Objective To explore the application value of the Plan-Do-Check-Act(PDCA)cycle in the refined whole-process management of low-value medical consumables.Methods Using the PDCA cycle as a framework,the Plan phase in-volved analyzing the causes of traceability difficulties for low-value medical consumables.The Do phase implemented multiple im-provement measures,including establishing standardized management systems,strengthening personnel supervision,creating a split-item tertiary inventory,and introducing the Unique Device Identification(UDI)system.The Check phase evaluated man-agement effectiveness by comparing data from June to December 2023 and June to December 2024.The Act phase refined institu-tional norms and operational processes through a closed-loop feedback mechanism.Results After PDCA management,the appli-cation time for low-value medical consumables[(6.16±1.47)min]and the collection time[(15.08±1.89)min]were signif-icantly shorter than before implementation(P＜0.001).The acceptance qualification rate increased from 92.96％to 99.11％.The application of the split-item tertiary inventory ensured synchronization between inventory deduction and billing data.Conclu-sion The PDCA cycle improves the traceability of low-value medical consumables through systematic quality improvement.Its dynamic feedback mechanism supports continuous improvement,providing an effective pathway for hospitals to achieve refined management and cost control.

Objective To evaluate the impact of setting a 4-day incubation time on the detection performance of bloodstream infection(BSI)pathogens by the BacTALERT VIRTUO blood culture system(VIRTUO).Methods Retrospectively collecting blood culture(BC)results from Zhongshan Hospital,Fudan University,from June 2021 to December 2023,and comparing the time-to-detection for clinically significant microorganisms.Results A total of 87 052 BC bottles were collected,of which 7 167(8.23%)were positive.95%of aerobic and anaerobic bottles were reported positive at 65.67 h and 91.2 h respectively.The average(median)time-to-detection for Staphylococcus aureus(S.aureus)was 21.76(16.08)h,Klebsiella pneumoniae(KP)was 15.32(11.65)h,Escherichia coli(E.coli)was 16.14(10.87)h,and Candida species was 35.2(28.5)h.Only 213 bottles(0.24%)were reported positive after 4 days of incubation;among them,88 bottles(41.31%)cultured Propionibacterium acnes(P.acnse).Medical chart reviews for BC reported positive after 96 h(4 days)showed no clinical significance.Simulated growth experiments were conducted on 11 fastidious bacteria,and the median detection time was only 10.8 h,indicating that an incubation time of 4 days is sufficient for fastidious bacteria.Conclusion A 4-day incubation is adequate for VIRTUO system.Reporting 1 day earlier to the doctors can reduce the positive rate of contaminants and the use of antimicrobial agents.

OBJECTIVE To evaluate the value of matrix-assisted laser desorption ionization time-of-flight-mass spectrometry(MALDI-TOF MS)in direct identification of carbapenem-resistant Escherichia coli and Klebsiella pneumoniae positive for blood culture.METHODS The blood culture bottles that were positive for E.coli or K.pneumoniae were collected from the patients with bloodstream infection who were treated in Zhongshan Hospi-tal,Fudan University from Jul.2021 to Jun.2023.The isolates were collected by using a gel-contact clotting tube,then the tested strains were respectively mixed with 4 μg/ml of imipenem,4 μg/ml of meropenem and 2 μg/ml of ertapenem for coculture and were incubated at 35 ℃ for 4 and 5 hours,finally,the strains were i-dentified by using the mass spectrum.The minimum inhibitory concentrations(MICs)of the three types of drugs were tested by microbroth dilution method and were set as the golden standards for the test.RESULTS Totally 31 strains of E.coli and 28 strains of K.pneumoniae that were positive in blood culture bottles were collected,both of the effective rates of controlled growth of the E.coli strains were 100.00％after the incuba-tion for 4 and 5 hours,and the effective rates of controlled growth of the K.pneumoniae strains were 9 6.43％and 100.00％after the incubation for 4 and hours,respectively.The sensitivity,specificity,positive predictive value and negative predictive value of the K.pneumoniae strains against the three types of drugs were 100.00％after the incubation for 5 hours.The specificity and positive predictive value of the E.coli strains against imipenem,meropenem and ertapenem were 100.00％after the incubation for 5 hours;the sensitivities were 73.58％,78.93％and 78.93％,respectively;the negative predictive values were 70.60％,75.00％and 75.00％,respectively.CONCLUSIONS MALDI-TOF MS is rapid and accurate for direct identification of the carbapenem-resistant E.coli and K.pneumoniae strains positive in blood culture bottles,and the accuracy reaches at 100.00％for the test of drug-resistant K.pneumoniae strains after the incubation for 5 hours.The method may provide evidence for clinical treatment of bloodstream infections induced by carbapenem-resistant Enterobacteriaceae.

