Question 1

All deaths in the United States that are related to blood donation or blood transfusion must be reported to&#10;A)CBER&#10;B)CMS&#10;C)FDA&#10;D)NIH

Accepted Answer

CBER

Question 2

In the United States,which agency regulates workplace safety?&#10;A)CAP&#10;B)EPA&#10;C)FDA&#10;D)OSHA

Accepted Answer

OSHA (Occupational Safety and Health Administration) is the agency that regulates workplace safety in the United States. They are responsible for ensuring that employers provide a safe work environment for their employees and comply with safety regulations.

Question 3

Which law was the first American legislation to deal with biologics?&#10;A)Biologics Control Act&#10;B)Federal Food and Drugs Act&#10;C)Public Health Service Act&#10;D)Virus-Control Law

Accepted Answer

The Biologics Control Act, also known as the Virus-Toxin Law, was passed in 1902 and was the first law in the United States to regulate biologics. It required licensing for manufacturers of biologic products, such as vaccines and antitoxins, and established standards for safety, purity, and potency. The other options listed were enacted later and did not specifically deal with biologics in their initial form.

Question 4

All of the following are categories of enforcement action that the FDA can use except&#10;A)Administrative&#10;B)Advisory&#10;C)Deviation&#10;D)Recall

Accepted Answer

The FDA does not have a category of enforcement action called "deviation." The other choices are all categories of enforcement action that the FDA can use: 
-A) Administrative: The FDA can take administrative action against a company or individual for violating regulations, including issuing warning letters, fines, and seizure of products. 
-B) Advisory: The FDA can issue advisory letters to inform the public of safety concerns related to a product or to advise companies on how to comply with regulations. 
-D) Recall: The FDA can order a recall of a product if it is determined to be unsafe or in violation of regulations.

Question 5

What report must be submitted if an error could affect the safety,potency,or purity of a distributed blood product?&#10;A)Biological product deviation&#10;B)Fatality&#10;C)Hemovigilance&#10;D)Nonconformance

Accepted Answer

A biological product deviation must be submitted if an error could affect the safety, potency, or purity of a distributed blood product. This report is required by the FDA and helps to ensure that all blood products are safe for use. It is important to report any deviations from established procedures or any unexpected events that could impact the quality of the blood product. This helps to identify potential problems and prevent similar incidents from occurring in the future.

Question 6

Which organization represents one of the most common voluntary accreditations that apply to medical laboratories?&#10;A)American Association of Bioanalysts&#10;B)American Medical Technologists&#10;C)Board of Certification of the American Society of Clinical Pathologists&#10;D)College of American Pathologists

Accepted Answer

The College of American Pathologists (CAP) represents one of the most common voluntary accreditations that apply to medical laboratories. CAP is an organization that focuses exclusively on laboratory medicine and includes a rigorous accreditation process that evaluates areas such as quality control, personnel qualifications, and laboratory management. The other options (A, B, and C) are also accreditation organizations, but they are not as commonly used as CAP.

Question 7

Which of the following is usually issued by a professional society to indicate that a person has met a set of qualifications and is therefore qualified to perform a particular job?&#10;A)Certification&#10;B)Degree&#10;C)Licensure&#10;D)Registry

Accepted Answer

Certification is a credential issued by a professional society or organization that verifies that an individual has met predetermined qualifications for a particular job, such as passing an exam or completing certain education and experience requirements. A degree denotes completion of a course of study at a college, university, or other educational institution, but it does not necessarily indicate that the person is qualified to perform a specific job. Licensure is a government-issued permit that grants legal permission to practice in a particular profession, while a registry is a list of professionals who meet certain qualifications but may not necessarily be required to have a certification or license.

Question 8

Routine inspections include an evaLu&#7491;tion of how many layers of blood safety?&#10;A)Two&#10;B)Three&#10;C)Four&#10;D)Five

Accepted Answer

The answer of Routine inspections include an evaLu&#7491;tion of how...

Question 9

Which organization publishes Standards for Blood Banks and Transfusion Services?&#10;A)AABB&#10;B)ASCP&#10;C)CAP&#10;D)FDA

Accepted Answer

AABB (formerly known as the American Association of Blood Banks) is the organization that publishes Standards for Blood Banks and Transfusion Services. These standards are used by blood banks and transfusion services to ensure the safety and quality of blood products and transfusion procedures. The standards cover a wide range of topics such as donor eligibility, blood collection and processing, testing and labeling, and transfusion practices.

Question 10

Which code of federal regulations contains the rules for blood product safety?&#10;A)CFR title 10&#10;B)CFR title 21&#10;C)CFR title 29&#10;D)CFR title 42

Accepted Answer

CFR title 21 contains the rules for blood product safety. Title 21 includes regulations from the FDA that pertain to the safety and effectiveness of drugs, medical devices, food additives, and other products regulated by the agency.

Question 11

Most laboratory tests performed in blood banks and transfusion services are _________ tests.&#10;A)nonwaived&#10;B)waived&#10;C)centralized&#10;D)point-of-collection

Accepted Answer

The answer of Most laboratory tests performed in blood banks...

Question 12

Generally over-the-counter tests and some point-of-collection tests are classified as&#10;A)Nonwaived&#10;B)Waived&#10;C)Moderate complexity&#10;D)High complexity

Accepted Answer

The answer of Generally over-the-counter tests and some point-of-collection tests...

Question 13

When was the first license for a blood bank issued?&#10;A)1902&#10;B)1934&#10;C)1946&#10;D)1962

Accepted Answer

The answer of When was the first license for a...

Question 14

In North America,the three organizations currently most recognized for accrediting to ISO 15189 standards are all of the following except&#10;A)A2LA&#10;B)AABB&#10;C)CAP&#10;D)OLA

Accepted Answer

The answer of In North America,the three organizations currently most...

Question 15

Under which regulatory agency was the Bureau of Biologics housed?&#10;A)AMA&#10;B)CMS&#10;C)FDA&#10;D)NIH

Accepted Answer

The answer of Under which regulatory agency was the Bureau...

Question 16

Under which class of medical devices would reagents for diagnostic tests for HIV,HCV,and HBV fall?&#10;A)Class I&#10;B)Class II&#10;C)Class III&#10;D)Class IV

Accepted Answer

The answer of Under which class of medical devices would...

Question 17

Which organization enforces CLIA?&#10;A)AMA&#10;B)CBER&#10;C)CMS&#10;D)FDA

Accepted Answer

The answer of Which organization enforces CLIA?&#10;A)AMA&#10;B)CBER&#10;C)CMS&#10;D)FDA...

Question 18

All of the following organizations offer certification for clinical laboratory scientists except&#10;A)American Association of Bioanalysts&#10;B)American Association of Blood Banks&#10;C)Board of Certification of the American Society of Clinical Pathologists&#10;D)College of American Pathologists

Accepted Answer

The answer of All of the following organizations offer certification...

Question 19

In what year was the first test used to screen blood donors for HIV licensed?&#10;A)1976&#10;B)1981&#10;C)1985&#10;D)1990

Accepted Answer

The answer of In what year was the first test...

Question 20

A full inspection of all systems is designated as what level of inspection?&#10;A)Level I&#10;B)Level II&#10;C)Level III&#10;D)Level IV

Accepted Answer

The answer of A full inspection of all systems is...

Deck 20: Transfusion Safety and Regulatory Issues