CEN/TR 15299:2006

SLOVENSKI STANDARD
01-november-2006
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Health informatics - Safety procedures for identification of patients and related objects
Medizinische Informatik - Sicherheitsvorschriften für die Identifikation von Patienten und
dazugehörigen Objekten
Informatique de Santé - Procédures de sureté pour l'identification des patients et des
objets associés
Ta slovenski standard je istoveten z: CEN/TR 15299:2006
ICS:
35.240.80
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL REPORT
CEN/TR 15299
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
September 2006
ICS 35.240.80
English Version
Health informatics - Safety procedures for identification of
patients and related objects
Informatique de Santé - Procédures de sûreté pour Sicherheitsvorschriften für die Identifikation von Patienten
l'identification des patients et des objets associés und dazugehörigen Objekten
This 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, 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: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 15299:2006: E
worldwide for CEN national Members.

Contents Page
Foreword.3
0 Executive summary .4
1 Adverse events in the health care system .5
1.1 Background.5
1.2 Healthcare professional’s errors and Patient safety risk .7
2 Performances of the human operator in the healthcare system .10
2.1 General.10
2.2 The human activity space .10
2.3 Human errors and violations.11
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 The Patient safety framework.21
4.1 The process Minimum Object Set.21
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 MOS Identification and the MDS Retrieval.24
safe
5.2 The automatic Data 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 abbreviations.38
9 Terms and definitions .39

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 were 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 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 to 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.
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 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.
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 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 Clinton’s 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 Americans) 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 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 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 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 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 identification 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
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 critical 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 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 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 appropriate starting point for the health processes that involve non-hospitalised
Patients.
1 Adverse events in the health care system
1.1 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 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 increasing 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 today 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 organisational 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 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 Study 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
hospitalization, 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 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 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 necessary 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 - Patients.
 Passengers are generally in normal health conditions, while Pati
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