LRI+Validation+Suite+WG+2011-11-29

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**Meeting Agenda:**
CLIA Requirements ||  ||
 * **Topic** ||  ||
 * Juror Document

Meeting Notes
Rob Snelick began the meeting by reviewing the juror document and status. It has been categorized in a logical way in which they would appear in the EHR. In an earlier meeting, all of the elements of this juror document has been presented as specified in the implementation guide and are now being categorized by how they may be verified in the EHR system. The plan in terms of inspection testing here is to be able to verify in two ways. The first is the EHR display, where the inspection would view the EHR as a normal view. The administrator view is a second where it could be the display which may have a separate view or log in or to access the database or configuration files.
 * Juror Document**

Megan Sawchuck from the CDC asked how the determination was made in deciding what is required to be displayed. The patient sex and again is a requirement of the accrediting agencies. The response given from Mr. Snelick was looking at the requirements that could be found that determine what needs to be displayed. The only requirements are the adopted meaningful use for CLIA requirements. Mr. Snelick further advised that additional follow up is needed to ensure that the accrediting agencies requirements are also incorporated. He advised Megan to go back to the IG group with this issue before they go into their second ballot.

Rob Snelick advised clarity on the display page. He stated that at one point, the team discussed the LOINC code in regards to being associated with local codes so, the local code will be displayed versus the LOINC code. He further stated that it has not been fully reconciled the issue with the test message will send over the LOINC code with the LOINC text and allow the user to provide their local mapping to that so the test message is mapped to that.

Megan Sawchuck asked if the inspectors would be the accrediting bodies under NIST? The response from Rob Snelick was that the team is building the tools and the ATCB will be our target for the inspectors but, could also be the local lab people or could be the ATCB or certification bodies or could also be from other accreditors.

He also stated that NIST is in the process of going through the permanent program by certifying the ATCBs. It has not yet been determined if the inspectors will be expert terminologists which has been documented as a risk. The team acknowledged that once the determination has been made on whether or not terminology experts would be required as inspectors, there needs to be precise instructions on using the tool and possible using a separate document to explain how each element should be evaluated.

The certification will be done at the product module level. The current organizations that are functioning as ACTBs have been putting their heads together to decide how to decide if a new module requires new certification and ONC guidelines state if the additional capabilities have an impact on the certification criteria which ONC has published then they would have to have that major release re tested and certified.

In a separate process, each installation has to provide meaningful use that. This is on the eligible professional eligible hospital side. It is on the CMS side for meaningful use versus ONC. They go hand and hand but they are not the same. The hospital has to demonstrate that they are meeting the meaningful use measures using certified EHR technologies. This is how the two processes fit together.

Mr. Snelick advised the team that he is in the process of processing the spreadsheet for the juror document automatically so that they can be integrated into the tool. In 2-3 weeks it is hoped that a demonstration will be possible.

Mr. Snelick presented the color coded spreadsheet which was provided by the CDC. Megan Sawchuck confirmed with the team that the yellow items were previously discussed. She advised that in regards to the blue highlighted section, everything matched what was in the mandatory HL7 IG guide on page 123 so that was good. She did want to point out from a process standpoint that CLIA guidelines state that reference lab results cannot be revised so as a word of caution that whatever the EHR does to a reference line result needs to be delivered the way that the lab has sent it. It has not been determined how the EHR will process it.
 * CLIA Requirements**

Mr. Snelick asked if Megan would you anticipate a test case scenario that we could build up to confirm that this requirement is met.

Megan – this is an excellent suggestion. I would mostly be concerned about narrative reports and how they may pass. She will make a note to review this item with her team.

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