IFCC的临床实验室认证原则

1.  实验室认证的性质和目的
为了患者，社会，和政府的利益，临床实验室以高标准的专业技术能力来运作，理由如下：
  关于诊断、预后和治疗的决定通常是基于实验室测试的结果和解释作出的，不可逆的损害可能是由错误的结果引起。
  临床实验室服务的对象（包括患者和临床医生）不可能有足够的专业知识去允许他们确定一个实验室的运作是否在符合要求的水平。
  患者合在有限范围内的临床医生对实验室的使用也许没有选择。
  实验室检测可能是昂贵的，为这些检测付费的患者，保险公司或者政府希望实验室提供有用的信息。
  为了这些有能力的实验室的利益。这些实验室的能力是通过了核查，和合适的标准比较以及他们的良好标准的公开认证的过程。
认证是对一个提供高质量服务的实验室能力的外部核查。这就要求实验室服从如下内容：
  与发布的认证标准一致
  有室内和室间质量管理系统，在质量管理手册上有记载
和
  一个合格的由认证委员会提供的专家评估报告
2.  范围和管理
  检查和认证程序应该包括所有的实验室和体外诊断，包括内科诊所实验室和床旁检测（point－of－care testing）
  除了向核查机构提供信息外，认证应该基于核查性的参观和同行平议。认证系统的目的应该包括通过信息的传播和专业的教育来改善标准的操作。
  通过由能典型代表医学和科学专业领域的认证委员会，执行标准的设置和核查程序。政府机构和医疗保险公司也应参加到这个委员会，在必须的程度上确保受到接受和认证系统的公众责任。这个认证系统应该定期的修订。标准设置的主要责任扔属于从事临床实验室工作的医学和科学专家。
3.  评估标准
标准应该由认证委员会来定义，由同行来平议。这个标准应该包括：
  组织和管理
包括合适的行政和工作人员构成，责任和义务文件。
  工作人员资格
必须有受过相应教育和培训的足够的工作人员，这些工作人员得到了继续教育和确保职员的能力。负责实验的工作人员应该受过相应的后期第二科学项目教育，实验室操作规程的训练。实验室负责人或许有基本的大学医学或科学学位，或者由个别国家政策认可的其它大学学位；但是必须要受到过在临床实验室工作的专业的研究生专业教育。
  设备设施
工作环境对工作人员和患者必须安全，有足够的和合适的空间工作。设备，材料和试剂必须保证质量和适合与检测的目的。
  质量方针
必须有操作规程和方针的文件，实验方法的文件。必须有覆盖样品分析前，分析中和分析后的室内和室间的质量保证措施和系统评价。
4.  行为准则
患者越来越适度的关注保健问题，希望参与到影响他们健康的抉择中。临床实验室最大的责任就是对患者负责。
坚持高标准，比如检测结果及时，实验室准确度和精密度，所做检测的临床相关性，全体工作人员的资格认证和培训，差错的预防，是所有临床实验室工作人员的道德准则。
临床实验室的认证和核查也应该确保医院投资人，管理层和工作人员遵守道德标准，比如：
  保守患者隐私
  坚持采用合适的技术和专业标准，而不去考虑利益压力。
  避免个人，经济上的和组织上的利益冲突。
  对患者和工作人员无关于种族、性别、***或宗教信仰和经济条件的歧视。
5.  关于IFCC
国际临床化学和检验医学联合会成立于192年，目的是为了提供全世界的临床化学实践和科研水平，是为了全人类的利益。IFCC现在的目标是：
－ 建立，鼓励和培养高专业水准的临床化学和检验医学；
－ 促进在临床化学和检验医学上与研究、操作规程、原料、规则和实践、教育和培训、行业道德和相关科目的国际间的合作和协调；
－ 为全世界的临床化学家和检验医学专家提供一个相互联系和自由交流专业信息的平台；
－ 发起和支持国际临床化学大会；发起和支持地区会议和国际范围内和国际上感兴趣的会议
－ 鼓励，发起和/或指导研究，推荐、评论和报道临床化学和检验医学方面的国际上感兴趣的和关心的内容；
－ 为所有IFCC会员，其它国际和地区委员会，州，国家，工厂和其它提供健康服务和健康产品的相关机构提供临床化学和检验医学方面的咨询和建议；
－ 鼓励和协助建立与临床化学和检验医学相关的组织和协会；
－ 通过其他的方式，无论是实践和可能的对临床化学和检验医学的改善和对人类的服务，做出贡献。
IFCC现在有76个国家的代表临床化学和检验医学的成员协会，和41个从事体外诊断工业的合作成员
询问地址：
IFCC Office
Via Carlo Farini 81.
20159 Milano, Italy
Phone: +39 02 66809912
Fax: +39 02 60781846
E-mail: ifcc@ifcc.org
Web Site: www.ifcc.org
译后：
实验室的认证目前在发达国家比较普遍，也是临床实验室发展的一个趋势。这种认证是非官方的，非盈利性质的，权威的。摆脱从人为的因素占主导地位到标准化的操作规程（SOP）最后达到优良实验室（GLP）应该是我们检验科的发展方向。
现在的医院往往还存在资历深的操作人员做的结果与刚刚参加工作的人员做的结果影响临床判断的普遍现象，实验室的认证，sop的制定，GLP实验室的确认应该可以很好的解决这一问题。也是解决不同医院检验科做的测试结果不能相互认同的问题，否则患者在一个医院花费了大量的人力财力做的检查到了另一家医院就诊时，还得重来做一遍，这不但对患者造成沉重的经济负担，也是浪费有限的医疗资源。
实验室的认证对未来院外独立的检验中心也是一个很好的参照标准，随着技术和设备的进步，大型医疗器械带来的购置和维护成本给医院带来沉重的负担，院外的检验中心可以很好的解决这些问题，而且更加专业化和集中化，患者也有了更多的选择，医院也可以更加专著于对患者的healthcare。检验科不再会是医院的一个辅助科室，而是一个重要的独立的医疗机构。
随着国家经济的发展，人们对健康问题越来越重视，各种医患矛盾也越来越多。通过认证的实验室，可以有效的解决可能带来的医疗纠纷。临床实验室的操作应该是标准化的而不是平常科室负责人的苦口婆心式的说教（这种形式也不会有良好的效果）。目前医院关于检验科的一些规章制度是非常粗略的，不系统的，我们所说的是要标准化到每一个测试的每一个步骤，象计算机的程序一样精确，确认这些程序的正确与否就需要一个实验室的认证标准，既能提高检验科的运作水平也是对患者和检验从业人员的一种有效的保护。
目前药品生产有GMP认证，有ISO9001认证等等，都给药品企业带来了良性的发展。检验科目前在进行的PCR实验室的认证，标准化操作规程的制定等等，也是刚刚开始吧，还是国家行政性质的认证并非真正意义上的认证。各级临检中心现在还是个半官方的性质，承担这样的认证还有制度上的缺陷，标准的制定和认证的权威性应该是象IFCC这样的组织。我们国家的相关协会比如检验方面的协会应该承担起这样的作用，制定自己的标准认证，逐步与国际接轨。否则等到我们国家的检验科都必须参加国外的认证标准时，代价就很大了。
具体的认证过程也应该有标准化的程序，相当于认证的法律。只有这样才能保证认证的公平性和权威性。非官方的，第三方机构非常重要，否则会象评定医院等级一样的流于形式而失去本来的意义。
目前我国不知道是否有检验科通过或者正在参与这样的认证实验室工作，希望大家提供这方面的资料和信息。以上均为一己之言，不一定妥当，请提出批评和建议一起交流。我的email:zhou7859@hotmail.com