Objective To mine and analyze adverse drug reaction(ADR)signals of fluorouracil injections within real-world settings,and to offer a reference for the safe use of medications in clinical practice and for post-marketing safety assessments by pharmaceutical license holders.Methods The ADR reports for fluorouracil injections extracted from the database of the National Adverse Drug Reaction Monitoring System of Hubei province were collected from January 2004 to April 2024.The retrospective review was used to analyze the basic information,medication details and ADR manifestations of the patient.The ADR signals were mined and analyzed by using the reporting odds ratio(ROR)method,the Medicines and Healthcare Products Regulatory Agency(MHRA)method,and the Bayesian confidence propagation neural network(BCPNN)method.Results The study identified 1,292 ADR reports involving fluorouracil injections,encompassing 1,429 instances of the drug and 1,901 ADR manifestations across 18 system-organ classes.The demographic analysis revealed a male predominance and a peak proportion(61.07％)among patients aged 45 to 64 years.The majority of the underlying diseases were digestive system malignancies,accounting for 73.37％of the cases.ADRs were predominantly reported within the first 5 days post-administration(77.17％),with a favorable outcome in 85.84％of the patients.The ROR method identified 35 risk signals,including 15 novel signals,while the MHRA method identified 33 signals,with 14 being novel.The BCPNN method detected 19 signals,of which 6 were novel.Notably,elevated aspartate aminotransferase and alanine aminotransferase levels emerged as novel ADRs with significant signal strength across all three detection methods.Conclusion The common ADR signals of fluorouracil injections are consistent with instruction.However,it is essential to increase vigilance regarding ADRs such as liver and gallbladder system diseases,which are not recorded in the drug instruction,to bolster the safety profile of fluorouracil injections in clinical use.

Objective To explore the application value of the Plan-Do-Check-Act(PDCA)cycle in the refined whole-process management of low-value medical consumables.Methods Using the PDCA cycle as a framework,the Plan phase in-volved analyzing the causes of traceability difficulties for low-value medical consumables.The Do phase implemented multiple im-provement measures,including establishing standardized management systems,strengthening personnel supervision,creating a split-item tertiary inventory,and introducing the Unique Device Identification(UDI)system.The Check phase evaluated man-agement effectiveness by comparing data from June to December 2023 and June to December 2024.The Act phase refined institu-tional norms and operational processes through a closed-loop feedback mechanism.Results After PDCA management,the appli-cation time for low-value medical consumables[(6.16±1.47)min]and the collection time[(15.08±1.89)min]were signif-icantly shorter than before implementation(P＜0.001).The acceptance qualification rate increased from 92.96％to 99.11％.The application of the split-item tertiary inventory ensured synchronization between inventory deduction and billing data.Conclu-sion The PDCA cycle improves the traceability of low-value medical consumables through systematic quality improvement.Its dynamic feedback mechanism supports continuous improvement,providing an effective pathway for hospitals to achieve refined management and cost control.

Objective To evaluate the impact of setting a 4-day incubation time on the detection performance of bloodstream infection(BSI)pathogens by the BacTALERT VIRTUO blood culture system(VIRTUO).Methods Retrospectively collecting blood culture(BC)results from Zhongshan Hospital,Fudan University,from June 2021 to December 2023,and comparing the time-to-detection for clinically significant microorganisms.Results A total of 87 052 BC bottles were collected,of which 7 167(8.23%)were positive.95%of aerobic and anaerobic bottles were reported positive at 65.67 h and 91.2 h respectively.The average(median)time-to-detection for Staphylococcus aureus(S.aureus)was 21.76(16.08)h,Klebsiella pneumoniae(KP)was 15.32(11.65)h,Escherichia coli(E.coli)was 16.14(10.87)h,and Candida species was 35.2(28.5)h.Only 213 bottles(0.24%)were reported positive after 4 days of incubation;among them,88 bottles(41.31%)cultured Propionibacterium acnes(P.acnse).Medical chart reviews for BC reported positive after 96 h(4 days)showed no clinical significance.Simulated growth experiments were conducted on 11 fastidious bacteria,and the median detection time was only 10.8 h,indicating that an incubation time of 4 days is sufficient for fastidious bacteria.Conclusion A 4-day incubation is adequate for VIRTUO system.Reporting 1 day earlier to the doctors can reduce the positive rate of contaminants and the use of antimicrobial agents.

