Can safety assurance procedures in the food industry be used to evaluate a medical screening programme? The application of the Hazard Analysis and Critical Control Point system to an antenatal serum screening programme for Down's syndrome. Stage 1: identifying significant hazards

Rationale, aims and objectives Routine review of the Leicestershire district antenatal screening programme for Down's syndrome was carried out by its steering group. This raised suspicions that there were problems with the delivery of the programme. The steering group commissioned a project to adapt the Hazard Analysis and Critical Control Point (HACCP) system, as used in the food industry, to investigate this. The HACCP system is a systematic qualitative approach to problem identification and solution taken from the perspective of the production workers. This paper presents the first stage of the process, the hazard analysis. Methods Preliminary work comprised the preparation and verification of a flow diagram of the screening programme. Data about problems (termed hazards) perceived by Leicestershire health care staff delivering the screening programme were collected by observation, interview and telephone. The problems reported were categorized and assessed to identify those of sufficient importance in terms of their consequences or frequency of occurrence to merit the development of control measures. Hazards relating to operational issues were categorized according to the section of the programme to which they related. Results and conclusions A total of 16 categories of hazard were identified. In addition, nine groups of hazards constituting barriers to delivery of the screening programme as a whole were identified. The HACCP process made these hazards explicit. The first stage of the HACCP system proved a useful tool to identify problems experienced delivering a Down's serum screening programme and to assess which were sufficiently serious to require the development of control measures.