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recruitment and selection-F

recruitment and selection-F
recruitment and selection-F

Notes from Rachel’s revision:

●Methods of recruitment

●Why recruiters don?t follow the Rational Decision Making model, would it

improve the recruitment outcome if they did?

●Methods of selection ;

●advantages and disadvantages of selection methods

i.structured interviews

ii.psychometric assessment

iii.assessment centers

●why unstructured interviews are still popular and the problems associated with

them

●Why recruiters don?t follow the Rational Decision Making model, would it

improve the recruitment outcome if they did?

●Remember that when selecting you are trying to predict future performance.

Predictive validity is important –how do you improve this?

●Some of the diversity materials may be relevant to a selection question –

pressure for structured methods may come from a need to comply with diversity legislation.

Past exam questions:

Selection 题型:

1.(07/08-resit): Is it appropriate for SMEs to adopt structured approach to

selection?

2.(06/07-spring): “The use of the more sophisticated techniques for selecting new

workers has more to do with organizations being seen to comply with equal

opportunities dictates than any strategically-oriented attempt to improve the

validity and reliability of the selection process” Discuss.

3.(05/06-spring)“ The conclusion drawn from research is that the prescriptive,

rational decision-making process does not typically equate with what happens in practice and that methods of selection actually used by practitioners are often not high on criterion related validity” (Newell and Schackleton,2001).Why do you believe that rhetoric and reality differ so much in this area?

4.(04/05-Spring): Research has shown that job interviews have low predictive

validity. Explain why this might be, and how it can best to be overcome.

Recruitment 题型:

5.(06/07-resit ): Analyze the assertion that, in obtaining skilled labour, the key

problems lie in recruitment rather than selection .

6.(02/03-resit): Examine the respective merits of internal and external

recruitment. Would the choice of these methods of recruitment be likely to differ between small and large firms?

7.(02/03-spring) Distinguish between internal and external recruitment. What are

the advantages and disadvantages of each approach? What recruitment methods would you use to fill a deputy director of finance vacancy in a large

manufacturing firm?

******************************************************************

Recruitment

Definition of Recruitmen t:

Process of generating a pool of candidates from which to select the appropriate person to fill a job vacancy

Methods of Recruitment :

●Internal (is when the business looks to fill the vacancy from within its existing

workforce)

?Company job –sheet

?Notice board (accessible by current staff)

●External:( is when the business looks to fill the vacancy from any suitable

applicant outside the business)

?Informal personal contacts( word of mouth and speculative applications)

?Formal personal contacts( employee referral schemes, careers fairs and open

days)

?Notice boards(accessible by the general public)

?Advertising( local and national press, specialist publications, radio and TV)

?The internet

?External assistance ( job centers, careers service, employment agencies and

head- hunters)

附加阅读:NOTE of how to choose the most appropriate methods:

●Argument :

Decisions about the most appropriate method to choose, is likely to be influenced by the level of the vacancy and its importance within the organizations.

●Evidence:

The CIPD survey (2005a) that the recruitment agencies were rated as most effective for senior management and director level posts, whereas the local pres was more

likely to be rated effective for administrative and manual vacancies.

●Other factor:

Other factor to be taken into account when choosing the most appropriate method include the resources available within the organizations(in terms of personnel and finance, the perceived target groups, and the organization?s stance on internal versus external recruitment.

题型:内外招聘的优缺点:Advantages and disadvantages of Internal and External recruitment

Advantages of internal recruiting:

●Recruiting costs: Since the recruiting machinery is focused on an

already existing pool of employees to fill a vacant position, and

therefore selection and socializing processes are less time and cost

consuming, internal recruiting tends to be less expensive than external

recruiting.

●Motivation: The prospect of potential promotion or transfers provides

a clear sign to the current work force that the organization offers room

for advancement. This addresses the employee's need for

self-achievement. (But it may result in Peter principles, “In a hierarchy

every employee tends to rise to his level of incompetence” which can

be resolved by Temporary appointment)

●Familiarity: The familiarity of the employee has a two-side effect: On

the one hand the employee is familiar with the organization's policies,

procedures, and customs. At the same time, the organization has

established an employment history showing the workers formal and

informal skills and abilities.

Disadvantages of internal recruiting

●Inbreeding 缺乏新的IDEA: One drawback of extensive internal recruiting is

the reduced likelihood of innovation and new perspectives. A lack of new

employees from the outsides leads to a lack of new ideas and approaches.

(conversely, the external recruits will bring the new ideas and external ideas to the firm)

●EEO Criteria 机遇不平等: A use of the internal pool for the consideration of

vacant positions can lead to conflicts with the Equal Employment Opportunity

Commission. The organization has to ensure and continuously check its balance of a diverse workforce. This has to relate to the organization?s legal, political and geographical environment. ( external recruits: if political infighting over a

promotion might be a possibility, then external recruitment is one way of

eliminating that occurrence. Finally, with external recruitment, a firm does not have to worry about the Peter Principle)

●More training 投入更多的培训: Internal recruiting demands a higher degree

of employee training. In order to develop the skills needed to train the current

workforce in new processes and technologies, the organization has to provide a more expensive training program (for external recruitment , only those

applicants who have the exact qualifications will apply and be selected, it help save cost of training)

Advantages of external recruiting:

●The most obvious advantage of external recruitment is the availability

of a greater pool of applicants.