To evaluate the analytical performance of a specific IgE (sIgE) quantitative detection system and explore the clinical application effect of dust mite extract and component detection. The fluorescent magnetic particle chemiluminescence method was used to verify the analytical performance of sIgE for house dust mite (D1), dust mite (D2) extracts, and their components (Der p 1, Der p 2, Der p 10, and Der p 23), including precision, limit of blank (LoB), limit of detection (LoD), linear range, and interfering factors. This is a retrospective cohort study. A total of 50 patients with allergic rhinitis and 50 patients with allergic asthma diagnosed at Zhongshan Hospital Affiliated to Fudan University from January 2022 to August 2023 were selected, along with 70 apparently healthy individuals who underwent physical examinations in the hospital as the healthy control group. The positive rates of each sIgE component in the three groups were compared, and the receiver operating characteristic (ROC) curve for diagnosing dust mite allergy was plotted. The results showed that the fluorescent magnetic particle chemiluminescence method for detecting sIgE demonstrated good repeatability and intermediate precision within the range of 0.1-100 kU/L. The LoB, LoD, and linear range all met the specified requirements. Except for Der p 10, which was interfered by the presence of conjugated bilirubin and free bilirubin (exceeding 40 mg/dl), the detection of other allergens was not significantly affected by common endogenous substances. In healthy individuals, 10% had positive sIgE for dustmite extract; in asthmatic and allergic rhinitis patients, the positive rates were 70% and 82%, respectively. The double positive rate of D1 and D2 in the healthy group was 8.6%, while in asthmatic and allergic rhinitis patients, it was 66% and 70%, respectively. When 0.35 kU/L was used as the threshold, the sensitivity of sIgE for dust mite extract to predict component positivity was 100%, specificity was 61.5%, positive predictive value (PPV) was 80.2%, and negative predictive value (NPV) was 100%. When the threshold was optimized to 0.78 kU/L, the sensitivity was 96.8%, specificity was 92.1%, PPV was 95.2%, and NPV was 94.6%. In conclusion, the repeatability, intermediate precision, LoB, LoD, linear range, and anti-interference ability of the fluorescent magnetic particle chemiluminescence method for detecting sIgE meet the requirements of laboratory quality management. This ensures detection quality, meets clinical needs, and can be used for the auxiliary diagnosis of allergic diseases.

Objective To establish autoverification rules for six routine coagulation assays(PT,APTT,TT,Fib,DD,and FDP)based on the stratification of outpatients and inpatients,in accordance with CLSI AUTO-10A,AUTO-15,and WS/T 616-2018 guide-lines,and to validate the feasibility of this stratified strategy with clinical data while optimizing verification efficiency.Methods A to-tal of 323 451 coagulation test results from Zhongshan Hospital,Fudan University in 2022 were retrospectively analyzed to define auto-verification rules involving critical values,instrument flags,logical rules,historical comparison,and numerical ranges.A stratified au-toverification system was established by applying distinct rules for outpatient and inpatient populations.Subsequently,the rules were op-timized using 87 830 coagulation test results from January to March 2024,and the consistency between autoverification and manual veri-fication was prospectively evaluated using 33 968 consecutive coagulation specimens collected in April 2024.Results A stratified au-toverification system was successfully developed,comprising a total of 53 rules.The pass rate of overall verification was 77.16％(26 210/33 968),with a true-positive rate of 19.64％(6 672/33 968),a false-positive rate of 3.20％(1 086/33 968),a true-nega-tive rate of 77.16％(26 210/33 968),and no false negatives were detected.Conclusion The proposed autoverification system signifi-cantly improved verification efficiency.The stratified design based on outpatient and inpatient populations effectively minimized the risk of false negatives,and may provide a novel approach for the further development and optimization of coagulation test autoverification.

