Towards the creation of a flexible classification scheme for voluntarily reported transfusion and laboratory safety events.

Julie M Whitehurst,Dave Leonard,Heidi Cozart,John Schroder,Monica M Horvath,Jeffrey Ferranti

doi:10.1186/2041-1480-3-4

Julie M Whitehurst, Dave Leonard + Show 4 more

Open Access

https://doi.org/10.1186/2041-1480-3-4

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Abstract

BackgroundTransfusion and clinical laboratory services are high-volume activities involving complicated workflows across both ambulatory and inpatient environments. As a result, there are many opportunities for safety lapses, leading to patient harm and increased costs. Organizational techniques such as voluntary safety event reporting are commonly used to identify and prioritize risk areas across care settings. Creation of functional, standardized safety data structures that facilitate effective exploratory examination is therefore essential to drive quality improvement interventions. Unfortunately, voluntarily reported adverse event data can often be unstructured or ambiguously defined.ResultsTo address this problem, we sought to create a “best-of-breed” patient safety classification for data contained in the Duke University Health System Safety Reporting System (SRS). Our approach was to implement the internationally recognized World Health Organization International Classification for Patient Safety Framework, supplemented with additional data points relevant to our organization. Data selection and integration into the hierarchical framework is discussed, as well as placement of the classification into the SRS. We evaluated the impact of the new SRS classification on system usage through comparisons of monthly average report rates and completion times before and after implementation. Monthly average inpatient transfusion reports decreased from 102.1 ± 14.3 to 91.6 ± 11.2, with the proportion of transfusion reports in our system remaining consistent before and after implementation. Monthly average transfusion report rates in the outpatient and homecare environments were not significantly different. Significant increases in clinical lab report rates were present across inpatient and outpatient environments, with the proportion of lab reports increasing after implementation. Report completion times increased modestly but not significantly from a practical standpoint.ConclusionsA common safety vocabulary can facilitate integration of information from disparate systems and processes to permit meaningful measurement and interpretation of data to improve safety within and across organizations. Formation of a “best-of-breed” classification for voluntary reporting necessitates an internal examination of localized data needs and workflow in order to design a product that enables comprehensive data capture. A team of clinical, safety, and information technology experts is necessary to integrate the data structures into the reporting system. We have found that a “best-of-breed” patient safety classification provides a solid, extensible model for adverse event analysis, healthcare leader communication, and intervention identification.

Highlights

Transfusion and clinical laboratory services are high-volume activities involving complicated workflows across both ambulatory and inpatient environments
In the United States, the Food and Drug Administration Center for Biologics Evaluation and Research (CBER) inspects facilities according to specific quality standards [7] and the reporting of fatalities related to blood collection, transfusion, or medical device use is mandatory [8,9]
Safety classification creation and database design Prior to this project, safety event descriptions, comments, or recommendations at Duke University Health System (DUHS) were entered by both reporters and reviewers as free text within Safety Reporting System (SRS)

Summary

Introduction

Transfusion and clinical laboratory services are high-volume activities involving complicated workflows across both ambulatory and inpatient environments. In the United States, the Food and Drug Administration Center for Biologics Evaluation and Research (CBER) inspects facilities according to specific quality standards [7] and the reporting of fatalities related to blood collection, transfusion, or medical device use is mandatory [8,9]. Accrediting agencies such as the College of American Pathologists (CAP) provide comprehensive safety standards [10], and The Joint Commission (TJC) prioritizes problems with incompatible blood transfusions, laboratory patient identification, and communication by designating them as National Patient Safety Goals [11]. Incompatible blood transfusions are specified as “serious reportable events” and “never events” by the Centers for Medicare and Medicaid Services (CMS) and the National Quality Forum (NQF), respectively [12,13]

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