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The aims of this study were to develop reportable event codes that are applicable to the national hemovigilance systems for hospital blood banks, and to present expansion strategies for the blood banks.
The data were obtained from a literature review and expert consultation, followed by adding to and revising the established hemovigilance code system and guidelines to develop reportable event codes for hospital blood banks. The Medical Error Reporting System-Transfusion Medicine developed in the US and other codes of reportable events were added to the Korean version of the Biologic Products Deviation Report (BPDR) developed by the Korean Red Cross Blood Safety Administration, then using these codes, mapping work was conducted. We deduced outcomes suitable for practice, referred to the results of the advisory councils, and conducted a survey with experts and blood banks practitioners.
We developed reportable event codes that were applicable to hospital blood banks and could cover blood safety - from blood product safety to blood transfusion safety - and also presented expansion strategies for hospital blood banks.
It was necessary to add 10 major categories to the blood transfusion safety stage and 97 reportable event codes to the blood safety stage. Contextualized solutions were presented on 9 categories of expansion strategies of hemovigilance system for the hospital blood banks.
In 2008, hospital blood banks in Korea were observed for being poorly managed and having a high frequency of deviation occurrences. Hospital blood banks take charge of supplying only 0.6% of the total amount of blood product, but blood transfusion safety has a direct impact on people's life and health, and thus requires secure management. In 1970, a domestic law of Korea on blood safety was enacted, and Section 2 Part 5 of the first regulation on hemovigilance (specific transfusion reaction) law was added in 1999 and revised in January 2005. However, as only obligatory provisions require reporting to the government, a voluntary agency or system for guaranteeing quality is insufficient. According to reports from the UK and Ireland, from October 1996 to September 1998, a total of 366 cases of mortality and major complications associated with blood transfusion in hospitals had been reported to the Serious Hazards of Transfusion (SHOT). According to the operating results of Medical Error Reporting System-Transfusion Medicine (MERS-TM) in 2001, 61% of transfusion related events occurred at the bedside, 35% occurred in the laboratory, and 4% occurred in blood banks or other institutions. According to a SHOT report, 61% of the cases were related to blood collection, blood transfusion orders, and transfusion; 36% were related to the clinical laboratory; and 3% were related to deviation in blood banks. Some efforts have been made to scale measurements of noninfectious transfusion-related events, including MERS-TM, the voluntary program SHOT, the mandatory transfusion-related incidents/accidents/medical errors reporting system of the New York State Department of Health, the French Haemovigilance System, and Belgium's SANGUIS Group. Near-miss events were estimated to be five times that of the actual events. Although the hemovigilance system managed by the Red Cross is being demonstrated and executed as the primary reporting system, it cannot be established as a complete hemovigilance system without relationships to hospital blood banks. Therefore, it is necessary to develop codes of reportable events to expand the national hemovigilance system to hospital blood banks.
We investigated the transfusion-related deviation reporting systems of other countries, as well as the applicable laws and types of reporting used in those countries, in order to develop a bill appropriate for domestic use. In 2006, the Red Cross Blood Safety Administration developed a hemovigilance system based on Biological Product Deviation Report (BPDR), which was developed by the Food and Drug Administration (FDA) and the Department of Health and Human Services in the US. Then revision was performed twice—in 2007 and 2009. The system is sufficient for guiding the hemovigilance of blood product safety for blood banks, but not for blood transfusion safety for hospital blood banks. In this study, we used the reporting system developed by the Red Cross Blood Safety Administration, and added to it the MERS-TM, which is a voluntary reporting system developed by the US National Institutes of Health in 1995; we then reviewed and revised it. The data were obtained through a literature review on MERS-TM, SHOT, and Serious Hazards of Transfusion (SABRE) in several countries, and gathered advisory councils together by constructing a network of professionals to identify domestic status of reporting system in Korea. In the advisory councils, we obtained consultations regarding the literature review, case review, and code organization for early expansion of the hemovigilance system for the hospital blood banks. Specifically, 1) reviewed the revision of hemovigilance reporting provisions and guidelines; 2) deduced from international case reports (BPDR, eBPDR, MERS-TM, and report forms) for reviewing the reporting methods for hemovigilance systems; 3) referred to the development of the hospital blood bank hemovigilance system demonstration plan, according to the comments from unstructured discussion; and 4) reviewed the temporary proposal for the standard education program. The standard education program was implemented for 47 practitioners in the Red Cross and hospital blood banks in order to introduce the significance and advance cases of blood safety management, and describe ‘Errors in Transfusion-related Activities’ reporting and processing guidelines to introduce them to the background and status. We also educated them on the development process and instructions on reportable codes for the hemovigilance system. Finally, we gathered comments from the advisory councils and mail survey to collect and analyze opinions of the practitioners. The subjects of mail survey were the practitioners in 21 hospital blood banks where blood collection records exceeded 100 cases in 2008. Survey materials, including the ‘preliminary code comparison matrix’ and the ‘review forms’ were distributed to them. The mail survey was carried out from October 15 to November 11, 2009.
