Regulatory Compliance and Quality Assurance Flashcards

Which standard defines the structure and content of radiology reports to enable structured data exchange across imaging informatics systems?

Answer: RadLex Playbook and LOINC codes

RadLex Playbook provides standardized procedure naming while LOINC codes enable structured radiology report data exchange across informatics systems.

What is the purpose of the ACR's Dose Index Registry (DIR) in imaging informatics compliance?

Answer: Benchmark CT radiation dose indices against national and peer norms

The ACR DIR collects CT dose index data (CTDI, DLP) from participating facilities and provides benchmarking against national norms to support dose optimization.

In a PACS implementation, which quality assurance step ensures that images are stored and retrieved without data corruption?

Answer: Bit-exact verification of stored vs. retrieved DICOM files

Bit-exact verification (checksum comparison) confirms that stored DICOM files are retrieved without any data corruption or loss.

Which federal regulation requires hospitals to report certain adverse events related to medical devices, potentially including failures of imaging informatics systems?

Answer: FDA Medical Device Reporting (MDR) regulation 21 CFR Part 803

FDA MDR regulation (21 CFR Part 803) requires hospitals to report device malfunctions and adverse events, including failures of FDA-cleared medical device software like PACS.

What is the primary purpose of a Service Level Agreement (SLA) between a healthcare organization and a PACS vendor from a compliance perspective?

Answer: Define measurable uptime, response time, and support commitments to ensure regulatory compliance

An SLA defines enforceable performance metrics including uptime and support response times, helping organizations meet regulatory availability requirements for clinical systems.

Which quality improvement methodology is commonly used in radiology informatics to analyze and reduce repeat imaging studies caused by technical failures?

Answer: Six Sigma DMAIC process

Six Sigma's DMAIC (Define, Measure, Analyze, Improve, Control) methodology is widely applied to reduce defects and variability, including technical repeat rates in radiology.