ISBT Science Series (2012) 7, 24–28

ª 2012 The Author.

STATE OF THE ART 2A-D2-03 ISBT Science Series  2012 International Society of Blood Transfusion

Quality indicators: a tool for quality monitoring and

improvement
T. Vuk
Croatian Institute of Transfusion Medicine, Zagreb, Croatia

Quality indicators are one of the quality management system (QMS) tools to moni-
tor and control efficiency of the system key segments, while the results collected
serve as a basis for implementation of corrective measures and continuous quality
improvement. There are several classifications of quality indicators. According to
the objectives of their establishment and utilization, they can be internal and exter-
nal. In line with the tripartite quality model, quality indicators can be classified as
structural indicators, process indicators and outcome indicators. Quality indicators
should ideally possess a number of attributes. Besides objectivity (measurability),
the most common requirements are as follows: importance and potential for use,
reliability and validity. Quality indicators offer the possibility of fast and simple
insight into the level of product and service quality and their pattern over time to
the interested parties within and outside the institution. Although quality manage-
ment has long been recognized as being of utmost importance in transfusion medi-
cine, quality indicators as a QMS tool did not receive due attention until recently.
Implementation of quality indicators is a complex process which requires scientific
approach as well as testing and verification before routine usage. Quality indicators
are defined on the basis of scientific concepts, own experiences, results of literature
searches, discussion with experts within and outside the institution, etc. On setting
quality indicators, the numerator and denominator should first be strictly defined.
Quality indicators should be monitored continuously, including trend monitoring
and detection of deviations. Whenever considered necessary, appropriate corrective
measures have to be undertaken.
Key words: quality indicators, quality improvement, quality management.

countries, but also within a country or a region. In addition,

Introduction
there still are great variations in the treatment of the same
We are witnessing progressive advancement everyday in patient groups, while systematic evaluation of different
medical sciences consequential to the integration of numer- therapeutic procedure outcomes is lacking. Decentraliza-
ous scientific achievements and technological solutions, tion and privatization have resulted in greater autonomy of
resulting in the development of a series of diagnostic and medical institutions, which now find interest in achieving
therapeutic procedures. Unfortunately, these favourable competitive ability. However, those passing the regulations
trends are accompanied by an array of unfavourable ones. and ⁄ or providing financial resources should perform
These include continuously increasing healthcare costs, supervision to ensure that these institutions work in line
quite frequently disproportionate to healthcare quality. with the regulations.
Healthcare in general, and high quality healthcare in Therefore, the ever higher demands for the measurement
particular, is not uniformly available and considerable vari- and assessment of healthcare quality are no surprise. These
ations exist not only between developed and developing demands come from various interest groups involved in
healthcare system, first the users, but also the service pro-
Correspondence: Tomislav Vuk, Petrova 3, HR-10000 Zagreb, Croatia viders, regulators, insurance companies, etc. Although
E-mail: tomislav.vuk@hztm.hr quality measurement is a goal as important for all of them,

