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【Objective】 To analyze the correlation between the distribution interval of minipool nucleic acid testing(NAT) positive CT value and the resolution rate, so as to improve the retest model and reduce residual risk of blood transfusion. 【Methods】 The resolution testing results by Cobas S201 system of our blood center from January 2017 to December 2021 were retrospective analyzed, and the retest model was developed based on the distribution interval of CT values. For minipool NAT HBV positive samples from March 2022 to March 2023, synchronous detection was conducted by Cobas S201 and Panther detection system, and the detection results were statistically analyzed. 【Results】 From 2017 to 2021, 474 were minipool NAT positive, among which 324 were HBV positive, accounting for 68.35%. From 2017 to 2020, the proportion of HBV positive per year was significantly higher than that of HCV and HIV(P40, with the resolution rate at 95.8%, 56.5% and 14.8% respectively(P40, 36
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【Objective】 To establish a blood quality monitoring indicator system, in order to continuously improve blood quality and standardized management. 【Methods】 Based on the research of literature and standards, and guided by the key control points of blood collection and supply process, the blood quality monitoring indicator system was developed. Through two rounds of Delphi expert consultation, the indicator content was further revised and improved according to expert opinions after six months of trial implementation. The indicator weight was calculated by questionnaire and analytic hierarchy process. 【Results】 A blood quality monitoring indicator system covering the whole process of blood collection and supply was constructed, including five primary indicators, namely blood donation service, blood component preparation, blood testing, blood supply and quality control, as well as 72 secondary indicators, including definitions, calculation formulas, etc. Two rounds of expert consultation and two rounds of feasibility study meeting were held to revise 17 items and the weight of each indicator was obtained through the analytic hierarchy process. After partial adjustments, a blood quality monitoring indicator system was formed. 【Conclusion】 A blood quality monitoring indicator system covering the whole process of blood collection and supply has been established for the first time, which can effectively evaluate the quality management level of blood banks and coordinate blood quality control activities of blood banks in Shandong like pieces in a chess game, thus improving the standardized management level
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【Objective】 To objectively evaluate the quality control level of blood testing process in blood banks through quantitative monitoring and trend analysis, and to promote the homogenization level and standardized management of blood testing laboratories in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation service, blood component preparation, blood testing, blood supply and quality control was established. The questionnaire Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong province. Quality monitoring indicators of each blood bank from January to December 2022 were collected, and 31 indicators in terms of blood testing were analyzed using SPSS25.0 software. 【Results】 The proportion of unqualified serological tests in 17 blood bank laboratories was 55.84% for ALT, 13.63% for HBsAg, 5.08% for anti HCV, 5.62% for anti HIV, 18.18% for anti TP, and 1.65% for other factors (mainly sample quality). The detection unqualified rate and median were (1.23±0.57)% and 1.11%, respectively. The ALT unqualified rate and median were (0.74±0.53)% and 0.60%, respectively. The detection unqualified rate was positively correlated with ALT unqualified rate (r=0.974, P0.05), while the outrage rate was positively correlated with the usage rate (r=0.592, P<0.05). A total of 443 HBV DNA positive samples were detected in all blood banks, with an unqualified rate of 3.78/10 000; 15 HCV RNA positive samples were detected, with an unqualified rate of 0.13/10 000; 5 HIV RNA positive samples were detected, with an unqualified rate of 0.04/10 000. The unqualified rate of NAT was (0.72±0.04)‰, the single NAT reaction rate [(0.39±0.02)‰] was positively correlated with the single HBV DNA reaction rate [ (0.36±0.02) ‰] (r=0.886, P<0.05). There was a difference in the discriminated reactive rate by individual NAT among three blood bank laboratories (C, F, H) (P<0.05). The median resolution rate of 17 blood station laboratories by minipool test was 36.36%, the median rate of invalid batch of NAT was 0.67%, and the median rate of invalid result of NAT was 0.07‰. The consistency rate of ELISA dual reagent detection results was (99.63±0.24)%, and the median length of equipment failure was 14 days. The error rate of blood type testing in blood collection department was 0.14‰. 【Conclusion】 The quality monitoring indicator system for blood testing process in Shandong can monitor potential risks before, during and after the experiment, and has good applicability, feasibility, and effectiveness, and can facilitate the continuous improvement of laboratory quality control level. The application of blood testing quality monitoring indicators will promote the homogenization and standardization of blood quality management in Shandong, and lay the foundation for future comprehensive evaluations of blood banks.
