What organization is responsible for the nations blood supply?
The Food and Drug Administration
What is required to ship blood and blood products out of state?
A U.S. license
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
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
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.
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
Quality begins with:
People
What is quality assurance?
A planned, systematic activity implemented within the quality system to provide confidence that requirements for quality will be fulfilled.
What is quality control?
Operational techniques and activities used to fulfill the requirements for quality
What is a quality system?
An organizational structure, procedure, process, and resource needed to implement quality management
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
The process that detects, reports, evaluates, and corrects errors and accidents is:
Occurrence management
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
What are examples of quality control?
-reactivity of blood typing reagents
-calibration of blood bank instruments
-temperature monitoring of incubators
What are examples of quality system essentials?
-incident/errors
-internal assessments
-documents
What agency published the requirements for current Good Manufacturing Practices?
FDA
Blood Banks are required to have:
-Standardized SOPs
-Master list of documents/forms
-Annual review of procedures
Define problem if mislabeled specimens:
plan
Appraise drawing of specimens to the established standards:
implement
Perform ongoing audits:
assess
Monitor impact:
improve
Bg antibodies are characterized as:
Weak, variably reacting
Platelet refractoriness associated with lymphocytotoxic HLA antibodies is defined as:
Failure to achieve a rise in platelet count one hour after platelet infusion.
In HLA testing what term is used to denote the five genes (HLA-A, -B, -C, -D, -DR) on the same chromosomes:
haplotype
HLA-B27 is associated with which disease?
Ankylosing sponylitis
The test of choice for HLAS antigen testing is:
Cytotoxicity
The majority of HLA antibodies are:
IgG
A patient in Medical Oncology is multiply transfused. What is most likely to stimulate production of HLA antibodies in the patient?
White cells
What blood group system is NOT used in classic paternity testing? Which are?
a. Lewis
b. ABO, RH, and Kidd
What HLA loci are used in paternity testing?
A, B, DR, and DQ
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
When reporting DNA RFLP test results, what must be included?
-locus and probe used
-restriction enzyme used
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
In parentage testing, the classic trio is assumed to be:
the biologic mother, the child, and reputed father
A direct exclusion occurs when:
A marker is detected in the child but is absent in the mother and alleged father
An indirect exclusion occurs when:
A single marker is detected in the child and a different single marker is detected in the alleged father
A child is typed Jk(a+b-), and the alleged father is Jk(a-b-). This is one example of:
an indirect exclusion
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
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
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
True or False, Silent alleles can lead to false indirect exclusions.
True
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
Use of only male donors as a source of plasma intended for transfusion is advocated to reduce what reaction?
TRALI
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
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:
A11:B7
The RFLP technique is used in paternity testing. How can the results be explained?
