基于FMEA的C形臂X线机的使用风险分析与控制

??????? 目的 基于失效模式与效应分析（FMEA）方法分析控制C形臂X线机的使用风险。方法 成立FMEA 5人小组,运用现场观察和访谈的方法,识别C形臂X线机使用的潜在失效模式,并对其发生的严重度、发生概率及检测的难易度进行评价打分,计算失效原因的风险优先指数。结果 FMEA小组找出了必须优先解决的C臂机使用的失效模式,制定并实施了改进措施,在不增加管理成本的基础上,取得了良好的管理效果。结论 FMEA可以评估医疗设备使用过程的失效,并能排序优先解决的问题,不增加管理成本就能预防问题的发生,是有效的过程管理工具。     

北京某医院2007 —2008年急诊患者就诊及付费行为模式分析

目的 分析急诊患者就诊及付费行为模式。方法 定义内急诊就诊流程,计算急诊挂号人次数分布情况等。结果 医院急诊量大,患者缴费次数多。结论 预交金付费模式是改变传统就诊模式、优化医疗服务流程、减少患者排队拥堵现象的可行措施。     

失效模式与效应分析法在护理安全管理中的应用

目的 通过失效模式与效应分析法评估医院血液科护理风险的薄弱环节,探究护理风险的发生原因,并提出有针对性的改进措施。 方法 采用FMEA法对血液科护理风险进行识别。结果 分析得出血液科护理风险由高至低依次为输血风险、用药风险、职业暴露、针刺伤、坠床跌倒、患者投诉、压疮和医疗器械风险。结论 失效模式与效应分析法可以用于血液科护理风险的识别,在识别结果基础上制定改进措施,可以有效地避免护理风险,保证患者安全。

     

专家门诊预约挂号影响因素分析

??????? 目的 初步探讨影响专家预约挂号率的原因及相应对策。方法 以SPSS 13.0软件分析2012年4月—2013年1月专家门诊情况与预约挂号率的关系。结果 不同门诊时间（季度、周别、午别）、不同专科、不同专家、不同门诊级别以及挂号率与号源使用率对我院专家门诊预约挂号率均有影响。结论 影响专家门诊预约挂号率的因素是多方面的，需采取综合措施，加强医院核心竞争力才是根本。     

基于FMEA法的结肠癌根治术风险识别研究

目的 探讨结肠癌根治术的高危风险以及引起风险的主要原因,提出有效的干预策略。方法 应用失效模式与效应分析法对结肠癌根治术进行风险识别研究。 结果 分析得出结肠癌根治术共计8项流程,26项失效环节,排在前10位的高危风险分别为：观察患者药物反应失误、设备仪器准备不充分、检查时间过长、术前宣教不佳、麻醉前核对失误、手术时间过长、排药错误、术后注意事项告知有误、护士术后核对失误、手术者术后核对失误。结论 FMEA法可以有效地识别高危风险,据此有针对性地制定措施、采取策略,能够最终从源头上避免风险的发生。     

实施快速手术住院制度 降低平均住院日

目的 　探讨腹腔镜胆囊切除快速手术住院制度的可行性。方法　120例腹腔镜胆囊切除术患者被随机分为2组：对照组,按传统住院途径管理,60例;实验组,按快速手术住院制度管理,60例。分析2组平均住院日、住院费用、并发症及患者满意率的差异。结果　2组平均住院日与住院费用有显著性差异,而并发症及满意率无显著性差异。结论 实施快速手术住院制度,规范了医疗工作流程,有效降低了平均住院日,节约了住院费用,体现了病房的精细化管理。     

围术期管理对手术相关危险因素影响研究

目的 探讨手术并发症、死亡相关危险因素和改进围术期安全质量管理对其的影响及意义。方法 对可能引发术后并发症及死亡的危险因素进行单元性分析和多元性回归分析,并对实施新的管理制度和改进管理模式前、后手术并发症及死亡率作对照分析。结果 单元性与多元性回归分析显示,肥胖、吸烟史、麻醉风险评估≥2级、切口类型≥Ⅱ和手术时间>3 h与发生术后并发症及死亡有显著相关性（P在0.000～0.019以内）,而且均为诱发的高危因素(OR在2.860～9.710以内)。改进管理制度和管理模式后手术并发症发生率分别下降1.40% ( P=0.002)、1.30%( P=0.000)、1.62%（P=0.000),实施手术安全质量信息化管理系统之后手术死亡率降低了0.16%(P=0.002)。结论 加强和改进围术期安全质量管理能够有效预防和控制术后并发症及死亡,对持续改进手术质量、保障病人安全具有重要的现实意义。     

