All blood banks in the United States are regulated by what agency?
Software __________ is the establishment of documented evidence that provides a high degree of assurance that the information system will consistently function as expected.
What information might be found in a blood bank computer system? a. Inventory of blood components b. Antibodies identified in a patient c. The last date of donation for a blood donor d. All of the above
d. All of the above
Many accreditation agencies have checklist items that emphasize the responsibilities of operating an information system. Which of the following is NOT a volunteer accreditation agency? a. CAP b. AABB c. FDA d. Joint Commission
Which of the following is responsible for overseeing the safety of the blood supply? a. CAP b. AABB c. FDA d. Joint Commission
Fatalities related to blood transfusion are reported to ________
Which of the following is a peer voluntary accreditation and inspection agency? a. CAP b. CBER c. FDA d. OSHA
The temperature of a refrigerator must be between ______ and ______.
Refrigerators must: a. Have an audible alarm b. Have a continuous recording device c. Have temps taken daily d. All of the above
d. All of the above
A standard operating procedure (SOP) is: a. A statement of intent or course of action b. A description of resources and activities that transform inputs into outputs c. A set of directions for how to perform a particular task d. A form on which to record results
c. A set of directions for how to perform a particular task
Which of the following is used to determine if reagents and equipment are functioning prior to testing? a. critical control points b. control charts c. quality assurance d. quality control
d. quality control
According to federal law, what organization must be contacted when a biological deviation occurs in a blood bank and the error has the potential to affect the safety of the product or patient?
What is the primary focus of quality assurance?
To amend the system, procedure, or standard operating procedures, if deemed faulty
Which part of quality assurance ensures that products are consistently manufactured according to, and controlled by, the quality standards appropriate for their intended use?
Good manufacturing practices
Heat blocks for antibody screening are maintained at _______.
Which of the following might lead to unacceptable QC results? a. A technician who has not worked in the area for several months b. Deteriorated anti-A c. Uncalibrated serofuge d. All of the above
D. all of the above
The major focus of transfusion medicine is a. donor disease diagnosis b. recipient disease diagnosis c. donor/recipient blood group types d. donor/recipient compatibility
d. donor/recipient compatibility
The temperature of a freezer for plasma and cryoprecipitate must be maintained at _____
What blood component requires gentle agitation at room temperature during storage?
What testing must be repeated on donor units at the receiving facility when blood is shipped from a blood supplier?
True or False: The patient's room number is an acceptable unique identifier for use when labeling a tube of blood.
True or False: It is acceptable to omit date and time of collection on a specimen as long as this information is captured in the LIS
True or False: Measurement of compliance is on-going while quality management is only done at a point in time.
True or False: Reagent quality control must include both a positive and negative control.
True or False: Competency of personnel is assessed annually
What are the 3 components of Quality Management?
Quality control Quality assurance Quality maintenance systems
What temperature are platelet incubators set at?
True or False: Blood bank SOPs only need to address those tasks which are performed most often
Polyspecific AHG contains: a. Anti-IgG and Anti-IgM b. Anti-IgG and Anti-C3d c. Anti-IgG and Anti-IgA d. Anti-IgM and Anti-C3d
b. Anti-IgG and Anti-C3d
RBCs must be washed in saline at least three times before the addition of AHG reagent to: a. wash away any hemolyzed cells b. remove traces of free serum globulins c. neutralize any excess AHG reagent d. increase the antibody binding to antigen
b. remove traces of free serum globulins