Question 1

What is contained in Form FDA-483?
A) Objectionable conditions noted by an FDA inspector
B) An FDA checklist used by inspectors
C) A list of blood banks that perform in-house viral testing
D) A list of certified FDA inspectors

Accepted Answer

Form FDA-483 contains observations of objectionable conditions noted by an FDA inspector during an inspection.

Question 2

Why is the Center for Biologics Evaluation and Research (CBER) notified in the case of a transfusion-related fatality?
A) To recall all banked units
B) To disclose the name of the deceased
C) To determine if appropriate corrective action has been taken to prevent recurrence
D) To report all reagent lot numbers used in typing deceased patient

Accepted Answer

CBER is notified to ensure that appropriate corrective actions are taken to prevent similar incidents in the future, as part of their role in overseeing the safety of biological products.

Question 3

The law that began and mandated regulation of biological products in the United States was called:
A) PHS Act of 1902.
B) Product Safety Act of 1902.
C) Biologics Control Act of 1902.
D) none of the above.

Accepted Answer

The Biologics Control Act of 1902 was the first law in the United States to mandate the regulation of biological products, ensuring their safety and efficacy.

Question 4

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?
A) Joint Commission
B) AABB
C) CAP
D) CBER

Accepted Answer

The Center for Biologics Evaluation and Research (CBER) is the branch of the FDA responsible for regulating biological products, including blood and blood products. They must be contacted when a biological deviation occurs that could impact safety.

Question 5

FDA proposed regulations are published in .
A) Transfusion Medicine
B) The Federal Register
C) AABB Standards
D) Immunohematology

Accepted Answer

FDA proposed regulations are published in The Federal Register.

Question 6

The short supply agreement is between the blood establishment and:
A) the broker.
B) the final product manufacturer.
C) the donor.
D) none of the above.

Accepted Answer

The short supply agreement is typically between the blood establishment and the final product manufacturer, as it involves the supply of blood or blood components for further manufacturing into final products.

Question 7

What is the primary focus of quality assurance?
A) To place blame on employees who make recurring errors
B) To amend the system, procedure, or standard operating procedures, if deemed faulty
C) To analyze postmarket stability
D) To rewrite employee job descriptions as needed

Accepted Answer

Quality assurance primarily focuses on improving systems, procedures, or standards to prevent errors and ensure quality, rather than placing blame on individuals.

Question 8

One change that occurred under the FDA for oversight of biologics was that the FD&C Act now labeled biologics as:
A) blood products.
B) drugs.
C) reagents.
D) growth factors.

Accepted Answer

The FD&C Act (Federal Food, Drug, and Cosmetic Act) categorized biologics as drugs, which brought them under the regulatory oversight of the FDA.

Question 9

In what year did the FDA take over biologics regulation?
A) 1976
B) 1980
C) 1972
D) 1985

Accepted Answer

In 1972, the regulation of biologics was transferred to the FDA from the National Institutes of Health.

Question 10

Establishments that hold U.S. licenses for a biological product can:
A) ship products interstate and internationally for sale or exchange.
B) only ship and sell products interstate.
C) market multiple trademark for their product.
D) All of the above

Accepted Answer

Establishments with U.S. licenses for a biological product can ship products both interstate and internationally for sale or exchange, as long as they comply with relevant regulations.

Question 11

Which of the following provides just cause for a product recall by the FDA?
A) The donor blood pressure reading was omitted in donor screening.
B) An A-positive packed red blood cell unit was labeled as an A-negative packed red blood cell unit.
C) An autologous unit was found reactive for anti-HBc.
D) A therapeutic whole blood unit had a hematocrit of greater than 80%.

Accepted Answer

Labeling a blood product with the incorrect blood type can lead to serious transfusion reactions, which is a just cause for a product recall by the FDA.

Question 12

In 1970, the Public Health Service Act was expanded to include:
A) provisions for licensing products.
B) blood and blood components and derivatives.
C) guidelines for suspending licenses for violations.
D) authorization for facility inspection.

Accepted Answer

The 1970 amendment to the Public Health Service Act expanded its scope to include the regulation of blood, blood components, and derivatives.

