Objective:To address the inefficiency, safety hazards, and resource wastage in traditional medical laboratory management, this study proposes a digital laboratory information management system (LIMS) based on Total Quality Management (TQM) principles. The LIMS has been implemented at the National Center for Geriatric Medicine (Huashan) affiliated with Fudan University.Methods:Centered on the principles of " all-staff participation, whole-process control, and comprehensive management", a multidimensional management framework was developed to integrate personnel, equipment, reagents, and safety protocols. The system incorporated IoT, digital twin, and artificial intelligence (AI) technologies to achieve end-to-end digital control. A layered architecture (physical layer, data layer, model layer, etc.) was designed to integrate functional modules such as full lifecycle equipment management, dual-authentication for hazardous chemicals, and intelligent resource scheduling. A 3D digital twin model was deployed to visualize real-time laboratory operations.Results:Post-implementation, equipment reservation frequency and usage duration at the National Center increased by 114% and 124%, respectively, with no safety incidents reported. Equipment sharing utilization reached 85%, and reagent expiration waste decreased by 30%.Conclusions:The system transforms laboratory management from experience-driven to data-driven by breaking data silos and optimizing collaboration mechanisms. It provides a replicable technical pathway and practical insights for the healthcare industry′s digital transformation. However, further improvements are needed in mobile support and system scalability.

Objective:To address the inefficiency, safety hazards, and resource wastage in traditional medical laboratory management, this study proposes a digital laboratory information management system (LIMS) based on Total Quality Management (TQM) principles. The LIMS has been implemented at the National Center for Geriatric Medicine (Huashan) affiliated with Fudan University.Methods:Centered on the principles of " all-staff participation, whole-process control, and comprehensive management", a multidimensional management framework was developed to integrate personnel, equipment, reagents, and safety protocols. The system incorporated IoT, digital twin, and artificial intelligence (AI) technologies to achieve end-to-end digital control. A layered architecture (physical layer, data layer, model layer, etc.) was designed to integrate functional modules such as full lifecycle equipment management, dual-authentication for hazardous chemicals, and intelligent resource scheduling. A 3D digital twin model was deployed to visualize real-time laboratory operations.Results:Post-implementation, equipment reservation frequency and usage duration at the National Center increased by 114% and 124%, respectively, with no safety incidents reported. Equipment sharing utilization reached 85%, and reagent expiration waste decreased by 30%.Conclusions:The system transforms laboratory management from experience-driven to data-driven by breaking data silos and optimizing collaboration mechanisms. It provides a replicable technical pathway and practical insights for the healthcare industry′s digital transformation. However, further improvements are needed in mobile support and system scalability.

Objective:This study aims to summarize the theoretical basis and practical effect of interdisciplinary team building in the National Clinical Medical Research Center for Aging and Medicine, Huashan Hospital.Methods:Interactive memory was employed as the theoretical basis for building cross-disciplinary teams, and the work was carried out in three dimensions of specialization, credibility, and coordination.Results:The center had shaped a coordinative team atmosphere and strengthened its integrity in five dimensions, including discipline construction, open platform, innovation curation, science popularization, and technology transfer. The center also promoted the implementation of research tasks in the three core areas.Conclusions:As the aging healthcare issues are highly diversified, complex, and systematic, the center needs to continuously improve its ability to build interdisciplinary teams and provide a platform for integrating various types of resources into the solution of healthcare problems of the elderly.

Objective:To summarize the patient profiles and therapeutic efficacies of ABO-incompatible living-related kidney transplantations at 19 domestic transplant centers and provide rationales for clinical application of ABOi-KT.Methods:Clinical cases of ABO-incompatible/compatible kidney transplantation (ABOi-KT/ABOc-KT) from December 2006 to December 2009 were collected. Then, statistical analyses were conducted from the aspects of tissue matching, perioperative managements, complications and survival rates of renal allograft or recipients.Results:Clinical data of 342 ABOi-KT and 779 ABOc-KT indicated that (1) no inter-group differences existed in age, body mass index (BMI), donor-recipient relationship or waiting time of pre-operative dialysis; (2) ABO blood type: blood type O recipients had the longest waiting list and transplantations from blood type A to blood type O accounted for the largest proportion; (3) HLA matching: no statistical significance existed in mismatch rate or positive rate of PRA I/II between two types of surgery; (4) CD20 should be properly used on the basis of different phrases; (5) hemorrhage was a common complication during an early postoperative period and microthrombosis appeared later; (6) no difference existed in postoperative incidence of complications or survival rate of renal allograft and recipients at 1/3/5/10 years between ABOi-KT and ABOc-KT. The acute rejection rate and serum creatinine levels of ABOi-KT recipients were comparable to those of ABOc-KT recipients within 1 year.Conclusions:ABOi-KT is both safe and effective so that it may be applied at all transplant centers as needed.

