CIIP Regulatory Compliance and Quality Assurance

Question 1

Which accreditation body sets quality standards for diagnostic imaging in the United States that directly impact informatics systems?

Accepted Answer

American College of Radiology (ACR)

Answer

Joint Commission on Accreditation (TJC) only

Answer

College of American Pathologists (CAP)

Answer

American Board of Radiology (ABR)

Question 2

What does FDA 21 CFR Part 11 regulate in the context of imaging informatics?

Accepted Answer

Electronic records and electronic signatures in regulated environments

Answer

Radiation dose limits for CT and fluoroscopy procedures

Answer

Licensing requirements for medical imaging professionals

Answer

Import/export of medical imaging devices

Question 3

In the context of PACS quality assurance, what is the primary purpose of monitor calibration using DICOM GSDF?

Accepted Answer

Ensure consistent image brightness perception across different display systems

Answer

Reduce network bandwidth used by DICOM transmissions

Answer

Automatically compress images to save storage space

Answer

Synchronize timestamps across all imaging modalities

Question 4

Which regulatory body must clear or approve PACS software as a medical device before it can be used in clinical diagnosis in the US?

Accepted Answer

US Food and Drug Administration (FDA)

Answer

Centers for Medicare & Medicaid Services (CMS)

Answer

Office for Civil Rights (OCR)

Answer

National Institute of Standards and Technology (NIST)

Question 5

What is the main goal of a radiology department's Image Quality Management (IQM) program?

Accepted Answer

Ensure images meet diagnostic quality standards while managing dose and workflow

Answer

Maximize the number of studies processed per hour

Answer

Reduce the cost of imaging storage infrastructure

Answer

Comply with billing and coding requirements only

Question 6

Under CMS Conditions of Participation, which of the following is a compliance requirement for hospitals using electronic health records including PACS?

Accepted Answer

Medical records must be retained for a minimum period and be accessible to treating clinicians

Answer

All imaging records must be stored only on on-premises servers

Answer

PACS systems must use proprietary formats for image storage

Answer

Radiology reports must be dictated within 1 hour of image acquisition