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Quality Assurance in Medical Laboratories

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Instructor: Dan Washmuth

Dan has taught college Nutrition and Anatomy courses for over 5 years. He has a B.S. in Exercise Physiology from Furman University and a M.S. in Dietetics & Nutrition from Florida International University. He is a Registered Dietitian (RD) and a Certified Exercise Physiologist (EP-C)

Medical laboratories are a vital component of our healthcare system. Learn all about the various quality assurance measures that have been put in place to help make sure these labs function correctly and safely. Updated: 07/29/2021

Laboratory Error

Mary is a 68-year-old woman who has been feeling pretty sick lately, so she decides to see her doctor. The doctor evaluated Mary but couldn't determine what was causing her recent illness. Therefore, the doctor instructed Mary to go to a nearby medical lab to get her blood drawn and tested. He explained that perhaps getting her blood examined could help him find out what was causing her recent illness.

Mary went to the lab and got her blood drawn. A few days later, Mary's doctor called to let her know that her blood work looked very healthy and did not show any abnormalities.

However, a few days later, Mary was hospitalized with severe liver damage. This surprised her doctor because Mary's blood work did not show any elevated levels of liver enzymes, which indicates liver damage. After doing some investigating, the doctor found out that the medical lab mixed up Mary's blood work with another person. This error prevented the doctor from catching her liver damage earlier, which could have helped prevent Mary from being hospitalized.

How can this type of situation be prevented? Luckily, there are certain quality assurance measures in place for medical laboratories.

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Quality Assurance in Medical Labs

Quality assurance refers to establishing and maintaining a certain level of quality in a product or service. Therefore, quality assurance in a medical lab refers to making sure the lab is running smoothly, safely, and effectively without any errors. The procedures performed in a medical lab can be divided into three main phases. These include:

  1. The pre-analytical phase, which involves obtaining patient information and taking the specimen sample
  2. The analytical phase, which involves examining and testing the sample
  3. The post-analytical phase, which involves analyzing the test results and creating an official report

Let's take a closer look at the various quality assurance areas in each of these three phases of a medical lab. During the pre-analytical phase, quality assurance is focused on ensuring all patient information and documentation are correct, patient information is kept private, and proper procedures are followed when taking the sample (such as the medical professional wearing gloves when handling samples).

The quality assurance measures for the analytical phase include maintaining patient privacy and standard operating procedures (SOPs) during the testing of the sample. This includes ensuring that the proper temperature is maintained and that the sample is not contaminated.

Analyzing samples using the correct equipment, routinely calibrating equipment, and maintaining patient privacy are the quality assurance measures for the post-analytical phase. As you can see, patient privacy is a very important aspect of quality assurance in all three phases of a medical lab.

Clinical Lab Improvement Amendments

Clinical lab improvement amendments (CLIA) are a set of regulatory standards for clinical and medical labs created to help to make sure a medical lab maintains quality assurance. These regulatory standards include:

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