Quality assurance in Transfusion medicine Preeyanat Vongchan
QC REQUIREMENTS INVOLVE 1. Instruments 2. Reagents 3. Blood components - component collection - preparation - testing - storage and transport
Processes in blood transfusion Collection Storage Transportation Transfusion http://www.aabb.org/tm/Pages/default.aspx
Errors in transfusion service : 1. Blood sample 2. Blood sampling 3. Preparation, storage, transportation of blood components 4. Reagents and equipment 5. Process of testing
QC REQUIREMENTS INVOLVE 1. Instruments 2. Reagents 3. Blood components - component collection - preparation - testing - storage and transport
Quality control of equipment Objective: To determine the accuracy and precision of the equipment Ø Calibration Process of standardizing an instrument against a known value for accuracy Ø Maintenance Performed to decrease the down-time, avoid costly repair and enhance reliability
Suggested quality control performance interval for equipment 7 Equipment Frequency of QC Refrigerators / Freezers Recorder Daily Manual temperature Daily Alarm system board (if applicable) Daily Temperature chart (review daily) Weekly Alarm activation Quarterly
Suggested quality control performance interval for equipment 8 Equipment Frequency of QC Platelet incubators Recorder Daily Manual temperature Daily Temperature chart (review daily) Weekly Alarm activation Quarterly Ambient platelet storage Every 4 hours
Suggested quality control performance interval for equipment 9 Equipment Frequency of QC Centrifuges/cell washer Speed Quarterly Timer Quarterly Function Yearly Tube fill level (Serofuge) Day of use Saline fill volume (Serofuge) Weekly Volume of antihuman globulin dispensed (if applicable) Monthly Temperature check (refrigerated centrifuge) Day of use Temperature verification (refrigerated centrifuge) Monthly
Suggested quality control performance interval for equipment 10 Equipment Frequency of QC Heating blocks/water baths/view boxes Temperature Day of use Quadrant/area checks Periodically Component thawing devices Day of use pH meters Day of use
Suggested quality control performance interval for equipment Equipment Frequency of QC 11 Blood irradiators Calibration Yearly Turntable (visual check each time of use) Yearly Timer Monthly/quarterly Source decay Depend on source type Leak test Twice yearly Dose delivery check (with indicator) Each irradiator use Dose delivery verification - Cesium-137 Yearly - Cobalt-60 Twice yearly - Other source as specified by manufacturer
Suggested quality control performance interval for equipment 12 Equipment Frequency of QC Thermometers (vs NIST-certified or traceable) - Liquid-in-glass Yearly - Electronic As specified by manufacturer Timers/clocks Twice yearly Pipette recalibration Quarterly
Suggested quality control performance interval for equipment 13 Equipment and reagent Frequency of quality control Sterile connecting device Weld check Each use Function Yearly Blood warmers Effluent temperature Quarterly Heater temperature Quarterly Alarm activation Quarterly
Suggested quality control performance interval for equipment 14 Equipment and reagent Frequency of quality control Blood collection equipment Day of use Whole blood Day of use Agitators Yearly Balances/Scales Gram weight (vs NIST- certified) Quarterly Microhematocrit centrifuge Quarterly Timer clock Yearly Calibration Packed cell volume
Suggested quality control performance interval for equipment 15 Equipment Frequency of QC Cell counters/Hemoglobinometers Day of use Blood pressure cuffs Twice yearly Apheresis equipment As specified by manufacturer - Checklist requirements
QC REQUIREMENTS INVOLVE 1. Instruments 2. Reagents 3. Blood components - component collection - preparation - testing - storage and transport
Quality control of reagents Objective: To ensure that reagent is functioning as expected All reagents should be clearly labeled 1. with lot number 2. expiration date 3. storage temperature 4. manufacturer’s instructions
18 Perform daily QC of antisera used in each day and maintain record • Positive and negative control cells: to ensure that the antiserum is performing as expected • Control cells: prepared by pooling of 3 red cell samples of the same blood group
Suggested quality control performance interval for reagents 19 Equipment and Reagents Frequency Reagents Day of use Red cells Day of use Antisera Day of use Antiglobulin serum Each test run Transfusion-transmissible disease marker testing Day of use Copper sulfate
