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Transfusion and Apheresis Science j o u r n a l h o m e p a g e : w w w. e l s e v i e r. c o m / l o c a t e / t r a n s c i
An experience of the introduction of a blood bank automation system (Ortho AutoVue Innova) in a regional acute hospital Yuk Wah Cheng a, Jenny M. Wilkinson b,* a b
Blood Bank, Clinical Pathology Department, Pamela Youde Nethersole Eastern Hospital, Hong Kong School of Biomedical sciences, Charles Stuirt University, Wagga Wagga, Australia
A R T I C L E
I N F O
Article history: Received 3 October 2014 Received in revised form 4 February 2015 Accepted 9 March 2015 Keywords: Hospital blood bank Blood bank automation Type & screen Ortho AutoVue® Innova
A B S T R A C T
This paper reports on an evaluation of the introduction of a blood bank automation system (Ortho AutoVue® Innova) in a hospital blood bank by considering the performance and workflow as compared with manual methods. The turnaround time was found to be 45% faster than the manual method. The concordance rate was found to be 100% for both ABO/ Rh(D) typing and antibody screening in both of the systems and there was no significant difference in detection sensitivity for clinically significant antibodies. The Ortho AutoVue® Innova automated blood banking system streamlined the routine pre-transfusion testing in hospital blood bank with high throughput, equivalent sensitivity and reliability as compared with conventional manual method. © 2015 Elsevier Ltd. All rights reserved.
1. Introduction In some clinical situations blood transfusion is the only intervention that is able to save life rapidly; however, blood transfusion is also acknowledged to be a therapy that involves life threatening risk [1,2] and the hospital blood bank plays a key role in safe blood transfusion. Pretransfusion testing involves blood grouping, screening for clinically significant antibodies and compatibility testing and while regulatory guidelines and operational recommendations are designed to minimize risk, laboratory errors remain as a function of human interventions and the number of steps in the testing procedures [3]. Automation of blood banking seems to be the only solution to cope with the sophisticated manual procedures in hospital blood banking [4]. Fully automated analyzers have become an essential component of every discipline in clinical laboratories. The
* Corresponding author. School of Biomedical Sciences, Charles Sturt University, Wagga Wagga, NSW 2678, Australia. Tel.: +612 6933 4019; fax: +612 6933 2587. E-mail address: [email protected] (J.M. Wilkinson).
incorporation of blood bank automation systems can facilitate the reduction of human error, technique standardization, alleviate heavy workload and improve turnaround time (TAT). In addition, a traceable database of laboratory records can be achieved as the image captured in the interpretation of reactions can be stored permanently [5]. The Serious Hazard of Transfusion report (SHOT) [6] also noted that there were a considerable number of errors due to mishandling and storage of blood products. Therefore blood inventory monitoring is also a significant issue in transfusion safety. Some automation systems have installed middleware (e.g. Autovue® Innova installed with Sonet information system) or directly link with the laboratory information system for blood inventory management. From an occupational safety and health perspective, the biological safety of the operators can also be improved by adoption of automated systems with minimal sample handling procedures that reduce the operators’ exposure to potentially hazardous biological materials [7]. In 2009, the UK Transfusion Laboratory Collaborative report emphasized the importance of the staffing requirements and competency of blood bank technologists [8]. Employment of experienced staff with relevant qualifications are legislative requirements in both the UK and Hong Kong; however, recruiting qualified staff especially for work
http://dx.doi.org/10.1016/j.transci.2015.03.007 1473-0502/© 2015 Elsevier Ltd. All rights reserved.
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in shift non-core hours is increasingly difficult [9]. Since the quality of service cannot be compromised, if automation can take over some of the routine procedures such as pipetting, dispensing of samples and reagents, qualified staff are freed to perform high level skilled miscellaneous tests and also pay more attention in quality assurance. Currently, there are a wide range of automation systems available in automation of serological testing in the transfusion service [10,11]. Selection criteria for an instrument are based mainly on the need of the service and resources. Nevertheless, installation, evaluation, validation, interfacing and training of operators are essential in the implementation of a new automation system [12]. The British Committee for Standards in Haematology (BCSH), Blood Transfusion Task Force announced a recommendation for evaluation, validation and implementation of new techniques for blood grouping and antibody screening [13]. They recommend that when introducing new systems to improve performance the new system should be better than, or as good as, the currently used one. A range of samples and procedures should be tested for the sensitivity, specificity and reproducibility. Parallel comparison with both the new and old systems should be evaluated. Pamela Youde Nethersole Eastern Hospital (PYNEH) is a regional acute hospital located in the Hong Kong Eastern District and served a population of 588,094 in 2011 [14]. The PYNEH provides 24-hour comprehensive hospital services to various specialties such as surgical, internal medicine, orthopedic, and emergency critical care departments. The hospital blood bank is responsible for routine and emergency transfusion service support and provides pre-transfusion testing and various blood product allocations. The PYNEH blood bank performs approximately 18,000 Type & Screen and transfuses 16,000 units of red blood cells annually [15]. Miscellaneous antibody investigation and extra red cell phenotyping service profiles are also provided. Staffing of this service, and hospital policy and budget regarding staffing, is also a consideration, especially during the overnight shift. There are three technical staff during the normal day service hours (9–5 am) and only 1 technical staff on duty during off-hours (after 5 pm until 9 am next working day and during public holidays). In addition at times technical staff may be involved in other tasks such as blood product issuing, telephone enquiries and urgent blood inventory management. The heavy workload and low staff numbers particularly during the night shift present significant workplace challenges when considered in combination with accreditation assessments/requirements, increasing workload due to population expansion and budget restrictions on additional staff. Automation in blood banking services is now widely recognized as a means of quality improvement to ensure efficient and quality transfusion service and to assist in budget management. The aim of this study is to compare the performance of the automated blood bank system (ORTHO AutoVue® Innova, Ortho Clinical Diagnostics, USA) with the manual tile or tube method and DiaMed-ID Micro Typing System (Bio-Rad Laboratories, Switzerland) system in blood grouping and antibody screening for pre-transfusion testing, respectively.
