The distance between the main branches of intrahepatic duct and the Surface of the liver was measured on the stripping specimens of 30 adult livers.The results of this study will pro- vide anatomical data for the percutaneous transhepatic cholangiography.

Objective To study the internal quality control(IQC)designing procedure of the quantitative immunoassay testing i-tem to provide the most suitable IQC rule for the clinical laboratory immunoassay.Methods 3 quantitative detection items of thy-roxine,cortisol and thyroid stimulating hormone were taken for examples.The coefficient of variation(CV)of the method was ob-tained by the repeatability test for evaluating the methodological imprecision.Inaccuracy(bias)was obtained by the methods com-parison.The accuracy of the method was evaluated.Then the most suitable IQC rule for each quantitative detection item was select-ed by plotting the location of the operating point on the normalized operational process specifications(OPSpecs)chart according to CV and bias.Results Two multirule methods of 1 3s/(2of3)2s/R4s/3 1s/6 x and 1 3s/(2of3)2s/R4s/3 1s were identified when the oper-ating point was plotted on the normalized OPSpecs chart for N =6 and 90% analytical quality assurance(AQA)at the thyroxine de-cisive level of 0.064 4 mmol/L.When the cortisol decisive level was 0.735 μmol/L,the normalized OPSpecs chart for N =3 with 90%AQA showed the three solutions of 1 3s/(2of3)2s/R4s/3 1s ,1 2 .5s ,and 1 3s/(2of3)2s/R4s as for thyroid stimulating hormone,3 1s/2 2s/R4s/41s multirole procedure was the best choice for N =4,50%AQA at the upper control level,and the N =2 chart with 50%AQA showed a multirole procedure with 1 3s/2 2s/R4s at the lower control level.Conclusion The suitable internal quality control de-signing procedure of the quantitative immunoassay testing item can be selected by using the OPSpecs chart.

Objective To construct active recombinant cas pa ses-3 gene(r-caspases-3)eukaryotic expression plasmid and observe the apoptos is inducing activity of r-caspase-3 in pancreatic carcinoma cells. Methods pcDNA3.1(+)/r-caspase-3 was constructed and pan creatic carcinoma cells(PC-Ⅱ)were transfected with the pcDNA3.1(+)/r-caspases -3 by liposomes(LipofectAMINE).The expression of r-Caspase-3 mRNA in pancreat ic carcinoma cells was detected by reverse transcription process of the polymera se chain reaction(RT-PCR), and the signs of apoptosis were examined in pancreat ic carcinoma cells by the methods of the DNA electrophoresis and flow cytometry analysis(FACS).Results The sequence inserted in pBlueSKM/r-Caspase-3 p lasmid was coincident with that of the r-caspases-3. The evaluation result of pcDNA3.1(+)/r-caspases-3 through enzyme cutting was correct. A 894bp strap was observed by RT-PCR after pancreatic carcinoma cells being transfected with the pcDNA3.1(+)/r-caspases-3 by liposomes. No strap was found in control groups. A characteristic DNA ladder was observed in pancreatic carcinoma cells DNA elect r ophoresis, and transparent hypodiploid karyotype peak was found by FACS. Conclusion The plasmid of pcDNA3.1(+)/r-Caspase-3 was c onstructed successfully, the expression of r-Caspase-3 mRMA in pancreatic carc inoma cells was confirmed by RT-PCR, and pcDNA3.1(+)/r-Caspase-3 can induce a poptosis in pancreatic carcinoma cells.

Precision controls monitor assay random error (reproducibility),accuracy controls assess total error,both random error and systematic error,and trueness (bias)of an assay represents systematic error.A trueness control should be metro-logical traceable,ideally with a target value determined by use of a reference material or a reference method,without metro-logical traceable to a reference measurement system,patient test results for the same patient from different laboratories may not be comparable.A trueness control should be commutable and its analytical response to a reference method and a routine field method should be equivalent to that of a patient sample.And trueness control values should generally be set at medical decision levels and be prepared by the providers of reference materials and manufactured in the same fashion as a calibrator.

External quality assessment (EQA)as an effective tool for quality control can help clinical laboratories to discover quality problems during testing process and prompt clinical laboratories to improve their testing quality.Samples used for traditional EQA frequently have matrix effects which assign the target value by grouping.Ideal samples for EQA are com-mutable which have the same numeric relationship between different measurement procedures as that expected for patients’ samples.And they can assess accuracy against a reference measurement procedure or a designated comparison method.When analyzing,robust statistical method can be used to reflect the variability of testing results between laboratories more truly. And the evaluation standards should be desirable.If unsatisfactory results appear,we should investigate every aspect of tes-ting process,find the root cause,and take corrective action.On condition that no official EQA scheme is launched for some analytes,it is necessary for us to evaluate the performance of analytes by alternative evaluation procedures.