Daily controls: ABO and Rh blood groups 20 Reagents Control Anti-A A cells, B cells Anti-B A cells, B cells Anti-D Rh+ cells, Rh- cells A cells Anti-A, anti-B B cells Anti-A, anti-B O cells Anti-A, anti-B
Record of QC testing 1. Identification of - personnel performing - reagents (Lot No., expiration date) - equipment 2. Testing date and time 3. Results 4. Interpretation 5. Reviews
Changing lot numbers of antisera } Potency } Used to determine the concentration of antibody in antiserum } Antibody titration (Serial two-fold dilution): semi quantitative method } Titer of ABO antisera ≥ 256 } Avidity } Speed of agglutination of antibody in antiserum } Slide method } Avidity of ABO antisera ≤ 15 seconds
QC REQUIREMENTS INVOLVE 1. Instruments 2. Reagents 3. Blood components - component collection - preparation - testing - storage and transport
Quality Control of Blood Components WHEN and HOW • Should be performed on at least 1% of all components produced /month for all parameters to be measured • If fewer than 100/month, then at least 75% or more of components monitored must meet specifications
Sampling “NOT to be taken from the last part of the tube” 1. Non-destructive sampling methods : usually involve use of pack tubing 2. Mixing of product and stripping of lines : are vital and methods need to be standardized 3. For platelet counts : samples should be taken into a dry ETDA tube to prevent aggregation 4. Sampling methods must be validated : to ensure that they produce consistent samples, regardless of the operator
Visual inspection of blood components Indicators All components RBCs Platelets/FFP Intact and dry packaging x x x Intact ports and/or caps x x x Turbidity x x x Discoloration x x x Bacterial contamination x Hemolysis x Lipemia x Particulate matter x x RBCs in attached segments have the same appearance as RBCs in x bags RBCs contamination
1. Hemolysis http://medind.nic.in/aae/t11/i1/aaet11i1p61.htm http://www.slideshare.net/queueup/visual-inspection-guide-for- blood-compopnents 2. Clots and fibrin strands in RBC unit • Result from the activation of clotting processes and can be a mixture of clotting proteins and platelets. • May appear as small to large dark red or purple masses
White particular matter (WPM) • Non-cellular material and is a normal constituent of blood e.g. platelets, WBC, fibrin and cellular debris. • Lipid-rich material appearing in white color and variable in shape 1. Starry sky or Dandruff : <1mm, 20-50,000 particles/bag (often) 2. Wax, fat or gunk : White mucous 1-6 mm. 20-50 particles/bag (often) 3. Atypical oily bubbles 4. Large yellow white oil slick https://www.veripalvelu.fi/AmmattilaisetSite/Documents/Visual%20assessment%20guide_
WPM in RBCs unit https://www.veripalvelu.fi/AmmattilaisetSite/Documents/Visual%20assessment%20guide_ http://medind.nic.in/aae/t11/i2/aaet11i2p1 en.pdf 75.htm • No risk to patients • Filter out by standard filtration set (140-170 micron) WPM in platelets unit 29
Platelets or platelet concentrate All units should show ‘swirling’ effect ‘Absence of swirling in platelet concentrates is highly predictive of poor post-transfusion platelet count increments and increase risk of bacterial contamination’ http://www.ajts.org/viewimage.asp?img=AsianJTransf usSci_2012_6_2_139_98912_f1.jpg Photograph depicting large fibrinous coagulum in a platelet concentrate
Lipemic plasma and discoloration • Fatty meals before blood donation • Chronic condition i.e. hypercholesterolemia Oral contraceptive pillhttps://www.veripalvelu.fi/AmmattilaisetSite/Documents/Visual%20assessment%20guide_ en.pdf
Quality Control of Blood Components : Volume Volume (mL) =[Wt of bag + blood volume] (gm) – Wt of empty bag (gm) Specific gravity of component Specific gravity • Packed RBC = 1.080 • Platelets = 1.040 • Plasma = 1.030 • Whole blood = 1.050 NOTE!! • Volume should be recorded on all units • Appropriate labels should be attached on
QC of blood component (Thai Red Cross Society 2015) Whole blood Parameter Quality requirement 350/450 mL +10% Volume 49/63 mL Anticoagulants > 33% (ratio anticoagulant: WB = 1.4:10) Hematocrit Sterility By culture
QC of blood component (Thai Red Cross Society 2015) RBCs or packed red blood cells Parameter Quality requirement Volume Hematocrit 150-200 mL red cell <80% Hemoglobin >45 gm/unit (450 mL) >35 gm/unit (350 mL) Sterility By culture
QC of blood component (Thai Red Cross Society 2015) RBC suspension (in additive solution) Parameter Quality requirement Volume 150-200 mL red cell + 100 mL SAG-M Hematocrit 50-70% Hemoglobin 15 gm/dL (>45 gm/unit) Sterility By culture
