Clin Chem Lab Med 2017; 55(10): 1478–1488

Opinion Paper

Laura Sciacovelli*, Mauro Panteghini, Giuseppe Lippi, Zorica Sumarac, Janne Cadamuro,
César Alex De Olivera Galoro, Isabel Garcia Del Pino Castro, Wilson Shcolnik
and Mario Plebani

Defining a roadmap for harmonizing quality

indicators in Laboratory Medicine: a consensus
statement on behalf of the IFCC Working Group
“Laboratory Error and Patient Safety” and
EFLM Task and Finish Group “Performance
specifications for the extra-analytical phases”
DOI 10.1515/cclm-2017-0412 meaningful information on the risk of errors developing
Received for publication May 11, 2017; previously published online throughout the TEP, and for establishing reliable informa-
July 8, 2017 tion about error frequencies and their distribution. More
recently, the European Federation of Clinical Chemistry
Abstract: The improving quality of laboratory testing
and Laboratory Medicine (EFLM) has created the Task and
requires a deep understanding of the many vulnerable
Finish Group “Performance specifications for the extra-
steps involved in the total examination process (TEP),
analytical phases” (TFG-PSEP) for defining performance
along with the identification of a hierarchy of risks and
specifications for extra-analytical phases. Both the IFCC
challenges that need to be addressed. From this perspec-
and EFLM groups are working to provide laboratories with
tive, the Working Group “Laboratory Errors and Patient
a system to evaluate their performances and recognize the
Safety” (WG-LEPS) of International Federation of Clinical
critical aspects where improvement actions are needed. A
Chemistry and Laboratory Medicine (IFCC) is focusing its
Consensus Conference was organized in Padova, Italy, in
activity on implementation of an efficient tool for obtaining
2016 in order to bring together all the experts and inter-
ested parties to achieve a consensus for effective harmoni-
*Corresponding author: Laura Sciacovelli, Department of Laboratory zation of quality indicators (QIs). A general agreement was
Medicine, University-Hospital, Via Giustiniani 2, 35128 Padova, achieved and the main outcomes have been the release
Italy, E-mail: laura.sciacovelli@aopd.veneto.it. of a new version of model of quality indicators (MQI), the
http://orcid.org/0000-0003-3156-1399
approval of a criterion for establishing performance speci-
Mauro Panteghini: Department of Biomedical and Clinical Sciences
‘Luigi Sacco’, University of Milan, Milan, Italy
fications and the definition of the type of information that
Giuseppe Lippi: Laboratory of Clinical Chemistry and Hematology, should be provided within the report to the clinical labora-
University Hospital, Verona, Italy. http://orcid.org/0000-0001- tories participating to the QIs project.
9523-9054
Zorica Sumarac: Centre for Medical Biochemistry, Clinical Centre of Keywords: extra-analytical phases; harmonization;
Serbia, Belgrade, Serbia patient safety; performance specifications; quality indica-
Janne Cadamuro: Department of Laboratory Medicine, Paracelsus tors; total testing process.
Medical University, Salzburg, Austria
César Alex De Olivera Galoro: Laboratory of Clinical Pathology,
University of Campinas (UNICAMP), São Paulo, Brazil
Isabel Garcia Del Pino Castro: Area Laboratory, Complexo Introduction
Hospitalario, Universitario A Coruña, A Coruña, Spain
Wilson Shcolnik: Brazilian Society of Clinical Pathology/Laboratory
Medicine, Rio de Janeiro, Brazil
One of the leading missions of the Working Group “Labo-
Mario Plebani: Department of Laboratory Medicine, University ratory Errors and Patient Safety” (WG-LEPS) of the Inter-
Hospital, Padova, Italy. http://orcid.org/0000-0002-0270-1711 national Federation of Clinical Chemistry and Laboratory

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 Sciacovelli et al.: Harmonization of quality indicators in Laboratory Medicine 1479

