PenTips #189 – Regulation Changes


Breast Density and Personal Breast Cancer Indicators

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For modality resource optimization, last known breast density value was added to patient maintenance screen. Breast density value is also incorporated on the patient list, reading schedule and RIS order worklists as a number.

 

Gender Identity and Sexual Orientation

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The latest healthcare regulation recognizes patient’s preference for Gender Identity and Sexual Orientation. These additional controls were added to the patient maintenance screen.

 

When sexual orientation is dissimilar to the administrative gender, patient’s M/F indicator has a discreet suffix asterisk modifier displayed in patient information bar. An option is added to suppress both gender identity and sexual orientation controls.

*Clients should evaluate their patient correspondences and remove salutation references based on administrative gender to avoid the possible conflicts.

Implanted Device GUDID

Initially when introduced as part of new regulation from FDA’s Center for Devices and Radiological Health, all implanted items required the GUDID number (Global Unique Device Identification Database).

The number, body location and the patient were to be submitted to a GUDID registry. The GUDID number was to be included in the narrative report, and tracked by facility for product recalls for example.

PenRad’s initial 7.0 release required GUDID numbers for clips, based on the requirements. As of 6-2017 FDA has delayed requirement based on the FDA device class. We are awaiting official guidance for mark clips.
https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM561575.pdf

PenRad added an option not to require GUDID with procedure. Optional recording post exam is available via the patient GUDID tracking screen.

Synthetic 2D Modifier

Added “with synthetic 2D” modifier for tommographic mammogram. This modifier is incorporated into the exam title type for differentiation. This exam modifier can insert a custom phrase or be combined with tomographic imaging phrase located in exam narrative, to insure appropriate phraseology for reimbursement.

Interested in one-on-one training or a refresher? This insures your facility is incorporating all the latest technology, thus maximizing efficiency and economics. Give us a call at 763-475-3388.

Recommendation for product development?
[email protected] | 763.475.3388

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