●Thus, only those applicants who have the exact qualifications will

apply and be selected. This has consequences for the organization's

training budget. Whereas external recruits will require orientation upon

being hired, they will not require any extra training

●External recruits also bring new ideas and external contacts to the firm

hiring them. Also, if political infighting over a promotion might be a

possibility, then external recruitment is one way of eliminating that

occurrence.

●Finally, with external recruitment, a firm does not have to worry about

the Peter Principle.

Disadvantages of external recruitment:

●more time and cost consuming ( recruiting cost and agency fees,

advertisement fees)during the recruiting process;

●not familiar with the organization's policies, procedures, and customs;

●may not be effective enough to reveal the best candidates.

延展:More internal recruitment suggested but in practice more external

HRM Literature emphasizes the need to have well-developed internal labour market arrangements for promotion, training and career development, which would suggest that many openings can and should be filled internally( Beaumont,1993). However, a

number of organizations, particularly those in the public sector, have policies that require the majority of posts to be advertised externally. Finding from 2004 ( WERS) show that, although the majority of workplaces treat external and internal equally,

one-fifth give preference to internal candidates and one in ten prefer to recruit externally.

Selection (甄选)

大概:甄选的目的,从上一个recruitment process 所吸引过来的candidates中,选择最适合的人,甄选的过程中,使用了不同的方法,最主要的是下面黑字体蓝色的三种,这3个需要大概知道是什么意思,我觉得RACHEL会问,这3种方法如何提供甄选中的有效性(validity),其中interview 的会重要些

Definition of Selection

Selection is the process of assessing job applicants by using one or more of a variety of methods with a view of selecting the most appropriate person.

Methods of selection

1.biographical data ( biodata)

2.unstructured interview

3.structured interview

4.skills tests

5.psychometric tests

6.assessment centers

advantages and disadvantages of selection methods (3 methods important )

i.structured interviews

ii.psychometric assessment

iii.assessment centers

Structured interviews:

behavioral interviews: hypothetical situations are posed to the candidates( the same questions to each candidate) and the candidate is asked to say how they would react and behaviour to this situation.

Situational interviews :candidates are asked to identify where they have experienced certain job-relevant situation and report how they responded to these situations. Advantages

●Ability to gather better information

●Improved consistency between interviewers

●Increased ability for candidates to demonstrate their skills

Disadvantages:

●Less flexible as unstructured interviews

●Over structuring can be a problem ( Dipboye,1994)

以下的是用来解答,Remember that when selecting you are trying to predict future performance. Predictive validity is important –how do you improve the validity? 主要介绍3种主要的甄选方法,还有他们如何提高效度,有不明白的,请阅读企鹅书(74-77)为什么要提高效度,就是为了防止选错人。因为会影响到将来的performance。

企鹅书版:The interview is the most common selection tool used within organizations across many countries. Early research demonstrated that traditional unstructured interview had very low validity (Mayfield 1964 ;Ulrich and

Trumbo1965).Given the ubiquity of the interview, efforts has been devoted to improving its validity ,primarily by increasing the structure of the interview, so that at least all candidates are asked the same sort of questions and all interviewers use the same dimension to assess candidates. McDaniewl et al (1994) argue that increasing the structure of interview so that all candidates are asked the same question can improve predictive validity. Advantages included the ability to gather better information which leads to improve selection decisions, improved consistency between interviewers and the increased ability for candidates to demonstrate their skills. Structuring interviews can therefore potentially improve the quality of decisions made. However, (Dipboye1994) argues that over structuring can be a problem, as it will lose the opportunity for both parties to exchange information about the job which may help them negotiate “psychological contract”(心理契约:织与员工之间隐含的、未公开说明的相互期望的总合)

Psychometric assessment 心理评测

There are 2 types of Psychometric assessment: cognitive tests and personality measures.

●Cognitive tests (认知能力测试,用来衡量一个人学习及完成一项工作的恩那

个李的测试) are used to assess the cognitive abilities of candidates and are

normally test of general intelligence , it is typically been found to have high

predictive validity across a wide range of jobs and regarded as the valid

predictors of performance of candidates (Hunter and Schmidt1990) For example,

McMaus et al (2003) showed …”A –level” score was a good predictor of success in medial training and subsequent career progress. (But, it is debatable how much additional information they provide since they are other ways of estimating

ability, especially from academic qualifications and tests are sometimes biased against certain group s, for example, black Americans score lower on tests than whites and women score higher on verbal reasoning than men )

