To establish and validate a nomogram scoring system to evaluate the severity of the sepsis patient.

Clinical application scenarios clinical data available within 1 hour of admission to the ICU was used to establish the nomogram scoring system. Clinical predictors included age, sex, vital signs, vasopressor use and lactate level within 1 hour. 30-day mortality as an outcome. Logistic regression analysis model was used to determine independent risk factors and a nomogram was established to predict 30-day mortality.The validation was performed using repeated sampling method.

A nomogram of 30-day mortality was established in sepsis patients with a C-index of 0.759 (95% CI: 0.725~0.794) and a validated discriminant C-index of 0.762 (95% CI: 0.728~0.797) using repeated sampling methods.

Nomogram model will clinically be relevant for ultra-early determination of prognosis and severity of sepsis and has clinical significance. However, this model needs to be further validated.

To investigate the application value of Six Sigma in the evaluation of endocrine project analysis performance.

The data of internal quality control (IQC) from October 2018 to March 2019 and the data of external quality assessment (EQA) from second time in 2018 and first time in 2019 were collected respectively. Four different sources of performance specifications were used as quality goals, and the long-term cumulative coefficient of variation of IQC were used as precision and the percentage difference of EQA were used as bias to evaluate σlevels of endocrine items and σvalues of endocrine items with different quality objectives. Meanwhile, individualized IQC scheme was formulated. In addition, the quality target index (QGI) of items with σvalue below 6 were evaluated and the plan for laboratory quality improvement was provided.

According to the national EQA evaluation standard, biological variation, "appropriate" quality standard and quality standard recommended by CLSI are derived. The proportion of projects with σvalue ≥ 6 is between 20.0% and 35.4%; While, according to the Spanish EQA standard, no analytes with σvalue more than 6 were found. According to the analytical performance of each project, a personalized IQC scheme was developed: total triiodothyronine (TT3), thyroid stimulating hormone (TSH), luteinizing hormone (LH) and testosterone (T) were selected for single rule 1_3s for quality control, prolactin (PRL) was selected multiple rule 1_3s/2_2s/R_4s for quality control, free thyroxine (FT4) was selected multiple rule 1_3s/2_2s/R_4s/4_1s for quality control, free triiodothyronine (FT3), total thyroxine (TT4), estradiol (E2), follicle stimulating hormone (FSH) and progesterone (P) were selected multiple rule 1_3s/2_2s/R_4s/4_1S/8_X for quality control. According to the Chinese EQA standard, the precision of FT3, FT4, TT4, E2, FSH, P and PRL should be improved firstly.

Six Sigma can reasonably evaluate the analytical performance of the endocrine project and promote the continuous improvement of laboratory test quality.

To explore the clinical value of absolute count of peripheral lymphocytes in monitoring immune status of cancer patients with surgery therapy, we retrospectively analyzed the absolute counts of peripheral T-lymphocytes subsets and NK cells before and after surgery in patients with colorectal cancer or esophageal cancer.

Retrospectively analyzed the absolute counts of T lymphocytes and NK cells and the correlation between lymphocytes counts and tumor progression or pathological staging as well as dynamic characteristics of lymphocyte counts during perioperation in 64 cases of colorectal cancer and 55 cases of esophageal cancer with surgery therapy.