The hemovigilance reporting system developed by the Red Cross Blood Safety Administration in 2009 was classified into three levels—major, medium, and small; within these, there were 9 major, 43 medium [Tables [Tables11 and and2],2], and 351 small categories. MERS-TM was classified into two levels. Subsequently, the types of blood safety were classified into two stages: blood product safety and blood transfusion safety. The 9 major categories of the reporting system of the Red Cross Blood Safety Administration were included in the blood product safety stage, which is currently employed by the Red Cross Blood Bank. The 10 major categories of MERS-TM, excluding those that duplicate the reporting system of the Red Cross were included in the blood transfusion safety stage; these will be employed by hospital blood banks after the final decision made by the Department of Blood Safety Supervision, Korea Centers for Disease Control and Prevention (KCDC). The code mapping was performed between the two reporting systems. As a result, it was necessary to add 10 major categories for the blood transfusion safety stage, such as Product Check-in, Product Storage (Unit Storage), and Product Manipulation (Unit Manipulation). The medium categories were consolidated into six-digit codes by inserting 00 in the MERS-TM code. Finally, 97 reportable event codes were added to the blood safety stage. The codes of the major categories are presented in Table 1.
Expansion strategies were developed by collecting and analyzing the opinions of the advisory council and practitioners from the methods above. We organized the results according to a ‘Situations and Solutions’ structure. In this study, the situations and solutions are presented for 9 categories on expansion strategies for hospital blood bank hemovigilance systems. We organized these strategies by stage of Information Strategic Planning (ISP): the planning stage, analysis stage, design stage, implementation stage, and support stage as detailed below. These stages are summarized in Figure 1.
Cultivate an appropriate culture suitable for implementation by adopting the survey results, distribution of the code booklet, provision of incentives for promotion, changes in the participants’ recognition, and creation of consensus.
Determine reporting range and mandate the reporting events of the hospital blood banks.
Optimize the reporting method through an online reporting system, development of related applications, and classify reportable codes for both Red Cross blood services and hospital blood banks.
Construct online network support and education for the reporting system.
Promote education for users, in order to implement the reporting system appropriately.
Develop education program goals and curriculum, train instructors, and implement the plan.
Enforce the project after demonstration of stages I and II.
Enforce the standard education program.
Enforce an online version of the standard education program.
Develop and enforce the Root Cause Analysis (RCA) training program.
The ultimate aim of hemovigilance is to improve the safety of the blood transfusion chain from donor to patient. Some medical error reporting systems for collecting and analyzing adverse events including transfusion errors already exist. For example, in Australia, over 200 healthcare organizations or health services voluntarily send incident reports to the Australian Incident Monitoring System (AIMS). The Japan Council for Quality Health Care collects voluntarily reported adverse events from healthcare organizations in Japan, particularly sentinel cases with RCA. The National Reporting and Learning System (NRLS) in England and Wales is another example of a learning system. NRLS receives reports of patient safety incidents from local healthcare organizations. A World Health Organization (WHO) guideline on adverse event reporting and learning systems states that the effectiveness of the systems is measured not only by accurate collection and analysis of data but also by its usefulness in making recommendations that improve patient safety.
The challenge for hemovigilance is to make independent evidence-based recommendations, supported by robust and meaningful data from the reporting system. Therefore, it is necessary to expand the reporting and learning system to foster continuous improvement in blood product safety and transfusion safety for rapid identification of serious risks related to blood components at both local and national levels and a rapid initiation of appropriate risk minimization activities. Also, the systems should be operated such that they facilitate sharing of best practices and stimulate system-wide improvements.
In this study, 10 major categories were added to the blood transfusion safety stages, such as Product Check-in, Product Storage (Unit Storage), and Product Manipulation (Unit Manipulation). The medium categories were consolidated into six-digit codes by inserting 00 into the MERS-TM code. Finally, 97 reportable event codes were added to the whole blood safety stage. The situations and solutions were presented on 9 categories for expansion strategies of the hemovigilance system for the hospital blood banks. Through this study, we hope to foster improvement and standardization of the quality of blood distribution, and also create a consensus for expanding the hemovigilance system for hospital blood banks. Furthermore, we expect that this can be utilized as a reference for expansion strategies for other institutions reporting on blood safety. Improvement of blood transfusion safety will improve the quality of patient safety and become the foundation of international blood safety activities and research collaboration.
Source of Support: Nil
Conflict of Interest: None declared.