Deck 24: Transfusion Safety and Federal Regulatory Requirements

Question 1

In what year did the FDA take over biologics regulation?

A) 1976
B) 1980
C) 1972
D) 1985

Answer 1

C

Question 2

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

Answer 2

C

Question 3

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 post-market stability
D) To rewrite employee job descriptions as needed

Answer 3

B

Question 4

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

Question 5

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

Question 6

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

Question 7

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

Question 8

FDA proposed regulations are published in ________.

A) Transfusion Medicine
B) The Federal Register
C) AABB Standards
D) Immunohematology

Question 9

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

Question 10

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

Question 11

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.

Question 12

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%.

Question 13

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

Question 14

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.

Question 15

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.

Question 16

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

Question 17

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

Question 18

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.

Question 19

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.

Question 20

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.

Question 21

Blood grouping reagents are considered medical devices according to the CBER.

Question 22

A drug is considered adulterated if the methods used to manufacture it do not conform with current good manufacturing processes.

Question 23

What is the purpose of a prelicense inspection by the CBER?

A) To order mandatory injunctions
B) To determine the firm's readiness for an unannounced inspection
C) To determine the firm's ability to operate in compliance with applicable regulations
D) None of the above

Question 24

The establishment license and one product license are issued simultaneously by the CBER.

Question 25

Upon the event of an adverse reaction that results in a transfusion-related fatality, the CBER must be notified within what time frame ?

A) 24 hours
B) 7 days
C) 30 days
D) not necessary to contact the CBER, but must contact the FDA

Question 26

All of the following is covered under the PHS Act except:

A) penalty for violation.
B) labeling requirements.
C) inspection requirements.
D) budget control.