Adv Lab Med 2023; 4(1): 70–80 Imma Caballé, Antonio Buño, Francisco A. Bernabeu, Francesca Canalias, Antonio Moreno, Mercè Ibarz, José Puzo, Concepción González and Álvaro González* State of affairs and future challenges in laboratory medicine in Spain: an analysis of the Spanish Society of Laboratory Medicine (SEQCML) https://doi.org/10.1515/almed-2023-0013 million determinations). The level of specialization of labo- Received November 11, 2022; accepted November 16, 2022; ratory physicians and laboratory performance were higher in published online March 6, 2023 large laboratories. Most requests (87%) and determinations (93%) corresponded to biochemistry and hematology. As Abstract many as 63% of physicians had an indefinite contract, and 23% were older than 60 years. Objectives: Laboratory Medicine is a crucial discipline that Conclusions: Laboratory medicine is a consolidated disci- contributes to the diagnosis, management and monitoring of pline that is gaining relevance in Spain. It adds value to the patients. This branch of medicine faces two major challenges: diagnosis, prognosis and follow-up of diseases, and to New technologies and increased demand. There is limited treatment response monitoring. The results of this study will information available of the state of affairs in Laboratory help us address challenges such as the need for specialized Medicine in Spain. This study provides a picture of clinical training for laboratory professionals; the emergence of laboratories and clinical laboratory professionals. technological innovations; exploitation of Big Data; optimi- Methods: The Spanish Society of Laboratory Medicine zation of quality management systems and patient safety. distributed a questionnaire among the 250 most representative centers (the ones with the largest volume of determinations Keywords: future challenges; laboratory medicine; sector and training programs), of which 174 (69.6%) returned the status. questionnaire providing data for 2019. Results: Laboratories were classified according to the num- ber of determinations. In total, 37% identified themselves as Introduction small (<1 million determinations per year); 40% considered themselves medium-sized (1–5 million determinations per Laboratory Medicine is a branch of medicine concerned year) and 23% considered they were large laboratories (>5 with the quantitative determination or qualitative evalua- tion of any substance present in a biological fluid for clin- *Corresponding author: Dr. Álvaro González, Director del Laboratorio de ical or research purposes. This determination or evaluation Bioquímica, Clínica Universidad de Navarra, Avda, Pío XII, 36, Madrid, Spain, is known as diagnosis in vitro, since it is performed out of Phone: +34 948 255400 ext. 821115, Fax: +34 948 296500, the body [1]. The results of laboratory tests are translated E-mail: agonzaleh@unav.es. https://orcid.org/0000-0002-1423-273X into information that is useful to improve the health status Imma Caballé, Laboratorio Catlab, Terrassa, Barcelona, Spain or wellbeing of individuals or of the population [2, 3]. The Antonio Buño, Department of Clinical Laboratory Analytics, Hospital Universitario La Paz, Madrid, Spain results of clinical laboratories are also used for the Francisco A. Bernabeu, Servicio de Bioquímica – Clinical Laboratory, screening, prevention and early detection of diseases, as Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain. well as for the diagnosis, monitoring and prediction of https://orcid.org/0000-0001-7104-0200 response to treatment. It is estimated that 66% of clinical Francesca Canalias, Laboratori de Referència d’Enzimologia Clínica, decisions are based on laboratory results [4, 5]. Departament de Bioquímica i Biologia Molecular, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Spain Despite the significant value and relevance that labo- Antonio Moreno, Service of Clinical Laboratory Analysis, Hospital de ratory tests have for the diagnosis and management of Meixoeiro, Vigo, Spain patients, they only account for 3% of health expenditure in Mercè Ibarz, Clinical Laboratory ICS Lleida, Hospital Universitario Arnau de Spain [6]. Clinical laboratories face a growing demand for Vilanova de Lleida, Lleida, Spain. https://orcid.org/0000-0003-0590-946X determinations, as a result of the increase in the incidence José Puzo, Service of Clinical Laboratory Analysis and Biochemistry, of chronic and infectious diseases in an ageing population Hospital Universitario San Jorge, Huesca, Spain Concepción González, Service of Clinical Biochemistry, Hospital [7]. In Europe, the value of the in vitro diagnostics market Universitario Virgen Macarena, Seville, Spain was estimated to reach 13,825 million in 2019, and is Open Access. © 2023 the