Quality control and documentation

1. Quality control and documentation BY Ahmad Shihada Silmi,Msc, FIBMSLecturer of Haematology & Immunology Faculty of Science, IUG

2. Quality Management All activities of the overall management function that: • Determine quality policy objectives • Implement them by means such as quality planning, quality control, quality assurance, and quality improvement within the system.

3. Quality assurance • This describes all the steps taken both in and outside the laboratory to achieve reliable results, starting with the preparation of the patient and collection of the specimen and ending with the correct interpretation of the results.

4. Quality assurance WHO summarized quality assurance as: • " the right result at • right time on • the right specimen from, • the right patient with, • result interpretation based on , • with correct reference data and at • the right price" .

5. QUALITY CONTROL This describes the steps taken by the laboratory to insure that tests are performed correctly.

6. QUALITY CONTROL Is process for assessing the accuracy and precision of a test as the following: • Accuracy : agreement between the best estimate of quantity and its true value. • Precision : it is the agreement between replicate measurements .

7. Objectives of quality Main objectives • To help lab staff to establish, manage and monitor a testing process to assure the analytical quality of the test results . • To determine problems and solved it . • To develop uniform standard of lab.

8. Objectives of quality • To increase lab staff confidence . • To increase client confidence. • Available good database for decisions maker. • Help health planer to improve the programs. • Reduce cost.

9. 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

10. Internal Quality Control ( IQC ) • IQC refers to the set of procedures undertaken by the laboratory staff for the Continuous and immediate monitoring of the laboratory work in order to decide whether the results are reliable enough to be released

11. What is IQC? • The regular testing of quality control [QC] material along with the patient samples • Comparison of the QC results to specific statistical limits [ranges] • Rejection of patient results if QC is outside of limits But does this apply to qualitative tests? If not, Why not?

12. Why do we need Internal Quality Control? Ensure that test results are reliable Ensure that test results are reproducible Control quality of daily routine work

13. External Quality Control ( EQC ) • Is the objective evaluation by an outside agency of the performance by a number of laboratories on material which is supplied specially for the purpose. • Is usually organized on a national or regional basis

14. Why do we need External Quality Assessment? To detect hidden problem To receive help and support To compare our performance with others and improve quality

15. Quality • = Excellence • = Conformance to specifications • = Fitness for use • = Value for the price. • “Totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs [ ISO 8402,2.1:1994]”

16. QC in Blood Transfusion Service

17. Blood Transfusion Service Blood Bank Hospital ? Recipients Donors Safety Precautions Recruit – Screen – Bleed test – process – Xmatch transfuse – follow up Policies Regulation FUNDING Government

18. Quality in blood bank • A simple definition of quality is 'fitness for a purpose'. In blood transfusion service, the primary goal of quality is 'transfusion of safe unit of blood.' The quality system deals with all aspects to ensure that the product or the tested and 'safe unit of blood' is as safe as possible.

19. Objectives of quality in blood bank • Is to ensure availability of a sufficient supply of blood, blood components of high quality with maximum efficacy and minimum risk to both donors and patients. • To ensure maximum efficacy and safety of blood • To determine problems in the whole transfusion chain and solved it .

20. Need for Quality • A failure in the quality of blood collected or screening of donated blood unit can be very serious and may result in fatal consequences. A failure in the quality system can lead to numerous situations which may be potentially dangerous to the patient, i.e. 1- failure to identify the patient correctly 2- wrong sample labeling 3-mix-up of results amongst different patients 4-failure to detect presence of an abnormality in the patient's sample. 5- issue of unscreened blood due to faulty laboratory procedures

21. Quality Assurance in blood bank • In a blood transfusion centre, it means that a management system should exist to look into provision of a safe unit of blood and, if any errors are identified, these should be corrected

22. QC in Blood Bank Technology • Donor services and Blood collection • Blood grouping • Crossmatch & antibody screening • Transfusion • Component preparation • Storage , issue and transportation

23. QC in Blood Bank • Positive and negative controls on all tests • Reverse grouping • Good documentation, SOPs etc • Equipment monitoring, calibration, maintenance

24. Donor selection • Main purpose is to determine whether the person in good health, in order to protect the donor against damage to his/her own health, and to protect the recipient against transmission of disease or drugs which could be detrimental to the patient.

25. 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).

26. Donor selection Old age 17-60 year Hb more than 13.5g% and 12.5g% for female HCT more than 38%for male and 36% for female

27. Preparation for collection • The donation room must be wide with light enough • Equipment must be cleaned, calibrated & checked for performance e.g: a) blood container should be inspected for any defect in anticoagulant solution, moisture or discoloration of the surface of the bag or leakage, b) blood bag refrigerator , centrifuge- need to be checked

28. Blood collection & processing • Aseptic technique • Seal closed method • Immediate storage at 1-6ºC • Components preparation has to be done within 6 hours after collection • Labels/records : ABO and Rh grouping • Screening, expiratory date and volume of the blood

29. QC of blood component preparation • Whole blood: • Frequency of control: 1% of all units with minimum of 4 units per month • Storage :- 2ºC to 6 ºC, for CPDA-1 the storage time is 35 days, CPD & CD2D – 22days.