24
 Quality indicators 25

their motives vary, resulting in different concepts and thus perform systematic analysis of quality indicators used for
different definition of quality. monitoring and assessment of the quality of services
offered to patients.
There are several classifications of quality indicators.
Healthcare quality measurement
According to the objectives of their establishment and
Healthcare quality measurement has a long tradition in utilization, they can be internal and external. Considering
some countries, whereas in others these activities are per- their inter-dependence and importance for quality
formed at a variable frequency and extent. In the United improvement, distinction between these two classes may
States, quality measurement dates back to 1990s, while a frequently be quite vague or unclear. The main differ-
relative long history of these activities is also found in ence, however, lies in the objectives of their collection.
Australia, Canada and Scotland. More recent but often Internal indicators are defined by the institution manage-
emphasized as successful models of quality measurement ment to control their own processes, to upgrade their
are those carried out in Denmark, Germany, The Nether- quality, and consequentially, to achieve better manage-
lands, France, United Kingdom and Sweden. Active ment results. These indicators have to be detailed and
engagement of many organizations and institutions has specific, addressing specificities and problems of local
greatly contributed to the implementation of quality interest. External indicators are global, more general.
measurement and quality indicators. For instance, the They enable surveillance of the indicators to external
Agency for Healthcare Research and Quality (AHRQ) has partners (regulators, insurance companies, users), to pro-
been actively working on quality indicators for more tect their own interest. External indicators should be
than ten years [1]; in 2002, the Organization for Eco- clearly defined to obviate differences arising from differ-
nomic Cooperation and Development (OECD) initiated the ent practice and approach in data collection and process-
Health Care Quality Indicators project [2], aimed at ing. In line with the tripartite quality model (Donabedian)
healthcare quality measurement and comparison among [6], quality indicators can be classified as structural
various countries; a year later, the World Health Organi- indicators (how the processes are organized), process
zation (WHO) Regional Office for Europe launched the indicators (how the activity is performed) and out-
Performance Assessment Tool for quality improvement in come indicators (whether appropriate results have been
Hospitals (PATH) project [3] to collect data on various achieved). There is also the category of ‘performance
quality indicators in hospitals across Europe; in 2005, the indicators’, which overlaps with the above men-
Institute for Quality Laboratory Management (IQLM) Task tioned categories. Quality indicators can also be divided
Force defined and worked out a series of indicators in into key (strategic) indicators and auxiliary process indi-
the field of laboratory activities [4]. cators.
The objective of quality indicators is not just systematic
data collection at the local level, but also comparison of
Characteristics of quality indicators
various quality systems. Therefore, great efforts have been
invested in recent years to establish and validate quality Quality indicators should ideally possess a number of
indicators which could be used at the international level. attributes [7]. Besides objectivity (measurability), the most
This implies collection of relevant data from a large number common requirements are as follows: importance and rel-
of institutions, which cannot be properly done without a evance (in order to be relevant and important to the users
high level of transparency. or the institution, they should cover more common
events and problems); potential for use (when a problem
is identified by measurement, it should be possible to
What are quality indicators?
respond to it and to upgrade the quality); reliability (each
Quality indicators can be defined as measurable, objective indicator should have clear numerator and denominator,
indicators of the efficiency of the key segments of a system data collection should be uniform and comprehensible,
[5]. Quality indicators are one of the tools of Quality Man- and the results obtained should be reliable to be correctly
agement System (QMS) used to monitor and control process interpretable and comparable); and validity (the indicator
functioning, whereby the data collected provide a basis for should be adequately related to the problem monitored).
the implementation of corrective measures and continuous Depending on the goals of their utilization, some authors
quality improvement. According to the ISO 9001 Standard, have added some other attributes. For example, Pringle
conformity with the set quality standards and goals, and et al. propose a list of 12 attributes which should be
thus the efficiency of QMS has to be demonstrated by mea- taken in account on indicator selection [8]. Accordingly,
surement. The laboratories accredited according to the the selection of quality indicators is by no means an easy
international EN ISO 15189 Standard are obliged to process.

 2012 The Author

ISBT Science Series  2012 International Society of Blood Transfusion, ISBT Science Series (2012) 7, 24–28
26 T. Vuk