2. Methods 2.1. Sample processing The standard process for sample processing at the time of this study was that routine requests for pre-transfusion tests, referred to as Type & Screen (T&S), are received in the blood bank in an individual bag containing a request form and a blood sample. A laboratory number is assigned and a T&S request is registered in the Laboratory Information System (LIS). The determination of ABO/Rh(D) typing and antibody screening for clinically significant antibodies (Type & Screen) would be completed using the manual tile method and antibody screening by DiaMed-ID Micro Typing System (Bio-Rad Laboratories) manual system. In order to compare the ORTHO AutoVue® Innova (Ortho Clinical Diagnostics) automated system, T&S requests received by PYNEH Blood Bank in the period of 18th October to 12th November, 2010 were analyzed in parallel using both the manual and automated systems. Specific items to be compared were: accuracy, precision, carryover and specificity. Antibody identification determination and titration studies of anti-D reference and 13 commercial antisera were also conducted for assessing the sensitivity of the system. Both the AutoVue® Innova and DiaMed-ID system are applied column agglutination technology (CAT). Crosslinked dextran suspended in optimized buffers was selected as the matrix in the DiaMed-ID system [16], whereas a glass bead microcolumn is used in the AutoVue® Innova [17]. The AutoVue® Innova also uses different types of cassettes for specific purposes; ABO/ Rh(D) cassettes contain anti-A, anti-B and anti-D for corresponding antigen typing to determine ABO/Rh(D) group. Antiglobulin cassettes contain polyspecific anti-human globulin for use in antibody screening or direct antiglobulin test. 2.2. Manual Type & Screen For the manual grouping method and DiaMed-ID system, labeling of testing tiles and tubes, manual pipetting of sample and reagents (Table 1) are done by technicians following standard testing procedures as recommended by the manufacturer and laboratory guidelines. For ABO/Rh(D) determination, a 5% red cell suspension of patient samples is tested against the Seraclone commercial grouping antiserum:
Table 1 Comparison of equipment and reagents used in ABO/Rh(D) typing for AutoVue® Innova and manual method.
Equipment
Cassettes Antiserum (A, B, AB, D) Diluent ABO cells for reverse grouping
AutoVue® Innova
Manual method
Built-in incubator, centrifuge, and auto-reader ABO/Rh reverse cassettes Incorporated in ABO cards Phosphate buffered saline 3% Affirmagen A1, B red cells
Perspex hemagglutination tile, centrifuge – Seraclone Biotest antiserum
5% Pooled ABO cells from HKRCBTS
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Table 2 Manual interpretation of hemagglutination reactions in a scoring system of 0–12 [18]. Grade
Score value
Appearance
Complete 4+w or 3+s 3+
12 11 10
A single agglutinate. No free RBCs detected. Reactivity between scores 12 and 11. Strong reaction. A number of large agglutinates. Reactivity between scores 10 and 8. Large agglutinates in a sea of smaller clumps, no free RBCs. Many agglutinates – medium and small, no free RBCs. Many medium and small agglutinates and free RBCs in the background. Many small agglutinates and a background of free RBCs. Many very small agglutinates with a lot of free RBCs. Weak granularity in the RBC suspension. A few macroscopic agglutinates but numerous agglutinates microscopically. Appears negative macroscopically. A few agglutinates of 6–8 RBCs in most fields. Rare agglutinates observed microscopically. An even RBC suspension. No agglutinates detected.
3+w
or 2+
s
2+
9 8
2+w
7
1+s
6
1+
5
1+w
4
1±
3
(+)
2
(0R)rough 0
1 0
anti-A, anti-B, anti-A,B and anti-D, while ABO cell grouping was used by tile method and Rh (D) determination was used by tube method. Results of hemagglutination reactions are recorded by technicians following a scoring system of 0–12 (Table 2) where 0 is no agglutinates and 12 is a single agglutinate with no free erythrocytes. The results of ABO/ Rh(D) are available after 30 minutes. For the manual DiaMed-ID antibody screening system, procedures involved labeling of cassettes (LISS/Coombs Cards), pipetting of screening cells and patient plasma, incubation and centrifugation. The testing procedures strictly followed the manufacturer’s protocol and used a designated incubator and centrifuge (Table 3). After the final centrifugation step, the total antibody screening result takes at least 40 minutes for completion. The results are read by technologists and interpreted and transcribed on data sheets
Cassettes Diluent Reagent screen cells
ID panel cells Diluent for titration
according to a standard reaction scoring patterns. The scoring rates of the cassette from 0 to 4 with 0 being all erythrocytes pass through the column and 4 that agglutinated cells form a band at the top of the column. 2.3. Automated Type & Screen – AutoVue® Innova The AutoVue® Innova system has built-in robotic pipetting arms, incubator, centrifuge and digital camera. Anti-IgG/C3d polyspecific and ABO cassettes are designated for the T&S purposes respectively. A data terminal is installed for sample processing and analysis of results. Barcode labeled samples are put into a sample rack with ordering of requests done through the data terminal. After request ordering the rack of samples is put into the analyzer, and tests are completed automatically according to the test request worklist. ABO/Rh(D) typing results that require no incubation time are available in 8 minutes. Antibody screening results are available in 22 minutes. The built-in digital camera records images of the cassettes for result interpretation by the data terminal using image processing system software. This software uses a grading algorithm based on a predetermined scoring system as used in manual testing. The Autovue® blood bank system can also accommodate for the bidirectional linkage to the Laboratory Information System (LIS) by means of requests download for test ordering and results upload for the reporting. 2.4. Workflow analysis All hands-on processing steps included in the workflow analysis such as sample labeling, pipetting in manual system or barcode scanning in automated system were counted to compare the efficiency of the both system. 2.5. Throughput analysis
AutoVue® Innova
DiaMed-ID System
Measurement of the turnaround time is based on time from the receipt of blood samples until the result reporting of T&S results. In hospitals with acute care facilities emergency requests for blood transfusion are common and it would be preferable for a system to accommodate STAT samples to facilitate the urgent release of blood for patients. To verify the system can permit a ‘do first’ priority for a urgent request, a STAT sample was assigned into the system during full loading of the analysis cycle and the efficiency of the STAT Mode was measured so as to evaluate the minimal reporting time of an emergency sample.
Built-in incubator, centrifuge, and autoreader (digital camera) Anti-IgG/C3d polyspecific BLISS 0.8% Selectogen I and II and Miltenberger cells from (HKRCBTS) 0.8% Resolve panel A Phosphate buffered saline 6% Bovine serum albumin from DiaMed
ID Incubator 37 SI ID Centrifuge 24
3. Results
Table 3 Equipment and reagents used in antibody screening and identification.
Equipment
3
LISS/Coombs Card ID Diluent 2 0.8% DiaCell Asia I, II, and III (in DiaCell Asia: Cell III represents the Miltenberger cells) 0.8% ID DiaPanel
3.1. Quality assurance and accuracy of the AutoVue® Innova The analyzer produced consistent results in ABO/Rh(D) typing, antibody screening and antibody identification in comparison with manual DiaMed-ID system by means of accuracy, specificity, precision and carryover investigation. There was also an observation that the sensitivity of antibody detection was better in AutoVue® Innova for some antibodies where the detection end points of the respective clinically significant antibodies were higher (Fig. 1).