Medicine (IFCC) is to stimulate studies on the topic of consensus on terms, rationale, criteria and purpose of
errors in Laboratory Medicine, collect available data on each QI and its procedures for data collection [11].
this issue, and recommend strategies and procedures for A preliminary set of MQI, reviewed, approved and
improving patient safety in laboratory testing. A recent finally issued after the Consensus Conference, were used
substantial body of evidence has demonstrated that most since 2014, when a second Consensus Conference was
errors in Laboratory Medicine occur in the pre- and post- organized in Padova, on 26th October, 2016, entitled “Har-
analytical phases of laboratory testing [1–5]. Therefore, monization of quality indicators in Laboratory Medicine:
improving the quality of laboratory testing requires a deep 2 years later”. The aim of the meeting was to bring together
understanding of the many vulnerable steps involved in all experts and interested parties for:
the total examination process (TEP), along with the iden- – discussing experience previously accumulated in the
tification of a hierarchy of risks and challenges that need past few years;
to be addressed. From this perspective, the WG-LEPS is – establishing whether or not the list of QIs should be
focusing its activity on implementation of an efficient tool revised, modified or improved;
for obtaining meaningful information on the risk of errors – better understanding the feasibility of data collection
developing throughout the TEP, and for establishing reli- by clinical laboratories worldwide and identifying
able information about error frequencies and their distri- additional tools (e.g. based on information techno-
bution. The final purpose is to: logy) which may be effective to further improve the
– improve the awareness of laboratory professionals ongoing program;
regarding errors and patient safety; – streamlining all other potential improvements and
– define performance specifications for the extra-ana- the best way to achieve a broad consensus for effec-
lytical phases of the TEP, so providing laboratories tive QIs harmonization.
with a benchmark for performance evaluation and
increasing knowledge about the critical aspects need-
ing improvement actions. Conference
More recently, the European Federation of Clinical Chem- The 2016 Conference was very successful, hosting par-
istry and Laboratory Medicine (EFLM) has created the Task ticipants from 14 different Countries: Australia, Austria,
and Finish Group “Performance specifications for the extra- Brazil, China, Croatia, Estonia, France, Hungary, India,
analytical phases” (TFG-PSEP) for defining performance Italy, Serbia, Spain, the UK and the USA. The meeting was
specifications for extra-analytical phases [6]. Both the IFCC also attended by representatives of the Executive Board
and EFLM groups are working to provide laboratories with and Education and Management Division Executive Com-
a system to evaluate their performances and recognize the mittee of the IFCC; the EFLM Executive Board; the EFLM
critical aspects where improvement actions are needed. Working Groups on “Pre-analytical phase” (WG-PRE)
The WG-LEPS project, which commenced in 2008, and “Post-analytical phase” (WG-POST); Italian scientific
aims to define a model of quality indicators (MQI), com- societies of laboratory medicine; the Italian accreditation
plying with harmonization criteria and requirements of body (Accredia); in vitro diagnostic (IVD) manufacturers.
the International Standard ISO 15189:2012 [7]. Specifically, In summarizing what was reported, the purpose of
the quality indicators (QIs) included in the MQI should be the 2016 Conference was to achieve wide consensus on
representative of all the critical activities comprised within which QIs and performance specifications should be used
the TEP and should also be measurable by most labora- in clinical laboratories worldwide, so complying with the
tories worldwide, and be designed to be independent of ISO 15189:2012 requirements, monitoring the main critical
the health care context, laboratory testing’s purpose and activities and promoting minimization of error risk. The
goals, number and types of patients tested, type of activi- data collected and published in the past years were dis-
ties, sensitivity and training of staff, etc. [8–10]. cussed by all participants [12–15].
A preliminary MQI has been initially developed and All QIs included in the last MQI were revisited and
tested under actual conditions, by involving laboratories discussed, in an effort to investigate to what extent each
over a 5-year period (2008–2013). All the main findings indicator may still be valid or should be modified, or whether
that emerged during the experimentation phase were more accurate explanations should be provided (as a note)
discussed in a Consensus Conference held in Padova in for better understanding by the users (i.e. laboratory pro-
2013 (“Harmonization of quality indicators: why, how fessionals). The discussion was continued after the confer-
and when?”). The 2013 Conference reached a preliminary ence with electronic correspondence exchange.

