1、PUBLISHED DOCUMENTPD CEN/TR 15299:2006Health Informatics Safety procedures for identification of patients and related objectsICS 35.240.80g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3
2、g38g50g51g60g53g44g42g43g55g3g47g36g58Licensed Copy: Wang Bin, na, Mon Oct 22 00:49:09 GMT+00:00 2007, Uncontrolled Copy, (c) BSIPD CEN/TR 15299:2006This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 August 2007 BSI 2007ISBN 978 0 580 55675
3、 3National forewordThis Published Document was published by BSI. It is the UK implementation of CEN/TR 15299:2006.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request t
4、o its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Amendments issued since publicationAmd. No. Date CommentsLicensed Copy: Wang Bin, na, Mon Oct 22 00:49:09 GMT+00:00 2007, Uncontrolled Copy, (c)
5、BSITECHNICAL REPORTRAPPORT TECHNIQUETECHNISCHER BERICHTCEN/TR 15299September 2006ICS 35.240.80English VersionHealth informatics - Safety procedures for identification ofpatients and related objectsInformatique de Sant - Procdures de sret pourlidentification des patients et des objets associsSicherhe
6、itsvorschriften fr die Identifikation von Patientenund dazugehrigen ObjektenThis Technical Report was approved by CEN on 5 December 2005. It has been drawn up by the Technical Committee CEN/TC 251.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Est
7、onia, 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 STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISC
8、HES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. CEN/TR 15299:2006: ELicensed Copy: Wang Bin, na, Mon Oct 22 00:49:09 GMT+00:00 2007, Uncontrolled Copy, (c
9、) BSI2 Contents Page Foreword3 0 Executive summary .4 1 Adverse events in the health care system 5 1.1 Background5 1.2 Healthcare professionals errors and Patient safety risk 7 2 Performances of the human operator in the healthcare system 10 2.1 General10 2.2 The human activity space .10 2.3 Human e
10、rrors and violations11 2.4 The organizational accident .13 2.5 The area of intervention 15 3 The healthcare system and process framework 15 3.1 The organization hierarchy.15 3.2 The process hierarchy 15 3.3 The healthcare process in the IDEF framework .18 3.4 Productive and protective controls .20 4
11、 The Patient safety framework.21 4.1 The process Minimum Object Set21 4.2 The process Minimum Data Set .22 4.3 The protective control .23 5 Role of health informatics in the protective control 24 5.1 The MOSsafeIdentification and the MDS Retrieval24 5.2 The automatic Data Capture Technologies.24 5.3
12、 The MDS processing and the consensus to execution .27 5.4 How far to go in the ICT Systems Integration.28 6 The Patient Safety Paradigm 29 7 Conclusions .36 8 List of abbreviations38 9 Terms and definitions .39 CEN/TR 15299:2006Licensed Copy: Wang Bin, na, Mon Oct 22 00:49:09 GMT+00:00 2007, Uncont
13、rolled Copy, (c) BSI3 Foreword This document (CEN/TR 15299:2006) has been prepared by Technical Committee CEN/TC 251 “Health informatics”, the secretariat of which is held by NEN. This document has been prepared by working group (WG) III - Safety, Security and Quality. The authors of this document w
14、ere A. Sanna, M. Wilikens, A. Borio di Tigliole, G. Klein and P.A. Bonini. This work addresses how the procedures for identification of Patient and Patient Related Objects can be carried out in the healthcare process with the active support of Information Technologies, in order to minimize the risk
15、of errors with potential serious safety hazards. The Patient Related Objects include: pure information objects (i.e. electronic/physical records as physiological data or prescriptions), and physical objects obtained from the Patients (i.e., blood samples or other biological materials) and intended t
16、o be used for a specific Patient (i.e., medications or prostheses). The overall aim of this document is to provide a road map for the development of Patient safety related standards in the domain of health informatics that will actively support Patient safety in the healthcare process. CEN/TR 15299:
17、2006Licensed Copy: Wang Bin, na, Mon Oct 22 00:49:09 GMT+00:00 2007, Uncontrolled Copy, (c) BSI4 0 Executive summary The increasing organizational complexity of the healthcare system is widely recognized as a factor of risk for the Patient in the healthcare process. Thus, Patient safety is becoming
18、an emerging issue for the professional and social community. Healthcare professionals and Citizens are both calling for appropriate solutions, as it is evident when considering the high frequency and the contents of Patient Safety related articles in the scientific literature and in the mass media.