基于失效模式与效应分析法的临床药学服务风险研究

目的 探讨临床药学服务过程中的风险及引起风险的主要原因,通过一定的方式规避风险。方法 应用失效模式与效应分析法对临床药学服务模式进行风险识别管理和研究。结果 分析得出临床药学服务模式共计15项流程,21项失效环节,对其中排名靠前的高危风险提出了相应的干预措施。结论 失效模式与效应分析法可以前瞻地有效地识别高危风险,并结合风险产生的原因,针对性地采取干预措施,从而最大程度地规避风险的发生。     

临床路径管理在肾结石患者中的应用及变异分析

目的 探讨临床路径(CP)管理在经皮肾镜钬激光碎石术治疗肾结石患者中的应用及变异分析。 方法 180例符合CP管理入径标准者,按既定肾结石CP管理流程进行诊疗操作（CP组）。将此前196例非CP管理患者作为对照组, 对比2组间平均住院日、术后无石率、平均住院花费以及其中药品费用所占的百分比、患者出院满意度评分等量化指标的差异,并对其中变异情况进行分析。 结果 CP组入径率41.67%,变异率达58.33%,导致变异的主要原因在于医、患对CP管理流程的认识偏差;CP组在平均住院日、平均住院花费及患者满意度优于对照组,具有统计学差异（P ＜0.05）。术后无石率、平均住院费用、药品所占住院费用百分比2组未见统计学差异。 结论 CP管理可有效缩短PCNL手术患者平均住院日,降低医疗费用、提高患者满意度。加强CP管理的医患教育是推行CP管理的关键。     

Quality by Design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett–Burman Design of Experiments in the Identification of “Main Factors” in the Formulation and Process Design Space for Roller-Compacted Ciprofloxacin Hydrochloride Immediate-Release Tablets

As outlined in the ICH Q8(R2) guidance, identifying the critical quality attributes (CQA) is a crucial part of dosage form development; however, the number of possible formulation and processing factors that could influence the manufacturing of a pharmaceutical dosage form is enormous obviating formal study of all possible parameters and their interactions. Thus, the objective of this study is to examine how quality risk management can be used to prioritize the number of experiments needed to identify the CQA, while still maintaining an acceptable product risk profile. To conduct the study, immediate-release ciprofloxacin tablets manufactured via roller compaction were used as a prototype system. Granules were manufactured using an Alexanderwerk WP120 roller compactor and tablets were compressed on a Stokes B2 tablet press. In the early stages of development, prior knowledge was systematically incorporated into the risk assessment using failure mode and effect analysis (FMEA). The factors identified using FMEA were then followed by a quantitative assessed using a Plackett–Burman screening design. Results show that by using prior experience, literature data, and preformulation data the number of experiments could be reduced to an acceptable level, and the use of FMEA and screening designs such as the Plackett Burman can rationally guide the process of reducing the number experiments to a manageable level.KEY WORDS: failure mode effect analysis (FMEA), Plackett–Burman, quality by design (QbD), quality risk management, roller compaction, tablet and ciprofloxacin     

Validation plan of bone marrow collection,processing and distribution using the failure mode and effect analysis methodology: a technical report

Background aimsBone marrow (BM) is commonly used in the pediatric and adult setting as a source of hematopoietic stem cells (HSCs). The standards of the Joint Accreditation Committee of the International Society for Cell & Gene Therapy & European Society for Blood and Marrow Transplantation (JACIE) include specific requirements regarding BM collection, processing and distribution. To run this process, each transplant team develops a series of JACIE-compliant procedures, customizing them with regard to local settings and paths. Moreover, JACIE standards require that transplant teams validate and periodically revise their procedures to keep the entire process under control. In this article, the authors describe the methodology adopted in our center to fulfill the aforementioned JACIE requirements.MethodsThe authors developed a validation plan based on the failure mode and effect analysis (FMEA) methodology. According to the FMEA approach, the authors carefully revised activities and procedures connected to BM collection, processing and distribution at our institution. The entire process was initially divided into five main phases (assessment of donor eligibility, perioperative autologous blood donation, preparation of BM collection kit, BM harvesting and BM processing and distribution), comprising 17 subphases and 22 activities.ResultsFor each activity, one or more failure modes were identified, for a total of 28 failure modes, and a risk priority number (RPN) was then assigned to each failure mode. Although many procedures were validated, others were subjected to substantial changes according to the RPN rating. Moreover, specific indicators were identified for subsequent monitoring to contain the risk of failure of steps emerging as critical at FMEA.ConclusionsThis is the first study describing use of the FMEA methodology within an HSC transplant program. Shaping the risk analysis based on local experience may be a trustworthy tool for identifying critical issues, directing strict monitoring of critical steps or even amending connected procedures. Overall, the FMEA approach enabled the authors to improve our process, checking its consistency over time.     