In order to promote the effective butt joint between professional construction and region biopharmaceutical industry construction,the article discusses the professional construction of higher vocational pharmaceutical quality and safety program from four aspects:talent training objectives,job capability,curriculum system,and teaching faculty.This article establishes the objectives of training high-quality applied talents for the bio-pharmaceutical industry,analyzes the quality requirements of the core post group,discusses the construction of the core curriculum system based on typical work tasks,and how to build the "Double Qualification Double Ability" faculty.

Objective To evaluate the immune status of acute rejection recipients,and to improve the short-term and long-term survival rate of renal transplant recipients and grafts,and to investigate dynamically the changes in the immune repertoire of patients with acute rejection.Methods Combined multiplex PCR amplification technique and high throughput sequencing technique,the TCR β chain complementarity determining region 3(CDR3)diversity and repertoire characteristics at different time points during renal transplantation were analyzed,in order to reveal the immunological characteristics of T lymphocytes in patients with acute rejection.Results The diversity of TCR CDR3 in acute rejection patients was reduced to the lowest one day after surgery.The diversity of TCR CDR3 before acute rejection was higher than before.The acute rejection-related upregulated TCR CDR3 amino acid sequences were screened out.In addition,TCR beta chain V and J subfamily showed the phenomenon of advantage usage in pre-acute rejection,which may be due to T cell recognition of transplanted kidney antigens in vivo.Conclusions The immune diversity of patients with acute rejection is significantly lower.In addition,TCR beta chain V and J subfamily show the phenomenon of advantage usage.

A method was developed for determination of 12 kinds of phosphate compounds in water and sediment by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) coupled with solid phase extraction (SPE) and ultrasonic extraction.The water samples were concentrated by HLB solid-phase extraction (SPE) column and eluted twice with ethyl acetate, ultrasonic solvent extraction for sediment samples and then repeated the operation of water samples after diluted with deionized water.The sample were separated on a ZORBAX Eclipse Plus C18 (150 mm × 2.1 mm, 3.5 μm) column by a gradient elution with 0.2% formic acid aqueous solution and methanol as the mobile phase.Ion mode analysis was monitored by high performance liquid chromatography mass spectrometer (MRM).The target compounds were quantified by external standard method.At the spiked levels (0.05, 0.1 and 0.5 μg/L), the average recoveries of 12 kinds of OPEs in water samples ranged from 66.4% to 115%, except for TMP (28.5%-47.8%) and TEHP (22.4%-73.8%).The relative standard deviation RSD (n=3) was 0.5%-9.09%, and the method quantification (MOQ) was 0.001-0.05 μg/L, However at the spiked levels of 5, 10 and 50 μg/kg, the average recoveries of 12 kinds of OPEs in sediment samples ranged from 65.4% to 120.0%, except for TMP (35.7%-44.9%) and TCEP (31.2%-48.9%).The relative standard deviation RSD (n=3) was 0.01%-9.54%, and the MOQ for sediment was 0.02-2.0 μg/kg dw.Based on the above methods, the detection and analysis of the targets in the water and sediments samples of Taihu Lake were carried out.The results showed that the concentrations of ΣOPEs were 0.1-1.7 μg/L and 8.1-420 μg/(kg dw), respectively.

