Proposed evaluation of laboratory performance in an external hematology quality control scheme

The commercial control material for hematology Cell Dyn 16 Tri Level gave a good precision an accuracy using the four blood cell counters currently mostly used in Indonesia, the Coulter, Sysmex, Serono and Cell Dyn. It could be used as one of the hematology control material in an external quality control scheme. Result of the CV from participating laboratories are higher compared to this trial are caused by different level of laboratory technical ability although the geographical area and climate may also play a role. The new scoring calculation to evaluate the participant's performance gave a more wider range of DI scores, to give better insight to the performance of each laboratory.     

Quality control procedures for flow cytometric applications in the hematology laboratory

Clinical diagnosis is one of the areas in which flow cytometry (FCM) has gained wide popularity and FCM now plays a crucial role in several aspects of medical hematology. It has progressively replaced many traditional laboratory tests due to its greater accuracy, sensitivity and rapidity. Unfortunately, among the very large number of its potential applications, only a minority of flow cytometric protocols have been standardized. Numerous factors are responsible for variation in analytical conditions and may affect results obtained by FCM. All these variables can be schematically divided into three major groups: factors related to the biological samples, immunological and accessory reagent factors and factors associated with the use of instruments. The quality control program must monitor and evaluate all aspects of the procedure. This includes the following main aspects: 1) performance of the flow cytometer, 2) specimen collection, transportation and maintenance of its integrity, 3) reagents, particularly monoclonal antibodies and 4) sample measurement, data acquisition and their interpretation. Procedures described here are designed to assess all the settings which affect the reliability, reproducibility and sensitivity of the cytometer in order to ensure identical conditions on a daily basis.     

Quality control procedures for flow cytometric applications in the hematology laboratory

Clinical diagnosis is one of the areas in which flow cytometry (FCM) has gained wide popularity and FCM now plays a crucial role in several aspects of medical hematology. It has progressively replaced many traditional laboratory tests due to its greater accuracy, sensitivity and rapidity. Unfortunately, among the very large number of its potential applications, only a minority of flow cytometric protocols have been standardized. Numerous factors are responsible for variation in analytical conditions and may affect results obtained by FCM. All these variables can be schematically divided into three major groups: factors related to the biological samples, immunological and accessory reagent factors and factors associated with the use of instruments. The quality control program must monitor and evaluate all aspects of the procedure. This includes the following main aspects: 1) performance of the flow cytometer, 2) specimen collection, transportation and maintenance of its integrity, 3) reagents, particularly monoclonal antibodies and 4) sample measurement, data acquisition and their interpretation. Procedures described here are designed to assess all the settings which affect the reliability, reproducibility and sensitivity of the cytometer in order to ensure identical conditions on a daily basis.     

Performance evaluation of BC-3200 hematology analyzer in a university hospital

The BC-3200 automated hematology analyzer was evaluated and compared with the Beckman-Coulter AcT (Ac.T diff 2) 3-part differential hematology analyzer. The BC-3200 was evaluated according to guidelines published by the International Committee for Standardization in Hematology (ICSH), Clinical and Laboratory Standards Institute (CLSI), and Department of Food and Drug Administration (FDA). The results demonstrated no background, minimal carryover (<0.5%), and excellent linearity for hemoglobin (Hb) level, white blood cell (WBC), red blood cell (RBC), and platelet (PLT) counts (>0.998). Precision was generally acceptable for all complete blood count (CBC) parameters; coefficients of variation (CVs) were within the manufacturer's claims and CVs of CBC parameters, including WBC, RBC and PLT counts, Hb and mean corpuscular volume, were <6%. Correlation between the BC-3200 and Ac.T diff 2 was excellent (r > 0.98) for all major CBC parameters (WBC, RBC, and PLT counts and Hb). We conclude that the overall performance of the BC-3200 is excellent and compares well with that of the Coulter Ac.T diff 2.     

Plan and process for hematology laboratory standard in Thailand

In Thailand, there are around 2,000 clinical laboratories in private and government hospitals, By the end of year 2004, all of these laboratories are required to use the same or comparable standard nationwide. Many laboratories are in the process of starting ISO/IEC Guide 25 for the fulfillment of laboratory accreditation. To run the standard system of hematology laboratories in Thailand, we have considered three main aspects: standard in process, method selection and academic interpretation. Because of the wide spectrum of blood diseases in Thailand: thalassemia, iron deficiency anemia and G6PD deficiency hemolytic disease, the analysis and interpretation of laboratory results using different technology are of great importance. National plan has thus set up in two direction, one for standard process and another for academic approach.     

Evaluation of the stability of Cell Dyn 16 Tri Level as a control material for laboratory external quality assessment scheme on hematology

The implementation of a laboratory test should always implement a laboratory quality control program, i.e internal quality control and external quality assessment. In an external quality assessment scheme, a control material that is stable over delivery until tested by the participating laboratory. In this study, we evaluated the stability of Cell Dyn 16 Tri Level (TL) control material at room temperature (26-32 degrees C), stored in a transport vessel containing ice pack, and the precision and accuracy of the instrument Cell Dyn 1400. The control used was Cell Dyn 16 TL with low value (L), normal value (N) and high value (H). This study was done in the Clinical Pathology Department of FKUI-RSCM during February 2001 until May 2001. Control material was stored room in a transport vessel containing ice pack for 15 days, then analysed macroscopically, microscopically and evaluated for its stability. Test for precision and accuracy was done within run and for precision between day on Cell Dyn 1400. The result of this study showed a macroscopic change beginning on day 14 (L) day 12 (N) and day 15 (H). Microscopic change was observed on day 13 (L and N) and day 15 (H), Erythrocyte and hemoglobin level was stable until day 15. Changes in leukocyte was seen on day 14 (L), day 12 (N) and day 15 (H). Platelet showed instability on day 9 (L), day 10 (N and H). Mean erythrocyte volume was out of range on day 15 (L), but the N and H control was still stable. The precision and accuracy of Cell Dyn 1400 was in WHO recommended range. We concluded that the precision and accuracy of Cell Dyn 1400 is good. Cell Dyn 16 TL control material was stable until day 9, and its can be recommended to be used as a control material for external quality assessment scheme.     

Endpoint selection and evaluation in hematology studies

Observational studies and clinical trials in hematology aim to examine treatments for blood disorders. The outcomes being studied must address the goals of the study and provide meaningful information about treatment course, disease progression, describe patients’ survival experience and quality of life. Endpoints are the specific measures of these outcomes, and much consideration should be given to their selection. In this review, we describe the outcomes and endpoints frequently used in studying hematologic diseases and provide general guidelines for their statistical analysis. The main focus is on clinical outcomes which are commonly used in establishing treatment safety and efficacy. We also briefly discuss the role surrogate and composite endpoints play in hematology studies. The importance of patient reported outcomes to comprehensive assessment of the treatment effectiveness is highlighted. Provided practical considerations for choosing primary and secondary endpoints may be helpful in designing hematology clinical trials.     

Quality management and accreditation in laboratory hematology: Perspectives from India

Quality management (QM), including quality assurance and quality control, was developed in clinical laboratories in North America and Western Europe, but must be implemented worldwide to ensure accurate, reproducible, and clinically useful results. India, a middle income country with a population of over 1.34 billion, has limited budget allotted to health care. As yet accreditation for clinical laboratories is not mandatory, which contributes to challenges in implementing good laboratory practice. This review provides a summary of internationally laid down QM principles and their application in a middle income country like India.     

Performance evaluation of the PENTRA 60C+ automated hematology analyzer and comparison with the ADVIA 2120

The PENTRA 60C⁺ hematology analyzer provides a complete blood cell (CBC) count, including a five‐part differential (5‐DIFF) count and two leukocyte subpopulations, i.e. large immature cells (LIC’s) and atypical lymphocytes (ALY’s). We evaluated its analytical performance and assessed agreement with the ADVIA 2120, in order to install the analyzer in a small satellite hematology laboratory. First we assessed repeatability, reproducibility and carry‐over to evaluate the analytical performance. Then we used Pearson correlation coefficients, Passing and Bablok regression analysis and a graphical approach (n = 209) to evaluate agreement with the ADVIA 2120. Repeatability and reproducibility were excellent for the majority of CBC and 5‐DIFF count parameters. Carry‐over was negligible. Our data showed very good correlation for most CBC count parameters. Lower correlation coefficients were observed for red cell distribution width, mean corpuscular volume and mean platelet volume. As compared to the ADVIA 2120, the 5‐DIFF count performed very well. Agreement was poorer for low‐level eosinophils and basophils. Furthermore, the PENTRA 60C⁺ was equally able to identify pathological blood samples through the determination of LIC’s and ALY’s. Therefore, the PENTRA 60C⁺ is an eligible blood cell counter to be operational in a satellite laboratory setting.