20151023 OO FHIR conCall

HL7 OO on FHIR (for Orders and Observations) Call in details: Phone: +1 770-657-9270, Passcode: 398652 Join the meeting at: https://join.me/vernetzt.us		Date: 2015-10-22 2015 - 02:00 PM (Eastern Time, GMT -04 DST)
Chair:		Note taker(s): EH:

Quorum = chair + 4

no

Co chairs

Riki Merrick

Rob Hausam

Lorraine Constable

Patrick Lloyd

Ken McKaslin

Hans Buitendijk

Fhir Editor/Facilitator

Eric Haas

Attendees
	Hans Buitendijk
	Bill Gregory - Pfizer		Rob Hausam		Eric Haas
						.

Agenda and Notes

• Roll Call
• Agenda Check
• Administrative
• Discussion Topics
  • Device [1]
  • HL7 Whitepaper on UDI
    • Mapping to UDI and MU 2015
      • Spreadsheet mapping across standards and MU
      • Review guidance in notes and element comments and whether need to clearly point to what gos where in core or leave it to profile since I am unclear on whether the 6 parts are US Realm specific.
      • Do we need a resource for HCT/Ps or create an extension for the DIN?
      • MU mentions additional stuff that patients will have access to. - Extension candidates?

§ 170.315 2015 Edition health IT certification criteria.
... (pp 515ff)
(14) Implantable device list. 
(i) Record Unique Device Identifiers associated with a patient’s Implantable Devices.
(ii) Parse the following identifiers from a Unique Device Identifier:
	(A) Device Identifier;
	(B) The following identifiers that compose the Production Identifier:
		(1) The lot or batch within which a device was manufactured;
		(2) The serial number of a specific device;
		(3) The expiration date of a specific device;
		(4) The date a specific device was manufactured; and
		(5) For an HCT/P regulated as a device, the distinct identification code required by 21 CFR1271.290(c).
(iii) Obtain and associate with each Unique Device Identifier:
	(A) A description of the implantable device referenced by at least one of the following:
		(1) The “GMDN PT Name” attribute associated with the Device Identifier in the Global Unique Device Identification Database.
		(2) The “SNOMED CT® Description” mapped to the attribute referenced in paragraph (a)(14)(iii)(A)(1) of this section.
	(B) The following Global Unique Device Identification Database attributes:
		(1) “Brand Name”;
		(2) “Version or Model”;
		(3) “Company Name”;
		(4) “What MRI safety information does the labeling contain?”; and
		(5) “Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437).”
(iv) Display to a user an implantable device list consisting of:
	(A) The active Unique Device Identifiers recorded for a patient; and
	(B) For each active Unique Device Identifier recorded for a patient, the description of the implantable device specified by paragraph (a)(14)(iii)(A) of this section.
	(C) A method to access all Unique Device Identifiers recorded for a patient.
(v) For each Unique Device Identifier recorded for a patient, enable a user to access:
	(A) The Unique Device Identifier;
	(B) The description of the implantable device specified by paragraph (a)(14)(iii)(A) of this section;
	(C) The identifiers associated with the Unique Device Identifier, as specified by paragraph (a)(14)(ii) of this section;
	(D) The attributes associated with the Unique Device Identifier, as specified by paragraph (a)(14)(iii)(B) of this section.
(vi) Enable a user to change the status of a Unique Device Identifier recorded for a patient.

Tracker comments

Updated based on OO on FHIR discussion 20151022

*8925 add UDI string HRF formats to Identifer type codes (None) None
*8929 extensions for GUDID data elements (None) None
*5985 Suggest that if a UDI is present that it alone be recorded, and other values be recorded when there is not UDI present (Eric Haas) Not Persuasive
*5507 Jan 2015 Ballot Comment #444 (Leslie Tompkins) Not Persuasive with Mod
*8926 Provide Clearer guidance for UDI components (None) Persuasive
*8927 Clarify Device scope in introduction (None) Persuasive
*5623 scope and boundary between device and b/t/o, (Eric Haas) Persuasive with Mod
*7254 2015May core #373 - UDI doesn't identify repository/jurisdiction (Paul Knapp) Persuasive with Mod In Person
*8928 W5 Mapping and reordering of device (None) Persuasive with Mod

QA issues: possible assignments

DSTU_QA_Guidelines QA spreadsheet [2]

Minutes

Next Steps

Actions (Include Owner, Action Item, and due date) Create examples using both UDI and 6 parts, and using both styles. -EH , by DSTU 3.0

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