International Federation of Clinical Chemistry and Laboratory Medicine

Working Group “Laboratory Errors and Patient Safety”

MODEL OF QUALITY INDICATORS: KEY PROCESSES

The Model of Quality Indicators has been updated on the basis of the recent Consensus Conference “Harmonization of Quality indicators in Laboratory Medicine: Why,
How and When?”, held in Padova in the October 2013, and a priority score was designed to highlight the value of the individual QI for assessing not only the quality of the
service and possible effects on patient safety, but also the feasibility of data collection (order of priority: 1 = mandatory; 2 = important; 3 = suggested; 4 = valued).

KEY PROCESSES
QUALITY INDICATORS - PRIORITY 1

Quality Indicator Code Reporting Systems Data Collection Time

PRE-ANALYTICAL

Misidentification errors
Pre-MisR Percentage of: Number of misidentified requests/ Total a) count misidentified requests
number of requests. b) count total number of requests
c) calculate percentage
Pre-MisS Percentage of: Number of misidentified samples/ Total a) count misidentified samples
number of samples. b) count total number of samples
c) calculate percentage
Pre-Iden Percentage of: Number of samples with fewer than 2 a) count samples with fewer than 2
identifiers initially supplied/ Total number of samples. identifiers initially supplied
b) count total number of samples
c) calculate percentage
Pre-UnlS Percentage of: Number of unlabelled samples/ Total a) count unlabelled samples
number of samples. b) count total number of samples
c) calculate percentage
Data collection: Every day;
Input data: Monthly
Data collection: Every day;
Input data: Monthly
Data collection: Every day;
Input data: Monthly
Data collection: Every day;
Input data: Monthly

Test transcription errors
Pre-OutpTN Percentage of: Number of outpatients requests with
erroneous data entry (test name)/ Total number of
outpatients requests.
Pre-OutpMT Percentage of: Number of outpatients requests with
erroneous data entry (missed test)/ Total number of
outpatients requests.
a) count outpatients requests with errors Data collection: A week per month;
concerning test name (misinterpreted Input data: Monthly
test)
b) count total number of outpatients
requests
c) calculate percentage
a) count outpatients requests with errors Data collection: A week per month;
concerning missed tests (required tests Input data: Monthly
but not registered)
b) count total number of outpatients
requests

