Introduction

Clinical diagnostic laboratories conduct various tests that enable physicians in the diagnosis, treatment, and prevention of diseases. These laboratories conduct tests on patient samples for addressing medical and public health needs. Several factors must be contemplated before setting up a diagnostic testing facility. These include proper planning, staffing, managing workflows and lab supplies, managing biosafety and equipment, among others.

Following are some of the necessary factors one must consider before setting up or renovating a clinical diagnostic laboratory:

1. Automation of Lab Processes

Clinical diagnostic laboratories struggle to meet testing demands and maintain staff safety. It becomes difficult for them to meet quality goals and stay cost-effective at the same time. Laboratory automation helps increase productivity, decrease turnaround times, increase scalability, minimize errors, and assure high-quality test results. It provides ample benefits to laboratories and redefines the way they operate. With minimal human intervention, it helps reduce human efforts and simplifies repetitive tasks. Automation reduces variability in results that usually comes with manual processes and helps generate reproducible results. Automation eases the entire laboratory function as it helps process samples, load the samples into automated analyzers, assess test results, and store samples until they are disposed of.

2. Workflow Management

It is important to create a detailed plan to manage and optimize workflows before setting up a clinical diagnostic laboratory. The typical workflow of a clinical diagnostic laboratory includes receiving test requests, receiving samples, labeling samples and accessioning them, processing and testing samples, reporting results to patients or physicians, storing or disposing of samples. However, the workflow may vary from one laboratory to another. A good laboratory workflow ensures minimal sample transfers and minimal distance between workstations. Laboratories need to define workflows, properly coordinate with all stakeholders, optimally utilize resources, and ensure that staff members follow predefined standard operating procedures (SOPs).

3. Sample Management

Sample management is a crucial part of all laboratories, including clinical diagnostics. A laboratory should be capable of efficiently managing all types of samples that come for testing and maintaining sample integrity at all times. Samples require suitable storage containers and ambient storage conditions. Many times, manual management of samples becomes a bottleneck due to high volumes of incoming samples and a dearth of skilled staff. This may result in errors and inadequate sample tracking. A laboratory should have the required facilities to store samples at optimum conditions (temperature, relative humidity) and easily track samples at any point in their life cycle.

4. Equipment & Inventory Management

A laboratory should never be short of necessary diagnostic equipment and supplies. It is also crucial to look into the safety aspect of laboratory equipment before procuring them. It is recommended to have FDA-approved equipment to ensure patient safety. Laboratories should have a system to send alerts to laboratory managers if the quantity of supplies falls below a threshold level. This would help laboratory managers to initiate necessary actions for the timely replenishment of supplies.

Laboratory instruments should be capable of handling the daily workload. It is always good to have a preventive maintenance plan and a backup plan in case of equipment malfunctioning. Laboratories should regularly perform functional checks and properly maintain all laboratory instruments to ensure accurate and valid test results. The laboratory staff should be trained periodically on using all equipment related to the tests assigned to them. Personnel should follow manufacturers’ instructions, schedule timely calibration of instruments, and maintain current and previous calibration and maintenance records for quick reference.

5. Specialty Spaces

Clinical diagnostic laboratories should have spaces such as mechanical and electrical rooms, gas cylinder rooms, storage centers, and hazardous waste holding sections, among others.

6. Open-Plan Designs

Modern laboratories have started to adopt open-plan designs to carry out their daily processes. Open-plan designs have wide-open spaces with no interior walls. This enables reconfiguring the laboratory layout as and when needed. Many laboratories are adopting and implementing Lean operational models to reduce processing steps, minimize errors, and reduce wastage of space, energy, and time. Open-plan designs enable laboratories to continuously follow the objectives of Lean design.

7. Biosafety Level 3 (BSL-3) Laboratories

Possible threats from infectious diseases increase the need for constructing BSL-3 containment environments. BSL-3 proof environments ensure sample integrity and staff safety. BSL-3 laboratories are constructed using non-porous materials to prevent pathogens from settling and multiplying. Clinical diagnostic laboratories should have standard operating procedures (SOPs) to ensure uninterrupted workflow in BSL-3 laboratories. Everything from architectural and mechanical to plumbing systems is designed in a specialized manner. BSL-3 laboratories are particularly important for laboratories handling infectious disease samples, for example, COVID-19 diagnostic testing laboratories.

8. LIMS Deployment

Clinical diagnostic laboratories face several challenges, such as securely managing samples, patient data, tests and their results, managing resources, such as personnel, instruments, lab supplies, and meeting compliance such as HIPAA, CLIA, and ISO 15189:2012.

With evolving technologies such as the Internet of Things (IoT), Artificial Intelligence (AI), and big data, there is a growing need for hassle-free data management and safe data access. Cloud technology helps laboratories securely store all data at a centralized location, thus providing easy data access to users. Laboratories should implement a clinical diagnostics LIMS solution, also known as a clinical Laboratory Information Management System (LIMS) to digitize their operations, securely manage data, meet compliance, and stay ahead of the curve.

Conclusion

Clinical diagnostic laboratories must be well-designed with a futuristic approach to achieve flexibility and operational efficiency. Modern clinical diagnostic laboratories tend to seamlessly grow, transform, and adopt the changes that come with evolving technologies. Lab digitization, efficient workflow management, sample and equipment management, advanced infrastructure, enhanced safety measures, and a robust cloud-based Clinical diagnostics LIMS solution jointly set the base for a successful clinical diagnostic laboratory.