1、DRAFT FOR DEVELOPMENT DD CEN ISO/TS 22367:2010Medical laboratories Reduction of error through risk management and continual improvementICS 11.100.01nullnull nullnullnullnullnullnullnull nullnullnullnullnullnullnull nullnullnull nullnullnullnullnullnullnullnullnullnull nullnullnullnullnullnull nullnu
2、ll nullnullnullnullnullnullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnullnullIncorporating corrigendum January 2009 National forewordThis Draft for Development is the UK implementation of CEN ISO/TS 22367:2010. It is identical to ISO/TS 22367:2008, incorporating corrigendum Janu
3、ary 2009. It supersedes DD ISO/TS 22367:2008 which is withdrawn.This publication is not to be regarded as a British Standard.It is being issued in the Draft for Development series of publications and is of a provisional nature. It should be applied on this provisional basis, so that information and
4、experience of its practical application can be obtained.Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the international organization responsible for its conversion to an international standard. A review of this publication will be
5、initiated not later than three years after its publication by the international organization so that a decision can be taken on its status. Notification 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
6、 the end of the review period, the responsible BSI Committee will decide whether to support the conversion into an international Standard, to extend the life of the Technical Specification or to withdraw it. Comments should be sent to the Secretary of the responsible BSI Technical Committee at Briti
7、sh Standards House, 389 Chiswick High Road, London W4 4AL.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the n
8、ecessary provisions of a contract. Users are responsible for its correct application.DD CEN ISO/TS 22367:2010This Draft for Developmentwas published under theauthority of the StandardsPolicy and Strategy Committeeon 30 June 2008 BSI 2010Amendments/corrigenda issued since publicationDate Comments 31
9、August 2009 Implementation of ISO corrigendum January 2009, Clause 3.7 deleted30 April 2010 This corrigendum renumbers DD ISO/TS 22367:2008 as DD CEN ISO/TS 22367:2010ISBN 978 0 580 69153 9TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 22367 January 2010 ICS 11.10
10、0.01 English Version Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009) Laboratoires mdicaux - Rduction derreurs par gestion du risque et amlioration continue (ISO/TS 22367:2008, Cor 1:2009 inclus) Medizinische Labora
11、torien - Fehlerverringerung durch Risikomanagement und stndige Verbesserung (ISO/TS 22367:2008, einschlielich Cor 1:2009) This Technical Specification (CEN/TS) was approved by CEN on 4 January 2010 for provisional application. The period of validity of this CEN/TS is limited initially to three years
12、. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
13、promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached. CEN members are the national standards bodies of Austria, Belgi
14、um, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMI
15、TTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 22367:2010: EForeword The text
16、 of ISO 22367:2008, including Cor 1:2009 has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems” of the International Organization for Standardization (ISO) and has been taken over as CEN ISO/TS 22367:2010 by Technical Committee CEN/TC 1
17、40 “In vitro diagnostic medical devices” the secretariat of which is held by DIN. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. Acco
18、rding to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Irelan
19、d, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 22367:2008, including Cor 1:2009 has been approved by CEN as a CEN ISO/TS 22367:2010 without any m
20、odification. DD CEN ISO/TS 22367:2010 CEN ISO/TS 22367:2010iiiContents PageIntroduction vi1Scope . 12Normative references. 13Terms and definitions. 14Management responsibility in preventive and corrective actions, and continual improvement . 24.1 General. 24.2 Management responsibility in preventive
21、 actions 24.3 Management responsibility in corrective actions.24.4 Management responsibility in continuous improvement.35Identification of potential and actual laboratory non-conformities, errors and incidents 36Classification of laboratory non-conformities, errors and incidents 37Preventive action
22、and corrective actions. 48Assessment of risk arising from actual and potential laboratory non-conformities.59Review of collected laboratory non-conformities, errors and incidents 610 Preventive action and corrective action plans 611 Preventive action and corrective action plan files 612 Continual im
23、provement plan. 6Annex A (informative) Failure modes and effects analysis. 7Annex B (informative) Model for assessing risk of harm. 8Annex C (informative) Ranking of severitylevels. 9Bibliography. 10DD CEN ISO/TS 22367:2010 CEN ISO/TS 22367:2010viIntroduction It isa requirement of ISO 15189 that lab
24、oratories have an investigative process to identify aspects that do notconform with their own procedures orwith predetermined requirements in the q uality management system.ISO 15189 specifies that this be linked both to corrective actions and to preventive actions. In addition, itspecifies that man
25、agement review the suitability and effectiveness of the system and its activities in support ofpatient care, and that theyintroduce necessar y changes. This can best be done by considering potential risks introduced at each step of each process.Preventive actions are planned and appropriate anticipa
26、tory processes, based upon verifiable information, are undertaken to prevent a potential action from occurring. Corrective actions are similarly planned together withappropriate reactive processes; however,these are undertaken to amend identified problems and to avoid their recurrence. Riskmanagemen
27、t 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 uponinformation that is well-organized; classification systems and risk management analysis are two processes that provide
28、well-organized information. In the context of organizational management, risk has been described asa multidim ensional concern aboutstability and predictabilityof outcome. Organizational risk involves components that affect the operational,technical, liabilityand business aspects of the laboratory.