Personality measures: provide an assessment of an individual?s general disposition to behave in a certain way at certain times. Employees with different personalities may approach a job in a different way, but some candidates fake

test to give the required impression ( Griffen et al 2004). And as there was no

generally accepted model of personality, therefore, personality measures are

found with lower validity of predicting job performance( Schmitt et al, 1984) But recently, Research using the Big 5 model (五大人格特征) has shown that the 5 traits of person help to predict job performance. For example, Barrick and Mount (1991) found that conscientiousness(尽责)is a valid predictors for all

occupational groups and all criterion types. Day and Silverman et al, (1989),

however have proved that personality tests can help predict high performance

(Day and Silverman 1989). Tett et al demonstrated that using broad measures of personality obscured potentially useful linkages between the specific aspects of personality and performance. Thus they advocate focusing on specific

personality traits and specific measures of performance in order to improve

predictive validity

Assessment centers

Assessment centers make use of variety of exercises and test over a period of time to assess a small group of candidates on a number of dimension in terms of different competencies ) which are relevant to the particular job and organizations. It is widely used, as evidence shows that 65% of UK large firms are using them. Research has shown that assessment centres have low validity for following suggested reasons: Assessors are not able to assess them with the marking schema of exercises, for example competencies and the behavioral statements.

Ratings among candidates made by assessors are influence by the overall performance of candidates e rather than their ability to indicate how the competencies are played out in practice and it also influenced sometimes by the personal criteria of assessors. Despite of this, the validity of some types of exercises is very high (Newell & Scarbrough 2002)

To overcome this problem and improve the validity of the assessment centres, Lievens (1998) demonstrates a number of practical recommendations. Firstly,

assessment centres should use a small amount of competencies, which must be related to the job offered. Secondly, the assessors must be well trained and must understand the required competencies. Thirdly, the assessment centre must develop the appropriate activities, which will generate a large amount of competencies related to behaviour. Finally, lists of competencies and associated behaviours will need to be drawn up as check lists so that the assessors can easily observe and rate the candidates.

题目:Why recruiters don’t follow the Rational Decision Making model, would it improve the recruitment outcome if they did? 在这个理性决策模型中,有6个步骤,每个步骤都是相关联的,第一个步骤的outcome 会影响到下一个步骤。最后一步要achieve 最优决策,最终目标都是为了能选出合适的人。However, research evidence suggest that, in practice, the decision process is often far away from ideal. (决策在理想和实际中有区别,所以会造成不同的recruitment, selection and assessment 的outcome, 下面提到每个理性决策模型的步骤是做什么的,然后会出现什么特殊情况,这里可以理解成不遵循模型的步骤,注意,不管老师问的是何种outcome, 只要题目关于rational decision making model 的,就都塞进去好了) PS: 以下内容,是我低水平英文的总结,为了更好的wording , 仙女们看完我写的大概以后,请翻阅企鹅书(66-70)做成你们的版本。

What is rational decision making model and why important ?

The rational decision making model is applied in the process of recruitment as well of selection and assessment.( The decision- making perspective has been dominated by normative research, which prescribes know how decisions should be made.( Brunsson,1982). This assumes that the desire is to follow to make the decisions as rational as possible).The prescription of making decision rational is to follow a sequence of specified steps and each step is regarded as logical outcome of it previous step.

1.Understand the situation

2.Gathering information to help solve the problem

3.Generate potential solutions

4.Evaluate each solution

5.Monitor and evaluate results

6.Select best solution

●Understand the situation (空缺职位不是既定的,需要重新审视情况,知

道是否真的有招聘的需要)

Job vacancy is not presumed and it need to be reviewed and find out if it need to be filled , therefore, in this first step, recruiter need to undertake a review of situation to determine that if the need of recruitment actually exists and which kind of people need to be recruited. Sometimes, in this step, the decision whether or not to replace an employee is political ( Contu and Willmott 2003). Individuals are recruited for company but in reality they are recruited for particular department. A department is unlikely to admit voluntarily that they do not need to replace a particular person since that will diminish their “empire”. Large department has more power during this political process.

●Generate potential solutions (尽可能全面的搜集申请者的信息) 这边的

solution 是指找到适合的人来填补空缺的位置(这个空缺的位置在上一个step 里头被作为problem 或者situation)

Once the situation has been reviewed to ensure that a job vacancy exists, recruiter can move to next step to gathering information as widely as possible about job in order to determine the key tasks and role requirements in order to ensure the best pool of applicants. But research shows that, in practice, the alternatives are considered often less than exhaustive. Sometimes, recruiters have potential solutions ready. For example, some organizations only go to Oxford and Cambridge universities to recruit graduates. Other solution is the so-called …old boy network? which is still used actively within organizations. It is referred to personal contacts, one?s social capital which may lead to job opportunities rather than systematic recruitment and no need to follow the traditional rational decision model

●Evaluate each solution ( 利用搜集的信息和数据评价求职者)

In this step, the information and data collected from applicants need be evaluated and assessed in logic manner in order to select best candidate. But, whatever method recruiters and assessors are using, it doesn?t mean that they use the information and evidences collected from previous step to evaluate the situation during the recruitment and selection process. For example, interview decision are often made quickly and subjective (Janz1989) and during assessment centers, assessors do not use all the information they obtain.

