European Journal of Cardiovascular Medicine

In India, the last few decades there has been rapid expansion in different branches of health care services, as well as in the field of medical research. Consumer awareness and expectation of health care have simultaneously improved with increasing demands for high quality care, including laboratory services. Towards this goal, the laboratories should implement Good Clinical Laboratory Practices (GCLP) that will ensure timely processing of biological samples enabling early and accurate diagnosis and patient safety leading to desired clinical outcomes. Adoption of GCLP guidelines laid down by accreditation bodies will be a significant step forward in the betterment of health care services and health research in India. [1] The primary challenge laboratory face while implementing GLP is to balance the rising healthcare cost and quality of services particularly in resource-constrained laboratories. [2] There are various challenges faced by the laboratory while implantation of GLP such as lack of Infrastructure, organizational structure, awareness on the role of laboratory service, shortage of resources, poor management support, ineffective services, low quality control measures, absence of quality assurance programs in health institutions, shortages of training and poor staff motivation and trained man power displacement were reported which affects the standard care of the patients laboratory results [3]. However these challenges are unique to the laboratories depending on the type, size, location, functionality and accreditation status. There are few review article/ limited original articles which enlightens on GLP, However there are no studies available to know various challenges faced in laboratories which are exclusively attached to tertiary care centers. Hence this study is undertaken to know the challenges faced during the implementation of Good Laboratory Practices in laboratories which are attached to the tertiary care centers.

A questionnaire based experimental study was conducted in various tertiary care hospitals in central Bengaluru, India, from July 2023 to December 2023. The study was conducted after obtaining ethical clearance from the institutional ethics committee (Ref No:SABVMCRI/IEC/RP/205/23-24), and all participants provided consent for the study.

Sample size:

In this study, 26 laboratories attached to tertiary care hospitals were enrolled, After obtaining the consent, participants were Doctors, Laboratory Directors, Laboratory In-charges, Quality Heads and the remaining laboratory assistants from three departments (Department of Biochemistry, Pathology and Microbiology) of various tertiary care hospitals in central Bengaluru. Samples were chosen using a non- probability convenience sampling method since the study was based on an online questionnaire.

Procedure

A pilot study was conducted in our hospital with a group of 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 0.90. The revised questionnaire was used for data collection.

Questionnaire : A pre-designed questionnaire in the English language was used in the study.  The questionnaire was distributed electronically using Google Forms, with a link sent to all participants. The questionnaire was explained to all participants, including the types of questions (Yes/No). Participants were asked to rate their level of agreement related to laboratory quality. Anonymity of responses was maintained throughout the study. The questionnaire consisted of 34 questions, including 26 closed-ended questions with predefined options and 8 questions regarding participants’ opinions on Laboratory management and leadership.

Data collection: A consent form was provided to each participating hospital. The data collection was in two stages. The researcher first began with the observations data at stage one. Followed by in-depth questions in the second stage. The purpose of using a sequential approach is that the observational data collected in the first stage will lead to identification of additional questions. The questionnaires and observations will offer the description of the current status of the medical laboratory and the leadership behavior of laboratory Directors/ Supervisors. This study has used demographic questionnaire developed by the researcher. Socio-demographic data includes the following: Name, gender, age, years of experience, educational background, position at work and department. The study includes questions pertaining to the current scenario of the laboratory such as infrastructure ; laboratory personnel, training and development ; laboratory equipment & reagent management ; quality control & quality services ; laboratory safety etc. The purpose of this questionnaire is to identify the Good Laboratory Practices in tertiary care hospitals in Bengaluru. 

After analyzing this data, second stage of descriptive questionnaire was prepared in order to gain an insight into the hospital laboratories in terms of leadership in action, to assess the managerial challenges experienced and how those challenges were overcome during implementation of good laboratory practices in the laboratory. This comprises the second stage of data collection.

ETHICAL CONSIDERATIONS

Ethical committee permission was obtained to conduct the research from Institutional Ethics Committee. The study was conducted after obtaining ethical clearance from the institutional ethics committee (Ref No: SABVMCRI/IEC/RP/205/23-24).

