Presentation Transcript

1. No shortcuts to evolution: A holisticlaboratoryapproach to bloodsafety Dr. NeelamMarwaha, M.D., F.A.M.S, F.I.S.H.T.M. Professor& Head Department of Transfusion Medicine, PGIMER, Chandigarh
2. Shortcuts on keyboard may be fineShortcuts elsewhere brew trouble
3. Establishment of a well-organized, nationally coordinatedblood transfusion service that can provide adequate and timely supplies of safe blood for all patients in need; Collection of blood only from voluntary unpaid blood donors at low risk of acquiring transfusion-transmissible infections, and stringent blood donor selection criteria; Testing of all donated bloodfor transfusion-transmissible infections, blood groups and compatibility; Production of blood componentsto maximize the use of donated blood and enable the provision of therapeutic support for patients with special transfusion requirements; Comprehensive quality system covering the entire transfusion process, from donor recruitment to the follow-up of recipients of transfusion Appropriate clinical use of blood and the use of alternatives, where possible, to minimize unnecessary transfusions;
4. Change in the Blood Banking Scenario Blood banks to Departments of Transfusion Medicine Introduction of Cord blood banks and Stem cell therapy Slides to Automation in grouping & compatibility testing Blood bottles to Multiple Blood Bags with integral filter Whole blood to Blood Components Single donor apheresis Specialised products ( Leucodepleted ,irradiated,washed,pooled) Basic TTI Screening tests to NAT testing Simple Blood storage to Specialized blood storage systems Simple Freezer to Blast Freezer
5. No Yes Disposal, Donor notification Inventory, Storage Key activities in blood transfusion services Requisition Quality Practice
6. Holistic approach in laboratories
7. Laboratories Area for receiving samples from donors and requests from wards Blood Group Serology Crossmatch and Issue TTI Testing Blood Component Preparation Quality Control Training
8. Laboratory Staff Minimum employed as per Drug Rules Director / MO - in charge Q manager – not yet a req. of Drug rules Technical Supervisor Technician /s Lab Attendant/s Adequate staff / no pendency of work / no undue delays
9. Standard operating procedures SOPs are an essential part of the quality system SOPs should be written for all the procedures through team work SOPs must be clear, concise and easy to follow Staff should be trained to use SOPs SOPs should be validated SOPs should be reviewed and updated regularly Staff must have easy access to the SOPs SOPs must be followed
10. Equipment Management Program Maintains a high level of performance Reduces interruption of services due to breakdowns and failures Lowers repair costs Lengthens life of instrument Provides greater reliability of results

11. Red Cell Serology

12. Serological tests in blood banks ABO grouping and Rh typing Weak D or Du testing Antibody detection and identification Cross matching Antibody titration Direct antiglobulin test Haemagglutination inhibition test
13. Immunohematology testing
14. Effects of alloantibodies
15. Blood Grouping: Manual to Automated Work Area: Shifting of grouping lab Sample collection: 3 clotted pilot tubes to 1 ACD and 1 clotted Centrifugation: Essential step now Barcode labelling: Essential additional step Reagents:More stringent inventory management Training: Test runs, interpretation, troubleshooting, validation Staff change: Two senior technicians Duty hours: To balance workload and throughput Results:Change in format of documentation
16. Managing test errors Clerical errors Mislabeled tubes Patient misidentification Inaccurate interpretations recorded Computer entry error Reagent or equipment problems Using expired reagents Using an uncalibrated centrifuge Contaminated or hemolyzed reagents Incorrect storage temperatures Procedural errors Reagents not added Manufacturer’s directions not followed RBC suspensions incorrect concentration Cell buttons not resuspended before grading reaction
17. Reagents e.ggrouping antisera Define expectations - quantity required (annual demand) - one time supply / in instalments - technical specifications - documentary support e.g. approval from DCGI / NIB, - original reagent inserts - cold chain maintenance
18. Department of Transfusion Medicine, PGIMER, Chandigarh Quality Control Report of Anti A monoclonal antisera 30-12-11 Remarks: Anti A monoclonal antisera from _M_ does not meet the required Q.C. criteria (DGHS technical manual) and are not found to be satisfactory. Signed by: 1 2 3 Signature of HOD

19. Safety from Transfusion Transmissible Infections

    Prion disease
20. Essential elements governing TTI testing Quality of the specimen used for testing Quality of kits used for testing Calibration and validation of equipment used Use of SOPs for testing Type of Controls used while testing Interpretation of results Validation of results Record keeping- kits,results Training of staff-induction, refresher
21. Controls
22. Levey-Jennings Chart -Record and Evaluate the Control Values +3SD +2SD +1SD Mean -1SD -2SD -3SD Day Look for trends, shifts and random errors
23. Window Period Infection HIV Ab Negative HBsAg Negative Window Period HCV Ab Negative Detection by Serology markers
24. 4th generation ELISA Simultaneous detection of both antigen and antibody HIV HIV P24 antigen Anti-HIV1 and HIV2 antibody HCV Capsid core antigen Anti-HCV capsid antibody
25. Window Period Closure * Sources: (1) Busch et al. Transfusion. 2005;45(2):254-264. (2) Kleinman and Busch. J Clin Virol. 2006;36:S23-S29. (3) Data on file at Chiron, Novartis Vaccines and Diagnostics, Inc.
26. Current Risk Estimates
27. Platelet PGD test Blood bag with diversion pouch Safety from bacterial contamination : an issue of concern Rapid, qualitative immunoassay for the detection of aerobic and anaerobic Gram-positive and Gram-negative bacteria in leukocyte reduced apheresis platelets (LRAP) .

28. Blood Component Preparation and Special Processing

29. Planning a component lab Type of hospital and bed strength Trained manpower Adequate AC space (+ 50 m2) Trained SOPs QC program Equipment License from Regulatory authorities Double, triple or quadruple bags
30. Critical Control Points : Donation Strict guidelines for selection of blood donor Adequate disinfection of venipuncture site Single non-traumatic venepuncture Blood and anticoagulant mixing Volume of blood collected Total time of collection No aspirin in 48 hrs. -Platelets 31
31. Critical Control Points:Pre-processing Storage conditions for blood prior to component preparation- (cold chain:4/ 20-240 C) Time restrictions for processing (6 hours)
32. Critical Control Points:Processing Validated equipment and program Refrigerated Centrifuge 1. Time, speed, temperature 2. Monitor QC results in components prepared in each centrifuge Trained personnel
33. Critical Control Points: Post-processing Proper storage temp. Quarantine Labeling and releasing product from quarantine for issue Separate storage: positive for TTI, their disposal and record of discarded units
34. Leukodepletion - How far 104 105 106 107 108 109 1010 G, M NHFTR M, B Alloimmunization CD4+ HTLV-1 G, M, L CMV GVHD CD4+, CD8+ : High occurrence : Unknown : Preventable G: Granulocytes M : Monocytes L : Lymphocytes B : Lymphocytes-B Transfusion Reaction (WBC-associated)
35. Documentation The job is not done until the paperwork is complete Do what is documented; document what you do It is a legal requirement
36. Why Documentation To ensure: Consistency Reproducibility Traceability Efficiency Who performed the test? When was it done? What method was used? What were the results? Who approved the results?
37. “Challenges are what make life interesting;Overcoming them is what makes life meaningful”Joshua J. Marine THANK YOU