不良事件加急上报手册 - 美国国立卫生研究院( NIH) DAIDS - 于

(严重)不良事件/(S)AE的处理与报告SOP I目的：为了及时、规范的对临床试验中出现的AE/SAE进行处理与上报。

II适应范围：所有的临床试验III规程：一、不良事件与严重不良事件的定义1、GCP中不良事件(Adverse Event, AE)的定义是：病人或临床试验受试者接受一种药品后出现的不良医学事件，但并不一定与治疗有因果关系。

在临床试验方案中，常用如下定义：自患者签署知情同意书入选试验开始到试验结束，期间发生的任何不良医学事件，无论与试验用药有无因果关系，均判定为不良事件。

2、严重不良事件(Serious Adverse Event, SAE)：临床试验过程中发生需住院治疗、延长住院时间、伤残、影响工作能力、危及生命或死亡、导致先天畸形等事件。

二、AE的处理与报告1、根据GCP中的相关规定，研究者负责作出与临床试验相关的医疗决定，保证受试者在试验期间出现不良事件时得到适当的治疗。

2、对于试验过程中出现的不妨碍试验继续进行的不良事件，在研究者对受试者进行适当治疗后，应继续进行试验直到试验完成，受试者自己退出的除外。

3、按要求将不良事件记录到病历表与CRF表的规定位置，不良事件的发生时间、严重程度、持续时间、采取的措施与转归等基本内容不应缺失;并按要求判定不良事件与试验用药间的关系。