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Comparison of Titration scores of commercial antiserum in AutoVue and DiaMed-ID System 40 AutoVue
Sum total of titration scores
35
DiaMed-ID
30 25 20 15 10 5 0 C
c
E
e
Fya
Fyb Lea Leb Jka
Jkb
M
N
K
Commerci a l Anti s erum
Fig. 1. Comparison of detection end point of clinically significant antibodies.
3.2. ABO/Rh(D) typing 3.2.1. Accuracy Two hundred and eighteen samples of ABO/Rh(D) typing were performed by the manual tile method and by AutoVue® Innova. There were 65 group A, 60 group B, 74 group O and 19 group AB samples; 7 Rh(D) negative samples were also included. In comparing with the interpretation results, the accuracy rate was 100%. The acceptance criteria included the interpretation results and also the reaction scoring. There were two samples which had weakened but comparable scoring in both the manual and automated systems. These cases were found to be specific patients of old ages (85 and 86 years old) from hematology and oncology specialties where antigen-antibody reactions are known to be weakened [19]. Five ABO subgroup samples provided by Hong Kong Red Cross Blood Transfusion Service (HKRCBTS) were also correlated accurately. 3.2.2. Specificity The concordance rate is 100%. Due to the low percentage of Rh(D) negative cases in Chinese populations, there were only 7 cases of Rh(D) negative samples included during the evaluation period. Among these samples, three of them of known weak D expression identified were specially arranged with HKRCBTS for evaluation. Both of the manual and automated system revealed D negative for those samples. 3.2.3. Precision Precision was verified by performing between run and within run analysis. ABO/Rh (D) typing of pooled A, B, and O cells was tested in three single run a day and run for 5 consecutive days, also 10 aliquots of each group were tested
in a single run. One hundred percent reproducible results were revealed, no discrepant result found. 3.2.4. Carryover Known ABO blood group samples from HKRCBTS were arranged in a repeated sequence of AB, AB, AB, O, O, O, AB, AB, AB, O, O, O for the testing of ABO/Rh(D) typing to rule out the possibility of carryover. No discrepant results were found, therefore no carry over was observed. 3.3. Antibody screening 3.3.1. Accuracy Antibody screening tests of 196 samples were performed by the two methods. One hundred and fifty samples were antibody screening negative and 45 samples were antibody screening positive. One hundred percent concordance rate was obtained. 3.3.2. Specificity The 150 antibody screening negative samples were taken into account for the calculation of specificity. No false positive results were found in both systems. The concordance rate was found to be 100%. 3.3.3. Precision A 0.05 IU/mL anti-D reference was used to perform the antibody screening in three single run a day and run for 5 consecutive days, and 10 aliquots for repeated analysis were prepared for a single run to reveal the reproducibility of the analyzer. No discrepant results were found. 3.3.4. Carryover Antibody screening of neat anti-D and 6% bovine serum albumin in a sequence of anti-D, anti-D, 6% BSA, 6% BSA,
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anti-D, anti-D, 6% BSA, 6% BSA, were performed to rule out the possibility of carryover. No carryover was found. 3.3.5. Sensitivity Ten weak known antibodies scoring ≦1 (in a scoring scale of 0–4) from the DiaMed system were chosen to test the sensitivity of the system. Concordance results of scoring 0.5–1 were reproduced in AutoVue system. Titration studies were performed using doubling dilution of 2.0 IU/mL anti-D reference to produce a reaction score of 1 and 6% bovine serum albumin acted as reagent blank. Guidelines for Pretransfusion published by the Australian and New Zealand Society of Blood Transfusion (2007) stated that the sensitivity of antibody screening system should be capable of detecting anti-D at a concentration of 0.1 IU/ mL or lower [20]. The result revealed that a score value of 0.5–1 was produced by a 1 in 64 dilution and a negative result of score 0 produced by a 1 in 128 dilution. The result implies that the detection limit and sensitivity of the AutoVue system would be as low as 0.03125 IU/mL anti-D. 3.4. Antibody identification Forty-one antibody positive cases from daily patient samples during the evaluation period were selected for the antibody identification comparison. The antibodies included anti-E, anti-c, anti-D, anti-Jka, anti-M, anti-Mi, antiFya and anti-P1. Forty-one (41) results were concordant, only 1 sample which was identified as anti-E in DiaMed system was identified as anti-E by AutoVue with one more unidentified antibody. Since the two systems were using their specific panel cells for the identification of antibodies, the unidentified antibodies from AutoVue result may be because of the panel cells of single donor with a low incidence antigen. 3.5. Titration studies of commercial antiserum Titration of 13 commercial antiserum (C, c, E, e, Jka, Jkb, Fy , Fyb, Lea, Leb, M, N, K) (Biotest, Dreieich, Germany) in doubling dilution with 6% albumin as the dilution blank was performed to evaluate the performance of the two systems in terms of sensitivity of clinically significant antibody detection. The higher dilution or the higher titer detection obtained would be defined as the more sensitive of the system. By adding the total of dilution gradient for each of the antiserum, the sensitivity would be compared. The Wilcoxon–Mann–Whitney test was used to compare the data and showed no statistically significant difference (P = 0.1003) between the titration scores obtained in the 13 antiserum as shown in (Fig. 1). It was concluded that the two systems showed no difference in detection sensitivity for clinically significant antibodies. However, in terms of titer detection, a generally higher detection end point was obtained by the AutoVue® Innova automated system and especially for anti-Lea, anti-Leb and anti-M. The glass bead cassettes of AutoVue® Innova are known to produce more sensitive results for those cold reacting antibodies [21]. For the anti-Jka and anti-Jkb, the big differences of titer were because of the heterozygous expression of DiaMed screening cells and led to lower titer detection. a
5
