Assessment of Health Information Technology-Related Outpatient Diagnostic Delays in the US Veterans Affairs Health Care System: A Qualitative Study of Aggregated Root Cause Analysis Data.

Importance: Diagnostic delay in the outpatient setting is an emerging safety priority that health information technology (HIT) should help address. However, diagnostic delays have persisted, and new safety concerns associated with the use of HIT have emerged. Objective: To analyze HIT-related outpatient diagnostic delays within a large, integrated health care system. Design, Setting, and Participants: This cohort study involved qualitative content analysis of safety concerns identified in aggregated root cause analysis (RCA) data related to HIT and outpatient diagnostic delays. The setting was the US Department of Veterans Affairs using all RCAs submitted to the Veterans Affairs (VA) National Center for Patient Safety from January 1, 2013, to July 31, 2018. Main Outcomes and Measures: Common themes associated with the role of HIT-related safety concerns were identified and categorized according to the Health IT Safety framework for measuring, monitoring, and improving HIT safety. This framework includes 3 related domains (ie, safe HIT, safe use of HIT, and using HIT to improve safety) situated within an 8-dimensional sociotechnical model accounting for interacting technical and nontechnical variables associated with safety. Hence, themes identified enhanced understanding of the sociotechnical context and domain of HIT safety involved. Results: Of 214 RCAs categorized by the terms delay and outpatient submitted during the study period, 88 were identified as involving diagnostic delays and HIT, from which 172 unique HIT-related safety concerns were extracted (mean [SD], 1.97 [1.53] per RCA). Most safety concerns (82.6% [142 of 172]) involved problems with safe use of HIT, predominantly sociotechnical factors associated with people, workflow and communication, and a poorly designed human-computer interface. Fewer safety concerns involved problems with safe HIT (14.5% [25 of 172]) or using HIT to improve safety (0.3% [5 of 172]). The following 5 key high-risk areas for diagnostic delays emerged: managing electronic health record inbox notifications and communication, clinicians gathering key diagnostic information, technical problems, data entry problems, and failure of a system to track test results. Conclusions and Relevance: This qualitative study of a national RCA data set suggests that interventions to reduce outpatient diagnostic delays could aim to improve test result management, interoperability, data visualization, and order entry, as well as to decrease information overload.

Root Cause Analysis of Quality Defects Using HPLC-MS Fingerprint Knowledgebase for Batch-to-batch Quality Control of Herbal Drugs.

INTRODUCTION: The batch-to-batch quality consistency of herbal drugs has always been an important issue. OBJECTIVES: To propose a methodology for batch-to-batch quality control based on HPLC-MS fingerprints and process knowledgebase. METHODS: The extraction process of Compound E-jiao Oral Liquid was taken as a case study. After establishing the HPLC-MS fingerprint analysis method, the fingerprints of the extract solutions produced under normal and abnormal operation conditions were obtained. Multivariate statistical models were built for fault detection and a discriminant analysis model was built using the probabilistic discriminant partial-least-squares method for fault diagnosis. RESULTS: Based on multivariate statistical analysis, process knowledge was acquired and the cause-effect relationship between process deviations and quality defects was revealed. The quality defects were detected successfully by multivariate statistical control charts and the type of process deviations were diagnosed correctly by discriminant analysis. CONCLUSION: This work has demonstrated the benefits of combining HPLC-MS fingerprints, process knowledge and multivariate analysis for the quality control of herbal drugs.