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ORIGINAL RESEARCH

Total Clinical Chemistry Laboratory Errors and

Evaluation of the Analytical Quality Control Using
Sigma Metric for Routine Clinical Chemistry Tests
This article was published in the following Dove Press journal:
Journal of Multidisciplinary Healthcare

1
Mulugeta Teshome Background: Currently, the use of clinical laboratory tests is growing at a promising rate
Abebaw Worede 2 and about 80% of the clinical decisions made are based on the laboratory test results.
Daniel Asmelash 2 Therefore, it is a major task to achieve quality service. This study was conducted to assess
1
the magnitude of errors in the total testing process of Clinical Chemistry Laboratory and to
Department of Medical Laboratory,
Dessie Comprehensive Specialized evaluate analytical quality control using sigma metrics.
Hospital, Dessie, Ethiopia; 2Department Methods: A cross-sectional study was conducted at Dessie Comprehensive Specialized
of Clinical Chemistry, School of Hospital Clinical Chemistry Laboratory, Northeast Ethiopia, from 10 February 2020 to
Biomedical and Laboratory Sciences,
College of Medicine and Health Sciences, 10 June 2020. All Clinical Chemistry Laboratory test requests with their respective samples,
University of Gondar, Gondar, Ethiopia external quality control and all daily internal quality control data during the study period
were included in the study. Data were collected using a prepared checklist and analyzed
using SPSS version 21.
Results: A total of 4719 blood samples with their test requests were included in the study. Out of
145,383 quality indicators, an error rate of 22,301 (15.3%) was identified in the total testing
process. Of the total errors, 76.3% were pre-analytical, 2.1% were analytical and 21.6% were
post-analytical errors (p<0.0001). Of the total 14 analytes in the sigma metric evaluation, except
ALP, all routine clinical chemistry tests were below the standard (<3). In multivariate logistic
regression, the location of patients in the inpatient department was significantly associated with
the specimen rejection ((AOR=1.837, 95% CI (1.288–2.618), p=0.001).
Conclusion: The study found a higher frequency of errors in the total testing process in the
Clinical Chemistry Laboratory and almost all test parameters had an unsatisfactory sigma
metric value.
Keywords: analytical errors, Clinical Chemistry Laboratory, post-analytical errors, pre-
analytical errors, sigma metrics, Ethiopia

Introduction
The use of clinical laboratory test results in clinical decisions has become an
integral part of clinical medicine and studies showed that laboratory medicine
determines 70% of clinical decisions; however, small variations around this figure
(60–80%) were reported.1,2 The quality laboratory service ensures accurate, precise
Correspondence: Daniel Asmelash and timely results. The total testing process (TTP) of a laboratory is a complex
Department of Clinical Chemistry, School procedure that includes three phases: the pre-analytical, analytical and the post-
of Biomedical and Laboratory Sciences,
College of Medicine and Health Sciences, analytical. In all phases of TTP, quality indicators (QIs) are used by health
University of Gondar, P.O Box 196, laboratories based on the requirements of the International Organization for
Gondar, Ethiopia
Email daniel.asmelash111@gmail.com Standardization (ISO) 15,189:2012.3,4