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Pre-OutpAT
Incorrect sample type
Incorrect fill level
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c) calculate percentage
Percentage of: Number of outpatients requests with a) count outpatients requests with errors Data collection: A week per month;
erroneous data entry (added test)/ Total number of concerning added test (registered test Input data: Monthly
outpatients requests. but not required)
b) count total number of outpatients
requests
c) calculate percentage
Pre-InpTN Percentage of: Number of inpatients requests with a) count inpatients requests with errors Data collection: A week per month;
erroneous data entry (test name)/ Total number of concerning test name (misinterpreted Input data: Monthly
inpatients requests. test)
b) count total number of inpatients
requests
c) calculate percentage
Pre-InpMT Percentage of: Number of inpatients requests with a) count inpatients requests with errors Data collection: A week per month;
erroneous data entry (missed test)/ Total number of concerning missed tests (required tests Input data: Monthly
inpatients requests. but not registered)
b) count total number of inpatients
requests
c) calculate percentage
Pre-InpAT Percentage of: Number of inpatients requests with a) count inpatients requests with errors Data collection: A week per month;
erroneous data entry (added test)/ Total number of concerning added test (registered test Input data: Monthly
inpatients requests. but not required)
b) count total number of inpatients
requests
c) calculate percentage
Pre-WroTy Percentage of: Number of samples of wrong or a) count samples of wrong or Data collection: Every day;
inappropriate type (i.e. whole blood instead of plasma)/ inappropriate type (i.e. whole blood Input data: Monthly
Total number of samples. instead of plasma)
b) count total number of samples
c) calculate percentage
Pre-WroCo Percentage of: Number of samples collected in wrong a) count samples collected in wrong Data collection: Every day;
container/ Total number of samples. container Input data: Monthly
b) count total number of samples
c) calculate percentage
Pre-InsV Percentage of: Number of samples with insufficient a) count samples with insufficient Data collection: Every day;
sample volume/ Total number of samples. sample volume Input data: Monthly
b) count total number of samples
c) calculate percentage
Pre-SaAnt Percentage of: Number of samples with inappropriate a) count samples with inadequate Data collection: Every day;
sample-anticoagulant volume ratio/ Total number of sample-anticoagulant volume ratio
b) count total number of samples with Input data: Monthly
samples with anticoagulant.
anticoagulant
c) calculate percentage
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Unsuitable samples for
transportation and storage
problems
Pre-ExcTim
Contaminated samples Pre-MicCon
Sample haemolysed
Samples clotted
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Pre-NotRec Percentage of: Number of samples not received/ Total a) count samples not received Data collection: Every day;
number of samples. b) count total number of samples Input data: Monthly
c) calculate percentage
Pre-NotSt Percentage of: Number of samples not properly stored a) count samples not properly stored Data collection: Every day;
before analysis / Total number of samples. before analysis Input data: Monthly
b) count total number of samples
c) calculate percentage
Pre-DamS Percentage of: Number of samples damaged during a) count samples damaged during Data collection: Every day;
transportation/ Total number of samples. transportation Input data: Monthly
b) count total number of samples
c) calculate percentage
Pre-InTem Percentage of: Number of samples transported at a) count samples transported at Data collection: Every day;
inappropriate temperature/Total number of samples. inappropriate temperature Input data: Monthly
b) count total number of samples for
which the transport temperature is
checked
c) calculate percentage
Percentage of: Number of samples with excessive a) count samples with excessive Data collection: Every day;
transportation time/ Total number of samples. transportation time Input data: Monthly
b) count total number of samples for
which the transport time is checked
c) calculate percentage
Percentage of: Number of contaminated samples a) count contaminated samples rejected Data collection: Every day;
rejected/ Total number of microbiological samples. b) count total number of microbiological Input data: Monthly
samples
c) calculate percentage
Pre-Hem Percentage of: Number of samples with free Hb>0.5 g/L a) count samples with free Hb>0.5 g/L Data collection: Every day;
(clinical chemistry)/ Total number of samples (clinical (clinical chemistry)* Input data: Monthly
chemistry)* b) count total number of samples
(clinical chemistry)
*clinical chemistry: i.e. all samples which are analysed on the c) calculate percentage
chemistry analyser which is used for detection of HIL indices. If
laboratories are detecting hemolysis visually, they count all samples
with visible hemolysis. We suggest that a colour chart is provided for
this purpose.
Pre-Clot Percentage of: Number of samples clotted/ Total number a) count samples clotted Data collection: Every day;
of samples with an anticoagulant. b) count total number of samples ith an Input data: Monthly
anticoagulant
c) calculate percentage
INTRA-ANALYTICAL
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Test with inappropriate
ICQ performances
Test uncovered by an EQA-
PT control
Unacceptable performances
in EQA-PT schemes
Data transcription errors Intra-ErrTran
Intra-FailLIS
Intra-Var Percentage of: Number of tests with CV% higher than a) count number of tests with CV% Data collection: Every year;
selected target, per year/ Total number of tests with higher than selected target Input data: December
CV% known for at least: b) count total number of tests with CV%
- Glucose known*
- Creatinine c) calculate percentage
- Potassium
- C-Reactive Protein
- Troponin I or Troponin T
- TSH * if laboratory checks all proposed tests, the total
- CEA number is 9.
- PT (INR)
- Hemoglobin (Hb)”.
Intra-EQA Percentage of: Number of tests without EQA-PT a) count number of tests without EQA- Data collection: Every year;
control/Total number of tests in the menu. PT control Input data: December
b) count total number of tests in the
laboratory menu
c) calculate percentage
Intra-Unac Percentage of: Number of unacceptable performances in a) count number of unacceptable Data collection: Every year;
EQAS-PT Schemes, per year/ Total number of performances in EQA Schemes Input data: December
performances in EQA Schemes, per year. b) count total number of performances
in EQA Schemes
c) calculate percentage
Percentage of: Number of incorrect results for erroneous a) count incorrect results for erroneous Data collection: Every day;
manual transcription / Total number of results that need manual transcription Input data: Monthly
manual transcription. b) count results that need manual
transcription
c) calculate the percentage
Percentage of: Number of incorrect results for a) count incorrect results for information Data collection: Every day;
information system problems-failures/ Total number of system problems-failures Input data: Monthly
results. b) count total number of results
c) calculate the percentage

POST-ANALYTICAL
Inappropriate turnaround Post-OutTime Percentage of: Number of reports delivered outside the a) count reports delivered outside Data collection: Every day;
times specified time/ Total number of reports. specified time Input data: Monthly
b) count total number of reports
c) calculate the percentage
Post-PotTAT Turn Around Time (minutes) of Potassium (K) at 90th a) estimate the TAT (minutes) of Data collection: A week per month -
percentile (STAT). Potassium at 90th percentile (STAT) per three months;
b) calculate the median value of Input data: April - August - December
estimated TAT

