FDA - Keeping it Clean
HIPAA - Basic Training
FDA University
HIPAA - Ture or False
100
This product line falls under FDA Regulations
What is telehealth
100
The acronym, HIPPA, stands for what?
What is Health Insurance Portability & Accountability Act
100
The acronym, FDA, stands for what?
What is the Food & Drug Administration
100
VRI, not Care Partners are required to have HIPAA policies in place and train staff annually?
False, Care Partners ARE required to have HIPAA policies in place and train their staff annually
200
Critical items present a high risk for infection if they are contaminated with microorganism. Objects that enter sterile tissue or the vascular system are critical items. In contrast, Telehealth Equipment is considered what type of item requiring less rigorous disinfection?
Non critical as they come in contact with intact skin but not mucous membranes. Intact skin acts as ab effective barrier to most microorganisms.
200
Under HIPAA, VRI considers itself this designation?
What is Covered entity under the definition of a healthcare provider who transmits health information in electronic form
200
This Federal government agency governs the FDA?
What is the Department of Health and Human Services
200
HIPAA requires that VRI and Care Partners inform their clients in writing of their rights and expecations of privacy with regards to their Protected Health Information?
True
300
This public entity creates guidelines for disinfection and sterilization of healthcare devices
What is CDC or Centers for Disease Control & Prevention
300
A person or entity that, on behalf of a covered entity, performs any of the following: function involving use or disclosure of individually identifiable health info including claims processing, data analysis, benefit management, any function or activity regulated by HIPA or provides legal, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation or financial serivces for such covered entity.
VRI considers Care Partners under this designation
300
As a distributor, VRI is required to disclose reportable events to this entity
What is FDA or Food and Drug Administration
300
HIPAA does not deal with physical facility security but focuses on hard copy and computer storage of personal health information
False, HIPAA Deals with physical facility security as well as hard copy and computer storage and transmission of personal health information
400
Non critical items should be exposed to an approved disinfectant for this period of time
What is 30-60 seconds
400
VRI requires a signature on this type of agreement (in addition to a contract)
What is a Business Associate Agreement or BAA
400
VRI is required to promptly notify and remove products that are recalled. Once units are retrieved they must be maintained in what until all units are received and shipped back to the Manufacturer.
What is a Quarantine
400
Client authorization is required for release of information related to treatment, payment or healthcare operations and once that authorization is received, any and all information can be shared
False, clients can restrict access and release of information
500
Why doesn't Telehealth Equipment require sterilization?
It is a non critical item that does not come in contact with mucous membranes
500
Establishment of permitted and required uses and disclosures of personal health information, ensuring that the entity will use personal health information as permitted or required by law, use appropriate safeguards, report any disclosures not permitted by the contract, ensure the agents to whom it provides protected health information will abide by the same restrictions and conditions, make protected health information available to individuals and makes it record available to the Department of Health and Human Services and authorize termination of contract by VRI if VRI determines there has been a violation is agreed upon in this document
What is a Business Associate Agreement or BAA
500
Unit #, Manufacturer's Serial #, New, Used Status, Sanitization, Tech Test, QC Test, Clean and Repack Represent What?
What is a Telehealth Equipment Checklist or FDA Log
500
The following are not required to be removed/de identified when transmitting data: telephone numbers, first 3 digits of a zip code containing 20,000 people or less, account numbers, fax numbers
False, all of these are to be removed, de-identified