International Journal of Laboratory Hematology

The Official journal of the International Society for Laboratory Hematology

ORIGINAL ARTICLE INTERNAT IONAL JOURNAL OF LABORATO RY HEMATO LOGY

Internal Quality Control Practices in Coagulation Laboratories:

recommendations based on a patterns-of-practice survey
A. MCFARLANE*, B. ASLAN*, A. RABY*, K. A. MOFFAT † , R. SELBY ‡ , R. PADMORE §

*Institute for Quality S U M M A RY

Management in Healthcare
(IQMH), Toronto, ON, Canada
†
Hamilton Regional Laboratory
Medicine Program, Hamilton,
ON, Canada
‡
Sunnybrook Health Sciences
Centre and University Health
Network, Toronto, ON, Canada
§
Ottawa Hospital—General
Campus, Ottawa, ON, Canada
Correspondence:
A. McFarlane, Institute for
Quality Management in Health-
care (IQMH), 393 University
AvenueSuite 1500, Toronto
M5G 1E6, Ontario, Canada.
Tel.: +1-416-323-9540;
Fax: +1-416-323-9324;
E-mail: amcfarlane@iqmh.org
doi:10.1111/ijlh.12397
Received 18 February 2015;
accepted for publication 19 May
2015
Keywords
Coagulation, quality control,
hemostasis, laboratory practice
Introduction: Internal quality control (IQC) procedures are crucial
for ensuring accurate patient test results. The IQMH Centre for Pro-
ficiency Testing conducted a web-based survey to gather informa-
tion on the current IQC practices in coagulation testing.
Methods: A questionnaire was distributed to 174 Ontario laborato-
ries licensed to perform prothrombin time (PT) and activated partial
thromboplastin time (APTT).
Results: All laboratories reported using two levels of commercial QC
(CQC); 12% incorporate pooled patient plasma into their IQC pro-
gram; >68% run CQC at the beginning of each shift; 56% follow-
ing maintenance, with reagent changes, during a shift, or with
every repeat sample; 6% only run CQC at the beginning of the day
and 25% when the instruments have been idle for a defined period
of time. IQC run frequency was determined by manufacturer rec-
ommendations (71%) but also influenced by the stability of test
(27%), clinical impact of an incorrect test result (25%), and sam-
ple’s batch number (10%). IQC was monitored using preset limits
based on standard deviation (66%), precision goals (46%), or
allowable performance limits (36%). 95% use multirules. Failure
actions include repeating the IQC (90%) and reporting patient
results; if repeat passes, 42% perform repeat analysis of all patient
samples from last acceptable IQC.
Conclusion: Variability exists in coagulation IQC practices among
Ontario clinical laboratories. The recommendations presented here
would be useful in encouraging standardized IQC practices.

optimal quality control (QC) program, can minimize

INTRODUCTION
The laboratory plays a key role in providing test
results that help guide the management of patient
care [1]. Laboratories that design and implement good
quality assurance (QA) practices, which includes an
analytical errors and better ensure accurate patient
results and the quality of test performance [2]. Over
time, QA has evolved from just running QC on analy-
sis to included aspects that are outside of the analytic
process, such as pre-analytical, postanalytical, and

