苯甲醇含量测定能力验证研究

目的：评价参与药用辅料苯甲醇含量测定的实验室的能力。方法：依据CNAS-RL02《能力验证规则》和ISO/IEC 17043《合格评定能力验证的通用要求》实施实验室能力验证活动。通过研究,制备了均匀性和稳定性均符合能力验证要求的测试样品,根据CNAS-GL03《能力验证样品均匀性和稳定性评价指南》,对检测结果进行单因子方差分析和t检验分析,结果显示样品均匀性和稳定性均符合要求。以结果的中位值作为测试样品含量的指定值,以整体标准差作为能力评判标准差,根据GB/T 28043-2011/ISO13528：2005,利用稳健统计分析,用Z比分数进行结果判定,对190家参加实验室的报告结果进行评价。结果与结论：190家实验室中有4家实验室的检测结果可疑,4家实验室结果不满意,整体满意率95.8%;通过本次能力验证数据分析和研究,多数参加能力验证苯甲醇含量测定的检测结果满意,不满意结果有仪器、称量、人员等方面引入的误差,并要求相关实验室结合自身情况查找原因进行整改。     

体外诊断试剂能力验证应用策略探讨

目的：探讨体外诊断检测领域能力验证策略,为能力验证提供者组织能力验证活动提供参考,推动实验室质量体系持续改进。方法：通过对组织体外诊断检测领域能力验证活动的工作进行总结,从方案设计到结果分析所涉及的关键环节进行梳理剖析,只有将这些关键环节进行有效的质量控制,才能成功地开展能力验证活动。结果与结论：能力验证提供者持续改进质量体系建设,为实验室提供质量评价保障的同时,推动了实验室间结果的一致性和标准化。     

国家药品标准物质保障供应综合数据平台建设

目的：进一步提高国家药品标准物质供应保障的能力和水平,更好支撑药品监管需求和服务行业发展。方法：将信息化管理和分析方法与现有的标准物质管理技术要求相结合,研究建立数字化、可视化的数据共享系统。结果：建成的国家药品标准物质保障供应综合数据平台,可显示各品种的研制生产阶段和效率。结论：该平台试运行一年来已成为指导研制、生产和管理的有力抓手,为对接国际标准ISO 17034奠定了重要基础。     

药品标准物质基本特性与规范生产有关质量管理要求

目的：为规范药品标准物质的研制生产提供参考。方法：结合ISO导则34,根据药品标准物质的基本特性,探讨在全面质量管理新形势下,药品标准物质在均匀性、稳定性、准确性和程序合规性等几方面应遵循的有关要求。结果与讨论：规范和完善药品标准物质生产技术要求和质量管理,是标准物质量值准确、稳定、可靠的保障。     

药品中核磁共振检测定性能力验证样品制备与评价结果分析

目的：评价参与药品中核磁共振检测定性能力验证实验室的检测能力。方法：制备高纯阿魏酸纯度标准物质;参照国家标准物质研制技术规范采用单因素方差分析考察样品均匀性;采用t检验考察样品分别在高温和光照下储藏7天、14天的运输稳定性,采用标准曲线法考察样品在常温放置12个月的长期稳定性;按照CNAS规定的程序实施本次能力验证。结果：阿魏酸纯度标准物质在均匀性、稳定性方面均能满足药品中核磁共振检测定性能力验证使用的要求。在13家实验室16台仪器的反馈结果中,12家15台仪器的测定结果评定为合格,1家实验室的1台仪器结果为不合格,合格率为93.75%。结论：本次能力验证可以真实地反映参试单位的检测水平,绝大多数参加能力验证的实验室具备了药品中核磁共振检测定性能力。     