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1480 Sciacovelli et al.: Harmonization of quality indicators in Laboratory Medicine

Despite the importance of using QIs as a quality information that should be provided within the report to
assurance tool, it was also recognized that the number the clinical laboratories participating in the QIs project.
of participating laboratories applying QIs is not as large
as it could and should be. The underlying reasons may
be mainly attributable to time constraints and shortage Model of quality indicators
of human resources for data collection, which may make
it difficult to implement most QIs and to assure continu- The reviewed MQI are reported in Tables 1–3. A general
ous participation over time. Moreover, some national agreement was achieved for all QIs included in the
surveys organized by national scientific societies or MQI. Several measurements (53) have been identified to
external quality assessment (EQA)/proficiency testing monitor 27 QIs (Table 4) and some explanatory notes have
(PT) providers, using a limited number of QIs proposed been exploited for facilitating interpretation of measur-
by WG-LEPS, have potentially distracted the focus on the able events.
MQI project. The agreed MQI are now (2017) available from the ded-
According to the consensus of the 2014 EFLM Stra- icated WG-LEPS website (www.ifcc-mqi.com), as an Exter-
tegic Conference “Defining analytical performance goals nal Quality Assurance Program (EQAP). The participating
15 years after the Stockholm Conference on Quality Spec- laboratories are not required to use all the QIs proposed
ifications in Laboratory Medicine”, for the definition in the MQI. They can, at least in the initial phase, select
of performance specifications the models based on the the most appropriate QIs for their specific setting (particu-
impact on clinical outcome and on the state-of-the-art larly from among those rated as “priority 1”) and collect
have been discussed, as the biological variation model is and report the corresponding data. Afterwards, they may
not applicable to extra-analytical QIs [16]. In particular, eventually implement and use additional QIs.
it has been widely recognized that performance specifi- Data of participating laboratories will be collected
cations based on a reliable state-of-the-art, defined on through the dedicated website and each participant will
QIs’ data, is the most feasible and attainable criterion to have a confidential username and password for assuring
be immediately applicable because no data can be col- confidentiality.
lected from clinicians’ opinion. Participants’ views have
been exchanged regarding the opportunity to define one,
two or even three limits for defining laboratory perfor- Performance specifications
mance. In particular: one limit set at the 25th percentile
to define the acceptable or unacceptable performance; The limits for evaluation of laboratory performance are
two limits set at 10th–80th percentiles for high, medium fixed at the 25th and 75th percentile according to the QIs
and low performance; three limits set at 25th–50th– data collected during the previous year. The performance
75th for high, medium, low, unacceptable performance, is then classified as follows:
respectively [17]. – individual results <25th percentile of value distribu-
Finally, considerations about the information in the tion = performance of high quality;
reports currently generated for the single laboratories par- – individual results between 25th and 75th percen-
ticipating in the WG-LEPS project have been exchanged, tile of value distribution = performance of medium
in order to evaluate their completeness, adequacy and quality;
effectiveness. Importantly, all participants approved the – individual results >75th percentile of value distribu-
reports without modifications, so judging them to be tion = performance of low quality.
adequate and useful for identifying local laboratory per-
formance and allowing benchmarking with other labora- At the end of each year of data collection, QIs data from
tories both in the same country and around the world. participating laboratories will be processed and analyzed,
so allowing the calculating of the 25th and 75th percentiles
to be used as performance limits for the following year (for
Consensus statement 2017, 2016). The new performance specifications will be
introduced only if the state-of-the art is improving, other-
A general agreement was achieved. The main outcomes wise previous quality specifications should be active. This
of the conference have been the release of a new version criterion, based on the state-of-the-art, allows aligning
of MQI, the approval of a criterion for establishing per- performance specifications to the path of general labora-
formance specifications and the definition of the type of tory improvement and, at the same time, laboratories will

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 Table 1: Quality Indicators concerning the key processes.

Key processes

Quality indicator Code Measurements Priority order Explanatory note

Pre-analytical phase
Misidentification errors Pre-MisR Percentage of: Number of misidentified requests/Total number of 1
requests
Pre-MisS Percentage of: Number of misidentified samples/Total number of 1
samples
Inappropriate test Pre-OffQue Percentage of: Number of requests without clinical question 2 Offside patients = not hospitalized patients
requests (offside patients)/Total number of requests (offside patients)
Pre-OffReq Percentage of: Number of inappropriate requests, with respect to 4 Offside patients = not hospitalized patients
clinical question (offside patients)/Number of requests reporting
clinical question (offside patients)
Pre-InsReq Percentage of: Number of inappropriate requests, with respect to 4 Inside patients = hospitalized patients

