知情同意书质量分析与改进对策

目的 检查了解手术与有创操作知情同意书签署缺陷,分析原因,寻找对策.方法 随机抽取某院2013年1月-2014年3月手术及有创检查6369份归档病案,根据卫生部颁布的《病历书写基本规范》与总部病案检查评分标准,就知情同意书填写格式、项目、内容签署缺陷进行质控检查并做统计.结果 在手术与有创检查的6369份病案中检出各类知情同意书缺陷病案631份（达9.91％）.631份病案中各类知情同意书均有一项至多项缺陷,其中手术知情同意书缺陷580频次;麻醉知情同意书缺陷236频次;输血知情同意书缺陷173频次;有创治疗检查操作同意书缺陷213频次;其它缺陷167频次.结论 病案中知情同意书规范性、完整性尚存在不足,须采取有效措施加以提高.保障知情同意书作为法律依据的完整性、有效性,是有效规避医疗纠纷的有力措施.

Quality Analysis of Informed Consent and Improvement Countermeasures

Objective To examine and understand the defects existing in the surgery and invasive procedures of the informed consent signature, analyze the causes and find countermeasures. Methods 6369 cases of archived medical records copies with surgery and invasive procedures of a hospital from January 2013 to March 2014 were selected randomly, then conducted a quality control examination and statistical analysis on the defects in forms, items and content of informed consent according to the score standard in ＂basic norms of medical writing＂ issued by the Ministry of Health. Results There were 631 cases of defects medical records in the 6369 cases with surgery and invasive procedures, which accounted for 9.91%. There were one or several defects existing in the informed consent of 631 cases of medical records, 580 cases were existing defects in operation 236 cases were existing defects in anesthesia informed consent, 173 cases were existing defects in blood transfusion informed consent, 213 cases were existing defects in invasive procedures and 167 cases other defects. Conclusions The standard and complete signature of informed consent could guarantee the integrity and effectiveness of medical records as legal evidence, which would be an effective measure to avoid medical disputes.