医疗器械检测用2-氯乙醇标准物质的研究

目的：以2-氯乙醇（Ethylene Chlorohydrin,ECH）为原料制备用于医疗器械检测用的ECH标准物质。方法：采用气相色谱质谱连用技术对原材料进行筛选和考核,采用气相色谱技术对ECH标准物质的含量进行测定,采用多家实验室协作标定的方式进行定值,并进行不确定度评定,另对ECH标准物质的均匀性和稳定性进行了考察。结果：所研制的ECH标准物质原料纯度高,量值稳定,ECH含量为97.92%±0.02%;均匀性考察结果：ECH含量的统计量F=0.70,小于F（0.05）临界值2.76;稳定性试验结果表明ECH标准物质在12个月时纯度的相对标准偏差RSD是0.46%。结论：所研制的ECH标准物质纯度高,不确定度小,均匀性和稳定性良好,适宜作为医疗器械检测用ECH标准物质。     

药品标准物质的管理与研制生产质量控制

目的：介绍药品标准物质管理的组织结构与研制、生产和分发中的质量控制要求,为药品标准物质的质量和供应提供更好的保障。方法：基于ISO 17034国际标准要求,梳理药品标准物质研制、生产与管理工作流程,分析研制生产与管理各环节中应控制的质量要素,强调遵循规定要求的重要性。结果：建立和完善药品标准物质研制、生产和管理的质量控制和持续供应的有效机制。结论：为确保药品标准物质的质量和可获得性,加强药品标准物质各流程环节管理很有必要。     

盐酸托烷司琼国家一级化学纯度标准物质研究

目的 通过准确可靠的定值方法及不确定度分析研究,研制具有可溯源和量值传递功能的盐酸托烷司琼国家一级化学纯度标准物质。方法 以5-HT₃受体拮抗剂盐酸托烷司琼为研究对象,根据我国计量法和一级标准物质研制技术规范与相关技术文件要求,采用HPLC对盐酸托烷司琼纯度标准物质进行均匀性和稳定性检验;采用HPLC和差示扫描量热法2种不同原理方法联合定值,并完成不确定度评估。结果 研制的盐酸托烷司琼纯度标准物质具有良好的均匀性和稳定性,纯度标准值为99.7%,不确定度为0.4%（k=2）。结论 研制的盐酸托烷司琼为国家一级标准物质（GBW09494）。该研究可实现相关成分的量值溯源及量值传递,同时为我国药品的标准化和现代化提供了重要的标准物质和标准分析方法。     

人血白蛋白的蛋白质含量测定能力验证结果与分析

目的：对全国血液制品批签发授权药检机构及相关生产企业或单位实验室的人血白蛋白蛋白质含量检测能力进行评价。方法：选择符合要求的人血白蛋白产品作为原料进行合并、除菌、分装。制备后按照《中国药典》2015年版三部蛋白质含量（凯式定氮）测定,组织协作标定后确立指定值。均一性和稳定性监测合格后按能力验证要求发放样品。以多中心协作标定结果作为评价参加者能力验证结果的依据。结果：能力验证样品确立的指定值及其参考范围为（193.30±5.08） g·L^-1,参加本次能力验证的药检机构或企业实验室共13家,10家实验室结果为优秀,1家实验室为合格,2家实验室为不满意。整体满意率为84.6%,优秀率76.9%,不合格率15.4%。结论：国内血液制品的7家批签发授权药检机构能力验证结果均为优秀,部分企业实验室能力验证结果为满意,但也有个别实验室测定结果出现偏差,参加者应调查并改进。     

金银花中镉元素残留量测定能力验证研究

目的：评价参与能力验证实验室的镉元素残留量测定能力，提高残留检测质量水平。方法：根据CNAS相关文件要求，对制备的能力验证用金银花样品进行均匀性和稳定性检验，以参加实验室检测结果的中位值为指定值，采用实验室的检测结果与指定值的百分相对差（D）对能力验证结果进行统计分析，评价标准：|D|≤ 16%，评价结果为"满意"；|D|>16%，评价结果为"不满意"。结果：在252家参加实验室中，有249家实验室按要求提交有效数据，满意率为94.4%，不满意率为5.6%。结论：大多数参加实验室对标准的执行能力和质量保障体系均比较良好。根据收集到的信息，对于产生偏离的原因，从总体上对共性问题进行技术分析，并给出相关的技术建议，有助于提升参加实验室的检验能力。     

Training Providers at a University Health Center in Substance Use Screening

Abstract

NYU MAINSTREAM fellows collaborated with a student health center. An objective structured clinical evaluation (OSCE) was conducted by the fellows for the center's personnel.     