STATISTICAL ANALYSIS

Descriptive analysis was carried out by frequency and proportion for categorical variables. Continuous variable was presented as median (IQR). Fisher-exact test was used to test the statistical significance of cross-tabulation between categorical variables. P value < 0.05 was considered statistically significant. RStudio Desktop Version 2023.03.0+ 386 was used for statistical analysis. (Reference: RStudio Team (2023). RStudio: Integrated Development for R. RStudio, PBC, Boston, MA URL http://www.rstudio.com/.)

Demographic characteristics of the personnel working in tertiary care hospital laboratories in Bengaluru were measured. Most participants were Doctors, Laboratory Directors, Laboratory incharges. Two thirds of the participants had a Doctor of Medicine (MD) degree, the remainder had a Doctor of Philosophy (PhD) degree.

[Table 1] represents characteristics of the study population and [Table 2] represents the participants’ responses to closed-ended questions regarding the Good Clinical Laboratory Practices in their laboratory. It consists of 24 questions, related to the infrastructure, equipment, transport of sample, communication, training of Staff,  maintenance, documentation and quality control in the laboratory. The data showed no statistically significant difference in the responses of participants except the proportion of adequate number of laboratory staffs which is statistically significantly higher in NABL accredited labs as compared to labs which were not NABL accredited (p=0.012).

[Table 3] summarises the responses of participants to assess the leadership and management skills. This section included 8 descriptive questions and 2 closed-ended questions. The close ended question responses showed no statistically significant difference in the responses of participants.

In descriptive question (Q1: What is your role as a laboratory manager in implementation of GLP?). Respondents from NABL accredited & Non accredited labs mention the importance of leadership and coordination in managing laboratory operations effectively. Coordinating activities, facilitating communication between team members and ensuring that all aspects of daily activities are covered. Several responses highlight the role of the laboratory manager in ensuring good quality and standard reporting of laboratory results. This involves implementing quality control measures and evaluating the accuracy and reliability of test results.

In descriptive question (Q2 - 6: What are the challenges faced in your laboratory in terms of infrastructure, Laboratory Equipments and Reagent, Laboratory Personnel, Training, Quality Control and Quality Assurance, Safety practices?) Respondents from NABL accredited labs mentioned there is delay in obtaining approval from finance and management for necessary changes or upgrades. This includes challenges related to budget constraints and administrative processes. Respondents express challenges related to reagent management, including delays in reagent supply and issues with quality control (QC) supply. Workload and documentation load are cited as challenges, indicating that the implementation of quality control and assurance processes can be laborious and time-consuming. The need for a designated safety officer is highlighted as a potential solution to improve safety practices. Many respondents mention challenges related to training and education, including issues with staff understanding the importance of safety protocols, the need for ongoing training and difficulties in training certain groups of staff such as group D personnel.

Whereas a common challenge has been mentioned from the respondents from Non-NABL accredited labs is inadequate space for laboratory operations. Some respondents highlight issues with old or outdated infrastructure, the need for better equipment and facilities. Another significant challenge is the shortage of manpower and disinterested management. Difficulties in obtaining approval for equipment purchases. Some mention the need for new technology including upgrades to Laboratory Information Systems (LIS). A common challenge mentioned is the maintenance and management of laboratory equipment. This includes concerns about ensuring proper functioning through timely calibrations, maintenance, and backups in case of sudden breakdowns. Manpower is also cited as necessary for managing equipment storage and monitoring temperatures. Several respondents highlight challenges related to staff knowledge and commitment to quality control and assurance processes. This shows the concerns about the level of knowledge on troubleshooting, commitment of laboratory technicians and staff, and negligence from senior staff members. Some respondents mention challenges related to coordination between different departments within the laboratory, such as biochemistry, pathology and microbiology. This highlights the importance of effective communication and collaboration across the departments. Attitudes towards laboratory safety and compliance with safety protocols are cited as significant challenges. Mentions of laziness, lack of seriousness, reluctance and taking shortcuts by some staff members, which can compromise safety practices

Descriptive question Q7: (What are the challenges faced by you as laboratory manager during implementation of GLP?) Respondents from NABL accredited labs mentioned financial constraints and challenges related to managing the financial aspects of GLP implementation. Additionally, getting all stakeholders on the same page is cited as a challenge, indicating difficulties in coordinating efforts and achieving consensus among different parties involved in GLP implementation. Managing records and improving turnaround time (TAT) are cited as challenges. Difficulties in implementing new processes or protocols and ensuring consistent adherence to GLP standards over time.

