From Concept to Reality: Maximizing Value in a State-of-the-Art Clinical Laboratory

Clinical laboratory builds are complex efforts that require a streamlined strategy, a high degree of technical expertise, foresight to future operational and business needs, and an ability to be creative and flexible along the way. In my previous post, I talked about the Laboratory Director role (learn more about my journey as a Laboratory Director) and my philosophy for serving in that role. In this blog, I will introduce my approach to building a new clinical laboratory and discuss how to extract value at each stage of the buildout of a clinical laboratory operation. The clinical laboratory needs to be built so that it adapts to future needs and puts patient safety front and center. My roles as clinical laboratory builder and Laboratory Director are intertwined, and my goal is to build clinical laboratories to the quality standard that I would want for a clinical laboratory that I direct, even if I will not be its Laboratory Director. I build clinical laboratories that I would feel confident signing my name to.

Overall, I take a phased approach to building a clinical laboratory, and I build value within the laboratory space and its systems at each milestone throughout the build process. I think of these milestones in a clinical laboratory’s build cycle as prototypes and each milestone allows for a specific type of work to be performed and ensures specific levels of quality (Services).

The Clinical Laboratory as a Workplace

The first phase of a clinical laboratory buildout establishes the laboratory as a workplace. In this early phase a company needs to map out its workflows and consider the risks associated with biohazardous materials, hazardous chemicals, electrical safety, fire prevention and response. The company needs to invest in engineering controls to ensure that risks are mitigated to the extent possible to ensure employee safety by including chemical safety showers, eye wash stations, chemical and/or biological safety hoods, and segregated storage of chemicals (flammables, corrosives, etc). The company needs to provide the proper personal protective equipment (PPE) for each workflow. There are important policies and procedures that need to be documented and training programs need to be established to ensure that a culture of safety is borne in the earliest days for a clinical laboratory.

At this earliest stage, the clinical laboratory can purchase its instrumentation, equipment, reagents, and supplies.

The Clinical Laboratory as a Product Development Environment

At the point that the instrumentation and equipment is received by the laboratory, it needs to undergo the installation qualification (IQ) and the operational qualification (OQ) processes to ensure proper initial performance. Later, the equipment and instrumentation will be subjected to the performance qualification (PQ), but that process will require performance verification of the actual tests to be performed by the clinical laboratory. The standard operating procedures (SOP) to specify the calibration and preventative maintenance should be developed and implemented as soon as these systems are installed and qualified.

Additional aspects of the Quality Management System (QMS) should be created and implemented, including the SOPs to manage environmental control (temperature, humidity, etc). When the instrumentation and the environment is under control, the laboratory can begin to develop and refine the SOPs to support the analytic phase of testing with reasonable assurance that the data will be reproducible over time.

Building Towards a Clinical Laboratory

To bridge the gap between a stable environment that can reliably support product development and a high-quality clinical laboratory, the laboratory must build and implement a complete QMS to support all activities within the laboratory and for those impacting the laboratory. The clinical laboratory needs to document and lock the SOPs associated with all aspects of the testing workflow (pre-analytic, analytic, and post-analytic). Then, those SOPs need to be verified and/or validated for the clinical laboratory’s intended use.

The clinical laboratory requires personnel who are qualified to perform the roles within the laboratory and are trained and competent on all tasks that they perform. The clinical laboratory needs a way to maintain chain of custody of specimens and all the associated data across the complete testing workflow. Most clinical laboratories choose to fulfill this requirement with a commercial off-the-shelf laboratory information management system (LIMS) that is, at least partially, adapted to the lab’s needs.

Verifying and/or Validating the Clinical Laboratory

The final phase for building a clinical laboratory is to verify and/or validate all the systems that are part of the diagnostic testing workflows to ensure that they perform as intended and that the interfaces between them are operational.

The clinical laboratory will need to verify or validate the assays that will be included in the initial test menu prior to performing patient testing. If the assay is FDA-approved or FDA-cleared and the clinical laboratory will be using the test as specified on the label, then the clinical laboratory can verify the manufacturer’s claims for performance in the clinical laboratory’s anticipated testing population. If the assay has not been approved/cleared by the US FDA, then the test is a laboratory developed test (LDT), and its analytical and clinical performance characteristics will need to be determined by the clinical laboratory that performs it.

The clinical laboratory will need to validate the LIMS prior to using it in the lab’s production environment. Ideally, the LIMS development and implementation effort included members of the clinical laboratory team, who had significant input into the requirements and participated in the verification process for each aspect of the workflow included in the LIMS.

Prior to going live with a new clinical laboratory or a new test on an existing clinical laboratory’s menu, the clinical laboratory will need to perform a total process validation to ensure that all systems are performing to specification to support high quality testing for patients. After all the systems are validated and the QMS is implemented, the clinical laboratory is ready to apply for a CLIA certificate of registration.

In my next blog post, I will go into more detail on how I weave all these systems together to launch a clinical laboratory and its initial menu of tests.

Building a new clinical laboratory or adding a new test to an existing testing menu does not have to be an intimidating process. If you have questions about your clinical laboratory buildout or test menu expansion, contact us for information or assistance (Contact Us).

Clinical Laboratory Leadership and Strategy