Strategic Lab Management: Avoiding Post-Analytic Failures Through Better Systems

In my last post, I discussed some of the silent errors that can occur during the pre-analytic phase of testing and how those errors can lower the quality of diagnostic test results and patient healthcare. Many of those issues during the pre-analytic phase show up again in the post-analytic phase, when the diagnostic test result reports are generated. Let’s look at how the pre-analytic and post-analytic workflows are interdependent and discuss best practices for preventing laboratory errors in the post-analytic phase.

The Challenge: Traceability and Chain of Custody

In a previous post, I noted that the pre-analytic phase includes collection of a significant amount of patient metadata (e.g. date of birth, ICD10 codes, etc). Additional data is collected during the analytic phase of testing. All this data must be linked to the original patient specimen to maintain chain of custody across the workflow. Most laboratories use a barcoded alphanumeric identifier assigned to the specimen upon receipt by the clinical laboratory. Most labs refer to the alphanumeric identifier as an accession number or a patient identifier.

All of this data is used to generate a test result and a test result report for each patient. Some of or all of the metadata must appear on the patient test result report. It is critical that the right data appear on the right patient’s test result report. The clinical laboratory needs a system to maintain chain of custody of all this information collected across the entire testing workflow. Complete traceability is necessary for ensuring high quality diagnostic test results.

Most clinical laboratories implement a laboratory information management system (LIMS) to maintain chain of custody across the workflow.

Laboratory Information Management Systems (LIMS)

One of the most important decisions a clinical laboratory makes is how it manages its processes and its data. There are many options when it comes to LIMS, and the LIMS can come in many forms:  

• Worksheets,

• Excel files,

• Commercial off the shelf LIMS (customized for the lab’s needs), and

• Custom in-house built LIMS.

Each of these systems have strengths and weaknesses, which I won’t detail here (I will do that in a future post.). No matter which type of system is used by the laboratory, the lab must maintain chain of custody and traceability of all data collected across the testing workflow. The specific requirements depend on the laboratory’s tests and testing workflows, the patient populations, reimbursement requirements, and the regulatory requirements for the laboratory. The activities during the implementation phase of a LIMS build effort can have long-lasting impacts on the post-analytic phase of diagnostic testing (i.e. test result report generation and delivery).

The Solution

Whether your clinical laboratory is selecting its first LIMS or making modifications to an existing LIMS, the LIMS implementation stage requires detailed planning, thorough requirements gathering and communication, verification testing to ensure proper implementation of requirements, and user-based validation testing to confirm that the system performs as required.

These concepts are relatively simple; however, successful implementation is not always easy. I encourage laboratories to plan for these processes early to avoid delays or quality issues later.

If your laboratory has questions about the post-analytic phase of testing (i.e. generation of test result reports) or needs assistance selecting or implementing a LIMS, send me a message (Contact me). I will use my wealth of experience selecting and implementing LIMS to fit your company’s needs and your laboratory’s requirements.