3.6. Workflow analysis Blood samples and request documents were received in the reception counter of the blood bank and logged. Inspection of samples and request forms, labeling of samples by assigning laboratory numbers was completed upon receipt. Labeling of testing apparatus such as test tubes, grouping tile and AHG cassettes was done as for manual tests. Repeated verification of labeling corresponding to samples and apparatus need time. Moreover, due to the limitation of incubation time and occupancy of centrifuge, random access of samples or ‘one at a time’ would occupy the staff continuously by doing different samples in overlapping time and easy to have confusing of laboratory steps. To streamline the workflow, usually batching of samples would be used. In contrast, using the AutoVue® Inova, ordering of requests can be facilitated by barcode scanning and labeling of apparatus would be omitted. Moreover, there are two built-in centrifuges in the system; STAT (priority) samples can be assigned at anytime even though there may be a batch of samples in progress. The delay processing time of the STAT sample only was at most 3 min when comparing to a single specimen processing in an idle system. The automated system showed an improvement of the workflow by application of barcode recognition system, and the STAT mode function. The most important patient identification issue can be facilitated by advance technology that can greatly decrease the possibility of human error and alleviate the pressure of the operators. 3.7. Turnaround time analysis The processing time for the manual T&S procedure is comprised of several components and includes ABO/Rh(D) typing (30 minutes) and antibody screening (25 minutes). In addition for each assay time is require for staff to manually check sample identification at each stage of the process, record their observations and interpret the results. The minimum turnaround time for manual procedures is therefore 1 hour; this aligns with guaranteed TAT of T&S in local hospitals in Hong Kong. In contrast turnaround time for samples processing by the AutoVue® Innova is 22 minutes. Based on these data the use of AutoVue® Innova for T&S procedures results in at least a 63% reduction in TAT. 4. Discussion Two T&S methods of pre-transfusion testing were evaluated in this project; Ortho AutoVue ® Innova is a fully automated blood banking analyzer whereas the DiaMedID system and manual tile method for blood grouping are manual systems requiring repetitive laboratory procedures. The aim of the comparison is not only to assess the functionality or quality from a technological aspect, the project also aimed to verify that the implementation of the automated system can improve the transfusion safety. In terms of functionality, satisfactory concordance results were revealed in ABO/Rh(D) typing and antibody screening. For detection of irregular clinically significant antibodies, AutoVue® Innova and manual DiaMed-ID micro typing system were found to have comparable sensitivity. With respect to
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efficiency or turnaround time, the minimum reporting time of the automated system was found to be 45% faster than the manual system. In terms of sample identification, barcode recognition of samples during request ordering and processing in the automated system would significantly reduce the errors inherent in manual labeling and transcription. For quality assurance, standardized procedures and interpretation of results can be enhanced by the algorithm of the automated system. A further advantage of the automated system is the incorporated informatics in which detailed inventory control of reagents, cassettes in terms of lot specified, expiry date, validation period can be documented. Images of cassettes, reaction grading and interpretation of result can all be retained and enhance the traceability of records. Bidirectional interface with the laboratory information system can facilitate the request downloading and result uploading for result reporting. This will greatly diminish the chance of transcription error. Operator’s level security can also be assigned to facilitate the management of personnel. Therefore, the automated system is found to be comparable to and in some respects superior to the manual system. The implementation of automated blood bank system can provide a safe, reliable and efficient transfusion service. Moreover, the quality can also be maintained and meet the requirement of various legal guidelines and accreditation authorities. According to the tight budget, extensive expansion of population leading to increasing service demand and as well as shortage supply of qualified staff, hospital blood banks are facing to imminent ordeal for maintaining the quality of service. But, we all know that transfusion services are a loop of services that still hiding series of loop holes and weakest links. In order to overcome these loop holes, to implement new technologies really can help and improve these situations. Hospital management should consider the opportunities to implement the use of the automation systems in hospital blood banking services to improve blood transfusion safety. References [1] Brown MR, Fritsma MG, Marques MB. Transfusion safety: what has been done; what is still needed? MLO Med Lab Obs 2005;37:20–4. [2] World Health Organisation. Improving blood safety worldwide. Lancet 2007;370:361–456.
[3] Davies A, Staves J, Kay J, Casbard A, Murphy MF. End-to-end electronic control of the hospital transfusion process to increase the safety of blood transfusion: strengths and weaknesses. Transfusion 2006;46:352–64. [4] Klouche RM. Impact of automation for testing in transfusion medicine and blood banking. Laboratoriumsmedizin 2008;32:57–8. [5] Dada A, Beck D, Schmitz G. Automation and data processing in blood banking using the ortho AutoVue® Innova System. Transfus Med Hemother 2007;34:341–6. [6] Taylor C (Ed.) CH, Mold D, Jones H, et al, on behalf of the Serious Hazards of Transfusion (SHOT) Steering Group. The 2008 Annual SHOT Report. ; 2009 [accessed 01.07.11]. [7] Barkham TMS. Laboratory safety aspects of SARS at Biosafety Level 2. Ann Acad Med Singapore 2004;33:252–6. [8] Chaffe B, Jones J, Milkins C, Taylor C, Asher D, Glencross H, et al. UK Transfusion Laboratory Collaborative: recommended minimum standards for hospital transfusion laboratories. Transfus Med 2009;19:156–8. [9] Maynard MJ. Ten-hour shifts solved our turnover problem-medical laboratory. MLO Med Lab Obs 1986;18:61–6. [10] Delamaire M. [Automation of the immunohematology laboratory]. Transfus Clin Biol 2005;12:163–8. [11] Turner CL, Casbard AC, Murphy MF. Barcode technology: its role in increasing the safety of blood transfusion. Transfusion 2003;43:1200– 9. [12] Butch SH. Automation in the transfusion science. Immunohematology. Immunohematology 2008;24:86–92. [13] British Committee for Standards in Haematology (BCSH). Recommendations for evaluation, validation and implementation of new techniques for blood grouping, antibody screening and crossmatching. Transfus Med 1995;5:145–50. [14] Census and Statistics Department Hong Kong. Population census – fact sheet for Eastern District Council District. ; 2011 [accessed 08.08.14]. [15] PYNEH Blood Bank Annual Statistics, 2011, Clinical Pathology Department, Pamela Youde Nethersole Eastern Hospital, Hong Kong. [16] Lapierre Y, Rigal D, Adam J, Josef D, Meyer F, Greber S, et al. The gel test: a new way to detect red cell antigen-antibody reactions. Transfusion 1990;30:109–13. [17] Reis KJ, Chachowski R, Cupido A, Davies D, Jakway J, Setcavage TM. Column agglutination technology: the antiglobulin test. Transfusion 1993;33:639–43. [18] Breacher ME. Technical manual. 15th ed. Bethesda, MD: American Association of Blood Banks; 2005. [19] Mollison PL, Engelfreit CP, Contreras M. Mollison’s blood transfusion in clinical medicine. 11th ed. USA: Blackwell Science Ltd; 2005. [20] Scientific Subcommittee Australian & New Zealand Society of Blood Transfusion Ltd. Guidelines for pretransfusion laboratory practice. 5th ed. Sydney, Australia: Australian & New Zealand Society of Blood Transfusion Ltd; 2007. [21] Lim G, Park KS, Park TS, Lee HJ, Suh JT, Park SY. The frequency and distribution of unexpected antibodies in transfusion candidates with the use of the Ortho Biovue System: recent four year experience. Korean J Blood Transfus 2009;20:23–31.
