The SEQCML presents the first White Paper on Laboratory Medicine in Spain
15/11/2021
Despite its importance, to date there has been no reliable database on the number of laboratories in operation in Spain, which has made it difficult to know their activity, staff, and organization
Recently, due to the COVID-19 pandemic, the Clinical Laboratory has become more visible to the general population and its essential role in improving health has been highlighted.
However, despite its importance, to date there has been no reliable database on the number of laboratories in operation in Spain, which has made it difficult to know their activity, staff, and organization.
The Spanish Society of Laboratory Medicine (SEQCML) is the Spanish representative in the European (EFLM, European Federation of Clinical Chemistry and Laboratory Medicine) and international (IFCC, International Federation of Clinical Chemistry and Laboratory Medicine) federations. Aware of its responsibility as a leading scientific society in Spain, it has decided to prepare the first White Paper on Laboratory Medicine, in order to shed light on and give visibility to clinical laboratories in Spain and thus obtain an up-to-date picture of them, collecting information that did not previously exist.
All the members of the Executive Board of the SEQCML participated in its preparation, and partners from different Autonomous Communities and an external consultant have collaborated as well.
Dr Imma Caballé, president of the Spanish Society of Laboratory Medicine, considers that having this White Paper allows us to know better the reality of the profession, understand the size of the sector, number of laboratories, organizational structure, response capacity, professionals involved, and the activity carried out. With the data included therein, it is possible to analyse current and future needs, evaluate decisions to be made, and act in the best interests of the future of our profession.
Data for 2019 were collected from 174 clinical laboratories, which reported having made 55.9 million requests and 800 million determinations. Preparing a study with the data from 2020 was ruled out due to the distortion that the COVID-19 pandemic would cause in the analysis.
The FENIN Report for 2018 places the number of determinations at 880 million, while the data collected in this report would represent approximately 90% of that value.
Professional and technological challenges for innovation and change management in the Laboratory
Dr Antonio Buño, vice president of the Spanish Society of Laboratory Medicine, believes that this White Paper aims to help identify and establish the professional and technological challenges necessary for innovation and management of change in the Clinical Laboratory.
A clear example, Dr Caballé points out, is the need to renew the professional staff. The aging of the workforce makes it necessary to seriously consider replacement by new professionals. However, in order to expand the number of residents it is necessary to know the current situation, and this information on clinical laboratories was totally insufficient prior to the preparation of this White Paper.
According to the data collected in the document, clinical laboratories in Spain have a need for job openings to renew the workforce that will involve around 20-25% of qualified professionals in the next 5 years (23% of staff are over 60 years old).
In a broader view, in the next 15 years it will be necessary to renew more than half of the clinical laboratory staff, so if the plans are not adapted in time to the expected demand, in a few years the shortage of professionals in the sector will begin to be evident.
Another essential issue for the future of Laboratory Medicine, as extracted from the document presented under the auspices of the National Congress of the Clinical Laboratory (LabClin 2021), is the unification of the specialties of Clinical Analysis and Clinical Biochemistry into one single specialty that unifies the training of residents and increases the possibility of work in all the Autonomous Communities. For the president of the SEQCML, this unification cannot be delayed any longer, and while carrying it out it will be necessary to also increase the number of residents to compensate for the decrease in professionals due to age.
The activity of the Clinical Laboratory is also determined by technological change and by innovations in in vitro diagnostics. However, Dr Buño points out, in order for innovation to start, we need to improve the regulation of procurement systems with public contracts so that they can be adapted to the reality of the laboratory.
The Value of Laboratory Medicine
Laboratory Medicine contributes to the screening of diseases, their prevention and early detection, diagnosis, monitoring of the disease progression, and prediction of the response to treatment. The informati on generated in the Clinical Laboratory allows for crucial clinical decisions to be made that change the course of the disease, allow the best treatments to be chosen and, as a result, increase people's health and well-being.
The latest studies indicate that a large number of clinical decisions depend on data from the Clinical Laboratory, and their weight in the healthcare process is increasing significantly. The work of the Clinical Laboratory plays a fundamental role in clinical decisions compared to the cost it represents, which for Spain is around 3% of healthcare spending. According to data from FENIN, the total number of requests to clinical laboratories is around 65 million per year, resulting in the performance of around 880 million determinations per year.
Regarding the situation of Laboratory Medicine in Spain compared to other European countries, Germany continues to lead the per capita expenditure in reagents with 26 euros / inhabitant, followed by France (24 €) and the United Kingdom (16 €). Spain presents figures similar to its neighbouring countries, with an average expenditure of 22 euros / inhabitant and year.
Regarding accreditation by the ISO 15189 standard, which recognizes the technical competence of a laboratory and the reliability of the results, guaranteeing that certain quality and competence criteria are met, there is no uniformity among European countries, and depends on whether or not it is required. Thus, while in 2014 94% of the centres had this accreditation in the United Kingdom, in Spain this figure was negligible.
The SEQCML has advocated for years for the obligatory accreditation of all clinical analysis laboratories, and is the only laboratory society in Spain that has made this commitment. As its president highlighted, we must bear in mind that the Clinical Laboratory contributes decisively to the diagnosis, prognosis, and treatment of diseases and to the improvement of public health. Laboratory accreditation is a crucial step in achieving these goals.
Currently, in Spain only 85 laboratories are accredited according to this standard, according to the data of the National Accreditation Entity (ENAC).
Future trends in Laboratory Medicine
The aging of the population will have an impact on the general burden of disease on the public, mainly in chronic diseases, so the Clinical Laboratory will be directly affected by this greater demand for services.
Technological innovation also represents one of the determining factors in the future evolution of the Clinical Laboratory. The increasing level of automation that has been achieved in laboratories represents a remarkable milestone, allowing greater efficiency. In fact, the surveyed centres have carried out intensive work to incorporate digital and automation technologies into their operating models: 90% of the centres achieved the automation of more than 75% of their tests and 82% of the centres had electronic requests for more than 75% of their tests.
Likewise, the Clinical Laboratory will play a leading role in what has been called the Bio-revolution. Molecular biology and genomics are offering new sequencing opportunities that allow tests that were previously conducted only in research contexts to be performed in everyday clinical practice.
In addition, the application of big data and artificial intelligence in the Clinical Laboratory will be useful in areas such as the setting of reference values, quality assurance, clinical decision support, and population health monitoring.
Finally, environmental commitment is increasingly relevant in laboratories. According to the data collected in the questionnaire, at the national level approximately 90% of the laboratories have an environmental management program and 98% have a waste management protocol.