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1、DRAFT FOR DEVELOPMENT DD ISO/TS 22367:2008 Medical laboratories Reduction of error through risk management and continual improvement ICS 11.100.01 ? Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI DD ISO/TS 22367:2008 This Draft for Development was publishe
2、d under the authority of the Standards Policy and Strategy Committee on 30 June 2008 BSI 2008 ISBN 978 0 580 54506 1 National foreword This Draft for Development is the UK implementation of ISO/TS 22367:2008. This publication is not to be regarded as a British Standard. It is being issued in the Dra
3、ft for Development series of publications and is of a provisional nature. It should be applied on this provisional basis, so that information and experience of its practical application can be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience c
4、an be reported to the international organization responsible for its conversion to an international standard. A review of this publication will be initiated not later than three years after its publication by the international organization so that a decision can be taken on its status. Notification
5、of the start of the review period will be made in an announcement in the appropriate issue of Update Standards. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into an international Standard, to extend the
6、 life of the Technical Specification or to withdraw it. Comments should be sent to the Secretary of the responsible BSI Technical Committee at British Standards House, 389 Chiswick High Road, London W4 4AL. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs. A
7、list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Amendments/corrigenda issued since publication DateComments Lic
8、ensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI Reference number ISO/TS 22367:2008(E) TECHNICAL SPECIFICATION ISO/TS 22367 First edition 2008-05-01 Medical laboratories Reduction of error through risk management and continual improvement Laboratoires mdicaux R
9、duction derreurs par gestion du risque et amlioration continue DD ISO/TS 22367:2008 Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI ii Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv I
10、ntroduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 Management responsibility in preventive and corrective actions, and continual improvement . 2 4.1 General. 2 4.2 Management responsibility in preventive actions 2 4.3 Management responsibility in corrective actions . 2
11、4.4 Management responsibility in continuous improvement. 3 5 Identification of potential and actual laboratory non-conformities, errors and incidents 3 6 Classification of laboratory non-conformities, errors and incidents 3 7 Preventive action and corrective actions. 4 8 Assessment of risk arising f
12、rom actual and potential laboratory non-conformities. 5 9 Review of collected laboratory non-conformities, errors and incidents 6 10 Preventive action and corrective action plans 6 11 Preventive action and corrective action plan files 6 12 Continual improvement plan . 6 Annex A (informative) Failure
13、 modes and effects analysis . 7 Annex B (informative) Model for assessing risk of harm. 8 Annex C (informative) Ranking of severity levels. 9 Bibliography. 10 DD ISO/TS 22367:2008 Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI iv Foreword ISO (the Internat
14、ional Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has bee
15、n established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical stand
16、ardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for
17、 voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of document: an ISO Pu
18、blicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreemen
19、t between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an I
20、nternational Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. Attention is drawn to the possibility that some of the elements of this document m
21、ay be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TS 22367 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. DD ISO/TS 22367:2008 Licensed CopyChinese University of
22、Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI v Introduction It is a requirement of ISO 15189 that laboratories have an investigative process to identify aspects that do not conform with their own procedures or with predetermined requirements in the quality management system. ISO 15189 spe
23、cifies that this be linked both to corrective actions and to preventive actions. In addition, it specifies that management review the suitability and effectiveness of the system and its activities in support of patient care, and that they introduce necessary changes. This can best be done by conside
24、ring potential risks introduced at each step of each process. Preventive actions are planned and appropriate anticipatory processes, based upon verifiable information, are undertaken to prevent a potential action from occurring. Corrective actions are similarly planned together with appropriate reac
25、tive processes; however, these are undertaken to amend identified problems and to avoid their recurrence. Risk management is a planned process that is part of preventive actions and corrective actions. Preventive actions and corrective actions can be more effectively directed when they are based upo
26、n information that is well-organized; classification systems and risk management analysis are two processes that provide well-organized information. In the context of organizational management, risk has been described as a multidimensional concern about stability and predictability of outcome. Organ
27、izational risk involves components that affect the operational, technical, liability and business aspects of the laboratory. In the context of continual improvement, the risk elements of potential for loss are considered with higher priority than the elements of gain. Consideration of risk necessari
28、ly includes the linked but different elements of likelihood of occurrence and severity of impact. Factors that impact upon risk can act either directly or indirectly. The framework of risk management can be described as consisting of the following steps: a) planning for risk, b) identifying risk and