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Contents lists available at ScienceDirect
Transfusion and Apheresis Science j o u r n a l h o m e p a g e : w w w. e l s e v i e r. c o m / l o c a t e / t r a n s c i
An experience of the introduction of a blood bank automation system (Ortho AutoVue Innova) in a regional acute hospital Yuk Wah Cheng a, Jenny M. Wilkinson b,* a b
Blood Bank, Clinical Pathology Department, Pamela Youde Nethersole Eastern Hospital, Hong Kong School of Biomedical sciences, Charles Stuirt University, Wagga Wagga, Australia
A R T I C L E
I N F O
Article history: Received 3 October 2014 Received in revised form 4 February 2015 Accepted 9 March 2015 Keywords: Hospital blood bank Blood bank automation Type & screen Ortho AutoVue® Innova
A B S T R A C T
This paper reports on an evaluation of the introduction of a blood bank automation system (Ortho AutoVue® Innova) in a hospital blood bank by considering the performance and workflow as compared with manual methods. The turnaround time was found to be 45% faster than the manual method. The concordance rate was found to be 100% for both ABO/ Rh(D) typing and antibody screening in both of the systems and there was no significant difference in detection sensitivity for clinically significant antibodies. The Ortho AutoVue® Innova automated blood banking system streamlined the routine pre-transfusion testing in hospital blood bank with high throughput, equivalent sensitivity and reliability as compared with conventional manual method. © 2015 Elsevier Ltd. All rights reserved.
1. Introduction In some clinical situations blood transfusion is the only intervention that is able to save life rapidly; however, blood transfusion is also acknowledged to be a therapy that involves life threatening risk [1,2] and the hospital blood bank plays a key role in safe blood transfusion. Pretransfusion testing involves blood grouping, screening for clinically significant antibodies and compatibility testing and while regulatory guidelines and operational recommendations are designed to minimize risk, laboratory errors remain as a function of human interventions and the number of steps in the testing procedures [3]. Automation of blood banking seems to be the only solution to cope with the sophisticated manual procedures in hospital blood banking [4]. Fully automated analyzers have become an essential component of every discipline in clinical laboratories. The
* Corresponding author. School of Biomedical Sciences, Charles Sturt University, Wagga Wagga, NSW 2678, Australia. Tel.: +612 6933 4019; fax: +612 6933 2587. E-mail address: [email protected] (J.M. Wilkinson).
incorporation of blood bank automation systems can facilitate the reduction of human error, technique standardization, alleviate heavy workload and improve turnaround time (TAT). In addition, a traceable database of laboratory records can be achieved as the image captured in the interpretation of reactions can be stored permanently [5]. The Serious Hazard of Transfusion report (SHOT) [6] also noted that there were a considerable number of errors due to mishandling and storage of blood products. Therefore blood inventory monitoring is also a significant issue in transfusion safety. Some automation systems have installed middleware (e.g. Autovue® Innova installed with Sonet information system) or directly link with the laboratory information system for blood inventory management. From an occupational safety and health perspective, the biological safety of the operators can also be improved by adoption of automated systems with minimal sample handling procedures that reduce the operators’ exposure to potentially hazardous biological materials [7]. In 2009, the UK Transfusion Laboratory Collaborative report emphasized the importance of the staffing requirements and competency of blood bank technologists [8]. Employment of experienced staff with relevant qualifications are legislative requirements in both the UK and Hong Kong; however, recruiting qualified staff especially for work
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in shift non-core hours is increasingly difficult [9]. Since the quality of service cannot be compromised, if automation can take over some of the routine procedures such as pipetting, dispensing of samples and reagents, qualified staff are freed to perform high level skilled miscellaneous tests and also pay more attention in quality assurance. Currently, there are a wide range of automation systems available in automation of serological testing in the transfusion service [10,11]. Selection criteria for an instrument are based mainly on the need of the service and resources. Nevertheless, installation, evaluation, validation, interfacing and training of operators are essential in the implementation of a new automation system [12]. The British Committee for Standards in Haematology (BCSH), Blood Transfusion Task Force announced a recommendation for evaluation, validation and implementation of new techniques for blood grouping and antibody screening [13]. They recommend that when introducing new systems to improve performance the new system should be better than, or as good as, the currently used one. A range of samples and procedures should be tested for the sensitivity, specificity and reproducibility. Parallel comparison with both the new and old systems should be evaluated. Pamela Youde Nethersole Eastern Hospital (PYNEH) is a regional acute hospital located in the Hong Kong Eastern District and served a population of 588,094 in 2011 [14]. The PYNEH provides 24-hour comprehensive hospital services to various specialties such as surgical, internal medicine, orthopedic, and emergency critical care departments. The hospital blood bank is responsible for routine and emergency transfusion service support and provides pre-transfusion testing and various blood product allocations. The PYNEH blood bank performs approximately 18,000 Type & Screen and transfuses 16,000 units of red blood cells annually [15]. Miscellaneous antibody investigation and extra red cell phenotyping service profiles are also provided. Staffing of this service, and hospital policy and budget regarding staffing, is also a consideration, especially during the overnight shift. There are three technical staff during the normal day service hours (9–5 am) and only 1 technical staff on duty during off-hours (after 5 pm until 9 am next working day and during public holidays). In addition at times technical staff may be involved in other tasks such as blood product issuing, telephone enquiries and urgent blood inventory management. The heavy workload and low staff numbers particularly during the night shift present significant workplace challenges when considered in combination with accreditation assessments/requirements, increasing workload due to population expansion and budget restrictions on additional staff. Automation in blood banking services is now widely recognized as a means of quality improvement to ensure efficient and quality transfusion service and to assist in budget management. The aim of this study is to compare the performance of the automated blood bank system (ORTHO AutoVue® Innova, Ortho Clinical Diagnostics, USA) with the manual tile or tube method and DiaMed-ID Micro Typing System (Bio-Rad Laboratories, Switzerland) system in blood grouping and antibody screening for pre-transfusion testing, respectively.
