Test 5 Part 20

Question 1

______ requires specific medical device information to be reported within 10 days
User facility report number
Name and address of the device manufacturer
Device brand name and common name
Product model, catalog, serial, and lot numbers
Brief description of event reported to manufacturer and the FDA
Where report was submitted (FDA, manufacturer, or distributor)

Answer 1

FDA

Question 2

Medical Device Reporting done through Safety Information and Adverse Event Reporting Program

Answer 2

MedWatch

Question 3

Medical device: FDA also encourages _________ of adverse events related to products or technologies to MedWatch

Answer 3

voluntary reporting

Question 4

Medical device: FDA does not regulate ________ working with ONC and FCC representatives to improve the safe use of EHR technology, encourages voluntary reporting of problems with EHRs

Answer 4

EHRs

Question 5

_______ allows medical device reporting without patient authorization

Answer 5

HIPAA

Question 6

Under Freedom of Information and Privacy Act, _____ information may be accessed but _____ is required to delete

Answer 6

FDA

Question 7

Federal law requires that hospitals notify designated ___________ in a timely manner regarding specified organ donors who die in the hospital or for whom death is imminent

Answer 7

organ procurement organization (OPO)

Question 8

Hospital and OPO must do annual ______ record reviews

Answer 8

death

Question 9

_______ is not violating confidentiality by calling the OPO and providing information about an individual who has died

Answer 9

Hospital

Question 10

No _______ in statute or regulations that family be informed about hospital’s notification to OPO before OPO can be contacted

Answer 10

requirement