NGSP annual certification for the sixth time

Author: Laboratorio Clínico Hematológico

Publication date: 01/25/2023

The Clinical Hematology Laboratory received from the NGSP, for 2022-2023 and for six consecutive years, the certification of traceability as a level I laboratory for the glycated hemoglobin test, which is routinely measured in clinical laboratories to estimate the average blood sugar levels in the last quarter. This information allows us to know if a person is in a state of prediabetes or diabetes, or if the disease is well managed. To learn more about this certification we interviewed Dr. Catalina Franco Alzate, Medical Director of Hematológico, who shared with us what the renewal of the NGSP quality certification for glycated hemoglobin is and what it means.

1. ¿What is the NGSP?

NGSP stands for the National Glycohemoglobin Standardization Program, which was the original name of this program for the harmonization of HbA1c testing, established in 1996 following an initiative in the United States to define a standardized assay for the measurement of glycated hemoglobin that could be used in all laboratories worldwide and for any population. This, through the certification of methods that are traceable to two important studies conducted in patients with diabetes mellitus: “Diabetes Control and Complications Trials (DCCT)” and “United Kingdom Prospective Diabetes Study (UKPDS)”, in which the glycated hemoglobin values that represent a risk of development and progression of chronic vascular and degenerative complications of diabetes were established. As the program grew and became international in scope, the official name was shortened to the acronym NGSP.

2. ¿What do you mean by standardization?

There are different methods for the assessment of glycated hemoglobin in a clinical laboratory; for example, in Hematológico we use the high performance liquid chromatography (HPLC) method; however, in order for the results obtained to be clinically useful, they must be reproducible, regardless of the method or where the measurement is made. When we talk about standardization we refer to a rigorous process that establishes the fundamental parameters by which a method of assessing a test conforms to pre-established parameters and demonstrates that it is adequate to deliver reliable results. In this sense, glycated hemoglobin is a test that allows the diagnosis of Diabetes Mellitus and helps to define the risk of developing chronic complications of this disease. Standardizing this type of test allows laboratories to speak the same language. Once the titration method is standardized, it should ideally be subjected to continuous monitoring through the use of test quality controls and comparison tests between the method itself and that performed by a reference laboratory, in order to quickly adjust the identified improvement points. In this case we do it with the NGSP. To learn about the concepts of “traceability” and “harmonization”, closely related and sometimes confused with the standardization process in the context of glycated hemoglobin click here . Quality concepts related to standardization, in the context of glycated hemoglobin: Traceability: supports the standardization process. For glycated hemoglobin we say that the measurement method is traceable when the results it provides are comparable and comparable to the international DCCT and UKPDS studies (which we have already mentioned), through comparison tests with reference laboratories; in our case with the NGSP laboratories. This also makes it possible to demonstrate the equivalence of results with other laboratories that are members of the network. Harmonization: consists of standardizing, in addition to the measurement methods and their results, other aspects to be taken into account during the total testing process, such as the type of sample to be used, the units of measurement, the reference values, the interpretation and diagnostic decision criteria, among others; through the application of an international consensus protocol in order to issue a reliable result regardless of the laboratory that generated the information. In this sense, the NSGP is the international body dedicated to the harmonization of glycated hemoglobin measurement for the diagnosis and care of diabetes.

3. ¿What does the NGSP program consist of?

The program consists of a network of reference laboratories that are part of and authorized by the NGSP, whose method of measuring glycated hemoglobin is adjusted to the international studies mentioned (DCCT and the UKPDS), which are responsible for monitoring the individual participating laboratories, such as ours. 

What they do is process a series of fresh blood samples, with which they establish the initial glycated hemoglobin data for standardization (calibration) of methods and assays for comparison of results. These same samples are then sent for processing in our laboratory with the analytical equipment and glycated hemoglobin measurement method that we routinely use for testing our patients. 

Once processed, the results are sent to the NGSP to be verified and assessed by members of the program. Once it is confirmed that our results for glycated hemoglobin are concordant with those of the reference laboratory, that is, that they are within the parameters established by the program, the Traceability Certificate is issued.

4. ¿What certification did Hematológico receive from the NGSP and why is it important?

The NGSP offers three types of certification to those laboratories that successfully complete the evaluation process: method certification, level I laboratory certification and level II laboratory certification. This is done on an annual basis, specifically for the reagents and instruments used for Hb1Ac titration in submitted samples. For level I laboratories, a quarterly monitoring is also performed, which allows a quick detection of eventual difficulties with the test.

At Hematológico, our Hb1Ac titration technique has met the NGSP evaluation criteria to achieve certification for traceability and as a level I laboratory for the study of diabetes for the sixth year in a row. This is a very important certification for us because it indicates that our results are comparable, reproducible and give us accurate information on the risk of complications in patients with diabetes.

It is a source of pride for all of us to have obtained this certification in the 2022-2023 period, as it is the result of the joint work of the entire team involved in the process, the bacteriologists, the quality assurance coordination and the laboratory coordination.

At the Laboratorio Clínico Hematológico.

In Colombia, Hematológico was the first laboratory in Colombia to be part of the NGSP program and to receive the level I certification. Thanks to this, we can provide our physicians and patients with glycated hemoglobin results with maximum reliability for the study and follow-up of diabetes. Currently, only two laboratories in the country have this level of certification, so we congratulate all those who are part of this process and invite them to continue working to provide quality services, humanized and supported by a high level team.

Learn more about the medical utility of the glycated hemoglobin test byclicking here.

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