Accreditation is distinguished from certification in that the former, in addition to ensuring compliance with the ISO standard, assesses the quality with which the work is carried out
- External quality assessment programs (EQAS) are used to measure the reliability of clinical laboratory results
- The objective is for the results of the clinical tests to be comparable to each other, regardless of the laboratory that performs them
The Spanish Society of Laboratory Medicine (SEQCML) has obtained accreditation from the National Accreditation Entity (ENAC) as a provider of the external quality assessment program (EQAS) for serum. The SEQCML has among the objectives set by its strategic plan that its EQAS programs are leaders at the national level, and this accreditation guarantees the reliability of the laboratory results, giving a very important added value with respect to other non-accredited external quality evaluation programs. In Spain, there are only two other entities accredited by ENAC in this area, in addition to the SEQCML.
The SEQCML has extensive experience, since 1981, as a provider of external quality assessment programs in all areas of clinical biochemistry. It currently offers 11 programs in which the majority of the measurands analysed in the clinical laboratory are compared. Continuing with the main objective of continuously improving the quality of its programs, the SEQCML plans to gradually achieve ENAC accreditation of all its programs. This would guarantee the reliability of control materials used, of calculations performed, and the reports of results sent to participants.
The objective of external quality assessment programs is to evaluate the reliability of clinical laboratory results, comparing them between laboratories or using pre-established reference values. For this reason, they are also known as intercomparison programs. The program organizer distributes samples of control material of unknown concentration to all participating laboratories, which analyse them and send their results to the organizer. This entity then evaluates these results and informs each laboratory of the degree of deviation with respect to the assigned value of the control material. There are external quality programs for most of the tests analysed by the laboratories, whether at a national or international level.
ENAC is designated by the Spanish Government as the sole accreditation body. It is a non-profit, independent, impartial, and transparent public entity, whose decisions are based on exclusively technical criteria, with no commercial interest. As explained by Dr Carmen Perich, president of the Committee for External Quality Programs of the SEQCML, "being accredited by ENAC means recognition of the technical competence of an entity and its reliability, both nationally and internationally." In the case of EQAS programs, this means that their organizers meet the requirements established in the ISO 17043: 2010 standard, so that the control materials used, the calculations performed, and the result reports sent to the participants are reliable.
"It is important that the results provided by laboratories are comparable to each other, regardless of the laboratory that performed the analyses," explains Dr Perich, who adds that this fact redounds to the assurance that the patient will obtain the same diagnosis, or the same monitoring of a disease, regardless of the laboratory. At present, the SEQCML accreditations covers 36 of the tests that are most frequently performed in blood analysis, and the objective of the Society is the gradual accreditation of all its external quality programs.
Difference between accreditation and certification
To highlight the importance of this recognition, Dr Perich pointed out a series of differences between being an entity accredited by ENAC and one that simply accepts its certification.
“A certified entity implies that the fact that it performs its activities in accordance with established guidelines has been evaluated, following the requirements of the corresponding ISO standard, but it does not mean that it performs these activities in a technically competent manner, that they are reliable. On the other hand, an entity accredited by ENAC shows that the entity carries out its activities in compliance with the requirements of the corresponding ISO standard, but also that these activities are carried out in a technically competent manner, that is, that they are reliable”, the specialist pointed out. "Put simply: the certification assesses that the entity does what it says it does and the accreditation assesses that it does what it says it does and also does it well," she adds.