Sciacovelli et al.: Harmonization of quality indicators in Laboratory Medicine

clinical question (inside patients)/Number of requests reporting
clinical question (inside patients)
Test transcription errors Pre-LabTDE Percentage of: Number of requests with erroneous data entered 1 Laboratory personnel = personnel that are under the
by laboratory personnel/Total number of requests entered by laboratory control
laboratory personnel
Pre-OffTDE Percentage of: Number of requests with erroneous data entered 1 Offside personnel = personnel that are not under the
by offside personnel/Total number of requests entered by offside laboratory control
personnel
Unintelligible requests Pre-OffUn Percentage of: Number of unintelligible offside patients requests/ 3 Offside patients = not hospitalized patients
Total number of offside patients requests
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Pre-InsUn Percentage of: Number of unintelligible inside patients requests/ 3 Inside patients = hospitalized patients
Total number of inside patients requests
Incorrect sample type Pre-WroTy Percentage of: Number of samples of wrong or inappropriate 1
sample matrix (e.g. whole blood instead of plasma)/Total number
of samples
Pre-WroCo Percentage of: Number of samples collected in wrong container/ 1
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Total number of samples

Incorrect fill level Pre-InsV Percentage of: Number of samples with insufficient sample 1 Insufficient = when the sample volume is less than that
volume/Total number of samples requested independently of the possibility to perform
the test. It has to measure the incorrect collection
(volume inferior than defined), independently of
collected volume (50% or 80 % or 90%)
Samples of pediatric patients have to be excluded
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Pre-SaAnt Percentage of: Number of samples with inappropriate sample- 1

anticoagulant volume ratio/Total number of samples with
anticoagulant

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 Table 1 (continued)

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Key processes

Quality indicator Code Measurements Priority order Explanatory note

Sciacovelli et al.: Harmonization of quality indicators in Laboratory Medicine

Unsuitable samples for Pre-NotRec Percentage of: Number of samples not received/Total number of 1
transportation and storage samples
problems Pre-NotSt Percentage of: Number of samples not properly stored before 1
analysis/Total number of samples
Pre-DamS Percentage of: Number of samples damaged during 1
transportation/Total number of transported samples
Pre-InTem Percentage of: Number of samples transported at inappropriate 1 This QI has to be collected if the transportation
temperature/Total number of samples temperature is measured through appropriate
measuring device or a procedure that guarantees the
detection of the temperature
Pre-ExcTim Percentage of: Number of samples with excessive transportation 1 This QI has to be collected if the transportation time is
time/Total number of samples measured through appropriate measuring devices or a
procedure that guarantees the detection of the times
Contaminated samples Pre-MicCon Percentage of: Number of microbiological contaminated samples 1 Microbiological samples: blood culture, urine,
rejected/Total number of microbiological samples sputum, pharyngeal, etc.
Pre-Cont Percentage of: Number of contaminated samples rejected/Total 1 Contaminated samples = samples which are
number of not microbiological samples contaminated by infusion, drugs, anticoagulants
(EDTA, citrate), parenteral nutrition, X-ray contrast
material, etc.
Haemolysed sample Pre-HemV Percentage of: Number of samples with free hemoglobin (Hb) 1 Checked samples = all samples verified for
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>0.5 g/L detected by visual inspection/Total number of checked hemolysis have to be included (clinical chemistry,
samples for hemolysis immunochemistry, coagulation, etc.)
Pre-HemI Percentage of: Number of samples with free hemoglobin (Hb) 1 Checked samples = all samples verified for
>0.5 g/L detected by automated hemolytic index/Total number of hemolysis have to be included (clinical chemistry,
checked samples for hemolysis immunochemistry, coagulation, etc.)
Pre-HemR Percentage of: Number of samples rejected due to hemolysis/Total 1 Checked samples = all samples verified for
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number of checked samples for hemolysis hemolysis have to be included (clinical chemistry,
immunochemistry, coagulation, etc.).
Clotted samples Pre-Clot Percentage of: Number of samples clotted/Total number of 1 Checked samples = all samples verified for clots have
samples with an anticoagulant checked for clots to be included (hematology, coagulation clinical
chemistry, etc.)
Inappropriate time in Pre-InTime Percentage of: Number of samples collected at inappropriate time 2 This QI has to be collected if time of sample collection
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sample collection of sample collection/Total number of samples requiring a specified is required (e.g. cortisol)
time for data collection
Intra-analytical phase
Test uncovered by an IQC Intra-IQC Percentage of: Number of tests without IQC/Total number of tests 1 IQC: internal quality control
in the menu
Unacceptable Intra-UnIQC Percentage of: Number of IQC results outside defined limits/Total 1 IQC: internal quality control
performances in IQC number of IQC results
 Table 1 (continued)