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Laboratory errors can occur at any stage of the pre- a major issue. For example, studies in Ghana revealed
analytical phase to the post-analytical phase of the TTP.5 unsatisfactory sigma level (<3) for all analytes.15
Pre-analytical errors include all errors that occur prior to Laboratory personnel should control the whole TTP
analysis. Some of the pre-analytical errors include hemo­ using QIs and focus on improving extra-laboratory proce­
lyzed sample, insufficient sample, incorrect label, incorrect dures, in particular test selection and interpretation in
requisition, clotted sample and tube broken in centrifuges. coordination with other medical staff.16
The impact of pre-analytical error occurs in the analytical The achievement of sustainable laboratory perfor­
and the post-analytical stage. At the analytical phase mance in accreditation has also been a major challenge
where analysis takes place, non-conformity with quality in African countries and there are still gaps in strength­
control, calibration failure, random and systematic errors ening laboratory services.17 According to previous stu­
can be occurred.6 Common post-analytical errors include dies, the majority of Ethiopian clinical laboratories
failure to report test results, delay in reporting, incorrect provide sub-optimal service and the quality of the ser­
calculation, critical results not reported or delayed, and vice is severely compromised, which may lead to the
results sent to the wrong patient.7 occurrence of several laboratory errors.18 Despite very
Sigma metric quantifies the analytical performance of few studies on the overall distribution of laboratory
a laboratory process as a rate of Defects-Per-Million errors in Clinical Chemistry, no studies have yet been
Opportunities (DPMO). The evaluation of laboratory
conducted to evaluate analytical performance using
errors in terms of sigma metric is more meaningful than
sigma metric in Ethiopia.19,20 Therefore, the current
the number of defects alone. For the analytical process of
study will assess the distribution of errors in each
the laboratory system, the sigma metric analysis identifies
phase of the clinical chemistry testing process and the
errors in quality indicators of the process and provides
analytical performance of routine chemistry tests using
error corrections based on results. Using the Six Sigma
sigma metric.
principles, it is possible to assess the quality of laboratory
testing processes and the number of quality controls
needed to ensure the desired quality.8 Materials and Methods
Attainment of Six Sigma performance represents 3.4 Study Design and Setting
DPMO and the achievement of 3 sigma values is the mini­ A cross-sectional study was conducted at the Dessie
mum acceptable quality for a process to be applied.9 Comprehensive Specialized Hospital Clinical Chemistry
A higher sigma metric value means fewer analytical errors Laboratory from 10 February 2020 to 10 June 2020.
and fewer acceptable test results are falsely rejected, a lower Dessie Comprehensive Specialized Hospital laboratory
sigma metric value of the parameters indicates higher ana­ was involved in the Stepwise Laboratory Quality
lytical errors and many acceptable test results are falsely Improvement Process towards Accreditation, although its
rejected, which is more difficult to use in the analysis of performance was not satisfactory.
patient samples. However, low sigma metrics could also
mean that there are high true rejections that may occur as
a result of inadequate QC data and the short study period.10 Study Variables
Laboratory errors that occur at any phase of the TTP The study variables included all phlebotomists, laboratory
can directly contribute to increased healthcare costs, professionals in the Clinical Chemistry laboratory, Clinical
decreased patient satisfaction, delayed diagnosis, misdiag­ Chemistry test requests with their respective blood samples
nosis and a serious risk to the patient’s health.11 Studies for routine Clinical Chemistry tests, quarterly external qual­
showed that 6.4% to 12% risk of inappropriate care and ity control (EQC) and all daily internal quality control
death occurs due to laboratory errors.12 Studies in the (IQC) data from the Clinical Chemistry laboratory during
United States indicated that diagnostic errors occur in the specified study period. Therefore, the study covered the
5% of the outpatients and about half of the errors may pre-analytical, analytical and post-analytical phases of the
cause severe harm to patients. This is supported by a study TTP in the Clinical Chemistry Laboratory. However, body
conducted in Malaysia with 3.6% errors.13,14 fluids other than venous blood samples and not routine
Although analytical errors contain fewer errors than clinical chemistry tests were excluded from the sigma
pre-and post-analytical phases, analytical quality is still metric evaluation.