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730 A. MCFARLANE ET AL. | INTERNAL QUALITY CONTROL PRACTICES IN ONTARIO COAGULATION LABORATORIES
other issues that may impact patient results [1, 2].
Internal quality control (IQC) remains the fundamen-
tal component of most laboratory QA programs and
provides documented evidence that the laboratory’s
results are accurate and acceptable for release [3].
Although, external QC and external quality assess-
ment (EQA) or proficiency testing programs are help-
ful in assuring accuracy and, to some extent,
precision, the daily IQC demonstrates day-to-day
method consistency between external challenges and
the original method validation [4].
Currently, there are many challenges facing labora-
tories, such as increased workload and scope of test-
ing, usually with no additional resources or staffing.
In addition, implementation of automated platforms
for higher throughput and increasing use of auto-veri-
fication requires close monitoring of systems to ensure
accurate results are reported [5, 6].
The interpretation of IQC data has evolved from
manual plotting of data and visual inspection of Le-
vey–Jennings graphs to the use of multiple-rule IQC
computer software. The use of integrated software
programs rapidly alert users to potential IQC changes
thereby ensuring better reliability of results. The
advent of advanced software, within or interfaced to
the laboratory information system (LIS), has greatly
accelerated the ability of laboratories to deploy more
advanced IQC practices. Ongoing education is
required to ensure appropriate understanding and use
of IQC when developing and implementing advanced
software programs [5, 6].
National and international guidelines focusing on
good laboratory practice are available for the manage-
ment of IQC. It is important for laboratories to con-
sider the appropriate requirements and guidance
documents including the International Organization
for Standardization (ISO), specifically ISO 15189, and
the Clinical and Laboratory Standards Institute (CLSI)
in the development of an IQC program [7, 8]. A well-
developed IQC program will continuously monitor the
performance of an assay to ensure the reported results
are accurate, reliable, and reproducible. The design of
the IQC system in a routine coagulation laboratory
consists of a number of critical decisions that will ulti-
mately determine its overall effectiveness. Coagulation
tests are essential in the diagnosis of coagulopathies
and to monitor the effectiveness of some anticoagu-
lant therapies. Quality assurance practices in coagula-
tion laboratories, as in all clinical laboratories, have a
significant role in ensuring accurate and precise
patient test results for the management of patient care
and improvement of laboratory services [9].
The Institute for Quality Management in Health-
care (IQMH) [formerly Quality Management Program
—Laboratory Services (QMP-LS)] provides ISO 17043-
accredited proficiency testing for medical laboratories
[10]. In 2012, a web-based patterns-of-practice survey
was conducted to gather information on current IQC
practices in Ontario laboratories for coagulation test-
ing.
The scope of this review is not to provide the basics
of QC, but to provide guidance and recommendations
to clinical laboratories for the planning and imple-
mentation of a good IQC program in coagulation test-
ing. Standardization of IQC practice within and across
laboratories will help provide a means for detecting
important errors and minimize false rejection of test
results to ensure quality patient care.
METHODS
A web-based questionnaire was created and distributed
to 174 Ontario clinical laboratories that are licensed to
perform prothrombin time (PT), reported as interna-
tional normalized ratio (INR) and activated partial
thromboplastin time (APTT). Results were collected
electronically using QViewTM and assessed using MS
Excelâ (Microsoft, Redmond, WA, USA). All 174 labo-
ratories responded. One hundred and forty-one (81%)
laboratories were affiliated with either small or med-
ium hospitals with less than 500 beds; 12 (7%) partici-
pants were from large hospitals with greater than 500
beds; 17 (10%) were ‘community’ (private) laborato-
ries; and four (2%) participants were affiliated with
ambulatory care centers. The average number of
patient samples tested for PT/INR and APTT per day
varied from less than 20 to greater than 600 (Figure 1).
R E S U LT S
Types of quality control materials
Laboratories were asked what types of quality control
materials they used. All laboratories used commercial
quality control materials with 131 (75%) running
commercial QC material from their analyzer’s manu-
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 A. MCFARLANE ET AL. | INTERNAL QUALITY CONTROL PRACTICES IN ONTARIO COAGULATION LABORATORIES 731

APTT PT/INR

Average number of tests reported daily

>600
401 – 600

201 – 400

101 – 200

51 – 100

21 – 50
Figure 1. Average number of
patient samples tested for PT ≤20
and APTT in Ontario 0% 10% 20% 30% 40% 50% 60% 70%
laboratories. Laboratories (%)

