Regulatory Legal and Standards Flashcards

1
Q

The attending radiologist or medical director has the final determination on whether to scan or not scan any patient with an implant or device. True or False?

True

False

A

True

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1
Q

The attending radiologist or medical director has the final determination on whether to scan or not scan any patient with an implant or device. True or False?

True

False

A

True

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2
Q

Scheduled patients can be screened by one staff member in order to save time. True or False?

True

False

A

False

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3
Q

The three most common non contrast related events reported to the FDA are:

hearing loss, allergic reactions, staff lifting injuries

thermal injuries, patient complaints, scheduling delays

thermal injuries, projectiles, hearing loss

A

thermal injuries, projectiles, hearing loss

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4
Q

The FDA approves how devices can be used and therefore we should never use them in any other way. True or False?

True

False

A

False

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5
Q

When the radiologist is unfamiliar with an implant or safety procedure, the responsibility for clearing that implant falls to the MRSO on duty. True or False?

True

False

A

False

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6
Q

According to The Joint Commission, MRI sites should collect data on all of the following EXCEPT:

any MRI-related patient thermal injuries

incidents where ferromagnetic objects have unintentionally entered the MRI scanner room

how many adverse events each staff member is responsible for

injuries resulting from the presence of ferromagnetic objects in the MRI scanner room

A

how many adverse events each staff member is responsible for

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7
Q

Scheduled patients should be screened by at least 2 separate individuals, one of whom should be Level 2 MR trained. True or False?

True

False

False

A

True

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8
Q

MRI access not restricted appropriately is a common citation on Joint Commission surveys. True or False?

True

False

A

True

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9
Q

MRI safety training (Level 1 and Level 2) and safety screening should be completed annually. This does not apply to the radiologists/physicians supervising MR contrast administration. True or False?

True

False

A

False

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10
Q

In the U.S. the color of medical gas cylinders is regulated by:

The FDA

The president

The Department of Transportation

The medical gas supplier

A

The Department of Transportation

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11
Q

According to the 2016 TJC review of survey results related to MR safety, the top 4 citations included all the following except:

Lack of zone and warning signage

Ferromagnetic items entering Zone 4

MRI access not restricted

Documentation of required MR personnel training

Patient screening

A

Patient screening

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12
Q

“Direct supervision” means that the physician must be immediately available and interruptible during contrast administration. True or False?

True

False

A

True

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13
Q

MRSO certification through the ABMRS lasts for:

forever and ever

one year

10 years, after which it must be renewed

it depends on where you live

A

10 years, after which it must be renewed

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14
Q

According the the ACR Guidance Document, what types of incidents should be reported to the medical director in a timely manner?

Near incidents

Incidents in which patients experienced harm

Contrast Reactions and Incidents in which patients experienced harm

Any and all adverse events

A

Any and all adverse events

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15
Q

Ferromagnetic objects unintentionally entering the scan room only need reported if they result in an injury. True or False?

True

False

A

False

16
Q

If no policies and procedures are in place, it is acceptable for a technologist to cancel an MRI examination due to screening questions without consulting the attending radiologist. True or False?

True

False

A

False

17
Q

Patients should be educated that they might feel tugging or pulling on large implanted metallic nonferrous devices when being moved into or out of the bore. True or False?

True

False

A

True

18
Q

For the purposes of MR safety, patients are considered __________.

Level 1 MR personnel because they have been screened

Level 2 MR personnel if they have had prior MRI’s

Non-MR personnel and must be under the supervision of Level 2 personnel while in Zone 4

A

Non-MR personnel and must be under the supervision of Level 2 personnel while in Zone 4

19
Q

According to the Centers for Medicare & Medicaid Services (CMS), it is acceptable to administer contrast without a physician immediately available. True or False?

True

False

A

False

20
Q

According to the ACR Guidance Document, what is an acceptable window of time in which any and all adverse events, MR safety incidents, or “near incidents” that occur in the MR site are to be reported to the medical director?

24 hours

48 hours

1 week

Quarterly

A

24 hours

21
Q

Who defines the operating modes for MR systems - Normal, First Level, Second Level?

Each manufacturer defines its own limits

Applications when setting up the system with the user

International Electrotechnical Commission (IEC)

The scanning technologist

A

International Electrotechnical Commission (IEC)

22
Q

There are no consequences to cancelling an MRI if the technologist wishes to do so. True or False?

True

False

A

False

23
Q

According to the Centers for Medicare & Medicaid Services (CMS), “direct supervision” means the physician should be in the MRI room. True or False?

True

False

A

False

24
Q

It is acceptable for non-MRI staff to perform initial patient screening as long as it is followed by screening by Level 2 MRI staff. True or False?

True

False

A

True

25
Q

The FDA approves:

All devices for all possible scenarios of use

How the device was tested and the information that was submitted to support the testing

The maximum exposure a device can have before it fails

The only way a device should be used

A

How the device was tested and the information that was submitted to support the testing