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Data Collection Procedure of errors in the Clinical Chemistry Laboratory was sum­
A standardized pre-tested assessment checklist was used to marized by descriptive statistics using frequency tables.
evaluate the pre-analytical, analytical and post-analytical The sigma metrics value of each analyte was summarized
phases of the Clinical Chemistry Laboratory. The checklist in tables after extracting Total Allowable Error (%TEa)
was prepared using variables from different studies and value of each analyte from Clinical Laboratory
International Federation of Clinical Chemistry.21 The Improvement Amendment (CLIA).23 A chi square test
selected data collectors were trained on how to collect all was used to check the presence of statistical difference
the necessary data in the assessment of the completeness between the three phases of Clinical Chemistry testing
of the standard laboratory request forms (such as, patient process.
age, gender, signature of physicians, location, date and In addition, the chi square test was also used to assess
authorized request formats), in the assessment of specimen the association between selected independent variables
quality, analytical and post-analytical QIs based on the with pre-analytical and post-analytical errors. Bivariate
checklist. and multivariate logistic regression were used to assess
All required data were collected using a checklist in all the association between work shift and location of patients
phases of the TTP. In addition, face-to-face interviews with prolonged turnaround time (TAT). The strength of the
were also used to collect socio-demographic data. Data association was measured using the adjusted odds ratio
on pre-analytical variables, specifically laboratory speci­ (AOR) and 95% confidence interval (CI). The p-value
mens, were collected through observation. Color charts <0.05 was considered statistically significant. The chi
were used to assess the quality of the specimens, which square test and logistic regression were conducted for
were used to standardize the reports of each data collector. selected independent variables (work shift and patient
Furthermore, a routine automatic biochemistry analy­ location) because the assumptions were not fulfilled by
zer (DIRU CS-T240, Dirui Industrial Co., Ltd. China) was other independent variables.
evaluated by sigma metric and important data generated by Analytical quality control performance for routinely
tested 14 analytes [aspartate transaminase (AST), alanine
the analyzer were extracted by using observation. Daily
transaminase (ALT), alkaline phosphatase (ALP), urea
IQC data collected during the analytical phase were
(UR), creatinine (CRE), glucose (GLU), total cholesterol
entered in the checklist and record formats. The laboratory
(TC), triglyceride (TG), high-density lipoprotein (HDL),
was involved in the EQC program by analyzing five dif­
low-density lipoprotein (LDL), total protein (TP), albumin
ferent concentration proficiency test samples provided by
(ALB), total bilirubin (TBIL) and uric acid (UA)] was
one world Accuracy and the most recent quarterly EQC
evaluated using a sigma metric quality monitoring tool.
laboratory performance report was taken and transferred to
The TEa source for each of the analytes was CLIA. The
the checklist. Post-analytical QI outcomes were collected
bias of all analytes except LDL was calculated using the
before the results were delivered to clients, and each vari­
performance of the Laboratory in the EQC and the peer
able was entered as a record in the checklist.
groups mean. Since LDL was not properly documented in
the EQC documentation chart, its bias was calculated
Data Quality and Statistical Analysis using the observed mean from the daily IQC and the target
The standardized data collection checklist was pre-tested value from the manufacturer. The CV for all analytes was
on 30 venous blood specimens with their corresponding calculated from the observed mean and SD of the daily
test requests for Clinical Chemistry at Boru-Meda Hospital IQC in the study period. For all analytes, two levels
to check its feasibility and ensure the validity of the study (normal and pathological) of IQC materials were used,
tool.22 The checklist was modified based on the pre-test and sigma metrics value was calculated separately. The
results. The investigator undertook a continuous monitor­ estimates of sigma metrics were optimistic because the
ing and support to ensure complete, consistent, clear and quality control materials were not from third parties. The
accurate data. cause of low sigma value (<6) in all parameters was
The data were checked for completeness and reliability. identified using the calculated Quality goal index (QGI).
After ensuring this, data were entered to EPI info version 7 The sigma metrics was calculated with the Sigma =
and transferred to SPSS version 21 (IBM Corporation, (TEa – Bias%)/CV. In addition, the QGI ratio was calcu­
Armonk, NY, USA) for analysis. The overall distribution lated using a Bias%/1.5 × CV%.24 A sigma value between

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3 and 4 quality requires a multi-rule procedure 13S/22S/R4S Table 1 Frequency of Missed Information on Laboratory
/41S/10x, with four levels of control measurement in two Request Forms
runs (N=4, R=2) or two levels of control measurement in S. No. Variables Missed
four runs (N=2, R=4). However, <3-sigma cannot be con­ Information

trolled with statistical QC protocols of Westgard rules and %(Error/Total)

the method must be rechecked.25 1 MRN 0(0/4719)
2 Patient age 26.9(1271/4719)
3 Gender of patient 24.1(1138/4719)
Results 4 Signature of the physician 77.5(3658/4719)
General Information of the Study 5 Clinical history of the patient 100(4719/4719)
A total of 4719 test requests with venous blood samples were 6 Location of the patient (Clinic/ward) 66.2(3122/4719)
included and 18,636 tests were analyzed in the study. Of the 7 Date of ordered 57.5(2715/4719)
8 Test ordered 0(0/4719)
total test requests, 153 (3.2%) were from Emergency depart­
9 Appropriate and authorized requests 1.7(80/4719)
ment, 879 (18.6%) were from outpatient department (OPD)
and 545 (11.6%) were from the impatient department (IPD), Total 39.3(16,703/42,471)

but the remaining 3142 (66.6%) test requests were with Abbreviation: MRN, medical record number.