2. Methods 2.1. Sample processing The standard process for sample processing at the time of this study was that routine requests for pre-transfusion tests, referred to as Type & Screen (T&S), are received in the blood bank in an individual bag containing a request form and a blood sample. A laboratory number is assigned and a T&S request is registered in the Laboratory Information System (LIS). The determination of ABO/Rh(D) typing and antibody screening for clinically significant antibodies (Type & Screen) would be completed using the manual tile method and antibody screening by DiaMed-ID Micro Typing System (Bio-Rad Laboratories) manual system. In order to compare the ORTHO AutoVue® Innova (Ortho Clinical Diagnostics) automated system, T&S requests received by PYNEH Blood Bank in the period of 18th October to 12th November, 2010 were analyzed in parallel using both the manual and automated systems. Specific items to be compared were: accuracy, precision, carryover and specificity. Antibody identification determination and titration studies of anti-D reference and 13 commercial antisera were also conducted for assessing the sensitivity of the system. Both the AutoVue® Innova and DiaMed-ID system are applied column agglutination technology (CAT). Crosslinked dextran suspended in optimized buffers was selected as the matrix in the DiaMed-ID system [16], whereas a glass bead microcolumn is used in the AutoVue® Innova [17]. The AutoVue® Innova also uses different types of cassettes for specific purposes; ABO/ Rh(D) cassettes contain anti-A, anti-B and anti-D for corresponding antigen typing to determine ABO/Rh(D) group. Antiglobulin cassettes contain polyspecific anti-human globulin for use in antibody screening or direct antiglobulin test. 2.2. Manual Type & Screen For the manual grouping method and DiaMed-ID system, labeling of testing tiles and tubes, manual pipetting of sample and reagents (Table 1) are done by technicians following standard testing procedures as recommended by the manufacturer and laboratory guidelines. For ABO/Rh(D) determination, a 5% red cell suspension of patient samples is tested against the Seraclone commercial grouping antiserum:
Table 1 Comparison of equipment and reagents used in ABO/Rh(D) typing for AutoVue® Innova and manual method.
Equipment
Cassettes Antiserum (A, B, AB, D) Diluent ABO cells for reverse grouping
AutoVue® Innova
Manual method
Built-in incubator, centrifuge, and auto-reader ABO/Rh reverse cassettes Incorporated in ABO cards Phosphate buffered saline 3% Affirmagen A1, B red cells
Perspex hemagglutination tile, centrifuge – Seraclone Biotest antiserum
5% Pooled ABO cells from HKRCBTS
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Table 2 Manual interpretation of hemagglutination reactions in a scoring system of 0–12 [18]. Grade
Score value
Appearance
Complete 4+w or 3+s 3+
12 11 10
A single agglutinate. No free RBCs detected. Reactivity between scores 12 and 11. Strong reaction. A number of large agglutinates. Reactivity between scores 10 and 8. Large agglutinates in a sea of smaller clumps, no free RBCs. Many agglutinates – medium and small, no free RBCs. Many medium and small agglutinates and free RBCs in the background. Many small agglutinates and a background of free RBCs. Many very small agglutinates with a lot of free RBCs. Weak granularity in the RBC suspension. A few macroscopic agglutinates but numerous agglutinates microscopically. Appears negative macroscopically. A few agglutinates of 6–8 RBCs in most fields. Rare agglutinates observed microscopically. An even RBC suspension. No agglutinates detected.
3+w
or 2+
s
2+
9 8
2+w
7
1+s
6
1+
5
1+w
4
1±
3
(+)
2
(0R)rough 0
1 0
anti-A, anti-B, anti-A,B and anti-D, while ABO cell grouping was used by tile method and Rh (D) determination was used by tube method. Results of hemagglutination reactions are recorded by technicians following a scoring system of 0–12 (Table 2) where 0 is no agglutinates and 12 is a single agglutinate with no free erythrocytes. The results of ABO/ Rh(D) are available after 30 minutes. For the manual DiaMed-ID antibody screening system, procedures involved labeling of cassettes (LISS/Coombs Cards), pipetting of screening cells and patient plasma, incubation and centrifugation. The testing procedures strictly followed the manufacturer’s protocol and used a designated incubator and centrifuge (Table 3). After the final centrifugation step, the total antibody screening result takes at least 40 minutes for completion. The results are read by technologists and interpreted and transcribed on data sheets
Cassettes Diluent Reagent screen cells
ID panel cells Diluent for titration
according to a standard reaction scoring patterns. The scoring rates of the cassette from 0 to 4 with 0 being all erythrocytes pass through the column and 4 that agglutinated cells form a band at the top of the column. 2.3. Automated Type & Screen – AutoVue® Innova The AutoVue® Innova system has built-in robotic pipetting arms, incubator, centrifuge and digital camera. Anti-IgG/C3d polyspecific and ABO cassettes are designated for the T&S purposes respectively. A data terminal is installed for sample processing and analysis of results. Barcode labeled samples are put into a sample rack with ordering of requests done through the data terminal. After request ordering the rack of samples is put into the analyzer, and tests are completed automatically according to the test request worklist. ABO/Rh(D) typing results that require no incubation time are available in 8 minutes. Antibody screening results are available in 22 minutes. The built-in digital camera records images of the cassettes for result interpretation by the data terminal using image processing system software. This software uses a grading algorithm based on a predetermined scoring system as used in manual testing. The Autovue® blood bank system can also accommodate for the bidirectional linkage to the Laboratory Information System (LIS) by means of requests download for test ordering and results upload for the reporting. 2.4. Workflow analysis All hands-on processing steps included in the workflow analysis such as sample labeling, pipetting in manual system or barcode scanning in automated system were counted to compare the efficiency of the both system. 2.5. Throughput analysis
AutoVue® Innova
DiaMed-ID System
Measurement of the turnaround time is based on time from the receipt of blood samples until the result reporting of T&S results. In hospitals with acute care facilities emergency requests for blood transfusion are common and it would be preferable for a system to accommodate STAT samples to facilitate the urgent release of blood for patients. To verify the system can permit a ‘do first’ priority for a urgent request, a STAT sample was assigned into the system during full loading of the analysis cycle and the efficiency of the STAT Mode was measured so as to evaluate the minimal reporting time of an emergency sample.
Built-in incubator, centrifuge, and autoreader (digital camera) Anti-IgG/C3d polyspecific BLISS 0.8% Selectogen I and II and Miltenberger cells from (HKRCBTS) 0.8% Resolve panel A Phosphate buffered saline 6% Bovine serum albumin from DiaMed
ID Incubator 37 SI ID Centrifuge 24
3. Results
Table 3 Equipment and reagents used in antibody screening and identification.
Equipment
3
LISS/Coombs Card ID Diluent 2 0.8% DiaCell Asia I, II, and III (in DiaCell Asia: Cell III represents the Miltenberger cells) 0.8% ID DiaPanel
3.1. Quality assurance and accuracy of the AutoVue® Innova The analyzer produced consistent results in ABO/Rh(D) typing, antibody screening and antibody identification in comparison with manual DiaMed-ID system by means of accuracy, specificity, precision and carryover investigation. There was also an observation that the sensitivity of antibody detection was better in AutoVue® Innova for some antibodies where the detection end points of the respective clinically significant antibodies were higher (Fig. 1).