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【Objective】 To establish an effective quality monitoring indicator system for blood quality control in blood banks, in order to analyze the quality control indicators for blood collection and supply, and evaluate blood quality control process, thus promoting continuous improvement and standardizing management of blood quality control in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation services, component preparation, blood testing, blood supply and quality control was established. The Questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process was distributed to 17 blood banks in Shandong, which clarified the definition and calculation formula of indicators. The quality monitoring indicator data from January to December 2022 in each blood bank were collected, and 20 quality control indicators data were analyzed by SPSS25.0 software. 【Results】 The average pass rate of key equipment monitoring, environment monitoring, key material monitoring, and blood testing item monitoring of 17 blood banks were 99.47%, 99.51%, 99.95% and 98.99%, respectively. Significant difference was noticed in the pass rate of environment monitoring among blood banks of varied scales(P<0.05), and the Pearson correlation coefficient (r) between the total number of blood quality testing items and the total amount of blood component preparation was 0.645 (P<0.05). The average discarding rates of blood testing or non-blood testing were 1.14% and 3.36% respectively, showing significant difference among blood banks of varied scales (P<0.05). The average discarding rate of lipemic blood was 3.07%, which had a positive correlation with the discarding rate of non testing (r=0.981 3, P<0.05). There was a statistically significant difference in the discarding rate of lipemic blood between blood banks with lipemic blood control measures and those without (P<0.05). The average discarding rate of abnormal color, non-standard volume, blood bag damage, hemolysis, blood protein precipitation and blood clotting were 0.20%, 0.14%, 0.06%, 0.06%, 0.02% and 0.02% respectively, showing statistically significant differences among large, medium and small blood banks(P<0.05).The average discarding rates of expired blood, other factors, confidential unit exclusion and unqualified samples were 0.02%, 0.05%, 0.003% and 0.004%, respectively. The discarding rate of blood with air bubbles was 0.015%, while that of blood with foreign body and unqualified label were 0. 【Conclusion】 The quality control indicator system of blood banks in Shandong can monitor weak points in process management, with good applicability, feasibility, and effectiveness. It is conducive to evaluate different blood banks, continuously improve the quality control level of blood collection and supply, promote the homogenization and standardization of blood quality management, and lay the foundation for comprehensive evaluation of blood banks in Shandong.
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【Objective】 To establish an effective quality indicator monitoring system, scientifically and objectively evaluate the quality management level of blood banks, and achieve continuous improvement of quality management in blood bank. 【Methods】 A quality monitoring indicator system that covers the whole process of blood collection and supply was established, the questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong. Statistical analysis of 21 quality monitoring indicators in terms of blood donation service (10 indicators), blood component preparation (7 indicators ), and blood supply (4 indicators) from each blood bank from January to December 2022 were conducted using SPSS25.0 software The differences in quality monitoring indicators of blood banks of different scales were analyzed. 【Results】 The average values of quality monitoring indicators for blood donation service process of 17 blood banks were as follows: 44.66% (2 233/5 000) of regular donors proportion, 0.22% (11/50) of adverse reactions incidence, 0.46% (23/5 000) of non-standard whole blood collection rate, 0.052% (13/25 000) of missed HBsAg screening rate, 99.42% (4 971/5 000) of first, puncture successful rate, 86.49% (173/200) of double platelet collection rate, 66.50% (133/200) of 400 mL whole blood collection rate, 99.25% (397/400) of donor satisfaction rate, 82.68% (2 067/2 500) of use rate of whole blood collection bags with bypass system with sample tube, and 1 case of occupational exposure in blood collection.There was a strong positive correlation between the proportion of regular blood donors and the collection rate of 400 mL whole blood (P<0.05). The platelet collection rate, incidence of adverse reactions to blood donation, and non-standard whole blood collection rate in large blood banks were significantly lower than those in medium and small blood banks (P<0.05). The average quality monitoring indicators for blood component preparation process of 17 blood banks were as follows: the leakage rate of blood component preparation bags was 0.03% (3/10 000), the discarding rate of lipemic blood was 3.05% (61/2 000), the discarding rate of hemolysis blood was 0.13%(13/10 000). 