2024-01-09 SHIELD Topic#2 Meeting Notes

Date

Jan 9, 2024

Attendees

Slides:

From Chat:

SZARFMAN 12:19 PM
Wanted to share that I reviewed the HHS ONC 2024 Interoperability Standards Advisory (ISA) Reference Edition.Regarding the 38 mentions in the ISA:“Secure Message Router – Securely route and enforce policy on inbound and outbound messages without interruption of delivery.” Advocated adding after “without interruption of delivery” the following specific recommendation for assuring a successful comprehension and delivery of the messages: “need to have multi-directional feedback loops for prompt access to ancillary data, for clarifications, and for quickly reporting and addressing system and data transmission errors.” See https://www.nature.com/articles/s43856-022-00148-x.

Steve Powell to Everyone 12:20 PM
Overview of our findings and recommendations https://synensysglobal.com/wp-content/uploads/2024/01/FDA-System-Safety-Final-Report_One-Page-Summary_Revised-3-1.pdf

Jim Case to Everyone 12:27 PM
Most SDOs do not have an enforcement structure for either updates or adherence to guidelines

SZARFMAN 12:30 PM
Many thanks for the great, very informative presentations!

Andrea Pitkus 12:31 PM

+ Jim Case. LOINC has Best Practice to update to newest release within 90 days, but correct there is no enforcement mechanism. Closest is Public Health for ELR submissions

SandiMitchell 12:32 PM
CDQ believes that the data transitions have similar risk profiles to the accepted healthcare understanding of increased patient risk during transitions of care levels

Andrea Pitkus 12:34 PM
What is the ground truth for laboratory test naming?

Keith.Campbell@fda.hhs.gov to Everyone 12:34 PM
In my view, LIDR...
UDI + LIDR + USCDI = regulatory grade data.

SZARFMAN 12:35 PM
Need to establish version controls with "as dates"

Serge Jonnaert 12:36 PM
- I absolutely take offense to the comments that SDOs don’t have feedback loops. IICC, HL7, and IHE consist of volunteer contributors from industry and lab practice that continuously test their contributions in real world practice. This is complemented by formal surveys as new standards are contemplated and defined. I find it laughable that from the leading SDO contributors, nobody on their team was interviewed or consulted on this matter. What is new here? We’ve known this argument for 20+ years. Every couple of years, we just have different actors prepare a different Powerpoint argument, refresh the data, and push the reset button on a new initiative. This control systems analysis is very abstract. We’re way past that point. I did like the Detailed Control Structure slide! We know clearly where the friction points in the ecosystem are and what needs to be addressed, but there has to be a willpower to do so. We’ve had workable standards for years, but we need ONC, VA, HHS to require their mandatory

Andrea Pitkus 12:36 PM
@Keith.Campbell@fda.hhs.gov Thanks. Currently each performing laboratory is the source of truth for their test names per their CLIA validation of those tests. Many EHRs "rename" to provider preferred terms. This topic will need some work ;)

Steve Powell 12:37 PM
Coordinated and collaborative action for system redesign has the best opportunity for short and long term improvements without creating unintended consequences

Serge Jonnaert 12:37 PM
We’ve had workable standards for years, but we need ONC, VA, HHS to require their mandatory adoption, especially for large federal contracts. Only then will we have adoption of the standards.

Steve Powell 12:38 PM
Executive Summary https://synensysglobal.com/wp-content/uploads/2023/12/Executive-Summary_System-Safety-within-Laboratory-Data-Exchanges-Report.pdf

Riki Merrick 12:38 PM

+ Serge - I agree there are well established feedback loops for SDOs - it's the adoption of the standards that has been a big issue

Andrea Pitkus 12:39 PM
@Serge Jonnaert One of your points is there is quite a bit of variability in laboratory standards adoption for a number of the reasons indicated. This is a huge part of the current state.

Steve Powell to Everyone 12:39 PM
Full report https://synensysglobal.com/wp-content/uploads/2023/12/System-Safety-within-Laboratory-Data-Exchanges-Report.pdf

Pam Banning - 3M Health Info Systems 12:39 PM
+Serge - thank you for providing this feedback. +Riki

Keith.Campbell@fda.hhs.gov 12:39 PM
So keep in mind that the interviewees where the ones saying that they did not feel they had appropriate feedback.
So it points out that there is a problem, and one of the problems is underfunding of essentially voluntary activities.

Andrea Pitkus 12:45 PM
I think one of the points highlighted is although LIVD is available, and a number of key vendors have implemented, many more have not yet. Those reporting with paper/fax/non discrete data aren't able to map well etc.

M. E. (Doc) de Baca, MD, FCAP to Everyone 12:46 PM
I appreciate that Syetems analysis has been brought into this conversation. I am glad sysnensis and the MIT people have learned a lot. Lab people know and have known for years there are gaps — there’s no real surprise here. IM professional Opinion, there are a lot of gaps in the analysis due to lack of overall understanding of the relationships of medicine and laboratory. While I appreciated the comment at the end that “laboratories should be included in the fixes (rough quote)”— I’d contend that the lab should be the driver include other people from other specialities. AND there need to be carrots/sticks to get things done. Lab uses 3% of the medical $$, gets budget cuts all the time and is expected to respond to all the new informatics needs while adding to their testing. Labs and therefore data need to be recognized as the foundational important part of the house of medicine that they are and get funding and regulatory support to foster development and strengthening of the data environment.

M. E. (Doc) de Baca, MD, FCAP 12:48 PM
I didn’t see (in this cursory review) the barriers that exist at an institutional level to have the IS people actually implement what the lab director states is crucial for lab data

Andrea Pitkus 12:49 PM

+ Dr. de Baca One of the reasons laboratory professionals are not volunteering is labs are short staffed and just trying to keep the lights on with all these burdens. Funding is needed to help them move forward with informatics changes.

M. E. (Doc) de Baca, MD, FCAP 12:49 PM
+DrPitkus — totally agree.

Jim Case 12:49 PM
One of the key issues is the incentive structure to properly adopt standards as they often place an additional burden on the day to day activities of laboratories.

Riki Merrick 12:51 PM
+Dr. DeBaca and + Jim Case - I agree that the laboratory does not get the attention from the business side of the healthcare system

Andrea Pitkus 12:54 PM
PAMA is another regulation that has had cuts to laboratories.
Another factor is EHRs have been primarily designed for their primary end users: providers.

If it was an easy solution, it would have been applied by now. It is a complex system

Steve Powell 12:56 PM
Dr. deBaca, check out Appendix C and D of the full report for some of those specific and identified challenges you've mentioned at the controller level (laboratory, care facility, practitioner, etc.)

M. E. (Doc) de Baca, MD, FCAP 12:57 PM
@DrPitkus: I’d contend EHRs are electronic filing cabinets built for billing. They’ve tacked on stuff for patient-facing-physicians— that’s kludgy. And then try to add in lab….

You 12:58 PM

+ Dr DeBaca - 100%

Andrea Pitkus 1:00 PM
Thank you for sharing these important findings.

Pam Banning - 3M Health Info Systems 1:00 PM
Great conversation; thank you all

Recording:

https://youtu.be/XI3P_rl916U

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