SEQC Spanish Society of Laboratory Medicine

Spanish Society of Laboratory Medicine

XVIII Conference of the Scientific Committee of the Spanish Society of Laboratory Medicine (SEQCML)

13/03/2021

Accreditation of clinical laboratories is key to guaranteeing the reliability of results, making clinical decisions, and responding to the desire to optimize the care of clinical laboratory clients, while always focusing the patient

The Scientific Committee of the Spanish Society of Laboratory Medicine (SEQCML), as it does every year, held its traditional meeting, the XVIII Conference of the Scientific Committee, which addressed and updated various important aspects in the clinical laboratory field. This year’s meeting took place in virtual format.

Accreditation of clinical laboratories is key to guaranteeing the reliability of results, making clinical decisions, and responding to the desire to optimize the care of clinical laboratory clients (requesting physicians / clinicians), while always focusing on the main beneficiary: the patient. To analyze the current situation and advance in this field, the Spanish Society of Laboratory Medicine (SEQCML) has organized the course 'Accreditation in Genetic Diagnosis Laboratories: Key Aspects ”, within the framework of its Scientific Committee Conference, which was held for the first time in virtual format from March 1 to 5.

"The Scientific Committee Conferences are one of the most important activities in which the Society's commissions participate and are one of its main objectives," says Dr Eva Guillén Campuzano, president of the Scientific Committee of the SEQCML.

As this expert notes, “the format of the courses and the combination of the topics covered in each lead to them being very well received, among both experienced professionals and residents, allowing them to update their scientific knowledge of the topics covered”. These courses –adds Dr Guillén- combine new topics or those of greater current interest with more academic topics, condensing the most important aspects related to the topic at hand. "The distribution and duration of the talks allows the speakers to adequately transmit the content, leaving a space for the attendees’ participation, which is always very attractive and interesting," she points out.

Reliability and confidence of laboratory results

The ISO 15189 standard assesses technical competence and is the most effective tool to ensure the quality and competence of laboratory results.

“Accreditation facilitates the work of the clinical professional by giving them added confidence in the reliability of the result they receive and provides greater trust to the patient when it comes to viewing their reports and analytical results. It also allows the application and maintenance of an effective quality control system, gives the user confidence in the use of the service, provides national / international recognition of technical competence, and helps the clinical laboratory in the face of legal controversies regarding the results, especially in genetic studies”, says Dr Silvia Izquierdo Álvarez, member of the Laboratory Accreditation Commission of the SEQCML and coordinator of this course.

Furthermore, when a clinical laboratory outsources certain tests / studies to other laboratories, in the drafting of the bidding documents, "one of the technical criteria / requirements to be assessed, even to the point of becoming a criterion / requirement for exclusion, is accreditation by ISO 15189”, she said.

For this reason, clinical laboratory accreditation is one of the strategic focuses of the Spanish Society of Laboratory Medicine, whose members need help in understanding the requirements, both managerial and technical, in the process of implementing ISO 15189 in their laboratories.

Since 2015, the SEQCML has established conversations -which continue today- with institutions such as the Ministry of Health, Consumption, and Social Welfare in order to promote the importance of knowing and using the accreditation criteria for the ISO 15189 standard for the choice of and trust in health centres and laboratories and, in a way, to support the obligatory nature of accreditation in clinical laboratories in all their areas.

Advances in the accreditation of genetic diagnostic tests

It is estimated that there are more than 85 accredited clinical laboratories in the various areas and around 23 have an accredited scope that falls within molecular genetics and / or molecular biology.

In recent years, there has been a slight increase in requests for accreditation in the molecular area, especially in techniques increasingly implemented in genetic diagnostic laboratories such as massive sequencing (NGS, Next Generation Sequencing), by means of panels highly aimed at diseases related to neurological and cardiological areas, intellectual disability, oncology, digestive issues, predisposition to hereditary cancer, etc. Many of these opt for a more flexible scope (so as to be able to expand the number of genes involved in these syndromes / diseases).

In this line, Dr Izquierdo asserts that for the genetic diagnostic laboratory that has decided to enter the accreditation process, it may be more complicated to know how to meet the requirements of the standard, especially the technical requirements, given the distinctive features of the tests in this laboratory area, both with respect to the methodological complexity of the techniques and the variety of types of results / reports that are produced, among other aspects. Hence the interest in and importance of this course for laboratories.

To date, accreditation is not mandatory in Spain, while it is in other European countries such as Belgium (for all genetics laboratories), or France and Romania (for all clinical laboratories including molecular genetics / molecular biology).

Currently, the Ministry of Health, Consumption, and Social Welfare has established the accreditation requirement for Neonatal Screening laboratories that want to be designated as Reference Centres (CSUR) and “it can be foreseen that the requirement will expand to other laboratory disciplines such as molecular genetics, at least those that are a reference centre; hence the need to gradually implement ISO 15189 in these areas”, explains Dr Izquierdo.

In conclusion, Dr Izquierdo details other genetic diagnostic techniques, in addition to NGS panels, accredited by clinical laboratories:

  • The TP-PCR (Triplet Primed Repeat-PCR) for the analysis of expansion of diseases such as Friedreich's ataxia, fragile X syndrome, Steinert's disease, spinocerebellar ataxias, C9orf72 gene expansion (ALS, amyotrophic lateral sclerosis / FTD, frontotemporal dementia).
  • RT-PCR (Real Time-PCR) to detect mutations and / or polymorphisms in studies of thrombophilia, hereditary hemochromatosis type 1 (HFE).
  • Allele-specific PCR (ARMS), for the study of cystic fibrosis mutations, for example, or QF-PCR.
  • There is also a range of techniques such as aCGH (60K, 180K), MLPA, Sanger sequencing for more frequent point mutations in certain syndromes / diseases, and other variants of PCR (Huntington's disease).