Knowledge of Travel Medicine Providers: Analysis from a Continuing Education Course

BACKGROUND: With millions of international travelers, there has been an increase in the scope and variability of travel medicine providers. A study was conducted to measure the baseline knowledge of providers, determine factors affecting this knowledge, and assess acquisition of knowledge after a continuing education course. METHODS: A one-day continuing medical education course was held for health care professionals interested in travel medicine. Prior to the course, attendees completed a test determining knowledge in malaria chemoprophylaxis, traveler's diarrhea management, vaccines, jet lag, the returned traveler, and other areas. An identical test was given after completion of the course. Performance on the test was analyzed by profession, area of specialty training, and experience in travel medicine. RESULTS: Seventy-seven attendees completed the precourse test. Forty-eight percent were physicians and 47% were nurses; 29% specialized in infectious diseases, 22% in occupational medicine and student health, and 18% in family or internal medicine; 60% had >/= 1 year of travel medicine experience while 20% had no experience. The precourse test score for all participants was 62.7% 6 6.5 (sd). Analysis by profession found that physicians scored the highest (71%). Providers with >/= 1 year of travel medicine experience scored higher than those with no experience (67% vs 53%, p <.01). Statistically significant correlations were found between precourse exam results and profession (+.432, p <.001) and travel medicine experience (+.365, p =.002). No significant correlation was found between precourse exam and area of specialty training. Combined mean score on the postcourse exam improved to 81.8% 6 4.5, an increase of 17.2% over the precourse score for those who took both tests (p <.001). CONCLUSIONS: The profession of the provider and the duration of experience in travel medicine were the most important correlations of baseline knowledge in travel medicine. All groups improved their knowledge following the course.     

Contrasting the Views of Substance Misuse and Mental Health Treatment Providers on Treating the Dually Diagnosed

Service delivery to dually diagnosed individuals is often impeded by the divergent treatment approaches used by mental health and substance misuse treatment providers. This paper describes findings from a survey of mental health and substance misuse treatment program administrators and staff in Los Angeles County (n=275) on their views about treating the dually diagnosed. All groups agreed about the challenges of treating dually diagnosed patients; however, there were differences both between and within providers in the two treatment systems on other aspects of treatment. The findings are discussed within the context of clinical and programmatic efforts to improve service delivery to the dually diagnosed.     

Exploring Massachusetts Health Care Reform Impact on Fee-for-Service-Funded Substance Use Disorder Treatment Providers

Abstract

The Affordable Care Act (ACA) is forecast to increase the demand for and utilization of substance use disorder (SUD) treatment. Massachusetts implemented health reforms similar to the ACA in 2006–2007 that included expanding coverage for SUD treatment. This study explored the impact of Massachusetts health reforms from 2007 to 2010 on SUD treatment providers in Massachusetts, who relied on fee-for-service billings for more than 50% of their revenue. The changes across treatment facilities located in Massachusetts were compared to changes in other similar fee-for-service-funded SUD treatment providers in Northeast states bordering Massachusetts and in all other states across the US. From 2007–2010, the percentage changes for Massachusetts based providers were significantly different from the changes among providers located in the rest of the US for admissions, outpatient census, average weeks of outpatient treatment, residential/in-patient census, detoxification census, length of average inpatient and outpatient stays, and provision of medication-assisted treatment. Contrary to previous studies of publicly funded treatment providers, the results of this exploratory study of providers dependent on fee-for-service revenues were consistent with some predictions for the overall effects of the ACA.