Respondents from Non NABL accredited labs mentioned interpersonal problems, staff resistance, and reluctance to change are mentioned as significant challenges. Resistance from senior technicians, discipline among lab personnel and the need for continual retraining and updating of technicians. One of the most common challenges mentioned is insufficient manpower and inadequate infrastructure.

Descriptive question Q8: (how did you overcome the challenges?) Respondents from NABL & Non NABL accredited labs highlighted the importance of continuous improvement and adaptation in overcoming challenges. Respondents emphasised the importance of motivating staff, spreading awareness about best practices, and fostering a culture of continuous improvement. Respondents emphasised the importance of remaining persistent, continuously reinforcing positive behaviours, and providing ongoing training and support. Many respondents highlighted the importance of teamwork and collaboration to address issues collectively and find solutions in overcoming challenges.

Establishing and maintaining Good Laboratory Practices (GLP) is essential for ensuring the quality and reliability of laboratory testing procedures, yet laboratories face significant challenges in this regard. According to Banister et al. (2012), establishing GLP-compliant infrastructure in academic health centers involves overcoming several critical challenges, including securing funding, training personnel, and maintaining rigorous quality control measures. Both accredited and non-accredited laboratories face common infrastructure challenges that directly impact their ability to maintain quality standards and adhere to GLP. The study by Banister et al. revealed that while most laboratories have basic facilities such as reception areas, specimen collection rooms, and uninterrupted power supply, issues like inadequate space, outdated infrastructure, and lack of storage facilities persist. These challenges can hinder the implementation of quality assurance measures, including proper specimen handling, equipment maintenance, and record-keeping practices. Without adequate infrastructure, laboratories may struggle to comply with regulatory requirements and ensure the accuracy and reliability of test results, ultimately compromising patient care and safety. Agrawal et al. (2013) support these findings by noting that accredited laboratories demonstrate better infrastructure and more rigorous maintenance schedules for equipment. This ensures that all instruments are calibrated and functioning correctly, which is crucial for producing reliable and reproducible results. In contrast, non-accredited laboratories often lack such stringent maintenance protocols, impacting the accuracy of their experimental outcomes.

Implementing GLP is also challenged by the need for comprehensive staff training. Interpersonal problems, resistance to change, and reluctance among staff members can be significant barriers to effective GLP implementation. Overcoming these obstacles requires promoting a culture of compliance, providing comprehensive training, and effectively allocating resources to support GLP implementation efforts. According to Santos et al. (2023), the use of multicriteria decision analysis (MCDA) helps in evaluating and enhancing the quality management systems in GLP laboratories, providing a structured approach to decision-making that improves compliance and efficiency.

Finance management plays a crucial role in addressing the challenges faced by laboratories in maintaining quality standards and implementing GLP. Limited financial resources can hinder laboratories' ability to invest in essential infrastructure upgrades, staff training, and equipment maintenance. Challenges related to supply chain management, reagent costs, and infrastructure investment underscore the need for effective financial planning and resource allocation strategies. Laboratories must prioritize investments based on their needs and objectives, seek alternative funding sources, and advocate for adequate funding to support quality assurance efforts. Collaborating with institutional finance departments and stakeholders is essential to address financial constraints and ensure the sustainability of laboratory operations.

In conclusion, addressing the challenges faced by laboratories in maintaining quality standards, implementing GLP, and managing finances requires a multifaceted approach. Laboratories must invest in infrastructure upgrades, prioritize staff training, and adopt effective financial management practices to overcome these obstacles. By addressing these challenges proactively, laboratories can enhance the quality and reliability of their testing services, ultimately improving patient outcomes and safety. Collaboration between laboratory managers, staff members, institutional stakeholders, and regulatory bodies is essential to ensure continuous improvement and adherence to best practices in laboratory management.

CONFLICT OF INTEREST

None declared by the authors.

 ACKNOWLEDGEMENT

The authors would like to express gratitude to the Department of Biochemistry, Pathology and Microbiology of SABVMCRI, Bengaluru , India, for collaborating in conducting the pilot study and validation of questionnaire. Thank you once again for your invaluable contribution.

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