author(s), published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0 International License. Caballé et al.: Situation and challenges in laboratory medicine in Spain 71 projected to exceed 18,000 million by 2027, at a compound This study complied with Organic Law 3/2018 on the Protection of annual growth rate of 4.5% [7]. Personal Data Protection and Guarantee of Digital Rights. Data was treated as confidential and anonymous. Evidence about the current status of clinical labora- tories in Spain is limited, as evinced by the lack of a national database. This study is intended to provide an overview of Statistical analysis the state of affairs in clinical laboratories in Spain. This will be the first hallmark in the way to define strategies and Qualitative variables are expressed as total number and percentage. actions aimed at improving clinical laboratory performance Quantitative variables are presented as mean or median and inter- quartile range. Statistical analysis was carried out using Excel with in the future. customized add-ins. The purpose of this study was to gather information on the activity of clinical laboratories in Spain, describe their portfolio of services and areas with the highest de- mand, and provide a picture of the situation of clinical Results and discussion laboratory professionals. Another objective was to provide information on research and training activities promoted Structure and model of clinical laboratories by clinical laboratories. This initiative, launched by the in Spain Spanish Society of Laboratory Medicine, led to the release of the White Book of Laboratory Medicine. This paper As many as 66% of the laboratories interviewed were provides a first overview and reports the most relevant general laboratories, whereas 90% only had one associ- findings [8]. ated hospital. In total, 37% considered themselves a small laboratory (<1 million determinations per year); whereas 40% considered themselves medium-sized laboratories (1–5 million determinations per year); and 23% deemed Materials and methods they were large laboratories (>5 million determinations). Most laboratories had 3 to 5 specialties, with the smallest Research site selection laboratories having the highest number of specialties (Figure 1A). This could indicate that organizational models To obtain a general picture of clinical laboratories, a selection was were determined by the size of the laboratory, and that performed of the 250 most representative laboratories in the list pro- vided by the Spanish Ministry of Health, Consumption and Social large laboratories are most oriented to large-scale diag- Wellbeing in January 2020 [9]. Centers were considered representative if nostic testing. Biochemistry, hematology, microbiology they were included in the National Portfolio of Hospitals, with priority and a blood bank were available in the majority of centers having been given to large hospitals (those with the highest number of (>60%). Immunology, pharmacology, andrology, repro- beds) with education and training activity (Supplementary Figure S1). A duction and anatomical pathology services were available questionnaire was distributed among the selected centers. in half of the centers (Figure 1B). As many as 80% of cen- ters had an integrated emergency service in the Variables of interest laboratory. An analysis was carried out of data for year 2019, where 55.9 million requests and 800 million determinations were performed. Data for subsequent years was not collected to prevent bias due to the COVID-19 Clinical laboratory activity in Spain pandemic. Data collection included general laboratory data (services, In relation to laboratory activity by specialty, clinical ownership); information on the organizational and activity model biochemistry and hematology accounted for most of (number of requests, continuing care model; equipment or consum- requests (87%) and determinations (93%). In total, 20% of able procurement); human resource data (types of contracts, employee demographics); information on education and training requests and 13% of determinations were urgent activity (number of faculty members and residents); quality man- (Figure 1C). Most of requests and determinations were sent agement systems adopted; type of research led by the laboratory from Primary Care (34% for both) and Specialty Care (dissertations, master’s degree final project) and level of process (23 and 29% for requests and determinations, respec- automation. Lastly, participants were asked to identify future chal- tively). Requests from Specialty Care were the ones that lenges and priorities. The data obtained were compared against data from the Spanish included the highest number of determinations, with a Federation of Healthcare Technology Companies (FENIN) 2018 report mean of 16 determinations per