Question 13

Which of the following prevents interstate shipment of biological products by an establishment?
A) An FDA warning letter
B) An FDA suspension
C) FDA form 483
D) Short supply

Accepted Answer

An FDA suspension prevents interstate shipment of biological products by an establishment, as it indicates that the establishment is not in compliance with regulatory requirements.

Question 14

Biological products are defined as any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component (or derivative allergenic products) or analogous product applicable to the prevention, treatment, or cure of disease or injuries of man. Which specific product was missing in the original PHS statute?
A) Vaccine
B) Blood component
C) Antitoxin
D) Virus

Accepted Answer

Blood components were not originally included in the Public Health Service (PHS) statute when it was first enacted.

Question 15

Which of the following would constitute short supply and an exemption from licensure?
A) RBCs used in the manufacturing of check cells
B) Recovered plasma used in the making of platelets
C) Recovered plasma used in the manufacturing of factor VIII
D) Whole blood used in the manufacturing of hemoglobin substitute

Accepted Answer

Recovered plasma used in the manufacturing of factor VIII is considered in short supply and may be exempt from licensure requirements.

Question 16

All of the following is correct regarding recovered plasma except:
A) it is derived from single units of expired whole blood.
B) it is derived from single units of unexpired whole blood.
C) it is a licensed source material used in the manufacturing of licensed products.
D) it is an unlicensed source material used in the manufacturing of licensed products.

Accepted Answer

Recovered plasma is a licensed source material used in the manufacturing of licensed products, not an unlicensed one.

Question 17

What is the function of the CBER?
A) To monitor continuing education at designated facilities
B) To issue federal licenses to establishments that are manufacturing biological products
C) To issue certification to medical technologists
D) None of the above

Accepted Answer

The Center for Biologics Evaluation and Research (CBER) is responsible for regulating biological products, including issuing federal licenses to establishments that manufacture these products.

Question 18

What protocol is followed for licensed products generated at a different site from the original licensed site or establishment?
A) Product license is automatically transferred from site to site.
B) An amendment is filed to the product license application.
C) A separate product license must be issued for each additional site.
D) None of the above

Accepted Answer

An amendment is filed to the product license application to include the new site, ensuring regulatory compliance and oversight for the new manufacturing location.

Question 19

Which part of quality assurance ensures that products are consistently manufactured according to, and controlled by, the quality standards appropriate for their intended use?
A) Quality control
B) Reproducibility
C) Delta check
D) Good manufacturing practices

Accepted Answer

Good manufacturing practices (GMP) ensure that products are consistently produced and controlled according to quality standards appropriate for their intended use.

Question 20

The FDA-directed civil action that calls for removal of products from distribution channels is known as:
A) injunction.
B) seizure.
C) prosecution.
D) quarantine.

Accepted Answer

Seizure is the FDA-directed civil action that involves removing products from distribution channels to prevent them from being sold or distributed.

Quiz 27: Transfusion Safety and Federal Regulatory Requirements

What is contained in Form FDA-483?

Why is the Center for Biologics Evaluation and Research (CBER) notified in the case of a transfusion-related fatality?

The law that began and mandated regulation of biological products in the United States was called:

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?

FDA proposed regulations are published in .

The short supply agreement is between the blood establishment and:

What is the primary focus of quality assurance?

One change that occurred under the FDA for oversight of biologics was that the FD&C Act now labeled biologics as:

In what year did the FDA take over biologics regulation?

Establishments that hold U.S. licenses for a biological product can:

Which of the following provides just cause for a product recall by the FDA?

In 1970, the Public Health Service Act was expanded to include:

Which of the following prevents interstate shipment of biological products by an establishment?

Which of the following would constitute short supply and an exemption from licensure?

All of the following is correct regarding recovered plasma except:

What is the function of the CBER?

What protocol is followed for licensed products generated at a different site from the original licensed site or establishment?

Which part of quality assurance ensures that products are consistently manufactured according to, and controlled by, the quality standards appropriate for their intended use?

The FDA-directed civil action that calls for removal of products from distribution channels is known as: