2012-03-26 PCD Pulse Oximetry Project Meeting
Weekly Conference Call
Date: Monday, March 26th, 2012 Meeting will start at 1 pm.
Attendees
[actual]
- Leah Krynicky
- Ioana Singureanu
- Toni Philips
- Rob Rawlins
- Sean McFarland
- Tocher Kellom
- Serafina Versaggi
- Ken Fuchs
[expected]
- Don Morge
- Sara Toscano
- Ben Loewenbach
- Greg Staudenmaier
- John Rhoads
- Catherine Hoang
Agenda
- (05 min) Roll call and meeting minutes approval
- (20 min) Document Review Process We will discuss the process used
to peer-review the analysis model.
- (20 min) Finalize data requirements analysis.
- (5 min) Action item update
Meeting Notes
- Document Review Process: Ioana will put the documentation together and distribute through email. She will also provide a summary document to those new to the project. We will then walk through the document. Folks can annotate the document and return it and/or provide comments through a comment spreadsheet.
Ioana stated that she performed some research based on last week's discussion and learned that FDA does not prohibit but does not prefer devices sending default data when they cannot get a reading. Rob stated that he believes that this does not apply when there is a basis for the measurement. Rob stated that you want to make sure that if there is data available you get it. Rob stated that pulse oximeters can send a lot of data. We need to decide if we want the device to send this or if there should be an intermediary device. Ioana stated that we are building a spec for the future and are trying to make the information "better" than what we get right now. Rob stated that we may want to identify time boundaries for when a device reports data as current, reports it but flags it as not current, and when a device does not report data. This may be done by the device manager. Ioana stated this is not an interoperability requirement but might be an algorithmic requirement. Sean stated that knowing when the data was a real value would be important for research or for determining when an emergency event happened, but it is not key from a clinical perspective. Sean recommending having real data time stamped and having the information system sort/display information based on clinician defined intervals.
Ioana reviewed the information flow and workflow.
Regarding the data analysis model, Ioana stated that we are not trying to invent new standards. We are looking at reusing standards. All value sets are examples and will be adopted into standard terminology.
Toni asked if there should be a box for ICD-9 codes that might affect the oxygen saturation such as supplemental oxygen. These do not affect the device. Ioana stated that she would add this in because it is important for interpretation, but she would not expect the device to know these. Toni stated that the device may not be able to supply supplemental oxygen information. Ioana stated that this could be useful for decision support. Sean stated that supplemental oxygen, etc would be useful for spot checking. Toni asked if the information system is the final storage place for data. Ioana stated that the information could be used for research and that other devices might need the information. Toni suggested two work flows, one with the data going directly to the information system and one that indicates validation by a clinician prior to sending to the information system.
Ioana stated that the oximeter and the device manager might speak their own proprietary language, which is fine. We are using standards to allow communication with the information system