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Writer's pictureAngie Purvis, LLC

The Post-Analytic Phase: Diagnostic Testing in Your CLIA Laboratory

As more laboratories are implementing SARS-CoV-2 testing and as new laboratories are being built, I am receiving more and more questions about the post-analytic phase of diagnostic testing—specifically the requirements around reporting. At this time, a lot of established laboratories are reviewing their current test result reports at the same time as they are designing new reports for COVID-19 to ensure that all required information is included. Brand new laboratories are wanting to know what the requirements are for reporting overall. In this post, I will review some special considerations for the post-analytic phase of diagnostic testing for your CLIA laboratory to ensure high quality testing.


The Post-Analytic Phase—The Importance of Accurate and Timely Reporting

When the words “post-analytic processes” are mentioned, most people think about the patient test result report, but the requirements for post-analytic processes goes much deeper than the test result report. In this blog, we will consider what is needed on the test result report along with the system-level requirements to ensure accurate and reliable test result delivery at the provider and public health levels.


The Test Result Report

The importance of the patient test result report is paramount because the quality of the results has a direct impact on the quality of patient care. The patient test result report must include the available information that a physician would need to interpret the results. The information that is needed to interpret the test results depends on the specific test being performed and the specific clinical context. At a minimum, every test result report must include the following elements of information:


· the name and address of lab where test was performed

· patient identifiers

· test report date

· test performed

· specimen type/source

· info on specimen quality

· test result (including unit of measure, if applicable) with interpretation

· normal values for the test performed


Before the laboratory releases patient test results reports, a qualified member of the laboratory staff must review the results to ensure accuracy and quality.

After the results are reviewed, the report must be delivered to the ordering physician in a timely manner. Fast turn-around of results is especially important for STAT testing. Whenever your laboratory is involved with STAT testing, be sure those tests are prioritized and that the delivery of those results take first priority. For tests that have established panic values, be sure that information is included on the patient’s test result report and that results that reach the panic level are communicated back to the provider quickly.


Sometimes test result reports are released containing errors. When that happens, the CLIA laboratory must issue an amended report. The laboratory must be sure to notify the healthcare provider immediately when errors are identified. The laboratory must submit an amended test result report. The laboratory must retain a copy of the original as well as the amended report as part of the patient test record.


Test Reporting Systems

In my consulting work with CLIA laboratories, I find that most labs need to make improvements on their verification and validation practices of their test reporting systems. The CLIA laboratory must have accurate and reliable test reporting systems and records storage and retrieval systems. One of the biggest risks that threaten the reliability and accuracy of a laboratory’s reporting system happens when changes are made by the provider’s office and the laboratory is unaware of those changes. Even in this case, it is the clinical laboratory’s responsibility to ensure patient test results are communicated back to the healthcare provider in a timely manner. Therefore, validation of the laboratory’s test reporting systems must be performed routinely in order to ensure that the integrity, accuracy, and reliability of the overall reporting process. The design of this validation depends on the design of the test result reporting system that your laboratory uses. Good practices for Risk Management should be used by the laboratory in order to identify potential break-points in the result reporting system before those breaks happen.


Public Health Reporting

Some diseases have special public health reporting requirements at the local, State, and/or federal level. This requirement warrants special attention, given the importance of accurate COVID-19 case numbers at the community and national levels. Now is a good time to review the requirements for reportable diseases that impact your laboratory. Be sure your laboratory is following all of the applicable public health reporting requirements at the local, State, and federal levels for each of the reportable diseases included in your laboratory’s testing menu.

The importance of the integrity and timeliness of clinical diagnostic test reporting cannot be emphasized enough and was covered here only briefly. If your laboratory has questions or needs assistance with these or other aspects of the post-analytic phase of diagnostic testing, reach out to an experienced CAP/CLIA Laboratory Director and CLIA laboratory builder (Contact).

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