Good patient care requires accurate and comparable laboratory test results. To achieve standardization, a reference system consisting of a hierarchal framework of validated and reliable analytical methods linked by reference materials must be in place. Supported by national and municipal research programs, construction of reference systems has been pursued and progress been made. Candidate reference methods have been set up or developed for some important tests, and the methods have been used in the calibration or evaluation of routine methods, study of commutability of control materials and characterization of reference materials. Phenomenal roles of reference systems are expected in diagnostic reagent manufacturing, internal quality assurance and external quality assessments.

specifications are essential for total quality management in laboratory medicine. A consensus among worldwide professionals has been achieved and a hierarchy of strategies for setting analytical quality specifications has been proposed based on their relevance to medical decision-making. Quality specifications derived from biological variations have been widely accepted because of their objectivity and practicability and have more and more been used in the quality management in laboratory medicine.

Roles of reference method in clinical biochemistry were introduced.Reference method is an important component of the reference system.Reference methods are primarily used for the establishment and assurance of the traceability of measurement results through calibrating and evaluating routine methods and assigning values to reference materials.Calibration biases and non-specificities of routine methods and the commutability of reference materials are the major issues in the standardization of clinical biochemistry.Standardization also requires availability of commutable reference materials.Reference methods are irreplaceable tools to identify the issues and to characterize reference materials.

Objective: To investigate clinical and hematological features of malignant lymphoma (ML) combined with venous thromboembolism (VTE). Methods:The clinical data of 65 patients with ML combined with VTE were collected between October 2010 and April 2014 and then retrospectively reviewed. Coagulation function and hemorheology were analyzed. Results:The proportion of males and females among patients with ML combined with VTE was 2.61:1. ML combined with VTE was mainly observed in patients with end-stage cancer. The highest incidence (81.54%) of ML combined with VTE was found in StageⅢB-Ⅳtumor. Among 65 patients with VTE, 43 (66.15%) were found after ML was diagnosed, 55 (84.62%) were deep vein thrombosis (DVT), 7 (10.77%) were pulmonary embolism (PE), and 3 (4.62%) were complicated with both DVT and PE. Common DVT locations were the upper limb and the neck vein of 37 cases (67.27%). Clinical manifestations of ML combined with DVT are limb pain, swelling, and increased skin temperature. Unexplained difficulty in breathing, chest pain, and syncope are also found in ML combined with PE. The total effective rate of 55 cases with DVT was 49.09%, and the rate of those cases with PE was 14.29%. The levels of platelet aggregation, D-dimer, high cut blood viscosity, low cut blood viscosity, plasma viscosity, hematocrit, assembly index of erythrocyte, and rigidity index of erythrocyte were significantly higher in patients with ML combined with VTE than in patients with ML alone;by contrast, APTT, erythrocyte sedimentation rate, deformability index of erythrocyte, and average velocity of blood flow were reduced in patients with ML combined with VTE than in patients with ML alone. Conclusion:DVT, which exhibits high incidence in males, is the most common type observed in ML combined with VTE. DVT is commonly manifested in the upper limb and the neck vein;furthermore, DVT is mainly observed in patients with end-stage cancer. Hematological indexes indicated changes in the sensitivity state of thromboembolism.

A reference system for the completed blood count (CBC) have been established in National Center for Clinical Laboratory (NCCL) according to the standards published by International Council for Standardization in Hematology (ICSH) and International Organization for Standardization (ISO) in order to calibrate hematology analyzer.The contents of our study mainly include:(1)Establishment of calibration laboratory for CBC, which is the first calibration laboratory accepted by China National Accreditation Board for Laboratories in all medical laboratories.(2)We firstly set up the reference method for CBC in China. In addition, the data between NCCL and a foreign reference laboratory have been compared. (3)We have calibrated some instruments from routine laboratories by the fresh blood or calibrator valuated by the reference system, which acts as a new way to calibrate hematology analyzer.(4) A secondary standard assay system has been established and the data between it and the foreign reference laboratory have been compared chronically. The experience has been introduced to local laboratories in 26 provinces.(5) We have drafted out several documents about technical standard for laboratory medicine. The main institution of applications includes: local center for clinical laboratory, clinical laboratories for routine examination, institutions for identification to instruments and reagents, centers for disease control and prevention, and so on.

