SIST-TS CEN ISO/TS 22367:2010
(Main)Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009)
Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009)
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 post-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.
Medizinische Laboratorien - Fehlerverringerung durch Risikomanagement und ständige Verbesserung (ISO/TS 22367:2008, einschließlich Cor 1:2009)
Die vorliegende Technische Spezifikation charakterisiert die Anwendung von ISO 15189 als ein System zur Verringerung von Laborfehlern und zur Verbesserung der Patientensicherheit durch Anwendung der Prinzi-pien des Risikomanagements unter Bezugnahme auf Untersuchungsaspekte, insbesondere auf prä- und postanalytische Aspekte, des Zyklus der labormedizinischen Versorgung. Diese Technische Spezifikation schlägt eine Methodologie zum Finden und Charakterisieren von Fehlern medizinischer Laboratorien vor, die durch die Anwendung von ISO 15189 vermieden werden würden.
Laboratoires médicaux - Réduction d'erreurs par gestion du risque et amélioration continue (ISO/TS 22367:2008, Cor 1:2009 inclus)
Medicinski laboratoriji - Zmanjšanje števila napak z obvladovanjem tveganja in stalnim izboljševanjem (ISO/TS 22367:2008, vključno s popravkom Cor 1:2009)
Ta tehnična specifikacija določa uporabo ISO 15189 kot sistem za zmanjšanje števila laboratorijskih napak in izboljševanje varnosti bolnikov z uporabo načel obvladovanja tveganja v zvezi z vidiki preiskovanja, predvsem z vidiki pred in po preiskavi, cikla laboratorijske zdravstvene oskrbe. Ta tehnična specifikacija predlaga metodologijo za ugotavljanje in določanje napak v medicinskih laboratorijih, ki se jim lahko izognemo z uporabo ISO 15189.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 22367:2010
01-junij-2010
0HGLFLQVNLODERUDWRULML=PDQMãDQMHãWHYLODQDSDN]REYODGRYDQMHPWYHJDQMDLQ
VWDOQLPL]EROMãHYDQMHP ,6276 YNOMXþQRVSRSUDYNRP&RU
Medical laboratories - Reduction of error through risk management and continual
improvement (ISO/TS 22367:2008, including Cor 1:2009)
Medizinische Laboratorien - Fehlerverringerung durch Risikomanagement und ständige
Verbesserung (ISO/TS 22367:2008, einschließlich Cor 1:2009)
Laboratoires médicaux - Réduction d'erreurs par gestion du risque et amélioration
continue (ISO/TS 22367:2008, Cor 1:2009 inclus)
Ta slovenski standard je istoveten z: CEN ISO/TS 22367:2010
ICS:
03.100.01 Organizacija in vodenje Company organization and
podjetja na splošno management in general
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
SIST-TS CEN ISO/TS 22367:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TS CEN ISO/TS 22367:2010
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SIST-TS CEN ISO/TS 22367:2010
TECHNICAL SPECIFICATION
CEN ISO/TS 22367
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
January 2010
ICS 11.100.01
English Version
Medical laboratories - Reduction of error through risk
management and continual improvement (ISO/TS 22367:2008,
including Cor 1:2009)
Laboratoires médicaux - Réduction d'erreurs par gestion du Medizinische Laboratorien - Fehlerverringerung durch
risque et amélioration continue (ISO/TS 22367:2008, Cor Risikomanagement und ständige Verbesserung (ISO/TS
1:2009 inclus) 22367:2008, einschließlich 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. 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
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, Belgium, 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 COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 22367:2010: E
worldwide for CEN national Members.
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SIST-TS CEN ISO/TS 22367:2010
CEN ISO/TS 22367:2010 (E)
Contents Page
Foreword .3
2
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SIST-TS CEN ISO/TS 22367:2010
CEN ISO/TS 22367:2010 (E)
Foreword
The text 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 140 “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.
According 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, Ireland, 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 modification.
3
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SIST-TS CEN ISO/TS 22367:2010
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SIST-TS CEN ISO/TS 22367:2010
TECHNICAL ISO/TS
SPECIFICATION 22367
First edition
2008-05-01
Medical laboratories — Reduction of error
through risk management and continual
improvement
Laboratoires médicaux — Réduction d'erreurs par gestion du risque et
amélioration continue
Reference number
ISO/TS 22367:2008(E)
©
ISO 2008
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SIST-TS CEN ISO/TS 22367:2010
ISO/TS 22367:2008(E)
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ii © ISO 2008 – All rights reserved
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SIST-TS CEN ISO/TS 22367:2010
ISO/TS 22367:2008(E)
Contents Page
Foreword. iv
Introduction . 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
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 from 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 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
© ISO 2008 – All rights reserved iii
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SIST-TS CEN ISO/TS 22367:2010
ISO/TS 22367:2008(E)
Foreword
ISO (the International 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 been
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 standardization.
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 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 Publicly 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 agreement 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 International 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 may 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.
iv © ISO 2008 – All rights reserved
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SIST-TS CEN ISO/TS 22367:2010
ISO/TS 22367:2008(E)
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 specifies 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 considering 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 reactive 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 upon
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. Organizational 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 necessarily 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 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 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 laboratory 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 national regulations normally apply.
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SIST-TS CEN ISO/TS 22367:2010
TECHNICAL SPECIFICATION ISO/TS 22367:2008(E)
Medical laboratories — Reduction of error through risk
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 post-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 indispensable 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 — 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, 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 interpreting
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 A cognitive error is also referred to as an “attentional error” or a “mistake” (see Reference [9]).
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ISO/TS 22367:2008(E)
3.4
failure modes and effects analysis
FMEA
systematic review of a system or product involving 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 “bottom-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 expected 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 the
chance of an unintended adverse event
4 Management responsibility in preventive and corrective actions, and continual
improvement
4.1 Gene
...
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