Quality Assurance in clinical laboratory. Part 01.

(The precise and dependable reporting of laboratory results is of most important for patients due to its significant medical, social, ethical, emotional, and economic implications. Quality Assurance (QA) and Quality Control (QC) programs are implemented throughout every stage of the testing process, which includes pre-analytic, analytic, and post-analytic phases, to guarantee the dependability of patient results. These programs scrutinize and evaluate all activities connected to a patient result, ensuring the overall quality of the testing process. Clinical laboratories can ensure the trustworthy reporting of patient results by implementing comprehensive QA and QC programs. In this series of blogs, we will delve into the details of the quality assurance of clinical laboratory testing, and this is the first blog of the series)

Introduction to Quality Assurance and quality control.

In the clinical laboratory, Quality Assurance (QA) and Quality Control (QC) are crucial processes that ensure the accuracy and consistency of patient test results. These processes encompass three phases: pre-analytical, analytical, and post-analytical, to ensure reliable and valid results throughout the testing process. in this blog we will discusse about these phases

01. Pre-Analytivcal Phase.

The pre-analytic phase of testing involves various processes from the test order to the arrival of the sample for testing, including patient preparation, sample collection, handling, transportation, storage, and login. Errors can occur in all phases of testing, but the pre-analytic phase tends to have the highest number of errors due to the involvement of several manual and error-prone steps. Therefore, pre-analytic Quality Assurance is crucial in ensuring the accuracy and reliability of laboratory results. 

To ensure the accuracy and reliability of laboratory results, pre-analytic Quality Assurance involves addressing various questions such as 

• whether the correct test was ordered,.
• whether the patient followed instructions for test preparation,
• whether the appropriate tube type and volume were used for sample collection, 
• whether swabs need to be placed in specific media during transportation, 
•  whether the sample needs to be refrigerated or frozen or can be held at room temperature. 
• These questions are crucial in minimizing errors and ensuring the integrity of the testing process.

02. Analytivcal Phase.

The testing process's analytic phase involves all the procedures performed once the sample arrives at the testing bench and involves the direct testing of samples. The Quality Assurance (QA) program in the analytical phase primarily focuses on monitoring the quality of instruments and reagents used in testing to detect any problems that may arise. As this phase deals with the direct testing of shb, it is the most closely regulated and monitored phase of the entire testing process.

Various aspects of Analytic Quality Assurance (QA)

• Instrument selection: Selecting appropriate instruments that meet the laboratory's needs and can provide accurate and reliable results.

• Method validation: Verifying that the test method used for sample analysis is accurate, precise, and reliable.

• Quality control: Implementing a system of quality control checks to monitor and detect any variations in test results caused by the testing process.

• Test performance: Ensuring that laboratory staff performs tests correctly and follows the established protocols.

• Result verification: Verifying the accuracy of test results through various verification methods, such as independent review, repeat testing, or correlation with previous results.

• Proficiency testing: Participating in external proficiency testing programs to evaluate the laboratory's performance and identify areas for improvement.

Overall, these aspects of analytic Quality Assurance ensure that the laboratory can provide accurate and reliable results for patients.

03. Post Analytical phase.

The post-analytic phase of testing encompasses all the procedures that take place following the actual test execution. If errors occur during this phase, it can lead to incorrect or delayed reporting. Quality assurance during this stage is crucial for producing precise, dependable, and prompt results.

Post-analytic Quality Assurance involves various elements such as:

• Conveying results

• Identifying critical and high-priority results

• Providing recommendations based on results

• Documenting and storing results and communications

• Maintaining specimen storage

• Tracking the distribution statistics of results