Quality Assurance (QA) in Blood Banking ensures the accuracy, reliability, and safety of all blood transfusion processes — from donor collection to component transfusion. This chapter focuses on regulatory standards, quality management systems, documentation, and modern technologies shaping the future of transfusion medicine.
In an era of automation, molecular testing, and hemovigilance, maintaining rigorous quality systems is essential to patient safety and laboratory compliance.
Topics Covered in This Chapter
- Quality Assurance (QA) and Quality Control (QC) in Blood Banking
- Standard Operating Procedures (SOPs) and documentation requirements
- Regulatory and accreditation agencies:
- AABB (Association for the Advancement of Blood & Biotherapies)
- FDA (Food and Drug Administration)
- CAP (College of American Pathologists)
- WHO and local regulatory bodies
- Equipment calibration, validation, and maintenance
- Internal and external audits
- Error management and corrective actions
- Hemovigilance systems for monitoring transfusion outcomes
- Modern advancements in Blood Banking:
- Automation and electronic crossmatching
- Molecular genotyping of blood groups
- Pathogen reduction technologies
- Data management and traceability systems
Why It Matters
Quality systems form the backbone of safe and effective transfusion services.
Through strict adherence to QA/QC practices and regulatory compliance, laboratories maintain trust, safety, and operational excellence in blood banking and transfusion medicine.
Learning Outcomes
After studying this section, learners should be able to:
- Define quality assurance and its role in blood banking.
- Recognize the responsibilities of regulatory and accrediting agencies.
- Apply documentation and SOP standards to laboratory processes.
- Understand modern technological trends in transfusion medicine.
- Implement hemovigilance and quality improvement strategies.
60 MCQs (4841 – 4900):
- Anti-E is identified in a panel at the antiglobulin phase. When check cells are added to nonreactive tubes, no agglutination is seen. The most appropriate action is to:
a) Quality control the AHG reagent and check cells and repeat the panel
b) Open a new vial of check cells for subsequent testing that day
c) Open a new vial of AHG for subsequent testing that day
d) Record the check cell reactions and report the antibody panel result - What is the desired quality control result when testing the last wash from an elution procedure?
a) Reactive with all cells tested
b) Nonreactive with all cells tested
c) Reactivity equal to the direct antiglobulin test (DAT) result
d) Stronger reactivity than the DAT result - A new lot of anti-B fails quality control by not reacting with known B-positive cells and also reacting with B-negative cells. What action should be taken?
a) Document the results and place into use
b) Mark the lot as “not for use” and investigate the results
c) Place the lot into use as long as repeat testing is different
d) Ask a different technologist to QC the lot and accept those results - A sterile connection device requires quality control of the weld at what frequency?
a) With each weld
b) Day of use
c) Weekly
d) Quarterly - Crossmatch results at the antiglobulin phase are negative. When check cells are added, no agglutination is seen. The most likely explanation is that the:
a) Red cells were overwashed
b) Centrifuge speed was set too high
c) Residual patient serum inactivated the AHG reagent
d) Laboratorian did not add enough check cells - AHG control cells (Check Cells):
a) Can be used as a positive control for anti-C3 reagents
b) Can be used only for the indirect antiglobulin test
c) Are coated only with IgG antibody
d) Must be used to confirm all positive antiglobulin reactions - A serological calibration is completed for a new centrifuge. Given optimal results at 20 seconds (clear supernatant, easy resuspension, 1+ reaction), what time should be set?
a) 15 seconds
b) 20 seconds
c) 25 seconds
d) 30 seconds - A blood bank serologic centrifuge lid and wiring had to be repaired and replaced. What must be completed before the centrifuge is placed back into service?
a) Reregister the centrifuge with the FDA
b) Requalify the centrifuge with the local board of health
c) Recalibrate for speed and functionality
d) Nothing, as the instrument can be used immediately - Which of the following represents an acceptably identified patient for sample collection and transfusion?
