Clin Chem Lab Med 2018; aop
Yuzhu Huang, Wei Wang, Haijian Zhao, Yuxuan Du, Jiali Liu, Falin He, Kun Zhong, Shuai Yuan
and Zhiguo Wang*
Quality assessment of interpretative commenting
and competency comparison of comment
providers in China
https://doi.org/10.1515/cclm-2018-0877
Received August 14, 2018; accepted September 14, 2018
Abstract
Background: This study aimed to evaluate the ability of
comment providers who were responsible for interpreting
results in clinical laboratories in China and to improve the
quality of interpretative comments.
Methods: Basic information and interpretative comments
for five cases of 1912 routine chemistry External Quality
Assessment (EQA) participant laboratories were collected
by web-based EQA system in May 2018. EQA organizers
assigned scores to each key phrase of comments based on
predetermined marking scale and calculated total scores
for each participant’s answer. Final scores and ranking
were calculated according to scores of cases. Finally, we
comprehensively analyzed the type of hospital and the
professional title of participants.
Results: In total, 772 clinical laboratories, 1472 partici-
pants, from different Chinese provinces submitted inter-
pretative comments. Median scores, interquartile ranges
and score ranges of the five cases were 13 (11–15, 1–20),
13 (10–16, 0–20), 15 (12–17, 0–21), 7 (5–9, −2 to 14) and
12 (10–13, −2 to 18). The final scores and ranking of partici-
pants that came from tertiary hospitals were higher than
those from secondary and other hospitals; however, there
*Corresponding author: Zhiguo Wang, National Center for Clinical
Laboratories/Beijing Engineering Research Medicine, Beijing
Hospital, National Center of Gerontology, Beijing, P.R. China; and
Graduate School of Peking Union Medical College, Chinese Academy
of Medical Sciences, Beijing, P.R. China, E-mail: zgwang@nccl.org.cn
Yuzhu Huang: National Center for Clinical Laboratories/Beijing
Engineering Research Medicine, Beijing Hospital, National Center
of Gerontology, Beijing, P.R. China; and Graduate School of Peking
Union Medical College, Chinese Academy of Medical Sciences,
Beijing, P.R. China
Wei Wang, Haijian Zhao, Yuxuan Du, Jiali Liu, Falin He, Kun Zhong
and Shuai Yuan: National Center for Clinical Laboratories/Beijing
Engineering Research Medicine, Beijing Hospital, National Center of
Gerontology, Beijing, P.R. China
were no significant differences (0.774). When grouped by
professional title, we found that although no significant
variability existed among senior, intermediate, junior and
others (0.699), it existed between laboratory physicians
and technicians, as the median final scores of the former
were higher than the latter.
Conclusions: Practice and quality of interpretative com-
ments are indeed different among different laboratories
and participants in China. Laboratories should train and
assess the interpretative ability of personnel. EQA organiz-
ers should also improve the scoring method and establish
peer assessors team through this survey.
Keywords: continually professional development; Exter-
nal Quality Assessment; interpretative commenting;
quality assessment.
Introduction
Interpretative commenting (IC), provided by laboratory
professionals, is the clinical interpretation of labora-
tory results based on the clinical situation of a patient,
either verbally or in printed report [1]. With increasingly
complex diagnosis and therapeutic options, as well as the
expanding laboratory test menu, clinicians may not be
familiar with the tests they ordered and the correspond-
ing results, making it difficult for them to make medical
decisions [2, 3]. IC based on patients’ medical records can
help to integrate laboratory data to therapeutic options
with medical appropriateness and economic benefits [4].
In Section 5.8.3 (Report Content), the International Stand-
ard for the Accreditation of Medical Laboratories, ISO
15189:2012, states that the report shall include, but not be
limited to, interpretation of results, where appropriate [5].
In China, laboratory physicians should be responsi-
ble for the interpretation of testing results because they
have knowledge of clinical and laboratory medicine and
clinical experience. However, there is no clear consen-
sus and requirement of their job responsibility in routine
work [6–8]. The main reason is the reform of the education
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2      Huang et al.: Interpretative commenting
system of laboratory medicine in China; fewer and fewer
students can be laboratory physicians after graduation
[9]. Moreover, technicians dominate clinical laboratory,
and there are few physicians. As a result, technicians with
high qualification and rich clinical experience provide IC
in China. However, the big difference between comment
providers due to different abilities and even part of inter-
pretation comments is incorrect and misleading [10]. The
diversity of IC and the lack of personnel ability are the
main obstacles in developing this activity of postanalyti-
cal phase in full scale.
There are no golden standards and quality require-
ments to assess the quality of IC, and no consensus about
whether, when and how the results of common tests
should be interpreted, although several recommendations
on IC have been published in recent years [4, 11]. External
Quality Assessment (EQA) scheme evaluates the ability of
participants via interlaboratory comparison, which can
determine the expertise and qualification of comment pro-
viders, ensure the quality of IC and reduce the risk of error
[12]. The EQA scheme of IC plays a part in assessing the
competence of laboratory personnel and has a vital effect
on their education and continuing professional develop-
ment, which is different from the analytical EQA scheme
[9]. In the past two decades, UK, Australia and other coun-
tries have already conducted the EQA scheme of IC, but
they only open to native English speakers [4, 13, 14]. At
present, there are no relevant investigation and study of
it in China.
To compare the capability of laboratory comment
providers all over China and to evaluate the quality of
IC, as well as to explore the best practices for the formal
IC EQA scheme, the National Center for Clinical Labo-
ratories (NCCL) conducted relevant investigation from
May 2018.
Materials and methods
Subjects
In total, 1912 laboratories in China were included in this investiga-
tion for IC, which enrolled an EQA program of routine chemistry in
2018.
Definitions
Laboratory personnel – in China, laboratory personnel include labo-
ratory managers, physicians, technicians and part of nurses who
work in laboratory.
Laboratories physicians – part of laboratory personnel who
obtain the qualification certification for practicing physician and
work in laboratory.
Laboratory technicians – part of laboratory personnel who
obtain the qualification certification for laboratory medicine and
work in laboratory.
Intermediate personnel – in China, once laboratory personnel
pass the exam for intermediate qualification of technicians or physi-
cians and get corresponding certification, they can be intermediate
personnel.
Senior personnel – developed from intermediate personnel;
once they pass the exam for senior qualification of technicians or
physicians and comprehensive assessment for capability, papers and
so on, after getting corresponding certification, they can be senior
personnel.
Methods
Five cases (numbers 1, 2, 3, 4 and 5) that came from the UK National
External Quality Assessment Scheme (NEQAS) [15] and the Interpre-
