Participation in community centralized service by clinical laboratories by public tertiary hospitals / 中华医院管理杂志

This article introduced the practice of tertiary hospitals′ clinical laboratories in making full use of its advantageous medical resources ,and using community centralized detection service. The authors hold that public hospitals have more advantage and needs to use this service ,and such a centralized model requires further innovation and improvement. Participation in centralized service by these clinical laboratories enjoys a good development prospect .

Establishment and application of networked information management system for clinical laboratories in community of Suzhou City / 临床检验杂志

Objective To establish a networked information management system for clinical laboratories in community of Suzhou and evaluate its clinical application.Methods Based on dedicated network of public health information in Suzhou City,laboratory information management system (LIS) and hospital information management system (HIS),the management for centralized detections of clinical samples from the health institutions of intra-regional community were performed as the key mission,and a regional,networked and informationized management system was designed for the clinical laboratories of community.Results The informationized management of whole process including test application,specimen collection,delivery and receiving,report releasing and payment,etc.was achieved on line.The information of clinical laboratories among the communities was transferred and shared in whole Suzhou City.Conclusion The established system should be safe,convenient and efficient online network-based information management system between the Suzhou clinical laboratory center and the laboratories in each local community,by which the centralized detections in the clinical laboratories of community could be performed readily.

Analysis on high risk human papillomavirus genotypes among male outpatients in Suzhou area / 国际检验医学杂志

Objective To understand the infection status ,genotype distribution of high risk human papillomavirus (HR-HPV ) infection and its relation with diseases among male outpatients in Suzhou area .Methods The HR-HPV DNA genotyping detection in 1432 male outpatients was performed by using multiple polymerase chain reaction and flow cytometry fluorescence hybridization technique .Results The total infection rate of HR-HPV was 25 .6% (367/1432) ,single infection ,double infection and multiple infection accounted for 72 .20% ,21 .25% and 0 .65% respectively .The HR-HPV infection rate had no statistical difference among different age groups(χ2 =1 .912 ,P=0 .861) .The top five places of HR-HPV subtypes were HPV-16 ,HPV-52 ,HPV-58 ,HPV-18 and HPV-59 .HPV-16 ,HPV-52 ,HPV-58 infections were most common among the age groups of ＜20 years old ,＞ 60 years old and ＜20 years old ,and the top 3 diseases related to HR-HPV were verruca ,urethritis and balanitis .Conclusion HPV-16 is the most common HR-HPV infection type in male outpatients ,followed by HPV-52 and-58 .The HR-HPV infection has a certain age specificity and is related to male verruca ,urethritis and balanitis .

Clinical trial data management and quality metrics system / 药学学报

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.

Beta-lactamase Gene and intⅠ1 Gene in ESBLs-producing Klebsiella pneumoniae / 中华医院感染学杂志

OBJECTIVE To investigate the beta-lactamase gene and intⅠ1 gene in ESBLs-producing Klebsiella pneumoniae.METHODS Beta-lactamase gene and intⅠ1 gene were analyzed by PCR.RESULTS The positive rates of TEM,SHV,OKP,CTX-M-1group,CTX-M-2group,CTX-M-9group,GES,PER,VEB,OXA-10,ACT-1,LEN,DHA,and intⅠ1 were 51.4%,0%,0%,17.1%,0%,11.4%,0%,0%,0%,0%,0%,5.7%,17.1%,and 60%,respectively.Beta-lactamase gene was found in 62.9%,intⅠ1 gene was found in 60%.CONCLUSIONS There are very high positive percentages of beta-lactamase gene and intⅠ1 gene in ESBLs-producing K.pneumoniae.