质量保证:复合记录审计用于错误预防
1U.S. Department of Veterans Affairs, Lexington VA Health Care System, Lexington, Kentucky. jessical.hawkins@va.gov.
International journal of pharmaceutical compounding
|June 2, 2023
概括
这项研究强调积极审计药品组合记录,以检测和防止错误. 实施美国药典标准确保了无菌和非无菌制剂的质量保证.
科学领域:
- 药品复合品质量保证 药品复合品质量保证
- 药房的监管合规性 药房的监管合规性
背景情况:
- 制药复合设施必须遵守严格的记录保存要求.
- 2022年美国药典 (USP) 第795章和第797章概述了非无菌和无菌化合物的关键标准.
- 复合中的不一致性可能会导致患者安全面临重大风险.
研究的目的:
- 概述一个主动的策略,以确定药品组合在设施层面的不一致性.
- 审查USP <795>和USP <797>所规定的记录保存要求.
- 展示如何利用这些要求来有效地保证质量和预防错误.
主要方法:
- 从USP <795>和USP <797> (2022) 中对主配方和复合记录要求的审查.
- 分析利用记录保存用于设施级审计和报告的策略.
- 将审计结果纳入全面的质量保证计划.
主要成果:
- 通过系统的记录审查,建立了一个主动检测复合错误的框架.
- 强调USP <795>和USP <797>合规的重要性,以保持化合物的完整性.
- 证明了定期审计和报告在加强药品质量保证方面的有用性.
结论:
- 药品组合记录的积极审计对于错误检测和预防至关重要.
- 遵守USP <795>和USP <797>标准,加上强有力的质量保证计划,改善了设施级复合实践.
- 实施定期审计可确保药物化合物的安全性和有效性的持续改进.
相关概念视频
01:05Quality Control
206
Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
206
01:19Quality Assurance
167
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
167
01:15Systematic Error: Methodological and Sampling Errors
1.6K
In the case of systematic errors, the sources can be identified, and the errors can be subsequently minimized by addressing these sources. According to the source, systematic errors can be divided into sampling, instrumental, methodological, and personal errors.
Sampling errors originate from improper sampling methods or the wrong sample population. These errors can be minimized by refining the sampling strategy. Defective instruments or faulty calibrations are the sources of instrumental...
Sampling errors originate from improper sampling methods or the wrong sample population. These errors can be minimized by refining the sampling strategy. Defective instruments or faulty calibrations are the sources of instrumental...
1.6K
01:11Purpose of Health Records I
1.3K
The vital purpose of health records is to provide a complete and accurate account of a patient's medical history, including communication, diagnostic and therapeutic orders, care planning, research, and quality review.
Here's a breakdown of how health records serve these purposes:
Here's a breakdown of how health records serve these purposes:
1.3K
01:18Guidelines and Strategies for Safe Computer Charting
842
The guidelines and strategies provided by the American Nurses Association (ANA) and the Canadian Nurses Association (CNA) offer essential principles for ensuring safe and secure computer charting systems in healthcare settings. Let's break down each recommendation:
Maintain Confidentiality and Security:
Maintain Confidentiality and Security:
842
01:06Legal Guidelines for Documentation
1.4K
The legal guidelines for nursing documentation are essential for ensuring accurate, professional, and ethical recording of patient care. The guidelines are discussed here:
1.4K