23-06-2018, automation in blood banking

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AUTOMATION IN BLOOD BAKING

DR.A.YASHOVARDHAN MD
ASSISTANT PROFESSOR
DEPT. OF TRANSFUSION MEDICINE
NARAYANA MEDICAL COLLEGE, NELLORE
INTRODUCTION
• Safety of blood and blood components is the major concern of every
blood centre.

• Blood centre needs quality systems and state of the art infrastructure
to maintain good laboratory practices in spite of heavy workload.

• safety issues at each & every step (vein to vein).

• To prevent manual errors blood bank should preferably have


automation.
ADVANTAGES
• Avoids phlebotomy failures.

• Required component collection. (Apheresis)

• Decreasing human errors in sample identification which has often been


quoted as a significant cause of near miss events and transfusion
reactions due to mismatched blood transfusion.

• Reducing human errors while performing tests and subjective variations


during interpretation of results.
• Preventing transcription errors during documentation of results.

• Improving objectivity, reproducibility, and storage and retrieval of


results of tests.

• Improving traceability of all variables during testing including,


samples, reagents and operating staff.

• It reduces manual input and therefore results in manpower


economy.

• High throughput devices with lesser turnaround time improve the


quality of services in large tertiary care settings.
AREAS – AUTOMATION
• Donor section
• Hemoglobin estimation
• Blood pressure measurement
• Phlebotomy
• Blood collection
• Apheresis

• Lab I
• Grouping, Crossmatching, antibody screening

• Lab II
• TTI Screening

• Component preparation
• Component extractors

• Documentation
• Blood Bank Software
HEMOGLOBIN ESTIMATION
BLOOD PRESSURE
PHLEBOTOMY
• Drawing donor's blood is a challenge – difficult veins – multiple
punctures required

• Vein illumination device uses near infrared light to illuminate


subcutaneous veins on skin surface.

• AccuVein, VeinViewer, Venoscope and Veinite are some of the


major brands available in the market.
BLOOD COLLECTION
• Blood component quality depends on methodology used for whole
blood collection.

• RDP can be prepared if 450 ml of blood collected with in 7 minutes.

• Automatic Blood Collection Monitor (BCM) or blood mixer help in


good quality blood collection
• Portable & easy to carry (use in camps)
• Proper mixing of blood with anticoagulant
• Adjust volume of blood collected
• Flow of blood can be monitored (if flow < 15ml/min it warns,
usual rate 50-70ml/min)
APHERESIS
• Required component can be collected and remaining blood is
returned to donor.

• Components collected
• Platelets
• Red cells
• Plasma
• Stem cells
• Granulocytes , monocytes etc.,
ADVANTAGES OF APHERESIS
• The product quantity is more hence full effective dose of
component is given at a time.

• There is a reduced multiple donor exposure thus reducing risk


of alloimmunization and transfusion transmitted infections.

• Leucoreduction good.

• Purity and quality of the product is better than the manually


collected component.
• The instruments for apheresis based on centrifugation
• Intermittent flow
• Haemonitics Corporation (MCS-LN9000/MCS-LN8150)
• Continuous flow
• Baxtrer (CS-3000/Amicus)
• Fresenius Kabi (Com.Tec)
• Caridian BCT (Trima Accel)
• Terumo BCT (COBE Spectra & Optia)

• Based on needle access


• Single needle
• Double needle
GROUPING, CROSSMATCHING
& ANTIBODY SCREENING
• Conventional tube techniques though a gold standard for
immunohematological testing, but it carries some limitations
• Sample identification errors.

• Variability in red cell concentration in red cell suspension which


affects the antigen to reagent/antibody ratio.

• Elution of low affinity antibodies during the washing by centrifugation.

• Lack of consistency in reading agglutination reaction.

• Human errors
• Interpretation of results
• Transcription errors while documentation

• Turn Around Time (TAT) for grouping and cross matching reduced
• Automation in immunohematology have following advantages
• Barcode system – sample identification errors
• Prevent human errors in interpretation of results
• Prevention of transcription errors – compatible with LIS & HIS

• Automated machines classified


• Based on automation
• Semi automated
• Fully automated

• Based on technology
• Column Agglutination Technology (CAT)
• Bio-rad, Biovue, Autovue, Orthovision, Grifols
• Solid Phase Red Cell Adherence Assay (SPRCA)
• Immucor
• Erythrocyte Magnetized Technology (EMT)
• Diagast
• Semi Automated Technology (Usually in CAT)
• Biorad
• BioVue

• The major issue that remains with semi-automated systems is the


lower level of safety features than those available in fully automated
systems
• Scope of human errors due to manual steps involved in sample
labeling, dilution, reagent addition, and interpretation of results.

• Lack of interfacing with hospital information systems (HIS) in


some of the equipment's may lead to manual transcription errors
while handling the data.
ELECTRONIC CROSSMATCHING
• Computer cross-matching is an efficient and safe method for assigning
blood components, based on Information Technology applied to typing
and screening.