tative Comments Educational Programme 2011 of Asian and Pacific
Federation of Clinical Biochemistry (APFCB) [16] translated into
Chinese were sent to laboratories via Internet. The following details
were provided: patient location, age and sex, brief clinical notes and
a set of biochemistry results and reference range. Key phrase options
and textbox were provided for the comment to simplify the report
form for the first investigation. Participants were required to inter-
pret the results according to case information and submit IC by the
Clinet (www.clinet.com.cn) EQA reporting system version 1.5. Apart
from IC, participants also need to provide professional title, working
years, educational background, clinical experience and laboratory
information.
Reference comments, similar to the targeted value of the quan-
titative EQA scheme, came from expert opinions of UK and Australia
experts with medical and scientific background. Each reference com-
ment was broken up into components that were then translated into
common key phrases. As there was no peer assessor panel for IC in
China at present, EQA organizers used reference comments from the
UK NEQAS and the APFCB quality assurance program and scored key
phrases through discussion. The EQA scheme organizers discussed
cases and assigned a numerical score (+2 to −2) to each key phrase
based on the degree of coincidence. The final score provided to par-
ticipants for each case was the sum of scores for each component,
which help rank all comments of each case.
Marking scale
The EQA scheme of IC was originated from the “Case for Comment”
program developed by Dr. Gordon Challand on October 1997 [17]. In
2001, this was integrated into a formal EQA scheme for IC in Clini-
cal Biochemistry by the UK NEQAS [18, 19]. About 10 peer assessors
with scientific and medical backgrounds assess whole comments
according to added value, and numerical scores are from −1 to +3
(−1 represents incorrect or misleading comments). EQA organizers
calculate the mean score of each participant, which enables the
ranking of all comments [1]. Furthermore, Australia carried out the
EQA scheme of IC formally in the same year as well [20, 21]. In the
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EQA program of Australia, comments are broken up into components
that are translated into common key phrases, which will be classified
into four grades: preferred, less relevant, not supported and mislead-
ing, according to the degree of appropriateness [1]. In 2016, the Inter-
national Federation of Clinical Chemistry and Laboratory Medicine
(IFCC) WG Harmonization of Quality Assessment of Interpretative
Comments (ICQA) proposed a more comprehensive marking scale,
assessing the whole comments rather than key phrases based on the
degree of coincidence; the numerical scores were from 1 to 5 [9].
To avoid subjectivity, this survey combined the above-mentioned
four evaluation criteria and proposed the marking scale (see Table 1)
to assess each key phrase.
Statistical analysis
The score of interpretative comment for each case and each partici-
pant was equal to the sum of scores for key phrases, and the final
scores of this investigation for each participant were equal to the
sum of scores for submitted cases divided by the number of cases.
Ranking was based on final scores. The distribution of scores and
the ranking were abnormal distribution after Kolmogorov-Smirnov
testing; therefore, scores and ranking were presented as median and
percentiles. Participants were grouped by hospital and individual
information. The Kruskal-Wallis H-test was applied to compare at
least three groups, and the Mann-Whitney U-test was used to test the
statistical significance of two groups. Statistical analysis was per-
formed using the Statistical Package for the Social Sciences (SPSS)
(IBM SPSS Statistical for Windows, Version 20.0; IBM Corp, Armonk,
NY, USA) and Excel (Microsoft, Redmond, WA, USA) (2016 version). A
value of p < 0.05 was considered to be statistically significant.
Results
In total, 772 clinical laboratories (40%), 1472 participants,
from different Chinese provinces submitted interpretative
comments through the Clinet EQA reporting system. A total
of 1443 (98%), 1355 (92%), 1455 (99%), 1413 (96%) and 1425
(97%) provided comments for cases 1, 2, 3, 4 and 5. Partici-
pants were required to submit at least three of five cases in
our survey to ensure the validity of the EQA scheme for IC.
Six percent of participants only provided IC for three cases,
whereas 88% of participants interpreted five cases.
Table 1: A proposed marking scale developed by NCCL.a
Score Grade Definition
+2 Optimal Identical interpretation as the panel leading to optimal diagnosis and/or follow-up
+1 Good A similar interpretation that would lead to the optimal or acceptable diagnosis and/or follow-up
0 Neutral A different interpretation that may not contribute to diagnosis or follow-up, but no harm either
−1 Unsatisfactory A different interpretation that will lead to an inadequate diagnosis and/or follow-up
−2 Poor A different interpretation that will lead to a major diagnostic error and/or inappropriate follow-up
Revised from evaluation criteria of “Case for Comment” program and IFCC WG ICQA.
a
Huang et al.: Interpretative commenting      3
Key phrase scores
The supplementary material provides the cases and rel-
evant key phrases of our survey (Supplementary Table
1–5). More than 85% of participants could give “optimal”
components of diagnosis and recommendations for all
cases except case 4, which was the most difficult case in
this investigation. Participants were generally aware of
the importance of communicating with clinicians as the
key phrase of communicative category made up a large
proportion. In addition, Section 5.4.3 (Request Form Infor-
mation) of ISO 15189:2012 points out that the request form
or an electronic equivalent shall allow space for the inclu-
sion of, but not be limited to, clinically relevant informa-
tion about the patient and the request, for examination
performance and result interpretation purposes.
As for case 1, the key point was to distinguish between
a new pregnancy and the retained products of conception.
However, although majority of participants (97%) consid-
ered “incomplete miscarriage”, only 34% of participants
realized that positive urine pregnancy test might suggest
new pregnancy. In terms of case 2, menstrual cycle is
the key; that is, if all were tested in the period of folli-
cle maturity, then the result of luteinizing hormone (LH)
was normal. If not, it is considered as “primary ovarian
failure”, and 87% of participants provided this key phrase.
In addition, drug would cause increased LH, and 78% of
participants had considered it. In case 3, as alanine ami-
notransferase (ALT) and aspartate transaminase (AST)
increased and the increased extent of the former was
higher than the latter, the most likely diagnosis of this
patient was acute hepatocellular injury, and 1378 of 1455
participants considered it. As for case 4, although 83% of
participants considered “does not suggest gout” based on
limited information, only about 40% of participants real-
ized that this patient’s kidney function was mildly lost and
suggested microscopy of fluid from affected joint and rec-
ognition of typical crystals. Worse still, even 46% of par-
ticipants considered primary hyperparathyroidism. After
analyzing the submitted results of case 4, we found that
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4      Huang et al.: Interpretative commenting