request (Figure 1D). [10], the Ministry of Health [11, 12], and global data [13]. Requests from Primary Care included a mean of 15.5 72 Caballé et al.: Situation and challenges in laboratory medicine in Spain Figure 1: Sector model and activity. (A) Percentage of laboratories with the presence of a specific number of specialties; (B) specialties available in clinical laboratories by size and availability of an emergency service; (C) percentage of requests and determination by specialty; (D) requests and determinations by referring unit; (E) distribution of clinical laboratories by number of determinations by physician. determinations. Personnel performance based on the of specialization of their physicians, thereby resulting in number of determinations by clinician was higher in large higher performance. Globally, clinical laboratories could laboratories. Ninety-five percent of large laboratories perform internally 97% of the determinations requested. performed 100,000 to 400,000 determinations per year per This indicates that, to face the increasing demand, it is clinician (Figure 1E). Large laboratories, which perform necessary that the capacity of clinical laboratories is large-scale testing, probably benefit from the higher level improved. Caballé et al.: Situation and challenges in laboratory medicine in Spain 73 Management, strategy, procurement and Human resources hiring practices There was a direct relationship between the number of All laboratories were involved in management or strategy physicians per center and the size of the center (Figure 3A). activities. The most common activities included atten- As many as 63% of physicians had an indefinite contract. dance to meetings of clinical commissioning groups (92%); Twenty-four percent had substitution contracts; 10% had control of demand (93%); and equipment and reagent fixed-term contracts; and 3% were back-up staff (Figure 3B). procurement activities (84%) (Figure 2A). Eighty-nine Hiring practices were influenced by geographic location. percent of laboratories had a continuing care model, Catalonia, Navarra, Asturias and Galicia were the autono- including stand-by duty shifts (65%) or on-site duty shifts mous communities with the highest percentage (>70%) of (39%) (Figure 2B). physicians with an indefinite contract. In general, a rela- Procurement was centralized in 126 public centers via tively high percentage of professionals were full-time. specific platforms. It is estimated that 65% of purchases were With regard to education and training, 38% of physicians centralized (Figure 2C). had a Master’s degree in Pharmacy; 37% in Medicine; 16% in Figure 2: Management, strategy, procurement and hiring practices. (A) Percentage of laboratories that perform management and strategy activities and breakdown by main management and strategy activities; (B) continuing care model; (C) level of centralization of procurement. 74 Caballé et al.: Situation and challenges in laboratory medicine in Spain Figure 3: Human resources. (A) Number of physicians by laboratory and size, according to self-reported data; (B) distribution of the types of contracts in the participating laboratories; (C) distribution of certified specialists; (D) distribution of certified specialists by area of knowledge; (E) age distribution of graduate professionals by specialty. Biology and Biochemistry and 8% in Chemistry (Figure 3C). (61%). In contrast, biologists and biochemists were more There were more physicians and pharmacists in classical frequently found in areas such as genetics (49%), andrology specialties such as laboratory analysis (82%) or biochemistry and reproduction (42%) or other (84%) (Figure 3D). Caballé et al.: Situation and challenges in laboratory medicine in Spain 75 In relation to the age of physicians in Spain, 23% were central for health systems to be able to meet current and older than 60 years, which means that 20–25% of positions future challenges through the use of effective, state-of-the- will need to be filled by 2024 (Figure 3E). art services. Regulatory framework and standards Continuing training, education and research Only 49% of participants held ISO 9001 certification. Most clinical laboratories (63%) had a structured education According to the Spanish National Certification Agency and training plan involving rotations (50%) or not (13%) (ENAC), in relation to Quality Management in Clinical Lab- (Figure 4A). oratories, only 85 laboratories had been granted UNE-EN ISO The number of internal medicine residents (known as 15189 certification (Figure 5A) [14]. These results demon- MIR in Spain) decreased by 2% between 2015 and 2017, strate that there is a lot of room for improvement in most of although it increased by 5% between 2017 and 2019, taking the centers in the field of procedure