unknown location. The majority 3423 (72.5%) of the samples

were analyzed during the first work shift (morning) from 7 Analytical Errors
AM to 1 PM and equal number of laboratory professionals Of the estimated total 1382 daily IQC, 73 (5.3%) were not
were assigned in both shifts. Performance of 14 routine clin­ performed. Of the 1317 IQC data, 81 (6.2%) were out of
ical chemistry tests with two levels of IQC material was the acceptable range. In addition, 15 (23.1%) of the EQC
evaluated using the sigma metric monitoring tool. performance was reported as unacceptable. Of the total
samples analyzed, 141 (3%) tests were interrupted due to
electricity fluctuations and all (100%) non-linearity patient
Missed Information on Test Requests test results were released without retesting. Of the total
Of the total of 4719 clinical chemistry test requests, there
QIs (13,206) in the analytical phase, 457 (3.5%) analytical
were 100% completeness of medical record number errors were identified (Table 3).
(MRN) and test ordered, but the clinical data (100%) of
the patients and (77.5%) the signature of physicians was
missed in the test request form. Of the total test requests
Post-Analytical Errors
Of the total critical test results, 6 (13.3%) were not imme­
assessed, 16,703 defects (more than 3 defects per request)
diately reported to physicians. Almost all (99.5%) labora­
were found. In addition, of the total number of QIs
tory test results were not verified and signed. It was also
(42,471) evaluated, 16,703 (39.3%) showed missed infor­
found that 62 (1.3%) and 53 (1.1%) laboratory results
mation on the laboratory test request (Table 1).
were unrecorded and reported out of the established TAT,
respectively. Of the total post-analytical QIs (37,797),
Pre-Analytical Errors Related to 4827 (12.8%) post-analytical errors were identified
Specimen Quality (Table 4).
In the assessment of the quality of the specimens, 111 (2.4%)
of the specimens were hemolyzed and 97 (2.1%) of the Overall Clinical Chemistry Laboratory
specimens were icteric. In addition, 45 (1%) of the specimens Errors
were incorrectly labelled. Of a total of 51,909 QIs, 314 Of the total 145,383 quality indicators, an error rate of
(0.6%) specimen quality-related errors were observed. Of 22,301 (15.3%) was found in the three phases of the
the total sample-related errors, 35.4% were due to hemolysis testing process. The chi square test revealed that there
and 30.9% were due to excessive icteric sample. For one or was a statistically significant difference between the error
more reasons, 223 (4.7%) specimens were not suitable for frequency of the three phases (χ2=2153, p <0.0001). The
analysis. Of the total pre-analytical QIs (94,380), 17,017 highest frequency of Clinical Chemistry Laboratory errors
(18%) pre-analytical errors were identified (Table 2). was 17,017 (76.3%) in the pre-analytical phase, while

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Table 2 Analysis of Errors in Pre-Analytical Quality Indicators

S. No. Variables Pre-Analytical Errors

%(Error/Total) % Total Errors

1 Hemolyzed specimen 2.4(111/4719) 35.4

2 Icteric specimen 2.1(97/4719) 30.9
3 Mislabeled specimen 1(45/4719) 14.3
4 Lipemic specimen 0.5(25/4719) 8
5 Inadequate specimen 0.3(14/4719) 4.5
6 Clotted sample 0.3(13/4719) 4.1
7 Specimen collected at wrong time 0.2(8/4719) 2.5
8 Test tube broken in the centrifuge 0.02(1/4719) 0.3
9 Specimen collected with wrong test tube 0(0/4719) 0
10 Specimen without its request 0(0/4719) 0
11 Specimen collected for unavailable test 0(0/4719) 0

Overall rejection rate of specimens 4.7(223/4719)

Total pre-analytical errors from all pre analytical QIs (Including laboratory test 18(17,017/94,380)
requests form and specimens)
Abbreviation: QIs, quality indicators.

Table 3 Analysis of Errors in Analytical Quality Indicators

S. No. Variables Analytical Error

%(Error/Total)

1 Non-linear results released without retesting 100(38/38)

2 Questionable results contradicted 100(28/28)
3 EQC failed 23.1(15/65)
4 Preventive maintenance not performed 16.7(9/54)
5 Equipment malfunction 9.1(4/44)
6 Reference range not available 6.3(1/16)
7 Laboratory fail to establish linearity range 6.3(1/16)
8 IQC result failed 6.2(81/1317)
9 Failure to perform daily IQC 5.3(73/1382)
10 Working reagents prepared incorrectly 4.5(4/88)
11 Electric interruption 3(141/4719)
12 Reagent stock out during analysis 1.3(62/4719)
13 Calibration failed 0(0/13)
14 Methods not updated upon new reagent 0(0/16)
15 Reagents used after their expiration date 0(0/691)

