Journal:Effect of good clinical laboratory practices (GCLP) quality training on knowledge, attitude, and practice among laboratory professionals: Quasi-experimental study

Full article title	Effect of good clinical laboratory practices (GCLP) quality training on knowledge, attitude, and practice among laboratory professionals: Quasi-experimental study
Journal	Journal of Clinical and Diagnostic Research
Author(s)	Patel, Seema; Garima, Gini; Bhatia, Sonam; Latha, Thammineni K.; Thakur, Nidhi; Pujani, Mukta; Sharma, Suman B.
Author affiliation(s)	ESIC Medical College and Hospital, Sidda Ganga Medical College and Research Institute, Amrita School of Medicine
Primary contact	t dot krishnalatha at gmail dot com
Year published	2023
Volume and issue	17(9)
Page(s)	BC05 - BC09
DOI	10.7860/JCDR/2023/62492.18453
ISSN	0973-709X
Distribution license	Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
Website	https://www.jcdr.net//article_fulltext.asp
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Abstract

Introduction: Good clinical laboratory practices (GCLP) play a vital role in early and accurate diagnosis, providing high-quality data and timely sample processing. Adhering to a robust quality management system (QMS) that complies with GCLP standards is crucial for laboratory personnel in a clinical laboratory to deliver outstanding healthcare services and reliable, reproducible reports.

Aim: To assess the knowledge, attitude, and practice (KAP) of laboratory professionals towards quality in the laboratory through GCLP training.

Materials and methods: This pre-test, post-test quasi-experimental study was conducted in the Department of Biochemistry at ESIC Medical College and Hospital, Faridabad, Haryana, India, from February 2022 to June 2022. The study included 58 participants, consisting of 22 doctors and the remaining laboratory assistants. The GCLP online training program was conducted every Friday in March 2022 for four weeks. An online questionnaire containing 34 questions was administered to all the participants before and after the training. Data were collected and analyzed using a paired t-test.

Results: A total of 58 responses were received from the participants via Google form before and after the training. The results indicate no significant difference in participants’ responses to 12 closed-ended questions regarding a QMS before and after training. A similar trend was observed for 22 questions on a Likert scale, where participants rated their agreement, neutrality, or disagreement.

Conclusion: The study demonstrates that all technical staff fully complied with GCLP guidelines and accreditation requirements. Furthermore, the laboratory staff acknowledged the importance of standard operating procedures (SOPs), document maintenance, record-keeping, and identifying non-conformities, all of which contribute to effective traceability of the testing process in the clinical laboratory.

Keywords: clinical laboratory assistants, good clinical laboratory practices, quality assurance, quality control, standard operating procedures

Introduction

Clinical laboratories are an indispensable part of healthcare services as they provide test results crucial for decision-making by physicians and clinicians in the screening, diagnosis, treatment, and monitoring of disease. [1–3] The quality of reports generated by laboratory personnel significantly impacts patient outcomes and treatment. Errors in any of the three phases (pre-analytical, analytical, and post-analytical) of analysis can have disastrous consequences for patient care. [4] Therefore, it is essential for laboratorians to have a comprehensive understanding of quality systems, as laboratorians are the first point of contact in sample handling and test procedures.

To provide reliable and reproducible results for outstanding healthcare services, laboratory personnel must adhere to a robust quality management system (QMS) that complies with good clinical laboratory practice (GCLP) standards. [5] Currently, there are multiple standards available to guide laboratorians on quality control (QC), quality assurance (QA), and QMSs. Well-known organizations such as the International Organization for Standardization (ISO) [6] and the Clinical and Laboratory Standards Institute (CLSI) [7] establish standards and guidelines for laboratory quality. Additionally, organizations like the World Health Organization (WHO), Indian Council of Medical Research (ICMR), and Division of AIDS (DAIDS) provide guidelines for improving laboratory quality from time to time.

Good laboratory practices (GLPs) are a set of principles that define a quality system concerning the organizational process and conditions under which laboratory studies are planned, performed, monitored, recorded, archived, and reported. [8] GCLP is based on the implementation of GLP principles for the analysis of clinical samples. GCLP focuses on key aspects of a quality system, including QC, assay validation, laboratory safety, sample management, records management, proficiency testing programs, laboratory information systems (LIS), overall quality management plans, and training of laboratory personnel. Implementing GCLP ensures the generation of high-quality data along with timely sample processing, enabling early and accurate diagnosis, in turn leading to desired clinical outcomes. To protect patient safety and ensure data reliability, it is vital to avoid GCLP breaches by executing integrated, harmonized operations and establishing an effective laboratory QMS. [9]

Clinical laboratories and laboratory personnel have an ethical obligation to provide accurate and precise results that are cost- and time-effective, necessitating strict adherence to quality planning. Quality planning includes standardizing laboratory processes, QC, QA, and continual quality improvement (CQI). [5], [10] Training plays a key role in ensuring correct implementation of guidelines and achieving quality output at all levels of laboratory personnel. (11) Furthermore, laboratorians need to have good knowledge and a positive attitude towards QA, which can be achieved through training on GCLP for QA implementation.

Therefore, this study aimed to assess the knowledge, attitude, and practice (KAP) towards quality in the laboratory through GCLP training, as the quality system depends on the skills, knowledge, commitment, and continuous practice of laboratory personnel.

Materials and methods

A pre-test, post-test quasi-experimental study was conducted in the Department of Biochemistry at ESIC Medical College and Hospital, Faridabad, Haryana, India, from February 2022 to June 2022. The study was conducted after obtaining ethical clearance from the institutional ethics committee (Ref No: 134 X/11/13/2022-IEC/12), and all participants provided verbal consent for the study.

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. No other changes were made in accordance with the "NoDerivatives" portion of the content license.