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RATIONALE, AIMS AND OBJECTIVES: An adaptation of the first stage of the systematic qualitative tool, the Hazard Analysis and Critical Control Point (HACCP) system from the food industry, was used to identify problems in the delivery of a district-wide antenatal screening programme for Down's syndrome. The aim of the second stage, described here, was to develop specific solutions (termed controls) for these problems. METHODS: The views of staff delivering the programme and of members of the Down's screening steering group were used to identify control measures. The steering group members were also asked to identify which controls were critical to a risk management strategy, i.e. whether a control was essential to eliminate the hazard or if other control measures operating further down-line would be sufficient. The control measures were piloted both to determine if they were operationally feasible and whether they were practical in the context of staff workload and attitude. Two main control measures were the development of a rolling education programme for staff and of a written protocol with a checklist to verify stepwise delivery of the Down's screening programme. The checklist was designed to be included in the notes of every pregnant woman to enable audit of the offer of screening and delivery of each step of the screening programme. The control measures were all tailored specifically to overcome the problems reported by staff during the first stage of the work, the hazard analysis. RESULTS AND CONCLUSIONS: The HACCP system proved useful in confirming the existence of problems in delivery of a Down's serum screening programme and in determining solutions tailored to overcome those problems. Future work is required to monitor and evaluate the usefulness of the control measures implemented.


Journal article


J Eval Clin Pract

Publication Date





49 - 57


Clinical Protocols, Diffusion of Innovation, Down Syndrome, Female, Food Industry, Humans, Inservice Training, Mass Screening, Medical Audit, Organizational Policy, Pilot Projects, Pregnancy, Prenatal Diagnosis, Safety Management, Systems Analysis, United Kingdom