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Comparison of Titration scores of commercial antiserum in AutoVue and DiaMed-ID System 40 AutoVue
Sum total of titration scores
35
DiaMed-ID
30 25 20 15 10 5 0 C
c
E
e
Fya
Fyb Lea Leb Jka
Jkb
M
N
K
Commerci a l Anti s erum
Fig. 1. Comparison of detection end point of clinically significant antibodies.
3.2. ABO/Rh(D) typing 3.2.1. Accuracy Two hundred and eighteen samples of ABO/Rh(D) typing were performed by the manual tile method and by AutoVue® Innova. There were 65 group A, 60 group B, 74 group O and 19 group AB samples; 7 Rh(D) negative samples were also included. In comparing with the interpretation results, the accuracy rate was 100%. The acceptance criteria included the interpretation results and also the reaction scoring. There were two samples which had weakened but comparable scoring in both the manual and automated systems. These cases were found to be specific patients of old ages (85 and 86 years old) from hematology and oncology specialties where antigen-antibody reactions are known to be weakened [19]. Five ABO subgroup samples provided by Hong Kong Red Cross Blood Transfusion Service (HKRCBTS) were also correlated accurately. 3.2.2. Specificity The concordance rate is 100%. Due to the low percentage of Rh(D) negative cases in Chinese populations, there were only 7 cases of Rh(D) negative samples included during the evaluation period. Among these samples, three of them of known weak D expression identified were specially arranged with HKRCBTS for evaluation. Both of the manual and automated system revealed D negative for those samples. 3.2.3. Precision Precision was verified by performing between run and within run analysis. ABO/Rh (D) typing of pooled A, B, and O cells was tested in three single run a day and run for 5 consecutive days, also 10 aliquots of each group were tested
in a single run. One hundred percent reproducible results were revealed, no discrepant result found. 3.2.4. Carryover Known ABO blood group samples from HKRCBTS were arranged in a repeated sequence of AB, AB, AB, O, O, O, AB, AB, AB, O, O, O for the testing of ABO/Rh(D) typing to rule out the possibility of carryover. No discrepant results were found, therefore no carry over was observed. 3.3. Antibody screening 3.3.1. Accuracy Antibody screening tests of 196 samples were performed by the two methods. One hundred and fifty samples were antibody screening negative and 45 samples were antibody screening positive. One hundred percent concordance rate was obtained. 3.3.2. Specificity The 150 antibody screening negative samples were taken into account for the calculation of specificity. No false positive results were found in both systems. The concordance rate was found to be 100%. 3.3.3. Precision A 0.05 IU/mL anti-D reference was used to perform the antibody screening in three single run a day and run for 5 consecutive days, and 10 aliquots for repeated analysis were prepared for a single run to reveal the reproducibility of the analyzer. No discrepant results were found. 3.3.4. Carryover Antibody screening of neat anti-D and 6% bovine serum albumin in a sequence of anti-D, anti-D, 6% BSA, 6% BSA,
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anti-D, anti-D, 6% BSA, 6% BSA, were performed to rule out the possibility of carryover. No carryover was found. 3.3.5. Sensitivity Ten weak known antibodies scoring ≦1 (in a scoring scale of 0–4) from the DiaMed system were chosen to test the sensitivity of the system. Concordance results of scoring 0.5–1 were reproduced in AutoVue system. Titration studies were performed using doubling dilution of 2.0 IU/mL anti-D reference to produce a reaction score of 1 and 6% bovine serum albumin acted as reagent blank. Guidelines for Pretransfusion published by the Australian and New Zealand Society of Blood Transfusion (2007) stated that the sensitivity of antibody screening system should be capable of detecting anti-D at a concentration of 0.1 IU/ mL or lower [20]. The result revealed that a score value of 0.5–1 was produced by a 1 in 64 dilution and a negative result of score 0 produced by a 1 in 128 dilution. The result implies that the detection limit and sensitivity of the AutoVue system would be as low as 0.03125 IU/mL anti-D. 3.4. Antibody identification Forty-one antibody positive cases from daily patient samples during the evaluation period were selected for the antibody identification comparison. The antibodies included anti-E, anti-c, anti-D, anti-Jka, anti-M, anti-Mi, antiFya and anti-P1. Forty-one (41) results were concordant, only 1 sample which was identified as anti-E in DiaMed system was identified as anti-E by AutoVue with one more unidentified antibody. Since the two systems were using their specific panel cells for the identification of antibodies, the unidentified antibodies from AutoVue result may be because of the panel cells of single donor with a low incidence antigen. 3.5. Titration studies of commercial antiserum Titration of 13 commercial antiserum (C, c, E, e, Jka, Jkb, Fy , Fyb, Lea, Leb, M, N, K) (Biotest, Dreieich, Germany) in doubling dilution with 6% albumin as the dilution blank was performed to evaluate the performance of the two systems in terms of sensitivity of clinically significant antibody detection. The higher dilution or the higher titer detection obtained would be defined as the more sensitive of the system. By adding the total of dilution gradient for each of the antiserum, the sensitivity would be compared. The Wilcoxon–Mann–Whitney test was used to compare the data and showed no statistically significant difference (P = 0.1003) between the titration scores obtained in the 13 antiserum as shown in (Fig. 1). It was concluded that the two systems showed no difference in detection sensitivity for clinically significant antibodies. However, in terms of titer detection, a generally higher detection end point was obtained by the AutoVue® Innova automated system and especially for anti-Lea, anti-Leb and anti-M. The glass bead cassettes of AutoVue® Innova are known to produce more sensitive results for those cold reacting antibodies [21]. For the anti-Jka and anti-Jkb, the big differences of titer were because of the heterozygous expression of DiaMed screening cells and led to lower titer detection. a
5