三、SAE的处理与报告1、根据GCP中的规定，由研究者负责受试者试验期间的医疗安全保障。

1)试验期间发生严重不良事件，无论何种原因研究者均应对受试者进行适当及时的医疗救治;研究者的此项职责应在试验方案中写明，并在培训会上予以申明。

2)对受试者进行救治的过程要详细记录，所有的原始化验单据应妥善保存，以便需要时查阅或作为证据提交。

3)在对受试者进行救治的过程中，要积极查找原因，确定此严重不良事件与试验药物之间的关系。

2、研究者应在第一时间通报本单位的伦理委员会与申办者;申办者应立即派出监查员或其它相关人员协同研究者、试验单位管理机构与伦理委员会共同进行严重不良事件的处理。

Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse EventsVersion 2.0November 2014Division of AIDSNational Institute of Allergy and Infectious DiseasesNational Institutes of HealthUS Department of Health and Human ServicesTable of ContentsGlossary and Acronyms (1)Introduction (3)Instructions for Use (4)Major Clinical Conditions (7)Cardiovascular (7)Dermatologic (9)Endocrine and Metabolic (10)Gastrointestinal (11)Musculoskeletal (13)Neurologic (14)Pregnancy, Puerperium, and Perinatal (16)Psychiatric (17)Respiratory (18)Sensory (19)Systemic (20)Urinary (22)Site Reactions to Injections and Infusions (23)Laboratory Values (24)Chemistries (24)Hematology (27)Urinalysis (29)Appendix A. Total Bilirubin Table for Term and Preterm Neonates (30)Glossary and AcronymsAE Adverse event; Any unfavorable and unintended sign (including anabnormal laboratory finding), symptom, or disease temporallyassociated with the use of a medical treatment or procedure regardlessof whether it is considered related to the medical treatment orprocedure.ALT (SGPT) Alanine aminotransferase (serum glutamic pyruvic transaminase) ANC Absolute neutrophil countAST (SGOT) Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) AV AtrioventricularBasic Self-care Functions AdultActivities such as bathing, dressing, toileting, transfer or movement,continence, and feeding.Young ChildrenActivities that are age and culturally appropriate, such as feeding one’sself with culturally appropriate eating implements.BMI z-score Body mass index z- score; A body reference norm. Specifically, thenumber of standard deviations a participant's BMI differs from theaverage BMI for their age, sex, and ethnicity.BMD t-score Bone mineral density t-score; The number of standard deviations aboveor below the mean bone mineral density of a healthy 30 year old adultof the same sex and ethnicity as the participant.BMD z-score Bone mineral density z-score; The number of standard deviations aparticipant's BMD differs from the average BMD for their age, sex, andethnicity.BPAP Bilevel positive airway pressure; A mode used during noninvasivepositive pressure ventilation.Chemical Pregnancy A pregnancy in which a positive pregnancy test is followed by anegative pregnancy test without evidence of a clinical pregnancy loss. CNS Central nervous systemCPAP Continuous positive airway pressureDAERS DAIDS Adverse Experience Reporting System; An internet-basedsystem developed for clinical research sites to report ExpeditedAdverse Events (EAEs) to DAIDS. It facilitates timely EAE reportsubmission and serves as a centralized location for accessing andprocessing EAE information for reporting purposes.Disability A substantial disruption of a person’s ability to conduct normal lifefunctions.ECG ElectrocardiogrameGFR Estimated glomerular filtration rateHospitalization Does not include the following hospital admissions: under 24 hours,unrelated to an adverse event (e.g., for labor and delivery, cosmeticsurgery, social or administrative for temporary placement [for lack of aplace to sleep]), protocol-specified, and for diagnosis or therapy of acondition that existed before the receipt of a study agent and which hasnot increased in severity or frequency.INR International normalized ratioGlossary and AcronymsIntervention Medical, surgical, or other procedures recommended or provided by ahealthcare professional for the treatment of an adverse event.IV IntravenousIVIG Intravenous immune globulinLDL Low density lipoproteinLLN Lower limit of normalLife-threatening AE Any adverse event that places the participant, in the view of theinvestigator, at immediate risk of death from the reaction when itoccurred (i.e., it does not include a reaction that would have causeddeath if it had occurred in a more severe form).NA Not applicableParticipant ID The identification number assigned to a study participant which is usedto track study-related documentation, including any reported AEs.PR Interval The interval between the beginning of the P wave and the beginning ofthe QRS complex of an electrocardiogram that represents the timebetween the beginning of the contraction of the atria and the beginningof the contraction of the ventricles.PT Prothrombin timePTT Partial thromboplastin timeQTc Interval The measure of time between the onset of ventricular depolarizationand completion of ventricular repolarization corrected for ventricularrate.RBC Red blood cellSI Standard international unitULN Upper limit of normalUsual Social & Functional Activities Activities which adults and children perform on a routine basis andthose which are part of regular activities of daily living, for example:AdultsAdaptive tasks and desirable activities, such as going to work,shopping, cooking, use of transportation, or pursuing a hobby.Young ChildrenActivities that are age and culturally appropriate, such as socialinteractions, play activities, or learning tasks.WBC White blood cellWHO World Health OrganizationWNL Within normal limitsIntroductionThe Division of AIDS (DAIDS) oversees clinical trials throughout the world which it sponsors and supports. The clinical trials evaluate the safety and efficacy of therapeutic products, vaccines, and other preventive modalities. Adverse event (AE) data collected during these clinical trials form the basis for subsequent safety and efficacy analyses of pharmaceutical products and medical devices. Incorrect and inconsistent AE severity grading can lead to inaccurate data analyses and interpretation, which in turn can impact the safety and well-being of clinical trial participants and future patients using pharmaceutical products.The DAIDS AE grading table is a shared tool for assessing the severity of AEs (including clinical and laboratory abnormalities) in participants enrolled in clinical trials. Over the years as scientific