Aspects of the Pre-analytic Phase of diagnostic testing in your CLIA lab impacting quality
The importance of diagnostic testing has risen to the forefront of our national discussions in light of the COVID-19 (SARS-CoV-2) pandemic. For that reason, I have decided to provide some guidance to clinical laboratories on the important points to consider when introducing a new diagnostic test into your laboratory. In this series, I will address each phase of testing (pre-analytic, analytic, and post-analytic) in its own blog. Today I will discuss the pre-analytic factors impacting every clinical diagnostic laboratory.
The Pre-analytic Phase
One of the most critical aspects of the pre-analytic phase of testing is specimen quality. This factor cannot be stressed enough—garbage in/garbage out, as the adage goes. The quality of specimens starts and ends with your CLIA laboratory. Your laboratory needs to communicate clearly to the specimen collection sites and to their personnel what the requirements are for specimen collection, handling, preparation, storage, and shipping.
Common Challenges
One of the biggest issues I have encountered is specimens that are of insufficient volume or quantity for the diagnostic test. A specimen with insufficient quantity for testing should be rejected by the clinical laboratory because the risk of a false negative result is too high. Another problem that I come across often is delayed delivery of specimens to the laboratory that results in thawed specimens. This error scenario can result in a false negative result due to potential degradation of analytes within the specimen (i.e. specimen stability). The third error scenario that I see that impacts specimen quality is interfering substances. Sometimes these interferents are obvious (e.g. hemolysis, bilirubin, etc), and sometimes they are more covert (e.g. medications taken by the patient). Your laboratory personnel and the collection site personnel function as a team to ensure patient safety by reducing the risk of false negative results for your laboratory’s patients.
Beyond the quality of the specimen itself, another issue I have seen frequently in the pre-analytic phase that adversely impacts the quality of diagnostic testing is the traceability (i.e. chain of custody) of the specimen back to the patient. This issue relies on good practices for patient identification and labeling of the requisition and specimen. I will cover this issue more thoroughly in the post-analytic blog, but for now, I will say that reliable labeling of specimens ensures that each patient receives the right result every time. Be sure that your entire pre-analytic testing team is trained on best practices for patient identification and requisition and specimen labeling.
The Solution
These issues can be mitigated with robust procedures and personnel training across the pre-analytical testing team. Typically, the CLIA labs I work with will deliver an instruction guide and provide training to collection sites to ensure that high quality specimens are delivered to the laboratory (Services). I have seen the improved results when an instruction guide is created and implemented across the pre-analytic testing team. This standard operating procedure improves the diagnostic testing experience for the CLIA lab, the collection site, and most importantly, the patient.
Your clients expect high quality results, and your patients deserve it! If your laboratory has questions or needs assistance with the pre-analytic phase of diagnostic testing, reach out to an experienced CAP/CLIA Laboratory Director and CLIA laboratory builder (Contact).
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