(1) In patients with colorectal cancer, CD3⁺T lymphocytes, CD3⁺ CD4⁺ T lymphocytes and CD3⁺CD8⁺ T lymphocytes counts gradually increased from stageⅠto stageⅣ, but only CD3⁺CD4⁺ T lymphocytes and CD3⁺CD8⁺T lymphocytes increased significantly (P<0.05). No striking difference were found on the absolute counts of lymphocytes from stage Ⅰ to stageⅣafter surgery therapy. (2) In patients with esophageal cancer, the counts of preoperative T lymphocytes subsets in Ⅰ-Ⅳ stage has no significant difference (P>0.05); and the count of postoperative CD3⁺, CD3⁺CD4⁺, CD3⁺CD8⁺T lymphocytes gradually increased from stageⅠto stageⅢ (P<0.05). (3) In higher differentiated tumor lower preoperative counts of peripheral T lymphocytes existed in the patients with colorectal cancer (P>0.05). Patients with metastasis have more counts of T lymphocytes subsets and lower count of NK cells than that of patients without metastasis, and only CD3⁺CD8⁺T lymphocytes significantly increased (P<0.05). There was no association between peripheral T lymphocytes count and degree of tumor differentiation or tumor metastasis in patients with esophageal cancer. (4) Dynamic analysis of absolute counts of perioperative T lymphocyte subsets and NK cells showed that postoperative T lymphocytes and NK cells firstly strikingly decreased (P<0.05), then increased (P<0.05).

The correlation of peripheral T lymphocytes or NK cells count with TNM staging, degree of tumor differentiation as well as tumor metastasis was not the same between colorectal cancer and esophageal cancer. In patients with colorectal cancer the responsively increasing preoperative T lymphocytes counts and suppression of preoperative NK cells may be caused by high tumor burden and poorly differentiated tumor; surgery trauma could cause transiently decrease of postoperative T lymphocytes and NK cells.

To explore the significance of rehabilitation therapy for functional recovery of patients with spinal cord injury (SCI).

Eighty inpatients with spinal cord injury in major hospitals in Lishui during December 2016 and October 2017 were enrolle in this study, and were assigned to two groups (control group with general treatment and experimental group with rehabilitation therapy). Function independent measure (FIM) and clinical follow-up were used to evaluate the application value of rehabilitation therapy in SCI.

Rehabilitation therapy had high efficiency and practicability in improving the living standard of patients with SCI. The recovery of cognitive function and motor function was not bad in patients with SCI. 73.33% of the patients were priority to restore the dietary ability. The degree of cooperation of patients affected the recovery.

FIM evaluation can effectively reflect the true situation of patients with SCI. Rehabilitation can help SCI patients to improve their ability to live independently, and will become a powerful assistant to tackle SCI, a common intractable disease.

Use the self-developed all-factor intelligent auditing platform in the KMClient laboratory information system to release a large number of inspection reports, the automatic auditing and early warning rules of items are set up in biochemical luminescence, clinical blood, clinical immunology, mass spectrometry, microorganism, gene and pathology and a large number of inspection reports originally required to be issued by manual auditing are submitted to the computer for publication, thus reduce the number of people and the error of the report result caused by manual error, reduce the sample turn around time (TAT), save labor costs and improve work efficiency.

According to the technical requirements and industry standards of biochemical luminescence, clinical blood, clinical immunology, clinical microbiology, gene and pathology, several autoverification rules are set up respectively to judge the results. The results can be released by computer if judgement is passed, otherwise the results will be intercepted and released by manual verification statistical regularly on the status of automatic audit approval of each test item, and gradually optimize the early warning rules, compare the TAT changes before and after the use of automatic audit function and the number changes of report approval personnel to evaluate the effectiveness of automatic audit.

After the use of the automatic audit in all disciplines of the laboratory, the accuracy and timeliness of the report have been significantly improved. The average TAT in each department has been shortened by 0.5 h and the total number of staffs has been reduced by 4, and the defect rate of the report defect rate has been reduced by 80%.

The all-factor intelligent auditing platform developed by our center can meet the needs of many disciplines, and is superior to most of the automatic audit middleware in the market. The use of automatic audit can not only further improve the efficiency of laboratory work and shorten TAT, but also reduce the quality defects caused by human factors, and maintain the quality assurance of laboratory analysis.

To study the detection capability of bacterial identification items of the clinical microbiology external quality assessment (EQA) in Shanxi medical institutions for the past 9 years.

The EQA feedback results of bacterial identification in Shanxi Province from 2009 to 2017 were collected, and the accuracy rate of bacterial identification was statistically analyzed.