knowledge and experience have expanded, revisions to the DAIDS AE grading table have become necessary.The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 replaces the grading table published in 2004 and updated in 2009. In version 2.0, AEs not previously included, but which now are deemed medically important events, are included while other AEs have been removed. Some AE severity grading descriptions have been revised to more appropriately reflect the presentation of these events in clinical settings and their impact on clinical trials. For example, DAIDS performed an extensive literature search and reviews of select DAIDS clinical trial data in revising certain hematology parameters (i.e., hemoglobin, white cell counts, and absolute neutrophil counts). DAIDS also took into consideration the U.S. Food and Drug Administration’s guidance regarding the use of local laboratory reference values and ethnic differences among certain healthy adolescent and adult populations in defining parameter limits. Finally, the revised DAIDS AE grading table also contains an updated glossary and acronyms section, an expanded instructions for use section, and an appendix that provides more age-specific information for an AE of concern to DAIDS. DAIDS is grateful to the DAIDS Grading Table Working Group, numerous government and non-government affiliated medical subject matter experts and reviewers who were instrumental in the revision of the DAIDS AE grading table.Instructions for UseGeneral ConsiderationsThe Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 consists of parameters, or AEs, with severity grading guidance that are to be used in DAIDS clinical trials for safety data reporting to maintain accuracy and consistency in the evaluation of AEs. The term “severe” is not the same as the term “serious” in classifying AEs. The severity of a specific event describes its intensity, and it is the intensity which is graded. Seriousness, which is not graded, relates to an outcome of an AE and is a regulatory definition.Clinical sites are encouraged to report parameters in the DAIDS AE grading table as they are written to maintain data consistency across clinical trials. However, since some parameters can be reported with more specificity, clinical sites are encouraged to report parameters that convey additional clinical information. For example, diarrhea could be reported as neonatal diarrhea; seizures, as febrile seizures; and pain, as jaw pain.The DAIDS AE grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines:•Grade 1 indicates a mild event•Grade 2 indicates a moderate event•Grade 3 indicates a severe event•Grade 4 indicates a potentially life-threatening event•Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table).Other points to consider include:•Use parameters defined by age and sex values as applicable.•Male and female sex are defined as sex at birth.•Unless noted, laboratory values are for term neonates. Preterm neonates should be assessed using local laboratory normal ranges.•Where applicable, Standard International (SI) units are included in italics.Selecting and Reporting a Primary AE TermWhen selecting a primary AE term to report, sites should select the term that best describes what occurred to the participant. For example, a participant may present with itching, urticaria, flushing, angioedema of the face, and dyspnea. If the underlying diagnosis is determined to be an acute allergic reaction, sites should report “Acute Allergic Reaction” as the primary AE term. Primary AE terms should be reported using the DAIDS Adverse Experience Reporting System (DAERS) only if they meet expedited reporting criteria. However, all primary AE terms should be reported using protocol-specific case report forms (CRFs). Because the reported information is stored in different databases (i.e., safety and clinical), sites should report primary AE terms using the same terminology for data consistency.When reporting using DAERS, other clinically significant events associated with a primary AE term that more fully describe the nature, severity, or complications of the primary AE term should be entered in the “Other Events” section. However, the severity grade for these events must be lower than or equal to the severity grade of the primary AE term. In the example above, dyspnea and angioedema of the face may be entered in the “Other Events” section, because they are more descriptive and provide additional information on the severity of the acute allergic reaction. However, their severity grades must be lower than or equal to the severity grade of the primary AE term of “Acute Allergic Reaction”.Differences exist in the reporting and recording of information (e.g., signs and symptoms, clinically significant events) in DAERS and CRFs. Therefore, sites should refer to their protocols and CRF requirements for further instructions.Grading Adult and Pediatric AEsWhen a single parameter is not appropriate for grading an AE in both adult and pediatric populations, separate parameters with specified age ranges are provided. If no distinction between adult and pediatric populations has been made, the listed parameter should be used for grading an AE in both populations.Reporting Pregnancy OutcomesIn the Pregnancy, Puerperium, and Perinatal section, all parameters are pregnancy outcomes and should be reported using the mother's participant ID. If an infant is not enrolled in the same study as the mother, any identified birth defects should be reported using the mother's participant ID. However, if an infant is enrolled in the same study as the mother or in another study, any identified birth defects should be reported using the infant's participant ID. Sites should refer to the applicable network standards for reporting abnormal pregnancy outcomes on the CRFs. Determining Severity Grade for Parameters between GradesIf the severity of an AE could fall in either one of two grades (i.e., the severity of an AE could be either grade 2 or grade 3), sites should select the higher of the two grades.Laboratory ValuesGeneral. An asymptomatic, abnormal laboratory