented — not just predicted — and the quality of human life would be much better with efficient and cost-effective treatments.

Big data, artificial intelligence, robotics, three digital printing, internet of things (IOT), social media, virtual reality, and simulation are the new tools shaping the 4.0 industry revolution. Today, cyber-physical systems are being implemented to monitor, analyse and automate all kinds of businesses, not just industrial facilities, and quality has always been the mirror of good indusial outcomes. It accompanied all manufacturing industrial revolutions without obvious exposure, until after the second world war when Dr. Edward Deming and other quality gurus started to put the framework of quality as a science and put its applications and statistical tools in action to monitor and improve processes and their efficiencies and effectiveness. They started to identify customers and classify them into external, internal, and other stakeholders. They provided approaches to measure their satisfaction, expectations, and feedback.

Rise of quality protocols

Quality control (QC) standards started to become dominant between the ‘50s and ‘60s to ensure consistency, focusing on output and based on inspectorate responsibility then matured to quality assurance (QA) between the mid-60s to mid-70s. Quality Assurance works through a system for the purpose of efficiency using a feed-forward mechanism, unlike QC which used a feedback mechanism. In Quality Assurance, each business unit carries the responsibility for it.

The concept of Quality Management was introduced between the mid-80s to 90s when corporate leadership started to recognise quality as a management style to improve business outcomes and increase market shares. In the mid-90s, Total Quality Management (TQM) was introduced as an ultimate, mature approach because it works through people with the purpose of effective results.

The focus of an organisation that adopts the TQM approach is on the outcome with special attention to corporate social responsibility. In TQM laboratories, everybody is responsible for the quality. A TQM company depends on a mutual relationship mechanism with its customers which is a much better proactive approach than being reactive and awaiting feedback after the products or services have been delivered.

The TQM model has been recognised by many organisations such as the European Foundation for Quality Management (EFQM) as a roadmap for organisational excellence, which each corporate vision aims to achieve and excel. With the advancement of industrial revolution 4.0 based on digital acceleration and quality maturity to improve the human quality of life, the international community of quality professionals claimed the start of quality 4.0 aiming to take all healthcare worldwide including clinical laboratories to a much higher paradigm. Quality 4.0 is not really a story about technology. It is about how that technology improves culture, collaboration, competency, agility, empathy, sustainability, and leadership.

We should shed the light on different laboratory accreditations models which are obtained to ensure that the laboratory is implementing a set of requirements or standards to ensure laboratory workflow from pre-analytical, analytical, and post-analytical are correctly and appropriately followed to ensure laboratory results are useful for proper diagnosis and follow ups.

In 2006, I wrote an article in Medlab magazine highlighting the importance to build laboratories based on quality, not just accreditations. Accreditation is just a destination while quality is a journey where every member of the laboratory shall join, contribute, and enjoy. From many lessons over the years, we have learned that creating healing and safe environment of care is way beyond compliance and accreditation. It is important for any leadership to understand that everyone in the organisation has a role to make quality happen not just the quality officer, champion, or department. Sharing knowledge, people engagement, and patient involvement in care planning are critical factors not only in achieving excellence but in creating a “just culture” for safety and quality.

Clinical laboratories worldwide have the right recipe in their foundation to get the biggest advantage of shaping the future of health and quality of life as a national index of social and economic well-being using 4.0 industrial revolutionary tools and a 4.0 quality approach.

Dr. Nashat Nafouri is the Medical and Quality Director, Futurelab Medical Laboratories; Chair, Healthcare Interest Group; Executive Officer, Saudi Quality Council. 

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This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.