附原文如下：

PRINCIPLES OF CLINICAL LABORATORY ACCREDITATION
A POLICY STATEMENT BY THE INTERNATIONAL FEDERATION OF CLINICAL CHEMISTRY AND LABORATORY MEDICINE (IFCC)
and
THE WORLD ASSOCIATION OF SOCIETIES OF PATHOLOGY AND LABORATORY MEDICINE (WASPaLM)
1. THE PURPOSES AND NATURE OF LABORATORY ACCREDITATION
It is in the interests of patients, of society, and of governments that clinical laboratories operate at high standards of professional and technical competence, for the following reasons:
.   Decisions about diagnosis, prognosis and treatment are frequently based on the results and interpretations of laboratory tests, and irreversible harm may be caused by erroneous results
.   Users of clinical laboratory services (both patients and clinicians) may not have sufficient technical knowledge to allow them to determine whether a laboratory operates at a satisfactory level
.   Patients, and to a lesser extent clinicians, may have no choice about the laboratory to be used
.   Laboratory testing can be expensive and the patients, insurance organisations, or governments who pay for testing expect the laboratory to provides valid information
. It is in the interests of competent laboratories that their competence is verified through a process of inspection, comparison against appropriate standards, and public affirmation of their good standing.
.Accreditation is an external audit of the ability of a laboratory to provide a high quality service. This requires a laboratory to submit information demonstrating:
.   conformity with published accreditation standards,
. existence of a management system addressing internal and external measures of quality, outlined in a quality management manual,
.and
.   a qualified expert appraisal by an accreditation body.


