Molecular diagnosis in a pregnancy at risk for both spondyloepiphyseal dysplasia congenita and achondroplasia

In any medical service or procedure, standards need to be maintained, and this includes screening practice. The importance of instituting screening programmes in an organised and disciplined way is recognised, as is the importance of quality assurance and the need to monitor effectiveness. In general, this is best achieved with appropriate experience and professional supervision within organisations. This encourages a collective sense of responsibility and ownership over the service and its quality. In certain areas, external audit and quality control may be appropriate, but the justification for this is that acceptable standards could not otherwise be achieved or maintained. The principle driver should be internal responsibility and recognition of achievement and quality rather than adherence to external rules or scrutiny. A controversial area is that of accreditation or certification in respect of specific procedures or measurements. The aim of certification, to ensure competence and appropriate expertise, is laudable. However, by encouraging an authoritarian approach, it tends to move responsibility from the practitioner or the individual programme to the certifying body. There tends to be an automatic acceptance that the criteria set out by the certifying body are appropriate. This can tend to stifle legitimate diversity. There is a possibility that the process will become more of a bureaucratic licensing procedure than one in which people are encouraged to be self-critical, examine their own practice, and improve it themselves. The policy also begs the question as to who will certify the certifying body. The general ethos is one that tends to encourage exclusiveness rather than inclusiveness. Quality-assessment programmes such as NEQAS (National External Quality Assurance Scheme) are valuable. These conduct assessment of laboratory measurement with a view to monitoring and reporting on accuracy and consistency. What is less certain is the desirability for certification, and if warranted, whether it should be conducted by a private organisation. One such example is certification of the measurement of nuchal translucency in Down syndrome screening by the Fetal Medicine Foundation. The same group recently added the certification of laboratories performing first-trimester screening and certification of interpretive software used for this purpose. All of this applies to a method of screening that the group is promoting, implying that it is the method of choice. Certification is more authoritarian than the NEQAS programme, implying that if practitioners do not meet certain standards and certain criteria specified by the certifying authority, they may lose their certified status, which may restrict or prevent their right to practice. Certification has sufficiently serious implications for those involved in screening practice that it should be considered only when other methods of ensuring satisfactory performance have failed. If introduced, it should be done on a regional or national basis through professional organisations that have a broad representation in terms of relevant expertise and practice in the field. It should also apply to disciplines or specialities not to individual procedures or tests. Certification in respect of specific tests or procedures could become a slippery slope. How many other tests, components of tests, or procedures will be subject to such licensing procedures? Is much of medical practice to become drawn into this, limiting what people can do through what many would judge to be an artificial and unjustified restriction on medical or screening practice? Certification should come with a warning—it can do harm as well as good. It should be used sparingly when a clear case of need can be made and by independent professional bodies.