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Reasons for Proficiency Testing Failures in

Routine Chemistry Analysis in China


Tingting Li, MSc,1,2** Haijian Zhao, MSc,1** Cuanbao Zhang, MSc,1 Wei Wang, BA,1
Falin He, MSc,1 Kun Zhong, MSc,1 Shuai Yuan, PhD,1 Zhiguo Wang, MSc1,2*
Laboratory Medicine 50:1:103-110

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DOI: 10.1093/labmed/lmy032

ABSTRACT
Objective: To understand the reasons for proficiency testing (PT) 37.4%; PT Evaluation, 0.5%; Unexplained, 11.5%; and Other, 0.7%.
failures, toward the goal of continuous improvement of laboratory Reasons unique to the PT process accounted for 15.6% of all reasons.
services. Corrective actions mainly included correcting calibration, maintaining
or changing equipment, strengthening reagent management, rewriting
Methods: Laboratories participating in PT of routine chemistry procedures, and retraining staff members.
testing provided by the National Center for Clinical Laboratories
(NCCL) of China were given 3 schemes for handling PT failures in Conclusions: The causes for PT failures relate mainly to laboratory
2016. If they had unsatisfactory PT performance, they were notified problems, not to the PT process itself. Therefore, PT sponsored by the
and requested to investigate failure errors and submit data regarding NCCL is an effective evaluation tool for laboratory performance. Also,
those errors. laboratories should strive to improve analytical performance.

Results: Failure types were distributed as follows, per error group: Keywords: proficiency testing, clinical chemistry test, PT error, quality
Clerical, 10.2%; Methodological, 16.2%; Equipment, 23.6%; Technical, assurance, performance evaluation, corrective action

The scope of proficiency testing (PT) in the clinical labora- Laboratory Improvement Amendments (CLIA) of 19884 in
tory has evolved considerably since Belk and Sunderman the United States, the PT program was voluntary in China.
provided the first PT program in the late 1940s.1 However,
the first PT program in China was not provided until 1982 Because laboratory test reports are released from pro-
by the National Center for Clinical Laboratories (NCCL) of cesses that meet their quality specifications, an evaluation
China. Today, the PT program has become an essential that reveals unacceptable results by a PT provider yields
component of the quality management system in laborato- an unexpected outcome for the laboratory. In response, the
ries; it is required by laboratory accreditation organizations laboratory should investigate the causes of error and correct
in many countries, including China.2,3 Unlike the Clinical the procedure that led to PT failures, to reduce or eliminate
the chances of recurrences. Outcomes of investigations
into the reasons of PT failures can be used by laboratories,
Abbreviations by manufacturers, and by the PT providers themselves in
PT, proficiency testing; NCCL, National Center for Clinical Laboratories; improving their respective products and service.5–8
CLIA, Clinical Laboratory Improvement Amendments; CAP, College of
American Pathologists; EQA, External Quality Assessment; CLSI, Clinical & The results of a survey by Klee and Forsman6 of the Mayo
Laboratory Standards Institute; SDI, standard deviation index; QC, quality
control. Clinic during 1985 and 1986 showed that only 28% of PT
failures were associated with analytic errors, 23% were unex-
1
National Center for Clinical Laboratories/Beijing Engineering Research plained, and the rest were related to the difference between
Center of Laboratory Medicine, Beijing Hospital, National Center of
processes in the PT program and in the handling of patient
Gerontology, Beijing, China; 2Graduate School, Peking Union Medical
College, Chinese Academy of Medical Sciences, Beijing, China specimens. In contrast, the College of American Pathologists
(CAP) Q-Probes study6 of 665 laboratories and the study
*To whom correspondence should be addressed.
by Hoeltge and Duckworth indicated that PT is a good indi-
zgwang@nccl.org.cn
cator of the technical ability of the laboratory to perform a
**
Joint first author: contributed equally to this work. test.7,8 To determine the value of using PT results in judging

© American Society for Clinical Pathology 2018. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 103
Management & Administration

laboratory performance, it should be demonstrated that the by the NCCL), before the deadline. If the results for a spe-
causes of PT failures relate mainly to laboratory-operation cific analyte were not submitted in a timely manner by a
problems other than the PT process itself. Therefore, we laboratory, that laboratory would obtain a score of 0 for
initiated an investigation into the reasons for PT failures, to the analyte in this testing event. Two weeks after the dead-
determine whether PT sponsored by the NCCL of China is an line for results reporting, participants received a report that
effective evaluation tool for laboratory performance. included an evaluation of whether their performance met
the acceptable criteria of specific analytes from the NCCL.

