在住院药房推行ISO9001质量管理体系的体会

目的 :运用现代质量管理的科学理念和先进方法建立住院药房的质量管理体系。方法 :在我部推行ISO9001质量管理体系的条件下 ,住院药房要以病人为关注焦点 ,持续改进工作 ,向病人和临床科室提供优质、规范的服务。结果与结论 :推行ISO9001质量管理体系 ,既规范了住院药房的质量管理 ,又提高了医患满意度 ,可取得较好的经济效益和社会效益 ,实现住院药房管理的自我完善和持续改进     

建立中医临床教学全面质量管理体系的探讨

在既往临床教学管理经验的基础上,汲取ISO9000族标准管理理念的精华,结合东方医院自身特点,探讨建立符合高等中医教育规律,具有自我监控、自我改进能力的中医临床教学全面质量管理体系。     

Reference hearing threshold levels for chirp signals delivered by an ER-3A insert earphone

Abstract

Objective: To establish reference hearing threshold levels for chirps and frequency-specific chirps. Design: Hearing thresholds were determined monaurally for broad-band chirps and octave-band chirps using the Etymotic Research, ER-3A insert earphone. The chirps were presented using two repetition rates, 20 and 90 stimuli/s, and with alternating polarity in blocks of one second duration. The test procedure and test conditions were in accordance with the recommendations given in . The ascending method () was applied using a step size of 5 dB. The chirps were played back from a Tucker Davies Technologies System II, and a Matlab program controlled the test setup. The results are specified in dB peak-to-peak equivalent threshold sound pressure levels (dB peETSPL). Study sample: The test group consisted of 25 otologically-normal young adults (age 18–25 years). Results: The results are in good agreement with the results from another investigation of hearing thresholds using the same chirp stimuli, and the values for the octave-band chirps are in line with the standardized reference values for corresponding tone bursts (). Conclusions: The results of the present investigation are relevant for the international standard on short duration signals, .     

Performance of blood glucose meters in compliance with current and future clinical ISO15197 accuracy criteria

Since 2003, blood glucose meters for patient self testing are approved in Europe based on the accuracy performance criteria as defined by the ISO15197 guideline. A new draft ISO guideline is currently under regulatory review, which suggests more strict accuracy acceptance criteria, and which may not be entirely fulfilled by currently commercialized blood glucose meter systems. In order to investigate the compliance of BG*Star and iBG*Star and several other blood glucose meters with the new draft ISO guideline, we performed a post-hoc analysis of data obtained from a recently performed ISO-conforming clinical accuracy performance study. This study was performed with 106 patients, clinically presenting with blood glucose levels distributed over the entire measurement range and in line with the glucose distribution requirements as demanded by the guideline. The YSI 2300 STAT Plus analyzer (glucose oxidase) served as reference method.

While all tested meters had been in a high degree of compliance with the current ISO criteria, performance was lower when analyzed in accordance with the new acceptance criteria (95% of readings have to be within ±15?mg/dL for values <100?mg/dL, and within ±15% for values ≥100?mg/dL). The following meters met the new criteria: Accu-Chek Aviva (95.5%/98.6%), BG*Star (98.5%/97.3%), iBG*Star (98.5%/97.3%), FreeStyle Freedom Lite (95.5%/96.6%), and OneTouch Ultra2 (95.5%/96.5%). One meter failed with low blood glucose values (Contour: 90.9%/95.9%).

In conclusion, BG*Star and iBG*Star and several other branded meters met the new draft ISO15197 acceptance criteria, when tested in accordance with the instructions for use and with the ISO accuracy testing protocol in a clinical setting.     

红景天对异丙肾上腺素(ISO)致大鼠急性心肌缺血的保护作用

 目的  研究中药红景天(Rhodiola Rosea,R)对异丙肾上腺素(isoproternol,ISO)致大鼠急性心肌缺血的保护作用并初步探讨其机制。方法  SD雌性大鼠28只,随机分为4组,每组7只:正常对照组(N组);ISO模型组(ISO组);红景天保护组(R组);普萘洛尔(propranolol,PRO)阳性对照组(PRO组)。采用皮下注射ISO的方法建立大鼠急性心肌缺血模型。观察各组心电图改变、血流动力学参数(LVSP、LVEDP、±dp/dt max)的变化,测量各组心肌缺血面积(myocardial ischemia area,MIA),并检测血清超氧化物歧化酶(superoxide dismutase,SOD)活力。结果  ISO组心电图J点改变大于N组(P<0.05);与ISO组相比,R组的±dp/dt max有明显升高(P<0.05),MIA明显减少(P<0.05),SOD活力明显升高(P<0.05)。结论  红景天对ISO致大鼠急性心肌缺血具有保护作用,该作用可能与清除受损心肌细胞内自由基有关。     