they had not combined clinical information when partici-
pants provided IC, only diagnosed by low serum phos-
phate. As far as we could see, although case 5 obtained a
consistent diagnosis for statin-induced myopathy (88%),
over 50% of participants went deeply into a matter of why
this patient was on simvastatin. Participants only need to
provide result interpretation by the given case information
in the EQA scheme of IC, and they do not have to explore
the detailed courses of diseases.
Comment scores and ranking
The median scores of each case were 13, 13, 15, 7 and 12,
in which the interquartile ranges were 11–15, 10–16, 12–17,
5–9 and 10–13. The range of scores for each case were
1–20, 0–20, 0–21, −2 to 14 and −2 to 18. Table 2 shows the
detailed final scores and ranking of all participants by
type and category of hospitals. The results indicated that
despite higher median final scores and ranking of par-
ticipants in tertiary hospital, there was no significant dif-
ference between every two groups, that is, for groups of
laboratories that passed and did not pass ISO 15189.
Statistical analysis also found that significant differ-
ences existed in the final scores and ranking between labo-
ratory technicians and physicians. Laboratory physicians
were mainly from 264 tertiary hospitals; meanwhile, the
number of laboratory physicians in each hospital was less
than 10%. Analyzing the final scores and ranking accord-
ing to professional title (Table 3), we found that senior per-
sonnel provided interpretative comments for more cases
with higher final scores and ranking than intermediate
and junior personnel, and there were no significant dif-
ferences between them. Moreover, 508 laboratories (66%)
give responsibility to senior and intermediate technicians
to interpret laboratory results. They considered that com-
pared with physicians who had just worked and had not
been clinically trained, laboratory technicians with high

