self study review Flashcards
High incidence antigens are:
Found in a majority of the population
Sometimes referred to as public genes
Dosage is:
A stronger expression of a trait inherited in the homozygous state, as compared to being inherited in the heterozygous
state
Which of the following are possible genotypes for an individual who is blood type B?
BO
BB
AB
BO
BB
GMP systems include:
Reagent / equipment suppliers
Testing personnel and procedures
Storage systems
Customer reviews
Which of the following organizations are federal agencies that are involved with laboratory inspection / accreditation?
The Joint Commission
CAP
FDA
The Joint Commission
CAP
FDA
With what aspect(s) of the laboratory operation is OSHA concerned?
Safety in the workplace
The purpose of Good Manufacturing Processes (GMPs) in the laboratory:
Ensure that testing is conducted in a controlled and auditable manner
Ensure that testing is accurate, consistent, and reliable
If an SOP is changed, the laboratory must:
Document the date of, and reason for, the change
Train employees on the new procedure
Of the following options, select all that are expectations the public have for blood banks:
A service performed at 99.9% perfection
A quality service
Increased testing and screening
The result of blood being defined as “Biologic” in 1970 was the FDA defining “blood” as a a drug product which would have to adhere to the good manufacturing processes as outlined in the Code of Federal Regulations
TRUE OR FALSE
True
Failure to follow the FDAs guidelines, “Good Manufacturing Processes” when creating blood products can result in:
Suspended blood product production - resulting in lost revenues
Licenses revoked
legal indictment of all personnel involved
Quality Assurance
Evaluation and monitoring of all aspects of a process or system.
Quality Control
Activities performed to insure reagents /equipment / techniques used are functioning
Process Control
Assures that procedures were followed and the products made are of the highest standards
Trackability
A sequential audit trail
Traceability
What was done, when, & by whom?
Validation
Documented evidence that provides assurance that a specific process will consistently produce an appropriate result
Competency Testing, performed once a year, assesses a department member’s :
Interpersonal Skills
Compliance to all accreditation requirements
Critical Decision Making Skills
Technical Skills
Competency testing evaluates:
Familiarity with pre-analytical factors and problems
Adherence to all SOPs
Analytical skills to include accuracy and timeliness of results
Familiarity of post-testing evaluation and interpretation
Error management is a requirement of the FDA as a method to detect errors, deviations, accidents, and incidents. An Error management system is in place to:
Prevent recurrence of similar errors
Determine corrective action to errors
Prevent and detect errors
Some blood bank errors must be reported to prevent being held liable including:
Reporting when a unit was transfused but it should’ve been deferred (and destroyed).
Discovery of or Use of incorrectly labeled units
Detection of contamination in a unit
Veno-Arterial (VA)
Used for cardiopulmonary deficits
Veno-Venous system (VV)
Used for pulmonary deficits
An infant can stay on ECMO up to 3 weeks!
true or false
true
Which of the following are risks for a patient on ECMO?
Transfusion
Infection
Clots
Bleeding
Stroke
Air Bubbles
A thromboelastographic instrument, which is utilized to determine blood product usage and necessity, may be referred to by what 3letter term:
TEG
ECMO stands for
Extracorporeal
Membrane
Oxygenation
