Background A Quality Management System (QMS) analyses, controls and monitors the processes in order to identify areas that require improvement.
Purpose To describe the incidents detected by the staff of a Pharmacy Service (PS) during the implementation of a QMS based on the ISO 9001:2008 standard.
Material and methods Descriptive study (December 2013–August 2014). The quality improvement logbook, in which the incidents were recorded, was designed by the PS Quality Manager (PSQM), based on the experience of other hospitals and according to a general procedure, authorised by the PS Quality Subcommittee and reflected in the PS Organisation Handbook. The logbook was presented in a PS meeting, where its location and how to fil it in [record number, date, process involved, description of the incident, reporting/detecting staff, first actions taken] were explained. Once the incident is booked, it was reviewed by the PSQM and the responsible pharmacist. If needed, due to frequency and/or severity, the PSQM proceeds with the opening of a nonconformity and/or a corrective/preventive action, communicating this to the PS Manager. These are evaluated by the PS Quality Subcommittee.
Results 60 incidents in 4 key processes and 1 support process were recorded. Process distribution: logistics (37), dispensing (11), sterile (6) and non-sterile (5) preparation, pharmacoeconomics management (1). With respect to the logistics incidents, 18 of them were identified jointly by nursing and administrative assistants and the most common incidents involved the lack of a standard label on the outer package, to indicate that the drug can’t be dispensed outside the hospital (25) and incorrect temperature in fridge (4). In relation to incidents to do with productions, 6 nonconformities were opened (expired drug dispensed, wrong non-sterile preparation dispensed, autologous serum contamination, laminar flow cabinet contamination, mislabelling of a cytostatic and delay in orders for non-sterile materials).
Conclusion It is important to educate health staff in detecting weaknesses or failures in the system in order to perform the “Deming Continuous Improvement Cycle”.
References and/or acknowledgements No conflict of interest.
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