standardization and data from the National Health System as a reference (SNS) quality management. [12]. In the 2015–2019 period, the number of new specialists With regard to environmental issues, 90% of labora- decreased at an annual rate of 7%. The specialties related to tories had an environmental management program, and clinical laboratory medicine are among the specialties 98% had a waste disposal protocol (Figure 5B). These results with the lowest demand. The drop-out rate was 12–14% evince laboratories’ commitment to environmental (Figure 4B). These percentages indicate that these spe- sustainability. cialties are not attractive to new physicians. This may be explained by the low attention paid to laboratory medicine in medicine schools, and to limited interaction with pa- Spanish laboratory medicine in the European tients in the clinical laboratory. This trend was not context observed in other disciplines, such as biology or chemistry. At national level, 82% of participants were under- In Spain, the average expenditure in in vitro diagnostic graduate professors, 72% were graduate professors, and supplies was 1,033 million euros in 2019, vs. 2,161 million 86% were vocational education and training teachers euros in Germany, 1,623 in France, and 859 in the United (known as FP in Spain). The totality of the centers in the Kingdom [15]. Expenditure increased significantly In Valencian Community, Castile and Leon, the Canary Spain between 2019 and 2020. These figures place Spain Islands, Castile-La Mancha, the Balearic Islands, Extrem- in a similar range as other European countries, with adura and Cantabria were vocational training centers a mean expenditure of 22 euros per inhabitant. In (Figure 4C). Likewise, 13.5% of clinical laboratory special- contrast, the number of specialists per million inhabitants ists worked as professors with different contractual is considerably higher in Spain (53.3 specialists per modalities. Each professor in active service had published a million inhabitants), as compared to other European mean of 13.5 papers in indexed journals in the preceding countries such as Germany (25.5 specialists per million five years. Professors in large centers led a higher number inhabitants). It is worth mentioning that laboratory spe- of research projects. Forty-five percent of centers had a cialty is not available for pharmacists in the United partnership with a research center or institute. In total, Kingdom and Germany. Differences in laboratory techni- 18% of centers had research agreements with the industry, cian training may also affect comparative analysis of the with a mean of three agreements per center. number of specialists. The relevance that centers ascribe to knowledge, edu- cation and training is demonstrated by their intense research and education activity (undergraduate, graduate Trends and future challenges or vocational). Another proof is the sustained presence of internal residents in the centers and the availability of The Spanish population is one of the most rapidly ageing in training programs for internal residents. In half the cen- Europe. This phenomenon will translate into increased ters, structured training programs included rotations for general morbidity rates and higher prevalence of chronic internal residents. The intense research activity reported diseases. As a result, the demand for laboratory analyses will by the centers is a clear proof of the relevant role that grow. Advances in molecular biology and genomics, along research has in the participating centers. Innovation is with the emergence of new scientific disciplines such as 76 Caballé et al.: Situation and challenges in laboratory medicine in Spain Figure 4: Lifelong learning, teaching and research. (A) Percentage of centers with structured training and education programs by autonomous community; percentage of rotation residents by autonomous community and percentage of rotation residents in the laboratory by autonomous community; (B) intern specialists, new specialists and drop-out rate in clinical analysis and clinical biochemistry; (C) Percentage of clinical laboratories that offer undergraduate, graduate and vocational training by autonomous community. Caballé et al.: Situation and challenges in laboratory medicine in Spain 77 Figure 5: Regulatory framework and quality standards. (A) Number of UNE-EN-ISO 15189-certified centers by specialty reported by ENAC (May 2021); (B) percentage of centers with an environmental sustainability program and waste disposal protocol. 