These results indicate a further improvement is required in the laboratory interpretation and knowledge of the laboratory diagnosis of thalassemia. The established system should facilitate the prevention and control program of thalassemia in the region.

Introduction Hemoglobin (Hb) analysis is a key testing for diagnosis of hemoglobinopathies. Accurate analysis, interpretation of results, and genetic risk assessment are important. We report on 8 years of the proficiency testing (PT) program for hemoglobinopathies in Thailand. Methods Laboratory participants were required to test two simulated PT items in each cycle using capillary electrophoresis, one was a husband and another was his pregnant wife. Related hematological parameters were provided. The participants also provide interpretation and evaluate the risk of having three severe thalassemia diseases in an expected fetus. Three cycles were operated per year in accordance with the ISO17043 and ISO13528 guidelines. A total of 84 laboratories throughout Thailand were participated. Results A total of 24 PT cycles were performed during 2012‐2019. Most participants had Excellent performance for the PT items with normal, β‐thalassemia trait, hemoglobin E trait, hemoglobin E trait with α‐thalassemia, and Hb H disease. However, when the PT items with homozygous Hb E and Hb E‐β‐thalassemia were tested, an increase in a Needs improvement performance was noted. From 24 PT cycles, the performance with Excellent, Good, Fair, and Needs improvement was ranging from 10.5%‐95.8%, 0%‐11.3%, 0%‐77.2%, and 2.3%‐37.0%, respectively. Conclusion Most participants have proven their performance to be reliable and demonstrated their abilities to provide interpretation and genetic risk assessment on most of the PT items. For complex thalassemia however, a need to improve the interpretation and risk assessment skills is required which is essential for effective prevention and control of severe thalassemia diseases in Thailand.

Introduction:Hemoglobinopathies are major public health problems worldwide.Accurate laboratory diagnosis of the carrier is essential, which includes initial screening, Hb analysis, and DNA analysis. For the first time, we have developed a single-tube quality control (QC) sample for these laboratory tests. Methods:The QC sample was made from a lyophilized mixture of the stabilized hemolysate with carbon monoxide saturation and the white blood cells of known thalassemia mutations. Homogeneity and stability were examined by Hb and DNA analyses on day 0 and every month for 12 months, at room temperature, 4°C, and −20°C. A preliminary proficiency testing (PT) program for hemoglobinopathies using this single QC material was developed.Results: Hemoglobin (Hb) and DNA analyses of a single-tube QC sample demonstrated satisfactory results of Hb analysis for at least five months and DNA analysis for at least one year of storage at −20°C. The results obtained from a preliminary PT program on five expert laboratories confirmed that a single tube QC sample prepared could be used as a PT item with various Hb and DNA analyses methods. Conclusion:A single lyophilized control sample has been generated for use in hemoglobinopathies' internal and external quality control program. Unlike other available control materials, which are used for individual testing, a single-tube QC sample generated can be used to control the pre-analytical and analytical processes of both Hb and DNA analyses and is suitable for use in the PT program of hemoglobinopathies.