Blood Banking Exam:HLA, Paternity, and Regulations

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Blood Banking Exam:HLA, Paternity, and Regulations
2013-06-26 02:31:11
HLA Paternity Regulations

HLA, Paternity, and Regulations
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  1. What organization is responsible for the nations blood supply?
    The Food and Drug Administration
  2. What is required to ship blood and blood products out of state?
    A U.S. license
  3. What FDA regulatory remedy results in the discontinuation of all operations by the company until adequate corrections are made and verified by the FDA?
    Prohibitary injunction
  4. Why does the Center for Biologics Evaluation and Research want transfusion related facilities reported?
    • -to ensure incidents are thoroughly investigated
    • -to determine if appropriate corrective action has been taken to prevent a reoccurence
    • -to evaluate reports for trends that may warrant action by the FDA or HCFA
  5. What was the tragedy that prompted passage of the Public Health Service Act in 1902 (also known as the Virus, Serum, and Antitoxin Act)?
    Ten children died after receiving diphtheria antitoxin contaminated with tetanus.
  6. What are the functions of current Good Manufacturing Practices (cGMP)?
    • -cGMPs are legal requirements
    • -ensure safety and efficacy of blood products
    • -compliance is met by following Standard Operating Procedures
    • -achieve quality by reducing variation in processes and products
  7. Quality begins with:
  8. What is quality assurance?
    A planned, systematic activity implemented within the quality system to provide confidence that requirements for quality will be fulfilled.
  9. What is quality control?
    Operational techniques and activities used to fulfill the requirements for quality
  10. What is a quality system?
    An organizational structure, procedure, process, and resource needed to implement quality management
  11. A set of activities that ensues a given process will keep operating in a state that is continuously able to meet process goals without compromising the process itself:
    Process control
  12. The process that detects, reports, evaluates, and corrects errors and accidents is:
    Occurrence management
  13. A group of people representing different parts of a process who have been brought to identify and to implement ways to remove a problem and improve a process is called:
    process improvement team
  14. What are examples of quality control?
    • -reactivity of blood typing reagents
    • -calibration of blood bank instruments
    • -temperature monitoring of incubators
  15. What are examples of quality system essentials?
    • -incident/errors
    • -internal assessments
    • -documents
  16. What agency published the requirements for current Good Manufacturing Practices?
  17. Blood Banks are required to have:
    • -Standardized SOPs
    • -Master list of documents/forms
    • -Annual review of procedures
  18. Define problem if mislabeled specimens:
  19. Appraise drawing of specimens to the established standards:
  20. Perform ongoing audits:
  21. Monitor impact:
  22. Bg antibodies are characterized as:
    Weak, variably reacting
  23. Platelet refractoriness associated with lymphocytotoxic HLA antibodies is defined as:
    Failure to achieve a rise in platelet count one hour after platelet infusion.
  24. In HLA testing what term is used to denote the five genes (HLA-A, -B, -C, -D, -DR) on the same chromosomes:
  25. HLA-B27 is associated with which disease?
    Ankylosing sponylitis
  26. The test of choice for HLAS antigen testing is:
  27. The majority of HLA antibodies are:
  28. A patient in Medical Oncology is multiply transfused. What is most likely to stimulate production of HLA antibodies in the patient?
    White cells
  29. What blood group system is NOT used in classic paternity testing? Which are?
    • a. Lewis
    • b. ABO, RH, and Kidd
  30. What HLA loci are used in paternity testing?
    A, B, DR, and DQ
  31. When there is a mismatch found in paternity testing, it refers to:
    bands in DNA testing between child and alleged father that do not match
  32. When reporting DNA RFLP test results, what must be included?
    • -locus and probe used
    • -restriction enzyme used
  33. Criteria for selection of genetic systems for use in parentage testing should include:
    • -system should be polymorphic i.e. have multiple alleles
    • -inheritance pattern should be well established and follow Mendell's rules
    • -Mutation rates shouled be known to be low
    • -Databases of allele frequencies should be available for all ethnic groups that may be tested
  34. In parentage testing, the classic trio is assumed to be:
    the biologic mother, the child, and reputed father
  35. A direct exclusion occurs when:
    A marker is detected in the child but is absent in the mother and alleged father
  36. An indirect exclusion occurs when:
    A single marker is detected in the child and a different single marker is detected in the alleged father
  37. A child is typed Jk(a+b-), and the alleged father is Jk(a-b-). This is one example of:
    an indirect exclusion
  38. A child is typed Jk(a+b-), and the alleged father is Jk(a-b-). This is one example of:

    in the example given above, the situation is termed:
    apparent opposite homozygosity
  39. A child is typed Jk(a+b-), and the alleged father is Jk(a-b-). This is one example of:

    in the example given above, the situation is termed: apparent opposite homozygosity

    in a situation like the one described above, assumed or proven?
    the homozygosity is assumed and not directly proven
  40. False direct exclusions can occur as a result of:
    • -mutations that are significant enough to alter the final product
    • -lack of precursor substance
    • -suppressor activity at a locus unlinked to the one tested
    • - a chimeric state of one of the tested individuals
  41. True or False, Silent alleles can lead to false indirect exclusions.
  42. The following results were obtained:

            Mom            Child             Alleged Dad
    ABO  O                 O                 B
    Rh    D+C+E-c-e+  D+C+E-c+e+ D+C-E+c-e-
    Paternity may be excluded on the basis of Rh typing
  43. Use of only male donors as a source of plasma intended for transfusion is advocated to reduce what reaction?
  44. What part of a blood sample is used in paternity testing?
    • -WBCs: HLA and gentic testing
    • -Plasma/serum: subtyping by electrophoresis
    • -RBCs: antigen testing and RBC enzymes
  45. HLA results

    Mother           Child              Father
    A3A9:B5B12   A3A11:B7B12  A2A11:B5B12

    Based on the information given in this case, the biological father's actual haplotype must be:
  46. The RFLP technique is used in paternity testing. How can the results be explained?

                          Mom          Child          Dad
    D2S44/HaeIII   3.42,4.24   2.9,3.42   2.9,3.11
    D4S139/HaeIII  4.28,9.42  4.28,6.5  4.28, 7.25
    D10S28/HaeIII  1.7,2.9      1.7,3.32  1.05,3.32
    The father is not excluded due to a possible point mutation
  47. What is the best way to ensure compliance with cGMP?
    Standard Operating Procedures
  48. True or False, it is not a deviation when there is a variation from the SOP and quality is not affected.
  49. A quality program will not:
    increase costs
  50. What are benefits of a self audit?
    • -opportunities for improvement
    • -continuous quality improvement
    • -prevent errors
    • -leads to better compliance with regulations
  51. 1b,2c,3a,4e,5c,6b,7c,8d,9a,10c,11a,12b,13b,14d,15b,16b,17d,18c,19d,20a,21b,22a,23c,24a,25b,26c,27d,28c,29d,30d,31c,32d,33e,34c,35b,36a,37b,38a,39a,40e,41a,42c,43c,44d,45a,46b,47a,48a,49d,50e