The laboratories that participated in the external quality assessment of clinical microbiology in Shanxi Province were mainly secondary public medical institutions, accounting for 74.5%. Over the past 9 years, 90 samples have been issued, including 33 genera and 54 species. A total of 1530 copies were returned by Internet. The qualified rate of quality evaluation was 83.8% in 2012, 95.7% in 2015, and the cumulative rate was 91.0% in the past 9 years. The accuracy rate of quality evaluation samples ranged from 33.1% to 100.0%.

By participating in the EQA, the quality management of the clinical microbiology laboratories can be strengthened to find out existing problems and deficiencies and promote the detection capability.

To evaluate the performance of B-rapidly accelerated fibrosarcoma(BRAF) gene mutation detection in 2017 external assessment(EQA) program, analyze the existing problems in clinical laboratories and put forward the suggestions for improvement measures.

The Shanghai clinical laboratory center (hereinafter referred to as the ″center″) sent two EQA sample plates to 45 laboratories in 2017 for BRAF detetection, each containing 5 samples. Forty-five participating laboratories were asked to upload the results to the center database within one week. Then according to the return results, the center summarized the EQA scores of each laboratory, and calculated the coincidence rate of each sample.

The two BRAF mutation detection EQA activities received 42 and 41 laboratories valid returns respectively. The coincidence rates of each sample in the two EQA activities were from 76.2% to 100%, and the overall coincidence rates of wild type samples, p.V600K samples, p.V600R samples and p.V600E samples were 99.2% (123/124), 79.8% (67/84), 87.8% (36/41) and 95.2% (119/125), respectively. 73.8% (31/42) and 75.6% (31/41) of the laboratories submitted correct results for all samples. Among them, 79.8% (27/34) and 81.3% (26/32) of the laboratories obtained completely correct results using the registered reagent, while only 50% (4/8) and 55.6%(5/9) laboratories obtained completely correct results using lab-developed tests (LDTs).

The total coincidence rate of the BRAF gene mutation detection in the clinical laboratories of Shanghai is relative high in the 2017 EQA programs, and the coincidence rates of the test results are higher in laboratories using registered reagents than in the laboratories using LDTs. The testing ability of some laboratories should be improved, and the quality control of the BRAF mutation detection should be strengthened so as to ensure the accuracy of the test results.

Through analysis of common nonconformities in the assessment of clinical immunology laboratory with ISO15189 medical laboratory accreditation, in more than one year′s implementation process of China National Accreditation Service for Conformity Assessment (CNAS)CL39:2012, we put forward reasonable corrective methods. The aim is to improve clinical immunology laboratory quality management system, ensure the laboratory results accuration, provide the high quality service for clinicians, and help to understand deeply the CNAS-CL02:2012 and CNAS-CL39:2012.

To evaluate the analytical performance of endocrine testing using six sigma(σ), and find the cause of dissatisfied performance for some projects combined with the quality goal index (QGI), so that provide rectification direction for the improvement of the endocrine projects quality.

Nine endocrine items which participated in the clinical laboratory external quality assessment (EQA) of the Ministry of Health in 2016 was selected in this study. The two levels of laboratory internal quality control were accumulated in coefficient fo varivation (CV), respectively, as the estimation value. By adopting the quality evaluation standard of the Ministy of public healty the acceptable range of endocrine items was measured as the total allowah error (TEa). CV and Bias with the data of internal quality control (IQC) and EQA was evaluated. The sigma metrics based on the TEa from the National Center for Clinical Laboratory were in accord with the formula σ=(TEa-|Bias|)/CV for each endocrine test. Quality goal index(QGI) was also calculated to investigate the reason for dissatisfied performance as follows: QGI=Bias/(1.5*CV). Evaluate the quality levels of nine endocrine tests with σstatistics. Analyze which improvement measures were needed for each project with QGI.