Participants who received unsatisfactory PT performance

Materials and Methods score(s) for 1 or more analytes in each testing event of

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2016 were notified and required to submit the corre-
Study Design sponding information on PT results via the EQA reporting
A large number (n = 2369) of laboratories distributed in dif- system within 24 hours of receiving PT reports. The dead-
ferent provinces in China voluntarily participated in the 2016 line for reporting the information was November 30, 2016.
routine chemistry PT program. An estimated 30.4% of labo- Information requested included the description of the rea-
ratories participated in voluntary PT organized by the NCCL. son for failure for each unacceptable PT result and the cor-
Participating laboratories came from hospitals with different responding corrective actions. In the beginning of 2016, we
categories (general hospital, 56.2%; specialist hospital, 11.1%; provided laboratories with 3 schemes for handling PT fail-
maternal and child care service centers, 10.0%; Traditional ures; laboratories could investigate the causes of PT failures
Chinese Medicine hospitals, 10.7%; hospitals of Traditional referring to any of these 3 schemes. When reporting rea-
Chinese and Western medicine, 6.2%; and other, 5.8%) and sons for unacceptable results, laboratories were to describe
different scales. The numbers of beds that hospitals offered the reasons and corrective actions in detail. Researchers
were as follows: 0 to 500, 50.1%; 501 to 1000, 20.1%; 1001 working on the study would carefully read the information
to 1500, 10.5%; 1501 to 2000, 10.8%; and greater than 2000, submitted and classify reasons mainly based on Clinical &
8.5%. To a certain extent, the results from these hospitals rep- Laboratory Standards Institute (CLSI) document QMS24.5
resented the entire performance of laboratories in China.
If there were queries regarding the submitted information,
In the routine chemistry PT program organized by the we would call the reporting personnel for verification. At the
NCCL, 5 specimens were provided for each of 3 testing same time, combining categorization for problems in CLSI
events every year. The concentrations within the 5 lots of document QMS 24 and the failure types that laboratories
specimens encompass the reportable range that was typical reported in the investigation, we could modify, add, or
of most analytical systems. PT specimens were provided delete some reasons and form the modified reason classi-
through mailed shipments in February 2016, along with PT fication that was suited for more laboratories. At the end of
instructions that detailed how to reconstitute, store, and the study and after summarizing reasons for PT failures in
prepare PT specimens. Laboratories were notified once PT other clinical-chemistry analyses, we could provide the PT
specimens were sent out, and they could find the tracking Exception Investigation Worksheet for Clinical Chemistry
number at the Clinet website (http://www.clinet.com.cn/). Analysis (Supplementry Appendix 1) to the laboratory, which
applied to most quantitative clinical-chemistry analytes (the
After PT specimens were received, the laboratories were reasons for PT failures in other clinical chemistry analyses
to examine them and determine whether there were prob- have not been published).
lems that might affect the measurement or results report-
ing (eg, damaged packaging, double labeling, confusing Definition of Challenge and Event
identification, misplaced). When specimens were missing Challenge―for quantitative tests, an assessment of the
or damaged, a laboratory could notify the NCCL to obtain amount of substance or analyte present or measured in
replacements. Laboratories were to examine PT speci- a specimen
mens in the same way as they examine patient specimens
and to submit the results via the Clinet External Quality PT event―a single round of proficiency testing, which
Assessment (EQA) reporting system, version 1.5 (developed included 5 challenges in routine chemistry analysis

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DOI: 10.1093/labmed/lmy032
Management & Administration

Target Value equipment or performance of the method. Problems with PT


Evaluation had non-subgroups. The Unexplained category
The target value of routine chemistry in the PT program was referred to those problems for which, after investigation,
determined as a peer-group method mean. We estimated no specific cause was revealed. The last major group was
this value according to robust analysis of algorithm A, as Other, which was used for problems that could not be cate-
described in ISO 13528: 2015.9 gorized within the previous groups. The difference between
Unexplained and Other was that the reasons for the former
Evaluation Criteria were unknown, but those for latter were clear and could not
be categorized within any of the aforementioned groups.
For this study, we used equation 1 to determine the analyte