facturer and 56 (32%) using third party QC from these indicated that both College of American Pathol-
another manufacturer’s source. Additionally, 13 (7%) ogist (CAP) and LA requirements were used, one
participants reported that their laboratory used com- (0.06%) participant reported use of IQMH Consensus
mercial QC from their analyzer’s manufacturer and Practice Recommendations, two (1%) participants
another source. A minority (22; 12%) of laboratories used recommended or regulatory guidelines which
used an in-house QC of pooled patient plasma. Of were not specified, and one laboratory (0.06%) used
these, 18 (10%) used patient controls at times by itself the CLSI guideline H47-A2. Five (3%) participants
or four (2%) in addition to running a commercial QC reported that QC testing frequency was based on past
material. Two (1%) participants indicated that they experience, and one participant reported that the
used in-house material, one for checking precision length of workday dictated QC frequency. In six (3%)
and the other ran in-house normal plasma pool every organizations, the medical laboratory director or he-
2 h for monitoring the stability of the analytical sys- matopathologist determined frequency of QC runs.
tem between commercial QC runs. All laboratories Other factors considered included the following: the
ran at least one normal and one abnormal CQC daily. stability of the test (46; 27%), clinical impact of incor-
Almost half of the participants reported that their lab- rect test result (42; 25%), and the number of samples
oratory ran one normal and one level of abnormal potentially requiring repeat analysis if QC fails
commercial QC, PT/INR: 81 (47%) and APTT: 79 (17; 10%) (Figure 2).
(46%). The other participants reported that they ran The results were similar for how laboratories estab-
one normal and two levels of abnormal control, PT/ lish the frequency of commercial QC for the APTT test.
INR: 93 (53%) and APTT: 92 (54%). Of 169 laboratories who responded, the majority 119
(70%) based QC frequency on manufacturer recom-
mendations. Other factors considered included the fol-
Frequency of internal quality control runs
lowing: the stability of test (45; 27%), clinical impact
Laboratories were asked how they established the fre- of incorrect test result (42; 25%), and the number of
quency for running commercial controls for PT. Of samples potentially requiring repeat analysis if QC fails
the 172 laboratories who submitted answers for this (18; 11%). Seventy-two (41%) participants selected
question, 122 (71%) follow manufacturer recommen- ‘other’ as an option in the survey with 50 (30%) who
dations for establishing QC frequency of PT runs, 72 reported that they establish frequency of QC runs
(42%) chose alternate options, with 31 (18%) select- based on IQMH LA requirements, 2 (1%) of these
ing one other option, and 41 (24%) selecting multiple indicated that both College of American Patholo-
options. Fifty (29%) laboratories indicated that they gist (CAP) and LA requirements were used, one
use the IQMH Laboratory Accreditation (LA) Stan- (0.06%) participant reported use of IQMH Consensus
dards for determining QC run frequency, two (1%) of Practice Recommendations, two (1%) participants