a) A patient with a handwritten band on their leg with name and hospital ID
b) An addressographed hospital band taped to the patient’s bed
c) An unbanded patient who responds when his name is called
d) A chart transported with the patient containing an unattached armband - A pretransfusion sample is received labeled “Smith, Sam J. MR# 7070111, DOB 6.23.71” but the request says “Smith, Sam L. MR# 7070111, DOB 5.22.70”. What action should be taken?
a) Obtain a new blood sample and new transfusion request
b) Have the phlebotomist relabel the sample to match the request
c) Have the physician resubmit the request to match the sample
d) No action is required since the medical record numbers match - Pathogen reduction technology for blood components:
a) Promotes antibody formation to microbial antigens
b) Prevents infections by inhibiting microbial nucleic acid replication
c) Allows patients to receive blood products without infectious disease testing
d) Prevents infections by using DTT to rupture microbial membranes - DNA arrays evaluate the encoding genes for common blood groups by detecting small differences in:
a) Stop codons
b) mRNA
c) Single nucleotide polymorphisms (SNPs)
d) cDNA - Which of the following genes is analyzed with molecular assays to distinguish weak D from partial D?
a) RHD
b) RHCE
c) LW
d) RHAG - In which of the following clinical situations would DNA-based testing be most useful?
a) Identification of a maternal alloantibody that has caused HDFN
b) Resolution of suspected TRALI
c) Evaluation after extracorporeal photopheresis
d) Evaluation of a patient with warm AIHA and a positive DAT - The most widely accepted quality control test to measure probable Hematopoietic Progenitor Cell (HPC) engraftment is:
a) Clonogenic assay
b) Cell viability
c) CD34+ cell enumeration
d) Manual differential - Use of the computer to detect ABO incompatibility (computer crossmatch) can only be used when:
a) The patient has a historical ABO and Rh in the computer system
b) The computer system manual states such application is acceptable
c) The patient fails to demonstrate clinically significant alloantibodies
d) The immediate spin (IS) crossmatch is also negative - When preparing an eluate, what is the desired quality control result when testing the last wash?
a) Reactive with all cells tested
b) Nonreactive with all cells tested
c) Reactivity equal to the direct antiglobulin test (DAT) result
d) Stronger reactivity than the DAT result - Which of the following is useful for removing IgG from red blood cells with a positive DAT to perform a phenotype?
a) Bromelin
b) Chloroquine
c) Low ionic strength saline (LISS)
d) Dithiothreitol (DTT) - A false-negative indirect antiglobulin test (IAT) can be the result of:
a) Over-reading the test
b) IgG-coated screening cells
c) Addition of an extra drop of serum
d) Too heavy a cell suspension - Which of the following might cause a false-negative indirect antiglobulin test?
a) Under-centrifugation
b) Over-centrifugation
c) Dirty glassware
d) Use of EDTA plasma - According to AABB Standards, Apheresis Platelets shall demonstrate with 95% confidence that >75% of units contain ≥ how many platelets?
a) 5.5 × 10¹⁰
b) 6.5 × 10¹⁰
c) 3.0 × 10¹¹
d) 5.0 × 10¹¹ - According to AABB Standards, Apheresis Platelets shall demonstrate with 95% confidence that >95% of units have what minimum pH at the time of issue?
a) 6.0
b) 6.2
c) 6.8
d) 7.0 - In a quality assurance program, Cryoprecipitated AHF must contain a minimum of how many international units of Factor VIII?
a) 60
b) 70
c) 80
d) 90 - Quality control of Apheresis Granulocytes must demonstrate which granulocyte count in 75% of units tested?
a) 1.0 × 10¹⁰
b) 2.0 × 10¹⁰
c) 3.0 × 10¹⁰
d) 4.0 × 10¹⁰ - An important determinant of platelet viability during storage is:
a) Plasma potassium concentration
b) Plasma pH
c) Prothrombin time
d) Activated partial thromboplastin time - According to AABB Standards, Platelets prepared from Whole Blood shall have at least:
a) 5.5 × 10¹⁰ platelets per unit in at least 90% of units tested
b) 6.5 × 10¹⁰ platelets per unit in 90% of units tested
c) 7.5 × 10¹⁰ platelets per unit in 100% of units tested
d) 8.5 × 10¹⁰ platelets per unit in 95% of units tested - Methods for preparing Red Blood Cells Leukocytes Reduced must retain at least what percentage of the original red cells?