• The computer or electronic cross-match replaces the immediate spin


crossmatch for detecting ABO incompatibility.

• It is essentially a computer assisted analysis of the data entered from


testing done on donor unit and blood samples drawn from intended
recipient.

• Based on the barcode of the accepted sample, the software prevents the
allocation of ABO incompatible blood.

• The software allocates a unit, choosing the one that is most compatible
with regards to ABO/Rh blood groups and closest to the end of its shelf-
life.
TTI SCREENING
• Platforms used for TTI Screening
• Semi Automated
• ELISA

• Fully Automated
• ELISA (Enzyme Linked Immunosorbent Assay)
• Bio-rad (EVOLISA), Biomerieux,
• CLIA (Chemiluminescence Immuno Assay)
• Vitros, Abbott Architect, Roche-Cobas
• NAT (Nucleic Acid Amplification Assay)
• Minipool NAT – Cobas Taq Screen - Roche
• ID NAT – Procleix, Ultrio Assay (Chiron Corporation
Automation)
ELISA
CHEMILUMINISCENCE
NAT
• NAT tested blood increases blood safety decrease in window
period
• Simultaneously tests the presence of viral nucleic acid
(RNA/DNA) of HIV, HBV, HCV.
COMPONENT EXTRACTOR
• Manual Blood Component processing is a tedious process involving
many operations such as centrifugation, component separation etc.

• Semiautomatic equipment is available for separation of plasma, red


blood cells (RBC), platelets, with the advantage of leukoreduced
products.

• These component processors use top and bottom or top and top blood
bag system. Different models are Optipress manufactured by Baxter
Healthcare Corporation, Compomat G4 of Fresinius Kabi, T-ACE of
Terumo Penpol and Dual Press of JMS Co Ltd.

• An automated cell processing system ACP 215 has been


manufactured by Haemonetics Corporation for RBC washing
BLOOD BANK SOFTWARE
DECISION - AUTOMATION
• Location of blood bank • Back-up for automated
equipment

• Semi or Fully Automated


• Staff Training

• Cost Issues
• Sample Collection and
Sample Flow
• Feedback from users

• Validation of Equipment
• HIS/LIS interfacing

• Continuous Quality
Assurance
COST ISSUES
• Automation in blood bank is expensive and initially requires large
investment.

• Workload substantial – Reagent Rental Agreement

• Initial investment
• Space – restructuring room
• Reagent storage – refrigerator, shelves
• Furniture, UPS
• Hard ware and software for interfacing with HIS

• Cost per test usually decreases as the number of samples processed


increases.
FEEDBACK FROM USERS
• Actual user provide useful information.

• Information
• Installation issues
• Time taken for completion of installation
• Air conditioner, electrical refitting etc.,
• After sales Service Support
• TAT of service Call
• Competency of vendors service staff
• Staff training
• Reagent Supply chain
• Down time due to delay in receiving reagents from vendor
• Gap between receiving reagent & expiry
• Cold chain maintenance
HIS/LIS INTERFACING
• The instrument installed should be compatible with HIS/LIS of the
hospital / institute.

• An agreement with the vendor regarding the interfacing should be


done during negotiations.

• Delay in interfacing - The customer should not take full advantage of


automation in terms of decreased documentation
BACK-UP FOR AUTOMATED
EQUIPMENT
• Equipment will invariably have down time

• Most of the vendors provide semi-automated equipment as back-up


usually suites for moderate work load, but fully automated equipment
is better option.

• The staff must trained both on regular and backup equipment.

• This can be achieved by assigning certain category of tests to be on


backup equipment.
STAFF TRAINING
• Training of staff is an important component while introducing a new
laboratory technique or technology

• Protocols for staff training must be discussed and planned with the
vendor beforehand in a manner so that the routine patient care does
not suffer.

• A comprehensive training program, is given to staff to make full use


of the new technology; otherwise the staff is often overwhelmed by
the new technology and tends to fall back on traditional methods of
testing.
SAMPLE COLLECTION
&SAMPLE FLOW
• Automated systems may have stringent sample requirements to be
loaded on to the system.

• It may not be possible to bring out uniformity if samples are


receiving from other hospitals.

• New SOPs (standard operating procedures) and workflow charts


should be designed with the requisite information to be circulated in
that area.
VALIDATION OF EQUIPMENT
• The purpose of validation of an automated system is to test the
competence of an automated system and demonstrate control
over the processes executed by the automated system.

• It is also to ensure compliance to the accuracy and safety


standards and enhance knowledge regarding maintenance
and calibration of the equipment.
CONTINUOUS QUALITY
ASSURANCE
• To continuously maintain the quality of work and improve
performance a continuous appraisal of the following should be
done –
• Audit of equipment

• Optimization of reagent inventory

• Staff competence in performing procedures

• Audit of results & down time


CONCLUSION

• Automation – improves quality of services by reducing human


errors.

• Choosing automation is based on workload – for proper


utilization of available resources

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