Key processes

Quality indicator Code Measurements Priority order Explanatory note

Test uncovered by an Intra-EQA Percentage of: Number of tests without EQA-PT control/Total 1 EQA: external quality assessment; PT: proficiency
EQA-PT control number of tests in the menu testing
Unacceptable Intra-Unac Percentage of: Number of unacceptable performances in EQAS-PT 1 EQA: external quality assessment; PT: proficiency
performances in EQA-PT Schemes, per year/Total number of performances in EQA Schemes, testing
schemes per year
Data transcription errors Intra-ErrTran Percentage of: Number of incorrect results for erroneous 1
manual transcription/Total number of results that need manual
transcription
Intra-FailLIS Percentage of: Number of incorrect results for information system 1
problems/Total number of results
Post-analytical phase

Sciacovelli et al.: Harmonization of quality indicators in Laboratory Medicine

Inappropriate turnaround Post-OutTime Percentage of: Number of reports delivered outside the specified 1 Specified time = this concerns the reports (not results)
times time/Total number of reports
Post-PotTAT Turnaround time (minutes), from sample reception in laboratory to 1
release of result, of potassium (K) at the 90th percentile (STAT)
Post-INRTAT Turnaround time (minutes), from sample reception in laboratory to 1
release of result, of the international normalized ratio (INR) value
at the 90th percentile (STAT)
Post-WBCTAT Turnaround time (minutes), from sample reception in laboratory 1
to release of result, of white blood cell (WBC) count at the 90th
percentile (STAT)
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Post-TnTAT Turnaround time (minutes), from sample reception in laboratory 1

to release of result, of cardiac troponin (TnI or TnT) at the 90th
percentile (STAT)
Post-TATPotH Percentage of: Number of potassium results (K) released after 1
1 h/Total number of potassium results (STAT)
Incorrect laboratory Post-RectRep Percentage of: Number of rectified reports by laboratory after the 1 For example: Reports could be rectified for erroneous
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reports release/Total number of released reports results or inappropriate/missed interpretative

comments or wrong patient’s details, etc.
Notification of critical Post-InsCR Percentage of: Number of critical results of inside patients notified 1 Critical results = results that are so “extremely”
results after a consensually agreed time (from result validation to result abnormal and are considered life threatening because
communication to the clinical ward)/Total number of critical results they may be associated with a significant dangerous
of inside patients to communicate event unless a medical action is promptly established.
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Consensually agreed time = time established by

laboratory in which the critical result has to be
effectively reported to the clinical ward
Inside patients = hospitalized patients

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 Table 1 (continued)

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Key processes

Quality indicator Code Measurements Priority order Explanatory note

Sciacovelli et al.: Harmonization of quality indicators in Laboratory Medicine

Post-OffCR Percentage of: Number of critical results of offside patients 1 Critical results = results that are so “extremely”
notified after a consensually agreed time (from result validation to abnormal and are considered life threatening because
result communication to the general practitioner)/Total number of they may be associated with a significant dangerous
critical results of offside patients to communicate event unless a medical action is promptly established.
Consensually agreed time = time established by
laboratory in which the critical result has to be
effectively reported to the general practitioner
Offside patients = not hospitalized patients followed
by general practitioner
Post-InsCRT Median value of time (from result validation to result 4 Critical results = results that are so “extremely”
communication to the clinical ward) to communicate critical results abnormal and are considered life threatening because
of inside patients (minutes) they may be associated with a significant dangerous
event unless a medical action is promptly established.
Inside patients = hospitalized patients
Post-OffCRT Median value of time (from result validation to result 4 Critical results = results that are so “extremely”
communication to the general practitioner) to communicate critical abnormal and are considered life threatening because
results of offside patients (minutes) they may be associated with a significant dangerous
event unless a medical action is promptly established
Offside patients = not hospitalized patients
Interpretative comments Post-Comm Percentage of: Number of reports with interpretative comments 4
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impacting positively on patient’s outcome/Total number of reports

with interpretative comments
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 Sciacovelli et al.: Harmonization of quality indicators in Laboratory Medicine 1485

Table 2: Quality indicators concerning the support processes.