3.6. Workflow analysis Blood samples and request documents were received in the reception counter of the blood bank and logged. Inspection of samples and request forms, labeling of samples by assigning laboratory numbers was completed upon receipt. Labeling of testing apparatus such as test tubes, grouping tile and AHG cassettes was done as for manual tests. Repeated verification of labeling corresponding to samples and apparatus need time. Moreover, due to the limitation of incubation time and occupancy of centrifuge, random access of samples or ‘one at a time’ would occupy the staff continuously by doing different samples in overlapping time and easy to have confusing of laboratory steps. To streamline the workflow, usually batching of samples would be used. In contrast, using the AutoVue® Inova, ordering of requests can be facilitated by barcode scanning and labeling of apparatus would be omitted. Moreover, there are two built-in centrifuges in the system; STAT (priority) samples can be assigned at anytime even though there may be a batch of samples in progress. The delay processing time of the STAT sample only was at most 3 min when comparing to a single specimen processing in an idle system. The automated system showed an improvement of the workflow by application of barcode recognition system, and the STAT mode function. The most important patient identification issue can be facilitated by advance technology that can greatly decrease the possibility of human error and alleviate the pressure of the operators. 3.7. Turnaround time analysis The processing time for the manual T&S procedure is comprised of several components and includes ABO/Rh(D) typing (30 minutes) and antibody screening (25 minutes). In addition for each assay time is require for staff to manually check sample identification at each stage of the process, record their observations and interpret the results. The minimum turnaround time for manual procedures is therefore 1 hour; this aligns with guaranteed TAT of T&S in local hospitals in Hong Kong. In contrast turnaround time for samples processing by the AutoVue® Innova is 22 minutes. Based on these data the use of AutoVue® Innova for T&S procedures results in at least a 63% reduction in TAT. 4. Discussion Two T&S methods of pre-transfusion testing were evaluated in this project; Ortho AutoVue ® Innova is a fully automated blood banking analyzer whereas the DiaMedID system and manual tile method for blood grouping are manual systems requiring repetitive laboratory procedures. The aim of the comparison is not only to assess the functionality or quality from a technological aspect, the project also aimed to verify that the implementation of the automated system can improve the transfusion safety. In terms of functionality, satisfactory concordance results were revealed in ABO/Rh(D) typing and antibody screening. For detection of irregular clinically significant antibodies, AutoVue® Innova and manual DiaMed-ID micro typing system were found to have comparable sensitivity. With respect to
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efficiency or turnaround time, the minimum reporting time of the automated system was found to be 45% faster than the manual system. In terms of sample identification, barcode recognition of samples during request ordering and processing in the automated system would significantly reduce the errors inherent in manual labeling and transcription. For quality assurance, standardized procedures and interpretation of results can be enhanced by the algorithm of the automated system. A further advantage of the automated system is the incorporated informatics in which detailed inventory control of reagents, cassettes in terms of lot specified, expiry date, validation period can be documented. Images of cassettes, reaction grading and interpretation of result can all be retained and enhance the traceability of records. Bidirectional interface with the laboratory information system can facilitate the request downloading and result uploading for result reporting. This will greatly diminish the chance of transcription error. Operator’s level security can also be assigned to facilitate the management of personnel. Therefore, the automated system is found to be comparable to and in some respects superior to the manual system. The implementation of automated blood bank system can provide a safe, reliable and efficient transfusion service. Moreover, the quality can also be maintained and meet the requirement of various legal guidelines and accreditation authorities. According to the tight budget, extensive expansion of population leading to increasing service demand and as well as shortage supply of qualified staff, hospital blood banks are facing to imminent ordeal for maintaining the quality of service. But, we all know that transfusion services are a loop of services that still hiding series of loop holes and weakest links. In order to overcome these loop holes, to implement new technologies really can help and improve these situations. Hospital management should consider the opportunities to implement the use of the automation systems in hospital blood banking services to improve blood transfusion safety. References [1] Brown MR, Fritsma MG, Marques MB. Transfusion safety: what has been done; what is still needed? MLO Med Lab Obs 2005;37:20–4. [2] World Health Organisation. Improving blood safety worldwide. Lancet 2007;370:361–456.
[3] Davies A, Staves J, Kay J, Casbard A, Murphy MF. End-to-end electronic control of the hospital transfusion process to increase the safety of blood transfusion: strengths and weaknesses. Transfusion 2006;46:352–64. [4] Klouche RM. Impact of automation for testing in transfusion medicine and blood banking. Laboratoriumsmedizin 2008;32:57–8. [5] Dada A, Beck D, Schmitz G. Automation and data processing in blood banking using the ortho AutoVue® Innova System. Transfus Med Hemother 2007;34:341–6. [6] Taylor C (Ed.) CH, Mold D, Jones H, et al, on behalf of the Serious Hazards of Transfusion (SHOT) Steering Group. The 2008 Annual SHOT Report. ; 2009 [accessed 01.07.11]. [7] Barkham TMS. Laboratory safety aspects of SARS at Biosafety Level 2. Ann Acad Med Singapore 2004;33:252–6. [8] Chaffe B, Jones J, Milkins C, Taylor C, Asher D, Glencross H, et al. UK Transfusion Laboratory Collaborative: recommended minimum standards for hospital transfusion laboratories. Transfus Med 2009;19:156–8. [9] Maynard MJ. Ten-hour shifts solved our turnover problem-medical laboratory. MLO Med Lab Obs 1986;18:61–6. [10] Delamaire M. [Automation of the immunohematology laboratory]. Transfus Clin Biol 2005;12:163–8. [11] Turner CL, Casbard AC, Murphy MF. Barcode technology: its role in increasing the safety of blood transfusion. Transfusion 2003;43:1200– 9. [12] Butch SH. Automation in the transfusion science. Immunohematology. Immunohematology 2008;24:86–92. [13] British Committee for Standards in Haematology (BCSH). Recommendations for evaluation, validation and implementation of new techniques for blood grouping, antibody screening and crossmatching. Transfus Med 1995;5:145–50. [14] Census and Statistics Department Hong Kong. Population census – fact sheet for Eastern District Council District. ; 2011 [accessed 08.08.14]. [15] PYNEH Blood Bank Annual Statistics, 2011, Clinical Pathology Department, Pamela Youde Nethersole Eastern Hospital, Hong Kong. [16] Lapierre Y, Rigal D, Adam J, Josef D, Meyer F, Greber S, et al. The gel test: a new way to detect red cell antigen-antibody reactions. Transfusion 1990;30:109–13. [17] Reis KJ, Chachowski R, Cupido A, Davies D, Jakway J, Setcavage TM. Column agglutination technology: the antiglobulin test. Transfusion 1993;33:639–43. [18] Breacher ME. Technical manual. 15th ed. Bethesda, MD: American Association of Blood Banks; 2005. [19] Mollison PL, Engelfreit CP, Contreras M. Mollison’s blood transfusion in clinical medicine. 11th ed. USA: Blackwell Science Ltd; 2005. [20] Scientific Subcommittee Australian & New Zealand Society of Blood Transfusion Ltd. Guidelines for pretransfusion laboratory practice. 5th ed. Sydney, Australia: Australian & New Zealand Society of Blood Transfusion Ltd; 2007. [21] Lim G, Park KS, Park TS, Lee HJ, Suh JT, Park SY. The frequency and distribution of unexpected antibodies in transfusion candidates with the use of the Ortho Biovue System: recent four year experience. Korean J Blood Transfus 2009;20:23–31.
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