quality control in blood banking

quality control in blood banking

1. Quality assurance in blood banking

2. Quality is a process Quality is an ongoing activity,

3. Quality control Checks puts in places to ensure that process, procedures and products meets the quality requirements. (consistency)

4. How to start QC Start from today and make a plan for QC.

5. The quality requirements involve:- 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

6. RBB must be located , designed, constructed and adapted to suit the operation to be carried out.It should include separate areas for :- Donor selection Blood collection Blood processing Storage Laboratory facilities ( Supportive facilities) .

7. QA IN COLLECTION OF 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

8. 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

9. Blood processing After blood Collection immediate storage at 1-6 º C 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

10. Equipment requirements :- All the 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 .

11. Equipments Method of control Frequency of control Control executed by Laboratory refrigerator, freezers, water bath Thermometer, precision thermometer Daily Technologist blood bag refrigerators, Freezer containing transfusates Graphic recorder plus independent audible and visual alarm for appropriate high and low temperature parameter Daily Technologist Laboratory refrigerator, Freezer, water bath Precision thermometer # For Calibration # Every 6 month Technologist Equipments QC

12. Equipment Method of control Frequency of control Control executed Cryofuge Precision RPM meter plus stopwatch to control speed, acceleration and retardation Twice / month Technologist Cryofuge Temperature Daily Technologist Table centrifuge RPM meter plus stopwatch to control speed, acceleration and retardation Daily Technologist Haemoglobin spectrophotometer Calibrate with standard Daily Technologist Haemoglobin spectrophotometer Hb- QC Sample Monthly Technologist Equipments QC

13. Equipment Method of control Frequency of control Control executed by Cell counter Calibration; reference samples, Daily Technologist pH meter Control solution pH 4-7, 7-10 Each time of use Technologist Platelet agitator Frequency of agitation Monthly Technologist Laminar flow hood Air pressure Daily Microbiologist Laminar flow hood and sterile area filter Particle counter 3 times / Month Microbiologist Equipments QC

14. Equipment Method of control Frequency of control Control executed by Blood mixer Control weighing and mixing Twice /month BM Engineer Blood bag tube sealer Pressure on bag and tube Every bag and weld Technologist Blood transport container Temperature control device Every time on use (on receipt ) Technologist Equipments QC

15. -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:

16. Quality control for reagents Select the reagent with high specifications- reference preparation has been established for ABO, Rh and anti-human globulin (AHG) 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

17. Grouping laboratory Parameters to be checked Minimal requirement for testing Control samples Frequency of control Control executed by ABO Typing Use of Anti A and Anti B duplicate 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

18. Parameters to be checked Minimal requirement for 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

19. Blood Processing and Quality Control No leakage or puncture. Whole blood Pack Red cell Platelets FFP Cryoprecipitate

20. QC of Blood Components Products Storage Volume W/B 2 ºC to 6 º C 500ml ±50 ml P/C 2 ºC to 6 º C 280ml ± 50ml Platelets 20 ºC to 24 º C Volume > 40ml

21. QC of Blood Components Blood Components Sterility W/B No Growth P/C No Growth Platelets No Growth

22. FFP CP Every 10 unit/week estimate the volume Volume: 220-250ml Storage: 24 months at below –30 º C 12 months at –25 to –30 º C 3 months at –18 to –25 º C Factor VIII : > 70 IU/unit every 2 months Every 10 unit/week estimate the volume Volume : 10-20 ml Storage: 24 months at below –30 º C 12 months at –25 to –30 º C 3 months at –18 to –25 º C Factor VIII : > 70 IU/unit Fibrinogen : > 140 mg per unit

23. FFP CP Macroscopic : no abnormal color or visible clots Residual cell: Leukocyte: < 0.1 x 10 ⁹ /l Red cell: < 6.0 x 10 ⁹ /l Platelets : < 50 x 10 ⁹ /l Macroscopic : homogenous Sterility: no growth

24. Transportation W/B 1-10 º C P/C 1-10 º C Platelets 20 – 24 º C Frozen Components –18 º C or colder Maintain cold chain during transportation

25. QC OF INFECTIOUS DISEASE 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.

26. Following manufacturer instructions for performing an assay Adequate training Using sensitive assays to screen samples IQAS (Internal Quality Assurance System) EQAS (External Quality Assurance System)