The Spanish Association, Bioerix and Abbott held a symposium on Quality Management in clinical laboratories, which featured the director of Customer Services & Technology, Sten Westgard – who came from the United States – and the presence of the undersecretary of the Ministry of Public Health (MSP), José Luis Satdjian.
The focus of the conference was aimed, mainly, at the decisions made by the medical body based on the tools provided by the laboratories and the analytics they use to achieve reliable results.
The professor and technical director of the laboratory of the Spanish Association and the University Hospital, Raquel Ballesté, emphasized the importance of carrying out instances of discussion and analysis linked to quality management in clinical laboratories. “The development of technology must necessarily be accompanied by this type of talks and events, which point to the quality of laboratory results,” she said.
In this logic, the doctor indicated that laboratories report test results, and these results have an impact on the clinic. “The clinician makes decisions based on these results, so it is very important to ensure the quality of these studies,” she stated.
Although the existing laboratories in the country use internal and external quality controls, in accordance with the regulatory requirements through the ministerial ordinance, this does not guarantee that all quality tools are being used to ensure accuracy and precision.
“So, what we want to promote is that the quality tools regarding the analytical part of the laboratory, which is the exact measurement of certain values in the laboratory, are used as such. And that these platforms are really used and applied in order to obtain reliable results”, concluded Ballesté.
quality measurement
Prior to Westgard’s exposition, and by way of introduction, Ballesté highlighted the difficulties that arise when measuring quality. “When one talks about processes in general, both in the laboratory and in any other area of medicine and non-medicine, the fact of how to achieve quality objectives is always raised. But when we go to see how to measure quality, it becomes more complicated”, stated the technical director.
“How do we measure quality? How do we measure that what we do is really correct and effective? In the laboratory, quality is fundamental and it is a tool that we have to measure, because the laboratory clearly impacts medical decisions, decisions for diagnosis, prognosis and treatment”, he argued.
So much so that evidence-based medicine shows that around 70% of clinical decisions are based on laboratory results.
“This positions the laboratory in a relevant role that means that, in some way, it has to measure the quality of its processes so that its results are reliable, so that the clinician can work with confidence on those results and also to provide security to the patient about which decisions are going to be made,” said Dr. Ballesté.
The technical director explained that quality is a horizontal issue in all areas of the laboratory and that -although there are areas in which greater experience and trajectory in quality stand out, such as biochemistry or immunology- it is necessary not to lose sight of quality in all other areas, such as microbiology, molecular biology or autoimmunity, among others.
Clinical laboratory as a pillar
The clinical laboratory is a fundamental pillar in quality, since it must contemplate all the parts of the laboratory process, Ballesté reaffirmed.
“We must not forget three fundamental parts: the pre-analysis, which is when the doctor sees the patient and makes the request for the study until it arrives at the laboratory, the analysis, which is the process by which we measure what we want to study and the post analytics, which is the final phase in which the doctor or biochemist makes an interpretation of that result and issues a result with certain characteristics”, the doctor listed.
As for pre-analytics, many actors stand out, both inside and outside the laboratory, Ballesté said. “This is the most difficult phase to control quality, because many members are involved, and there are aspects that escape us, and the measurement of each of these steps in the process is much more complex.”
That is the reason why in the clinical laboratory, between 60% and 70% of laboratory errors occur in the pre-analytical phase. The analytical phase, on the other hand, is more controlled. “In this phase there is more experience, and once we enter that process we have many tools to control it,” Ballesté specified. Finally, in the post-analytical phase there are many tools that contribute to the interpretation of this result and its validation.
During the event, emphasis was placed on the analytical phase. “To ensure that our results are reliable, it is necessary to have quality strategic planning. And when we talk about this, we have to take into account three considerations: a quality control system, a quality control evaluation system and finally we have to have a documentation system of said quality controls”, he graphed.
“In this way we will be able to show transparently and objectively what our processes are like. If we don’t measure and don’t document, we don’t know if that’s the case”, concluded Ballesté.
Six Sigma Metrics
During the dissertation, the international speaker, Sten Westgard, addressed aspects of Six Sigma metrics, a platform for working and measuring the quality of clinical studies, widely recognized worldwide but little used nationally.
For nearly 25 years, Westgard has managed the Westgard website and training portal, creating and managing online courses, as well as editing and writing hundreds of reports, essays, and applications on quality control, method validation, Six Sigma, risk management and laboratory management.
operational excellence
At the end of the conference, the general manager of the Spanish Association, Julio Martínez, thanked Westgard for his presence in Uruguay and praised the dissertation, describing it as “interesting and enriching” for all those present.
“The safety that was discussed here today implies aiming at operational excellence and the application of Six Sigma, which leads to reliable results in the laboratory. For this reason, when Dr. Ballesté asked us to organize this event jointly with Abbott and Bioerix, we immediately said yes, because the issue of safety and quality is one of our priorities”, stated Martínez.
“Generally we don’t organize events jointly with suppliers or brands, but in this case we do because the theme really seemed of prime importance to us, and also because we have really been very satisfied with this experience we have had with Abbott. And although I don’t usually pass, nor do I, notices about suppliers, Bioerix more than a supplier is a strategic ally in many aspects and also in this”, said the manager of the Spanish Association.
Martínez stressed that since the health emergency began, this was the first public event held by the Spanish Association.
“And also doing it with the laboratory theme is significant, because prior to the pandemic it was in doubt whether we were going to maintain the molecular biology laboratory due to cost issues. Then came the pandemic and to date we have carried out 260,000 PCR tests and almost 200,000 antigen tests that have passed through the Institution’s laboratory, which came to work in the most complicated moments of the pandemic with 4 shifts and 24 hours. So we could not ignore this approach, ”he stressed.
“The issue of quality and safety is a topic of the first order in health and as a tribute to all the laboratory personnel who worked during the pandemic, we decided to accompany them in this event and be lucky enough to learn important things,” he said. the manager of the Spanish Association.
