Journal:Knowledge of internal quality control for laboratory tests among laboratory personnel working in a biochemistry department of a tertiary care center: A descriptive cross-sectional study

Full article title	Knowledge of internal quality control for laboratory tests among laboratory personnel working in a biochemistry department of a tertiary care center: A descriptive cross-sectional study
Journal	Journal of Nepal Medical Association
Author(s)	Mishra, Bijaya; Lal Das, Binod K.; Khan, Seraj A.; Gelal, Basanta; Niraula, Apeksha; Chaudhari, Rejendra K.; Lamsal, Madhab
Author affiliation(s)	B.P. Koirala Institute of Health Sciences, Tribhuwan University
Primary contact	bjaya dot mp at gmail dot com
Year published	2023
Volume and issue	61(258)
Page(s)	167–70
DOI	10.31729/jnma.8040
ISSN	1815-672X
Distribution license	Creative Commons Attribution 4.0 International
Website	https://jnma.com.np/jnma/index.php/jnma/article/view/8040
Download	https://jnma.com.np/jnma/index.php/jnma/article/download/8040/4607/38965 (PDF)

Abstract

Introduction: The clinical laboratory holds a central position in patient care, and as such, ensuring accurate laboratory test results is a necessity. Internal quality control (QC) ensures day-to-day laboratory consistency. However, unless practiced, the success of laboratory quality management systems (QMSs) cannot be achieved. This depends on the efforts and commitment of laboratory personnel for its implementation. Hence, the aim of this study was to find out the knowledge of internal QC for laboratory tests among laboratory personnel working in the Department of Biochemistry, B.P. Koirala Institute of Health Sciences (BPKIHS), a tertiary care center.

Methods: This was a descriptive cross-sectional study conducted from July 1, 2022 to August 30, 2022 after receiving ethical approval from the Institutional Review Committee (Reference number: 2341/022). A semi-structured questionnaire was used to assess knowledge on internal QC. Three non-respondents were excluded. The operational definition of the knowledge domain was set before finalizing the questionnaire. The convenience sampling method was used. Point estimate and 95% confidence interval were calculated.

Results: Among 20 laboratory personnel, five (25%) (6.02-43.98, 95% confidence interval) had adequate knowledge of internal QC. The mean knowledge score was 12 ± 2.44.

Conclusions: The prevalence of adequate knowledge of internal QC for laboratory tests among laboratory personnel working in the Department of Biochemistry at BPKIHS was similar to another study done in a similar setting.

Keywords: biochemistry, knowledge, laboratory personnel, quality control

Introduction

The clinical laboratory plays a central role in providing information about the health of patients for appropriate prevention, diagnosis, and management of diseases. [1] For confidence in reports generated within the laboratory, quality control (QC) plays a pivotal role.

QC, which includes internal and external QC, describes a set of procedures used to check if laboratory results are reliable for the intended clinical use. Internal quality control (IQC) ensures day-to-day laboratory consistency. [2] Currently, the majority of laboratory results are generated by automated analyzers, with the shift in laboratory personnel’s duties from manual work to equipment maintenance, internal and external QC, instrument calibration, and data management of generated results. [3] The success of implemented quality management systems (QMSs) in the laboratory cannot be achieved if not practiced properly, and this ultimately depends upon the knowledge, efforts, and commitment of laboratory personnel towards QMS implementation. [4]

The objective of this study was to find out the level of knowledge of IQC for laboratory tests among laboratory personnel working in the Department of Biochemistry, B.P. Koirala Institute of Health Sciences (BPKIHS), a tertiary care center.

Methods

A descriptive cross-sectional study was conducted in the Department of Biochemistry, BPKIHS, Dharan, Nepal after obtaining ethical approval from the Institutional Review Committee (Reference number: 2341/022). The data were collected from July 1, 2022 to August 30, 2022. Personnel working in laboratories under the Department of Biochemistry were included. The faculty in-charge, the technical staff in-charge, and those not willing to participate were excluded from the study. Convenience sampling was used. The sample size was calculated by using the following formula:

$n=Z^{2}\times {\frac {p\times q}{e^{2}}}$
$n=1.96^{2}\times {\frac {0.50\times 0.50}{0.1^{2}}}$
$n=97$

Where n = minimum required sample size, Z = 1.96 at 95% confidence interval (CI), p = prevalence taken as 50% for maximum sample size calculation, q = 1-p, and e = margin of error 10%. Thus, the calculated sample size was 97. The above-calculated sample size was then adjusted for a finite population as:

$n'={\frac {n}{1+{\frac {n-1}{N}}}}$
$n'={\frac {97}{1+{\frac {97-1}{23}}}}$
$n'=19$

Where n' = adjusted sample size for a finite population, and N = the total number of laboratory personnel, 23. Thus, the final sample size was 19. However, a total of 20 sample size was used for this study.

A semi-structured questionnaire was used for data collection. The questionnaire comprised two segments, including a socio-demographic profile and knowledge questions in regard to IQC. Socio-demographic variables of sex, education level, position held in the laboratory, and laboratory QC training ware taken. The operational definition of knowledge on IQC was set prior to finalizing the questionnaire, and the questionnaire was designed and finalized based on it. Questions on knowledge of IQC were based on the understanding of the purpose of IQC, the types of control materials, various control charts, how and when IQC should be performed, and interpretations of the Levey-Jennings Chart using the Westgard rule. There were a total of 20 questions to assess the IQC knowledge domain. The scores were calculated by assigning one point to each correct answer and zero to incorrect/don’t know/blank answers. A score of ≥10 was assigned as adequate knowledge, and ≤9 was assigned as inadequate knowledge. [5]

The participants were provided with information regarding the purpose of the study and what they was expected to do to minimize bias. The questionnaire was collected back within 24 hours. The con!dentiality of each laboratory personnel filling out the questionnaire was maintained throughout the study. Data were entered and analyzed using Microsoft Excel 2011. Point estimate and 95% CI were calculated.

Notes

This presentation is faithful to the original, with changes to presentation, spelling, and grammar as needed. The PMCID and DOI were added when they were missing from the original reference.