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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.
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OBJECTIVE: To analyze the occupational hazard factors and their critical control points in the process of construction of a large-scale construction project.METHODS: The engineering analysis, worksite survey occupational health and occupational hazard factor testing were conducted in a large-scale construction project, and the results were analyzed. RESULTS: During the process of construction of this large-scale construction project, there were many occupational hazard factors such as silicon dust, welding smoke, wood and other dusts, inorganic compounds of manganese, carbon monoxide, carbon dioxide, nitric oxide, ozone, noise, high temperature, hand-transmitted vibration and ultraviolet irradiation, among them, silicon dust and noise were the most common ones. The over standard rates of exposure concentration of short term of total dust and respirable dust in the workplace were 68.2%(15/22) and 40.9%(9/22), and the over standard rates of exposure concentration of time weighted average were 54.5%(12/22) and 13.6%(3/22), respectively. The over standard rates of the noise intensity of area sampling and personal sampling in workplace were 69.2%(45/65) and 61.0%(25/41) respectively. The four hours energy equivalent frequency-weighted acceleration to vibration of three hand-transmitted vibration positions has been detected, and the result has surpassed the occupational exposure limit.The results of other occupational hazard factors such as high temperature, ultraviolet radiation, wood dust, welding smoke, other dust, manganese inorganic compounds, carbon monoxide, carbon dioxide, nitric oxide, nitrogen dioxide, hydrogen sulfide, hydrogen cyanide and ozone all met the occupational exposure limits. CONCLUSION: There are various occupational hazard factors in the process of construction of this large-scale construction project, among them, noise, dust and hand-transmitted vibration are the most prominent hazards.These hazards are the critical control points of this type of construction projects.
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Good agricultural practices(GAP) for Chinese herbal medicine(CHM) is the source of quality control in the production of CHM. To ensure the safety, efficacy, and quality of Chinese herbal and natural medicine, the international community has been exploring the implementation of GAP for CHM. The implementation of GAP for CHM has a far-reaching impact, and the scale planting of CHM has been expanding. However, the medicinal materials produced by the GAP bases for CHM still cannot fully meet the market demand, and the output and quality of CHM remain to be improved. This paper summarizes construction status of GAP bases for CHM.The 129 companies that passed the certification during the implementation of GAP for CHM included 196 GAP bases, forming the scale CHM production zone with Sichuan province, Yunnan province, Jilin province, Henan province, and Shandong province as the core.The total area of GAP bases for CHM in China is about 250 000-500 000 Mu(1 Mu≈667 m2), which is still less than 1% of the total production area of CHM. The international agricultural production quality management strategies are all market-oriented behaviors.Drawing on the international good agricultural and collection practice(GACP) and hazard analysis critical control point(HACCP) as well as the relevant policies of Chinese quality management of CHM, we put forward feasible suggestions for the further implementation of GAP for CHM:(1)The market rules and international experience should be followed and employed to promote GAP management of CHM and third-party implementation of GAP certification;(2)The sound development of GAP for CHM should be boosted with the HACCP management system and the revision of GAP for CHM;(3)The implementation of policies and standards should be stepped up to facilitate the building of a whole-course traceability system for the production of CHM with high quality and reasonable prices.
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Humans , China , Drugs, Chinese Herbal , Hazard Analysis and Critical Control Points , Medicine, Chinese Traditional , Quality ControlABSTRACT
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.
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OBJECTIVE:To evaluate the feasibility and effectiveness of Hazard analysis and critical control point (HACCP) system in the process of production of Loratadine tablets. METHODS:Taking wet granulation and tableting technology of Lorata-dine tablets as an example,and through the introduction of the concept of HACCP,the basic theory and method of HACCP were applied for hazard analysis on each production link to find critical control points and set critical limits for production quality man-agement. RESULTS:By HACCP analysis,three links namely drying,granules fitting and mixing,internal and external packaging were finally determined as the critical control points in the process of production of Loratadine tablets,thereby critical control lim-its were set for monitoring. After effective control over the risks in the process was ensured,HACCP work plan was made and veri-fied,and the results showed that HACCP system could effectively control and reduce the risks in the process of production and en-sure quality safety. CONCLUSIONS:Application of HACCP system to wet granulation and tableting technology of Loratadine tab-lets can fully embody its feasibility and effectiveness.
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En el medio ambiente de las instituciones educacionales se presentan frecuentemente factores de riesgo para la salud de educandos y educadores, que favorecen la aparición de enfermedades transmisibles. En ocasiones estos factores de riesgo se relacionan en lo fundamental con el incumplimiento de procedimientos establecidos precisamente para su prevención. El objetivo de este trabajo fue identificar factores de riesgo de enfermedades transmisibles en una escuela primaria del Complejo Escolar Ciudad Libertad, en el municipio de Marianao, y orientar las medidas pertinentes para su eliminación en el proceso de implementación de un sistema de vigilancia. Como parte fundamental de la metodología de este sistema estuvo la capacitación del personal de salud en los aspectos higiénicos y epidemiológicos relacionados con las enfermedades transmisibles y sus factores de riesgo ambientales y personales. Se planteó además en el diseño aplicar el sistema de análisis de riesgo y puntos críticos de control utilizado en la higiene de los alimentos. Entre los principales resultados se identificaron múltiples factores de riesgo para las enfermedades transmisibles por diferentes vías en el ambiente de la institución educacional estudiada y de los hábitos y comportamientos de los educandos, así como sus causas. Se concluye que la identificación de los factores de riesgo de enfermedades transmisibles en las instituciones educacionales es realizable y pueden ser prevenidos o eliminados con medidas sencillas y aplicables en el mismo centro escolar.