Total Errors from all analytical QIs 3.5(457/13,206)

Abbreviations: EQC, external quality control; IQC, internal quality control; QIs, quality indicators.

the second observed error was 4827 (21.6%) in the post- missed information on Clinical Chemistry Laboratory
analytical phase, but the lowest frequency 457 (2.1%) was request formats (p<0.0001), hemolysis (p=0.04), icteric
identified in the analytical phase (Table 5). (p<0.0001), specimen rejection (p=0.001) and failure to
record results (p=0.01) (Table 6).
Location of Sample Collection with Pre-
and Post-Analytical Errors Factors Associated with Prolonged TAT
Using the chi square analysis, the location of sample The multivariate logistic regression showed that pro­
collection was found to be statistically associated with longed TAT was independently associated with

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Table 4 Analysis of Errors in Post-Analytical Quality Indicators

S. No. Variables Post-Analytical Error

%(Error/Total)

1 Requests released without result verification 99.5(4694/4719)

2 Critical values not communicated immediately 13.3(6/45)
3 Unrecorded test results 1.3(62/4719)
4 Results released out of TAT 1.1(53/4719)
5 All tests not performed as requested 0.2(8/4719)
6 Result printouts attached to the wrong request 0.1(4/4719)
7 Left over samples not retained as the policy 0(0/4719)
8 Laboratory requests with results lost 0(0/4719)
9 Request with incorrect unit of reporting 0(0/4719)

Total Errors from all post analytical QIs 12.8(4827/37,797)

Abbreviations: TAT, turnaround time; QIs, quality indicators.

Table 5 Distribution of Errors Frequency in the Total Testing Process

Phase Error % Total Errors % Errors Chi Square Test

Yes No

Pre-analytical 17,017 77,363 11.7 76.3 χ2 df p-value

Analytical 457 12,749 0.3 2.1 2153 2 <0.0001
Post-analytical 4827 32,970 3.3 21.6
Total 22,301 123,082 15.3 100

the second shift (AOR=8.354, 95% CI (4.453–15.670), Sigma Value and Quality Goal Index
p< 0.0001) in which the occurrence of prolonged TAT (QGI) of the Clinical Chemistry Tests
was 8 times higher in the second shift workers com­ Using CLIA as a source of TEa, the sigma metric values of
pared to the first shift workers (Table 7). 14 routine analytes were measured. Based on the measured

Table 6 Association of Patient Location with Pre-Analytical and Post-Analytical Errors

Variables Location of Patients (Clinic/Ward) Test of Significance χ2 (p-Value)

Emergency OPD IPD Unknown

Yes No Yes No Yes No Yes No

Patient age missed 9 144 116 763 21 524 1125 2017 392*(p<0.0001)
Gender of patient missed 5 148 72 807 17 528 1044 2098 432*(p<0.0001)
Signature of the physicians missed 69 84 599 280 318 227 2672 470 353.5*(p<0.0001)
Location of the patient missed 5 148 6 873 8 537 3103 39 4463.5*(p<0.0001)
Date of ordered missed 62 91 335 544 161 384 2157 985 487.5*(p<0.0001)
Unauthorized requests 0 153 9 870 1 544 70 3072 17.8*(p<0.0001)
Hemolyzed specimen 6 147 17 862 21 524 67 3075 8.3*(p=0.04)
Icteric specimen 4 149 9 870 23 522 61 3081 17.77*(p<0.0001)
Mislabeled specimen 1 152 4 875 3 542 37 3105 5.06(p=0.167)
Specimen rejection 9 144 31 848 43 502 140 3002 15.9*(p=0.001)
Unrecorded results 1 152 21 858 9 536 31 3111 11.4*(p=0.010)
Results released out of TAT 3 150 14 865 10 535 26 3116 7.67(p=0.053)
Note: *Statistically significant association (p<0.05).
Abbreviations: IPD, impatient department; OPD, outpatient department; TAT, turnaround time.