2. SCOPE AND ADMINISTRATION
.   Inspection and accreditation processes should include all laboratories and in-vitro diagnostic activities, including physician office laboratories and point-of-care testing.
.   Accreditation should be based on inspection visits and peer review, in addition to provision of information to an inspection agency. The aims of the accreditation system should include improvement of standards of practice through dissemination of information and through continuing professional education.
.   Standard-setting and the inspection process should be implemented by accreditation bodies in which medical and scientific professional societies are strongly represented. Government agencies or health insurance organisations should participate in these bodies to the extent necessary to ensure acceptance and public accountability of the accreditation system. The accreditation system should be revised regularly. The major responsibility for standard-setting remains with the medical and scientific professionals engaged in clinical laboratory work.


3. ASSESSMENT CRITERIA
Standards should be defined by the accreditation body and assessed by peer review. The standards should include:
   Organisation and administration
  This includes the existence of an appropriate administrative and staffing structure, with documentation of accountability and responsibilities.
.   Staff qualifications

There must be sufficient staff with appropriate education and training, with provision for continuing education and assurance of staff competencies.
Staff performing testing should have post-secondary education in appropriate scientific disciplines, and training in laboratory procedures.
Laboratory directors may have initial university qualifications in medicine or science, or another initial university qualification deemed appropriate by individual national policy; but must have specialised post-graduate professional education and training in clinical laboratory work.
   Facilities
  The working environment must be safe for staff and patients, and sufficient and appropriate for the work. Equipment, materials and reagents must be of suitable quality and appropriate for the purposes for which they are used.
.   Quality policy

There must be documentation of policies and procedures, and of laboratory methods. Internal and external quality assurance procedures, and systems evaluation, must cover the preanalytical, analytical and postanalytical phases of sample analysis or examination.

4. ETHICS
Patients are increasingly and appropriately aware of healthcare issues, and desire participation in decisions affecting their health. The ultimate responsibility of a clinical laboratory is to the patient.
Adherence to high standards, such as those related to timeliness of test results, laboratory accuracy and precision, clinical relevance of the tests performed, qualifications and training of personnel, and prevention of errors, is an ethical responsibility of all clinical laboratory staff.
Inspection and accreditation of clinical laboratories should also ensure that the owners, managers and staff comply with ethical standards, such as:
.   Maintenance of confidentiality of patient information
.   Adherence to appropriate technical and professional standards regardless of cost pressures
.   Avoidance of personal, financial and organisational conflicts of interest
.   Non-discrimination against patients or staff based on race, gender, political or religious beliefs, or economic circumstances.


5. ABOUT IFCC
The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) was founded in 1952 in order to advance the science and practice of clinical chemistry throughout the world, in the interests of the peoples of the world. The purposes of the IFCC are now to: - establish, encourage and foster high professional standards of clinical chemistry and laboratory medicine
-promote international co-operation and co-ordination in the development of clinical chemistry and laboratory medicine in matters of research, procedures, materials, regulations and practices, education and training, codes of ethics and related subjects
.- provide a basis for closer liaison and the free exchange of professional information among clinical chemists and other experts in laboratory medicine world wide
.- Sponsor and support International Congresses of Clinical Chemistry; sponsor and support regional congresses and meetings of international scope and interest
.- Encourage, sponsor and/or conduct studies, and prepare recommendations, reviews and reports on facets of clinical chemistry and laboratory medicine of international interest and concern
.- Provide consultation and advice on facets of clinical chemistry and laboratory medicine to all members of the IFCC, other international and regional societies, states, nations, industries and others concerned with the provision of health services and materials
.- Encourage and assist in the organisation and establishment of new societies concerned with clinical chemistry and laboratory medicine
.- Contribute in other ways wherever practical and feasible to the improvement of clinical chemistry and laboratory medicine and their services to humanity.

IFCC now has member societies representing clinical chemistry and laboratory medicine in 76 countries, and 41 Corporate Members engaged in the in-vitro diagnostics industries.
Enquiries should be addressed to:
IFCC Office Via Carlo Farini 81. 20159 Milano, Italy Phone: +39 02 66809912 Fax: +39 02 60781846 E-mail: ifcc@ifcc.org Web Site: www.ifcc.org

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