The COVID-19 pandemic took the world with surprise, and not a very pleasant one. The world collectively made several efforts to nip it in the bud by taking widely contrasting measures such lockdowns in some countries and allowing for herd immunity in others. However, it soon became evident that we were unprepared for what had hit us.
The last pandemic of this scale was over a century ago, therefore it seemed that the severity and consequences of such an event were long forgotten. To make sure we address the issue at hand appropriately and are not caught off guard in the future, we must recognize and address our shortcomings in the COVID-19 pandemic.
In healthcare today, medical laboratories are key partners in ensuring and maintaining patient safety, and it is seen that laboratory results influence approx. 70 percent of medical diagnosis. Maintaining quality standards of the laboratory service plays a major role in ensuring the accuracy of these results, providing better patient care as a whole and promoting excellence. While the absence of the same may lead to unreliable results, causing a delay in treatment, misdiagnosis and an increase in cost due to a need for retesting.
Good quality is never brought about by accident; it is almost always the cumulative result of sincere intentions, dedicated effort, intelligent direction and skilful execution. As a choice, good quality may not necessarily be the easiest or the cheapest; however it is definitely the wisest for both patient health and welfare as well as laboratory credibility.
International standard ISO15189, based upon ISO17025 and ISO9001 standards, provides the basic requirements for establishing competence and serves as the bible for quality in medical laboratories. And while this serves as an excellent guiding principle, no matter how good the quality mechanisms are on paper, truly good quality cannot be achieved if theory is not translated into practice day-in and day-out.
From the perspective of laboratory medicine, we can identify two clear areas that we should focus on moving forward:
- Infrastructure; and
India needs to invest significantly in lab infrastructure to be at par with its developed counterparts. India had approximately 100,000 laboratories as of 2017. The same for the USA is close to 175,000 laboratories for less than one fourth the population. This implies that India has 1 laboratory for close to 14,000 people while the same number for the US is 1,800.
Moreover, matching just the numbers is not sufficient; we must also consider the size and quality. A large number of laboratories in India are unable to go for necessary quality accreditations because they do not meet the minimum infrastructure requirements (such as a separate sample collection area in single room laboratories).
While this is an issue that needs the undivided attention of concerned people, it is one that can be addressed by directing the right amount of funds to the right organizations. However, let’s take a closer look into the second more severe issue at hand.
The entire process of managing a sample must be considered including the beginning i.e sample collection to end i.e reporting and saving results.
Laboratory tests are influenced by: Lab environment, knowledgeable staff, reagents and equipment, quality control, communications, process management, occurrence management, and record keeping.
With the challenges that lie ahead, laboratory personnel must focus on upskilling themselves continuously to be prepared. I have identified three domains in which the right education can lead to significant leaps in the overall healthcare system:
Firstly, laboratory personnel must be trained in the latest concepts of lab quality. For this, I recommend the ISO15189, the gold standard in laboratory quality management. Proper documentation, efficient management, and appropriate procedures laid out in ISO15189 can significantly improve response time and decrease Turnaround Times for laboratories. As we saw in the current pandemic, faster TAT can be detrimental in infection control post contact tracing. Further, a stronger QMS within the laboratory will also improve the accuracy and precision of results being reported
Secondly, laboratory personnel must be trained with the latest testing techniques. Molecular pathology, that formed the basis of PCR testing for COVID-19, is a relatively new technique in India. Therefore, a large number of laboratories, primarily in the rural parts, were unprepared to implement it. Regular and mandatory training for the latest techniques must be introduced in all parts of the country. Wherever possible, we can use the digital format to maximize reach and keep costs in check.
Finally, laboratory personnel must absolutely be adequately trained in infection control. Waste disposal and infection control formed a major bottleneck in a countrywide implementation of PCR testing. As molecular testing becomes mainstream, this bottleneck will grow further unless appropriately addressed.
These issues require much more than investment–the government, laboratories, and educational institutions must work together in tandem and launch a multipronged response to combat it. The basic idea is to ensure the following three points:
Appropriate funding and policy measures are taken by the government to encourage continuing education;
Ample opportunities are provided by laboratories to their employees; and
Well-structured training programs are provided by educational institutes which include training, communication skill, professionalism, and concept building through lectures, role plays, case studies, group interaction performance evaluation, and continual improvement of training through feedback and interactions.
Implementing an efficient quality management system does not guarantee a 100 percent error free laboratory, but it goes a long way in detecting errors that may occur commonly, and prevents them from recurring. It essentially puts us on the path to continuous improvement, and brings us closer to our vision of bettering healthcare facilities every day.
We encourage all institutions to come forward and help the nation’s healthcare system prepare itself for the challenges it faces in the near future.