Objective To establish and validate a method for simultaneous analysis of fluconazole,linezolid,voriconazole and cont-ezolid by liquid chromatography-tandem mass spectrometry,and conduct preliminary assessment its value of application value in clinical therapeutic drug monitoring.Methods Using an isotopic internal standard method,the serum samples were pretreated with protein precipitation.The supernatant was diluted after centrifugation,and detected by liquid chromatography-tandem mass spectrometer.Refer-ring to the Recommendations for Clinical Application of Liquid Chromatography-Mass Spectrometry(LC-MS)and Clinical and Labora-tory Standards Instituhe(CLSI)C62A,the performance of the LC-MS method was verified,including quantitation limits,linearity,trueness,precision,matrix effect,carry-over,interference,dilution consistency and stability.The blood samples from patients who were treated with fluconazole,linezolid,voriconazole,and contezolid were collected and measured for trough or peak concentrations.Results The quantitation limits of fluconazole,linezolid,voriconazole and contezolid by this method were 1 μg/mL,0.25 μg/mL,0.25 μg/mL and 0.1 μg/mL,respectively.The linear ranges were 1-100 μg/mL,0.25-25 μg/mL,0.25-25 μg/mL,and 0.1-10μg/mL,respectively.The recovery rates were 103.0％-105.7％,103.1％-108％,102.4％-106.2％and 101.0％-109.9％,respectively.The precisions,expressed as coefficient of variation(CV),were 1.7％-3.4％,2.1％-4.8％,1.9％-3.1％,and 3.1％-6.8％,respective-ly.No obvious matrix effect,carry-over contamination and interference were found.The dilution consistency and stability were satisfac-tory.The concentrations of fluconazole,linezolid and voriconazole within the reference interval accounted for 49.1％,52.5％and 80.7％of the total samples,respectively.The peak concentration of contezolamide was(14.02±4.94)μg/mL(n=4),and the trough concen-tration was(0.34±0.20)μg/mL(n=5).Conclusion In this study,a method for simultaneous analysis of the concentrations of flu-conazole,linezolid,voriconazole and contezolid was successfully established and verified by liquid chromatography-tandem mass spec-trometry.This method is simple,rapid,and suitable for therapeutic drug monitoring,and providing a basis for the optimization of drug regimens.

Objective To mine and analyze adverse drug reaction(ADR)signals of fluorouracil injections within real-world settings,and to offer a reference for the safe use of medications in clinical practice and for post-marketing safety assessments by pharmaceutical license holders.Methods The ADR reports for fluorouracil injections extracted from the database of the National Adverse Drug Reaction Monitoring System of Hubei province were collected from January 2004 to April 2024.The retrospective review was used to analyze the basic information,medication details and ADR manifestations of the patient.The ADR signals were mined and analyzed by using the reporting odds ratio(ROR)method,the Medicines and Healthcare Products Regulatory Agency(MHRA)method,and the Bayesian confidence propagation neural network(BCPNN)method.Results The study identified 1,292 ADR reports involving fluorouracil injections,encompassing 1,429 instances of the drug and 1,901 ADR manifestations across 18 system-organ classes.The demographic analysis revealed a male predominance and a peak proportion(61.07％)among patients aged 45 to 64 years.The majority of the underlying diseases were digestive system malignancies,accounting for 73.37％of the cases.ADRs were predominantly reported within the first 5 days post-administration(77.17％),with a favorable outcome in 85.84％of the patients.The ROR method identified 35 risk signals,including 15 novel signals,while the MHRA method identified 33 signals,with 14 being novel.The BCPNN method detected 19 signals,of which 6 were novel.Notably,elevated aspartate aminotransferase and alanine aminotransferase levels emerged as novel ADRs with significant signal strength across all three detection methods.Conclusion The common ADR signals of fluorouracil injections are consistent with instruction.However,it is essential to increase vigilance regarding ADRs such as liver and gallbladder system diseases,which are not recorded in the drug instruction,to bolster the safety profile of fluorouracil injections in clinical use.