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732 A. MCFARLANE ET AL. | INTERNAL QUALITY CONTROL PRACTICES IN ONTARIO COAGULATION LABORATORIES
APTT
IQMH laboratory accreditation, CAP, CLSI or
other guidelines
Stability of parameter/test to allow for
retesting
Clinical impact of incorrect test result if
error is undetected
Number of samples potentially requiring
repeat analysis
Manufacturer's recommendation
0% 10% 20% 30% 40% 50% 60% 70% 80%
Percent of participant laboratories
used recommended or regulatory guidelines which
were not specified, and one laboratory (0.06%) used
the CLSI guideline H47-A2. Five (3%) participants
reported that QC testing frequency was based on past
experience, and one participant reported that the
length of workday dictated QC frequency. In six (3%)
organizations, the medical laboratory director or he-
matopathologist determined frequency of QC runs
(Figure 2).
Most laboratories responded that the commercial
QC for the PT and APTT was run at the beginning of
each shift: 119 (69%) and 116 (68%), respectively,
and when the analyzer had not been in use for a
defined time period: 44 (25%) and 43 (25%), respec-
tively. A small number of participants only ran com-
mercial QC for the PT and APTT at the beginning of
the day: 12 (7%) and 11 (6%), respectively. In addi-
tion, some laboratories defined other times that com-
mercial QC would be run for the PT 102 (59%) and
APTT 95 (56%). These times included the following:
postmaintenance, after a reagent change, in the mid-
dle of each shift, with every repeat sample, following
a service on the instrument, every 100 patient sam-
ples, or at time prespecified intervals of either 1, 2, 3,
or 4 h.
The majority (146; 84%) of participants reported
that they do not use in-house patient QC materials
for PT analysis. However, 16 (9%) laboratories speci-
fied that in-house QC was performed with each
defined analytical run, nine (5%) reported in-house
QC was performed when an analyzer had not been
used for a defined time, three (2%) ran at the begin-
ning of each day, two (1%) at the beginning of each
shift, and six (3%) had other responses which stated
that in-house QC was run every one or 2 h between
PT/INR
Figure 2. Sources used in
determination of frequency of
IQC runs.
commercial controls and at the end of each analytical
run. Twenty-two (13%) participants noted that they
determined the stability time frame for in-house QC
materials, and six (3%) participants did not. For the
APTT, 147 (86%) did not use in-house patient QC
materials. However 15 (9%) laboratories specified that
they perform in-house QC with each defined analyti-
cal run, seven (4%) when an analyzer has not been
used for a defined time, three (2%) at the beginning
of each day, two (1%) at the beginning of each shift,
and three (2%) had other responses which included
every one or 2 h between commercial controls, and at
least three times during a shift. Nineteen (11%) par-
ticipants noted that they determined the stability time
frame for in-house QC materials, and six (3%) partici-
pants did not.
Participants were asked how many patient samples
they would run before retesting the commercial QC
for both the PT and APTT. The most common practice
was to run the commercial QC following an analysis
batch of <20 samples: PT (75;43%), APTT (97;56%),
followed by 21–40 samples: PT (33;19%), APTT
(31;18%); 41–60 samples PT (21;12%), APTT
(12;7%); 61–80 samples: PT (8;5%), APTT (6;3%);
and >80 samples: PT (14;8%), APTT (4;2%) (Fig-
ure 3). These results correlate well to the average
number of patient samples being run per day (Fig-
ure 1).
Monitoring internal quality control results
All participants reported that preset QC limits were
used for coagulation tests, but there was a variation in
the procedures used by Ontario laboratories to deter-
mine QC limits. The majority (114; 66%) of laborato-
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 A. MCFARLANE ET AL. | INTERNAL QUALITY CONTROL PRACTICES IN ONTARIO COAGULATION LABORATORIES 733

APTT PT/INR
Other - every 2, 4 or 8 h or after
reagent change
Only run commercial quality control(s)
once a day
>80 patient samples

61 – 80 patient samples

41 – 60 patient samples

21 – 40 patient samples
Figure 3. Number of patient
samples run prior to retesting <20 patient samples
the commercial QC. 0% 10% 20% 30% 40% 50% 60%

ries used the standard deviation (SD) of the QC mate-
rial to set the QC limits. However, many participants
indicated a combination of methods for determining
QC limits was used, including precision goals from
manufacturer recommendations (79; 46%), published
precision goals (45; 26%), and allowable performance
limits (APL) (62; 36%). Of the 107 laboratories that
reported their precision goals, the majority (94; 88%)
of participants use the limit of ≤5% coefficient of vari-
ation (CV) for both the PT and APTT. The remaining
laboratories (13; 12%) reported a wide variation of
precision goals ranging from 6% to 25% for both PT
and APTT (Figure 4).
Nine (5%) participants reported that their labora-
tory used only one QC rule to determine acceptability
for reporting patient results; of these, five (56%) use
12s and four (44%) use 13S. All other laboratories use
multirule procedures (Table 1). The majority (165;
95%) of laboratories use a combination of the 12s, 13S,
22s, R4s, 41s, and 10x rules. Additionally, 34 (20%) lab-
oratories reported also using the following QC rules:
14 (8%) laboratories use two of three 2SD rule (two
of last three results outside of 2SD), nine (5%) use
12x, five (15%) use 8x, 1 (0.5%) uses 7x, one (0.5%)
12x and 7T (seven consecutive data points for a single
level of control show an increasing or decreasing pat-
tern), one (0.5%) uses 7T, and one (0.5%) uses 14s
and 15s. Two (1%) participants that selected other did
not specify the rules that they used.
Laboratories used various methods to monitor the
IQC results: 114 (66%) used a QC program incorpo-
rated into their LIS, 78 (45%) used a QC software
from the QC provider, 69 (40%) used the QC software
on the coagulation analyzer, 21 (12%) used manual
documentation (pen and paper), and five (3%) used
an in-house computer software program built in MS
Excelâ.
Actions taken when internal quality control fails
Laboratories were asked to choose from a list of trou-
bleshooting actions taken when QC fails. Participants’
responses are summarized in Table 2. Almost all of
the responding laboratories (greater than or equal to
90%) repeat the QC and, if it passes, patient results
are reported; participants responded that they would

