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Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journalsNo manuscriptsNo authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."
Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011
Dr. Shankar P.R.
"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."
Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011 Anuradha
Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.
Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020
Original article / research
Full Version
Effect of Good Clinical Laboratory Practices Quality Training on Knowledge, Attitude and Practice among Laboratory Professionals- Quasi Experimental Study
Correspondence Address :
Thammineni Krishna Latha,
Assistant Professor, Department of Biochemistry, Sidda Ganga Medical College and Research Institute, Tumkur-572102, Karnataka, India.
E-mail: t.krishnalatha@gmail.com
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. 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 analysed 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 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 acknowledges 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.
Clinical laboratory assistants, Good clinical laboratory practices, Quality assurance, Quality control, Standard operating procedures
Clinical laboratories are an indispensable part of healthcare services as they provide test results crucial for decision-making by physicians and clinicians in screening, diagnosis, treatment, and disease monitoring (1),(2),(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 they 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 QMS that complies with GCLP standards (5). Currently, there are multiple standards available to guide laboratorians on Quality Control (QC), Quality Assurance (QA), and QMS. Well-known organisations such as the International Organisation for Standardisation (ISO) (6) and the Clinical and Laboratory Standards Institute (CLSI) (7) establish standards and guidelines for laboratory quality. Additionally, organisations like World Health Organisation (WHO), Indian Council of Medical Research (ICMR), and Division of AIDS (DAIDS) provide guidelines to upgrade laboratory quality from time to time.
Good Laboratory Practices (GLP) are a set of principles that define a quality system concerning the organisational 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, proficiency testing programmes, 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 leading to desired clinical outcomes. To protect patient safety and ensure data reliability, it is vital to avoid GCLP breaches by executing integrated, harmonised operations and establishing an effective laboratory quality system (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 standardising 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 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.
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 criteria: A total of 58 College and Hospital staff who enrolled for GCLP training were included in the study.
Exclusion criteria: 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 organised 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 programme consisted of four modules covering GCLP guidelines, infrastructure, organisation, personnel, equipment, reagents, examination process, pre and post-examination process, ethical considerations, internal QC, external assessment/proficiency testing, quality management, risk management, quality indicators, test method validation, verification, safety in laboratories, data management, laboratory information system, internal audit, and GCLP dos and don’ts. Participants who successfully completed the programme 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.
In the present study, the mean age of the study population was 33±5.3 years. Of the respondents, 59.3% were male and 40.7% were female.
(Table/Fig 1) represents the participants’ responses to closed-ended questions regarding their knowledge and attitude towards GCLP (Good Clinical Laboratory Practice) quality. The questions consisted of 12 statements, with 11 related to knowledge and 1 related to attitude. Ten statements had multiple options, requiring participants to choose the correct option, while 2 questions (Q3: Are you aware of the Scope of your laboratory? and Q12: Are you competent to achieve quality in your laboratory setting?) were of Yes/No type. The data showed no statistically significant difference in the responses of participants regarding knowledge and attitude before and after GCLP training.
(Table/Fig 2) summarises the responses from study participants using a three-point Likert scale. This section included 22 questions that assessed participants’ opinions on accreditation, IQC (Internal Quality Control), EQAS (External Quality Assessment Scheme), QMS, and other related topics. Among the 22 statements, 2 questions assessed knowledge, 11 questions assessed attitude, and 9 questions assessed practice. Participants were asked to rate their level of agreement related to laboratory quality. The data were presented as Mean±SD (Standard Deviation). The findings indicated no statistically significant difference in the responses of participants regarding the KAP before and after GCLP training.
Regarding attitude, three out of the 11 statements had responses of agree, disagree, and neutral, while the remaining eight statements were related to easiness, difficulty, or neutrality.
(Table/Fig 3) summarises the distribution of responses from study participants using a three-point Likert scale. In terms of attitude, when participants were asked about the necessity of accreditation in their laboratory, no difference was found in the responses before and after GCLP training. Similarly, in terms of practice, when respondents were asked if laboratory services were able to meet the needs of users, an equal number of respondents agreed, and no difference was found in the responses before and after GCLP training.
Overall, the study results suggest that there were no significant differences in participants’ knowledge, attitude, and practice regarding GCLP quality before and after GCLP training.