Table 2: Detailed final scores and ranking of all participants by type and category of hospitals.

  Number of  Number of  Final score  Final ranking

laboratories participants   
Median  IQR (Q1, Q3)a  p-Valueb Median  IQR (Q1, Q3)a  p-Valueb

Grade of hospitals
 Tertiary hospital   584  1120  12.1  2.8 (10.4, 13.2)  0.774  700  738 (363, 1101)  0.774
 Secondary hospital  127  200  12.0  3.4 (10.2, 13.6)    700  857 (263, 1120) 
 Others   61  152  12.0  2.4 (10.8, 13.2)    674  658 (363, 1021) 
Whether passed ISO 15189
 Yes   82  183  11.8  2.8 (10.6, 13.4)  0.665  770  753 (311–1064)  0.665
 No   690  1289  12.0  2.8 (10.4, 13.2)    700  738 (363–1101) 
a
IQR, interquartile range, is equal to the difference between the upper and the lower quartiles, IQR = Q3–Q1. bDifference in “Grade of
hospital” was tested by the Kruskal-Wallis H-test, and difference in “Whether passed ISO 15189” was tested by the Mann-Whitney U-test.

Table 3: Detailed final scores of all participants by professional title.

Number of participants Number of cases Final scores p-Valueb

3 4 5 Median IQR (Q1, Q3)a

Whether physicians or not?

 Laboratory physicians 264 20 15 229 12.5 2.9 (10.8, 13.7) 0.000
 Laboratory technicians 1208 72 68 1208 12.0 3.0 (10.2, 13.2)
Professional title
 Senior 544 39 43 462 12.0 3.2 (10.2, 13.4) 0.699
 Intermediate 624 35 27 562 12.0 2.6 (10.6, 13.2)
 Junior 248 15 9 224 12.2 2.6 (10.6, 13.2)
 Othersc 56 3 4 48 12.3 2.8 (10.8, 13.6)
a
Interquartile range (IQR) is equal to the difference between the upper and the lower quartiles, IQR = Q3–Q1. bDifference in “Professional
title” was tested by the Kruskal-Wallis H-test, and difference in “Whether physicians or not” was tested by the Mann-Whitney U-test.
c
“Others” included laboratory personnel who had just worked and had working years too short to obtain the corresponding qualification
certificate.

