| Part1.Analysis of internal quality control data for complete blood count and study on precision analytical quality requirementObjective:Internal quality control(IQC)is a key part of laboratory quality control.At present,there is no country-wide study on the analysis of internal quality control data of complete blood count.This study aims to investigate the current status and problems of IQC of complete blood count in China so as to perform IQC normally,to help clinical laboratories find problems and to propose quality improvement suggestions.At the same time,we conducted a simulation study on the precision requirements of the complete blood count,and provided a basis for formulating and improving related policies and standards based on the model of the quality requirements.Method:1.Analysis of the complete blood count IQC data:The IQC data of complete blood count(CBC)for five parameters were collected from laboratories participating in national external quality assessment during 2012-2017(totally 12 times),including WBC,RBC,Hb,Hct and PLT.After confirmation of all data,relative analysis are as follows ①collection of general laboratory information including the laboratory level/type,instrument brand,the proportion of use of quality control materials at different concentrations,and the use of quality control rules.②Statistical analysis of CV of IQC,including analysis of the change trend of P25,P50,P75,and P90 of CV in the lab for 12 times;compare the difference of CV in the laboratory using 3 concentration control materials at the same time;Laboratories with different concentration levels,different grades/types,and different geographical regions have coefficients of variation that meet industry standards;the 2017 laboratory CV is compared with the precision requirements of other criteria(Germany).2.study on precision quality requirement:①Derivation of allowable precision based on biological variation:Search for literature on biological variation in blood cell analysis published before April 1,2017,exclude poor quality literature according to the BIVAC criteria,and score the remaining literature.We assign different weights to the remaining literature,screening studies that are suitable for assessing biological variation in adult blood cell analysis,and generalizing biological variation data based on weights.②Derivation of allowable precision based on Sigma standards:the allowable total error allowed by the healthy standard and the above allowable total error derived based on the biological variation were calculated using the Sigma theory.The allowable precision reaching the levels of 3σ 4σ,5σ,and 6σ were calculated respectively.③Acquisition of precision data from various sources:professional institutions;2017 quality assessment participating in the laboratory with different concentrations of 80%,90%laboratory precision can be achieved;performance verification reports;precision data from different instrument brands;Academic experience.④Determine the blood cell analysis precision quality requirements based on the above information in the development of the reference value and importance of the analysis of quality requirements.⑤ Develop quality requirements for the analysis of blood cell precision.Whether or not the coefficient of variation of IQC used in the first national quality assessment program in 2018 is greater than 80%is used to assess its applicability.Results:1.Analysis of the IQC data of CBC:After eliminating invalid data,the number of laboratories remaining for analysis was 1431 to 2332(96.0%to 99.2%).Three-level medical institutions accounted for the highest proportion(62.0%～73.9%);the highest-use instrument brand was Sysmex(61.80%～66.8%);61.9%～66.1%,18.2%～23.6%,and 14.3%～respectively.17.3%of laboratories used 1,2,and 3 concentration controls,and laboratories using more than 2 concentration controls increased from 33.9%to 38.1%.The proportion of laboratories using 13s/22s quality control rules increased from 59.2%to 76.0%.The coefficient of variation at different levels had a decreasing trend with time,with the lowest values of PLT and Hct being the most significant;the pass rates of the three WBC and PLT high values were always above 90%.The pass rates of different concentrations of PLT and Hb varied greatly.The passing rate of all parameters of the Three-level medical institutions and independent laboratories was greater than 80%,while the pass rates of some parameters of the secondary and primary medical institutions were less than 80%;the pass rates of CV in North China,East China,and South China were relatively high(pass rate(More than 85%).The pass rate in the northeast region was below 80%for many times.Compared with the German Medical Association’s standards,80%of the other laboratory parameters of the CV reached the standards of the German Medical Association(except CVs with lower PLT quality controls).2.study on precision analysis quality requirements:①A total of 19 blood cell BV studies were searched.Eleven methods were abolished,three studies were completed for one or less weeks,one was for elderly women,and one for fingertip blood.The remaining 3 study quality scores were the same.Two of the literatures on biological variation in WBC andPLT were taken as the reliable BV data,and each of the remaining parameters was taken as reliable CVi.The remaining parameters were only 1 and were taken as the reliable BV data.②Take the maximum allowable precision calculated based on the a metric as the evaluation criteria.③Summarize China’s precision data,German standards,and list the retrieved literature results.