finding without an accompanying AE should not be reported to DAIDS in an expedited timeframe unless it meets protocol-specific reporting requirements. Sites should refer to the applicable network standards for reporting abnormal laboratory findings on the CRFs.Values below Grade 1. Any laboratory value that is between the ULN and grade 1 (for high values) or the LLN and grade 1 (for low values) should not be graded or reported as an AE. Sites should consult the Manual for Expedited Reporting of Adverse Events to DAIDS, Version 2.0 and their protocol when making an assessment of the need to report an AE.Overlap of Local Laboratory Normal Values with Grading Table Ranges. When local laboratory normal values fall within grading table laboratory ranges, the severity grading is based on the ranges in the grading table unless there is a protocol-specific grading criterion for the laboratoryvalue. For example, “Magnesium, Low" has a grade 1 range of 1.2 to < 1.4 mEq/L, while a particular laboratory’s normal range for magnesium may be 1.3 to 2.8 mEq/L. If a study participant’s magnesium laboratory value is 1.3 mEq/L, the laboratory value should be graded as grade 1.Appendix UsageAppendix A takes priority over the main grading table in all assessments of total bilirubin for term and preterm neonates.Using Addenda 1-3: Grading Tables Used in Microbicide StudiesIn protocols involving topical application of products to the female and male genital tracts or rectum, strong consideration should be given to using Addenda 1-3 (see below) as the primary grading tables for these areas. Although these grading tables are used specifically in microbicide studies, they may be used in other protocols as adjuncts to the main grading table (i.e., the Division of AIDS (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0). It should be clearly stated in a protocol which addendum is being used as the primary grading table (and thus takes precedence over the main grading table) and which addendum is being used in a complementary fashion.•Addendum 1 – Female Genital Grading Table for Use in Microbicide Studies – PDF •Addendum 2 – Male Genital Grading Table for Use in Microbicide Studies – PDF •Addendum 3 – Rectal Grading Table for Use in Microbicide Studies – PDFEstimating Severity Grade for Parameters Not Identified in the Grading TableThe functional table below should be used to grade the severity of an AE that is not specifically identified in the grading table. In addition, all deaths related to an AE are to be classified as grade 5.Major Clinical ConditionsCardiovascular1 Blood pressure norms for children < 18 years of age can be found in: Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents. Pediatrics 2011;128;S213; originally published online November 14, 2011; DOI: 10.1542/peds.2009-2107C.Cardiovascular2 As per Bazett’s formula.Dermatologic3 For pruritus associated with injections or infusions, see the Site Reactions to Injections and Infusions section (page 23).Endocrine and Metabolic4 Definition: A disorder characterized by fat loss in the face, extremities, and buttocks.5 Definition: A disorder characterized by abnormal fat accumulation on the back of the neck, breasts, and abdomen.Musculoskeletal6 BMD t and z scores can be found in: Kanis JA on behalf of the World Health Organization Scientific Group (2007). Assessment of osteoporosis at the primary health-care level. Technical Report. World Health Organization Collaborating Centre for Metabolic Bone Diseases, University of Sheffield, UK. 2007: Printed by the University of Sheffield.Pregnancy, Puerperium, and Perinatal7 Definition: A delivery of a live-born neonate occurring at ≥ 20 to < 37 weeks gestational age.8 Definition: A clinically recognized pregnancy occurring at < 20 weeks gestational age.PsychiatricRespiratorySensory9 Definition: A disorder characterized by nausea, headache, tachycardia, hypotension, rash, and/or shortness of breath.10 For pain associated with injections or infusions, see the Site Reactions to Injections and Infusions section (page 23).11 Definition: A disorder characterized by fever, arthralgia, myalgia, skin eruptions, lymphadenopathy, marked discomfort, and/or dyspnea.12 WHO reference tables may be accesed by clicking the desired age range or by accessing the following URLs: http://www.who.int/growthref/who2007_bmi_for_age/en/ for participants > 5 to 19 years of age andhttp://www.who.int/childgrowth/standards/chart_catalogue/en/ for those ≤ 5 years of age.UrinarySite Reactions to Injections and Infusions13 Injection Site Erythema or Redness should be evaluated and graded using the greatest single diameter or measured surface area.Laboratory ValuesChemistries14 Direct bilirubin > 1.5 mg/dL in a participant < 28 days of age should be graded as grade 2, if < 10% of the total bilirubin.15 Use the applicable formula (i.e., Cockroft-Gault in mL/min or Schwatrz in mL/min/1.73m2).16 To convert a magnesium value from mg/dL to mmol/L, laboratories should multiply by 0.4114.Hematology17 Male and female sex are defined as sex at birth.18 The conversion factor used to convert g/dL to mmol/L is 0.6206 and is the most commonly used conversion factor. For grading hemoglobin results obtained by an analytic method with a conversion factor other than 0.6206, the result must be converted to g/dL using the appropriate conversion factor for the particular laboratory.HematologyUrinalysisAppendix A.Total Bilirubin Table for Term and Preterm Neonates19 Severity grading for total bilirubin in neonates is complex because of rapidly changing total bilirubin normal ranges in the first week of life followed by the benign phenomenon of breast milk jaundice after the first week of life. Severity grading in this appendix corresponds approximately to cut-offs for indications for phototherapy at grade 3 and for exchange transfusion at grade 4.20 A laboratory value of 1 mg/dL is equivalent to 17.1 µmol/L.21 Definitions: Term is defined as ≥ 37 weeks gestational age; near-term, as ≥ 35 weeks gestational age; preterm, as < 35 weeks gestational age; and neonate, as 0 to 28 days of age.。

