Regulatory Legal and Standards Flashcards
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
True
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
True
Scheduled patients can be screened by one staff member in order to save time. True or False?
True
False
False
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
thermal injuries, projectiles, hearing loss
The FDA approves how devices can be used and therefore we should never use them in any other way. True or False?
True
False
False
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
False
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
how many adverse events each staff member is responsible for
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
True
MRI access not restricted appropriately is a common citation on Joint Commission surveys. True or False?
True
False
True
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
False
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
The Department of Transportation
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
Patient screening
“Direct supervision” means that the physician must be immediately available and interruptible during contrast administration. True or False?
True
False
True
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
10 years, after which it must be renewed
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
Any and all adverse events
Ferromagnetic objects unintentionally entering the scan room only need reported if they result in an injury. True or False?
True
False
False
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
False
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
True
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
Non-MR personnel and must be under the supervision of Level 2 personnel while in Zone 4
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
False
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
24 hours
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
International Electrotechnical Commission (IEC)
There are no consequences to cancelling an MRI if the technologist wishes to do so. True or False?
True
False
False
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
False
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
True
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
How the device was tested and the information that was submitted to support the testing
