TRAINING CHECKLIST FOR BLOOD BANK This form should be completed by the TRAINEE EMPLOYEE NAME: DATE OF TRAINING STARTED: 1. Read the SOPs and Manuals specific to this training program. Document date completed with trainee initials. SOP NO: SOP Title Date Completed Trainee Initials Yes No Yes No 2. Please Tick the appropriate box to the right Training Method Explanation Lectures Demonstration Practice Computer based Self study Training Materials SOP Manuals Package Inserts Book Lecture Hand outs Computer Program Handouts Videotape (s) Practice materials Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 1 of 12 Training checklist Training Element SOP: Discussed Observed Performed Proficiently Blood and Blood Components Temperature requirements during transport for RBCs and blood components Monitoring of transport temperatures Inspection on receipt o Visible abnormalities o Expiration date o screening platelet components for bacteria o documentation of this process includes the following: 1) date of inspection 2) donor identifying number 3) description of any visual abnormalities 4) action taken 5) identity of the staff performing the inspection Temperature requirements during storage Monitoring of storage temperatures Expiration date Storage Processing o Thawing FFP and Cryoprecipitated AHF o Quality control procedure to indicate functions for any thawing device. Request for transfusion Acceptance criteria for transfusion requests o Recipient identification o Kind and amount of blood component request o Special requests eg. irradiation o Physician name o Phlebotomist identification o Other information Verbal requests o When can be accepted o How to be documented Recipient’s Blood Specimens Specimen labeling o Two dependent patient identification o Collection date o Identical labeling of all tubes o Phlebotomist identification Compare information on the label and pretransfusion request form. o Should be identical Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 2 of 12 Training Element SOP: Discussed Observed Performed Proficiently o In case of discrepancy or doubt, another sample should be obtained Type of specimen Type of specimen for neonates Special considerations for incompletely clotted serum specimens: False positive results Addition of thrombin or protamin sulphate Specimen Age Storage of blood samples: Rrecipient samples and a segment from the donor red cell containing component should be stored at refrigerated temperatures for seven days after transfusion. Testing of Recipient’s Blood Specimen ABO group Principle Specimen Reagents Procedure for Testing RBCs o RBC washing o RBC suspension o Preparation of 2-5% o Type and size of tubes used for the test o No. of drops of antisera to be added o No. of drops of RBCs suspension to be added o Mixing o Centrifugation time & force (speed) o The proper way of resuspending cell buttons to examine for agglutination o How to read and the grade result o Interpretation of the result o Recording the result Special Cosiderations for Testing Serum o No. of drops of patient serum to be added o No. of drops of reagent cells to be added o Compare test results of forward grouping with those obtained by reverse grouping Quality Control Interpretation Causes of Discrepancies between RBC and serum tests Resolving ABO discrepancies If discrepancy is detected and transfusion is necessary before resolution only group O RBC’s shall be issued. Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 3 of 12 Training Element SOP: Discussed Observed Performed Proficiently Tube test for Determination of Rh (D) Testing Principle Reagents Procedure Control Interpretation: o D-positive o Weak-D o False positive reactions o False negative reactions Test for weak-D Principle Reagents o Reagent anti-D o Antihuman globulin reagent o IgG- coated red cells Procedure Type and size of tubes used for the test Control Interpretation o In case of invalid interpretation of the weak D test and if the specimen is from a potential transfusion recipient, Rh-negative blood should be given. If the specimen is from a donor, the unit should not be used for transfusion. o Causes of false- positive and false-negative indirect antiglobulin tests o Confirmation of negative test result. Antibody Detection Test Reagents Type and size of tubes used for the test Procedure o Incubation at 37ºC o LISS Indirect antiglobulin test Test reaction: o Reading o Grading o Recording o Confirmation of negative IAT results Quality Control: o Daily check with weak examples of antibody e.g. weak human IgG anti- C and weak human IgG anti- E o Confirmation of negative LISS Indirect antiglobulin test result. Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 4 of 12 Training Element SOP: Discussed Observed Performed Proficiently Action to be taken when clinically significant antibodies are detected Situations for the need to collect a sample from the patient within three days of the scheduled transfusion (Day 0 is the day of draw) Special considerations for neonates Direct Antiglobulin Test Principle Specimens Reagents Type and size of tubes used for the test Procedure Controls Interpretation The use of IgG coated RBCs Causes of false results How to resolve false results The use of monospecific antihuman globulin (anti IgG) and anti complement antisera. Comparison of Current and Previous Test Results ABO grouping and Rh typing performed during the past 12 months Difficulty in blood typing, clinically significant antibodies, significant adverse events to transfusion unit & special transfusion requirements. Gel Agglutination Technology Principle Specimens Materials ABO Typing Procedure Rh Typing Procedure Antibody Detection Procedure o Centrifugation of serum or plasma that has been stored frozen o Inspection of microtubes o Preparation of 0.8% RBCs suspension o The use of disposable calibrated transfer pipettes to deliver red cell suspension and serum/ plasma o Incubation of cards o Centrifugation process o Reading microtubes for agglutination o Interpretation of test reaction ( negative result, reaction grading & mixed reaction) Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 5 of 12 Training Element SOP: Discussed Observed Performed Proficiently o False results and interfering factors Direct Antiglobulin Test Procedure Compatibility Test Procedure Testing of Donor RBCs ABO Group Confirmation Rh type confirmation for Rh negative RBC units Discrepancies should be reported to KCBB and should be resolved before issue of blood for transfusion purposes. Selection of Donor RBC Unit and Components ABO & Rh type of whole blood or RBC components to be transfused to the patient ABO group of RBCs free components Special considerations for neonates Selection of compatible blood and components in special circumstances o Leukocytes-reduced components o Cytomegalovirus o Irradiation (patient at risk of transfusion associated graft versus host disease, donor is blood relative to the recipient or the donor is selected for HLA compatibility by typing or cross matching) o Hemoglobin S negative RBC or whole blood o Massive transfusion (patient has received an amount of blood approximating the total blood volume) Compatibility Testing (Crossmatch) Serologic o Immediate spin (Its significance) o Incubation at 370C o IAT Type and size of tubes used for the test The use of autocontrol Crossmatch for urgent blood transfusion Interpretation of crossmatch results Causes for incompatible immediate spin crossmatch Causes for incompatible indirect antiglobulin crossmatch Causes for positive antibody screen and compatible crossmatches, negative autocontrol. Electronic/computer crossmatch Labeling of blood or blood components with the recipients identifying information Two independent identifiers for the intended recipient Donor donation identification number Interpretation of compatibility testing Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 6 of 12 Training Element SOP: Discussed Observed Performed Proficiently Issuing blood or blood components Final inspection of blood components and derivatives before issue Presence of a final check of transfusion service records and each unit of blood or component o The intended recipient’s two independent identifiers, ABO group and Rh type. o The donor identification number, ABO group and Rh type o The interpretation cross match test o Special transfusion requirements o The date and time of issue The process to confirm agreement of the identifying information, the records, blood or component and the request. Resolving discrepancies Reissuing Blood and Components Conditions for reissuing blood and components that have been returned to the lab o Container closure has not been disturbed o All components maintained at the appropriate temperature o At least one sealed segment of integral donor tubing has remained attached to the container. Removed segments shall be reattached only after confirming that the tubing identification numbers on both the removed