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Table 7 Factors Associated with Prolonged TAT

Variable Category Prolonged TAT COR(95% CI) AOR(95% CI) p-Value

Yes No

Clinic/ward Emergency 3 150 1.66(0.49–5.63) 1.66(0.49–5.63) 0.412

OPD 14 865 1.596(0.82–3.09) 1.596(0.82–3.09) 0.165
IPD 10 535 1.58(0.75–3.34) 1.59(0.75–3.34) 0.224
Unknown 26 3116 1 1

Shift 1st shift 13 3410 1 1

2nd shift 40 1256 7.83(4.15–14.77) 8.35(4.45–15.67) <0.001
Note: p < 0.05= significant association.
Abbreviations: AOR, adjusted odds ratio; CI, confidence interval; COR, crude odds ratio; IPD, impatient department; OPD, outpatient department; TAT, turnaround time.

values, only one analyte (ALP) had above 3 sigma values than studies in Nigeria,28 Kenya29 and Uganda30 with an
and the remaining 13 analytes were found to be below 3 incompleteness rate of 14.3%, 22.7% and 17.9%, respec­
sigma values. The lowest sigma value (0.01) was observed tively. This disparity may be due to variation in quality
in ALB (level-I). In addition, the calculated QGI showed indicators, study designs, study periods, awareness and
that the presence of imprecision, inaccuracy and both experience of clinicians on the value of patient
imprecision and inaccuracy. It was found that the majority information.
of the poor performance of analytes in the sigma value was Of the total number of QIs, 39.3% showed missed
due to the imprecision of the QC (Table 8). information on Clinical Chemistry test requests. This find­
ing was higher than the study conducted in Ethiopia31 and
Nigeria28 with an overall incompleteness of 8.7% and
Quality Control Strategy Based on Sigma
10.5%, respectively. This large variation may be due to
Values differences in sample size, operational definition, test
Of all the analytes, only ALP had a sigma value of >3. The
requests ordered by inexperienced staffs and lack of com­
Westgard rule was established for ALP only and the
mitment to complete the required information.
remaining analytes showed poor performance in which
Based on our study, the clinical history of the patient
the methods should be rechecked prior to the analysis of
was not stated in all 4719 (100%) requests which were
patient samples. The Westgard multi rule selected for ALP
consistent with the study conducted in Gondar, Ethiopia
was 13S/22S/R4S/41S/10x. Although a multi rule was
with 99% incompleteness,20 but higher than studies con­
applied for ALP, the QGI indicated an imprecision that
ducted in Addis Ababa, Ethiopia (72.6%).19 In addition,
requires a close monitoring and troubleshooting in the
signature of physicians (77.5%) and location of patients
daily IQC (Table 9).
(66.2%) information were also incomplete in the test
request. These findings showed a wide difference from
Discussion previous studies conducted in Gondar (38.7% and
Although most modern medical laboratories have joined 1.8%),20 Addis Ababa (30.4% and 1.1%)19 and Nigeria
automation, it remains a challenge to ensure accurate and (19.8% and 20.1%)32 respectively. The higher incomplete
precise laboratory results.26 Therefore, the current study information in the current study may be due to lack of
used relatively comprehensive QIs to assess the total errors commitment, failure to create awareness and workload.
in the Clinical Chemistry Laboratory. In this study, hemolysis was the major cause of sample
In the current study, the majority of the pre-analytical rejection (35.4%) which was inconsistent with studies
errors found were incompleteness of the required informa­ conducted in Ghana (17.6%).33 The increased percentage
tion on the test request form (39.3%). This finding was of hemolysis may be due to untrained phlebotomists, high
consistent with the study conducted in Hawassa, workload and lack of regular monitoring and support.
Ethiopia27 (39.4%), but lower than a study conducted in According to this study, the prevalence of sample
Gondar, Ethiopia20 with an overall incompleteness of rejection was 4.7%, which was consistent with studies in
49.9%. In contrast, the current finding was much higher Egypt34 with a rejection rate of 4.6%. However, it was

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Table 8 Total Allowable Error (TEa), CV, Bias, Sigma Value and QGI of the Routine Clinical Chemistry Tests
Analyte IQC Level TEa% Average Bias (%) CV (%) Sigma QGI Problem