门诊数字标准化管理与一卡通缴费终端应用的探讨

门诊就诊一卡通的出现正是解决等待—排队——等待问题的一种方法,在医院现有的数字化管理系统基础之上,通过改变患者就诊流程,解决了患者看病过程中需要多次排队等待的现象,以后患者到医院看病只需通过银行卡、城市一卡通、医院门诊就诊卡,在自助缴费终端上通过简单食指操作,可以免去挂号、缴费、就诊等排队之苦。     

腹腔镜下完整系膜切除术治疗结肠癌的临床效果

目的:探讨腹腔镜下完整系膜切除术治疗结肠癌中的临床效果及安全性。方法:选取2015年1月至2017年5月在本院经纤维结肠镜及活组织病理检查确诊为结肠癌的患者作为研究对象,并按照手术方式不同分为开腹手术组及腹腔镜手术组两组,每组各选取93例。开腹手术组采用开腹完整结肠系膜结肠癌根治术进行治疗,腹腔镜手术组采用腹腔镜下完整结肠系膜切除结肠癌根治术进行治疗,比较两组的手术指标、术后并发症和手术质量。结果:与开腹手术组比较,腹腔镜手术组手术时间延长,术中出血量减少,术后排气时间缩短,术后引流量减少,引流管拔管时间缩短,住院时间缩短(P0.05)。腹腔镜手术组术后并发症总发生率(20.43%)显著低于开腹手术组(35.48%)(P0.05);切口相关感染发生率(1.08%)明显低于开腹手术组(6.45%),但差异无统计学意义(P0.05);总感染发生率(11.83%)低于开腹手术组(30.11%)(P0.05)。腹腔镜手术组与开腹手术组均达到完整系膜切除标准,肿瘤组织、系膜等均整块完整切除且系膜未发现损伤,切除标本质量分级达到C级及以上,切除肠管均距离恶性肿瘤上缘10 cm、下缘15 cm,且对切除肠管上切缘及下切缘的病理组织学检查结果均未发现恶性肿瘤细胞。腹腔镜手术组与开腹手术组在清扫淋巴结数量、肿瘤TNM病理分期方面比较均未发现具有统计学差异(P0.05)。腹腔镜手术组肿瘤大小明显小于开腹手术组(P0.05)。结论:腹腔镜下完整系膜切除术治疗结肠癌的手术创伤小,可降低术后并发症发生率,但手术时间还有待优化,应用指征还有待进一步拓宽。     

A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process

The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process understanding and to identify critical process parameters for the manufacture of controlled release multiparticulate beads using a novel disk-jet fluid bed technology. The material attributes and process parameters were systematically assessed using the Ishikawa fish bone diagram and failure mode and effect analysis (FMEA) risk assessment methods. The high risk attributes identified by the FMEA analysis were further explored using resolution V fractional factorial design. To gain an understanding of the processing parameters, a resolution V fractional factorial study was conducted. Using knowledge gained from the resolution V study, a resolution IV fractional factorial study was conducted; the purpose of this IV study was to identify the critical process parameters (CPP) that impact the critical quality attributes and understand the influence of these parameters on film formation. For both studies, the microclimate, atomization pressure, inlet air volume, product temperature (during spraying and curing), curing time, and percent solids in the coating solutions were studied. The responses evaluated were percent agglomeration, percent fines, percent yield, bead aspect ratio, median particle size diameter (d50), assay, and drug release rate. Pyrobuttons® were used to record real-time temperature and humidity changes in the fluid bed. The risk assessment methods and process analytical tools helped to understand the novel disk-jet technology and to systematically develop models of the coating process parameters like process efficiency and the extent of curing during the coating process.     