The present study aimed to evaluate the knowledge, practice, and attitude of laboratory professionals towards laboratory quality training using an online questionnaire. The study was conducted amongst laboratory professionals in the Clinical Laboratory at ESIC Medical College and Hospital, Faridabad. Participants were asked questions related to QA to assess their KAP. The same questionnaire was administered before and after GCLP training, and the responses were compared.
Knowledge, defined as the understanding of laboratory professionals regarding QA principles, was analysed based on participants’ agreement with statements about laboratory QA (13). Interestingly, the data showed no statistically significant difference in the responses of participants regarding KAP before and after GCLP training. A similar study conducted in Vermont, US, also reported high knowledge levels among laboratory staff, with 85% of the staff being oriented in QA guidelines (4).
Attitude refers to the perception of laboratory professionals regarding the significance of QA, while practice refers to their inclination to follow and comply with laboratory QA procedures (13). The results indicated no statistically significant difference in participants’ responses regarding attitude and practice before and after GCLP training. The study revealed that the working staff was well aware of the importance of GCLP and recognised the impact of quality on results, despite the additional workload associated with maintaining NABL/ISO standards. The consistent adherence to SOPs and maintenance of QC records demonstrated the competence of laboratory professionals, which played a significant role in the timely processing and reporting of samples in the clinical laboratory.
A recent study conducted in Croatia amongst employees of accredited medical laboratories reported a positive attitude towards accreditation and an existing awareness of its benefits. However, the study also highlighted concern such as lack of familiarity with accreditation requirements and insufficient information on new operating procedures and working instructions. These findings emphasise the need for establishing systems to ensure timely and accurate downstream information flow for full compliance with accreditation requirements and working protocols.
Correspondingly, a study conducted in Lahore, Pakistan regarding the knowledge level of their Medical Lab Technologists (MLTs) on QC stated that 76% of their MLTs had average knowledge and 10% had good knowledge (14). An Ethiopian study of 175 participants has reported that 81.7% of respondents had a better knowledge on internal QC (15). On the contrary, a Chennai based Indian study of 10 laboratory staff reported a lapse in basic knowledge of laboratory staff on external QA, however their knowledge levels were improved after the training (16). Previous studies reported that increased workload for maintaining records like CAPA, QC, LJ charts etc., require long-term time commitment and perceived as a disadvantage of accreditation (17).
The current study clearly indicates that all laboratory professionals acknowledge the importance of well-organised workflows, SOPs, document maintenance, records, and identifying non-conformities, which collectively contribute to the effective traceability of the testing process in the clinical laboratory.
Limitation(s)
The online nature of the GCLP training due to the ongoing Coronavirus Disease-2019 (COVID-19) pandemic, which may have differed from on-site training. Additionally, the assessment relied on subjective responses, potentially introducing response bias. Future plans should include on-site training to enhance knowledge and technical expertise among laboratory professionals.
In conclusion, the results of this study indicate no statistically significant differences in perceptions and attitudes of laboratory staff towards quality after GCLP training. The study emphasises that all technical staff fully comply with GCLP guidelines and accreditation requirements. Furthermore, the findings suggest a positive attitude towards GCLP guidelines and accreditation, with laboratory staff being well aware of the benefits they offer. However, frequent training and competence assessments of laboratory professionals are necessary to enhance their technical expertise in accordance with regulatory bodies’ requirements. Such training and assessments would also aid in evaluating the performance of laboratory staff, contributing to improved learning, execution of GLPs, and consistent patient care services.
The authors here would like to express our gratitude to Dr. Suchetha Banerjee Kurundkar and her team from the Clinical Development Services Agency, Translational Health Science and Technology Institute, Department of Biotechnology, Ministry of Science and Technology, Government of India, for organising and collaborating with ESIC MCH, Faridabad in conducting the online GCLP training program. Your support and expertise were instrumental in the successful implementation of the training program and the completion of this study. The authors appreciate your dedication to promoting quality laboratory practices and improving the knowledge and skills of laboratory professionals. Thank you once again for your invaluable contribution.
DOI: 10.7860/JCDR/2023/62492.18453
Date of Submission: Dec 26, 2022
Date of Peer Review: Feb 20, 2023
Date of Acceptance: Jul 12, 2023
Date of Publishing: Sep 01, 2023
AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA
PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Dec 28, 2023
• Manual Googling: Mar 16, 2023
• iThenticate Software: Jul 08, 2023 (6%)
ETYMOLOGY: Author Origin
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