AST I 20 7.4 10.6 1.2 0.46 Imprecision

II 20 7.4 6 2.1 0.82 Imprecision and inaccuracy

ALT I 20 4.2 9.6 1.6 0.3 Imprecision

II 20 4.2 7 2.3 0.4 Imprecision

ALP I 30 2.7 7 3.9 0.26 Imprecision

II 30 2.7 7.2 3.8 0.3 Imprecision

UR I 19 7 8.6 1.4 0.54 Imprecision

II 19 7 6.8 1.8 0.7 Imprecision

CRE I 15 5 7.2 1.4 0.46 Imprecision

II 15 5 6.6 1.5 0.5 Imprecision

GLU I 10 5.4 7.6 0.6 0.47 Imprecision

II 10 5.4 5.6 0.8 0.6 Imprecision

TC I 10 4 7.6 0.8 0.35 Imprecision

II 10 4 7.2 0.8 0.4 Imprecision

TG I 15 13.7 11.8 0.1 0.77 Imprecision

II 15 13.7 16 0.1 0.6 Imprecision

HDL I 20 18.7 18.9 0.1 0.7 Imprecision

II 20 18.7 10.8 0.1 1.1 Imprecision and Inaccuracy

LDL I 20 19.8 6 0.03 2.2 Inaccuracy

II 20 2.6 18.4 0.9 0.1 Imprecision

TP I 10 6.3 5.9 0.6 0.7 Imprecision

II 10 6.3 4.2 0.9 1 Imprecision and inaccuracy

ALB I 10 9.9 7.2 0.01 0.9 Imprecision and inaccuracy

II 10 9.9 6.2 0.02 1 Imprecision and inaccuracy

TBIL I 20 9.9 7.4 1.4 0.9 Imprecision and inaccuracy

II 20 9.9 6 1.7 1.1 Imprecision and inaccuracy

UA I 17 6.3 8.3 1.3 0.5 Imprecision

II 17 6.3 5.7 1.9 0.7 Imprecision
Abbreviations: CV, coefficient of variation; EQC, external quality control; IQC, internal quality control; QGI, quality goal index ratio; TE, total observed error; TEa, total
allowable error.

Table 9 Quality Control Strategy Based on the Sigma Value of the Test Parameters
Parameters Sigma Levels of Run Westgard Rules Status of the Decision
Metrics Control Method

AST, ALT, UR, CRE, GLU, TC, TG, HDL. LDL, <3 – – – Poor Needs
TP, ALB, TBIL, UA rechecking

ALP 3.8 2 4 13S/22S/R4S/41S/10x Good Acceptable

Note: No Westgard rule, IQC level and runs selected rather immediate trouble shooting requires.

higher than studies conducted in India (3.45%),35 South rejection may be due to untrained phlebotomists, lack of
Africa (1.46%),36 Turkey (0.65%),37 Saudi Arabia cooperation and communication, incompetence, improper
(2.07%)38 and Ethiopia (1.4%).39 The higher rate of processing of specimens.

