病人安全通報制度法案研究

The Preliminary Research of Patient Safety Reporting System Act in Taiwan

病人安全的議題近來甚受到重視，病人安全工作主要採預防性措施，推 動策略則以「病人安全通報」為軸心，從國內外推動經驗，主管支持、秘密 保護、法律責任及通報文化是否形成等為共同面臨的核心問題，本計畫即針 對國內外病人安全通報制度、主要國家病人安全通報相關法律現況、國內通 報相關法律環境分析及實務操作面之可行性進行探討，並研擬立法建議。 為彙整醫療院所通報系統執行人員對於實施通報制度的正負面想法，辦 理病人安全通報制度焦點團體意見蒐集，其中下列項目認為應該受到重視： （一）建立醫院病人安全通報機制，需設立專責單位，且作業規範應明確訂 立。（二）建立醫院內部與外部的病人安全通報系統，包括通報目的、通報 範囝及內容、通報後的處理方式及通報流程須明確。（三）通報者及資料之 保護，包括通報資料之管理、通報資料使用原則、不作為之處罰、鼓勵及獎 勵措施暨執行通報之配套措施等。其後為求立法構想之周全性，另召開病人 安全通報制度立法構想，邀請醫院病安委員會具醫師資格之成員及焦點團體 會議進行意見蒐集，並以問卷方式調查衛生主管機關及醫療機構主管對於病 人安全通報制度有關法律及相關議題之看法，結果發現：建置醫院病人安全 通報機制、設立病人安全通報~統及提供通報者、通報資料之保護，均為相 關與會人士所認同，惟「成立共同基金提供補償」、「外部強制性通報制度」 及「不作為之處罰」等項目，相對性贊同度較低，上述意見可供未來研擬病 人安全通報制度立法構想之參考。

Background: 'Harm Prevention' is the main goal of patient safety. The underlining strategy consists of a patient safety reporting system. According to experiences from other countries, support of leadership, protection of confidentiality, legal requirements, and non-punitive culture are core issues that need to be faced. This research focus on the legal framework of a national patient safety reporting system to encourage a culture of safety and quality in Taiwan health care system by providing legal protection of information reported voluntarily for the purposes of quality improvement and patient safety. Method: First, we reviewed experiences from the United State, the United Kingdom, Australia, Japan, and Singapore, and identified characteristics of international patient safety reporting systems. Then we investigated potential positive and negative perceptions of hospitals towards a reporting system through focus groups. An expert group was then convened to provide opinions on the legal framework for a reporting system. A second round of focus groups included physicians who are in-volved with patient safety activities. An additional survey gathered information from Government health administrators and hospital managers' opinions focusing on requirements, scope, content, implementation, the question which agency should coordinate and house the external reporting system, and protection of privacy. Finally, we conducted discussions and invited suggestions regarding the required legal framework for both internal and external reporting systems. This included the need for medical regulations, peer review regulation, computer security, administrative procedures, Government's information disclosure and incident investigation regulation. Result: Currently, Taiwan lacks confidentiality and peer review protection such as provide by the 2005 U.S.A Patient Safety and Quality Improvement Act. We need to revise the law to protect privacy and prevent the misuse of sensitive patient safety data. Conclusion: Before implementation of a reporting system, a clear legal framework needs to be developed, especially in the areas of confidentiality and peer-review protection to prevent subpoenas for civil or criminal proceeding. Furthermore, establishing legal protection for both reported data and reporting staff including reported criteria, defining the management of data, protecting against punishment, and providing incentives for reporting are essential for promoting a reporting system. Finally, a complete patient reporting system should clearly define the purpose, scope, responsible parties, and process of reporting and managing data. Designing a patient safety reporting system for hospitals included the support by a designated team from the central agency and clearly defined processes.