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testing event score. Analyte Score for the Testing Event Statistical Analysis
Number of acceptable for the analyte
= ´100 (1) Data received were analyzed using the SPSS Statistical
Total number of challenges forr the analyte
Package for the Social Sciences (IBM SPSS Statistics for
Windows, version 20.0, IBM Corporation) and MS Excel 2007
Failure to attain a score of 80 for each analyte in each test- (Microsoft Corporation). The Kruskal-Wallis H test was used to
ing event constituted unsatisfactory analyte performance for determine whether the SDI in different reason categories was
the testing event. Failure to attain a score of 80 for an ana- different; P <.05 was considered to be statistically significant.
lyte in 2 consecutive or 2 of 3 consecutive testing events We used Mann-Whitney U tests to run pairwise comparisons
constituted unsuccessful PT performance. after the H test and used the Bonferroni method for correcting
the H test ad hoc analysis. A corrected value of P <.002 was
Standard Deviation Index Range
considered to be statistically significant for results of U testing.
We used equation 2 to determine the standard deviation
index (SDI):

SDI =
PT result of your laboratory - Target value
(2)
Results
Standard deviation
The 2369 laboratories evaluated 762,120 challenges that
where the target value was determined as the robust mean occurred during 152,424 PT events. Of the 152,424 PT
of the peer group and the SD refers to the robust SD of the events, 4838 were evaluated as showing unsatisfactory PT
peer group; both values were calculated by robust analysis performance for a specific analyte in the entire year. Of these,
via Clinet EQA statistical analysis software, version 5.5.0.46 1186 were evaluated as showing unsuccessful PT perfor-
(developed by the NCCL). For example, if a laboratory mance for an analyte (882 of which failed 2 testing events
reported a serum sodium concentration of 140 mmol per L, [302 failed successively and 580 discontinuously], 304 of
the target value for the peer group was 130 mmol per L, and which failed 3 successive testing events); the rest (3652) only
the peer group SD was 2.7 mmol per L, and then the SDI was failed 1 testing event for a specific analyte. Overall, 1907 par-
determined as ([130 mmol/L―140 mmol/L]/ 2.7 mmol/L) = 3.7. ticipating laboratories (80.5%) had at least 1 unacceptable
PT result (ie, failed at least 1 challenge in a testing event). Of
Classifying PT Failures these, 474 (24.9%) had no unsatisfactory analyte performance
in every testing event; the remaining laboratories may have
Table 1 shows the final version of classification for routine had unsatisfactory PT performance for 1 or more analyte.
chemistry in the study. In the Table, classes of possible
causes of unacceptable results included 7 major groups. In this investigation, participants submitted information,
Clerical problems were related to errors in the process when including reasons and corrective actions taken, for 7883
reporting PT results. Methodological problems were related to unacceptable challenge results (60.0% of all unaccept-
the analytical test system or the documented procedure itself. able results) in 2568 unsatisfactory PT events (53.1% of
Equipment problems were related to analytical instruments or all unsatisfactory PT events). As for problematic submitted
pieces of equipment used as part of the method. Technical information (15.0% of all responding results), 85.2% was
problems were related to personnel and the operation of verified by telephone, and the reasons were all corrected.

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DOI: 10.1093/labmed/lmy032
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Table 1. Categories of Causes of Unacceptable Proficiency Testing Results in the NCCL-Sponsored


Routine Chemistry PT Programs
Category Subgroup Unacceptable Result, no. % of All Reasons
Clerical Total 802 10.2
Result transcription errora,b 466 5.9
Incorrect units reportedb 99 1.3
Incorrect instrument or method reported on the formb 95 1.2
Results submitted not related to correct analyteb 77 1.0
Not submittedb 65 0.8
Methodological Total 1277 16.2

