1、PUBLISHED DOCUMENTPD CEN/TR 15299:2006Health Informatics Safety procedures for identification of patients and related objectsICS 35.240.80g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3
2、g38g50g51g60g53g44g42g43g55g3g47g36g58PD 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 3National forewordThis Published Document was published by BSI. It is the UK implementatio
3、n 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 to its secretary.This publication does not purport to include all the necessary provisions o
4、f a contract. Users are responsible for its correct application.Amendments issued since publicationAmd. No. Date CommentsTECHNICAL REPORTRAPPORT TECHNIQUETECHNISCHER BERICHTCEN/TR 15299September 2006ICS 35.240.80English VersionHealth informatics - Safety procedures for identification ofpatients and
5、related objectsInformatique de Sant - Procdures de sret pourlidentification des patients et des objets associsSicherheitsvorschriften 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 Commit
6、tee CEN/TC 251.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spai
7、n, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES 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 Membe
8、rs.Ref. No. CEN/TR 15299:2006: E2 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 act
9、ivity space .10 2.3 Human errors 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 an
10、d protective controls .20 4 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
11、Capture Technologies.24 5.3 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 15299:20063 Foreword This document (CEN/TR 15299:2006)
12、 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 were A. Sanna, M. Wilikens, A. Borio di Tigliole, G. Klein and P.
13、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 of errors with potential serious safety hazards. The Patient Rel
14、ated 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 to be used for a specific Patient (i.e., medications or prosthese
15、s). 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 15299:20064 0 Executive summary The increasing organizational complexi
16、ty of the healthcare system is widely recognized as a factor of risk for the Patient in the healthcare process. Thus, Patient safety is becoming an emerging issue for the professional and social community. Healthcare professionals and Citizens are both calling for appropriate solutions, as it is evi
17、dent when considering the high frequency and the contents of Patient Safety related articles in the scientific literature and in the mass media. US President Clinton on December 7, 1999 “ took strong new steps to ensure Patient safety through the prevention of medical errors” according to the result
18、s 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 to preventable medical errors, placing as many as 98 000 Americans at unnecessary risk. In addition to the severe health consequences these errors can caus
19、e, their cost in lost income, disability, and health care is as much as $29 billion annually.” President Clintons initiatives include the creation of a task force to submit recommendations, the emission of a directive to federal agencies which administer health plans (serving over 85 million America
20、ns) to implement error reduction techniques, the approval of a multi-million dollar investment in research and additional budget for error prevention 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
21、 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, biological samples and Patient records, the misinterpretation of objective data). In this respect, the healthcare system performance in a given clinical c
22、ase is but the result of the system as a whole, i.e. the result of interdependent performances of innumerable co-operating subsystems, most of them being, or depending from, the performances of human operators. The system performance (a very complex issue indeed) includes the risk of failure due to
23、the human component, i.e. the operator performance: in order to minimise the impact of human fallibility in the safety critical environment of the healthcare system, it is important to design processes that addresses the positive control of Patient safety critical data. The procedures of identificat
24、ion of Patient and Patient Related Objects is the unique intervention point with the highest potential for minimising the risk of human errors and violations in the healthcare system and for deploying an appropriate infrastructure for maximising the performance of the interaction of the health infor
25、matics systems with the real world. In order to obtain such a result, the present CEN/TR defines a framework for: the definition of safety critical objects in the healthcare process (MOS: Minimum Object Set) and the related safety critical data (MDS: Minimum Data Set) according to modelling methodol
26、ogies as IDEF or UML, the definition of the rules of interaction among safety critical objects in the process, and the acquisition and processing of safety critical data by health informatics systems. Finally, the present CEN/TR defines a possible roadmap for a stepwise approach for an effective sta
27、ndardisation activity in the area of Patient Safety, including the main health sub-processes that involve the hospitalised Patient as: Laboratory Medicine and Pathology, Bio-imaging, Drug Therapy Management, Blood Transfusion Management, Surgery Management. Such sub-processes can be considered, from
28、 a process modelling perspective, a case-mix that covers most of the process requirements of Patient safety for the hospitalised Patient and an appropriate starting point for the health processes that involve non-hospitalised Patients. CEN/TR 15299:20065 1 Adverse events in the health care system 1.
29、1 Background The healthcare sector is the largest single 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
30、system, which is an obvious consequence of its mission 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 incre
31、asing number of individuals undergoing a greater number 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 toda
32、y than it was in the past. In addition, because of financial 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 o
33、rganisational complexity, the human operator performance 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
34、 processes (e.g. diagnosis in a clinically complex case), 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 S
35、tudy that has been carried out by the Harvard School of 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 hospit
36、alization, produced a disability at the time of discharge, 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
37、 disabilities of up to 6 months duration; 2,6 % caused 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
38、United States, this situation would be the equivalent 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 necessar
39、y from a cultural point of view, not to consider healthcare 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 -
40、Patients. Passengers are generally in normal health conditions, 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
41、 systems toward a more general safety problem individuation 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 ca
42、ll for increasing system defences versus hazards. Both 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 15299:20066 Table 1 Aviation and Healthcare system differences with re
43、spect 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 decreases the business) Safety does not incre
44、ase 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 system safety database Incrementing operat
45、or 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 enterprise level Accident lawsuit impact vs.
46、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-Gross Domestic Product) History 150 yea
47、rs 2000+ years Human Bias Fear of accident Expectation of miracles CEN/TR 15299:20067 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 y
48、ears is producing awareness of the problem both in the healthcare professional and in the man-of-the-street. Distinctive initiatives in this area have been launched by: The American Medical Association (AMA) in 1997. This initiative, the National Patient Safety Foundation (NPSF) has the mission of i
49、mproving Patient safety in the delivery of health care. Distinct literature is available in the NPSF Web Bibliography, grouped in categories such as: “Administration, legal and policy”, “Anesthesia”, “Core”, “ Critical care, Intensive Care Units”, “Diagnostic decision making”, “Drug, medication”, “Effects of error on doctors, patients, and their Relationships”, “Ergonomics and cognitive factors”, “General adverse events”, “Human-machine interface”, “Laboratory”, “Pediatrics”, “Radiology”, “Reporting systems”, “Surgery”. The Italian Tribunale dei
