University Medical Center Utrecht, Division of Perinatology and Gynaecology, Department of Reproductive Medicine, Heidelberglaan 100, NL-3584 CX Utrecht, The Netherlands
1 To whom correspondence should be addressed. e-mail: P.Kastrop{at}azu.nl
Dear Sir,
We read the opinion of Alper and co-authors with interest (Alper et al., 2002). In this article the four authors from different countries propose an international standard, such as the International Organization for Standardization (ISO) 9001 for units providing fertility services. They state that such an international standard would have the major advantage of eliminating the need to set up country-specific regulations for quality in the field of assisted reproduction technologies (ART). Furthermore, they suggest that such an international standard would also better define the outcome measures that are important to our patients and create a mechanism to improve the provided care. Since currently, many national registries focus on pregnancy rates as the primary outcome measure, the authors express their concern about the fact that this can be very deceptive and misguiding, if factors such as multiple pregnancies, ovarian hyperstimulation, patient satisfaction, and the proper evaluation of laboratory and clinical protocols are not taken into account.
Although we fully agree with this opinion, it is unfortunate that the authors dont bring forward extant and forthcoming international standards which can be implemented in ART laboratories and that are more suitable than the ISO 9001:2000 standard. Indeed the latest version of the ISO 9001 standard does provide an improved basis for establishing a quality management system and aims to enhance customer satisfaction. But still ISO 9001 certification does not ensure that an ART programme will be successful, or that it achieves the highest level of care for the patients that are served. Therefore, ART centres should meet additional requirements, especially on qualification and competence of personnel, and should always strive for accreditation rather than certification.
For the ART laboratory, a relevant and applicable standard is provided by the ISO/IEC 17025. This international standard, released in the beginning of 2000, covers both the ISO/IEC Guide 25 and its European counterpart EN 45001, which were applied from the early nineties onwards by clinical testing laboratories seeking accreditation. At the moment, ISO is preparing a new and specific international standard for the accreditation of clinical laboratories, ISO 15189. A second draft of this new standard has recently been submitted for approval to all member bodies of ISO. This international standard, based upon ISO/IEC 17025 and ISO 9001 provides particular requirements for the quality and competence of medical laboratories and is intended for use throughout the currently recognized disciplines of medical laboratory services. The standard includes requirements concerning not only management, personnel, accommodation, equipment, resolution of complaints and assessments, but additionally patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples with subsequent validation, interpretation, reporting, and advice, as well as safety and ethics of medical laboratory work. Therefore, this new international standard, ISO 15189, would serve perfectly as the desperately needed international standard to assess the quality of IVF centres worldwide, as stated by Alper and co-authors.
Although this standard will have the major advantage of unifying national guidelines for ART centres, it remains questionable, however, whether it will also result in a consensus on what are important outcome measures in our field. Political and socio-economical differences between countries make it hardly possible to assess and compare the overall quality of ART programmes. In our opinion, strict and worldwide agreements between all societies of ART specialists as well as editors of related professional journals, will be also necessary to achieve consensus on specific outcome measures within well-defined populations of fertility patients in order to facilitate the comparison of quality between ART centres throughout the world.
References
Alper, M.M., Brinsden, P.R., Fischer, R. and Wikland, M. (2002) Is your IVF programme good? Hum. Reprod., 17, 810.
EN 45001:1991. General criteria for the operation of testing laboratories.
ISO 9001: 2000. Quality management systems Requirements.
ISO/DIS 15189.2: 2002 Medical Laboratories Particular requirements for quality and competence. (Draft International Standard).
ISO/IEC 17025: 1999. General requirements for the competence of testing and calibration laboratories.
ISO/IEC Guide 25:1990. General requirements for the competence of testing and calibration laboratories.