19、US President Clinton on December 7, 1999 “ took strong new steps to ensure Patient safety through the prevention of medical errors” according to the results of a study released by the US Institute of Medicine estimating that “ more than half of the adverse medical events occurring each year are due
20、to preventable medical errors, placing as many as 98 000 Americans at unnecessary risk. In addition to the severe health consequences these errors can cause, their cost in lost income, disability, and health care is as much as $29 billion annually.” President Clintons initiatives include the creatio
21、n of a task force to submit recommendations, the emission of a directive to federal agencies which administer health plans (serving over 85 million Americans) to implement error reduction techniques, the approval of a multi-million dollar investment in research and additional budget for error preven
22、tion initiatives in 2001. It is important to highlight that the adverse medical events can be generated in the healthcare process either as a result of the overwhelming complexity of a specific clinical case and as a result of trivial errors in a well known procedure (e.g. the mix up of medications,
23、 biological samples and Patient records, the misinterpretation of objective data). In this respect, the healthcare system performance in a given clinical case is but the result of the system as a whole, i.e. the result of interdependent performances of innumerable co-operating subsystems, most of th
24、em being, or depending from, the performances of human operators. The system performance (a very complex issue indeed) includes the risk of failure due to the human component, i.e. the operator performance: in order to minimise the impact of human fallibility in the safety critical environment of th
25、e healthcare system, it is important to design processes that addresses the positive control of Patient safety critical data. The procedures of identification of Patient and Patient Related Objects is the unique intervention point with the highest potential for minimising the risk of human errors an
26、d violations in the healthcare system and for deploying an appropriate infrastructure for maximising the performance of the interaction of the health informatics systems with the real world. In order to obtain such a result, the present CEN/TR defines a framework for: the definition of safety critic
27、al objects in the healthcare process (MOS: Minimum Object Set) and the related safety critical data (MDS: Minimum Data Set) according to modelling methodologies as IDEF or UML, the definition of the rules of interaction among safety critical objects in the process, and the acquisition and processing
28、 of safety critical data by health informatics systems. Finally, the present CEN/TR defines a possible roadmap for a stepwise approach for an effective standardisation activity in the area of Patient Safety, including the main health sub-processes that involve the hospitalised Patient as: Laboratory
29、 Medicine and Pathology, Bio-imaging, Drug Therapy Management, Blood Transfusion Management, Surgery Management. Such sub-processes can be considered, from a process modelling perspective, a case-mix that covers most of the process requirements of Patient safety for the hospitalised Patient and an a
30、ppropriate starting point for the health processes that involve non-hospitalised Patients. CEN/TR 15299:2006Licensed Copy: Wang Bin, na, Mon Oct 22 00:49:09 GMT+00:00 2007, Uncontrolled Copy, (c) BSI5 1 Adverse events in the health care system 1.1 Background The healthcare sector is the largest sing
31、le service sector, accounting for approximately 600 billion Euro in the European Union (approximately 9 % of the GDP): a remarkable and unique feature of this market is represented by the relevant social and political attention on the healthcare system, which is an obvious consequence of its mission
32、 to protect the health of millions of citizens. The complexity of the healthcare system is rapidly growing, due to the concurrent increase in medical knowledge, biomedical technologies and age of population. This results in an exponentially increasing number of individuals undergoing a greater numbe
33、r of medical acts (either preventive or therapeutic) during their lifetime. In a typical case of hospitalization, the number of medical events, as well as the number of healthcare professionals taking care of a single Patient, is much higher today than it was in the past. In addition, because of fin
34、ancial constraints, hospital management is pressured to reduce the Patient stay. Thus, not only the number of medical events per Patient increases significantly, but they are also concentrated in a shorter time. In such a tremendous increase of organisational complexity, the human operator performan
