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TOPIC: Quality of a Lab! What you should know.

Quality of a Lab! What you should know. 3 months 5 days ago #189

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What is Quality of a Pathology Lab?

When someone tells you that the Quality of their Lab is 99%, how do you evaluate this lab?
Very Good?

99% Quality means accepting 1% Error.
Is 1% big or small?

In France Alone 1% Error means Daily:
1. 14 minutes without water or electricity
2. 50,000 parcels lost by postal services
3. 22 newborns falling from midwives’ hands
4. 600,000 lunches contaminated by bacteria
5. 3 bad landings at Orly Paris airport

So going back to the question again: What does 99% of Quality Means?

The Answer is:

In areas like Medicine or Aviation, Errors can kill people. In Aviation: One mistake and aircraft can crash and kill 100s of people. One mistake in Medical Lab: can lead to missed diagnosis or wrong diagnosis leading to delayed treatment or wrong treatment respectably, which might kill the patient.

In our Country like Nepal, when everything is on chaos state: it is indeed very difficult be confident on any existing medical labs in Nepal. The best way to judge a Lab is to ask the question to Lab itself “what is their Error Rate”? If they are able to say their “error rate” for the period of given time frame, that means they have very good quality management system in place and you can trust that Lab. If a Lab cannot tell you exact figure of their Error Rate, or even says that they don’t make mistakes that means, they do not have any quality management system and these Labs would not even know when they make mistakes.

The quality of Medical Lab is a very complex system and it’s a continuous process at every step. It starts from the time patient enters a medical facility and registration process, and continuous even after the reports are dispatched to the patient.

The processes in Lab are divided into 3 phases:
1. Pre-Analytical Phase: which consist of everything that is done even before testing your sample, and contributes 50% on over all Quality.
2. Analytical Phase: which consists of actual performing the tests of samples by staff and equipment, and which contributes only 20% to the Quality.
3. Post-Analytical: which consists of everything that is done after the testing of sample is completed and contributes to 30% of Quality.

As you can see, actual sample testing process by Lab Staff and lab equipments, which is an analytical phase, contributes only 20% on Quality. Everything that is done before the sample testing and after the sample testing actually contributes 80% on Quality. So having the best equipment and best qualified staff can only guarantee 20% in Quality. If attentions lack in Pre-Analytical and Post-Analytical Phases then you can imagine all sorts of error, including the change in Blood Groups and resulting in transfusion for wrong blood group to the patient.

You probably have heard a best surgeon in the world amputated a healthy right leg, instead of the diseased left leg? The surgeon might be the best in the world, the equipments can be the best in the world, but this can only contribute 20% on the quality. What happens even before the surgery and after surgery actually contributes to 80% of success.

There are more than 1000 things that goes in the lab as a quality management system: but there are few things that are most important:

1. Before doing the test of a patient Lab must run a quality control samples with normal value QC and abnormal value QC. And also run a standard sample, which is supplied with the chemical reagents. If the results of these Quality control samples are in the range, then only you can proceed to do tests of real patients samples. These are called Internal Quality Control. Every Lab that has Quality Control Systems will have the results of Internal Quality Control displayed in their Lab for most of the tests like for Blood Sugar, Uric acid, Cholesterol, etc in the form of the Standard deviation Graph.

2. Participation in External Quality Control: This is very interesting and hardly any Lab in Nepal are doing this. The Lab will get samples from External Quality Control Organization for a whole year, different sample for each month. At the end of the each month you must perform the tests of these samples and publish the results online. Then after the month is over, the Ext QC Organization will send the results to the Lab for every test that was done and let the lab know if they are in the range or not. At the end of the Year- the Lab will receive a certification of participation on this External Quality Control Program.

Said all these, just having a fancy equipment and some fancy experienced staff in a lab hardly guarantee any quality of the reports. In order to have the Lab with Zero Error reports, apart from equipments and staffs, one must have a quality management systems in place that will as well cover extensive work done in Pre-Analytical phase, Analytical Phase and Post-Analytical Phase.

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