30. QC of blood component preparation • Volume : 450ml ± 10 % of body volume excluding anticoagulant • HCT : 40±5% • pH > 6.5 • K < 27mmol/L • Sterility : no growth

31. Red cell concentrates • Perform the same assay as for Whole blood on the expiry date • Storage : 2-6º C, for 35 days if prepared from WB collected in CPDA-1 • QC: • Volume : 280ml± 50ml, frequency of control 1% of all units • HCT : 65% -75% • pH > 6.5 • K < 78 mmol/L • Hb : minimum 45g/unit • Sterility : no growth

32. Platelet concentrates: • Prepared within 6H of blood collection • Must evaluate at least 4 platelet preparations monthly for platelet count, pH and plasma volume • Platelets should be selected from each centrifuge in use

33. Platelet concentrates

34. Platelet concentrates: • The Tº at which pH is measured should be the same as stored • Label the volume, the actual volume by measurement must be 10% of the stated volume • Storage : 20-24ºC • Tº should be recorded at least every 4H during storage.

35. Platelet concentrates: QC • Volume > 40ml • pH : 6.8-7.4 • Plt count : at least 5.5 x 1010 /bag • WBC contamination: < 2 x 103/bag • RBC contamination: < 2 x 109/bag • Macroscopic appearance : no visible platelets aggregates • Sterility : no growth

36. Fresh Frozen Plasma • Storage: • 24 months at below –70ºC • 12 months at –25 to –30ºC • 3 months at –18 to –25ºC • Thawed at Tº between 30-37ºC and transfused within 24H after thawing

37. Fresh Frozen Plasma • Macroscopic : no abnormal color or visible clots • Residual cell: • Red cell: < 6.0 x 109/l • Leukocyte: < 0.1 x 109/l • Platelets : < 50 x 109/l

38. Fresh Frozen Plasma • Volume: 220-250ml • Factor VIII : > 0.7IU/ml- every 2 months • No leakage after pressure in plasma extractor, before freezing and after thawing

39. Cryoprecipitate • Assayed on at least 4 bags/ month –for factor VIII • Storage: • 24 months at below –70ºC • 12 months at –25 to –30ºC • 3 months at –18 to –25ºC • Must be thawed at 37ºC and used within 6H

40. Cryoprecipitate • Volume : 10-20 ml • Factor VIII : > 70 IU/unit • Fibrinogen : > 140 mg per unit • Macroscopic : homogenous • Sterility: no growth

41. QC of Blood storage and Transportation Storage :- 2ºC to 6 ºC, for CPDA-1 the storage time is 35 days, CPD & CD2D – 22days. • A system must be use to ensure that all blood and blood components shipped by or received into a blood bank or blood transfusion service have been maintained within T required.

42. QC of Blood storage and Transportation • All liquid RBC components kept at T of 1-10ºC during transport • All component routinely stored at 20-24ºC should be maintain T during shipment

43. Transportation • All frozen components should be transport in frozen state at –18ºC or colder • Periodic T check and documented to ensure the transportation adequate to meet the criteria

44. QC IN BLOOD GROUP SEROLOGY Principle: • The four main blood group A,B,O and AB are determined by forward grouping " cell typing" to detect presence or absence of A and B Antigens on red blood cells with Anti A and Anti B " Antisera" • Rh positive or Rh negative red blood cells are classified by presence or absence of D Antigen which can be detected by Anti D.

45. QC IN BLOOD GROUP SEROLOGY • Blood sample for ABO grouping 1. Type of specimen is whole blood , collected in EDTA tube , 2ml of volume . • We reject the clotting sample , Inadequate identification of specimen. Samples should be stored at 4°C and preferably be tested within 48 hours.

46. QC IN BLOOD GROUP SEROLOGY • 5. Cells from the test sample should be washed in 0.9% normal saline and a 2-5% cell suspension should be prepared

47. QC IN BLOOD GROUP SEROLOGY 1. ABO grouping tests should be done at room temperature 2. Antisera used in the ABO grouping must be used as per the manufacturer’s instructions. 3. Before use all the reagents must be checked grossly to rule out any turbidity or contamination. 4. Tubes, slides, tiles, microplates or gel cards should be labelled properly.

48. QC IN BLOOD GROUP SEROLOGY 6. The glassware used should be dry and clean. 7. Results should be recorded immediately after observation. 8. Concave mirror (agglutination viewer) or microscope may be used to examine reactions that appear negative by the naked eye.

49. QC IN TRANSFUSION PRACTICE • Safety measure :- • Transfusion transmitted diseases • Donor compatibility • Comparing the identity information received from pt with data on the lab certificate of compatibility testing • Checking the certificate of the pt’s blood group against the blood group denoted on the blood unit label • Checking the expiry date • Recording the identity of the pt • Sterility

50. Cont… • Clinical surveillance • Careful observation of the pt during early stage of transfusion is mandatory to observe any transfusion reaction • Transfused blood components on recommended time to avoid compromising clinical effectiveness and safety. • Warming of blood • Warming device used must be controlled and monitored to ensure the correct Tº achieved