In low level of IQC, the rates of endocrine items for 4≤σ<5σ, 3≤σ<4, σ<3 were 22.22%, 44.44%, 33.33%, respectively. In high level IQC, the rates of endocrine items for σ≥6, 5≤σ<6, 4≤σ<5, 3≤σ<4, σ<3 were 11.11%, 11.11%, 11.11%, 55.56% and 11.11%, respectively. In the dissatisfied performance of the endocrine tests, which the QGI<0.8 include FT3, FT4, FSH, LH, Prog, Folate, VitB₁₂, which the QGI>1.2 include TSH, T.

Sigma performance verification can be used to evaluate the performance of laboratory testing projects. The sigma and QGI can be used for investigation of the reason for dissatisfied perfarmance of the project, and guiding the improvement of clinical laboratory quality.

To analyse the comparison result of internal quality control of WBC, RBC, hemoglobin (Hb), hematocrit (HCT) and platelet (PLT) which were detected by different blood cell analyzers, and to evaluate the consistency of the results between different instruments within the same laboratory by standard deviation index (SDI) and coefficient of variation ratio (CVR), at the same time to provide a more accurate and reliable test results for clinicl.

By analyzing quality control data of the tests of WBC, RBC, Hb, HCT and PLT with five blood cell analyzers to calculate the coefficient of variation (CV), SDI and the CVR from May 1, 2014 to 31, each item has three levels level1 to 3 from Medical Experimental center, General Hospital of Ningxia Medical Univertisy.

The SDI and CVR index of the WBC, RBC, Hb, HCT and PLT were -1.37-1.84 and 0.72-1.46, -3.35-2.59 and 0.83-1.21, -3.28-3.57 and 0.40-1.67, -2.79-1.88 and 0.53-1.61, -1.25-1.21 and 0.52-1.59. The data were callected by analyzing 465 numbers totally from the five blood cell analyzers from May 1 to 31, 2014. The highest number of SDI>2 were RBC and HGB, which were 5 and 7, respectively. There was only one that was SDI>2 in HCT, and two that was SDI<2 in WBC and PLT. The unqualified rates of WBC, RBC, HGB, HCT and PLT were 0, 33.33%, 46.67%, 6.67% and 0. The CVR of five items in each instrument compared to all laboratory instruments were less than 2.

It is beneficial to carry on quality control of consistency and comparability of the results in the same test with different systems by using SDI and CVR index for accuracy and precision of laboratory evaluation, and it has good application results of laboratory quality assurance. The SDI and CVR can be used to a new model of internal quality control about the same item to test in different blood cell analyzers.

To present the main problems in the use of chemistry analyzing daily, through analyzing the common nonconformities in ISO 15189 assessment. We put forward the reasonable advices in corrective action, according to the ISO 15189 standard and the guidance on the application in chemistry. To help the laboratory improve the use of analyzer in operation, maintenance, repair. To reduce the troubleshooting, and to ensure the accuracy. This paper also provides the beneficial reference for the deep understanding of the terms of ISO 15189.

To analyze the comparative results of prothrombin time (PT) and activated partial thromboplastin time (APTT) in different SYSMEX coagulation analyzers.

PT and APTT were detected in three instruments (two of Sysmex CA7000 and one was CA1500). The comparative analysis of test results by industry standards WS/T407-2012 and WS/T406-2012.

Using the scheme WS/T407-2012, the relative deviations of PT and APTT of sample one were 7.10% and 5.20%, respectively; the relative deviations of sample two were 5.74% and 2.46%, respectively; both were less than the comparative request of 7.50%. Using the scheme WS/T406-2012, 20 samples were detected by the three instruments, the relative deviation <7.50% and the coincidence rate≥80% set as the standard. Compared with the benchmark instrument CA7000, the coincidence rates of PT and APTT in CA1500 were 85% (17/20) and 80% (16/20), respectively; those in CA7000-2 were 85% (17/20) and 90% (18/20), respectively.

