Wednesday, June 10, 2009

The First Meeting of the Clinical Operations Workgroup

Today, the HIT Standards Committee Clinical Operations Workgroup met for the first time to discuss our charge, our deliverables, and our workplan.

As I discussed in Monday's blog, the broad charge of the workgroup is to make recommendations to the HIT Standards Committee on requirements for standards, implementation specifications, and certification criteria related to EHRs and clinical operations. The specific charge is to make recommendations to the HIT Standards Committee on the role of EHRs and e-prescribing, clinical summaries, laboratory and radiology report functionality within two (2) months of the workgroup’s first meeting.

That means that by August 9, we must complete our initial work.

What will that work be?

On the call we discussed that the HIT Policy Committee will review a draft of meaningful use criteria at its June 16th meeting. Once this draft is delivered to the HIT Standards Committee, its workgroups can review the standards and certification criteria which map to meaningful use. Imagine a 4 column table

Column 1 - An aspect of meaningful use i.e. e-Prescribing

Column 2 - The standards and implementation guidance needed for meaningful use i.e. NCPDP Script 10.5 and RxNorm as implemented in the HITSP Capability document "Issue Ambulatory and Long-term Prescriptions"

Column 3 - The certification criteria i.e. Conformance testing using the CCHIT Laika tool for appropriate implementation of NCPDP Script 10.5

Column 4 - The meaningful use measure i.e. what percentage of prescriptions in a practice were e-prescribed?

The above examples are illustrative only - they are not work products of any committee.

Note that certification criteria and meaningful use measures are decoupled. Certification verifies the capability while the meaningful use measure documents the integration of the capability into daily workflow.

In addition to mapping all aspects of meaningful use to standards and certification criteria (leveraging all the work done by HITSP and CCHIT to date), the HIT Standards Committee and its workgroups will also consider the "ARRA 8" and how standards and certification support them.

1. Technologies that protect the privacy of health information i.e. common data transport, auditing, authentication, authorization

2. A nationwide health information technology infrastructure i.e. enveloping and delivery standards

3. The utilization of a certified electronic record for each person in the US by 2014 i.e. standards in support of meaningful use

4. Technologies that support accounting of disclosures made by a covered entity i.e. standards similar to audit trails that also include disclosures made to third party

5. The use of electronic records to improve quality i.e. aspects of meaningful use that enhance safety and standards which support quality measurement

6. Technologies that enable identifiable health information to be rendered unusable/unreadable i.e. encryption

7. Demographic data collection including race, ethnicity, primary language, and gender i.e. standards which support demographic exchange

8. Technologies that address the needs of children and other vulnerable populations i.e. standards supporting immunization registries

Thus, the Clinical Operations Workgroup will complete two documents over the next 60 days - one which provides the standards/certification guidance needed for implementation and measurement of meaningful use and one supporting the ARRA statutory requirements. The documents will be forwarded to the HIT Standards Committee for review/approval and then forwarded to ONC.

It's going to be a busy summer. The pace of the Clinical Operations Workgroup accelerates as soon as the HIT Policy Committee completes its meeting on June 16.


Steve Daviss MD said...

Thanks for posting this, John. Does any aspect of "usability" fit in here? Like capture of number of clicks to perform given tasks. Or % of new charting that is somehow touched or viewed by physician. Or institution of the same rating scale across all EHRs so that actual users can rate how well the EHR works for them (which would incentivize EMRs to have good UI *and* to streamline & improve the site implementation process.

Example: at my hospital, when I am transferring a pt from the medical floor to the psych unit (new chart, new episode of care), I get CPOE pop-ups that I have ordered duplicate meds -- one pop-up for EACH med which I reorder -- which take 4 clicks in 4 different areas of the screen to clear each one. This is not an example of "meaningful use" but rather "meaningless use".

How to write standards so that the EMR company focuses on how to make it work well for the user, rather than just saying "It's in there" and they get a check mark for that standard element?

Ran said...

Thank you for this post.

As for the ARRA8 list, one challenge we discovered is that texting, SMS Messaging, Instant Messaging and Mobile Phones are circumventing the existing systems created to capture, review and control communications privacy and the ability to securely transport private data. Therefore, the largest gap/threat to regulatory compliance is the mobile phone, specifically the hardware commonly known at the “Smart Phone”. A key aspect of helping to protect such communication is a pre-emptive review and approval of out-bound calls, e-mails, messaging and other forms of communications.

John Halamka said...

A followup for Steven - Based on CCHIT's recent press release, I think we'll be hearing about usability metrics and user satisfaction measurement from live sites soon.

Tom Mariner said...


Wouldn't the usability standard the same as all medical device folks have to comply with (IEC 60601-1-6)?