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Problem in manufacturing of reagents or reference materialsa 587 7.4
Incorrect assignment of calibrator valuea 165 2.1
Staff not adequately trained or proven competent to perform procedures 132 1.7
Biased method, or method lacks sensitivity and/or specificity 64 0.8
Imprecision due to variation between reagent lots 62 0.8
Inadequate QC method 62 0.8
Environmental change (eg, source of water and decoration) 53 0.7
Unstable calibration 49 0.6
Carryover from previous specimen(s) 37 0.5
Regent, calibrators, or control materials from different manufacturers 16 0.2
Result affected by factors related to PT specimens 28 0.4
Problem with procedure or inappropriate reference intervals 22 0.3
Equipment Total 1859 23.6
Failure to adhere to scheduled instrument maintenance proceduresa 1535 19.5
Equipment malfunctiona 272 3.5
Obstruction of instrument tubing or orifice by clog or protein 31 0.4
Dysfunctional instrument settings specified by manufacturer 21 0.3
Technical Total 2949 37.4
Calibration problems (eg, expired calibration curve and calibrator) a 1368 17.4
Management problems for reagent (eg, contamination of reagent)a 786 10.0
Improper reconstitution, preparation, or storage of PT specimensa–c 229 2.9
Improper preparation or storage of reference materials or reagent 111 1.4
Failure to test correct PT specimensb,c 106 1.3
Failure to act on QC results that indicate a method problem 90 1.1
Mixed use of reagent with different lot numbers 86 1.1
Delay in testing after reconstitution of PT specimensb,c 52 0.7
Pipetting or dilution errorc 38 0.5
Failure to follow written procedures or recommended instrument 55 0.7
function checks
Calculation error 19 0.2
Contamination of PT specimen during processingc 9 0.1
PT Evaluation Inappropriate peer groupb 41 0.5
Unexplained a Total 903 11.5
Other Total 52 0.7
NCCL. National Center for Clinical Laboratories; PT, proficiency testing; QC: quality control.
a
One of the main reasons for discordant PT findings (80.0% of all reasons).
b
Deemed by the authors to be unique to the PT process (15.6% of all reasons for unsatisfactory PT events).
c
Deemed by authors to potentially have multiple analyte failure within a PT event.

Comprehensive Analysis of Reasons for PT consensus by several experts of the NCCL in China, 9 sub-
Failure groups were deemed as being unique to the PT process,
accounting for 15.6% of all reasons, and 5 subgroups were
In Table 1, we show the categories of causes of unaccept- deemed to potentially contribute to multiple analyte failure
able PT results. A total of 9 subgroups accounted for 80.0% within a PT event.
of the reasons for PT failures, with the problem of “Failure
to adhere to scheduled instrument maintenance proce- Laboratories reporting “Failure to test correct PT speci-
dures” being the most common reason. According to the mens” as a reason for failure indicated that they failed 9

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DOI: 10.1093/labmed/lmy032
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Figure 1
Box plot of the Standard Deviation Index (SDI) for the major groups of reasons for proficiency testing (PT) failure.

to 20 analytes. Almost all laboratories (88.9%) reporting Corrective Action


“Improper reconstitution, preparation, or storage of PT
specimens” indicated that they failed 6 or fewer analytes, Some participants (31.4%) corrected the problems in cali-
and 11.1% reported failing between 10 and 25 analytes. bration, including increasing calibration frequency, changing
None of the participants reporting “Delay in testing after calibration method, or calibrator. A total of 27.2% of partic-
reconstitution of PT specimens” or “Pipetting or dilution ipants took actions to improve problems with instruments
error” indicated failing more than 3 analytes. All labora- or equipment used as part of the method—for example,
tories reporting “Contamination of PT specimen during replacing old equipment. Also, 17.9% removed the prob-
processing” failed 3 analytes in a testing event. lems with reagents, which involved obtaining suggestions
from reagent vendors or even changing reagent manufac-
turers. In addition, some participants (6.6%) strengthened
Analysis of PT Failure Type by SDI
management in works related to the PT process, including
A box plot of the SDI over the different major reason multiple checks when submitting PT results and staff train-
groups is shown in Figure 1. The results of H testing ing on the PT process. As a result, a fraction of laboratories
showed that the SDI in different categories differed signifi- (10.4%) that could not explain the unacceptable results
cantly (P <.001). Multiple comparison (U test) showed that after investigation did not take any corrective actions.
the differences in the groups between Methodological and
Equipment (P = .006), Technical (P = .03), Unexplained
(P = .13), Other (P = .009), Equipment and Technical
(P = .01), Unexplained (P = .008), Other (P = .01), Discussion
Technical and Unexplained (P = .02), Other (P = .01), and
Unexplained and Other (P = .007) were all nonsignificant. This study characterized how 2369 participating laborato-
The SDIs for the Clerical and PT Evaluation groups were ries performed on 762,120 challenges in routine chemistry
significantly greater than other groups (all P <.001). provided by the NCCL during 2016. The results are unique

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Table 2. Distribution of Reasons for Proficiency Testing Failure in 3 Studies


Variable NCCL Study, 2016 Zhao et al, 201311 CAP Q-Probes Study, 19926
Laboratories, No. 2369 1779 665
All PT challenges, No. 762,120 38,826 PT eventsa 616,467
Failed PT challenges, no. 7883 699 PT eventsa 7792
Analytes Routine Chemistry Routine Chemistry Clinical Chemistry and Blood Gas Analysis
Technical (%) 37.4 6.5 18.80
Equipment (%) 23.6 28.5 14.20b
Methodological (%) 16.2 45.1 18.40
Unexplained (%) 11.5 11.7 24.10

