Volume 8, Issue 9, September – 2023 International Journal of Innovative Science and Research Technology

ISSN No:-2456-2165

Laboratory Quality Indicators: An Essential Tool of the

Quality Management System
Dr.Lakshmi jyothi.T
Additional professor
Department of Microbiology
All India Institute of medical sciences, Bibinagar
Corresponding author

Kamalakar Sarva Karthik Kamani

Quality manager Quality Head
Department of Microbiology St Theresa Hospital, Hyderabad
All India Institute of medical sciences, Bibinagar

Abstract:- identifies the lacunae in quality management system and

gives the best services to its client or patients
 Objective:
Laboratory quality is defined as the accuracy, reliable Keywords - Pre-Analytical Process, Analytical Process, Post-
and timely issuing of reported results. To measure the Analytical Process, Quality Indicators.
quality of the laboratory there are various indicators
available, those are called Quality indicators. I. INTRODUCTION

 Material & method: The outcome of the laboratory diagnostics was to provide
The retrospective study was taken place at St. Teresa a quality report to its patients or clients. Laboratory quality is
hospital, Hyderabad. The following QIs are identified and defined as accuracy, reliable and timely issuing of reported
analyzed over a period of 2 years (January-2019 to results (1). The testing processes are complex, involve many
December-2020). The following indicators are evaluated procedures, and it is difficult to always maintain the desired
Pre analytical: Patient/Specimen identification, Sample quality. In this context, laboratory quality needs to be
rejections, Adherence of Lab safety policy, Analytical: Re measured and monitored regularly for desirable out come. To
do’s/Repeat testing, Post analytical: Critical alert measure the quality of the laboratory there are various
information, Turnaround time. indicators available, those are called Quality indicators (QI).

 Results: Quality indicators (QIs)are measurable, objective,

Sample rejection was high in 2020 (0.20%), the most quantitative measures of key system elements performance.
prevalent rejected sample was clotted sample for both They indicate the extent to which a certain system meets the
years, in 2019 n=134(49.6%), in 2020 n=140 (44.8%) needs and expectations of the customers (2).QIs should cover
followed by hemolyzed samples (36.6%, 31.7%), all three processes of the laboratory; those are pre-analytical,
Insufficient samples (8.8%, 15.5%). 100% of the analytical, and post-analytical. QIs which are applied in the
laboratory staff followed laboratory safety measures. For pre-analytical process are sample registration errors, patient
the analytical process, we evaluated retesting of the identification and sample rejections, needle stick injuries etc.
primary sample, in 2019 the percentage of retesting was Analytical QIs area failure in the internal quality controls and
0.24%, and in 2020 was 0.39%. In the post-analytical external quality assurance system results (EQAS), Blood
process, 0.34% and 0.54% of critical values were not culture contamination rate, frequency of calibration failure and
notified in 2019 and 2020 respectively. 1% and 0.63% of equipment breakdown etc., and post-analytical QIs are
laboratory reports were issued after laboratory-defined Turnaround time (TAT) and short turnaround time (STAT),
TAT in 2019 and 2020 respectively. Reporting errors, and critical alert information etc. (3).

 Conclusion: Depending on the size of the laboratory, workload, test

Current study indicates the status of the laboratory volume, and mainly laboratory quality objectives the
quality compared to national and international standards. laboratory can decide the number of QIs they measure,
Based on the evaluated quality indicators the laboratory however, all three processes should be covered. In the current

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Volume 8, Issue 9, September – 2023 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
study, we have chosen a few of the QIs for monitoring the II. MATERIALS AND METHODS
quality in our laboratory.
The retrospective study was taken place at 330 bedded
super specialist Hospital with NABH & NABL accreditation
in Hyderabad. The following QIs are identified and analyzed
over a period of 2 years (January-2019 to December-2020)

Table 1: List of quality indicators evaluated.

