Regulatory Compliance and Quality Assurance Flashcards

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

Answer: American College of Radiology (ACR)

The ACR establishes practice guidelines and technical standards for diagnostic imaging, including requirements for PACS, structured reporting, and image quality.

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

Answer: Electronic records and electronic signatures in regulated environments

FDA 21 CFR Part 11 governs electronic records and electronic signatures, ensuring their integrity, authenticity, and trustworthiness in regulated healthcare environments.

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

Answer: Ensure consistent image brightness perception across different display systems

DICOM Grayscale Standard Display Function (GSDF) calibration ensures that monitors display images with consistent perceived brightness, critical for accurate diagnosis.

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

Answer: US Food and Drug Administration (FDA)

The FDA regulates PACS and diagnostic imaging software as medical devices, requiring 510(k) clearance or PMA approval before clinical use.

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

Answer: Ensure images meet diagnostic quality standards while managing dose and workflow

An IQM program systematically monitors image quality, radiation dose, equipment performance, and workflow to maintain diagnostic standards and patient safety.

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

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

CMS Conditions of Participation require that medical records, including imaging, be retained per state law minimums and remain accessible to authorized clinicians.