QC of blood component (Thai Red Cross Society 2015) Leukocyte Poor RBCs (LPRCs) Parameter Quality requirement Hematocrit 50-70% Hemoglobin >40 gm/unit White cells <1.2x109 cells/unit
QC of blood component (Thai Red Cross Society 2015) Leukocyte depleted RBCs (LDPRCs) Parameter Quality requirement Red blood cell recovery >85% of original RBCs White blood cells <1x106 cells/unit (EU, Thai) <5x106 cells/unit (USA) RBC recover (%) = RBC volume (post-filtration) x Hematocrit (post-filtration) x 100 RBC volume (pre-filtration) x Hematocrit (pre-filtration)
QC of blood component (Thai Red Cross Society 2015) Fresh frozen plasma (FFP) Parameter Quality requirement Volume 200-300 mL Stable coagulation factors 200 IU of each factor Fibrinogen 200-400 mg Factor VIII At least 70% of normal fresh plasma Absence of labile factor: wrong temperature storage Absence of both factors: 1) longer storage or 2) delaying in centrifugation
QC of blood component (Thai Red Cross Society 2015) Cryoprecipitate Parameter Quality requirement Volume 10-20 mL Factor VIII >70 IU/unit Fibrinogen >140 mg/unit *von-Willebrand factor 40-70% of the original *Factor XIII 20-30% of the original Parameters marked with an asterisk are not
QC of blood component (Thai Red Cross Society 2015) Platelets from whole blood Parameter Quality requirement Volume 40-70 mL Platelet count >6x1010 /unit pH >6.2 RBC contamination <0.5 mL (<1.2x109 RBCs) For LPPC Quality requirement WBC contamination <0.2x109 /unit No pink/red discoloration on visual inspection
QC of blood component (Thai Red Cross Society 2015) Single donor platelets from apheresis Parameter Quality requirement Volume 250-350 mL/unit Platelet count > 3.0x 1011 pH > 6.4 RBC contamination Traces to 0.5 mL Residual leucocytes <1.0 x 106 To do QC of platelets : at the expiry date of storage
QC of blood component (AABB) Irradiated blood product 25 Gy at the central area of bag and not less than 15 Gy at the other part
Bacterial contamination - Skin flora (resulting from incomplete skin decontamination or a skin plug) - Endogenous bacteremia in the asymptomatic donor - Containers and disposables - Environment
Bacterial contamination (organism involved) Exogenous Normal skin Staphylococcus epidermidis Staphylococcus aureus Diphteroids spp. Micrococcus spp. Pseudomonas spp. 44 Bacillus cereus Propionibacterium acnes Flavobacterium spp. SCACM Conference Jan. 20, 2009
Endogenous Bacterial contamination (organism involved) Osteomyelitis Teeth • Staphylococcus • S. cholera suis • Staphylococcus spp • Streptococcus viridans SCACM Conference Jan. 20, 2009 • Serratia liquefaciens Intestines • Yersinia enterocolitica • Salmonella spp. • Campylobacter spp. 45
AABB ACCREDITATION • AABB Standards for Blood Banks & Transfusion Services, 23rd ed, Effective May 1, 2004 • Implement standard 5.1.5.1: The blood bank or transfusion service shall have methods to limit and detect bacterial contamination in all platelet components. Standard 5.6.2 applies • Standard 5.6.2- Protection Against Contamination: The venipuncture site shall be prepared so as to minimize risk of bacterial contamination. Green soap shall not be used. SCACM Conference Jan. 20, 2009 46
AABB ACCREDITATION • Standard 5.1.5.1.1 (Standard 5.1.5.2, 25th ed, 2008) When a true-positive result is obtained and an appropriate specimen is available, additional testing to identify the organism shall be performed. Additional testing and follow-up shall be defined. Standards 5.2.2 and 7.1 to 7.1.4 apply. • Standard 5.2.2: Donor Notification of Abnormal Findings and Test Results (Standard 5.2.3, 25th ed, 2008) • Standards 7.1-7.1.4: Non-conformances SCACM Conference Jan. 20, 2009 47
AABB ACCREDITATION • Standard 5.6.6.1 (25th ed, 2008) Blood collection containers with draw line (inlet) diversion pouches shall be used for any collection of platelets, including whole blood from which platelets are made. SCACM Conference Jan. 20, 2009 48
Bacterial detection Bacterial detection tests - Three devices are cleared for quality control monitoring of platelet collection process of leukoreduced platelets • BioMeriuex BacT/ALERT® • Pall eBDS (bacterial detection system) • HemoSystems Scansystem™ - Other non approved and non validated methods are also being used to meet the AABB standard for bacterial detection SCACM Conference Jan. 20, 2009
BIOMERIUEX BACT/ALERT® Colorimetric technology/Sensor Culture bottles • CO2 release causes sensor bottle to turn yellow • Instrument measures & detects color change, analyzes data to determine positivity, alerts when positive culture SCACM Conference Jan. 20, 2009
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