Objectives of the quality indicator Defining quality indicators

implementation
Implementation of quality indicators is a complex process
Quality indicators offer the possibility of fast and simple which requires scientific approach as well as testing and
insight into the level of product and service quality and verification before routine usage. Determination of qual-
their pattern over time to the interested parties within ity indicators requires thorough exploration of the pro-
and outside the institution. The institution management cesses underlying particular service, assessment of the
can assess the QMS conformity with the set goals, iden- risk and frequency of particular problem, and the possi-
tify weak chains in the process and select priorities to bilities of improvement. Quality indicators are defined on
be solved, with the ultimate goal of quality improve- the basis of scientific concepts, own experiences, results
ment. In addition, quality indicators enable the effi- of literature searches, discussion with experts within and
ciency of corrective measures to assess. Quality outside the institution, etc. [5]. Indicators should prefera-
indicators enable comparison of institutions of similar bly address all activities within the institution, but their
characteristics (benchmarking). They are also important number should not be too great in order to avoid admin-
for the process of accreditation and certification. The istrative burden upon the workers. In laboratory activi-
laboratories accredited according to the international EN ties, quality indicators should cover pre-analytical,
ISO 15189 standards are obliged to perform systematic analytical and post-analytical processes.
analysis and monitoring of quality indicators, whereas Quality indicators would be best defined by a team con-
service users, on the other hand, have an opportunity to sisting of appropriate experts. The professionals thoroughly
choose among various service providers. Through con- familiar with the processes and their pitfalls should be
sensus on the minimal requirements for quality indica- included in the selection of quality indicators. On defining
tors, the institutions implementing the QMS have an quality indicators at the national or regional level, profes-
opportunity to choose most appropriate indicators. sionals from various fields should be involved to ensure
Although originally used in hospitals, quality indicators representation of the institutions of various size and struc-
have been increasingly extended to primary health care ture. This also holds for determination of international indi-
institutions. cators.
Quality indicators should be focused on the basic quality
requirements, product and service safety, and user and pro-
Quality indicators in transfusion medicine
vider expectations. They should also measure satisfaction
Although quality management has long been recognized as of the staff members as well as performance characteristics,
being of utmost importance in transfusion medicine, qual- safety, environment, etc.
ity indicators as a QMS tool did not receive due attention On setting quality indicators, the numerator and denomi-
until recently. Therefore, data on the selection and imple- nator should first be strictly defined. Once established,
mentation of quality indicators, and on the results of their quality indicators need not stay permanently valid. In case
monitoring in particular, are quite insufficient. Available of changes undertaken in the institution structure and
data mostly refer to the field of clinical transfusion medi- organization, particular indicators may be abolished or
cine and laboratory medicine. some new, more appropriate introduced.
During the IHN seminar held in Dubrovnik 2010,
implementation of quality indicators in blood establish-
Setting quality goals and critical action limits
ments at the international level was initiated, aiming at
uniform data collection and analysis, thus enabling com- For the quality indicators to be fully informative and
parison of various transfusion establishments. Discussion their utilization purposeful, acceptable action limits
on the project continued at the ISBT Haemovigilance and should be defined for each individual indicator. For con-
Quality Management working parties meetings. The pro- tinuous quality improvement, the institution should
ject is currently in the phase of discussion of numerators define quality goals for each indicator. Quality goals
and denominators, however, proposals and amendments should be realistic, and thus feasible. Acceptable limits
to the list of indicators presented in Table 1 are welcome. are primarily defined on the basis of scientific concepts
The project of implementation of the quality indicators and professional consensus, whereby each institution has
assessing and monitoring clinical use of blood products to take specificities of the manufacture, donor selection,
has recently been launched within the frame of the Eur- etc. in consideration. An example of setting goals and
open Directorate for the Quality of Medicines & Health- critical limits at a transfusion establishment is described
Care (EDQM). in a paper by Vuk [5].

 2012 The Author

ISBT Science Series  2012 International Society of Blood Transfusion, ISBT Science Series (2012) 7, 24–28
 Quality indicators 27

Table 1 Draft proposal of quality indicators for blood establishments (ISBT WP on Quality Management and WP on Haemovigilance project)

Process Quality indicator

Promotion and selection Accomplishment of the planned number of whole blood (WB) donors
Accomplishment of the planned
number of donors in the apheresis program
Donor deferral rate:
total
permanent
temporary
Blood collection Failed collections:
1. Venepuncture failures in the narrow sense
(failure to introduce needle into the donor’s vein)
2. Interrupted blood collection due to slow (inadequate) flow,
hematoma, donor faintness or collapse, other
(technical factors…)
Clots in red blood cell (RBC) products
Aggregates in platelet concentrates obtained by apheresis
Poor welds on blood collection
Lipemic plasma
Donor adverse reactions
Blood component (BC) production Production index
Product nonconformities
Poor welds on blood product manufacture
Hemolytic plasma
BC storage ⁄ distribution ⁄ issue (BE + HBB) Expired platelet concentrate shelf life
Expired RBC concentrate shelf life
Realization of requests for blood components
Wrong blood product issue
Returned blood products
Component wastage rate (RBC, PLT, FFP) at the hospital
Donor ⁄ product testing Donor sample nonconformities
Proficiency testing – performance evaluation
Positive findings on blood product bacteriological testing
Contamination rate of blood product cultures
Nonconformities in blood product quality control results
Quality management (BE + HBB) Blood product complaints
Donor complaints
SAE (Serious Adverse Events)
Product recall ⁄ withdrawal
Corrective measures completed on time
(initiated by QA department)
Corrective measures from external audits completed on time
Corrective measures from internal audits completed on time
Change controls completed on time
Customer satisfaction
Patient service* Patient sample nonconformities
Nonconformities in the requests for pretransfusion testing
Test turnaround time – urgent requests
C:T ratio
ABO ⁄ Rh(D) discrepancies
RBC units issued under the emergency release procedure

*Quality indicators related to efficacy or outcomes of transfusion therapy are not the subject of this project. Recently, EDQM initiated the project ‘‘Quality
indicators for the evaluation and monitoring the Optimal Use of Blood and Blood Components’’ and quality indicators mentioned will be covered with this
project.
BE, blood establishment; HBB, hospital blood bank.

