ABSTRACT
Objective:To build an investigator-initiated clinical research process management indicator system based on the theory of Hazard Analysis and Critical Control Point(HACCP).Methods:A plan was developed according to HACCP principles, and 23 experts were invited to form an expert advisory group. Literature research, panel discussion, and Delphi method were used to collect clinical research process management indicators, and the weight of each indicator was calculated via Analytic Hierarchy Process(AHP).Results:Two rounds of expert consultation were carried out with a high positive coefficient and a high expert authority level, and finally formed 3 primary indicators and 14 secondary indicators. The primary indicators were project establishment, project process management, and project implementation assessment, with weights of 0.142 8, 0.714 4, and 0.142 8, respectively.Conclusions:This study established a clinical research process management system based on HACCP theory from 3 dimensions: project establishment, project process management, and project implementation assessment, carried out precise management of clinical research according to the weights of secondary indicators, focusing on the content of indicators with great weight, and provided an important reference for the management of investigator-initiated clinical research.
ABSTRACT
OBJECTIVE:To strengthen the comprehensive control of drug dispensing errors in our hospitals and ensure the medication safety of patients. METHODS:The steps and related contents for drug dispensing errors implemented in our hospital based on hazard analysis and critical control point method(HACCP)were introduced,and the management effects were evaluated by comparing the dispensing error before(2015)and after management(2016). RESULTS:Starting from establishing groups,our hospital drew flow chart of drug dispensing,and plans [including hazard analysis,determining critical control points(CCP),estab-lishing critical limits (CL),monitoring system,correlative measures,confirming process and quality records] were developed based on HACCP principle. And 4 CCPs were identified,naming reviewing prescription,dispensing drugs,writing drug bags or pasting labels and delivering the drugs to patients. Related measures were implemented,which had achieved the effective manage-ment and control for drug dispensing. Compared with before implementing HACCP,the drug dispensing error rate in our hospital was declined by 84.73%(0.753‰ vs. 0.115‰). CONCLUSIONS:Scientifically applying HACCP for drug dispensing in hospital can effectively control the drug error risk and promote the medication safety of patients.
ABSTRACT
The Garrahan Hospital is a tertiary-care center for pediatrics patients with complex diseases. Infections, including food-borne infections, contribute considerably to the morbidity and mortality in this population at risk. In order to prevent food-borne infections, the Foodservice Area has developed a preventive process approach system of Hazard Analysis and Critical Control Point (process approach HACCP) in food production and service. Objective: To conduct a thorough review and assessment of risk from food borne pathogens according to the pathology of patients or the therapeutic practice used, and to standardize food production and service. With the criterion "degree of safety at the time of service" preventive measures were standardized. The food was classified into four levels of process. One or more food levels are indicated according to risk, and if necessary individual adjustments are made.
El hospital Garrahan brinda asistencia a pacientes pediátricos con patologías complejas. Las infecciones, incluidas las alimentarias, contribuyen considerablemente en la morbilidad y mortalidad en esta población en riesgo. Con la finalidad de prevenir infecciones alimentarias, el Área de Alimentación desarrolla un Sistema Preventivo de Análisis de Peligros y Puntos Críticos de Control con enfoque en procesos (HACCP process approach) en la producción y servicio de alimentos. Objetivo: realizar una exhaustiva revisión y evaluación de los patógenos alimentarios de riesgo según patología o práctica terapéutica de los pacientes y estandarizar la producción y servicio de alimentos. Con el criterio "grado de inocuidad al momento del servicio" se estandarizaron las medidas preventivas. La alimentación fue clasificada en cuatro niveles de proceso. A cada grupo de población asistida, según riesgo, se le indica uno o más niveles de alimentación y se realizan los ajustes individuales necesarios.