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Introduction: Specimen adequacy is a crucial preanalytical factor affecting accuracy and usefulness of test result. The aim of this study was to determine the frequency and reasons for rejected haematology specimens, preanalytical variables which may affect specimen quality, and consequences of rejection, and provide suggestions on monitoring quality indicators as to obtain a quality improvement. Materials and methods: A cross-sectional survey was conducted and a questionnaire was sent to 1586 laboratories. Participants were asked to provide general information about institution and practices on specimen management and record rejections and reasons for rejection from 1st to 31st July. Results: A total survey response rate was 56% (890/1586). Of 10,181,036 tubes received during the data collection period, 11,447 (0.11%) were rejected, and the sigma (σ) was 4.6. The main reason for unacceptable specimens was clotted specimen (57%). Rejected specimens were related to source department, container type, container material type, transportation method and phlebotomy personnel. The recollection of 84% of the rejected specimens was required. The median specimen processing delay in inpatient, outpatient and emergency department were 81.0 minutes, 57.0 minutes and 43.3 minutes, respectively. Conclusions: Overall, rejection rate was a slightly lower than previously published data. In order to achieve a better quality in the preanalytical phase, haematology laboratories in China should pay more attention on training for phlebotomy and sample transportation, identify main reasons for clotted specimen and take effective measures. The platform in the study will be helpful for long-term monitoring, but simplification and modification should be introduced in the following investigation.

Introduction: This survey was initiated to obtain knowledge on the current situation of internal quality control (IQC) practice for tumour markers (TMs) in China. Additionally, we tried to acquire the most appropriate quality specifications. Materials and methods: This survey was a current status survey. The IQC information had been collected via online questionnaires. All of 1821 clinical laboratories which participated in the 2016 TMs external quality assessment (EQA) programme had been enrolled. The imprecision evaluation criteria were the minimal, desirable, and optimal allowable imprecisions based on biological variations, and 1/3 total allowable error (TEa) and 1/4 TEa. Results: A total of 1628 laboratories answered the questionnaires (89%). The coefficients of variation (CVs) of the IQC of participant laboratories varied greatly from 1% (5th percentile) to 13% (95th percentile). More than 82% (82 - 91%) of participant laboratories two types of CVs met 1/3 TEa except for CA 19-9. The percentiles of current CVs were smaller than cumulative CVs. A number of 1240 laboratories (76%) reported their principles and systems used. The electrochemiluminescence was the most used principle (45%) and had the smallest CVs. Conclusions: The performance of laboratories for TMs IQC has yet to be improved. On the basis of the obtained results, 1/3 TEa would be realistic and attainable quality specification for TMs IQC for clinical laboratories in China.

Introduction: Prenatal screening and diagnosis is important for the detection of birth defects and genetic diseases. The nationwide proficiency testing (PT) of maternal serum prenatal screening in second trimester in China has been launched since 2003 and partly reflected the performance of screening laboratories. This study analysed the 2015 PT results to examine the performance of clinical laboratories and different platforms. Materials and methods: Fifteen lyophilized samples with different concentrations divided into three panels, were distributed to 613 clinical laboratories in 2015. Acceptable performance was defined as scores more than 80% of acceptable responses with the evaluation criterion of ± 30%. The robust coefficient of variation (CV) was also analysed. Chi-square (?2) test was used to compare the acceptable performance while Kruskal-Wallis test and Mann-Whitney test were applied to compare the robust CV among analytes and mainstream platforms. Results: Overall, 605, 61, 214, 416, 303 laboratories submitted effective results for alpha fetoprotein (AFP), total human chorionic gonadotropin (t-hCG), ß-hCG, unconjugated estriol (uE3) and free ß-hCG. The acceptable performances of AFP (µg/L), AFP (KIU/L), t-hCG, ß-hCG, uE3, and free ß-hCG were 98.45%, 99.24%, 95.58%, 98.72%, 94.50%, and 98.66%, respectively. The ?2 test indicated significant differences existed in the acceptable performances among different analytes and platforms for uE3. Kruskal-Wallis test and Mann-Whitney test suggested the robust CV differed significantly in different analytes and platforms. Conclusions: The majority of results were acceptable. However, further effort is needed to achieve the standardization and harmonization among analytes and various platforms, particularly for uE3.

Introduction: The aim of the study was to investigate the state-of-the-art of the performance of critical value reporting and provide recommendations for laboratories setting critical value reporting time frames. Materials and methods: The National Centre for Clinical Laboratories in China initiated a critical value reporting investigation in 2015. A questionnaire related to critical value reporting policy was sent to 1589 clinical laboratories in China online. The questionnaire consisted of a set of questions related to critical value reporting policy and a set of questions related to timeliness of critical value reporting. The survey data were collected between March and April 2015. Results: A total survey response rate was 61.2%. The critical value unreported rate, unreported timely rate, and clinical unacknowledged rate of more than half of participants were all 0.0%. More than 75.0% of participants could report half of critical values to clinicians within 20 minutes and could report 90.0% of critical values to clinicians within 25 minutes (from result validation to result communication to the clinician). The median of target critical value reporting time was 15 minutes. “Reporting omission caused by laboratory staff”, “communications equipment failure to connect”, and “uncompleted application form without contact information of clinician” were the three major reasons for unreported critical value. Conclusions: The majority of laboratories can report critical values to responsible clinical staff within 25 minutes. Thus, this value could be recommended as suitable critical value reporting time frame for biochemistry laboratories in China. However, careful monitoring of the complete reporting process and improvement of information systems should ensure further improvement of critical value reporting timeliness.

Introduction: To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. Materials and methods: 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. Results: The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479 / 1307), 38% (228 / 598), and 36% (449 / 1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Conclusions: Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them.