CIIP Regulatory Compliance and Quality Assurance 2

Question 1

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

Accepted Answer

RadLex Playbook and LOINC codes

Answer

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

Question 2

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

Accepted Answer

Benchmark CT radiation dose indices against national and peer norms

Answer

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

Question 3

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

Accepted Answer

Bit-exact verification of stored vs. retrieved DICOM files

Answer

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

Question 4

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

Accepted Answer

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

Answer

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.

Question 5

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

Accepted Answer

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

Answer

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

CIIP - Certified Imaging Informatics Professional Practice Test

CIIP - Certified Imaging Informatics Professional Practice Test

CIIP Regulatory Compliance and Quality Assurance 2