35、ce in the healthcare system is becoming a key issue. In fact, the Patient life is at stake in the healthcare system: unexpected negative Patient outcomes can be generated not only as a result of erroneous application of complex clinical cognitive processes (e.g. diagnosis in a clinically complex cas
36、e), but also as a result of a single, trivial error in a well known procedure (e.g. the mix up of biological samples). In order to gain an insight on the role of human performances in the healthcare system, we will refer to the Medical Practice Study that has been carried out by the Harvard School o
37、f Public Health. This comprehensive study focuses on the concept of Adverse Event (AE) on the Patient, where an AE is to be intended as an injury that was caused by medical management (rather than underlying disease) and that prolonged the hospitalization, produced a disability at the time of discha
38、rge, or both. The investigators reviewed 30 121 randomly selected records from 51 randomly selected acute-care, non-psychiatric hospitals in New York State. Adverse events were found in 3,7 % of hospitalizations. Of these, 70,5 % of events led to disabilities of up to 6 months duration; 2,6 % caused
39、 permanent disability and 13,6 % led to death. Technical errors or flaws in an operation procedure, or test were the most frequent (44,4%). It has noteworthy been pointed out by the authors that, extrapolating these data to the population of the United States, this situation would be the equivalent
40、of three jumbo jet crashes every two days. The use of a comparative risk approach, i.e. comparison with other systems having safety concerns in term of Customer/third parties risks as aviation, is a very delicate matter indeed, but it is necessary from a cultural point of view, not to consider healt
41、hcare as an absolute term of reference. In comparing the healthcare and the aviation systems, the two basic differences are: pilot and crew share the same risks as Customer - Passengers, that it is not the case for doctors, nurses and Customer - Patients. Passengers are generally in normal health co
42、nditions, while Patients are not. The first point, i.e. Operator and Customer risk sharing, is an element that forces systems toward a “synchronous” attention to the problem from either Customer and Operator perspective or, in other words, forces systems toward a more general safety problem individu
43、ation and solving. As far as the particular health state of the Customer/Patient is concerned, it should be pointed out that such an element does not justify differences in system performance: in fact, increased severity of consequences should call for increasing system defences versus hazards. Both
44、 in the Aviation and the Healthcare systems Customer safety represents a relevant interest. The following Table 1 compares the main differences between the two systems. CEN/TR 15299:2006Licensed Copy: Wang Bin, na, Mon Oct 22 00:49:09 GMT+00:00 2007, Uncontrolled Copy, (c) BSI6 Table 1 Aviation and
45、Healthcare system differences with respect to Customer safety Aviation System Healthcare System Customer vs. operator Pilot and crew share the safety risk with passengers Caregiver does not share the safety risk with Patient Safety vs. Market demand Safety increases the business (non-safety decrease
46、s the business) Safety does not increase business but it affects market competition Customer health conditions during system performance Passenger is in normal health conditions Patient is in particular health conditions Error reporting policy Anonymous PunitiveNear-miss accidents Incrementing syste
47、m safety database Incrementing operator expertise Accident outcomes Evident Wide range that varies from no effect to evident Chance for camouflage of accident outcomes Not realistic/minimal Existing Private interest in accident camouflage Not realistic/minimal High, both at the operator and enterpri
48、se level Accident lawsuit impact vs. enterprise profitability Relevant impact Marginal impact Role in Military Strategy Offensive Marginal/Defensive Synergy with military driven investment and spin off in past 50 years Relevant Marginal European market Not available 600 billions Euro/year (9 % EU-Gr
49、oss Domestic Product) History 150 years 2000+ years Human Bias Fear of accident Expectation of miracles CEN/TR 15299:2006Licensed Copy: Wang Bin, na, Mon Oct 22 00:49:09 GMT+00:00 2007, Uncontrolled Copy, (c) BSI7 1.2 Healthcare professionals errors and Patient safety risk Patient safety in the healthcare process is an emerging issue. The growing number of scientific as well as mass media information produced in the recent years is producing awareness of the problem both in the healthcare professional and in the man-of-the-street. Distinctive initiat