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Clerical (%) 10.2 6.5 11.90
PT evaluation (%) 0.5 0 6.80
Other (%) 0.7 0 5.90
PT, proficiency testing.
a
The data in the Zhao et al study were analyzed by PT events; there were 5 challenges in a PT event.

to the situation of routine chemistry analytes, and the cat- Of the 9 most-common problems for PT failures, which
egorizations are limited to use in evaluation of quantitative accounted for 80.0% of all the reasons, only 2, namely, “Result
measurement. transcription error” and “Improper reconstitution, preparation,
or storage of PT specimens”, were unique to the PT process.
Our findings indicated that repeated failures of PT events The small percentages (total: 7.8%) of the 2 reasons suggest
within a laboratory were very rare. Most of those failures that most problems identified from unacceptable results would
occurred in the next testing event or with 1 pass between also affect measurement of patient specimens. That is, labo-
2 events. Only a fraction of those events failed 3 PT events ratories were able to detect that analytical problems exist in
in a row. That is, unsuccessful PT performances for specific laboratory operation and quality management.
analytes were few; this result was similar to those from
other studies.7,11 The 3 main reasons for unacceptable PT results—“Failure to
adhere to scheduled instrument maintenance procedures”
Classifying the problem of PT failures was the most impor- (19.5%), “Calibration problems” (17.4%), and “Management
tant part of the study. Two previous studies from China problems for reagent” (10.0%)—can all be corrected funda-
and CAP investigated the reasons for early PT failures. mentally. As in other studies,7,10 we found that many unac-
Details about these 2 studies and the present one are ceptable results were unexplained. Because statistically
shown in Table 2. The percentages in the Unexplained cat- based PT grading systems determine PT failures based
egory during 2013 and 2016 in NCCL were smaller than on the distribution of PT results, statistical failures can be
that those percentages in the CAP study. The change in regarded as a result of random error when detected by this
the Unexplained category percentages may suggest that grading system and may explain why some unexplained
participants have more knowledge of the PT process and discordance exists. However, proper laboratory records
are better able to recognize errors of unacceptable results. may help laboratories determine the reason(s) for unaccept-
The main analytical related reasons for PT failures in these able PT performance, so the reports of some participants
studies were different. Blood gas analytes were included that their PT failures were unexplained may result from an
in the CAP Study, whereas in the others, they were not, so inability to reconstruct what happened when analyzing the
analyte-specific errors may exist. Comparing the results PT specimens.
of the present study with those from the study by Zhao
et al,10 we found that the percentages of problems in the Reasons unique to the PT process (Table 1) comprise 15.6%
Methodological category became smaller and may indicate of all failures; this percentage was smaller than that in the CAP
that laboratories themselves or manufacturers have made Study (which accounted for 24.5%).7 In contrast, most reasons
some improvements in their methodology for routine chem- (72.2%) were related to laboratory analytical performance,
istry analysis, such as using more-accurate methods or which demonstrated that PT, the most extensive external
changing manufacturers of reagents or reference materials. quality-control tool used by an accreditation organization, is a

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DOI: 10.1093/labmed/lmy032
Management & Administration

potential tool to monitor performance improvement over time contribute to a true PT failure but is also in a region susceptible
and to assess overall laboratory analytical performance. This to statistical noise that could indicate false problems.
finding is similar to that stated by many reports.12–14 Moreover,
it is suggested that laboratories have more knowledge of PT Now that we have elaborated the reasons for PT failures, how
and can be familiar with the PT process with time. Reporting can laboratory scientists use this information to help the lab-
reasons for PT failures and corrective actions taken not only oratory investigate PT failures? It is best that laboratories take
can help laboratories detect PT failures and pay more attention limited steps to investigate obvious clerical problems first and
to PT process but also can help the PT provider find problems then take more comprehensive steps to find hidden errors in
unique to the PT process—for example, improving the web- analytical processes, including those in the Methodological,
Equipment, and Technical categories. Perhaps laboratories