and the container are identical. o The records indicate that the blood or component has been inspected and that it is acceptable for reissue Urgent Requirement for Blood Components RBCs ABO group to be transfused to the patient o Recipients whose ABO group is not known shall receive O RBCs o If blood is issued before completion of compatibility testing, ABO type of RBCs or whole blood Should be compatible with the recipient’s ABO group that has been determined The container tie tag or label: should indicate clearly that compatibility and/or infectious disease testing was not completed at the time of issue Compatibility testing: should be completed quickly using a patient sample collected as early as possible Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 7 of 12 Training Element SOP: Discussed Observed Performed Proficiently Records: should contain a signed statement from the requesting physician indicating that the clinical situation was sufficiently urgent to require release blood before completion of compatibility testing or infectious disease testing The transfusion service medical director and the recipient’s physician should be notified immediately of abnormal test results that may affect patient safety. Quality Control Testing Refrigerator Alarms Testing Freezer Alarms Monitoring Temperature During Shipment Calibrating a Serologic Centrifuge for: o Immediate Agglutination o Washing and Antiglobulin Testing MONITORING BLOOD UTILIZATION AUDIT PROCESS TO MONITOR TRANSFUSIONS Transfusion Reactions Identification of a Transfusion Reaction Clinical Evaluation and Management of Transfusion Reactions (Patient and Component-focused steps) Standard Laboratory Investigations of Transfusion Reactions 1. Clerical check of the component bag, label, paperwork, and patient sample. 2. Repeat ABO testing on the posttransfusion sample. 3. Visual check of pre- and posttransfusion sample to look for evidence of hemolysis (hemolysis may not be visible if <50 mg/dL of hemoglobin is present). 4. Posttransfusion sample direct antiglobulin test (DAT). (If positive, DAT should also be performed on a pretransfusion specimen) 5. Findings reported to blood bank supervisor or medical director, who may request additional studies or tests. Additional laboratory evaluation may be required when an HTR is suspected: 1. Human error must be ruled out, primarily in the area of patient and sample identification. Repeat ABO and Rh testing should be performed on the unit of blood or available segment, pretransfusion specimen, and posttransfusion sample to exclude any clerical errors or sample mix-ups. 2. Antibody detection studies should be performed on the pre- and posttransfusion samples to look for any previously undetected alloantibodies. Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 8 of 12 3. The crossmatch should be repeated with both pre- and posttransfusion specimens using the indirect antiglobulin test (IAT) method, which has increased sensitivity over the immediate spin crossmatch. 4. When laboratory evidence of hemolysis is not evident, demonstration of decreased red cell survival may aid in the diagnosis. Serial hemoglobin levels may be adequate, or red cell survival studies may be required in more complex cases. Phenotypic differences be- tween the donor and the patient can be identified and followed using flow cytometry. The patient may be evaluated by serial mea- surement of certain laboratory values such as haptoglobin, lactate dehydrogenase (LDH), and unconjugated bilirubin levels. An increase in bilirubin may begin as early as 1 hour after the reaction, peak at 5 to 7 hours, and disappear within 24 hours if liver function is normal. 5. Examination of the returned components may yield important information concerning possible traumatic or mechanical causes of hemolysis. Both the blood bag and the administration tubing should be included in the examination. Hemolysis in both the component container and administration set could result from a process that affected the unit of blood, such as inappropriate warming of the unit. If the hemolysis was present only in the administration set, a faulty infusion pump, if used, could be the cause. The transfusion service must retain any patient records that are related to transfusion reactions, clinically significant antibodies, and special transfusion requirements. Additional information regarding special products, such as irradiated or washed components required for a particular patient, may