0.06 case had labeling errors, 8 bags had blood catheter leaks, 2.76 bags had blood puncture/connection leaks, and 0.59 cases had non-conforming consumables. The discarding rate of hemolysis blood of large blood banks was significantly lower than that of medium and small blood banks (P<0.05), and the discarding rate of lipemic blood of large and medium blood banks was significantly lower than that of small blood banks (P<0.05). The average values of quality monitoring indicators for blood supply process of 17 blood banks were as follows: the discarding rate of expired blood was 0.023% (23/100 000), the leakage rate during storage and distribution was of 0.009%(9/100 000), the discarding rate of returned blood was 0.106% (53/50 000), the service satisfaction of hospitals was 99.16% (2 479/2 500). The leakage rate of blood components during storage and distribution was statistically different with that of blood component preparation bags between different blood banks (P<0.05). There were statistically significant differences in the proportion of regular blood donors, incidence of adverse reactions, non-standard whole blood collection rate, 400 mL whole blood collection rate, double platelet collection rate, the blood bag leakage rate during preparation process, the blood components leakage rate during storage and distribution as well as the discarding rate of lipemic blood, hemolysis blood, expired blood and returned blood among large, medium and small blood banks (all P<0.05). 【Conclusion】 The establishment of a quality monitoring indicator system for blood donation services, blood component preparation and blood supply processes in Shandong has good applicability, feasibility and effectiveness. It can objectively evaluate the quality management level, facilitate the continuous improvement of the quality management system, promote the homogenization of blood management in the province and lay the foundation for future comprehensive evaluation of blood banks.
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There has been a growing amount of evidence that a balanced blood component transfusion with roughly equal ratio of units of packed red blood cells, fresh frozen plasma, and platelets leads to better outcomes in massive transfusion resuscitation of trauma victims. Therefore, the great interest of massive transfusion protocol (MTP) with whole blood was aroused. Low titer group O whole blood (LTOWB) is implemented in routine use for civilian prehospital ambulance services in large trauma centers of most European and American countries nowadays. There is a growing body of evidence to date to support that early use of LTOWB in patients with life-threatening bleeding improve their survival. In view of the current situation of whole blood supply in our country, most trauma resuscitation guidelines still recommend balanced component transfusion for MTPs in the early stage of resuscitation. The research and application of LTOWB abroad will be introduced in this article.
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【Objective】 To compare the detection performance of Cobas s201, a minipool(MP) nucleic acid test(NAT) system, and Panther, a individual donation(ID) NAT system, in blood donor screening. 【Methods】 NAT was conducted on 126 359 blood samples, and initially reactive (IR) samples were either discriminated or resolved by ID testing.The non-discriminated reactive (NDR) samples implicated in Panther sysytem were subjected to ID-NAT by Cobas s201. Some non-repeatable reactivet(NRR) and repeatable reactive (RR) samples implicated in Cobas s201 system were subjected to ID-NAT by Panther. 【Results】 61 MP-IR cases were implicated in a total of 85 128 samples that detected by Cobas 201, and 29(0.34‰) were RR after resolved by ID testing. 74(1.79‰)IR samples were implicated in 41 231 samples that detected by Panther, and 22 (29.73%) were DR-HBV after discriminatory test. Among the NDR 28 samples detected by Panther multiplex system, 7 were positive by Cobas s201 single sample (PP1) whereas non-reactive in simulated MPs of six by Cobas 201.In 28 RR samples resolved by Cobas 201, 24 positive and 4 negative samples were retested by Panther. Among the 11 samples presenting inconsistent retest results by Panther and Cobas 201, 10 were anti-HBc positive, carrying low viral load HBV. 【Conclusion】 The NAT-yield by Panther was significantly higher than that by Cobas s201. Some samples with negative discriminatory results were OBI, and it is necessary to further track and verify the unidentified samples. Cobas s201 is more suitable for a wide array of MP-NAT testing while Panther sample loading, which is flexible and easy to operate, is more suitable for ID-NAT with medium sample size.