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based submitting system.
can use the relationship between major groups and the SDI
The errors attributable to several subgroups that we com- as the basis for determining the most major group. Then, one
piled represent failure modes that should impact more than can use Table 1 to identify subgroups in which the ratios were
1 analyte or even, perhaps, the entire PT event. For these statistically created and consider the most common reason
reasons, we studied the number of analytes with failing at the beginning. In some conditions, the laboratory may
results within a PT event and found that most laboratories need the PT Exception Investigation Worksheet for Clinical
failed more than 6 analytes and some laboratories even Chemistry Analysis (Supplementary Appendix 1) to detect
reported failing all analytes within an event. Therefore, the problems comprehensively and thoroughly. Also, immediate
laboratory can consider these reasons when there are PT records of each step of the PT process may assist laboratory
failures for several analytes within a test event. However, scientists in finding technical problems. Finally, if one sus-
laboratories reporting “Delay in testing after reconstitu- pects that the problems are generated by the PT provider, it
tion of PT specimens”, “Pipetting or dilution error”, or is incumbent on the laboratory to inform the PT provider and
“Contamination of PT specimen during processing” only request suggestions. At the same time, the participating lab-
failed 2 or 3 analytes. The lack of multiple analyte failure oratories can analyze freely the tendencies of cumulative PT
within an event could be due to less impact on some ana- results at http://www.clinet.com.cn/; Liu et al19 report specific
lytes or wider acceptable ranges for analytes not failed. examples of the use of this website.

We were not surprised that none of the participants reported Despite its promising findings, our investigation has certain
PT Material problems and few reported PT Evaluation prob- limitations. First, because participants are distributed in dif-
lems. As for PT Material problems, such as inappropriate ferent Chinese provinces, it was impossible to perform field
stability or homogeneity, PT specimens that were mislabe- investigations of the reasons, and the information gathered
led, and PT specimen material that had deteriorated in tran- could only be submitted via the online reporting system.
sit, these errors are the responsibility of the PT provider and Second, because each laboratory voluntarily participated in
are often impossible for participants to detect. As for the PT the PT program and there are no punitive measures for the
Evaluation problems, participants having little knowledge of laboratories with unsatisfactory PT performance, it is only
what is required to interpret PT results (including the process required that the laboratory report failing reasons before a
of target value assignment and acceptable criteria) may con- set time, rather than within a specific ranges of dates after
tribute to unquestioning acceptance of all results from PT receiving the PT report. Finally, high percentages of unex-
reports.15–18 So, PT providers should comment on specific plained unsatisfactory performance may limit the use of PT
data-handling processes in the feedback report. results as the unique indicator of laboratory ability to meas-
ure routine chemistry analytes accurately.
As Figure 1 shows, the SDI in the Clerical and PT Evaluation
groups were greater than those in the other groups; the results As a critical evaluation tool for laboratory performance,
of Kruskal-Wallis testing also demonstrate this result. Thus, PT instructed us to routinely monitor laboratory analytic
when the SDI of the unacceptable result was greater than 10, performance and take corrective actions when the causes
the priority of investigation of reasons should be given to these for PT failures had been found to assure the accuracy of
2 groups. Yet, the differences among other major categories measurement of patient specimens. In this study, it was
were not significant. When the SDI of the unacceptable result shown that the reasons for PT failures relate mainly to
was lower than 5, the SDI may not provide help. An SDI in laboratory operation problems rather than the PT process
the range of 2 to 3 implies a developing problem that could itself. Therefore, PT, sponsored by the NCCL of China, is an

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DOI: 10.1093/labmed/lmy032
Management & Administration

effective evaluation tool for laboratory performance. This tool Laboratory Improvement Amendments of 1988 (CLIA)—HCFA. Final rule
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5. Clinical and Laboratory Standards Institute (CLSI). Using Proficiency
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Funding 6. Klee GG, Forsman RW. A user’s classification of problems
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Funding for this study was provided by the Beijing Natural
7. Steindel SJ, Howanitz PJ, Renner SW; College of American
Science Foundation (grant/award no. 7143182); and Beijing Pathologists. Reasons for proficiency testing failures in clinical
Hospital Foundation (grant/award number: BJ-2015–025). chemistry and blood gas analysis: a College of American Pathologists
Q-Probes study in 665 laboratories. Arch Pathol Lab Med.

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We thank the laboratories and institutions that participated
9. International Organization for Standardization (ISO). Statistical Methods
in this survey. We also thank the staff members of the Clinet for Use in Proficiency Testing by Interlaboratory Comparison. ISO
website (http://www.clinet.com.cn), who provided the com- 13528:2015. Geneva, Switzerland: ISO:2015 (revised 2016).

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110  Lab Medicine 2019;50;103–110 www.labmedicine.com


DOI: 10.1093/labmed/lmy032

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