Question 1

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

Accepted Answer

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

Question 2

Process control is defined as

Accepted Answer

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 
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 B

Question 3

A near-miss event is a(an)

Accepted Answer

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 
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 D

Question 4

Which of the following explains document control?

Accepted Answer

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 
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 5

The definition for policy would be which of the following?

Accepted Answer

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 
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 6

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

Accepted Answer

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

Question 7

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?

Accepted Answer

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

Question 8

Quality assurance is defined as

Accepted Answer

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 
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 9

A nonconformance event is defined as a

Accepted Answer

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 
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 10

Calibration is defined as

Accepted Answer

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 
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 11

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

Accepted Answer

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

Question 12

All of the following are true about quality control except

Accepted Answer

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 
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

Question 13

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?

Accepted Answer

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

Question 14

Regarding record retention,which statement is not true?

Accepted Answer

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. 
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 15

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

Accepted Answer

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

Question 16

A sentinel event is a(an)

Accepted Answer

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 
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 17

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

Accepted Answer

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 
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 18

All of the following are goals of a quality program except

Accepted Answer

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

Question 19

Validation is defined as

Accepted Answer

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 
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 20

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?

Accepted Answer

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

Exam 21: Quality Assurance

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

Process control is defined as

A near-miss event is a(an)

Which of the following explains document control?

The definition for policy would be which of the following?

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

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?

Quality assurance is defined as

A nonconformance event is defined as a

Calibration is defined as

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

All of the following are true about quality control except

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?

Regarding record retention,which statement is not true?

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

A sentinel event is a(an)

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

All of the following are goals of a quality program except

Validation is defined as

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?

The Immune Process: the Origin and Interaction Between Antigens and Antibodies

Immunogenetics: the Origin of Antigens

Blood Bank Applications of Antigenantibody Reactions

Abo and Hh Blood Group Systems

Rh, Rhag, and Lw Blood Group Systems

Other Blood Group Systems

Pretransfusion and Compatibility Testing

Identification of Unexpected Antibodies

Donor Selection, Phlebotomy, and Required Testing

Blood Products: Preparation, Storage, and Shipment of Blood Components

Component Therapy and Massive Transfusion

Adverse Reactions to Transfusion

Transfusion-Transmitted Infections

Perinatal and Neonatal Transfusion Issues

Autoimmune and Drug-Induced Immune Hemolytic Anemias

Platelet Refractory Patients

Transfusion Support of Selected Patient Populations

Human Histocompatibility

Methods in Parentage Testing

Transfusion Safety and Regulatory Issues

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