nci ctc ae -回复什么是NCI CTC AE（临床试验共同标准不良事件）？NCI CTC AE（临床试验共同标准不良事件）是一个用于评估临床试验中不良事件的共同标准。

它由美国国立卫生研究院（National Institutes of Health，简称NIH）的国家癌症研究所（National Cancer Institute，简称NCI）开发。

临床试验是一种人体医学研究，旨在评估新药物、治疗方案或诊断工具的安全性和疗效。

在这些试验中，研究人员必须准确记录和监测与试验相关的任何不良事件或副作用，以评估试验干预是否对患者造成了不良影响。

NCI CTC AE旨在提供一个统一的评估系统，使临床试验结果的报告具备可比性和可解释性。

这个标准系统涵盖了超过40个不同类型的不良事件，并根据其严重程度将它们分为五个等级：0级至4级。

- 0级：无不良事件- 1级：轻微不良事件，无治疗必要- 2级：中等不良事件，需要某种形式治疗- 3级：严重不良事件，可能需要住院治疗- 4级：生命威胁或永久性损害使用NCI CTC AE进行不良事件的评估有助于研究人员之间对这些事件的一致性判断，从而提高试验结果的可比性和可靠性。

同时，它也能够帮助研究人员更好地了解试验干预措施的潜在风险，并做出相应的调整。

NCI CTC AE的使用方法相对简单，一般包括以下步骤：1. 识别不良事件：研究人员需要根据试验的目标和干预措施，仔细收集患者经历的任何不良事件。

这些事件可以是身体症状、实验室指标异常、影像学结果异常等。

任何与试验相关的不良事件都应该被记录。

2. 归类不良事件：将收集到的不良事件与NCI CTC AE的标准进行匹配，确定其严重程度级别。

研究人员应该对每个不良事件进行分类，并将其分配到合适的级别中。

3. 记录信息：将收集到的不良事件和其对应的严重程度级别记录在试验数据表中。

这个表格可以作为后续分析和报告的依据。

4. 分析和报告：根据记录的信息，研究人员可以对试验中的不良事件进行分析。

患者安全(不良)事件报告制度1、患者安全（不良）事件定义患者安全（不良）事件是指患者在接受诊疗活动期间发生的医疗法规允许之外的行为后果；以及医院运行过程中，发生本可避免的涉及患者安全的不良事件/缺陷。