④Based on biological variability,sigma metrics,and the level of precision achieved in 80%and 90%laboratories in China.The simulation results for the low,medium,and high value analytical quality requirements of the WBC were:3.8%,3.8%,and 3.1,respectively.RBC were 2.1%,2.1%,2.1%,Hb was 2.1%,2.1%,1.5%,Hct was 3.0%,3.0%,2.3%,and PLT was 8.4%,6.7%,respectively.4.0%.⑤Each parameter takes the simulated analytical quality requirement as the evaluation standard,and the passing rate in 2018 is more than 80%.Conclusion:1.The laboratory quality control CV has shown a decreasing trend over the past 6 years.However,the control level and quality control rules used by some laboratories have not met the management requirements.Some laboratory CVs have not reached the minimum requirements of the China’s quality control industry standards,Further implementation of quality improvement is needed.For those laboratories that have not standardized the IQC and CV of IQC that do not meet the requirements of the industry standards,they should find out the reasons.Labs should strengthen technical training in key steps of quality control and take quality improvement measures.2.This study first scientifically evaluated the quality of its BV research literature.And then ensured the transferability of precision requirements based on BV,and then formulated the model for analyzing quality requirements according to EFLM,and introduced precision quality requirements based on a measures.Finally,preliminary appraisal of its applicability provides data and basis for improving relevant standards and criteria.Part2.Performance Verification of Anti-Mullerian Hormone and Routine Sex Hormone Tests and Study Protocol to Explore Their Clinical Significance in Ovarian Reserve EvaluationObjective:Anti-Mullerian hormone(AMH)and routine sex hormone tests are good indicators of ovarian reserve function.In order to confirm the analytical performance of AMH and routine sex hormone tests and to ensure the accuracy and reliability of the above test results,this study performes performance verification of AMH and routine hormone testing accroding to relative guidelines and manufacturer’s instructions.The impact of hysterectomy and hysterectomy with bilateral salpingectomy on ovarian reserve are inconclusive.This study plans to design an experimental protocol through the changes of AMH and serum sex hormone levels before and after surgery in patients undergoing hysterectomy to investigate the effect of hysterectomy on ovarian reserve,and further explore whether bilateral salpingectomy will aggravate the effects on overian reserve.Method:1.Performance verification:According to the requirements of the CLSI EP15-A3,EP-6,EP17 guide documents and the manufacturer’s requirements,the performance verification methods and indicators are clearly defined,and five items(including precision,accuracy,linearity,AMH detection limit)of the Beckman Access 2 enhanced automatic immunoassay AMH and sex hormones are identified for verification.2.Design clinical trial program:According to the purpose of the study,through searching a large number of professional literature,consulting clinical experts,to understand the influencing factors of this study,draw up the inclusion and exclusion criteria for the study object,the number of objects to be observed,set the observation period,formulate a standardized sample collection process,design the research road Lines,and select the appropriate way to analyze the data.Results:1,Performance verification:The methods and indicators for verifying the detection performance of the Beckman Access 2 enhanced automatic immunoassay unit(FSH,LH,PRL,E2,T)were defined.The result were as follows:① The precision is less than the manufacturer’s stated total imprecision requirement.②The accuracy is less than the acceptable range.③Linear verification results AMH,E2,FSH,LH,PRL,and T were 0.0～21.23 ng/mL,3～4856 pg/mL,0.0～172.75 mIU/mL,0.23～248.51 mIU/mL,0.0～177.96 ng/mL,and 0.0～14.37ng/mL,respectively.④AMH detection limit meet the manufacturer’s instruction requirments.2.Design clinical trial program:Choose specific hysterectomy as target surgical procedure.Endocrine diseases,age,history of ovarian surgery were identified as factors affecting ovarian reserve;patients with particular benign lesions were determined as research objects,and patients with endocrine diseases,history of ovarian surgery were excluded;the proposed number of patients with hysterectomy and bilateral salpingectomy were 100 cases,separately;the clinical follow-up period for each observation object was setted as 6 months.the standardized specimen collection process was established according to the influencing factors before analysis;the paired t test was intended to use for preoperative and postoperative comparison,independent t test was use to compare no preventive salpingectomy combined with bilateral salpingectomy on the impact of ovarian reserve.Conclusion:1.This study is based on the Beckman Access 2 enhance detection system and verified the performance of AMH and routine sex hormone tests.The results show that the performance meets the manufacturer’s stated requirements and allowable requirements based on biological variation.The verification scheme can be used for performance in other laboratories.2.This study developed a study programe of the impact of hysterectomy on ovarian reserve,and whether the combination of bilateral salpingoectomy aggravated the impact on overian reserve,which has passed the approval of the ethics committee and laid the foundation for the follow-up experiment. |
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