Support processes

Quality indicator Code Measurements Priority order Explanatory note

Employee competence Supp-Train Number of training events organized for all 2

staff, per year
Supp-CME Percentage of: Number of employees that 2 Credits are referred to continuing
obtained all credits required in a year/Total medical education (CME) in order
number of employees to maintain the competence of
medical professionals. Many
Countries require professionals
a specified number of credits (for
examples, 50 credits in a year) for
practicing
Client relationships Supp-Phys Percentage of: Sum of point given in 2
the enquiry to the question of global
satisfaction of the physician/Multiplication
of the maximum point defined in the
enquiries by the number of enquiries
Supp-Pat Percentage of: Sum of point given in 2
the enquiry to the question of global
satisfaction of the patient/Multiplication
of the maximum point defined in the
enquiries by the number of enquiries
Efficiency of laboratory Supp-FailLIS Number of laboratory information system 3
information system unplanned downtime episodes, per year

Table 3: Quality indicators concerning the outcome measures.

Outcome measures

Quality indicator Code Measurements Priority order Explanatory note

Sample Out-RecLab Percentage of: Number of patients with recollected 1 Examples of error:
recollection samples for errors due to laboratory staff/Total erroneous data collection;
number of patients wrong result, etc.
Out-RecOff Percentage of: Number of patients with recollected 1 Examples of error:
samples for errors not due to the laboratory staff/Total erroneous data collection;
number of patients wrong result, etc.
Amended results Out-InacR Percentage of: Number of amended results/Total 1
number of released results

Safety Out-Adv Number of incident/adverse events occurred in 1

laboratory concerning the health and safety of
laboratory staff
Out-Inj Number of needlestick injury/Total number of 1
venipunctures

not be discouraged from reaching unattainable limits, but Table 5 reports, as an example, quality specifications
will still acknowledge that achieving better performance concerning some QIs based on results collected in the
is possible. 2016 year.
Notably, when the QIs data were used to measure the
desirable events (Post-Comm, Supp-Train, Supp-Cred,
Supp-Phys, Supp-Pat), the high and low levels of per- Data reporting for laboratories
formance corresponded to the 75th and 25th percentiles,
respectively. When the percentile values were equal, the The participants’ reports to the EQAP should include the
use of a single value was feasible. following information.

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1486 Sciacovelli et al.: Harmonization of quality indicators in Laboratory Medicine

Table 4: Number of QIs and measurements included in the model of

quality indicators issued in the Consensus Conference in 2016.
Future achievements
Quality indicators Measurements Despite the large number of papers published and the
many presentations during international scientific meet-
Key processes 21 43
– Pre-analytical 11 25 Priority 1 = 19
ings, a large and steady participation of clinical laborato-
Priority 2 = 2 ries to the MQI project has been difficult to achieve. At the
Priority 3 = 2 2016 Conference, the need of using QIs has been empha-
Priority 4 = 2 sized once again, and proposals on applicable strategies
– Intra-analytical 5 6 Priority 1 = 6 were discussed among participants. An agreement on the
– Post-analytical 5 12 Priority 1 = 9
following activities was finally reached:
Priority 4 = 3
Support processes 3 5 Priority 2 = 4 – involvement of national scientific societies, accredita-
Priority 3 = 1 tion bodies and EQA/PT providers of different coun-
Outcome measures 3 5 Priority 1 = 5 tries, as a means for disseminating the MQI project
and promoting the participation of laboratories;
– selection and appointment of a National Leader, who
should coordinate and manage the MQI project in
1. Statistical data: each country. It is expected that the National Leader
a. laboratory result related to the specific period dur- should (i) encourage the use of MQI; (ii) “personalize”
ing which data has been collected and the relative the use of QIs in daily practice according to national
value calculated using Six-Sigma Metric (sigma practices, requirements and regulations; (iii) co-oper-
value = short-term sigma, which allows drift of ate with members of the WG-LEPS and TFG-PEPS pro-
1.5); viding valuable suggestions or improving the project;
b. mean of sigma values for participants of the same – definition of guidelines supporting the use of QIs
country; along with implementation of improvement actions
c. mean of sigma values for all participants. in clinical laboratories.
2. Time trends of both results and sigma values. – update of the website www.ifcc-mqi.com (i.e. entering
3. Frequency distribution of both results and sigma QIs data).
values. – identification of automated and computerized sys-
4. Laboratory performance categorization according to tems for a easy and systematic data collection and
the performance specifications. recording [18].

Table 5: Example of performances specifications for some QIs of the key processes.