涵盖医疗、护理、医院感染、药品、医疗器械和设备、公共设施、后勤保障、治安、信息安全和其他事件。

医院通过自愿的、（不）具名的报告途径获得显性或隐性患者安全（不良）事件信息，对不良事件、安全隐患的信息进行及时处理、定期分析，提出防范措施。

2、警讯事件定义警讯事件：1、指与患者自然病程或潜在病情无关的意外死亡（如自杀）或重大永久性功能丧失；2、手术患者错误、手术部位错误、手术操作错误；3、婴儿被抱错或盗窃、儿童被诱拐等。

3、患者安全（不良）事件分级依据对患者损伤的程度，医疗不良事件分为四级：Ⅰ级：在诊疗过程中由于医务人员的违规行为造成患者死亡或永久性功能丧失；Ⅱ级：造成患者机体与功能损害；Ⅲ级：给患者带来痛苦但未造成机体与功能损害或有轻微损害但不需要处理可完全康复；Ⅳ级：及时发现差错被纠正，没有形成事实。

4、患者安全（不良）事件的类别根据患者安全（不良）事件所属类别不同划分为15类：1、病房诊治问题：包括错误诊断、严重漏诊、错误治疗、治疗不及时等。

2、不良治疗：包括药物不良反应、输液反应、输血反应、用药错误、用药错误导致死亡、多用药、漏用药等。

3、意外事件：包括患者跌倒、坠床、烫伤、猝死等。

4、辅助诊查问题：包括报告错误、标本丢失、标本错误、检查中/检查后出现严重并发症等。

5、手术相关问题：包括住院期间的非计划再次手术、手术患者错误、手术部位错误、手术术式选择错误、患者术中死亡、手术器械遗留在体内、麻醉相关事件等。

6、术中/术后并发症：包括手术并发症导致的死亡、手术后伤口裂开、手术后肺栓塞或深静脉血栓、手术后出血或血肿、手术后髋关节骨折、术后生理与代谢紊乱、手术后呼吸衰竭、手术后败血症及其它并发症等。

7、包括院内感染爆发、职业暴露、医疗废弃物处理不当可能造成院感事件等。

临床试验不良事件的上报流程及时间要求下载温馨提示:该文档是我店铺精心编制而成，希望大家下载以后，能够帮助大家解决实际的问题。

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医疗安全〔不良〕大事报告制度与工作流程一、为了更好地保障医疗安全，削减医疗安全〔不良〕大事，确保患者安全，结合《医疗质量安全大事报告暂行规定》特制定医院医疗安全〔不良〕大事报告制度。

二、本制度所称医疗安全〔不良〕大事是指在临床诊疗活动中以及医院运行过程中，任何可能影响患者的诊疗结果、增加患者的苦痛和负担并可能引发医疗纠纷或者医疗事故，以及影响医疗工作的正常运行和医务人员人身安全的因素和大事。