29、 its impacts, c) developing risk-handling strategies, and d) monitoring for risk control. These steps are consistent with the management requirements described in ISO 15189, including: identifying and controlling non-conformities, establishing preventive actions and corrective actions, carrying out
30、internal audits and management reviews, and implementing continual improvement. This Technical Specification is intended to provide the first steps to introduce risk management into the structure, organization, operation and quality management system of the medical laboratory. Classification of labo
31、ratory non-conformities, errors and incidents is useful for monitoring purposes and allows the laboratory to determine their criticality, to set priorities in addressing them and to identify underlying causative factors that contribute to errors. Considerations contained within local, regional and n
32、ational regulations normally apply. DD ISO/TS 22367:2008 Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI blank Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI 1 Medical laboratories Reduction of error through risk
33、management and continual improvement 1 Scope This Technical Specification characterizes the application of ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with reference to examination aspects, especially to pre- and pos
34、t-examination aspects, of the cycle of laboratory medical care. This Technical Specification proposes a methodology for finding and characterizing medical laboratory error that would be avoided with the application of ISO 15189. 2 Normative references The following referenced documents are indispens
35、able for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000, Quality management systems Fundamentals and vocabulary ISO 14971:2007, Medical devices
36、Application of risk management to medical devices ISO 15189, Medical laboratories Particular requirements for quality and competence ISO/IEC Guide 73, Risk management Vocabulary Guidelines for use 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000,
37、 ISO 14971, ISO 15189, ISO/IEC Guide 73 and the following apply. 3.1 laboratory error failure of a planned action to be completed as intended, or use of a wrong plan to achieve an aim, occurring at any part of the laboratory cycle, from ordering examinations to reporting results and appropriately in
38、terpreting and reacting to them 3.2 active error error by a front-line operator NOTE See Reference 2. 3.3 cognitive error error of incorrect choices, owing to insufficient knowledge, misinterpretation of available information, or application of the wrong cognitive rule NOTE 1 See Reference 1. NOTE 2
39、 A cognitive error is also referred to as an “attentional error” or a “mistake” (see Reference 9). DD ISO/TS 22367:2008 Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI 2 3.4 failure modes and effects analysis FMEA systematic review of a system or product in
40、volving identification of potential failures and assessing the impact on total system/product performance of that failure NOTE 1 This analysis also includes (a) review(s) of the steps taken to guard against failure, or to mitigate its effect. NOTE 2 The procedure is sometimes referred to as a “botto
41、m-up” analysis. 3.5 latent error error due to underlying structural factors not under control of the front end operator EXAMPLE Faulty equipment, poor design, management decision, or organization structure (see Reference 2). 3.6 non-cognitive error error due to inadvertent or unconscious lapse in ex
42、pected automatic behaviour NOTE 1 See Reference 1. NOTE 2 A non-cognitive error is also referred to as a “schematic error” or a “slip” (see Reference 9). 3.7 failure mode and effects analysis prospective risk analysis process of high risk processes to identify needed improvements that will reduce th
43、e chance of an unintended adverse event 4 Management responsibility in preventive and corrective actions, and continual improvement 4.1 General Management should ensure the provision of adequate resources to ensure that both preventive and corrective actions can be identified and enacted. 4.2 Manage
44、ment responsibility in preventive actions The management should: define the policy and processes for collecting data about process performance across the testing cycle, analyse the data for trends and patterns that suggest the potential for problems or errors to occur, and formulate and implement pr
45、eventive actions through process improvement to eliminate the causes of potential non-conformities to prevent occurrence. 4.3 Management responsibility in corrective actions The management should: define the policy and processes for identifying and reporting non-conformities, errors, and incidents,
46、ensure all personnel are trained to properly identify and report non-conformities, errors, and incidents, review the results of the analysis of non-conformities, errors, and incidents, and DD ISO/TS 22367:2008 Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI
47、 3 formulate remedial and corrective actions to eliminate or reduce recurrence of the non-conformity, error, or incident. 4.4 Management responsibility in continuous improvement Management should ensure that the results of risk management, preventive actions and corrective actions are incorporated i
48、nto a continual improvement process. 5 Identification of potential and actual laboratory non-conformities, errors and incidents 5.1 Potential and actual laboratory non-conformities, errors and incidents should be identified by means of the following processes: a review of internal audits, incident r
49、eports, opportunities for improvement, or a prospective risk analysis process. 5.2 A map of the total analytical process can be used to identify potential and actual causes for erroneous results. Every step of the process should be analyzed to determine an estimation of probability for each hazard (see Annex A). 6 Classification of laboratory non-conformities, errors and incidents Identified laboratory non-conformities, errors, and incidents can be class