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Quality assurance is necessary in blood banking
- 1. Quality assurance inblood banking Dr. Shahida Baloch
- 2. Quality assurance inblood banking • Fitness for purpose Introducing Quality
- 3. Quality is aprocess A continues cycle of Plan Do Check Act (Deming cycle) Quality is an ongoing activity, not a goal to be reached.
- 4. Quality control Checks putsin places to ensure that process, procedures and products meets the quality requirements. (consistency)
- 5. How to startQC Start from today and make a plan for QC.
- 6. The quality requirementsinvolve:- Quality control and proficiency testing Internal and external audits Personnel and organization Premises, equipment and materials Documentation Blood processing Complaints and component recall Investigation of errors and accidents
- 7. Premises- must belocated , designed, constructed and adapted to suit the operation to be carried out.It should include separate areas for :- a) Donor selection b) Blood collection c) Blood processing d) Storage e) Laboratory facilities f) Auxiliary facilities (Supportive facilities) .
- 8. QA IN COLLECTIONOF BLOOD The quality, safety and efficacy of the product transfused is the result of many steps:- – Donor selection – Blood collection – Component preparation – Storage , issue and transportation
- 9. Donor Selection Information collection& evaluation – Consent form – Donor is registered for permanent record – Donor must be checked for possible self harm or potential harm to recipient( list of questionnaires). – Blood Collection: Aseptic technique Seal closed method
- 10. Blood processing After bloodCollection immediate storage at 1-6ºC Components preparation has to be done within 6 hours after collection Labels/Records : ABO and Rh grouping Screening, expiry date and volume of the blood
- 11. Equipment requirements :- Allthe equipment in blood transfusion laboratory should meet mandatory specifications. A written record of periodic function checks and maintenance on each piece of equipment should be mandatory. A preventive maintenance should be planned for trouble free operation. Uninterrupted power supply should be maintained for all the equipment with efficient back-up system. Annual maintenance contract with manufacturers and suppliers should be obtained.
- 12. Equipments Method ofcontrol Frequency of control Control executed by Laboratory refrigerator, freezers, water bath Thermometer, precision thermometer Daily Technician blood bag refrigerators, Freezer containing transfusates Graphic recorder plus independent audible and visual alarm for appropriate high and low temperature parameter Daily Technician Laboratory refrigerator, Freezer, water bath Precision thermometer # For Calibration # Every 6 month Technician Equipments QC
- 13. Equipment Method ofcontrol Frequency of control Control executed Cryofuge Precision RPM meter plus stopwatch to control speed, acceleration and retardation Twice / month Technician Cryofuge Temperature Daily Technician Table centrifuge RPM meter plus stopwatch to control speed, acceleration and retardation Daily Technician Haemoglobin spectrophotometer Calibrate with standard Daily Technician Haemoglobin spectrophotometer Hb- QC Sample Monthly Technician Equipments QC
- 14. Equipment Method ofcontrol Frequency of control Control executed by Cell counter Calibration; reference samples, Daily Technician pH meter Control solution pH 4-7, 7-10 Each time of use Technician Platelet agitator Frequency of agitation Monthly Technician Laminar flow hood Air pressure Daily Microbiologist Laminar flow hood and sterile area filter Particle counter 3 times / Month Microbiologist Equipments QC
- 15. Equipment Method ofcontrol Frequency of control Control executed by Blood mixer Control weighing and mixing Twice /month Engineer Blood bag tube sealer Pressure on bag and tube Every bag and weld Technician Blood transport container Temperature control device Every time on use (on receipt) Technician Equipments QC
- 16. -Control for equipment –Control for reagents – Control for techniques Based upon internal QC and external QC. Internal quality control are subdivided into Color codes for Anti sera by the FDA:
- 17. Quality control forreagents Select the reagent with high specifications- reference preparation has been established for ABO, Rh and anti- human globulin (AHG) by FDA Use according to manufacturer's instruction The new reagent has to be assessed & confirmed satisfactory The appearance each reagent has to be checked each day The reactivity and specificity has to checked each new lot
- 18. Grouping laboratory Parameters tobe checked Minimal requirement for testing Control samples Frequency of control Control executed by ABO Typing Use of Anti A and Anti B duplicate reagent (Monoclonal reagent) One blood sample each of the following: O,A and B Each test series or at least once a day provided the same reagent are used throughout Grouping laboratory
- 19. Parameters to be checked Minimal requirementfor testing Control samples Frequency of control Control executed by Rh- D typing Using 2 anti D sera from different batches, and should be different clones. 1 Rh – D Positive 1 Rh – D Negative Sample Each test series / at least once a day provided the same reagent are used throughout Grouping lab. Anti globulin testing, tube method Washing the cells 3 times before adding anti globulin Addition of sensitized blood cells to negative test Each negative test Grouping lab Grouping laboratory
- 20. Blood Processing andQuality Control No leakage or puncture. • Whole blood Pack Red cell Platelets FFP Cryoprecipitate
- 21. QC of BloodComponents Products Storage Volume W/B 2ºC to 6 ºC 500ml ±50 ml P/C 2ºC to 6 ºC 280ml ± 50ml Platelets 20ºC to 24ºC Volume > 40ml
- 22. QC of BloodComponents Blood Components Frequency of Control Sterility W/B 1% No Growth P/C 1% No Growth Platelets 1% No Growth
- 23. W/B P/C Platelets HCT: 40 ± 5% pH > 6.5 K < 27mmol/L Hb minimum 45g/unit HCT :65% to 75% pH > 6.5 K < 78 mmol/L Hb : minimum 45g/unit Platelet count : at least: 5.5 x 10¹º / bag At least 75% of the units tested at the end of the storage.. pH : 6.8-7.4 WBC contamination: < 2 x 10³/bag RBC contamination: < 2 x 10⁹/bag Macroscopic appearance : no visible platelets aggregates
- 24. FFP CP Every 10unit/week estimate the volume Volume: 220-250ml Storage: 24 months at below –30ºC 12 months at –25 to –30ºC 3 months at –18 to –25ºC Factor VIII : > 70 IU/unit every 2 months Every 10 unit/week estimate the volume Volume : 10-20 ml Storage: 24 months at below –30ºC 12 months at –25 to –30ºC 3 months at –18 to –25ºC Factor VIII : > 70 IU/unit Fibrinogen : > 140 mg per unit
- 25. FFP CP Macroscopic :no abnormal color or visible clots Residual cell: Leukocyte: < 0.1 x 10⁹/l Red cell: < 6.0 x 10 ⁹/l Platelets : < 50 x 10 ⁹/l Macroscopic : homogenous Sterility: no growth
- 26. Transportation W/B 1-10ºC P/C 1-10ºC Platelets20 – 24 ºC Frozen Components –18ºC or colder Maintain cold chain during transportation
- 27. QC OF INFECTIOUSDISEASE TEST To reduce the blood borne infectious disease Does not use assay beyond its expiry date. Storage conditions for samples. Preparation of samples. Test kit manufacturer's controls for every assay Positive and negative control Positive and negative control as test sample.
- 28. – Following manufacturerinstructions for performing an assay – Adequate training – Using sensitive assays to screen samples – IQAS (Internal Quality Assurance System) – EQAS (External Quality Assurance System)
- 29. References Guide to thepreparation, use and quality assurance of blood components, 7th edition, Council of Europe Publishing Technical Manual American Association of blood Banks, 11th edition