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【Objective】 To study and analyze the serological and viral charactereristics of hepatitis B virus(HBV) infection in voluntary blood donors in Qingdao. 【Methods】 315 520 blood samples of voluntary blood donors were screened by ELISA combined with nucleic acid testing (NAT). All HBsAg-/HBV DNA+ samples were subjected to high-precision viral load detection and five serological markers of HBV. The sequence of HBV S gene was detected by PCR direct sequencing, and virus genotypes and amino acid mutations were analyzed. 【Results】 A total of 604(0.20%)HBV ELISA or NAT reactive samples were detected: HBsAg+ /HBV DNA- in 307(0.10%) cases, HBsAg-/HBV DNA+ in 138(0.04%) and HBsAg+ /HBV DNA+ in 157(0.05%). Among the 138 HBsAg-/HBV DNA+ donors, 118(85.5%) carried anti-HBc, and 45 (32.61%) carried sole anti-HBc and 5 (3.62%) carried both HBsAg and anti-HBc. In viral load detection, 64 were quantitatively negative and 74 were quantitatively positive, of which 42 were HBV DNA 20 IU/mL. 13 HBsAg-/HBV DNA+ samples were successfully amplified and sequenced, and 5 were genotype B, presenting a total of 17 amino acid mutations without any deletion or insertion, and 8 were genotype C, presenting a total of 41 amino acid mutations and 2 amino acid deletions. 【Conclusion】 NAT, in combination of ELISA, provides additional safety in detecting potentially infectious HBV during the window period and occult HBV infection (OBI). The viral load was low in OBI infected donors, and anti-HBc+ was the main manifestation.The dominating HBV genotypes are genotype B and C, suggesting HBsAg amino acid mutations may be related to the formation of OBI.
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Objective To analyze the blood screening results after adjustment of critical value 40 to 50 U/L and to observe the effect of reducing blood scrap rate and to discuss the correlation between ALT and HBV,HCV infection.Methods We screened 2656 blood donors (ALT >40 U/L)by serological and nucleic acid amplification testing(NAT)in Qingdao blood center from 2013 to 2014,and conducted the correlation analysis by chi square test.Results 1 771 cases (66.68%)were ALT 40-50 U/L,including 6 cases of HBsAg ELISA (+),2 cases NAT (+),4 cases NAT(-).In the 8 cases of anti-HCV ELISA (+)samples,4 cases NAT (+),3 cases NAT (-),1 case with positive TP without NAT result.In 885 blood donors with ALT>50 U/L,5 cases were HBsAg-reactive,7 cases were anti-HCV-reactive,and 873 cases were negative.Related statistics showed that there was no signifi-cant difference between ALT and HBV infection (P 0.05).Conclusion The proportion of blood donors with ALT 40-50 U/L is much higher than that with ALT >50 U/L do-nors.Adjustment of the critical value greatly reduces blood scrap rate.Elevated ALT is associated with the infection of HBV but not with HCV.
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Objective To investigate the residual risks of transfusion-transmitted HBV/HCV/HIV in current donor screening system of Qingdao area.Methods After the ELISA tests(HbsAg,anti-HCV,anti-HIV) were performed,NAT tests of HBV-DNA,HCV-RNA,and HIV-RNA on plasma samples were conducted.Such specimens as have discrepant ELISA and NAT results(N+/E-,or N-/E+) were subject to further follow-up confirmation tests.Results Among 12000 donor samples,no sample with anti-HCV(-)/HCV-RNA(+) or with anti-HIV(-)/HIV-RNA(+) was detected.However,2 individuals were detected as HBsAg(-)/HBV-DNA(+).One donor had negative ELISA test results in HBsAb,HBeAg,HBeAb,and HBcAb at the first screening.But the HBsAg,HBeAg and HBcAb were confirmed positive along with HBV-DNA after 11 weeks.The other donor was negative for HBsAb,HBeAg,and HBeAb but positive for HBcAb.Follow up tests after 3 weeks indicated the same serological results,with a similar low viralload at about 1000 IU/mL.Conclusion Due to the window period and occult HBV infection,current blood donor screening system has some residual risks of transfusion-transmitted HBV.NAT and HBcAb tests should be implemented to reduce the residual risks of transfusion-transmitted HBV.