a) 50%
b) 70%
c) 85%
d) 100% - When storage devices do not have automated temperature recording, ambient temperature must be monitored and recorded:
a) Once a day
b) Twice a day
c) Every 4 hours
d) Every hour - Blood may be returned to inventory after issue provided that all of the following criteria are met EXCEPT:
a) The container closure has not been disturbed
b) At least one sealed segment remains attached
c) The unit has been maintained at the appropriate temperature
d) The unit has been absent from the blood bank for less than 30 minutes - Which of the following is a key advantage of performing antibody screening using gel technology?
a) Saline washing is not required
b) Centrifugation is not required
c) Special equipment is not required
d) Precise volumes of serum are not required - Hemolytic Disease of the Fetus and Newborn (HDFN) occurs when:
a) Maternal antibodies cross the placenta and destroy fetal red cells
b) Fetal antibodies attack maternal red cells
c) The fetus is Rh negative
d) The mother is ABO incompatible with the fetus - The most common cause of severe HDFN is:
a) Anti-K
b) Anti-E
c) Anti-D
d) Anti-Fyᵃ - The antibody class responsible for HDFN is:
a) IgM
b) IgG
c) IgA
d) IgD - The first pregnancy in an Rh-negative woman is usually:
a) Affected by HDFN
b) Unaffected unless sensitization occurs
c) Fatal to the fetus
d) Associated with ABO incompatibility - Sensitization of an Rh-negative mother can occur through:
a) Transfusion of Rh-positive blood or pregnancy with Rh-positive fetus
b) Infection with malaria
c) Vitamin deficiency
d) Platelet transfusion only - ABO hemolytic disease is usually:
a) More severe than Rh disease
b) Milder and often self-limiting
c) Fatal in all cases
d) Associated with anti-E antibodies - The antibody most commonly responsible for ABO HDFN is:
a) IgG anti-A, anti-B in group O mothers
b) IgM anti-A, anti-B in group A mothers
c) IgG anti-H in group B mothers
d) IgM anti-H in group O mothers - The direct antiglobulin test (DAT) on cord blood is used to:
a) Detect maternal antibodies bound to fetal red cells
b) Identify fetal hemoglobin
c) Measure bilirubin
d) Determine ABO group - The indirect antiglobulin test (IAT) on maternal serum detects:
a) Unbound maternal alloantibodies
b) Fetal red cell antigens
c) Fetal bilirubin
d) Fetal hemoglobin concentration - Which test measures fetal hemoglobin in maternal circulation?
a) Kleihauer–Betke test
b) Coombs test
c) RPR test
d) Hematocrit test - A positive Kleihauer–Betke test indicates:
a) Fetal-to-maternal hemorrhage
b) Maternal anemia
c) ABO incompatibility
d) Infection - The purpose of Rh immune globulin (RhIG) is to:
a) Prevent Rh-negative mothers from forming anti-D antibodies
b) Treat HDFN
c) Destroy fetal antibodies
d) Stimulate D antigen formation - RhIG should be administered to Rh-negative women:
a) Within 72 hours after delivery of an Rh-positive infant
b) After every pregnancy regardless of Rh type
c) Before delivery only
d) Only if antibody screen is positive - The standard dose of RhIG protects against:
a) 15 mL of fetal RBCs (30 mL of whole blood)
b) 5 mL of fetal RBCs
c) 50 mL of whole blood
d) 100 mL of plasma - The fetal screen (rosette test) is used to:
a) Detect D-positive fetal cells in maternal blood
b) Identify maternal antibodies
c) Quantify bilirubin
d) Measure antibody titer - If the fetal screen is positive, the next test performed is:
a) Kleihauer–Betke test
b) Indirect Coombs test
c) Rh typing
d) DAT - The exchange transfusion in newborns is used to:
a) Remove antibody-coated red cells and circulating bilirubin
b) Increase plasma volume
c) Replace lost electrolytes
d) Deliver nutrients - In ABO HDFN, the DAT is usually:
a) Weakly positive
b) Strongly positive
c) Always negative
d) Uninterpretable - Rh HDFN causes increased bilirubin due to:
a) Destruction of fetal red cells
b) Reduced liver enzymes
c) Maternal iron deficiency
d) Dehydration - The first indicator of fetal anemia in utero is detected by:
a) Middle cerebral artery Doppler velocity
b) Ultrasound only
c) Amniocentesis
d) Fetal heart rate - The Liley graph relates:
a) Amniotic fluid bilirubin to severity of HDFN
b) Maternal antibody titer to fetal age
c) Hemoglobin to gestational age
d) Antibody strength to bilirubin levels - The RhIG is prepared from:
a) Pooled human plasma containing anti-D
b) Recombinant anti-D antibody
c) Fetal cord plasma
d) Artificial monoclonal IgM - RhIG administration is unnecessary when:
a) The mother and infant are both Rh negative
b) The mother is O positive
c) The baby is preterm
d) The mother has an infection - What is the most common cause of severe kernicterus?