Precision goals -PT/ INR Precision goals -APTT

80 80.0
Number of laboratories
Number of laboratories

60 60.0

40 40.0

20 20.0

Figure 4. Precision goals for PT 0 0.0

3 3.5 4 4.5 5 7 8 10 15 20 25 1.4 2 3 3.5 4 5 6 8 10 15 20 25
and APTT.
Precision goals (%) Precision goals (%)

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734 A. MCFARLANE ET AL. | INTERNAL QUALITY CONTROL PRACTICES IN ONTARIO COAGULATION LABORATORIES

Table 1. QC acceptability rules used by Ontario Table 3. Documentation of investigation of failed QC

Laboratories
Number of Percent
No. of Laboratories Action Laboratories (%)
(total number of
laboratories = 174) % of Laboratories Record level and lot 165 95
number of QC material
12S 153 88 Analyzer name 154 89
13S 156 90 Rule violated 153 88
22S 152 87 Lot number of reagents 124 71
R4S 129 74 Date and time testing 109 63
41S 93 53 is resumed
10x 64 37 Root cause analysis 102 59
Other 34 20 Authorization for 72 41
Total 174 testing to resume
Lot number of calibrators 39 22

Table 2. Troubleshooting actions when QC fails

Participants were asked what information would be
Number of Percent
documented in the investigation of failed QC, and
Action Laboratories (%)
these responses are summarized in Table 3. Almost all
Repeat the QC, and if it 168 97 (170; 98%) participants document actions taken for
passes, report results troubleshooting, but only 24 (14%) of participants
Open new QC 166 95
include all details listed in their investigation reports.
Look for trending 161 93
Discontinue testing until 156 90 The majority (165; 95%) of laboratories record the
controls are within limits level and lot number of QC material, analyzer name,
Repeat all patient samples 73 42 the rule violated, and the lot number of reagents, and
from last acceptable QC the date and time testing was resumed and the root
Other actions for failed 44 25
cause analysis was performed. A minority (72; 41%)
QC results:
Change reagent 17 10 of laboratories document authorization for testing to
Repeat consecutive samples 8 5 resume and lot number of calibrators.
until no discrepancy Of 168 laboratories that responded to a question
is observed regarding using risk assessment for improvements to
Contact technical 5 3 patient safety, 120 (71%) reported that their labora-
service
tory used risk management techniques. In the coagu-
Calibrate if no analyzer 4 2
issue has been identified lation laboratories, QC issues were used by 131 (77%)
Use options depending 4 2 of participants as a mechanism for identification of
on the failure potential risks for patient safety.
Repeat effected samples 2 1
Confirm calibration 2 1
Repeat random samples 1 0.5 DISCUSSION
Inform charge technologist 1 0.5
A high percentage of medical decisions are influenced
by laboratory results [1]. The results of coagulation
open a new vial of QC, would look for trending of tests are essential for the diagnosis of coagulation dis-
results, would discontinue testing until QC was within orders, assessment of a patient’s risk for bleeding, and
acceptable limits, and 73 (42%) of participants would to monitor effectiveness of some anticoagulant thera-
repeat all patient samples from last acceptable QC. pies [3, 9]. As such, the QA practices for QC in coagu-
There were 44 (25%) participants that reported they lation laboratories, as in all clinical laboratories, have
would take other actions for failed QC results, which a significant role in ensuring accurate and precise
are itemized in Table 2. patient test results [9]. A world leader in quality con-

