The internal audit is important for the management system of laboratory .The article stated how to effectively implement internal audit in drug testing laboratories in terms of the planning , checklist, pattern, problem observation , CAPA of non-compliance and application of results in internal audit .

To understand the status of testing skills and quality management in drug testing laboratories. Methods:The items, pass rate and type of participating laboratories of measurement audit were analyzed during 2011-2014. Results:The number of application items was increased year by year, more than half of which focused on the content determination, and the overall pass rate was over 80%. Conclusion:The measurement audit is important for laboratories, which should be further strengthened and standard-ized.

BACKGROUND: The Childhood Experience of Care and Abuse Questionnaire (CECA.Q) compiled by the Institute of Psychiatry, University of London, has been verified to have good reliability and validity in the assessment of foreign community adults and patients with affective disorder,but the application of CECA.Q in China still needs verification of reliability and validity in various population.OBJECTIVE: To analyze the reliability and validity of CECA.Q in community population.DESIGN: The subjects were randomized selected; the principle for the analysis of scale reliability and validity was followed.SETTING: Mental Health Institute of Central South University.PARTICIPANTS: From September 2003 to February 2004, 608 adults were selected from two communities of Hunan Changsha city and Henan Xinxiang city as the common community population group, totally 608scales of CECA.Q were sent out, 8 invalid ones were excluded, and finally 600 subjects finished the investigation. Sixty adult inpatients with depressive disease were randomly selected from Henan Provincial Psychiatric Hospital as the depression group.METHODS: The common community population and patients with depressive disease were investigated with CECA.Q, which was a self-rating scale mainly to retrospectively survey whether the adults had suffered from physical, sexual or mental abuse in their childhood, and the mental abuse had two factors of antipathy and neglect, and each included 8 items. The answers for the items were quantified into 5 grades. The subjects evaluated whether their parents had given any abuse to them; the higher the score was, the greater the mental abuse they suffered. Of the community population, 40 cases were the positive samples with the history of physical and sexual abuse in childhood evaluated by CECA.Q, and they were then assessed with Bifulco provided childhood experience of care and abuse (CECA) together with 40 cases randomly selected from 560 samples with negative evaluation. A total of 100 cases in the community population were also evaluated with Zung self-rating depression scale (SDS), besides, 30 cases were retested with CECA.Q at 2 weeks after the first evaluation.MAIN OUTCOME MEASURES: The internal consistency, test-retest reliability, contents and criterion validity of CECA.Q were analyzed. RESULTS: Of the community population, 8 invalid questionnaires were excluded, and the other 600 cases entered the statistical analysis. ① Testretest reliability of CECA.Q: The Cronbach α coefficient for the mental abuse section was 0.87 (0.85 for maternal one, 0.83 for paternal one); including that of antipathy factor was 0.84 (0.80 for maternal one, 0.81 for paternal one), and that of neglect factor was 0.85 (0.84 for maternal one,.83 for paternal one. The test-retest reliability coefficient for mental abuse as 0.83 (0.81 for maternal one, 082 for paternal one), including that of antipathy was 0.81 (0.82 for maternal one, 0.70 for paternal one), and that f neglect was 0.79 (0.78 for maternal one, 0.75 for paternal one). The twice evaluations of physical and sexual abuse had good consistency (Kappa=0.78). ② Criterion validity of CECA.Q: The correlation coefficients of mental abuse, antipathy and neglect factors in CECA.Q with Zung SDS were 0.58, 0.55 and 0.60 respectively (P＜0.01). CECA.Q and CECA had good consistency in evaluating history of physical and sexual abuse, and the score of mental abuse in the depressive patients was higher than that in community population (P＜0.05).CONCLUSION: The CECA.Q shows acceptable reliability and validity in community population, and can be used as a self-rating measure for childhood abuse experience in China.