29、In the context of continual improvement, the riskelements of potential for loss are considered with higher prioritythan the elements of gain. Consideration of risk necessarily includes the linked but different elements of likelihood of occurrence and severity of impact. Factors that impact upon risk
30、 can act either directly or indirectly. The framework of riskmanagement can be described as consisting of the following steps: a) planning for risk, b) identifying risk and its impacts, c) developing risk-handling strategies, and d) monitoring for risk control. These steps are consistent with the ma
31、nagement requirements described in ISO 15189, including: identifying and controlling non-conformities, establishing preventive actions and corrective actions, carrying out internal audits and management reviews, and implementing continual improvement. This Technical Specification is intended to prov
32、ide the first steps to introduce risk management into thestructure, organization, operation and quality management system of the medical laboratory. Classification of laboratorynon-conformities, errors and incidents is useful for monitoring purposes and allows the laboratoryto determine their critic
33、ality, to set prioritiesin addressing them and to identifyunderlying causative factors that contribute to errors. Considerations contained within local, regional and national regulations normally apply.DD CEN ISO/TS 22367:2010 CEN ISO/TS 22367:20101Medical laboratories Reduction of error through ris
34、k management and continual improvement 1 Scope This Technical Specification characterizes the application of ISO 15189 as a systemfor reducing laboratoryerror and improving patient safety by applying the principles of riskmanagement, with reference toexamination aspects, especially to pre- and post-
35、examination aspects, of the cycle of laboratory medical care. This Technical Specification proposes a methodology for finding and characterizing medical laboratory errorthat would be avoided with the application of ISO 15189. 2 NormativereferencesThe following referenced documents are indispensable
36、for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the r eferenceddocument (including any amendments) applies.ISO 9000, Quality management systems Fundamentals and vocabulary ISO 14971:2007, Medical devices Applica
37、tion of risk management to medical devicesISO 15189, Medical laboratories Particular requirements for quality and competenceISO/IEC Guide 73, Risk management Vocabulary Guidelines for use3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000, ISO 14971
38、, ISO15189, 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 awrong plan to achieve an aim, occurring atanypart of the laboratory cycle, from ordering examinations to reporting results and appropriatelyinterpreting and r
39、eacting to them3.2 active error error by a front-line operatorNOTE See Reference 2.3.3 cognitive errorerror of incorrect choices, owing to insufficient knowledge, misinterpretation of available information, orapplication of the wrong cognitive rule NOTE 1See Reference 1.NOTE 2 A cognitive error is a
40、lso referred to as an “attentional error” or a “mistake” (see Reference 9). DD CEN ISO/TS 22367:2010 CEN ISO/TS 22367:20102 3.4 failure modes andeffects analysis FMEAsystematic review of a system or product involving identification of potential failures and assessing the impact on total system/produ
41、ct 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 “bottom-up” analysis.3.5 latent error error due to underlying structural factors not under contro
42、l of the front end operatorEXAMPLE Faulty equipment, poor design, management decision, or organization structure (see Reference 2). 3.6 non-cognitive errorerror due to inadvertent or unconscious lapse in expected automatic behaviourNOTE 1 See Reference 1.NOTE 2 A non-cognitive error is also referred
43、 to as a “schematic error” or a “slip” (see Reference 9). 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 correctiveactions can be identified and en
44、acted. 4.2Managementresponsibility in preventive actions The management should: define the policyand 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 an
45、d implement preventive actions through process improvement to eliminate the causes ofpotential non-conformities to prevent occurrence. 4.3Managementresponsibility in corrective actions The management should: define the policyand processes for identifying and reporting non-conformities, errors, and i
46、ncidents, 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 CEN ISO/TS 22367:2010 CEN ISO/TS 22367:20103 formulate remedial and corrective actions to eliminate
47、 or reduce recurrence of the non-conformity, error,or incident. 4.4Managementresponsibility in continuous improvementManagement should ensure that the results of riskmanagement, preventive actions and corrective actions are incorporated into a continual improvement process.5 Identification of potent
48、ial and actual laboratorynon-conformities, errors and incidents 5.1 Potential and actuallaboratorynon-conformities, errors and incidents should be identified by means of the following processes: a review of internal audits, incident reports, opportunities for improvement, or a prospective risk analy
49、sis process.5.2 A map of the total analytical process can be used to identify potential and actual causes for erroneousresults. 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 classified. Points for classification mayinclude, but are not limited to, those listed below.a) Cycle phase of event: pre-examination: incorrectpati