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 A. MCFARLANE ET AL. | INTERNAL QUALITY CONTROL PRACTICES IN ONTARIO COAGULATION LABORATORIES
trol, Dr. James Westgard, stated ‘Do the right QC
right’ and when this is applied, there is an assurance
of the quality of test results [11]. The incorrect use
and monitoring of quality control strategies can be
associated with serious patient risk when a wrong
result is reported and can add additional costs associ-
ated with performing unnecessary repeat or follow-up
tests [1]. Performing the QC ‘right’ is a shared respon-
sibility within the laboratory from the bench technol-
ogist to laboratory supervisors, managers, and
directors whose responsibility lies in overall quality
assurance within a quality management system [1, 2].
Coagulation testing is considered to be one of the
most complex in diagnostic laboratory testing and
needs to be well controlled for providing reliable
results for screening, diagnosis, and monitoring ther-
apy of hemostasis [12]. The summary of the results
from the 2012 IQMH patterns-of-practice survey
shows significant variability of IQC practices across
Ontario laboratories and suggests that standardization
could be beneficial for detecting errors, minimizing
false rejection of test results, and optimizing produc-
tivity [9, 13].
Choosing the ‘right’ QC is the first step for a good
IQC program [10]. In the results of our survey, all
participating laboratories reported that they used com-
mercial QC materials with approximately one-third
reported using third party QC and a minority of labo-
ratories also using an in-house QC comprised of
pooled patient plasma. Third party QC has the advan-
tage of being an independent assessment for the ana-
lytical performance over multiple reagents and
calibrator lot number changes as it is not optimized
for any specific instrument or reagent system. Choos-
ing the appropriate QC material is essential to ensur-
ing optimal error detection [8]. As there is no perfect
control material, several factors should be taken into
consideration when choosing QC materials, such as
matrix, cost, stability, ease of use, and the laboratory’s
intended application [8, 10, 11]. Part of choosing the
right QC is to include QC levels at or near to clinical
decision points as recommended in ISO 15189 [7].
In addition to commercial controls, patient controls
can be run with each batch, or periodically during
analytical runs, to show reproducibility over time.
This offers an economical approach to rapidly identify-
ing any issue that may develop between running
commercial controls. Repeat testing of a stable patient
© 2015 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2015, 37, 729–738
735
sample can be used as a risk mitigation tool and is a
good verification of precision. Results from a stable
patient sample are compared against previous results
and should be within predetermined and validated
limits. If the difference exceeds the limits, an investi-
gation should be performed to determine the cause.
The use of patient samples may also be used for inter-
and intralaboratory agreement between different ana-
lyzers and they are useful to eliminate matrix effects
when reagents are changed [14–17]. However, labora-
tories need to consider sample stability and the impact
on coagulation test results over time (i.e., loss of fac-
tor activity that may negatively impact reproducibility
of the assays) [18].
It is important to determine the stability of control
materials and effects of different reagents that may be
used in testing. Commercial control materials offer the
advantage of longer storage stability but do have the
disadvantage of possible matrix effects and may be
prone to errors from inaccurate reconstitution of
lyophilized samples [2, 15]. QC material may slightly
degenerate after opening, and a small amount of drift
may be seen before outdating of the QC material [17].
The frequency of running controls is also an impor-
tant part of initiating a good QC program [8]. The
majority of coagulation laboratories in Ontario indi-
cated that commercial QC was run at the beginning of
each shift with 25% of participants reporting that they
also ran their QC if the analyzer has not been in use
for a certain length of time. A small number of partic-
ipants only ran commercial QC at the beginning of
the day. Additionally, participants reported that QC
may be run following maintenance, reagent change,
middle of each shift, and with every repeat sample.
From the results of our 2012 survey, the frequency of
running QC is largely based on manufacturer recom-
mendations. However, other factors considered
included the following: stability of test, clinical impact
of incorrect test results, the number of samples poten-
tially requiring repeat analysis, directive from the lab-
oratory director, and past practices and/or the length
of the workday. About one-third of the participants
also reported using laboratory accreditation require-
ments and regulatory guidelines for determination of
IQC frequency. The most common guidance cited in
the laboratory responses was IQMH. Both IQMH and
CLSI recommend running a minimum of one normal
and one abnormal control during every 8 h of contin-