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Dovepress Teshome et al

In the current study, the total pre-analytical error (18%) each test parameter showed that analytical quality is still
was lower than studies conducted in Iraq (39%)40 and a major issue.
Egypt (43.7%),41 but it was much higher than studies in In the current study, the sigma metric value of most
Ghana (3.7%),33 Saudi Arabia (3.15%),42 Tunisia analytes was unsatisfactory. ALP (Level-I (3.9) and II
(7.7%),43 Greece (1.94%)44 and India (0.15%).45 This (3.8) IQC) was the only analyte with a sigma value
may be due to differences in the QIs, sample size, labora­ above 3. The remaining 13 analytes (AST, ALT, UR,
tory facilities and the experience of health professionals. CRE, GLU, TG, TC, HDL, LDL, TP, ALB, TBIL and
Our study found a lower frequency of 6.2% IQC failure UA) had low sigma values <3. This finding was incon­
compared to the study conducted in Pakistan (32%),46 but sistent with a study conducted in China51 that reported >3
higher than the study conducted in Ethiopia (2.95%)19 and sigma values for all test parameters (AST, ALT, ALP, UR,
India (0.6%).47 The difference between findings may be due to CRE, GLU, TC, TG, HDL, LDL, TBIL, UA, TP and
variation in equipment and laboratory personnel performance, ALB). This may be due to differences in the performance
storage condition of QC materials, the reconstitution of lyo­ of analyzer, poorly stored reagents and QC materials,
philized QC materials and availability of in-house mean/SD. study period, failure to perform regular maintenance of
The current study found a 23.1% failure of the proficiency analyzers and competency of laboratory staffs. In addition,
testing, which was inconsistent with a study conducted in the calculated QGI showed that the presence of impreci­
Pakistan (5.4%).48 This higher level of non-conformity with sion, inaccuracy and both imprecision and inaccuracy.
EQC proficiency testing may be due to improper transport/ This may be due to power fluctuation, incorrect calibra­
tion, improper reconstitution of QC/calibration materials
storage of EQC samples, improper reconstitution of the sam­
and interferences.
ples, analyzing by faulty instruments, untrained and incompe­
The current study found <2 sigma value for 11 test
tent laboratory staffs, reporting with unacceptable unit.
parameters at two IQC levels for (UR, CRE, GLU, TG,
In the current study, 99.5% of the test results were not
TC, HDL, LDL, TP, ALB, TBIL and UA). This result was
verified and signed by independent reviewers. This finding
consistent with a study conducted in Ghana15 for (GLU,
was far higher than the study conducted in Kenya
TG, TC, HDL, UR, CRE, TP and AST) and in Sudan52 for
(13.1%).49 This may be related to non-committed labora­
UR and CRE. It was also comparable to the study con­
tory staffs, the workload of the laboratory and failure to
ducted in India53 for ALT (Level-I), TBIL (Level-I), CRE
adhere to the laboratory quality policy. In addition, 1.1%
(Level-I) and UR (Level-I and II). In contrast, higher
of laboratory results were reported out of the established
sigma values >3 were reported in China51 and Turkey54
TAT, which was higher than the frequency of delayed TAT
for ALB, GLU, UA, TC, TG and CRE. This disparity in
in Pakistan (0.003%).48 The prolonged TAT in this study
the sigma metrics value may be due to differences in
may be due to the unavailability of Laboratory Information analytical methods, different IQC materials, different pro­
System (LIS), electric interruption, equipment malfunction ficiency testing bodies and manufacturers.
and stock out of distilled waters.
The current study found that the prevalence of errors in Conclusion
the TTP was 15.3%. This finding was lower than the study The study found a high frequency of errors in the Clinical
conducted in Addis Ababa, Ethiopia (33.1%)19 but higher Chemistry Laboratory and most of the errors were observed
than the study conducted in Saudi Arabia (4.35%)42 and in the pre-analytical phase. The majority of pre-analytical
Ghana (4.7%).33 This may be due to difference in the errors were significantly associated with the location of the
infrastructure of the laboratory, regular monitoring and sample collection. In addition, with the exception of the ALP,
evaluation, availability of functional LIS, competency of the sigma metric values for all routine clinical chemistry tests
laboratory staffs, in-house mean/SD, variation in the study were below the standard (<3). Although the sigma metric
designs, operationalization of variables and QIs. value of ALP was within an acceptable range, a multi-
Although IQC ensures a continuous monitoring of the Westgard rule (13S/22S/R4S/41S/10x) should be implemented
analytical method, the exact number of errors that under close monitoring rather than a single rule.
occurred during the analytical phase cannot be Specimen collectors, particularly in the IPD should be
evaluated.50 As a result, an effective quantifying sigma trained in the laboratory quality management system.
metrics tool was selected and the sigma metrics value for Besides the existing manual recording system, the

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Journal of Multidisciplinary Healthcare 2021:14 133
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Teshome et al Dovepress

laboratory should provide an electronic backup recording Acknowledgments

system. In addition, the sigma metric should be included We would like to thank the staff members of Dessie
as one of the quality indicators of the Clinical Chemistry Comprehensive Specialized Hospital Laboratory.
Laboratory and the DMAIC Process (Define, Measure,
Analyze, Improve and Control) for the improvement of Author Contributions
the laboratory services. A regular monitoring and evalua­ All authors made a significant contribution to the work
tion should be carried out in compliance with 15,189 ISO reported, whether that is in the conception, study design,
standards of the clinical laboratory. In addition, the clin­ execution, acquisition of data, analysis and interpretation,
icians should be encouraged to use the reference change or in all these areas; took part in drafting, revising or
value to help overcome all the noise generated by poor critically reviewing the article; gave final approval of the
instrument performance. version to be published; have agreed on the journal to
which the article has been submitted; and agree to be
Abbreviations accountable for all aspects of the work.
AOR, adjusted odds ratio; ALT, alanine transaminase;
ALB, albumin; ALP, alkaline phosphatase; AST, aspartate Funding
transaminase; CI, confidence interval; CRE, creatinine; No specific funding was obtained for this study.
CLIA, Clinical Laboratory Improvement Amendment;
DPMO, defects per million opportunities; EQC, external
quality control; GLU, glucose; HDL, high density lipopro­
Disclosure
Authors declare that they have no competing interests.
tein; IQC, internal quality control; IPD, inpatient depart­
ment; ISO, International Organization for Standardization;
LIS, laboratory information system; LDL, low density lipo­
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