Quality indicator Code Performance specifications

High Medium Low

Pre-anaytical phase
Misidentification errors Pre-MisR <0.002 0.002–0.13 >0.13
Pre-MisS 0 0–0.056 >0.056
Pre-Iden 0 0–0.23 >0.23
Incorrect sample type Pre-WroTy 0 0–0.03 >0.03
Pre-WroCo <0.003 0.003–0.03 >0.03
Incorrect fill level Pre-InsV <0.014 0.014–0.092 >0.092
Pre-SaAnt <0.07 0.07–0.57 >0.57
Unsuitable samples for transportation and Pre-NotSt 0 0–0.01 >0.01
storage problems Pre-ExcTim 0 0–0.13 >0.13
Clotted samples Pre-Clot <0.11 0.11–0.43 >0.43
Intra-anaytical phase
Unacceptable performances in EQA-PT schemes Intra-Unac <2.4 2.4–3.8 >3.8
Post-anaytical phase
Inappropriate turnaround times Post-PotTAT <55 55–70 >70
Incorrect laboratory reports Post-IncRep 0 0–0.03 >0.03

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 Sciacovelli et al.: Harmonization of quality indicators in Laboratory Medicine 1487

Conclusions interpretation of data; in the writing of the report; or in the

decision to submit the report for publication.
The valuable experts’ contribution and the consensus
statements described in this article should hopefully
pave the way to better understand the need of a harmo-
nized MQI. On the other hand, the definition of perfor- References
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to receive a report of their performances over time and a tion for Standardization, 2012.
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Participants at the conference: Mario Plebani (Italy), tory medicine. A preliminary consensus. Clin Chem Lab Med
Laura Sciacovelli (Italy), Eva Ajzner (Hungary), Tony 2014;52:951–8.
Badrick (Australia), Janne Cadamuro (Austria), Alex De 12. Sciacovelli L, Lippi G, Sumarac Z, West J, Garcia Del Pino Castro
Olivera Galoro (Brazil), Paul L. Epner (USA), Maurizio I, Furtado Vieira K, et al. Working Group “Laboratory Errors and
Patient Safety” of International Federation of Clinical Chemistry
Ferrari (Italy), Elisabeth Frank (India), Isabel Garcia Del
and Laboratory Medicine (IFCC). Quality Indicators in Labora-
Pino Castro (Spain), Mercedes Ibarz (Spain), Agnes Ivanov tory Medicine: the status of the progress of IFCC Working Group
(Estonia), Giuseppe Lippi (Italy), Keila Furtado Vieira “Laboratory Errors and Patient Safety” project. Clin Chem Lab
(Brazil), Frederick Meier (USA), Mauro Panteghini (Italy), Med 2017;55:348–57.
Rui Zhou (China), Rui Zhang (China), Wilson Shcolnik 13. Sciacovelli L, Aita A, Padoan A, Pelloso M, Antonelli G,
(Brazil), Xiaomei Tang (China), Zorica Sumarac (Serbia), Piva E, et al. Performance criteria and quality indicators for
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Author contributions: All the authors have accepted 14. Plebani M, Sciacovelli L, Aita A, Pelloso M, Chiozza ML. Per-
responsibility for the entire content of this submitted formance criteria and quality indicators for the pre-analytical
manuscript and approved submission. phase. Clin Chem Lab Med 2015;53:943–8. Erratum in: Clin
Research funding: None declared. Chem Lab Med 2015;53:1653.
15. Plebani M, Sciacovelli L, Aita A, Padoan A, Chiozza ML. Quality
Employment or leadership: None declared.
indicators to detect pre-analytical errors in laboratory testing.
Honorarium: None declared. Clin Chim Acta 2014;432:44–8.
Competing interests: The funding organization(s) played 16. Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Ooster-
no role in the study design; in the collection, analysis, and huis W, et al. Defining analytical performance specifications:

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1488 Sciacovelli et al.: Harmonization of quality indicators in Laboratory Medicine

Consensus statement from the 1st strategic conference of the extra-analytical phases of laboratory testing: Why and how. Clin
European federation of clinical chemistry and laboratory medi- Biochem 2017;50:550–4.
cine. Clin Chem Lab Med 2015;53:833–5. 18. Lippi G, Sciacovelli L, Simundic AM, Plebani M. Innovative soft-
17. Plebani M. EFLM Task Force on Performance Specifications for ware for recording preanalytical errors in accord with the IFCC
the extra-analytical phases. Performance specifications for the quality indicators. Clin Chem Lab Med 2017;55:e51–3.

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