Deck 21: Quality Assurance

Question 1

Which of the following is the process to track the disposition of blood products from previous donations when supplemental or confirmatory tests on a donor are positive for anti-HIV?

A)Backtrack
B)Lookback
C)Traceback
D)Trackback

Answer 1

Lookback

Question 2

All of the following are true about quality control except

A)acceptable results or ranges must be predetermined
B)frequency and method for performance is determined by the manufacturer's requirements and/or regulatory or accreditation requirements
C)results must be documented within 7 days
D)routinely includes testing a specified number of each type of component when monitoring blood component production processes

Answer 2

results must be documented within 7 days

Question 3

All of the following are goals of a quality program except

A)Adversarial relationship with regulatory agencies
B)Cost containment
C)Knowledgeable and well-trained employees
D)Safe work environment

Answer 3

Adversarial relationship with regulatory agencies

Question 4

Which type of audit is particularly effective in spotting errors that may be overlooked by routine record review?

A)External
B)Process
C)Product
D)Self

Question 5

Process control is defined as

A)a system that standardizes facility documents
B)activities used to create a controlled environment for processes and procedures
C)documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting predetermined specifications
D)standardization of an analytic instrument

Question 6

Calibration is defined as

A)conformance of a product or process with pre-established specifications
B)documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting predetermined specifications
C)monitoring performed to ensure that the quality system is being adhered to and is effective
D)standardization of an analytic instrument

Question 7

Which of the following is an example of a quality assurance activity?

A)Trend analysis
B)Strategic planning
C)Vendor selection
D)Visual inspection

Question 8

The definition for policy would be which of the following?

A)Document used to record data
B)Information that provides objective evidence that an activity was completed
C)Principle that guides decision making
D)Set of related steps that achieve a goal

Question 9

A sentinel event is a(an)

A)failure to meet accreditation requirements
B)event resulting in a patient or donor experiencing a fatal,life-threatening,or serious adverse outcome
C)measureable facet of a process
D)unexpected occurrence where an error was identified and corrected before a patient or product was adversely affected

Question 10

A nonconformance event is defined as a

A)corrected error where the patient or product was not adversely affected
B)departure from policies
C)deviation from cGMP
D)failure to meet accreditation requirements

Question 11

Which of the following is a program designed to ensure that laboratorians have mastered the skills and tasks related to processing,performing,and interpreting accurate laboratory tests?

A)CLIA
B)CMS
C)PT
D)QC

Question 12

Regarding record retention,which statement is not true?

A)Facilities must comply with all regulatory retention requirements.
B)Many records are stored electronically.
C)There must be a method for backing up all critical data.
D)Transfusion records must be stored for at least 7 years.

Question 13

In a total quality program which of the following would be a role of an executive officer?

A)Understand how each task and process within the scope of work contributes to the organizational goal.
B)Understand how to standardize processes and procedures
C)Understand the interrelationships between errors,near-misses,corrective actions,and preventive actions
D)Understand the interrelationships between processes,services,customers,suppliers,and employees within their business model

Question 14

A near-miss event is a(an)

A)failure to meet accreditation requirements
B)event resulting in a patient or donor experiencing a fatal,life-threatening,or serious adverse outcome
C)measureable facet of a process
D)unexpected occurrence where an error was identified and corrected before a patient or product was adversely affected

Question 15

Which of the following explains document control?

A)A system that standardizes facility documents
B)Activities used to create a controlled environment for processes and procedures
C)Documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting predetermined specifications
D)Standardization of an analytic instrument

Question 16

Regulation grants the authority to stop production of blood products in a blood manufacturing organization when a problem is detected to which group of people?

A)Executive members
B)Leadership administrators
C)Production managers
D)Quality assurance unit

Question 17

Validation is defined as

A)conformance of a product or process with pre-established specifications
B)documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting predetermined specifications
C)monitoring performed to ensure that the quality system is being adhered to and is effective
D)standardization of an analytic instrument

Question 18

Which agency is responsible for regulating transfusion services in the United States?

A)AABB
B)CAP
C)FDA
D)JCAHO

Question 19

The AABB Standards for Blood Banks and Transfusion Services are divided into how many quality system essentials?

A)10
B)13
C)21
D)23

Question 20

Quality assurance is defined as

A)conformance of a product or process with pre-established specifications
B)documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting predetermined specifications
C)monitoring performed to ensure that the quality system is being adhered to and is effective
D)standardization of an analytic instrument