Project Summary for Blood Center System to System Messaging
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Project Details
Number | 521 View Ballot Items List (with NIBs) |
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Name | Blood Center System to System Messaging |
Sponsor(s) | Orders and Observations Work Group |
Co-Sponsor(s) | |
Steering Division | Administrative |
Description | Blood center and transfusion services software is considered a Class II medical device by the U.S. Food and Drug Administration (FDA). Any modification to this type of software that impacts the decision making process will always require a 510(k) amendment as well as clearance from the FDA. Blood centers have historically had only one vended system that was expected to perform all of the functionality needed to meet their operational needs. However, with the increased trend in mobile and off-site collections and changing technologies, other system solutions are being utilized to meet these needs. This necessitates the use of multiple vended solutions which increases the need for system to system communication. With each system interface, the vendor has to go through the 510(k) amendment process which is very costly and delays implementing the solution. Meanwhile, manual entry of data from one system to another presents opportunity for error, and this negatively affects blood product labelling and safety of the patient. In the fall of 2008, blood centers, software vendors and the FDA had a meeting to discuss now to streamline the FDA 510(K) process to accommodate the introduction of new technology and integration among systems in blood banking. One of the outcomes of the meeting was an FDA recommendation to develop a standard for exchanging donor-related, blood product and transfusion services information. Initial work on data modeling for HL7 Version 3.0 had already been started through a different project which is not currently active. Several members of the Version 3.0 data modeling project are working on the project described in this document in order to provide some continuity. This intent of this project is to meet the current growing demands of the blood bank industry by creating the system to system messaging that is needed. The intent of this project is as follows: - Evaluate and enhance, as necessary, the existing messaging in the HL7 Version 2.x standard that will enable blood centers and transfusion medicine entities and operations to exchange data between systems in the same facility and systems in multiple facilities. - The enhanced messaging will include the transmission of donor and donor related information not currently included in the HL7 Standard. - The enhanced messaging will utilize existing messages, segments and fields in HL7 Version 2.x as much as appropriate to the trigger event. The initial scope of the project is to develop messaging for use during donor registration, medical screening, and phlebotomy to meet the growing industry demand for a standard means of communications between the various system solutions that provide different types of functionality to the blood center. Examples of current communication needs include the following: - Blood Establishment Computer System (BECS) may need to query a deferral database for deferred donors - BECS will need to transmit donor demographic and donor registration information to an Electronic Medical Screening System - Electronic Medical Screening System will need to transmit the results of the medical screening to the BECS - Electronic Medical Screening System will need to transmit the phlebotomy information related to the donor's donation to the BECS The goals of the project are as follows: - Evaluate the existing Enhance HL7 Version 2.x to include system to system messaging for the exchange of donor and blood product information between systems - Define trigger events, message types, and segments appropriate to the information to be exchanged - Incorporate, where appropriate, blood product/transfusion-related messaging structures that previously were developed for HL7 Version 2.5, including, but not limited to order entry and observation reporting. - Create messaging that conforms to defined HL7 standards - Incorporate ISBT 128 Blood Product Coding - Upon completion of initial scope, expand the initial scope to include messaging necessary for communications required by all steps within blood banking operations and transfusion services. |
Project Facilitator | Patti Larson; Jonathan Harber; Shankar Goudar |
Status | Archived |
SD Approval Date | Aug 17, 2009 |
TSC Approval Date | Aug 24, 2009 |
Type | Ballot - Informative |
Objectives / Deliverables | The objectives for the initial scope of the project include the following: - Define the functional events that would be cause a message to be triggered. - Determine the details of the donor demographic, pre-donation screen and phlebotomy data to be transmitted for each of the functional events - Create white paper for submission to HL7 for comment Target Date for the above: October, 2009 - Define the HL7 Trigger Events - Create new HL7 Message Types to be used transmit this information - Determine the HL7 Segments that will be used to transmit the information in each message - Create any new HL7 Segment that will be required for these messages - Define the fields for each of the new HL7 Segments - Submit new messages to HL7 for balloting. Target Date for the above: July, 2010 |
Next Milestone Date | 2012 January WGM |
Project End Date | 2012 January WGM |
Project Intent | Revise Current Standard |
Project Need | |
Implementers | 1) Blood Systems, Inc. (BSI) – Jonathan Harber, jharber@bloodsystems.org 2) BloodCenter of Wisconsin (BCW) – Rodeina Davis, rodeina.davis@bcw.edu |
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Lineage | |
Dependancies | None |
Project Document Repository | http://wiki.hl7.org/index.php?title=BTO_v2 |
Backwards Compatibility | |
External Vocabularies | |
Products | V2 Messages-Clinical |
Joint Copyright? | |
External Pjt Collaborators | Clinical Interoperability Council (CIC) Work Group Members of the Project are volunteers from the following organizations/facilities: - America's Blood Centers - North America's network of non-profit community blood centers - ICCBBA - International standards organization for the identification and labelling of blood, tissues and organs. - Vendors - Blood establishment and related computer system vendors - Industry experts from numerous Blood Centers The project team will need to include an HL7 Technical expert to assist in the creation and definition of HL7 Trigger Events, Messages Types, Segments and Fields and to assist with document submission and navigation within the HL7 Organization. Industry Outreach: There are many industry organizations and agencies which can be used to communicate or disseminate information to interested blood bank industry parties. These include but are not limited to: - ABC - America's Blood Centers - FDA - Food and Drug Administration - AABB - American Association of... |
Realm | - Choose One - |
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Ballot Cycle Info | 2011 Sept Ballot Cycle Info: INFORMATIVE Ballot results: Met basic vote requirements. 0 Negatives to reconcile Document Name: HL7 Version 2.6 Implementation Guide: Blood Bank Donation Services (US Realm), Release 1 Ballot Code: V26_IG_BBDONAT_R1_I2_2011SEP NIB Submitted By: Hans Buitendijk 2011 May Ballot Cycle Info: INFORMATIVE Ballot results: Ballot results: Met basic vote requirements. 2 Negatives to reconcile Document Name: HL7 Version 2.6 Implementation Guide: Blood Bank Donation Services, Release 1 - US Realm Ballot ID: V26_IG_BBDONAT_R1_I1_2011MAY NIB Submitted By: Hans Buitendijk |
Misc Notes | Jan 2012: TSC Approved the request for informative publication of HL7 Version 2.6 Implementation Guide: Blood Bank Donation Services (US Realm), Release 1. Dec 2011: HL7 Version 2.6 Implementation Guide: Blood Bank Donation Services (US Realm), Release 1 is requested for publication as an informative document. Jan 2010: We do not have anything ready to go to ballot in January - in fact that working group meeting will be our first face to face meeting. We have had regular phone meetings since the group was first started and have made some progress. We are looking to the expertise of several HL7 OO members and consultants in order to make some real progress. So, more than likely we can have something ready for ballot at a subsequent meeting. I think we will know more after the January WGM. PMO moved target dates out 1 trimester each. Initial ballot will be informative in the form of a white paper for Comment Only. Final ballot will be normative. 2010Sep: updated project repository URL |
U.S. Govt Interest? | |
USRSC Approval | |
FMG Approval | |
ARB Approval | |
Start Date | Aug 19, 2009 |
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