Don’t Wait Until It’s Too Late: Laboratory Errors in the Pre-Analytic Phase of Testing

One common theme I have seen over my career is laboratories delaying the build-out of pre-analytic and post-analytic processes to support high-quality laboratory testing. I see this mistake happen in clinical diagnostic labs, labs operating under good laboratory practices (GLP), and analytic laboratories performing other services. When the pre-analytic processes are neglected until a new test is about to be launched, the laboratory will experience a higher rate of laboratory errors and will deliver poor customer service. The customer will have a negative customer experience, and the result is often erroneous results being delivered back to the customer. If the laboratory performs diagnostic testing, laboratory errors of any kind can impact the quality of healthcare that the patient receives.

In this post, I will discuss impacts in the pre-analytic phase of testing specifically and how these issues can be avoided. Laboratory errors in the pre-analytic phase are particularly concerning because of the potential, direct impacts to patient care; however, these errors are detrimental to test results generated in analytic laboratories and in GLP environments as well.

The Pre-analytic Processes

As a reminder, the pre-analytic phase of testing includes the processes necessary to obtain, process, and ship primary specimens from the point of collection to the laboratory. The pre-analytic phase is critical for ensuring specimen/sample quality which directly impacts the quality of test results released by the laboratory.

The clinical laboratory has significant responsibility for the quality of primary specimens even before those specimens reach the laboratory. Previously, I have articulated the detectable pre-analytic issues that diagnostic clinical laboratories encounter (Pre-analytic Errors). In this post, I will discuss some of the more subtle (and largely undetectable) issues I see repeatedly with pre-analytic processes that negatively impact test results and the proactive steps the entire medical laboratory and its supporting functions can take to defend against these issues.

Challenges to Navigate

Many laboratory quality issues occur with primary specimens before the specimens even reach the clinical laboratory. In my previous post on this topic, I emphasized some of the issues that can be detected by skilled medical technologists, including insufficient quantity of primary specimen, thawed specimens, and the presence of interfering substances (Pre-analytic Errors). If these issues are not detected and handled appropriately by the medical laboratory, the laboratory may release results that are poor quality and/or incorrect. The best clinical laboratories use a variety of mitigation strategies to prevent issues at the point of specimen collection and have clear procedures in the laboratory that well-trained technologists follow.

As a Laboratory Director, the pre-analytic issues that keep me awake at night are the ones that are “silent” to the laboratory, meaning that the clinical laboratory processes the specimens unaware that the results may be erroneous due to errors that occurred before the laboratory even received the specimen. These issues are often undetectable by even the most skilled laboratorian.

Laboratory Errors: Pre-Specimen Collection. Some of these laboratory errors happen before the specimen is even collected. For example, there can be miscommunication with a patient prior to collecting the specimen (e.g. fasting prior to collection) that can impact test results. Further, blood specimens collected in the incorrect order of draw can be difficult to detect and can lead to erroneous results for certain clinical tests. Even with good attention to detail and barcoding, specimens can be mislabeled, which could lead to patients receiving the wrong test result entirely.

Laboratory Errors: Specimen Processing. Other “silent” errors can arise during specimen processing at the collection site. Even very simple processing instructions, specimen processing can be challenging in a high-pressure clinical environment. For example, specimens may not be centrifuged at too low of G-force due to instructions being given in rpm and the site not having the correct rotor for the centrifuge. Sometimes primary specimens may be held at room temperature (or uncontrolled temperature) for too long, leading to pH changes, bacterial growth, degradation of key analytes, and/or lysis of red blood cells. Incorrect specimen collection and/or specimen processing can lead to increased levels of interfering substances. In the worst cases, specimen processing issues at the point of collection can include cross-contamination of primary specimens for different patients. This error leads to the patient receiving the incorrect test result. Problems during specimen processing amplify when the laboratory requires a unique or modified processing procedure for a specific test.

In some cases, the results will not make sense to the treating physician, and the patient will have to undergo a new specimen collection and wait longer for test results. An extra specimen collection is a pain for the patient, a burden on the healthcare system, and an unnecessary delay for test results needed for patient care.  In the worst scenarios, these issues can have a significant impact on patients, including poor quality healthcare, lower quality of life, potentially lead to life-threatening situations.

The Solution

Most laboratories have procedures in place that address the preanalytic phase of testing (i.e. instruction guide). In my experience, the procedures exist, but often they are not designed or implemented sufficiently to proactively prevent silent laboratory errors. The best defense against issues in the pre-analytic phase is for the clinical laboratory to develop robust, integrated systems that build and maintain communication with healthcare providers that the laboratory serves. These programs must be developed to meet the needs of the healthcare providers and the laboratory for the system to be successful.

Does your laboratory have systems that mitigate silent laboratory errors in the preanalytic phase? If your laboratory is uncertain or needs assistance building or improving its pre-analytic processes, reach out to an experienced laboratory partner (Contact Us).