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qualifications, professional knowledge and clinical expe-
rience could better transfer laboratory data to clinical
information.
Discussion
The purpose of interpretative comments on laboratory
reports is to help clinicians interpret complex data, par-
ticularly when dynamic or uncommon test results are
reported, which is the added value of laboratory reports
[22]. Although majority of comments provided in labo-
ratory reports are acceptable and favored by clinicians,
there are many problems that need solving: In which field
of laboratory medicine do individual laboratories apply
IC? How to deal with the difference of IC present practice?
What kind of test item is mainly involved in IC service? [10]
The IFCC Working Group “Laboratory Errors and
Patient Safety” (WG-LEPS) updated the Model of Quality
Indicators in October 2016 and put forward interpretative
comments as postanalytical quality indicators. Interpreta-
tive comment is the percentages of the number of reports
with interpretative comments affecting positively on
patient’s outcome/total number of reports with interpre-
tative comments. However, this quality indicator is only at
the level of priority 4, and clinicians usually do not record
measures after receiving laboratory reports. Therefore, it
is hard to assess the effect of interpretative comments on
patients’ outcome [23]. In addition, the factors that influ-
ence the quality of interpretative comment are mainly
insufficient clinical information and inadequate expertise
in the subspecialty area of laboratory medicine and clini-
cal knowledge. Our survey showed that the proportion
of participants that approved it was 90% (1319/1472) and
89% (1305/1472). Above all, quality assurance programs
and appropriate clinical audit are required to evaluate and
improve on this activity [3].
The distribution of the hospital in this study was
exactly the same as that of the participants in the EQA
programs organized by the NCCL, and routine chemistry
is the essential EQA item, with more tertiary and fewer
secondary or other hospitals. In some terms, these partici-
pant hospitals represented good performance of interpre-
tative practice in China.
The UK NEQAS for interpretative comments sets
acceptable performance as a rolling time window score
≥+0.5 in addition to a 50% participation [24]. IFCC WG
ICQA also suggested that minimum standards of perfor-
mance would need establishing at the outset, including
a minimum return rate and a mean score for each cycle
Huang et al.: Interpretative commenting      5
[5]. As a result, more than three of five cases should be
provided IC for each participant, i.e. return rate >50%;
however, we did not set a regulation on the number of par-
ticipants who were from the same laboratory. As we were
the first study to investigate the ability of comment pro-
viders in clinical laboratories in China, lacking experience
and clinical cases, we chose cases from the UK NEQAS and
the APFCB, which were well studied and educational and
have less difference in options. Before the formal survey,
we sent these five cases to some laboratory experts to give
suggestion, combined them with reference comments of
cases and set options of key phrases, involving preana-
lytical and analytical phrase. Certainly, participants could
also provide supplemental comments in the textbox. The
setting options not only simplify the comments reporting
process but also make participants familiar quickly with
this activity.
The scoring components of comments have two
major advantages. To some extent, it decreases the sub-
jectivity of evaluation and it is easy to carry out [25].
However, there are some shortcomings in this investiga-
tion. As there was no peer assessor panel for IC in China
at present, EQA organizers were responsible for break-
ing down key phrases and scoring through discussion.
EQA organizers had certain specialized knowledge and
clinical experience, which were far less than experts with
medical and scientific backgrounds. Therefore, marking
scale should be improved, and a panel of experts should
be established after this survey. Moreover, if our survey
would be developed in the formal EQA scheme, EQA
organizers should restrict the number of peer expert
panel and ensure that decisions would not be dictated
by personal option. If there will be more than one panel,
organizers should also set evaluation criteria for experts
to reduce bias. Moreover, as most clinical laboratories
were not familiar with interpretative comment and there
were no criteria for case choosing in China, we quoted
cases from the UK NEQAS and the APFCB quality assur-
ance program for investigation. EQA organizers should
establish case choosing criteria and use Chinese cases
when IC is well studied and developed into formal EQA
scheme.
An important finding was that the final score and
ranking of laboratory physicians were higher than those
of technicians. Although there were few physicians in the
laboratory and they did not have clear job responsibilities,
they could be members of a panel of experts.
Clinical laboratories shall strengthen the communica-
tion with clinicians, train and evaluate the competency of
laboratory personnel regularly. Apart from that, clear job
responsibilities not only can strengthen the management
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6      Huang et al.: Interpretative commenting
for laboratory directors but also can surely improve the
quality of interpretative comments.
Acknowledgments: We appreciate the UK National Exter-
nal Quality Assessment Scheme (NEQAS), the Interpre-
tative Comments Educational Programme 2011 of Asian
and Pacific Federation of Clinical Biochemistry (APFCB)
and Dr. Gordon Challand for giving us copyright permis-
sions of cases for this study. We appreciate the participant
laboratories and institutions that participated in the EQA
schemes for this survey. We also thank the personnel of
the Clinet website (www.clinet.com.cn) who gave com-
puter technology support to establish the network plat-
form for the survey and relevant services.
Author contributions: All the authors have accepted
responsibility for the entire content of this submitted
manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played
no role in the study design; in the collection, analysis and
interpretation of data; in the writing of the report; or in the
decision to submit the report for publication.
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Supplementary Material: The online version of this article offers
supplementary material (https://doi.org/10.1515/cclm-2018-0877).
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