 2012 The Author

ISBT Science Series  2012 International Society of Blood Transfusion, ISBT Science Series (2012) 7, 24–28
28 T. Vuk

Persons responsible for data collection, method and management. These trends have resulted from continuous
intervals of data collection and processing should be clearly and ever more stringent requirements posed by the profes-
defined and documented. Quality measurement by use of sion, regulatory bodies and the public for quality, safe and
the ‘six sigma’ method enables comparison of quality levels efficacious transfusion treatment. The extent of our
among different institutions. Using this method makes the responding successfully to these challenges greatly
quality more comprehensible to the users. Nevelainen et al. depends, among others, on the body of information avail-
[9] were the first to introduce the sigma scale quality able and mode of our managing this information.
assessment in the area of clinical laboratories. Quality indicators make an important tool for accom-
plishment of the quality goals. This paper underlines their
importance and provides guidelines for their selection,
Monitoring, trend interpretation and
implementation and monitoring. Defining quality indica-
reporting
tors in transfusion service at the international level will
Quality indicators should be monitored continuously, enable standardized approach in data collection and in
including trend monitoring and detection of deviations. comparison of different blood establishments, all this aim-
The importance of each deviation should be assessed and ing at continuous quality improvement.
decide on further activities. Depending on the magnitude of
deviation and importance of the indicator, the decision
Disclosure
may imply intensified surveillance or additional explora-
tion of the root causes of deviation. Whenever considered No conflict of interests to declare.
necessary, appropriate corrective measures have to be
undertaken.
References
Quality indicators usually make part of periodical reports
submitted by persons responsible for their collection and 1 Elixhauser A, Pancholi M, Clancy CM: Using the AHRQ quality
monitoring to the institution management, then serving as indicators to improve health care quality. Jt Comm J Qual Patient
input indicators for assessment of the QMS conformity with Saf 2005; 31:533–538
the set goals (management review). Assuming that quality 2 Mattke S, Epstein AM, Leatherman S: The OECD Health Care
Quality Indicators Project. Int J Qual Health Care 2006; 18(Sup-
is an obligation of all institution employees, quality indica-
pl. 1):1–4
tors should be presented to all of them.
3 Groene O, Klazinga N, Kazandjian V, et al.: The World Health
Organization Performance Assessment Tool for Quality Improve-
Corrective actions ment in Hospitals (PATH): an analysis of the pilot implementa-
tion in 37 hospitals. Int J Qual Health Care 2008; 20:155–161
Continuous product and service quality improvement is 4 Stombler RE, Pollock A, Taylor JR, et al.: Institute for quality in
inconceivable without efficient corrective and preventive laboratory medicine: recognizing excellence in practice: high-
measures. On quality indicator selection, care should be lights from first landmark summit – an opportunity to enhance
exercised for them to carry a potential for quality improve- medical care. April 28–30, 2005, Atlanta, Georgia. Med Gen Med
ment, while the institution management is expected to 2005; 7:57
ensure adequate material and human resources. On decid- 5 Vuk T: Quality indicators in blood establishments: CITM experi-
ence. Blood Transfus 2010; 8(Suppl. 1):20–24
ing on a corrective measure to be undertaken, factors such
6 Donabedian A: The quality of care. How can it be assessed?.
as problem frequency and severity should be taken in con-
J Am Med Assoc 1988; 60:1743–1748
sideration, whereby risk assessment is of utmost impor-
7 Mainz J: Developing evidence-based clinical indicators: a state
tance. The efficiency of corrective measures should be of the art methods primer. Int J Qual Health Care 2003; 15:5–11
properly monitored. 8 Pringle M, Wilson T, Grol R: Measuring ‘‘goodness’’ in individu-
als and healthcare systems. BMJ 2002; 325:704–707
9 Nevelainen D, Berte L, Kraft C, et al.: Evaluating laboratory per-
Conclusion formance on quality indicators with the six sigma scale. Arch
Transfusion medicine is characterized by a dynamic devel- Pathol Lab Med 2000; 124:516–519
opment in both professional aspect and in quality

 2012 The Author

ISBT Science Series  2012 International Society of Blood Transfusion, ISBT Science Series (2012) 7, 24–28