The right internal quality control rules are really important for improving the quality of patient results report in clinical laboratory.In order to look for faster and simpler tools that will help laboratories select the right internal quality con-trol rules for their own applications,recently Westgard introduced a newer tool “Westgard Sigma Rules”which is quicker and easier to use than previous tools.And it is very easy to figure out the right internal quality control rules by using West-gard Sigma Rules.This article introduced the characteristics and usage of original Westgard Rules and sigma metrics graph, and focusing on the application methods and practices of Westgard Sigma Rules which is the combination of original West-gard Rules and sigma metrics graph.Once the sigma quality of the tests and methods in laboratories are calculated,the West-gard Sigma Rules diagram can make it easy to select the right control rules and the right number of control measurements.

Objective To investigate the status of report appropriateness in Clinical Hematology and to identify its potential influence factors to improve the quality of laboratory reports.Methods 1 120 National External Quality Assessment ( EQA ) participants laboratories were enrolled in this study.The questionnaires were assigned to all the participants in both electronic and printed form.The participants were asked to retrospectively count the total reports and the affected reports while the following quality indicators occurred in 2012:report delay, inconformity of data between instrument and LIS as well as between report and request erroneous report transportation, report recall, and report modification.All quality indicators were evaluated in two ways:percentage and sigma (σ) scale.Mann-Whitney Test and Kruskal-Wallis Test were used to analyze the potential impacts of report appropriateness.Results Totally 609 (54.38%)laboratories submitted the survey results .The sigma metrics of six quality indicators on report appropriateness were more than 4.The main reason for report delay was equipment failure.Group comparison suggested that the report appropriateness of laboratories in tertiary-A hospitals and accredited by ISO 15189 werebetter.Report appropriateness with electronic request, electronic form and electronic transmission were superior than that inother ways. Conclusions Report appropriateness in China differs from laboratory to laboratory. Laboratories should develop emergency action plan in case the instrument breaks down and strengthen information technology .Long-term internal quality control and external quality assessment scheme are very meaningful to identify the insufficient performance and improve laboratory quality .(Chin J Lab Med, 2015,38:632-636)

Although the key role of External Quality Assessment schemes ( EQAS ) in the standardization/harmonization process has been clear from the start, it has never been totally implemented, mainly due to the lack of commutable materials, the difficulty target values and acceptable range.EQAS may also improve standardization/harmonization by proposing rules for the post-examination phase.Improvements in standardization and harmonization will really be able to work under the joint efforts of stakeholders.

ObjectiveTo investigate and analyze the upper and lower limits and their sources of reference intervals in blood gas and acid-base analysis assays.Methods The data of reference intervals were collected, which come from the first run of 2014 External Quality Assessment (EQA) program in blood gas and acid-base analysis assays performed by National Center for Clinical Laboratories (NCCL). All the abnormal values and errors were eliminated. Data statistics was performed by SPSS 13.0 and Excel 2007 referring to upper and lower limits of reference intervals and sources of 7 blood gas and acid-base analysis assays, i.e. pH value, partial pressure of carbon dioxide (PCO2), partial pressure of oxygen (PO2), Na+ , K+, Ca2+ and Cl-. Values were further grouped based on instrument system and the difference between each group were analyzed.Results There were 225 laboratories submitting the information on the reference intervals they had been using. The three main sources of reference intervals wereNational Guide to Clinical Laboratory Procedures [37.07% (400/1 079)], instructions of instrument manufactures [31.23% (337/1 079)] and instructions of reagent manufactures [23.26% (251/1 079)]. Approximately 35.1% (79/225) of the laboratories had validated the reference intervals they used. The difference of upper and lower limits in most assays among 7 laboratories was moderate, both minimum and maximum (i.e. the upper limits of pH value was 7.00-7.45, the lower limits of Na+was 130.00-156.00 mmol/L), and mean and median (i.e. the upper limits of K+ was 5.04 mmol/L and 5.10 mmol/L, the upper limits of PCO2 was 45.65 mmHg and 45.00 mmHg, 1 mmHg = 0.133 kPa), as well as the difference in P2.5 and P97.5 between each instrument system group. It was shown by Kruskal-Wallis method that theP values of upper and lower limits of all the parameters were lower than 0.001, expecting the lower limits of Na+ withP value 0.029. It was shown by Mann-Whitney that the statistic differences were found among instrument system groups and between most of two instrument system groups in all assays.Conclusion The difference of reference intervals of blood gas and acid-base analysis assays used in China laboratories is moderate, which is better than other specialties in clinical laboratories.

Quality indicators (QIs)in laboratory medicine can measure how well a clinical laboratory meets the needs and re-quirements of users and the quality of all operational processes.The identification of reliable QIs is a crucial step in enabling users to quantify the quality of laboratory services.Different QIs and terminologies are currently used and,therefore,there is the need to harmonize proposed QIs.A model of quality indicators has been consensually developed by a group of clinical la-boratories according to a project launched by a working group of the International Federation of Clinical Chemistry and La-boratory Medicine.The model includes 57 QIs related to key processes (35 pre-,7 intra-and 15 post-examination phases)and 3 to support processes.The developed a model of quality indicators and the data collected provide evidence of the feasibility of the project to harmonize currently available QIs,but further efforts should be done to involve more clinical laboratories and to collect a more consistent amount of data.