According to these two kinds of schemes comparative methods, the determination results of PT and APTT in three detection systems are comparable. The laboratory might choose appropriate solutions for instruments alignment according to the actual situation in order to ensure the result comparability.

To analyze the methodology of serum alpha fetoprotein (AFP) assay by high-throughput enzyme-linked immunosorbent assay (ELISA) and appraise its clinical value.

A total of 170 serum samples of patients (hepatic carcinoma, hepatitis and hepatic cirrhosis patients) and 200 serum samples of healthy people were recruited from Qingdao Central Hospital from March to December 2013 in this study. The linear range, precision, accuracy, reference interval and diagnostic performance for primary liver cancer were estimated in accordance with EP5-A2 files and EP15-A2 files from the American association of Clinical Laboratory Standards Institute and related literatures. Compared with the electrochemical luminescence assay was performed to evaluated the detection accuracy and clinical value of high-throughput ELISA.

The linear range of high-throughput ELISA for AFP was 0.0-200.0μg/L. The intra-batch coefficient of variation (CV ) of different concentrations (low, medium and high) were 4.9%, 3.1%, 3.7% respectively, the inter-batch CVs of different concentrations were 3.8%, 1.5%, 2.1% respectively, while total CVs of different concentrations were 5.0%, 6.0%, 5.0% respectively. Compared with the results of the electrochemical luminescence, the relative bias was 7.9%. The recovery rate was 91%-109%, 97.76% on average. The reference interval of serum AFP detected by high-throughput ELISA in our laboratory was 0.00~7.20 μg/L. The diagnostic threshold of primary liver cancer was 195.7μg/L, with sensitivity of 39.5% and specificity of 93.3%.

This study established standard operating procedures for the quantitative detection of serum AFP by a high-throughput ELISA method. High-throughput ELISA assay for quantitation of serum AFP is an accurate, stable performance in diagnosis of primary liver cancer.

The neutrophil-lymphocyte ratio (NLR) may indicate the balance of the inflammatory and immune systems, making NLR a useful index to evaluate tumor development. However, its prognostic value in patients with gastric cancer was still unclear. A meta-analysis was performed to characterize the prognostic effect of NLR.

An extensive literary search for relevant studies was conducted on Embase, Medline and Web of Science databases. The search strategy included the following keywords "gastric cancer", "stomach cancer", "gastric carcinoma", "stomach carcinoma", "gastric neoplasm", "stomach neoplasm", "neutrophil" and "lymphocyte" . Effect measure was hazard ratio (HR) for overall survival (OS) and progression-free survival(PFS) /disease-free survival (DFS). Then pooled HRs and 95% confidence intervals (CIs) were calculated using the random or fixed effect models by the heterogeneity of included studies. The pooled HR and 95% CI >1 indicated elevated NLR was associated with a significantly poorer OS.

This meta-analysis has been based on 18 publications and comprises a total of 5 065 patients with gastric cancer. The pooled HR showed that elevated NLR was associated with a significantly poorer OS (HR 1.79, 95%CI 1.54-2.08). Subgroup analysis showed the prognostic effect of NLR was identical in multiple treatment methods subgroup and chemotherapy subgroup[HR 1.84, (95% CI 1.48-2.29) and 1.69, (95% CI 1.41-2.03), respectively]. The same effect was also seen in NLR≤3.2 subgroup and NLR>3.2 subgroup [HR 1.80, (95% CI 1.46-2.23) and 1.93, (95% CI 1.58-2.36), respectively]. At univariate meta-regression analysis in OS, the results indicated publication year, ethnicity, NLR cutoff value, treatment type, sample size, proportion of patients in advanced stage and proportion of male did not contribute to the cause of heterogeneity(P value of 0.585, 0.887, 0.731, 0.697, 0.613, 0.877, 0.775).

The overall findings of this study support the hypothesis that elevated NLR is associated with a significantly poorer OS and NLR could be a prognostic marker in gastric cancer.