Pre-analytical Analytical Post-analytical
Wrong billings Re-do’s/Repeat testing Critical alert information
Sample rejections Turnaround time (TAT)
Lab safety

 Analysis of QIs: For all QIs, benchmarks or thresholds were set up that
represented action limits. All the data was collected by the
 Pre-analytical: laboratory quality manager and was analyzed every month. If
 Patient/Specimen identification: any QI crosses the benchmark, corrective and preventive
Number of wrong bills/Total Number of Registrations x action (CAPA) was taken accordingly.
100
III. RESULTS
 Sample rejections
Number of samples rejected/Total number of samples The quality indicators are analysed into 3 phases: pre-
received x 100 analytical, analytical, and post-analytical. In pre-analytical we
monitor the number of wrong bills done in the billing section
 Adherence to Lab safety policy and a few samples which were rejected. The various pre-
Number of staff adheres to lab safety policy/ Total analytical quality indicators and their evaluation are
number of staff x 100 represented in Table 1. Sample rejections were high in 2020
(0.20%), the most prevalent rejected sample was clotted
 Analytical samples for both years, in 2019 n=134(49.6%), in 2020 n=140
 Re-do’s/Repeat testing (44.8%) followed by hemolyzed samples (36.6%, 31.7%),
Number of re-analyses of the samples/Total number of Insufficient samples (8.8%, 15.5%) (Fig1). 100% of the
samples tested x 100 laboratory staff followed laboratory safety measures (Table 2).

 Post analytical. In the Analytical process, we evaluated retesting of

 Critical alert information primary samples, in 2019 the percentage of retesting was
Number of critical results informed stipulated time 0.24% and it increased in 2020 (0.39%) (Table 3).
(<10min)/number of critical alert values x 100
In the post-analytical process, we considered the number
 Turnaround time of critical values unreported by the laboratory and Tern around
The number of samples deviated from lab Turnaround time/ time (TAT).0.34% and 0.54% of critical values were un-
number of investigations performed x 100 notified in 2019 and 2020 respectively. 1% and 0.63% of
laboratory reports were issued after laboratory-defined TAT in
2019 and 2020 respectively (Table 4 & 5)

Table 2: Pre-analytical quality indicators (The number of samples rejected)

Wrong billing
2019 2020
Number of bills 60878 50826
Number of wrong bills 114 147
% of wrong bills 0.19% 0.29%
No. Samples Rejection
2019 2020
Number of samples received 236340 155940
Number of samples rejected 270 312
Percentage of (%) of sample rejections 0.12% 0.20%

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Volume 8, Issue 9, September – 2023 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165

Fig 1: Reasons for sample rejection

Table 3: Analytical indicators (Number of Reanalysis of the samples)

2019 2020
Number of re-dos 568 610
Number of investigations performed 236340 155940
Percentage of (%) of re-dos 0.24% 0.39%

Table 4: Post-Analytical indicators (Number of critical values reported)

2019 2020
Number of critical values reported and notified 4081 2005
Number of critical values un-notified 14 11
Percentage % 0.34 0.54

Table 5: Post-Analytical indicators (Turnaround time(TAT))

2019 2020
Number of samples with lab-defined TAT 236340 155940
Number of samples out of the TAT 2338 983
Percentage (%) 1 0.63

IV. DISCUSSION testing, the rationale of the retesting is that the first test results
may represent a clinically significant analytical error, which is
From the writing of the request form to delivering the revealed by re-testing (5). In the current study, 0.63% of the
report to the person requested there are multiple complex steps samples were retested. The reason for the repeat testing was
involved in the process. The laboratory required addressing all obtained critical values in the first testing. All the critical
the steps and making the necessary corrective actions to values need not be repeated, as per the CAP/CLSI only
ensure the quality of the laboratory is maintained. Quality samples which exceeded the ‘allowable error limits’ for that
indicators (QI) were important tools for monitoring the entire parameter required repeat testing (6,7). The laboratory
process. In the current study,0.48% of the samples were implemented this guideline suggested by CLSI and reduced
rejected in two years. There is no acceptable threshold for the the number of repeat tests.
number of samples the laboratory can reject, however as per
the literature 0.3 to 0.8% (3,4) of the samples were rejected in Critical or panic values have been described as values
various institutions by different authors. The reason for the where abnormally high or low levels can cause irreversible
sample rejection was clotting in the samples primarily due to physical harm unless treated immediately (8,9). In the current
uneven mixing of the samples, followed by hemolysis. To study around 0.9% of the critical values were not notified and
address these issues the laboratory initiates training programs the critical value reporting frequency of 8.8 per 1000 samples.
frequently and developed a standard operating procedure and The reviews of previous literature showed the prevalence of
circulated in all the wards in the hospital. Reanalysis or repeat critical value reporting ranging from 1 in 2000 to 1 in 100

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Volume 8, Issue 9, September – 2023 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
samples (10,11) our study was correlated with other [8]. Lundberg, George D. “It is time to extend the laboratory
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