三、医疗安全〔不良〕大事按大事的严峻程度 4 个等级。

1、Ⅰ级大事〔警告大事〕——非预期的死亡或是非疾病自然进展过程中造成永久性功能丧失。

分三个级别：（1）一般医疗质量安全大事，造成 2 人以下轻度残疾、器官组织损伤导致一般功能障碍或其他人身损害后果。

（2）重大医疗安全大事：造成 2 人以下死亡或中度以上残疾、器官组织损伤导致严峻功能障碍；造成 3 人以上中度以下残疾、器官组织损伤或其他人身损害后果。

（3）特大医疗质量安全大事：造成 3 人以上重度残疾或死亡。

2、Ⅱ级大事〔不良后果大事〕——在疾病医疗过程中是因诊疗活动而非疾病本身造成的病人机体与功能损害。

3、Ⅲ级大事未造成后果大事——虽然发生了错误事实，但未给病人机体与功能造成任何损害或有稍微后果而不需任何处理可完全康复。

4、Ⅳ级大事〔隐患大事〕——由于准时觉察并修正错误未形成事实。

四、报告原则准时间一般不良大事要求 24h-48h 内报告，重大大事、状况紧急者应在处理的同时口头或报告，报告原则为自愿性、主动性、非惩罚性和保密性。

Ⅰ级和Ⅱ级大事属于必需报告范畴，报告原则应遵照国务院《医疗事故处理条例》国发[1987]63号、卫生部《重大医疗过失行为和医疗事故报告制度的规定》卫医发[2022]206 号以及卫生部《医疗质量安全大事报告暂行规定》执行。

Ⅲ、Ⅳ级大事报告具有主动性和非惩罚性的特点。

一般发生在 2 个工作内上报五、依据医疗安全〔不良〕时间所属类别不同，划分是一个类别〔一〕诊治问题：包括错误诊断、严峻漏诊、错误治疗、治疗不及时、院内感染等。

★医疗安全(不良)事件无责上报制度(终稿)#优选.医疗安全（不良）事件无责上报制度为了更好的落实卫生部提出的患者安全目标，鼓励全院职工及时、主动报告医疗安全（不良）事件，以便及时分析事件原因，采取相应措施，最大限度地避免类似事件的发生，以期达到发现各种隐患、持续改进医疗质量、确保医疗安全的目的，特制定本制度。

一、医疗安全（不良）事件的定义医疗安全（不良）事件是指临床诊疗活动中以及医院运行过程中，任何可能影响病人的诊疗结果、增加病人的痛苦和负担并可能引发医疗纠纷或医疗事故，以及影响医疗工作的正常运行和医务人员人身安全的因素和事件。

二、医疗安全（不良）事件的等级划分（SH9分类法）SH9分类法是指将有无过错事实、是否产生后果作为当前医疗安全（不良）事件的分类原则，据此方法，将医疗安全（不良）事件分为I-IV级：I 级——有过错事实并且造成后果的事件：如果两者有因果关系，根据后果的严重程度构成“医疗事故”或“医疗差错”，在不良事件中级别应属最高。

II级——无过错事实但造成后果的事件：医疗行为无过错，主要由药物、医疗器械、植入物等造成的医疗意外，或不可避免的医疗并发症和疾病的自然转归，其后果可能比较严重，但一般不构成“医疗事故”或“医疗差错”。

III级——有过错事实但未造成后果的事件：虽然发生的错误事实（指错误的行为已实施在患者身上），但未给病人机体与功能造成任何损害或有轻微后果，不需任何处理可完全康复。

IV级——无过错事实也未造成后果的事件：由于及时发现错误，未形成医疗行为的过错事实，其级别最低。

三、我院医疗安全（不良）事件归口管理、报告流程及各部门职责。

1、我院对医疗安全（不良）事件实行按部门分类及归口管理的方法。

各归口管理部门负责对本部门收集到的不良事件进行汇总分析，质量办负责对全院不良事件进行汇总分析。

2、归口管理：①医疗不良事件：尚未发生纠纷的上报医务科，已有纠纷苗头的上报安全科②护理不良事件：上报护理部③职业暴露及感染相关不良事件：上报感染管理科④药品不良事件：上报药学部⑤输血不良事件：上报输血科⑥医疗器械或设备不良事件：上报器械部⑦设施不良事件：上报总务科⑧公共管理不良事件：上报院办3、报告流程及各部门职责医疗安全（不良）事件发生后，各部门应相互协调，积极采取补救措施，尽量减少或消除不良后果，做好善后工作。