Regulatory Compliance and Quality Assurance Flashcards

Which accreditation standard specifically addresses the quality and safety of teleradiology services in the United States?

Answer: ACR Practice Parameter for Teleradiology

The ACR Practice Parameter for Teleradiology sets standards for image quality, turnaround time, credentialing, and communication in remote radiology interpretation.

What does IEC 62304 regulate in the context of imaging informatics software development?

Answer: Medical device software lifecycle processes

IEC 62304 defines lifecycle requirements for medical device software, including planning, development, testing, and maintenance applicable to PACS and CAD software.

In imaging informatics, which process ensures that a new PACS version does not introduce regression errors before clinical deployment?

Answer: User acceptance testing (UAT) with validated test cases

UAT with validated test cases verifies that new PACS releases meet clinical requirements and do not break existing functionality before go-live.

Which concept describes the process of formally documenting that an imaging informatics system performs as intended throughout its operational life?

Answer: System validation

System validation is the documented process of confirming that a system consistently performs according to its specifications and intended use over its lifecycle.

Under The Joint Commission standards, what must a hospital have in place to manage downtime procedures when PACS or RIS is unavailable?

Answer: Documented downtime procedures and backup processes tested regularly

Joint Commission standards require healthcare organizations to document, communicate, and regularly test downtime procedures to maintain continuity of care when IT systems fail.

What is the role of the CIIP professional during a regulatory audit of an imaging department's informatics systems?

Answer: Provide documentation of system configurations, validations, access controls, and compliance policies

The CIIP professional supports audits by providing organized documentation of system configurations, validation records, access control policies, and compliance evidence.