Oncology EHR Profile:Status20100615

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Ambulatory Oncology Functional Profile Project Status June 15, 2010

The objective of this project is to develop an HL7 EHR System Functional Profile for the ambulatory oncology setting based on, and conformant to, the ANSI-approved June 2009 EHR-S Functional Model release 1.1.

Background

A draft functional profile was developed by the National Cancer Institute (NCI) and contributed as a starting point to the HL7 standards development process. This profile leverages requirements work previously undertaken by the NCI in collaboration with the American Society of Clinical Oncology (ASCO) and various stakeholders from the NCI Community Cancer Care Program (NCCCP). This draft profile is based on the International Organization for Standardization (ISO) and American National Standards Institute (ANSI)-approved HL7 EHR-S Functional Model Release 1.1.

Activity To-Date

In January 2010, HL7 approved the formation of the Ambulatory Oncology Functional Profile (AOFP) project under the EHR Work Group. The AOFP team established a wiki (http://wiki.hl7.org/index.php?title=Oncology_EHR_Functional_Profile) and started weekly or bi-weekly conference calls to review the existing material. Significant progress was made in completing a detailed review and enhancement of the AOFP Overview Chapter including a comprehensive storyboard and glossary, implementation considerations and a series of narrative examples of oncology business practices. The AOFP team also reviewed and agreed upon the scope, approach and criteria for the functional profile. In April of 2010, the AOFP team decided to ballot the Overview document as a "Draft for Comment" to increase stakeholder awareness of the project and to solicit feedback on the Overview document. The ballot was conducted with 120 registered voters. The ballot results are summarized as follows:

	Aff.	Neg.	Abst.	NV
Affiliate	0	2	12	5
Consultant	7	0	2	2
General Int.	5	2	1	1
Payor	4	0	0	1
Pharmaceutical	4	11	11	6
Provider	14	0	8	4
Vendor	1	1	13	3
Totals	35	16	47	22
% of Votes	29.17%	13.33%	39.17%	18.33%
Quorum	81.67%
Approval	0

These results could be interpreted as follows: 120 voters is a significant ballot pool indicating a strong interest in the work; 40% abstaining plus 18% not voting usually indicates that these members are interested in the work going forward and wish to remain in the ballot pool, but do not have the current bandwidth or interest to submit a vote for or against. 30% Affirmative is a relatively strong endorsement of the project direction; however, 13% negative does indicate that a substantive number of voters had one or more points of concern that they would wish addressed as the work moves ahead.

A further analysis of the actual votes and comments is required.
Following the submission of the AOFP Overview Chapter to the HL7 Ballot, the AOFP team commenced a detailed review of the Direct Care Chapter functions. Team members reviewed the existing materials independently and then the group discussed any questions or issues during the weekly team conference calls. The review was completed to the end of section DC.1.1.4 – or approximately one-third of the way through the DC section.

Next Steps

The project's next steps can be grouped into four main areas: ballot reconciliation, requirements review, incorporation of new requirements and alignment with the EHR-S FM Release 2 activities.

Ballot Reconciliation

Whilst the ballot conducted on the Overview Chapter was a "Draft for Comment" and consequently does not carry with it any absolute requirements from HL7 to have the comments reconciled, failure to address these comments would be counterproductive to the project. Consequently, the reconciliation of the comments and responses to the HL7 members who submitted votes on the material remains a high priority for the project team.
Although there were sixteen negative votes cast, many of these referenced each other and there were only four distinct negative votes. Additionally, there were two affirmative votes with submitted comments. Consequently, there are a total of six comments to be reconciled, four in the form of ballot worksheets and two as marked up versions of the balloted document.
A preliminary review of the comments submitted suggests that reconciliation will be relatively easy and can be accomplished over a couple of team calls. However, following the HL7 ballot reconciliation guidelines does require some level of documentation and communication with voters to ensure that the ballot reconciliation is completed in an appropriately open and transparent manner.

Incorporation of New Requirements

Following the balloting of the Overview Chapter, a number of new interested stakeholders have become aware of the project. The existing material aligns with their organization’s work and they would wish to incorporate their material and requirements into the AOFP as appropriate going forward. This interest is excellent as it was one of the stated objectives of going to ballot; however, it does add to the activities of the project to review the new requirements and fold them into the existing Overview Chapter and ongoing Requirements Review activities.

Requirements Review

The continued line-by-line review of the Direct Care Chapter, as well as the Supportive and Infrastructure Chapters, are necessary to ensure that the functional requirements appropriately reflect the intent of the HL7 project team. To-date, the review has been very productive and resulted in numerous adjustments to the material to improve it and correct mistakes. However, the review has been primarily conducted by a sufficiently small number of team members as to question whether the concerns of the broad oncology business were adequately reflected. This activity can be extremely time-consuming and needs to be facilitated to ensure that all perspectives are represented and that the material is maintained and updated to reflect discussions. As new stakeholders are identified and are able to bring materials to the project, incorporating these materials into the existing work items needs to be managed.

Alignment with EHR-S Functional Profile R2.0

It is hoped that the future work will not only improve the AOFP, but maintain bi-directional alignment, as much as possible, with the emerging EHR-S FM Release 2.0 (R2) as it is presently being devised by the EHR Work Group (EHR WG). The EHR-S FM is currently expected to be balloted starting in October 2010 through 2011 – potentially in parallel with the AOFP. Whilst it is not essential that the AOFP be aligned with the R2, it would be advantageous for two reasons:

1. R2 addresses a number of shortcomings and missing sections from R1.0 that could be leveraged by the AOFP, and
2. R2 could be published within the same time period as the AOFP and it would be easier for implementers to have aligned materials from both projects to improve adoption of the AOFP. Specifically, when implementers are adding support for R2 (or AOFP), they could more easily adopt the other in parallel if they are aligned.

Challenges

To-date the AOFP project has been facilitated primary by Helen Stevens under the support of the NCI caEHR project. However, in May 2010 a change in focus and direction within the caEHR project occurred. A new project sponsor and/or a sufficient pool of volunteer resources are currently needed to move the materials forward.

Further information

If you are interested in sponsorship, volunteering, or receiving a status update of the project, please contact any of the HL7 EHR Work Group co-chairs:

Gary Dickinson; gary.dickinson@ehr-standards.com

Don Mon; don.mon@AHIMA.org

John Ritter; johnritter1@verizon.net ; jritter@cap.org

Pat Van Dyke; vandykp@odscompanies.com