The European I-MOVE Multicentre 2013–2014 Case-Control Study. Homogeneous moderate influenza vaccine effectiveness against A(H1N1)pdm09 and heterogenous results by country against A(H3N2)

BackgroundIn the first five I-MOVE (Influenza Monitoring Vaccine Effectiveness in Europe) influenza seasons vaccine effectiveness (VE) results were relatively homogenous among participating study sites. In 2013–2014, we undertook a multicentre case-control study based on sentinel practitioner surveillance networks in six European Union (EU) countries to measure 2013–2014 influenza VE against medically-attended influenza-like illness (ILI) laboratory-confirmed as influenza. Influenza A(H3N2) and A(H1N1)pdm09 viruses co-circulated during the season.MethodsPractitioners systematically selected ILI patients to swab within eight days of symptom onset.We compared cases (ILI positive to influenza A(H3N2) or A(H1N1)pdm09) to influenza negative patients. We calculated VE for the two influenza A subtypes and adjusted for potential confounders. We calculated heterogeneity between sites using the I² index and Cochrane's Q test. If the I² was <50%, we estimated pooled VE as (1 minus the OR) × 100 using a one-stage model with study site as a fixed effect. If the I² was >49% we used a two-stage random effects model.ResultsWe included in the A(H1N1)pdm09 analysis 531 cases and 1712 controls and in the A(H3N2) analysis 623 cases and 1920 controls. For A(H1N1)pdm09, the Q test (p = 0.695) and the I² index (0%) suggested no heterogeneity of adjusted VE between study sites. Using a one-stage model, the overall pooled adjusted VE against influenza A(H1N1)pdm2009 was 47.5% (95% CI: 16.4–67.0).For A(H3N2), the I² was 51.5% (p = 0.067). Using a two-stage model for the pooled analysis, the adjusted VE against A(H3N2) was 29.7 (95% CI: −34.4–63.2).ConclusionsThe results suggest a moderate 2013–2014 influenza VE against A(H1N1)pdm09 and a low VE against A(H3N2). The A(H3N2) estimates were heterogeneous among study sites. Larger sample sizes by study site are needed to prevent statistical heterogeneity, decrease variability and allow for two-stage pooled VE for all subgroup analyses.     

实验性心肌损伤与能量代谢关系的实验研究

本实验从病理、生化和电生理三个角度对异丙基肾上腺素所致心肌损伤与能量代谢的关系进行了研究。研究结果表明，异丙基肾上腺素确使心肌产生损伤，并随着时间的延长，损伤面积逐步扩大。损伤心肌辅酶Ｑ１０含量．全血ＡＴＰ，ＡＤＰ含量都显著降低，表明能量代谢发生障碍。也损伤心肌钙离子通道。复方丹参和辅酶Ｑ１０对心肌确有保护作用，使心肌损伤面积缩小，心肌匀浆和线粒体中琥珀酸脱氢酶活性，辅酶Ｑ１０含量和全血ＡＴＰ，ＡＤＰ含量都显著增高。钙离子通道也有明显的改善，说明这两种药物对心肌有明显的保护作用．为这种药物的临床应用提供了实验依据。     

基于ISO15189的临床实验室电子记录系统的设计和应用

目的 分析基于ISO15189的临床实验室电子记录系统的设计和应用。方法 利用SpringBoot+SpringMVC技术框架进行构建,采用JAVA等编程语言和MySQL 5.7数据库技术搭建Web平台,基于Apache/Nginx/Caddy应用服务器,设计研发临床实验室电子记录系统。结果 临床实验室电子记录系统包含ISO15189中管理要求和技术要求相关的电子表格和审批流程。在管理要求部分主要包括对文件的修订、不符合项的识别以及对管理评审等方面;技术要求部分主要包括在日常工作中所需的人员、设备设施以及在检验前中后期等的技术要求。结论 临床实验室电子记录系统实现了表格的规范填写,文档与数据的高效记录,可以追溯整个检验周期,查找更为有针对性,极大地提高了工作效率。