In the environment of educational institutions frequently there are risk factors for health of students and professors, favoring the appearance of communicable diseases. Some- times these risk factors are mainly related with the failure to fulfil of the established procedures precisely for its prevention. The aim of present paper is to identify the risk factors of communicable diseases in a primary school of «Ciudad Libertad¼ school complex in the Marianao municipality and to direct the pertinent measures for its elimination in the implementation of a surveillance system. As a fundamental part of the methodology of this system is the training of health staff in the hygienic and epidemiologic features related to the communicable diseases and its environmental and personal risk factors. Also, as regards the design authors propose to apply the risk analysis system and the critical control points used in the foods hygiene. Among the major results there were multiple risk factors for the communicable diseases by different routes in the environment of study educational institution and students habits and behaviors, as well as its causes. We conclude that identification of risk factors of communicable diseases in educational institutions is feasible and may to be prevented or eliminated using simple and applicable measures in the same school center.
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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.
Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Child , Adolescent , Foodborne Diseases/prevention & control , Hospitals, Pediatric/statistics & numerical data , Hospitals, Pediatric/supply & distribution , Food Handling/methods , Hazard Analysis and Critical Control Points , Genetic Diseases, Inborn/rehabilitation , Immune System Phenomena , Neoplasms/rehabilitationABSTRACT
The purposes of this study were to assess hospital foodservice quality and to identify causes of quality problems and improvement strategies. Based on the review of literature, hospital foodservice quality was defined and the Hospital Foodservice Quality model was presented. The study was conducted in two steps. In Step 1, nutritional standards specified on diet manuals and nutrients of planned menus, served meals, and consumed meals for regular, diabetic, and low-sodium diets were assessed in three general hospitals. Quality problems were found in all three hospitals since patients consumed less than their nutritional requirements. Considering the effects of four gaps in the Hospital Foodservice Quality model, Gaps 3 and 4 were selected as critical control points (CCPs) for hospital foodservice quality management. In Step 2, the causes of the gaps and improvement strategies at CCPs were labeled as "quality hazards" and "corrective actions", respectively and were identified using a case study. At Gap 3, inaccurate forecasting and a lack of control during production were identified as quality hazards and corrective actions proposed were establishing an accurate forecasting system, improving standardized recipes, emphasizing the use of standardized recipes, and conducting employee training. At Gap 4, quality hazards were menus of low preferences, inconsistency of menu quality, a lack of menu variety, improper food temperatures, and patients' lack of understanding of their nutritional requirements. To reduce Gap 4, the dietary departments should conduct patient surveys on menu preferences on a regular basis, develop new menus, especially for therapeutic diets, maintain food temperatures during distribution, provide more choices, conduct meal rounds, and provide nutrition education and counseling. The Hospital Foodservice Quality Model was a useful tool for identifying causes of the foodservice quality problems and improvement strategies from a holistic point of view.
Subject(s)
Humans , Counseling , Diet , Diet, Sodium-Restricted , Forecasting , Hospitals, General , Meals , Nutritional RequirementsABSTRACT
Avaliou-se a presença de Salmonella spp. em esfregaços superficiais em 135 carcaças de frangos, coletadas em cinco diferentes fases do abate, utilizando os métodos de microbiologia convencional, reação em cadeia de polimerase (PCR) e imunoanálise. Os três métodos resultaram em tendência semelhante de detecção de Salmonella spp. nas carcaças de frango, ao longo da linha de abate. A maior frequência de Salmonella spp. foi determinada após o chuveiro de lavagem das carcaças, localizado entre a evisceração e o pré-resfriamento. Vinte (14,8 por cento) esfregaços foram determinados pela metodologia convencional, 52 (38,5 por cento) pela PCR e 66 (48,8 por cento) pela imunoanálise. A menor contaminação foi encontrada na saída do pré-resfriamento, com frequências de 3,7 por cento, 0 por cento e 16,7 por cento, respectivamente. Salmonella spp. foi encontrada em todas as fases de abate, mostrando a importância do monitoramento de diferentes pontos críticos de controle eventualmente identificados no abate de frangos.
The presence of Salmonella spp. in superficial swabs collected from 135 chicken carcasses in five different slaugther steps using the conventional microbiology, PCR, and immunoanalysis methods was evaluated. The three methods presented similar tendency to detect Salmonella spp. in the chicken carcasses along the slaugther line. The highest frequency of Salmonella spp. was found after the shower, located between the evisceration and the chiller. Twenty (14.8 percent) swabes were determined by the conventional methodology, 52 (38.9 percent) by the PCR, and 66 (48.9 percent) by the immunoanalysis. The lowest contamination was found after chiller tank, where the frequencies were 5 (3.7 percent), 0 (0 percent), and 24 (16.7 percent), respectively. Salmonella spp. was found in all the slaugther steps. This shows the importance for monitoring different CCP (Control Critical Point) in the poultry slaughterhouses.
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Animals , Abattoirs , Birds , Salmonella/isolation & purificationABSTRACT
The concept of Hazard Analysis Critical Control point was introduced for implementing the 12 step procedures of HACCP in the production and the processing of food. The development and compliance of HACCP in food industry and trade in Vietnam were reviewed.