腹腔镜子宫切除术对宫颈癌患者近期疗效及远期复发率的影响

目的:探讨腹腔镜根治性子宫切除术对宫颈癌患者近期疗效及远期复发率和生存率的影响。方法:选取2013年5月-2015年5月在我院接受手术切除治疗的宫颈癌患者71例为研究对象,根据手术方法不同将所选患者分为两组。腹腔镜组37例患者采用腹腔镜根治性子宫切除术,开腹手术组34例患者采用改良式根治性肿瘤切除术。观察并比较两组患者的手术时间、术中出血量、肿瘤切除长度、淋巴结清扫数、盆腔引流量、术后拔管时间等近期疗效,以及远期复发率及生存率。结果:与开腹手术组比较,腹腔镜组患者手术时间长、术中出血量少,差异具有统计学意义(P0.05);两组患者的肿瘤切除长度及淋巴结清除数比较,差异无统计学意义(P0.05);与开腹手术组比较,腹腔镜组患者的盆腔引流量较少,术后排气时间较早,差异具有统计学意义(P0.05);但两组患者术后拔管时间及住院时间比较,差异无统计学意义(P0.05);两组患者术后五年的复发率及生存率比较,差异无统计学意义(P0.05)。结论:腹腔镜根治性子宫切除术治疗宫颈癌的近期疗效显著,且不会影响患者的远期复发率及生存率。     

Preoperative oral supplementation with carbohydrate and branched-chain amino acid-enriched nutrient improves insulin resistance in patients undergoing a hepatectomy: a randomized clinical trial using an artificial pancreas

Glucose metabolism is adversely affected in patients following major surgery. Patients may develop hyperglycemia due to a combination of surgical stress and postoperative insulin resistance. A randomized trial was conducted to elucidate the effect of preoperative supplementation with carbohydrates and branched-chain amino acids on postoperative insulin resistance in patients undergoing hepatic resection. A total of 26 patients undergoing a hepatectomy for the treatment of a hepatic neoplasm were randomly assigned to receive a preoperative supplement of carbohydrate and branched-chain amino acid-enriched nutrient mixture or not. The postoperative blood glucose level and the total insulin requirement for normoglycemic control during the 16 h following hepatic resection were determined using the artificial pancreas STG-22. Postoperative insulin requirements for normoglycemic control in the group with preoperative nutritional support was significantly lower than that in the control group (P = 0.039). There was no incidence of hypoglycemia (<40 mg/dL) observed in patients, including those with diabetes mellitus, when the STG-22 was used to control blood glucose levels. STG-22 is a safe and reliable tool to control postoperative glucose metabolism and evaluate insulin resistance. The preoperative oral administration of carbohydrate and branched-chain amino acid-enriched nutrient is of clinical benefit and reduces postoperative insulin resistance in patients undergoing hepatic resection.     

经腹腔镜实施结直肠癌根治术对高龄患者胃肠功能的影响

目的:探讨结直肠癌高龄患者经腹腔镜实施结直肠癌根治术对胃肠功能产生的影响。方法:选取92例接受结直肠癌根治手术的结直肠癌患者,将其随机数字表法随机分为试验组和对照组两组,其中对照组患者均采用开腹手术进行治疗,而试验组患者则采取腹腔镜下结直肠癌根治手术。观察比较两组患者的术中情况和术后的胃肠功能。结果:两组患者之间的淋巴结清扫数目和标本切除长度均无明显差异(均P0.05),试验组患者的术中出血量以及手术时间均低于对照组患者(t=10.394,P0.05;t=6.983,P0.05)。胃泌素和胃动素水平和患者术后的肛门排气时间以及腹胀持续时间呈显著的负相关关系;试验组患者的术后肛门排气时间和腹胀持续时间均低于对照组患者,并且其胃泌素和胃动素含量均明显高于对照组患者(均P0.05)。结论:腹腔镜下结直肠癌根治手术较开腹手术具有创伤小的优势,并且对于高龄结直肠癌患者术后的胃肠功能具有较好的恢复效果。     

Oral supplementation with carbohydrate- and branched-chain amino acid-enriched nutrients improves postoperative quality of life in patients undergoing hepatic resection

The long-term outcomes of branched-chain amino acid (BCAA) administration in patients undergoing hepatic resection remain unclear. The aim of this study is to assess the impact of oral supplementation with BCAA-enriched nutrients on postoperative quality of life (QOL) in patients undergoing liver resection. A prospective randomized clinical trial was conducted in 96 patients undergoing hepatic resection. Patients were randomly assigned to receive BCAA supplementation (AEN group, n = 48) or a conventional diet (control group, n = 48). Postoperative QOL and short-term outcomes were regularly and continuously evaluated in all patients using a short-form 36 (SF-36) health questionnaire and by measuring various clinical parameters. This study demonstrated a significant improvement in QOL after hepatectomy for liver neoplasm in the AEN group based on the same patients’ preoperative SF-36 scores (P < 0.05). Perioperative BCAA supplementation preserved liver function and general patient health in the short term for AEN group patients compared to those not receiving the nutritional supplement. BCAA supplementation improved postoperative QOL after hepatic resection over the long term by restoring and maintaining nutritional status and whole-body kinetics. This study was registered at (registration number: NCT00945568).