a) Unconjugated bilirubin crossing the blood–brain barrier
b) Maternal infection
c) ABO incompatibility
d) Iron deficiency - The exchange transfusion blood used should be:
a) Group O, Rh negative, crossmatch compatible with maternal serum
b) Group-specific and Rh positive
c) Group AB, Rh negative
d) Platelet-rich plasma - Intravenous RhIG is administered for:
a) Large fetomaternal hemorrhage or after transfusion accident
b) Every pregnancy
c) ABO incompatibility
d) Maternal anemia - A maternal antibody titer of 1:32 or higher suggests:
a) Significant risk of HDFN
b) Normal immune response
c) Low risk
d) False positive - Severe Rh HDFN can lead to:
a) Hydrops fetalis
b) Mild anemia
c) Iron overload
d) Hypocalcemia - The test used to measure bilirubin in amniotic fluid is:
a) Spectrophotometric scan at 450 nm
b) Coombs test
c) ELISA
d) IAT - Which of the following statements about RhIG is TRUE?
a) It prevents maternal sensitization by destroying fetal D-positive cells
b) It treats maternal antibodies already formed
c) It enhances immune response
d) It is effective in Rh-positive mothers
📌 How to Use This Practice Set
- Answer each question before checking the key.
- Focus on why the correct answer is right and the others are wrong.
- Use this set as timed practice to simulate the real exam environment.
Answer Key
Answer Key:
- a) Quality control the AHG reagent and check cells and repeat the panel
- b) Nonreactive with all cells tested
- b) Mark the lot as “not for use” and investigate the results
- a) With each weld
- d) Laboratorian did not add enough check cells
- a) Can be used as a positive control for anti-C3 reagents
- b) 20 seconds
- c) Recalibrate for speed and functionality
- a) A patient with a handwritten band on their leg with name and hospital ID
- a) Obtain a new blood sample and new transfusion request
- b) Prevents infections by inhibiting microbial nucleic acid replication
- c) Single nucleotide polymorphisms (SNPs)
- a) RHD
- d) Evaluation of a patient with warm AIHA and a positive DAT
- c) CD34+ cell enumeration
- c) The patient fails to demonstrate clinically significant alloantibodies
- b) Nonreactive with all cells tested
- b) Chloroquine
- d) Too heavy a cell suspension
- a) Under-centrifugation
- c) 3.0 × 10¹¹
- b) 6.2
- c) 80
- a) 1.0 × 10¹⁰
- b) Plasma pH
- a) 5.5 × 10¹⁰ platelets per unit in at least 90% of units tested
- c) 85%
- ((a) Once a day))
- d) The unit has been absent from the blood bank for less than 30 minutes
- a) Saline washing is not required
- a) Maternal antibodies cross the placenta and destroy fetal red cells
- c) Anti-D
- b) IgG
- b) Unaffected unless sensitization occurs
- a) Transfusion of Rh-positive blood or pregnancy with Rh-positive fetus
- b) Milder and often self-limiting
- a) IgG anti-A, anti-B in group O mothers
- a) Detect maternal antibodies bound to fetal red cells
- a) Unbound maternal alloantibodies
- a) Kleihauer–Betke test
- a) Fetal-to-maternal hemorrhage
- a) Prevent Rh-negative mothers from forming anti-D antibodies
- a) Within 72 hours after delivery of an Rh-positive infant
- a) 15 mL of fetal RBCs (30 mL of whole blood)
- a) Detect D-positive fetal cells in maternal blood