be retained by the transfusion service as well. Specialized Laboratory Investigations for Selected Reactions: Anaphylaxis: the patient should be tested for antibodies to immuno- globulin A (anti-IgA). IgA-deficient patients should be transfused with components from IgAdeficient donors. Washed cellular blood components may be considered in these patients. Sepsis: Visual examination of the returned compo- nent should be conducted in suspected cases of posttransfusion sepsis, paying particular attention to any color changes, especially brown or purple discoloration in a red cell component, and bubbles, especially frothiness in a platelet component. A Gram’s stain should be performed on the returned compo- nent, and cultures Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 9 of 12 should be performed on both the component and the patient’s post- transfusion blood sample. Transfusion-Related Acute Lung Injury: In cases of suspected transfusion-related acute lung injury (TRALI), the collecting facility should be consulted to coordinate the ap- proach to posttransfusion testing. Patient samples should be obtained at the time of the reaction because they may not be available at a later date. A serum sample should be drawn for antibody studies, and an acid-citratedex- trose tube should be drawn for HLA typing. The collecting facility may obtain a sample of the donor’s serum to test for HLA and neutro- phil antibodies. Trainee Performance Evaluation This part should be completed by the TRAINER Please Tick the appropriate box to the right Evaluation Method Yes Result Of Evaluation Satisfactory Un Satisfactory Oral evaluation Direct observation competency (If yes, complete the form) Written competency Unknown samples (If yes, include a copy of the result) Other Corrective Action If Needed DATE OF TRAINING STARTED DATE OF TRAINING COMPLETED TRAINEE SIGNATURE TRAINER SIGNATURE SUPERVISOR SIGNATURE DATE : …………………………… : …………………………… : …………………………….. : …………………………….. : …………………………….. : …………………………….. Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 10 of 12 No Suggested Reading: I. Technical Manual, AABB, 16th edition (2008) Chapters Chapter 2: Facilities, Work Environment, and Safety Chapter 8: Infectious Disease Screening Chapter 9: Storage, Monitoring, Pretransfusion Processing, and Distribution of Blood Components Chapter 12: ABO, H, and Lewis Blood Groups and Structurally Related Antigens Chapter 13: The Rh System Chapter 15: Pretransfusion Testing Chapter 22: Perinatal Issues in Transfusion Practice Chapter 27: Noninfectious Complications of Blood Transfusion Chapter 28: Approaches to Blood Utilization Auditing Methods Section 1 General Laboratory Methods METHOD 1-1. SHIPPING HAZARDOUS MATERIALS METHOD 1-1-1. MONITORING TEMPERATURE DURING SHIPMENT OF BLOOD METHOD 1-2. TREATING INCOMPLETELY CLOTTED SPECIMENS METHOD 1-3. SOLUTION PREPARATION PROCEDURE METHOD 1-5. DILUTION OF % SOLUTIONS PROCEDURE METHOD 1-6. PREPARING A 3% RED CELL SUSPENSION METHOD 1-7. PREPARING AND USING PHOSPHATE BUFFER METHOD 1-8. READING AND GRADING TUBE AGGLUTINATION Section 2 Red Cell Typing METHOD 2-2. DETERMINING ABO GROUP OF RED CELLS AND SERUM—TUBE TEST METHOD 2-4. INITIAL INVESTIGATION OF ABO GROUPING DISCREPANCIES PROCEDURE METHOD 2-13. DETERMINING Rh (D) TYPE—TUBE TEST METHOD 2-15. TESTING FOR WEAK D Section 3 Antibody Detection, Identification, and Compatibility Testing METHOD 3-1. USING IMMEDIATE-SPIN COMPATIBILITY TESTING DEMONSTRATE ABO INCOMPATIBILITY METHOD 3-2. DETECTING ANTIBODIES TO RED CELL ANTIGENS—INDIRECT ANTIGLOBULIN TESTS METHOD 3-2-1. SALINE INDIRECT ANTIGLOBULIN TEST PROCEDURE METHOD 3-3. PREWARMING PROCEDURE METHOD 3-2-3. LISS INDIRECT ANTIGLOBULIN TEST PROCEDURE Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 11 of 12 METHOD 3-4. DETECTING ANTIBODIES IN THE PRESENCE OF ROULEAUX—SALINE REPLACEMENT METHOD 3-6. PERFORMING A DIRECT ANTIGLOBULIN TEST Section 6 Blood Collection, Component Preparation, and Storage METHOD 6-12. THAWING AND POOLING CRYOPRECIPITATED AHF Section 8 Quality Control METHOD 8-2. STANDARDIZING AND CALIBRATING THERMOMETERS METHOD 8-2-1. CHECKING LIQUID-IN-GLASS LABORATORY THERMOMETERS METHOD 8-3. TESTING BLOOD STORAGE EQUIPMENT ALARMS METHOD 8-3-1. TESTING REFRIGERATOR ALARMS METHOD 8-3-2. TESTING FREEZER ALARMS METHOD 8-5. CALIBRATING A SEROLOGIC CENTRIFUGE II. Standards, AABB , 25th Edition (2008) Training and Competency Assessment Program/ Training Effective Date: 31 May, 2011 Version 1 ULC/TCP/10F Page 12 of 12