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 Post-INRTAT Turn Around Time (minutes) of International a) estimate the TAT (minutes) of Data collection: A week per month -
Normalized Ratio (INR) value at 90 percentile (STAT). International
th Normalized Ratio (INR) per three months; Input data: April -
value at 90th percentile (STAT) August - December
b) calculate the median value of
estimated TAT
Post-WBCTAT Turn Around Time (minutes) of White Blood Cell Count a) estimate the TAT (minutes) of White Data collection: A week per month -
(WBC) at 90th percentile (STAT). Blood Cell Count (WBC) at 90th per three months;
percentile (STAT) Input data: April - August - December
b) calculate the median value of
estimated TAT
Post-TnTAT Turn Around Time (minutes) of Troponin I (TnI) or a) estimate the TAT (minutes) of Data collection: A week per month -
Troponin T (TnT) at 90th percentile (STAT). Troponin I (TnI) or Troponin T (tnT) at per three months;
90th percentile (STAT) Input data: April - August - December
b) calculate the median value of
estimated TAT
Incorrect laboratory Post-IncRep Percentage of: Number of incorrect reports issued by the a) count number of incorrect reports Data collection: Every day;
reports laboratory / Total number of reports issued by the b) count total number of reports Input data: Monthly
laboratory c) calculate the percentage
Notification of critical Post-InpCV Percentage of: Number of critical values of inpatients a) count critical values of inpatients Data collection: Every day for a
values notified after a consensually agreed time (from result notified after a consensually agreed time month - three months per year;
validation to result communication to the clinician) / (from result validation to result Input data: April - August - December
Total number of critical values of inpatients to communication to the clinician)
communicate. b) count total number of critical values
of inpatients to communicate
c) calculate percentage
Post-OutCV Percentage of: Number of critical values of outpatients a) count critical values of outpatients Data collection: Every day for a
notified after a consensually agreed time (from result notified after a consensually agreed time month - three months per year;
validation to result communication to the clinician) / (from result validation to result Input data: April - August - December
Total number of critical values of outpatients to communication to the clinician)
communicate. b) count total number of critical values
of outpatients to communicate
c) calculate percentage
EQA: External Quality Assessment; PT: Proficiency Testing.

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Quality Indicator
Inappropriate test requests
Inappropriate time in
sample collection
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KEY PROCESSES
QUALITY INDICATORS – PRIORITY 2
Code Reporting Systems Data Collection Time
PRE-ANALYTICAL
Pre-Quest Percentage of: Number of requests without clinical a) count outpatients requests without Data collection: A week per month -
question (outpatients) / Total number of requests clinical question per three months;
(outpatients) b) count total number of outpatients Input data: April - August - December
requests
c) calculate percentage
Pre-InTime Percentage of: Number of samples collected at a) count samples collected at Data collection: Every day;
inappropriate time of sample collection/ Total number of inappropriate time of sample collection Input data: Monthly
samples b) count total number of samples
c) calculate percentage
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Quality Indicator
Unintellegible requests
Inacceptable performances
in EAQ-PT
EQA: External Quality Assessment; PT: Proficiency Testing.
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KEY PROCESSES
QUALITY INDICATORS – PRIORITY 3
Code Reporting Systems Data Collection Time
PRE-ANALYTICAL
Pre-OutUn Percentage of: Number of unintelligible outpatients a) count unintelligible outpatients Data collection: A week per month ;
requests/ Total number of outpatients requests requests Input data: Monthly
b) count total number of outpatients
requests
c) calculate percentage
Pre-InpUn Percentage of: Number of unintelligible inpatients a) count unintelligible inpatients Data collection: A week per month;
requests/ Total number of inpatients requests requests Input data: Monthly
b) count total number of inpatients
requests
c) calculate percentage
INTRA-ANALYTICAL
Intra-PPP Percentage of: Number of unacceptable performances in a) count number of unacceptable Data collection: Every year;
EQAS-PT Schemes per year occurring to previously performances in EQA Schemes grouped Input data: December
treated cause / Total number of unacceptable according to the error cause
performances b) count the total number of
unacceptable performances in EQA
Schemes
c) calculate percentage
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 KEY PROCESSES
QUALITY INDICATORS – PRIORITY 4

Quality Indicator Code Reporting Systems Data Collection Time

PRE-ANALYTICAL
Inappropriate requests Pre-OutReq Percentage of: Number of inappropriate requests, with
respect to clinical question (outpatients) / Number of
requests reporting clinical question (outpatients)
Pre-InReq Percentage of: Number of inappropriate requests, with
respect to clinical question (inpatients) / Number of
requests reporting clinical question (inpatients)
a) select and count outpatients requests Data collection: A week per month -
with clinical question per three months;
b) count the selected requests with Input data: April - August - December
inappropriate tests in relation to clinical
question and on the basis of guidelines
and scientific recommendations
c) calculate percentage
a) select and count inpatients requests Data collection: A week per month -
with clinical question per three months;
b) count the selected requests with Input data: April - August - December
inappropriate tests in relation to clinical
question and on the basis of guidelines
and scientific recommendations
c) calculate percentage

POST-ANALYTICAL
Interpretative comments Post-Comm Percentage of: Number of reports with interpretative a) analyse the reports with interpretative Data collection: A week per month -
comments, provided in medical report, impacting comments, concerning the patients from per three months; Input data: April -
positively on patient's outcome/ Total number of reports a clinical ward, with cliniciansb) August - December
with interpretative comments evaluate the clinical actions undertaken
on the basis of interpretative
commentsc) evaluate the patients
outcomed) count the positive
outcomese) count the total number of
reports with interpretative commentsf)
calculate the percentage
Results notification (TAT) Post-InCVT Time (from result validation to result communication to a) estimate the time (minutes) to Data collection: Every day for a
the clinician) to communicate critical values of communicate critical values of month - three months per year;
inpatients (minutes) inpatients Input data: April - August - December
b) calculate the median value of
estimated times
Post-OutCVT Time (from result validation to result communication to a) estimate the time (minutes) to Data collection: Every day for a
the clinician) to communicate critical values of communicate critical values of month - three months per year;
outpatient (minutes) outpatients Input data: April - August - December
b) calculate the median value of
estimated times

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