●Monitor and evaluate results (如何评价)

Rating of candidates? potential estimated during the recrui tment and selection can be compared with subsequent performance on the job. This provides measure of validity. In practice, it seems very few organizations evaluate their decisions and it is demonstrated that there is low validity even using methods which are regarded reasonable and on good level of validity. Research shows that the prescriptive, rational decision making process does not typically equate with reality and the methods of evaluation and selection used are not on criterion-related validity. To make sure what extent the rational, normative decision making model is actually followed, Roberson and Smith(2001)suggest to adopt structured recruitment and selection methods to improve validity.

select the best solution (找出合适的人)

Each candidate can be rated against the person specification or competency profiles in terms content of job. Candidates with highest score will be selected. However, in practice, the rating will justify decisions. As Beach (19900 states: …most decisions are made quickly and simply on the basis of …fittingness?. That means recruiters or assessors may weight scores to suit the candidate they like best.

The goal and outcome of recruitment is to select appropriate candidates which are later selected with different methods and assessed for sorting out the best fit of job vacancy. Steps of rational decision making model enable recruiters to make decision in a logic order and manner and each step is the logic outcome of its previous step. If recruiters don?t follow the model and miss some steps of it, it is safe to say that the outcome of recruitment may vary and may be not improved. Moreover, the validity of the recruitment outcome may be also influenced and the possible negative effect may extend to the process of selection and assessment.

题目:why unstructured interviews are still popular and the problems associated with them (鉴于企鹅书P72资料有限,我在做完SARAH的SECTION B INTERVIEW题目补给你们完整一点的,但我估计这不是考试重点)再对比一下structured interviews 答题的时候,见上文。

Unstructured Interviews are a method of interviews where questions can be changed or adapted to meet the respondent's intelligence, understanding or belief. Unlike a structured interview, they don have standard format and decision rules and do not offer a limited, pre-set range of answers for candidates to choose, but instead advocate listening to how each individual person responds to the question.

Problems of unstructured interviews:

●Unstructured interviews are acknowledged that they lack of reliability and

validity which refer to structure. They are not consistent, trustworthy in terms of procedure and not replicable.

●Unstructured interviews may bias the characteristics of researcher and diversity

of legislation, such as age, sex, race which may affect the candidates and lower the validity of selection outcome.

●Unstructured interviews bias in leading which refers to how the interviewers

guide the response of interviewees, as the logic of question proposed is up to the interviewers. For example, it will be affected verbally by the actual words used by interviewers, body language and the tone of the voice.

●Unstructured interviews is time consuming and expensive.

Unstructured interviews are still popular in the selection process, Despite these limitations of unstructured interviews, evidence suggests that unstructured interview and references remain the most dominant methods (Shackleton and Newell,1991) for several reasons as indicated as following. Research ahs supported that many problems with the selection interview have been identified in unstructured situations, as Dipboye?s model of the interview suggested, in an unstructured form of interview, interviewers can immediately point out the potential problems of such a strategy. In essence the extraneous factors that affect an interviewer?s decisions are given free rein.

Another reason is that the selection is not simply about valid selection, but also about commitment and motivation to follow up the decision with behaviors that encourage the individual selected to integrate into organization. A recruiter who feels that they have personally selected the candidate is much more likely to feel committed and motivated to helping achieve this integration. Similarly, the selected candidate may well be more committed to the organization because unstructured interviews are more likely to provide the opportunity to negotiate a …mutually agreeable psychological contract?(Dipboye 1997)

Some of the diversity materials may be relevant to a selection question – pressure for structured methods may come from a need to comply with diversity legislation. (RACHEL 邮件回复,对于structured methods,她focuses mainly on structured interviews rather than non-structured, being objective of recruitment methods, equal opportunity , diversity legislation means : sex ,race, religion, age, disability etc)

In the process of recruitment and selection, structured interviews are regarded as methods enable recruiters to ensure equal opportunities of candidates and to implement best practice with diversity issues, namely to comply with diversity legislation for example, sex, race, religion, age and disability etc. Structured interviews equip with characteristics of predetermined questions, scoring formats and decision rules. These characteristic enable recruiters to pinpoint the competences and subsequent job performance of candidates.