Objective To evaluate comparability of two different assay system for detecting CRP.Methods Following the profile of Clinical and Laboratory Standard Institute (CLSI)document EP9-A2,50 blood samples with anti-coagulant ED-TA-2K were collected from emergency patients at Changhai Hospital.The test result of samples by the i-CHROMA Reader was compared and evaluated with those by Beckman Immage 800.Results The linear regression equation for plasma CRP was:Y=1.076 5X-3.031 5,R2=0.986.The linear regression equation for whole blood CRP was:Y=0.882 6X-1.180 8, R2=0.931 1.For whole blood samples with low HCT (<30.45%).Used correction equation:CRP (after corrected)=CRP (before corrected)/(1-HCT).The regression equation (after corrected)was:Y=1.006 8X-3.612 2,R2=0.950 9.Con-clusion CRP concentration detected by i-CHROMA showed good correlation and comparability compared to laboratory ref-erence system by using plasma samples.Results form whole blood samples with low HCT should be corrected to improve comparability.

Objective To investigate the value of anti-human leukocyte antigen (HLA)antibody level detected by Luminex testing in predicting clinical prognosis of renal transplantation recipients. Methods A total of 1 105 patients scheduled to undergo renal transplantation (354 successfully undergoing renal transplantation)in the 181st Hospital of People's Liberation Army from June 2013 to November 2015 were selected. The serum samples were collected from 1 923 cases before and after renal transplantation. The positive rate and fluorescent intensity of anti-HLA antibody were detected by Luminex testing before and after renal transplantation. The renal function of recipients was also evaluated after renal transplantation. Results Prior to renal transplantation,51.0%(546/1 071)of serum samples were positive for anti-HLA antibody,including 26.0%(279/1 071)positive for anti-HLAⅠantibody,24.9%(267/1 071)positive for anti-HLAⅡantibody and 11.4% (122/1 071 )positive for both anti-HLA Ⅰ and anti-HLA Ⅱ antibodies. Among 354 patients undergoing renal transplantation,59 (17%)were positive for anti-HLA antibody after renal transplantation,including 25 (4 newly positive after surgery)positive for anti-HLAⅠantibody,15 (1 newly positive after surgery)positive for anti-HLAⅡantibody and 19 (4 newly positive after surgery)positive for both anti-HLA Ⅰ and anti-HLA Ⅱ antibodies. During subsequent follow-up,13 patients positive for anti-HLAⅠantibody,5 positive for anti-HLAⅡantibody and 1 1 positive for both anti-HLA Ⅰ and anti-HLA Ⅱ antibodies developed transplant kidney dysfunction. All patients newly positive for anti-HLA antibody after renal transplantation presented with transplant kidney dysfunction. Conclusions Luminex testing can perform dynamic detection of the positive rate of anti-HLA antibody,which is important in predicting clinical prognosis of recipients after renal transplantation.

Objective To explore the outcomes of the transplanted kidney as donor for clinical renal transplantation and summarize experience in combination with related literature.Method This study retrospectively analyzed the clinical documents of one case of uremia receiving renal allograft transplantation with the transplanted kidney as the donor in one case of renal transplantation after brain death in February,2015.The donor was a 31-year-old man who received renal transplantation for uremia in November,2014 and obtained normal renal function.Two months later,the patient was brain dead because of neurologic disorder and donated his transplanted kidney.The serum creatinine of the donor was 167 μmol/L,and the glomerular filtration rate was about 35 mL/min befor donation.The recipient was 27 years old who needed transplantation because of chronic renal function failure and uremia.Preoperation tests showed that PRA was negative,and serum creatinine was 1 353 μmol/L.After separating and dissecting the donor kidney carefully,we perfused and compensated the kidney by Lifeport Organ Perfusion and Preservation Conveyor.The warm ischemia time was about 15 min.The renal vein of the donor was anastomized with right external iliac vein of the receptor,artery with right external iliac artery,and ureter with right centrifugal ureter.Result The operating time was more than 3 h.Postoperatively,the recipient was given the immunosuppressive regimen as tacrolimus,mycophenolate mofetil and methylprednisolone to prevent rejection.At 1 st day postoperation,the 24-h urine volume of the receptor was 5 000 mL,serum creatinine was declined gradually to a minimum of 180μmol/L,and there was trace urine protein.The renal function of patient recovered well by now.Meanwhile,the patient was still under the follow-up.Conclusion It is practical that using transplanted kidney as donor kidney for re-transplantation.There were certain clinical significance for shortening the waiting time of renal transplantation in uremia patients and relieving the shortage of transplant kidney.