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The harmonization protocol Annex 1 is a novel protocol that was suggested by the working group of the current study. It aims at checking most of the key points that are considered as potential sources of variability in Sigma metrics calculation. Table 1 shows the performance characteristics of the parameters from Medical Research Institute, Alexandria University, Chemical Pathology Laboratory; Sigma metrics were calculated using the total allowable errors from the different sources as shown. Among the assayed parameters total bilirubin had the highest sigma Table 2 shows the performance characteristics of the parameters assayed in Zagazig University Hospital laboratory.
Sigma metrics were calculated using the total allowable errors from the different sources as shown in the table. Triglycerides and direct bilirubin had the highest sigma Table 3 shows the performance characteristics of the parameters from Ain Shams University hospital laboratory; Sigma metrics were calculated using the total allowable errors from the different sources as shown in the table.
Among the assayed parameters glucose had the highest sigma 4. Table 4 shows the performance characteristics of the parameters performed in a private laboratory in Alexandria governorate. Among the assayed parameters GGT had the highest sigma Table 5 shows comparison between sigma levels after unifying the TEa source for all four laboratories. This study is conducted over one year for four accredited medical laboratories. The sigma values were calculated based on performance approach and were compared to each other in a trial to highlight the lack of objective method of comparability.
Control of analytical performance is an essential procedure that shall be done by medical laboratories specially those who are seeking accreditation through method verification which by itself is a standardized process but has no harmonized approach. Implementing harmonized QC procedures in a medical laboratory requires both knowledge and practical updates.
For each of these updates a lot of considerations can be made and a lot of problems can be found. This is the main reason behind lack of harmonized approach in implementing QC procedures. Miller and Sandberg recommended that the choice of quality requirements that focus on patient centred care and the optimum clinical decision for each analyte, expressed as TEa based on the change in the analyte would need to be detected in order to make a clinical decision based on that change 8.
However, for some of the analytes, a relatively small change will affect the clinical decision in the management of the case such as electrolytes 8. Gami et al. High biological variation parameter such as triglyceride measured by any instrument will give acceptable sigma level. While electrolytes like sodium and potassium which are having low biological variation would give low results In our results the same observation was obtained as well. For triglyceride was calculated by three laboratories very high sigma Chemical Pathology department Medical Research Institute, Alexandria University, Zagazig University Hospital laboratory and the private lab from Alexandria , while on the other hand potassium that were calculated by three laboratories had very low sigma level Chemical Pathology department Medical Research Institute, Alexandria University, Zagazig University Hospital laboratory and Ain Shams University hospital laboratory.
Sometimes if we want use the same source like biological variation BV the TEa might not be available e. The BV will answer the questions of method performance in three different ways according to which subtype of BV used optimal TEa which equal half the desirable TEa and one third the minimal TEa. Precision and bias verification are considered the corner stones of the verification procedures and as mentioned previously both of them have no harmonized protocol, different materials and different targets to achieve, even in case of choosing the same inputs we might get different output for example in case of using the external quality assessment material to determine bias the mean percent bias will be different according to the number, levels, commutability and uncertainty of materials used as all of these characteristics differ from program to another.
Sigma metrics calculation harmonization will help laboratories not to waste time and efforts analysing SM values and changing TEa sources to fit for each analyte. Comparing the sigma levels in four accredited medical laboratories three universities and one private laboratory as an initiative to harmonize the sigma calculations to the best of our knowledge, authors in this study suggested a harmonized protocol for sigma calculation Annex 1. Our results showed different sigma levels for different parameters that were calculated using different TEa selected by each laboratory resulting in different categories of performance.
This was in agreement with Schoenmakers et al.
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This approach needs standardization in order to lead to better patient care and ultimately in reduction of costs Table 5 shows SM that was calculated in the four laboratories after harmonization of TEa source. These results highlighted how can the TEa source selection affects the sigma level significantly in a way that may obscure the analytical performance. Comparing the SM using the same TEa as step towards harmonization gives more real indicator of performance in a more objective approach than using different TEa by each laboratory.
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For example, total bilirubin SM according to the data calculated by each lab had far worse performance in MRI lab 2. Moreover, the data calculated by each laboratory showed that the magnesium had poor performance at MRI and Zagazig laboratory and excellent performance at the private laboratory, but after unifying the source of TEa and recalculating the magnesium SM using the same TEa CLIA the performance of magnesium at Zagazig proved to be excellent and even better than that of the private laboratory 6 and 5. The limitation of this study included: the Sigma metric equation as formulated by Westgard 17 is a subject of debate, with an alternate calculation being proposed by Coskun et al.
However, the most commonly used, published, and cited equation remains the Westgard formulation. This Westgard calculation was established through derivation of critical-systematic error equations 20 and was confirmed by comparison to CpK 21 Finally, numerous official standards committees have accepted the Westgard formulation, notably the International Federation of Clinical Chemistry IFCC committee for standardization of HbA1c; they recommend the use of the Westgard Sigma metrics formulation in assessing and selecting HbA1c methods 22 , In , a convocation of experts on quality control issued a collective opinion paper recommending the use of Sigma metrics in the Westgard formulation Simply put, the Coskun formulation of the Sigma metrics is neither in wide acceptance nor wide use.
There are many variables that affect the comparability of estimated Sigma metrics among medical laboratories which include: the time interval upon which Sigma metrics is calculated, the different vendor systems providing external proficiency testing programs and quality control programs upon which bias and imprecision values are calculated and different environmental conditions.
Also, the variability in the methods used for bias calculation.
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In addition to the different analytical or clinical benchmarks that are chosen for evaluation of TEa. The laboratories participating in this study determined analytical bias through EQA programs where the bias was calculated through the difference between laboratory result and that of the EQA group mean against the group mean. Therefore, this is not a true value.
UNHCR is not responsible for, nor does it necessarily endorse, its content. Trig - triglycerides. Specifically, the joint program will increase transparency and sustainability in the potato supply chain. Accessed February 5th, This is a fantastic group. Embassy in Cairo has concluded a week-long workshop in Cairo in partnership with the Egyptian Ministry of Antiquities on how to protect cultural property and investigate cases of illegally exported antiquities.
In conclusion, this study is considered the first to highlight the need for Sigma metrics harmonization. Therefore it is mandatory that all laboratory professionals interested in the analytical quality to harmonize the approach of sigma calculation with special empathizes on the bias and CV which are the main components of the sigma equation as well as to unify the methodology used among different laboratories. As for the bias calculation it is recommended to standardize the calculation by using duplicate readings of a number of materials with different concentrations to exclude the element of random error if the PT samples are used as a source for bias calculation.
This in turn will help laboratories to find a unified objective tool to judge their method correctly. Finally, the TEa sources shall be vigorously reviewed and only approved sources shall be adopted for calculation. Further studies shall be conducted by the accredited laboratories in different sectors adapting the concept of harmonized approach. One of the most important outcomes of this study is the suggested harmonized protocol presented in Annex 1. Levey S, Jennings ER.
The use of control charts in the clinical laboratory. Am J Clin Pathol.
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Henry RJ, Segalove M. The running of standards in clinical chemistry and the use of the control chart. J Clin Pathol. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem. Westgard JO. Embassy in Cairo, Egypt is postponing nonimmigrant visa appointments scheduled during the period …. Embassy in Cairo is sponsoring the participation of three American performance groups at the 10th edition of the Hakawy International Arts Festival.
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