脐带干细胞综述

脐带间充质干细胞的研究进展 间充质干细胞(mesenchymal stem cells,MSC S )是来源于发育早期中胚层 的一类多能干细胞[1-5],MSC S 由于它的自我更新和多项分化潜能,而具有巨大的 治疗价值 ,日益受到关注。MSC S 有以下特点:(1)多向分化潜能,在适当的诱导条件下可分化为肌细胞[2]、成骨细胞[3、4]、脂肪细胞、神经细胞[9]、肝细胞[6]、心肌细胞[10]和表皮细胞[11, 12];(2)通过分泌可溶性因子和转分化促进创面愈合;(3) 免疫调控功能,骨髓源(bone marrow )MSC S 表达MHC-I类分子,不表达MHC-II 类分子,不表达CD80、CD86、CD40等协同刺激分子,体外抑制混合淋巴细胞反应,体内诱导免疫耐受[11, 15],在预防和治疗移植物抗宿主病、诱导器官移植免疫耐受等领域有较好的应用前景;(4)连续传代培养和冷冻保存后仍具有多向分化潜能,可作为理想的种子细胞用于组织工程和细胞替代治疗。1974年Friedenstein [16] 首先证明了骨髓中存在MSC S ,以后的研究证明MSC S 不仅存在于骨髓中,也存在 于其他一些组织与器官的间质中:如外周血[17],脐血[5],松质骨[1, 18],脂肪组织[1],滑膜[18]和脐带。在所有这些来源中,脐血(umbilical cord blood)和脐带(umbilical cord)是MSC S 最理想的来源,因为它们可以通过非侵入性手段容易获 得,并且病毒污染的风险低,还可冷冻保存后行自体移植。然而,脐血MSC的培养成功率不高[19, 23-24],Shetty 的研究认为只有6%,而脐带MSC的培养成功率可 达100%[25]。另外从脐血中分离MSC S ,就浪费了其中的造血干/祖细胞(hematopoietic stem cells/hematopoietic progenitor cells,HSCs/HPCs) [26, 27],因此,脐带MSC S (umbilical cord mesenchymal stem cells, UC-MSC S )就成 为重要来源。 一.概述 人脐带约40 g, 它的长度约60–65 cm, 足月脐带的平均直径约1.5 cm[28, 29]。脐带被覆着鳞状上皮,叫脐带上皮,是单层或复层结构,这层上皮由羊膜延续过来[30, 31]。脐带的内部是两根动脉和一根静脉,血管之间是粘液样的结缔组织,叫做沃顿胶质,充当血管外膜的功能。脐带中无毛细血管和淋巴系统。沃顿胶质的网状系统是糖蛋白微纤维和胶原纤维。沃顿胶质中最多的葡萄糖胺聚糖是透明质酸,它是包绕在成纤维样细胞和胶原纤维周围的并维持脐带形状的水合凝胶,使脐带免受挤压。沃顿胶质的基质细胞是成纤维样细胞[32],这种中间丝蛋白表达于间充质来源的细胞如成纤维细胞的,而不表达于平滑肌细胞。共表达波形蛋白和索蛋白提示这些细胞本质上肌纤维母细胞。 脐带基质细胞也是一种具有多能干细胞特点的细胞,具有多项分化潜能,其 形态和生物学特点与骨髓源性MSC S 相似[5, 20, 21, 38, 46],但脐带MSC S 更原始,是介 于成体干细胞和胚胎干细胞之间的一种干细胞,表达Oct-4, Sox-2和Nanog等多

脐带血造血干细胞库管理办法(试行)

脐带血造血干细胞库管理办法(试行) 第一章总则 第一条为合理利用我国脐带血造血干细胞资源,促进脐带血造血干细胞移植高新技术的发展,确保脐带血 造血干细胞应用的安全性和有效性,特制定本管理办法。 第二条脐带血造血干细胞库是指以人体造血干细胞移植为目的,具有采集、处理、保存和提供造血干细胞 的能力,并具有相当研究实力的特殊血站。 任何单位和个人不得以营利为目的进行脐带血采供活动。 第三条本办法所指脐带血为与孕妇和新生儿血容量和血循环无关的,由新生儿脐带扎断后的远端所采集的 胎盘血。 第四条对脐带血造血干细胞库实行全国统一规划,统一布局,统一标准,统一规范和统一管理制度。 第二章设置审批 第五条国务院卫生行政部门根据我国人口分布、卫生资源、临床造血干细胞移植需要等实际情况,制订我 国脐带血造血干细胞库设置的总体布局和发展规划。 第六条脐带血造血干细胞库的设置必须经国务院卫生行政部门批准。 第七条国务院卫生行政部门成立由有关方面专家组成的脐带血造血干细胞库专家委员会(以下简称专家委

员会),负责对脐带血造血干细胞库设置的申请、验收和考评提出论证意见。专家委员会负责制订脐带血 造血干细胞库建设、操作、运行等技术标准。 第八条脐带血造血干细胞库设置的申请者除符合国家规划和布局要求,具备设置一般血站基本条件之外, 还需具备下列条件: (一)具有基本的血液学研究基础和造血干细胞研究能力; (二)具有符合储存不低于1 万份脐带血的高清洁度的空间和冷冻设备的设计规划; (三)具有血细胞生物学、HLA 配型、相关病原体检测、遗传学和冷冻生物学、专供脐带血处理等符合GMP、 GLP 标准的实验室、资料保存室; (四)具有流式细胞仪、程控冷冻仪、PCR 仪和细胞冷冻及相关检测及计算机网络管理等仪器设备; (五)具有独立开展实验血液学、免疫学、造血细胞培养、检测、HLA 配型、病原体检测、冷冻生物学、 管理、质量控制和监测、仪器操作、资料保管和共享等方面的技术、管理和服务人员; (六)具有安全可靠的脐带血来源保证; (七)具备多渠道筹集建设资金运转经费的能力。 第九条设置脐带血造血干细胞库应向所在地省级卫生行政部门提交设置可行性研究报告,内容包括:

卫生部办公厅关于印发《脐带血造血干细胞治疗技术管理规范(试行)

卫生部办公厅关于印发《脐带血造血干细胞治疗技术管理规 范(试行)》的通知 【法规类别】采供血机构和血液管理 【发文字号】卫办医政发[2009]189号 【失效依据】国家卫生计生委办公厅关于印发造血干细胞移植技术管理规范(2017年版)等15个“限制临床应用”医疗技术管理规范和质量控制指标的通知 【发布部门】卫生部(已撤销) 【发布日期】2009.11.13 【实施日期】2009.11.13 【时效性】失效 【效力级别】部门规范性文件 卫生部办公厅关于印发《脐带血造血干细胞治疗技术管理规范(试行)》的通知 (卫办医政发〔2009〕189号) 各省、自治区、直辖市卫生厅局,新疆生产建设兵团卫生局: 为贯彻落实《医疗技术临床应用管理办法》,做好脐带血造血干细胞治疗技术审核和临床应用管理,保障医疗质量和医疗安全,我部组织制定了《脐带血造血干细胞治疗技术管理规范(试行)》。现印发给你们,请遵照执行。 二〇〇九年十一月十三日

脐带血造血干细胞 治疗技术管理规范(试行) 为规范脐带血造血干细胞治疗技术的临床应用,保证医疗质量和医疗安全,制定本规范。本规范为技术审核机构对医疗机构申请临床应用脐带血造血干细胞治疗技术进行技术审核的依据,是医疗机构及其医师开展脐带血造血干细胞治疗技术的最低要求。 本治疗技术管理规范适用于脐带血造血干细胞移植技术。 一、医疗机构基本要求 (一)开展脐带血造血干细胞治疗技术的医疗机构应当与其功能、任务相适应,有合法脐带血造血干细胞来源。 (二)三级综合医院、血液病医院或儿童医院,具有卫生行政部门核准登记的血液内科或儿科专业诊疗科目。 1.三级综合医院血液内科开展成人脐带血造血干细胞治疗技术的,还应当具备以下条件: (1)近3年内独立开展脐带血造血干细胞和(或)同种异基因造血干细胞移植15例以上。 (2)有4张床位以上的百级层流病房,配备病人呼叫系统、心电监护仪、电动吸引器、供氧设施。 (3)开展儿童脐带血造血干细胞治疗技术的,还应至少有1名具有副主任医师以上专业技术职务任职资格的儿科医师。 2.三级综合医院儿科开展儿童脐带血造血干细胞治疗技术的,还应当具备以下条件:

卫生部关于印发《脐带血造血干细胞库设置管理规范(试行)》的通知

卫生部关于印发《脐带血造血干细胞库设置管理规范(试行)》的通知 发文机关:卫生部(已撤销) 发布日期: 2001.01.09 生效日期: 2001.02.01 时效性:现行有效 文号:卫医发(2001)10号 各省、自治区、直辖市卫生厅局: 为贯彻实施《脐带血造血干细胞库管理办法(试行)》,保证脐带血临床使用的安全、有效,我部制定了《脐带血造血干细胞库设计管理规范(试行)》。现印发给你们,请遵照执行。 附件:《脐带血造血干细胞库设置管理规范(试行)》 二○○一年一月九日 附件: 脐带血造血干细胞库设置管理规范(试行) 脐带血造血干细胞库的设置管理必须符合本规范的规定。 一、机构设置 (一)脐带血造血干细胞库(以下简称脐带血库)实行主任负责制。 (二)部门设置 脐带血库设置业务科室至少应涵盖以下功能:脐带血采运、处理、细胞培养、组织配型、微生物、深低温冻存及融化、脐带血档案资料及独立的质量管理部分。 二、人员要求

