Friday, July 21, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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1. Which of the following measures is the most important to decrease the risk of disease transmission in tissue transplantation?

 

o

An appropriate medico-social history

o

Performance of virus testing by NAT

o

Performance of blood cultures

o

Maintenance of a donor serum archive

 

 

2. What do you understand by risk?

 

 

o

Potential damage caused by a current process or a future event

o

The probability that an event of determined severity will occur in a specific place within a specific time frame

o

A situation characterized by a serious interruption of the normal functioning conditions or processes

o

Susceptibility and predisposition to suffer adverse events when impacted by a dangerous element

 

 

3. Which of the following combinations allows the evaluation of a defined risk with precision?

 

o

Probability and detectability

o

Probability and severity

o

Severity and detectability

o

Probability, severity and detectability

 

 

 

4. Which of the following is not a part of the risk management process?

 

o

Risk identification

o

Risk analysis

o

Risk evaluation

o

All are part of risk management

 

 

5. Which of the following measures is not suitable to reduce risks?

 

o

Reduce severity

o

Reduce probability

o

Reduce detectability

o

Reduce severity and probability

 

 

6. Within a system of risk management, the acceptance of the risk implies that there is a

 

o

a. Residual Risk

o

b. Theoretical risk

o

c. Treatment

o

d. Relative risk

 

 

7. Which of the following processes is being conducted in an inappropriate environment

 

o

Dressing for entering a processing area in grade D or locker room in grade D

o

Open sterile processing in Grade D

o

Packaged product stored in a non-classified area

o

Open sterile processing in Grade A

 

8. Which of the following actions can give rise to cross contamination?

 

o

Use of gloves

o

b. Inadequate maintenance of differential pressure

o

Leaving the doors opened

o

Daily cleaning

 

 

9. Which of the following statements regarding processing rooms is incorrect?

 

o

The disinfectants used for cleaning should be periodically alternated

o

The cleaning products need to be clearly specified in the cleaning procedure

o

There is a need to keep cleaning records

o

Processing rooms need to be cleaned only when dirty

10. Which one of the following controls is insufficient?

 

o

Annual microbiological monitoring of grade A surfaces

o

Annual air validation in grade D

o

Daily control of non-viable particles in grade C

o

Weekly microbiological sampling in changing rooms

 

 

11. A bio-vigilance system requires the notification, registration and communication of:

 

 

o

Possible infectious disease that has been transmitted to the recipient through a tissue transplant.

o

A failure in the tissue processing conditions within a Tissue Establishment

o

A lack of documentation at the implantation centre regarding the final destination of the tissue

o

All of the above

 

 

 

14. Quality control includes:

 

o

Calibration of equipment with a critical measurement function

 

o

Sampling and testing during the process

o

Quality verification of the final product

o

all of the above

 

 

 

 

16. According to DIRECTIVE 2004/23/EC the responsible person shall be responsible for:

 

 

o

a. Ensuring that human tissues and cells are procured, tested, processed, stored and distributed in accordance with the current European Regulations and national laws

o

b. Providing to the CA the required information related to accreditation, designation, authorisation or licensing of tissue establishments and tissue and cell preparation processes.

o

c. Reporting any relevant information to establishments engaged in the donation, procurement, testing, processing, storage and distribution of human tissues and cells in order to facilitate traceability and ensure quality and safety control.

o

d. Establishing a system to assure that any potential donor is detected in an adequate period of time to perform an effective donation

 

 

 

17. Which of the following conditions/qualifications is not compulsory for the TE responsible person?

 

o

Possession of a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences.

o

At least two years practical experience in the relevant fields

o

Knowledge in quality system, including training

o

PhD in the field of field of medical or biological sciences

 

18. In which of the following BINOMIOS independency is needed?

 

o

QC/Head of processing

o

QA/Head of processing

o

Qualified person/ QC

o

Qualified person/ Head of processing

 

 

19. Who evaluates donor suitability?

 

o

The director

o

The MD responsible for retrieval

o

The technician who performs the retrieval

o

The biologist

 

 

 

20. TEs:           

           

o

Have to plan a warning system for serious events and adverse reactions but they’re not forced to communicate them

o

Decide to manage a serious event or adverse reaction on their own and they’re not forced to communicate it

o

Have to plan a warning system to communicate serious events and adverse reactions to the competent authority

o

 

 

 

 

21. Tissue retrieval must be performed:

 

o

Within 24h since cardiac arrest being the corpse cooled

o

Within 12h since cardiac arrest being the corpse cooled

o

Within 8h since cardiac arrest being the corpse not cooled

o

Within 24h since cardiac arrest being the corpse not cooled

 

 

 

22. A donor is not suitable in case of:

 

o

Positivity for HIV or HBV

o

Risky social behaviour

o

Risky social behaviour during the last 12 months

o

All the answers are correct

 

23. Heart valves can be retrieved in:

 

o

NHB donors

o

HB donors

o

Domino donors

o

All the answers are correct

 

24. How long should the donor record be kept?

 

o

5 years

o

10 years

o

30 years

 

 

25. The tissue can be reported and distributed:

 

o

By any pharmaceutical company

o

After the competent authority permission

o

In case of emergency without permission

 

 

26. Distribution’s documentation must indicate:

 

o

Possible antibiotic traces

o

Storage temperature

o

All substances used to preserve tissues

o

All the answers are correct

 

 

27. All TEs must have:

 

o

A certified quality system

o

An accredited quality system

o

A quality system

 

 

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