736 A. MCFARLANE ET AL. | INTERNAL QUALITY CONTROL PRACTICES IN ONTARIO COAGULATION LABORATORIES
uous operation with the level of controls spanning the
clinically relevant reporting range. They both also rec-
ommend running a control specimen immediately fol-
lowing instrument maintenance, reagent change, or a
lot number change. Additionally CLSI suggests run-
ning QC more frequently in high-volume testing cen-
ters by running one of the two or three controls levels
once every 4 h [19, 20].
Manufacturers may offer recommendations for the
frequency of running QC, but it is the responsibility
of the laboratory to evaluate and validate the effec-
tiveness of the control process used in the laboratory
[3, 11]. The length of the analytical run is at the dis-
cretion of the laboratory and the medical director;
however, the decision for length of the analytical run
should take into consideration test volumes and time
between samples. Periodic reassessment of the analyti-
cal performance should be at a frequency that will
monitor the system and increase the likelihood of
detecting system errors, decreasing the potential
release of incorrect results [3, 8, 11, 21, 22]. The con-
cept of an analytical run is the time interval or the
number of measurements over which accuracy and
precision are expected to remain stable [15].
All Ontario laboratories reported the use of preset
QC limits for the assessment of QC results. The major-
ity of survey participants use a combination of the 12s,
13s, 22s, R4s, 41s, and 10X rules. Additionally, laborato-
ries responded also using the following QC rules: 2 of
3 2SD rule (2 of last 3 results outside of 2SD); 12x, 8x,
12x, and 7T (seven consecutive data points for a single
level of control show an increasing or decreasing pat-
tern); and 7T, 14s, and 15s. Monitoring of QC should
be a planned process and reviewed periodically for
detection of systematic and random errors. A system-
atic error is a change in a test system that is always in
one direction and causes a shift in the mean. System-
atic errors are detected by the 22s, 2 of 32s, 31s, 41s, 6X,
and 10X. A systematic error could occur after a QC
sample is tested and could remain undetected for a
period of time before the next QC measurement. A
random error is inherent in any process. It can be
either positive or negative and results in a change in
precision. Random errors are detected by the 13s, 15s,
and R4s rules [8, 11, 15]. These errors can be detected
on careful review of quality control charts.
Precision goals are often used to determine the
reproducibility of results. Precision is defined by the
closeness of agreement between replicate measure-
ments. It is expressed quantitatively in terms of
imprecision either as the standard deviation (SD) or
the coefficient of variation (CV) of results in a set of
replicate measurements [8, 15, 16]. Most often QC
limits are based on the standard deviation of the QC
results but may consider other sources such as preci-
sion goals provided by manufacturers or published lit-
erature or may be determined from allowable
performance limits. Clinicians expect that the labora-
tory report results that are accurate and reproducible
in order to allow the correct medical decision to be
made [23]. It is the responsibility of the laboratory to
determine the appropriate allowable performance lim-
its for each test [24]. In order to do this, laboratories
need to understand how precision goals were derived,
for instance limits will be more stringent if validated
on the same instruments under the same conditions,
or may be extremely wide when validated under dif-
ferent conditions, such as different laboratories with
different operators or when comparing different
instrument/reagent combinations [1, 25].
The majority of participants used the limit of ≤5%
coefficient of variation (CV) for both the PT and APTT.
However, our survey demonstrated a wide variation
of precision goals ranging from 6% to 25% for both
PT and APTT.
The majority of laboratories reported they would
repeat the QC when values are outside of the target
limits. Most would open a new QC sample/vial, and if
the repeat passes, patient results would be reported.
Other strategies for troubleshooting failed QC included
looking for trending, discontinue testing, and repeat-
ing all patient samples from last acceptable QC. The
development of a good QC plan should include identi-
fication of a problem in an assay and maintaining an
accurate documentation of actions taken [15].
The concept of risk management analysis has
become part of the medical laboratory’s day-to-day
operations for improved patient safety by reducing the
risk of patient harm [23–27]. The laboratory must
identify events that could cause the testing process to
be susceptible to errors [3, 23]. A comprehensive dis-
cussion on risk management is beyond the scope of
this document; however, the QC process should
include identifying the potential hazards and fre-
quency of occurrence, analyze the risk of each hazard,
implement controls, and monitor the process [23, 25].
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 A. MCFARLANE ET AL. | INTERNAL QUALITY CONTROL PRACTICES IN ONTARIO COAGULATION LABORATORIES 737

Table 4. Recommendations for IQC in Coagulation

Recommendations

Selection of control material

The QC material needs to reflect the matrix and range of analytes commonly reported for patient samples and at or
near the clinical decision values.
A minimum of two levels, at least one normal and one abnormal must be run.
It is acceptable to use patient controls in combination with commercial controls.
Commercial controls that are lyophilized or freeze dried must be reconstituted as per manufacturer’s directions.
QC should demonstrate stability over the claimed shelf life and the interval after opening or reconstitution.
Define the length if the analytical run and frequency of controls
The length of the run should be defined for each specific analytical system and procedure.
The commercial QC material must be run at least once per day. It is recommended to run controls for routine
coagulation with each batch or at appropriate times throughout a 24-hour period.
Use of Quality Control Rules
Select at minimum the 12s, 13S, 22s, R4s, 41s and 10X QC rules to detect clinically important errors and do not allow
for false rejections.
The 12s rule is a warning rule; it is not recommended to be used as a rejection rule, as it causes the most false
rejections [1].
Actions when quality control fails
Failure of a QC rule requires that patient testing should be stopped. It is common practice to hold and not release
patients’ results until the QC results have been evaluated, thus reducing the risk of reporting erroneous results.
Depending on the size of the batch, the placement of quality control samples at the beginning and also at the end of
an analytical run may help detect shifts in performance.
In laboratories that use auto-validation/auto-verification, results may be released as soon as they are run. Good
practice includes running controls at the beginning of the analytical run to ensure the system is performing
correctly and to include additional controls throughout the analytical run to detect immediate errors and to
monitor changes in the analytical performance and environment.
In determining the intervals, keep in mind that if there is a failure of the QC run, and investigation demonstrates an
analyzer fault, all patient samples since the previous “good” quality control event should be rerun.
Risk management
Document an accurate history of actions that have taken place in the testing system.
Maintain records of all actions that have impact on performance of the system.
Monitor and perform periodic review of records for troubleshooting and to prevent occurrence of QC failures.
Risk analysis should include identifying where failures have occurred, the potential hazards and frequency of
occurrence, analyze the risk of each hazard and determine the QC required to minimize the risks and monitor the
process [3, 5, 8].

One approach is to map the QC process in order to
identify where QC failures may occur and brainstorm
potential causes and determine the amount of QC
needed to minimize patient risk [23, 25]. Documenta-
tion records should include information on scheduled
maintenance, reagent lot number changes and expira-
tion dates, calibration records, quality control results,
summary of statistics including monthly means and
standard deviations, as well as cumulative means,
standard deviations, and control target limits. In addi-
tion, records should include QC problems such as
trends and shifts, corrective actions taken, and trou-
bleshooting reports [3, 13, 23]. When a QC failure is
detected, all testing on that analyzer for that assay
should be discontinued and effective corrective actions
implemented before resuming testing. Protocols
should be implemented to assess the impact on previ-
ously tested specimens since the last successful QC
event [3, 15].
CONCLUSIONS
Our data illustrate the wide variability in QC practices
for coagulation testing in Ontario. Laboratories should
establish an IQC program that ensures patient safety
by monitoring, detecting, and minimizing errors that

© 2015 John Wiley & Sons Ltd, Int. Jnl. Lab. Hem. 2015, 37, 729–738
738 A. MCFARLANE ET AL. | INTERNAL QUALITY CONTROL PRACTICES IN ONTARIO COAGULATION LABORATORIES

may cause harm to a patient and documentation of
investigation of failed QC. A good QC program should
include a ‘minimum’ of two IQC samples, normal and
abnormal, to optimize the probability of error detec-
tion, but minimize the probability of false error detec-
tion. It is important to establish a review system to
include benchmarks to monitor the QC program for
its effectiveness over time for confidence that the ana-
lytical system is producing accurate and good quality
results. This review uses survey results from Ontario
laboratories to provide guidance and recommenda-
tions (Table 4) for clinical laboratories in the planning
and implementation of a good IQC program in coagu-
lation testing. Standardization of IQC practice within
and across laboratories will help provide a means for
detecting important errors and minimize false rejec-
tion of test results to ensure quality patient care.

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