To assure the effective operation of certification and accreditation in the laboratory management system, further strengthen the instruments and equipment management, and provide specific recommendations on improvement of internal audit, management review and continuous improvement of management system. The inspector program had been firstly established and complemented. Through the inspection, we identified many deficiencies, made many specific recommendations for improvement. After inspection, the working procedures were improved;data from department were more rigorous, scientific and just;hardware foundation was established for international mutual recognition.

Objective:To evaluate the effect of coronary microvascular dysfunction (CMD) on left atrial and ventricular function in patients with ischemia and non-obstructive coronary artery disease (INOCA) under the drug stress of regadenoson by speckle tracking imaging and left ventricular pressure-strain ring ultrasound technology.Methods:A total of 43 patients with INOCA who were admitted to the Department of Cardiology of the First Bethune Hospital of Jilin University from May 2022 to October 2023 were prospectively enrolled, and drug stress tests were performed. The coronary flow velocity reserve (CFVR) values were obtained by transthoracic Doppler echocardiography, and the INOCA patients with CFVR<2.0 were assigned to the CMD group ( n=24), and those with CFVR≥2.0 were assigned to the contrast group (CON group, n=19), and 20 healthy people without chest pain matched by clinical data were selected as the negative group (NEG group). The differences in general clinical data, routine echocardiography before and after stress, left atrial strain, and myocardial work parameters were compared between the groups. The correlation analysis of intra-group parameters was performed, and then the ROC curve was used to evaluate the diagnostic value of ultrasound parameters for INOCA. Results:Compared with the CON group and the NEG group, the ratio of early diastoic velocity E peak of mitral value orifice to the late diastoic velocity A peak(E/A) decreased and the ratio of early diastoic velocity E peak of mitral valve orifice to the early diastoic velocity e′ of the mitral valve annulus(E/e′) increased in the CMD group, and the differences were statistically signnificant (all P<0.05).There were statistically significant differences in left atrial strain parameters including left atrial strain reservoir (LASr), left atrial conduit strain (LAScd), left atrial contraction strain (LASct) between CON group and CMD group before and after stress (all P<0.05).However, there were no statistically significant differences between CON group and CMD group in myocardial work parameters including global longitudinal strain (GLS), peak strain dispersion (PSD), global work index (GWI), global constructive work (GCW), global wasted work (GWW), global work efficiency (GWE) at rest (all P>0.05), and there were significant differences only after stress (all P<0.05). E/e′ was negatively correlated with LASr and LAScd in the CMD group and CON group ( rs=-0.36, r=-0.31; all P<0.05), GLS was positively correlated with GWI, GCW, GWE( r=0.81, 0.61, 0.37; all P<0.05). GLS was positively correlated with GWI, GCW and GWE at stress state( r=0.66, 0.51, 0.52; all P<0.05), and negatively correlated with GWW ( rs=-0.39, P<0.05). PSD was positively correlated with GWW ( rs=0.30, P<0.05), and negatively correlated with GWI, GCW and GWE ( r=-0.46, -0.40, -0.38; all P<0.05). Univariate regression analysis showed that left atrial strain and myocardial work had good predictive values for CMD, and the predictive values of rest LASr and stress GLS were higher, with AUC values of 0.927 and 0.882, respectively. Conclusions:In patients with INOCA and CMD, the left atrial strain capacity decreases at both rest and stress state, and the myocardial work capacity decreases only under the stress. The changes in parameters of left atrial strain and myocardial work provide new ultrasound parameters and predictors for clinical evaluation of CMD.

To assure the effective operation of certification and accreditation in the laboratory management system, further strengthen the instruments and equipment management, and provide specific recommendations on improvement of internal audit, management review and continuous improvement of management system. The inspector program had been firstly established and complemented. Through the inspection, we identified many deficiencies, made many specific recommendations for improvement. After inspection, the working procedures were improved; data from department were more rigorous, scientific and just; hardware foundation was established for international mutual recognition.
Accreditation ; Food Inspection ; legislation & jurisprudence ; Laboratories ; standards ; Pharmacy Administration ; legislation & jurisprudence