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公共卫生措施可以影响现行药敏折点的采用,但需要监管机构给予更多关注。

Public Health Efforts Can Impact Adoption of Current Susceptibility Breakpoints, but Closer Attention from Regulatory Bodies Is Needed.

机构信息

Acute Communicable Disease Control Unit, Los Angeles County Department of Public Health, Los Angeles, California, USA

Infectious Disease Clinical Outcomes Research Unit, Division of Infectious Disease, Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Torrance, California, USA.

出版信息

J Clin Microbiol. 2019 Feb 27;57(3). doi: 10.1128/JCM.01488-18. Print 2019 Mar.

Abstract

Microbiological testing, including interpretation of antimicrobial susceptibility testing results using current breakpoints, is crucial for clinical care and infection control. Continued use of obsolete carbapenem breakpoints is common in clinical laboratories. The purposes of this study were (i) to determine why laboratories failed to update breakpoints and (ii) to provide support for breakpoint updates. The Los Angeles County Department of Public Health conducted a 1-year outreach program for 41 hospitals in Los Angeles County that had reported, in a prior survey of California laboratories, using obsolete carbapenem breakpoints. In-person interviews with hospital stakeholders and customized expert guidance and resources were provided to aid laboratories in updating breakpoints, including support from technical representatives from antimicrobial susceptibility testing device manufacturers. Forty-one hospitals were targeted, 7 of which had updated breakpoints since the prior survey. Of the 34 remaining hospitals, 27 (79%) assumed that their instruments applied current breakpoints, 17 (50%) were uncertain how to change breakpoints, and 10 (29%) lacked resources to perform a validation study for off-label use of the breakpoints on their systems. Only 7 hospitals (21%) were familiar with the FDA/CDC Antibiotic Resistance Isolate Bank. All hospitals launched a breakpoint update process; 16 (47%) successfully updated breakpoints, 12 (35%) received isolates from the CDC in order to validate breakpoints on their systems, and 6 (18%) were planning to update within 1 year. The public health intervention was moderately successful in identifying and overcoming barriers to updating carbapenem breakpoints in Los Angeles hospitals. However, the majority of targeted hospitals continued to use obsolete breakpoints despite 1 year of effort. These findings have important implications for the quality of patient care and patient safety. Other public health jurisdictions may want to utilize similar resources to bridge the patient safety gap, while manufacturers, the FDA, and others determine how best to address this growing public health issue.

摘要

微生物学检测,包括使用当前折点解读抗菌药物敏感性检测结果,对临床治疗和感染控制至关重要。在临床实验室中,继续使用过时的碳青霉烯类药物折点是很常见的。本研究的目的是:(i)确定实验室未能更新折点的原因;(ii)为折点更新提供支持。洛杉矶县公共卫生部对洛杉矶县的 41 家医院开展了为期一年的外展计划,这些医院曾在加利福尼亚州实验室的一项先前调查中报告使用过时的碳青霉烯类药物折点。对医院利益相关者进行了面对面的访谈,并提供了定制的专家指导和资源,以帮助实验室更新折点,包括来自抗菌药物敏感性检测设备制造商的技术代表的支持。该计划针对 41 家医院,其中 7 家自上次调查以来已经更新了折点。在其余 34 家医院中,27 家(79%)假设其仪器采用了现行折点,17 家(50%)不确定如何更改折点,10 家(29%)缺乏资源在其系统上进行未经批准使用折点的验证研究。只有 7 家医院(21%)熟悉 FDA/CDC 抗生素耐药分离库。所有医院都启动了折点更新流程;16 家(47%)成功更新了折点,12 家(35%)从 CDC 获得了分离株,以便在其系统上验证折点,6 家(18%)计划在 1 年内进行更新。公共卫生干预措施在识别和克服洛杉矶医院更新碳青霉烯类药物折点的障碍方面取得了一定成效。然而,尽管进行了 1 年的努力,大多数目标医院仍继续使用过时的折点。这些发现对患者治疗质量和患者安全具有重要意义。其他公共卫生部门可能希望利用类似资源来弥合患者安全差距,同时制造商、FDA 和其他部门确定如何最好地解决这一日益严重的公共卫生问题。

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