Deck 27: Transfusion Safety and Federal Regulatory Requirements

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

Answer 1

A

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

Answer 2

C

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.

Answer 3

C

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

Question 5

FDA proposed regulations are published in .

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

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.

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

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.

Question 9

In what year did the FDA take over biologics regulation?

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

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

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%.

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.

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

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

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

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.

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

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

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

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.

Question 21

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

Question 22

Which FDA center regulates biological and related devices?

A) CBER
B) CDER
C) OBRR
D) OCBQ

Question 23

In a situation where exposure to a product is not likely to cause adverse health consequences, what type of recall will be issued?

A) Class I
B) Class II
C) Class III
D) None of these

Question 24

Which of the following is NOT included in the FDA's five layers of safety?

A) Competency testing of personnel
B) Donor screening and blood testing
C) Reviewing records of donor deferral
D) Quarantine of donor blood

Question 25

Which office performs FDA postmarket inspections of blood and blood component manufacturing facilities?

A) OBRR
B) OCBQ
C) ORA
D) None of these

Question 26

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

Question 27

In a situation where it is thought a product will cause serious adverse health consequences or death, what type of recall will be issued?

A) Class I
B) Class II
C) Class III
D) None of these

Question 28

Which of the following is are included in the FDA's five layers of safety?

A) Donor screening and review of deferral records
B) Blood testing and quarantine of donor unit
C) Investigation of all problems and deficiencies
D) All of these

Question 29

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 30

Which FDA center regulates therapeutic biological products?

A) CBER
B) CDER
C) OBRR
D) OCBQ

Question 31

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 32

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

Question 33

In a situation where there is a remote chance that a product will cause temporary or medically reversible adverse health consequences, what type of recall will be issued?

A) Class I
B) Class II
C) Class III
D) None of these

Question 34

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

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

Question 35

Under the regulated products section 21 CFR 607.20(a), who needs to register with the FDA?

A) The originating manufacturer
B) Contract manufacturers who produce the product for the originating manufacturer
C) Contract manufacturers who only perform one step of the manufacturing process
D) All of these

Question 36

Which of the following is true concerning a contract manufacturer?

A) Contract manufacturers are employed by another manufacturer to perform some part of the product's manufacturing.
B) Contract manufacturer is under the direct control of the original product manufacturer.
C) Contract manufacturers do not need to register with the FDA because they are not the originating manufacture.
D) All of these