Objective To explore the value of spiral CT in venous phase in measuring the diameter of bilateral transverse sinus.Methods The CT vascular imaging findings of 200 cases at torcular herophili area in our hospital were analyzed retrospectively.The resource images, volume rendering (VR) and maximum intensity projection (MIP) were performed to observe the presentation of vascular anatomy in the torcular herophili area, and to determine the dominant transverse sinus and types of torcular herophili (typeⅠ-Ⅵ).The diameters of bilateral transverse sinus were measured by original CT images.Two groups were categorized according to the genders, and four ones (20-30 years, 30-40 years, 40-50 years and 50-60 years) according to the age.Results Between different genders, there was significant difference in right transverse diameter (P<0.05), and there was no significant difference in left transverse diameter (P>0.05).There was no significant difference among four age groups in bilateral transverse diameter (P>0.05).Conclusion Spiral CT is helpful for the evaluation of the diameter of bilateral transverse sinus.These findings can provide anatomical basis for clinical disease with significant implication.

This article summarized recent correlative literatures focusing on international standards on glycated hemoglobin.The basic concept,determination of glycated hemoglobin,the present review in laboratory measurement and metrological traceability was introduced.The international community has established reference system and metrological traceability to the International System of Units on HbA1c.Determination in glycated hemoglobin is still in incipient stage in our country.Both clinical laboratorians awareness and clinical determination need to be strengthened.

Objective To investigate preanalytical and intraindividual biological variations of 19 biochemistry analytes. Methods For the study of preanalytical variations, 10 consecutive blood specimens were taken from each of 21 individuals and the specimens were taken from different arms and with various evacuated blood tubes and venous occlusion durations and processed with different storages before and after centrifugal separation of serum. Another 3 aliquots of blood, each at an interval of 1 week, were taken from the individuals for the study of intraindividual biological variations. All the serum samples were analyzed in duplicate for 19 biochemistry analytes. Analysis of variance was performed on the results for the estimation of preanalytical and biological variations. Results Various preanalytical treatments or factors caused some systematic variations but random specimen errors were the main contributors of preanalytical variations. Chloride, sodium and calcium showed preanalytical variations of less than 1% and other analytes ranging from 1%-7%. Different analytes showed varied intraindividual biological variations. The least biological variations ( <2% ) were observed on chloride, sodium and calcium and the largest ( >20% ) on bilirubin,triglycerides, alanine aminotransferase and creafine kinase. Conclusions Preanalytical variations under laboratory settings in China and intraindividual biological variations in Chinese for 19 biochemistry analytes have been estimated. These data will be useful in the estimation of measurement uncertainty and the interpretation of clinical laboratory results.

Objective To solve problems of ice bag in process of physical cooling for high fever patient, which is contacted area small and fixed difficulty and so on, and develop a new ice capsule for all kinds of special-site cooling. Methods Selecting glycol liquor, thin aluminum plate, high-density sponge, flexible plastic and other materials and according to clay characteristics, producing 12 different types of shaping ice capsule. Results "Wear-capsule of medical care" was developed in 2002 and assessed to national patents of utility model. The flexible shaping liquid ice capsule was declared national invention patents in 2007. Conclusion The liquid flexible ice capsule can not be coagulated, wear conveniently, applicable to each kind of different spot and had good cooling effect.

Objective To develop a candidate reference method for the determination of sodium in serum by inductively coupled plasma mass spectrometry method (ICP-MS). Methods Aluminum, as internal standard of sodium, was added into serum samples and sodium standard solutions by gravimetric analysis. The samples were digested by HNO3 and diluted, and its 23Na/27Al isotope ratios were obtained by ICP-MS. The sodium concentrations were calculated with the standard curve method in serum. Results The analytical recoveries of sodium were 100.67% and 100.15% respectively, and the precisions were 0.08% and 0.04% respectively for 2 different serum samples. The results of measuring sodium in serum of Standard Reference Material (SRM) gave the coefficients of variation (CVs) of 0.18% and 0.22% for 2 levels of standard reference material(SRM) 909b and 0.41%, 0.41% and 0.66% for 3 levels of SRM 956b. The relative deviations between the results and median of the certified value were 0.17% and 0.14% for 909b and -0.09%, -1.05%, -0.48% for 956b respectively. Conclusions The ICP-MS and aluminum internal standard method is proved to be not only precise and accurate, but also quick and convenient for measuring sodium in serum. It is promising to be a candidate reference method for determination of sodium in serum.