(一)脐带血库主任应具有医学高级职称。脐带血库可设副主任,应具有临床医学或生物学中、高级职称。 (二)各部门负责人员要求 1.负责脐带血采运的人员应具有医学中专以上学历,2年以上医护工作经验,经专业培训并考核合格者。 2.负责细胞培养、组织配型、微生物、深低温冻存及融化、质量保证的人员应具有医学或相关学科本科以上学历,4年以上专业工作经历,并具有丰富的相关专业技术经验和较高的业务指导水平。 3.负责档案资料的人员应具相关专业中专以上学历,具有计算机基础知识和一定的医学知识,熟悉脐带血库的生产全过程。 4.负责其它业务工作的人员应具有相关专业大学以上学历,熟悉相关业务,具有2年以上相关专业工作经验。 (三)各部门工作人员任职条件 1.脐带血采集人员为经过严格专业培训的护士或助产士职称以上卫生专业技术人员并经考核合格者。 2.脐带血处理技术人员为医学、生物学专业大专以上学历,经培训并考核合格者。 3.脐带血冻存技术人员为大专以上学历、经培训并考核合格者。 4.脐带血库实验室技术人员为相关专业大专以上学历,经培训并考核合格者。 三、建筑和设施 (一)脐带血库建筑选址应保证周围无污染源。 (二)脐带血库建筑设施应符合国家有关规定,总体结构与装修要符合抗震、消防、安全、合理、坚固的要求。 (三)脐带血库要布局合理,建筑面积应达到至少能够储存一万份脐带血的空间;并具有脐带血处理洁净室、深低温冻存室、组织配型室、细菌检测室、病毒检测室、造血干/祖细胞检测室、流式细胞仪室、档案资料室、收/发血室、消毒室等专业房。 (四)业务工作区域应与行政区域分开。

脐带血间充质干细胞的分离培养和鉴定

脐带血间充质干细胞的分离培养和鉴定 【摘要】目的分离培养脐带血间充质干细胞并检测其生物学特性。方法在无菌条件下用密度梯度离心的方法获得脐血单个核细胞,接种含10%胎牛血清的DMEM培养基中。单个核细胞行贴壁培养后,进行细胞形态学观察,绘制细胞生长曲线,分析细胞周期,检测细胞表面抗原。结果采用Percoll(1.073 g/mL)分离的脐血间充质干细胞大小较为均匀,梭形或星形的成纤维细胞样细胞。细胞生长曲线测定表明接后第5天细胞进入指数增生期,至第9天后数量减少;流式细胞检测表明50%~70%细胞为CD29和CD45阳性。结论体外分离培养脐血间充质干细胞生长稳定,可作为组织工程的种子细胞。 【关键词】脐血;间充质干细胞;细胞周期;免疫细胞化学 Abstract: Objective Isolation and cultivation of mesenchymal stem cells (MSCs) in human umbilical cord in vitro, and determine their biological properties. Methods The mononuclear cells were isolated by density gradient centrifugation from human umbilical cord blood in sterile condition, and cultured in DMEM medium containing 10% fetal bovine serum. After the adherent mononuclear cells were obtained, the shape of cells were observed by microscope, then the cell growth curve, the cell cycle and the cell surface antigens were obtained by immunocytochemistry and flow cytometry methods. Results MSCs obtained by Percoll (1.073 g/mL) were similar in size, spindle-shaped or star-shaped fibroblasts-liked cells. Cell growth curve analysis indicated that MSCs were in the exponential stage after 5d and in the stationary stages after 9d. Flow cytometry analysis showed that the CD29 and CD44 positive cells were about 50%~70%. Conclusions The human umbilical cord derived mesenchymal stem cells were grown stably in vitro and can be used as the seed-cells in tissue engineering. Key words:human umbilical cord blood; mesenchymal stem cells; cell cycle; immunocytochemistry 间充质干细胞(mesenchymal stem cells,MSCs)在一定条件下具有多向分化的潜能,是组织工程研究中重要的种子细胞来源。寻找来源丰富并不受伦理学制约的间充质干细胞成为近年来的研究热点[1]。脐血(umbilical cord blood, UCB)在胚胎娩出后,与胎盘一起存在的医疗废物。与骨髓相比,UCB来源更丰富,取材方便,具有肿瘤和微生物污染机会少等优点。有人认为脐血中也存在间充质干细胞(Umbilical cord blood-derived mesenchymal stem cells,UCB-MSCs)。如果从脐血中培养出MSCs,与胚胎干细胞相比,应用和研究则不受伦理的制约,蕴藏着巨大的临床应用价值[2,3]。本研究将探讨人UCB-MSCs体外培养的方法、细胞的生长曲线、增殖周期和细胞表面标志等方面,分析UCB-MSCs 作为间充质干细胞来源的可行性。

脐带血干细胞检测

脐带血干细胞检测 对每份脐血干细胞进行下列检测: ①母体血样做梅毒、HIV和CMV等病原体检测,这一检测使脐血干细胞适合于其它家庭成员应用。如任何一种病原体测试阳性,需重复测定。 ②每份脐血干细胞样本同时检测确定没有微生物污染。 ③细胞活性检测、有核细胞数、CD34+细胞数、集落形成试验等。CD34是分子量115KD 的糖蛋白分子,使用特定单克隆抗体(抗-CD34)确定,脐血祖细胞的大部分,包括体外培养产生造血集落的细胞都包含在表达CD34抗原的细胞群中。 ④HLA组织配型、ABO血型。 一、采血方式及其优点 再生缘生物科技公司采用最严谨的封闭式血袋收集法,避免在收集脐带血液时可能遭受微生物污染的发生,且以最少之操作步骤,收集最大量之脐带血液方式,在产房内即可完成。 二、脐带血处理与保存 脐带血收集于血袋,经专人运送至再生缘生物科技公司之无菌细胞分离实验室后,由专业的技术人员于完全无菌的环境下,依标准操作程序将血液进行分离,收集具有细胞核的细胞,其中含有丰富的血液干细胞,经加入冷冻保护剂和适当品管检测后,并进行以最适合