78 Caballé et al.: Situation and challenges in laboratory medicine in Spain Figure 6: Future challenges. (A) Main challenges faced by the specialty, based on questionnaire responses; (B) level of process automation by type of test, based on questionnaire responses; (C) percentage of centers with an automated chain, based on questionnaire responses. Caballé et al.: Situation and challenges in laboratory medicine in Spain 79 computation, data analysis and artificial intelligence, have significantly in the near future, as a result of advances in brought about a bio-revolution that will change the way we mobile health applications (m-Health). There are a variety understand laboratory medicine. of innovations in this field. According to the participants, laboratory medicine faces This study also reveals the need to provide an updated various challenges, including technological innovation, Big database of clinical laboratories to include them in Data analysis, provision of rapid response to patients, national health statistics. A regulatory progress is neces- quality certification systems and talent attraction and sary to align with the European context and advance in retention (Figure 6A). Technological advances do not only laboratory quality management certification practices. improve the efficiency of processes, but also open new ways Cooperation between national and international soci- to meet user’s needs, manage and interpret big data and eties may facilitate access to education and training and help laboratories provide a more efficient, safe and promote the incorporation of young professionals to personalized service. As a transversal element, technology decision-making boards and committees. Cooperation may may play a pivotal role. The application of Big Data and also improve access to grants and promote collaboration Artificial Intelligence in the clinical laboratory will be with medical research societies, in order to attract and crucial to clinical decision-making and health monitoring. retain new talent and boost innovation in our sector. Indeed, some initiatives have already been launched [16]. Laboratory medicine should expand its presence in the Participants have made great efforts to incorporate digital media to create awareness on its contribution to society. and automation technologies in their standard operating Moreover, laboratory medicine representatives should procedures. As many as 80% of participants received data also strengthen ties with regional and national entities to electronically. Ninety percent of tests were automated, and enlist their support in making advancements and acquiring two thirds (68%) had automated result reporting systems a more relevant position within the health system. (Figure 6B, C). Acknowledgments: To all our colleagues who returned the questionnaire and helped us collect data. To Dr. González Conclusions López-Valcarcel and Dr. Barber for their contribution to the SEQC’s White Paper. To the personnel of SEQCML This study provides a complete picture of the state of affairs Technical Secretariat for their administrative support. To in laboratory medicine in Spain and paves the way for FENIN for their support and review of objectives. To all future actions aimed at helping the sector improve and face patients, for whom we work every day. The authors want to future challenges. However, this study provides a cross- thank MFAR Clinical research and PhD Pau Doñate for sectional view, a snapshot in time. Longitudinal studies are helping us draft the manuscript. needed to infer trends and anticipate sector needs more Research funding: This study was funded by the Spanish accurately. The results of this study show that the spe- Society of Laboratory Medicine (SEQCML). cialties of Clinical Laboratory and Clinical Biochemistry Author contributions: All authors have accepted respo- have merged into a single specialty, which forces us to nsibility for the entire content of this manuscript and reconsider the situation to make grades equivalent to those approved its submission. in other European countries. Competing interests: Authors state no conflict of interest. Clinical laboratory staff does not only consist of physi- Informed consent: Not applicable. cians, as suggested in national estimations, but also includes Ethical approval: Not applicable. pharmacists, chemists and biologists. Biologists are widely present in emerging sectors such as genetics. This added to the need to replace retiring professionals will make it necessary to increase the number of vacancies offered. References Specialized training is pivotal to cope with the shortage of vacancies. 1. Louis St. Mosby’s medical dictionary, 10th ed. MO: Mosby Elsevier; 2016. The impact of COVID-19 was not analyzed in this study. 2. Lippi G, Plebani M. A modern and pragmatic definition of laboratory However, future studies should examine how the pandemic medicine: Clin Chem Lab Med 2020;58:1171. 3. Ministerio de Sanidad C y BS. Laboratorio clínico central. 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