- a) Kleihauer–Betke test
- a) Remove antibody-coated red cells and circulating bilirubin
- a) Weakly positive
- a) Destruction of fetal red cells
- a) Middle cerebral artery Doppler velocity
- a) Amniotic fluid bilirubin to severity of HDFN
- a) Pooled human plasma containing anti-D
- a) The mother and infant are both Rh negative
- a) Unconjugated bilirubin crossing the blood–brain barrier
- a) Group O, Rh negative, crossmatch compatible with maternal serum
- a) Large fetomaternal hemorrhage or after transfusion accident
- a) Significant risk of HDFN
- a) Hydrops fetalis
- a) Spectrophotometric scan at 450 nm
- a) It prevents maternal sensitization by destroying fetal D-positive cells
Top 8 Medical Laboratory Scientist (MLS) Exams:
Top 8 Medical Laboratory Scientist (MLS) Exams that are recognized globally and can help professionals validate their credentials and enhance their career opportunities:
1. ASCP – American Society for Clinical Pathology (USA)
- Exam Name: MLS(ASCP)
- Eligibility: Bachelor’s degree with clinical laboratory experience.
- Global Recognition: High
- Purpose: Certifies Medical Laboratory Scientists in the United States and internationally.
2. AMT – American Medical Technologists (USA)
- Exam Name: MLT(AMT) or MT(AMT)
- Eligibility: Academic and/or work experience in medical laboratory technology.
- Global Recognition: Moderate
- Purpose: Credentialing for medical technologists and technicians.
3. AIMS – Australian Institute of Medical and Clinical Scientists
- Exam Name: AIMS Certification Exam
- Eligibility: Assessment of qualifications and work experience.
- Recognition: Required for practice in Australia.
- Purpose: Certification and registration in Australia.
4. CSMLS – Canadian Society for Medical Laboratory Science
- Exam Name: CSMLS General or Subject-specific Exams
- Eligibility: Graduation from a CSMLS-accredited program or equivalent.
- Recognition: Canada
- Purpose: Entry-to-practice certification in Canada.
5. IBMS – Institute of Biomedical Science (UK)
- Exam Name: Registration and Specialist Portfolio Assessment
- Eligibility: Accredited degree and lab experience.
- Recognition: UK and some Commonwealth countries.
- Purpose: Biomedical Scientist registration with the HCPC (UK).
6. HAAD / DOH – Department of Health, Abu Dhabi (UAE)
- Exam Name: DOH/HAAD License Exam
- Eligibility: Degree in medical laboratory science and experience.
- Recognition: UAE (Abu Dhabi)
- Purpose: Licensure for medical laboratory practice in Abu Dhabi.
7. DHA – Dubai Health Authority (UAE)
- Exam Name: DHA License Exam for Medical Laboratory Technologists
- Eligibility: Relevant degree and experience.
- Recognition: Dubai, UAE
- Purpose: Professional license for clinical laboratory practice in Dubai.
8. MOH – Ministry of Health (Gulf Countries like UAE, Saudi Arabia, Kuwait)
- Exam Name: MOH License Exam
- Eligibility: BSc/Diploma in Medical Laboratory + experience.
- Recognition: Varies by country.
- Purpose: Required for practicing in public and private sector labs.
Tags:
#ASCPMLS #MLSexam #LabTech #MedicalLaboratory #BOCexam #FreePracticeQuestions #QualityControl #LaboratorySafety
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