血液干细胞的冷冻降温程序方式,进行细胞冷冻程序,达到避免细胞受到冷冻过程之伤害。完成后,冷冻细胞立刻保存于摄氏零下196度的液态氮槽中。所有操作程序记录和细胞保存相关数据,均由计算机条形码系统追踪确认,完全符合国际脐带血库之标准操作程序和品管要求。 母亲血液之检测 为确保所操作和保存的脐带血液细胞,符合国际血液操作规范,并提供客户最大的保障,对于产妇血液必须同时进行一些病毒传染病的检测,以确保没有下列病毒,如艾滋病毒(HIV)、C型肝炎病毒(HCV)、人类T细胞淋巴病毒(HTLV)和梅毒(syphilis),同时对于B型肝炎病毒(HBV)和巨细胞病毒(CMV)加以侦测和纪录,作为将来可能应用脐带血细胞时之必要参考数据并符合卫生医疗之要求。 脐带血细胞之品管 对于所保存之脐带血细胞均进行多项操作流程监控和品管检测,如微生物污染检测、血液细胞浓度、细胞存活率、细胞活性测定等,每一步骤均有详细之纪录,在操作方法和使用仪器方面均定期进行验证和校验,以符合国际医疗标准。 三、实验室、贮存处所介绍 再生缘生物科技公司拥有符合美国联邦标准(FED-STD-209E)和中华民国优良药品制造标准(一区、二区、三区)的生物安全实验室和无菌操作设备,在专业的技术人员依标准操作程序下进行血液分离和保存步骤,保障客户珍贵样品和权益。 分离后之细胞将依浓度分装入4-6个冷冻管,计算机降温冷冻完成后,即由食品工业发展研究所国家细胞库专业液态氮库房人员,将冷冻细胞分别存放于二个不同的脐带血细胞专属液态氮槽中保存,在安全机制上更有保障。液态氮库房拥有五吨的液态氮供应系统,每一液氮槽均有自动充填装置和异常警报系统,和每日值勤人员监控,确保冷冻细胞处于最佳的冷冻状态。 四、安全管制措施 脐带血液经快递送达无菌细胞分离实验室后,每一步骤均有专业技术人员操作和监督,并将所有分析数值详细填于具有条形码管制之分析表格和计算机数据表中,利用条形码和读码系统确认样品之专一性,避免人为失误,且便于追溯和数据品管。 在冷冻细胞保存上

胎盘干细胞与脐带血干细胞的区别

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脐带血造血干细胞库技术规范

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脐血干细胞移植实施方案

附件3 脐带血造血干细胞移植实施方案

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3、睡前、饭前、饭后(进食任何饮食后)认真漱口。 4、3%双氧水擦洗鼻前庭、外耳道每日三次,然后用碘伏消毒液擦拭,再涂以红霉素软膏等。 5、抗菌及抗病毒的眼药水交替点眼,每日三次。 6、经常以含KL-98消毒液棉球擦手(代替洗手)。 (二)入住后环境要求: 1、净化舱内地面、所有物品表面每日消毒液擦拭一次,发现有污染随时擦拭消毒。 2、室内墙壁隔天消毒液擦拭一次。 3、被服高压消毒更换每日一次。 4、空气喷雾消毒每日一次。 5、坐便桶、污水桶每日更换消毒一次。 (三)无菌饮食要求: 1、食物新鲜,彻底洗净、煮熟、微波炉消毒7分钟。 2、水时须做成水果羹后微波炉消毒,或须经消毒后用无菌刀削皮后方可食用。 3、饼干、馒头放微波炉隔水蒸7分钟。 4、饮水均须用开水经舱内电热水瓶二次沸腾后方可饮用。 5、餐具严格消毒。 工作人员入室要求: 严格控制入室人员。医护人员入室前先淋浴,更换清洁衣裤,戴清洁帽子。在缓冲间用肥皂洗手,清水冲净后,再用手快速消毒剂擦手,然后更换无菌拖鞋进入更衣间。戴一次性无菌手套,按无菌操作要求穿无菌分体式隔离衣,戴无菌口罩,进入消毒间再次消毒手,更换无菌拖鞋方可进入护士站。如果进入病人所在的百级层流病房,还需戴无菌手套,穿无菌隔离衣,更换无菌拖鞋方可进入。(二)预处理 定义:是指在输注造血干细胞前对病人进行的大剂量化疗或放疗。 目的:尽可能杀灭病人体内的异常细胞或肿瘤细胞,最大限度减少复发;破坏病人免疫系统,为造血干细胞的植入提供条件,防止移植物被排斥;为造血干细胞的植入、生长提供必要的空间。

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