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.

Inclusion and exclusion criteria

A total of 58 college and hospital staff who enrolled for GCLP training were included in the study. Participants unwilling to participate or who did not attend the GCLP training were excluded.

Sample size

In this study, 58 participants were enrolled, including 22 doctors and the remaining laboratory assistants from four departments (Department of Biochemistry, Pathology and Microbiology, Immunohaematology, and Blood Transfusion) of ESIC Medical College and Hospital. Samples were chosen using a non-probability convenience sampling method since the study was based on an online questionnaire.

Procedure

Data collection

The GCLP online training program was organized by the Clinical Development Services Agency (CDSA) and the Translational Health Science and Technology Institute (THSTI) in collaboration with the Employees’ State Insurance Corporation (ESIC) Medical College and Hospital, Faridabad. The training took place every Friday in March 2022 for a period of four weeks. Eminent experts and experienced trainers from CDSA and THSTI conducted the online training from 1:30 PM to 5:00 PM. The training program consisted of four modules covering GCLP guidelines, infrastructure, organization, personnel, equipment, reagents, examination processes, pre- and post-examination processes, ethical considerations, internal QC, external assessment/proficiency testing, quality management, risk management, quality indicators, test method validation, verification, safety in laboratories, data management, LISs, internal audits, and GCLP dos and don’ts. Participants who successfully completed the program and met the administrative requirements—including attendance, feedback, and a minimum score on the exit assessment—were awarded a certificate. The training module was prepared by THSTI in collaboration with ESIC MCH, referring to GCLP guidelines. [12] Each session started with a recap of the previous session presented by randomly chosen participants. An exit assessment, conducted as a proctored online exam by THSTI, Faridabad, was administered after the completion of the four modules.

The questionnaire was explained to all participants, including the types of questions (Yes/No, Likert Scale: agree 1/neutral 2/disagree 3), the mode of answering, and the deadline for submission. Anonymity of responses was maintained throughout the study. The questionnaire consisted of 34 questions, including 12 closed-ended questions with predefined options and 22 questions regarding participants’ opinions on accreditation, IQC, EQAS, QMS, etc. A pilot study was conducted with a group of 10 senior faculty members from the departments of Biochemistry, Pathology, and Microbiology to test the online questionnaire, and it was modified accordingly. The reliability score, calculated using Cronbach’s alpha test, was found to be 0.99. Participants included in the pilot study were excluded from the main study. The revised questionnaire was used for data collection. The questionnaire was distributed electronically to all participants using Google Forms. The same questionnaire was distributed to participants before and after GCLP training, and data were collected.

Questionnaire

A pre-designed questionnaire in the English language was used in the study, based on previous studies. [11,13] The questionnaire was distributed electronically using Google Forms, with a link sent to all participants. The participants were given 660 minutes to fill out the questionnaire. The questionnaire consisted of 34 questions, of which 22 were analysed using a Likert scale of 1-3 to indicate the participants’ level of agreement (1: agreement, 2: neutral, 3: disagreement). The remaining 12 questions were closed-ended with predefined options. Mean scores were calculated from the responses, where a mean score <2 indicated agreement and a mean score >2 indicated disagreement.

Statistical analysis

Completed responses were exported to Microsoft Excel 2016. Continuous measurements were presented as Mean±SD, including the 22 responses on the Likert scale. Categorical measurements were presented as percentages. A multiple comparison test was conducted to compare the questionnaire responses before and after GCLP training. The paired t-test was used to determine the significance of study parameters on both continuous and categorical scales. Statistical analysis was performed using GraphPad version 07 software. A p-value <0.05 was considered statistically significant.

Notes

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