LRI+Validation+Suite+WG+2011-11-01

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 * LRI Validation Suite Meeting Minutes**
 * Date: 11/01/2011**
 * Time: 1:00 - 2:00pm**
 * Dial in:**
 * WebEx link: **[|**siframework2.webex.com**]
 * Dial-in: 1-408-600-3600 Passcode: 664 208 0504 **
 * Meeting Agenda:**
 * **Topic** ||  ||
 * **Agenda **
 * **Review of LIS Test Plan Template **
 * **CLIA Testing **
 * **EHR testing (Juror Document) – Inspection Testing **
 * **Action Item List **
 * **Review Policy proposal for validating receiver **
 * **Planning **
 * **Q and A **

||  || Robert Allen, Neeli Bajaj, Tom Boal, Joan DuHaime, Freida Hall, Cynthia Levy, James Littlejohn, Scott Robertson, Rob Snelick, Virginia Sturmfels, Scott Robinson, Sheryl Taylor, Megan Sawchuck, Marybeth Gagnon, Bob Coli
 * Attendance**


 * Meeting Notes**


 * LIS test plan template **

Ms. Taylor discussed the draft test plan with the team. This draft is available on the wiki page and it is awaiting feedback. The sections in this draft plan discuss the following topics:
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Reference documents, which the foundation for is from others work which still needs to be referenced.
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">The overview of the testing process which is standard. It discusses context based and context free which does not require testing or a testing plan. The context base information is what this plan has been developed to address. It also shows an illustration of the context based testing.
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">How to fill in a data sheet. All test plans have constraint and constrictions. Now the LRI IG is still in the processes of finalization. Once that has been completed, this will be re looked at to ensure that it is in sync with the implementation guide.
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">There are several pages of pre requisites and a lot of information that would need to be in the LIS in order to populate all of the message fields.
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Test case summary to orient to the organization of the test case. There will be at least144 test cases and they will be summarized here
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Test case details. This is where it gets specific. The test dimensions are mentioned here and the constraints listed here are more specific to the specific test
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Test procedure steps. There are 4 steps posted.
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Expected test results.
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Example message in HL7 format.
 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Finally assumptions and constraints and now move forward into the next test plan document. Then an overall glossary and appendices.

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Scott Robertson advised that he has seen the NIST test template and advised that this is a great format. He asked if there are there tool anticipated for comparing the validation not within the document. Ms. Taylor advised that Mr. Allen’s team is working on that portion currently. <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Ms. Hall asked about section 1.8, where the IG has different profiles. She advised that there is another profile that does not require OIDS and wants to know if there will be one per profile or how that part will be managed. Ms. Taylor advised to forward this feedback to the wiki so that this issue can be addressed. She advised that the information available currently in this document is only to be an example and is being shown to receive feedback.

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">The support team advised that there will be a place located on the Wiki for feedback to be posted on this topic.

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Ms. Sawchuck requested to verify the intent of the workgroup for the input from the CDC to be for the compliance with CLIA. She further states that the EHR certification requirements have only incorporated <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">7 of the requirements for CLIA. Will this be minimally CLIA compliant or should it comply fully? Mrs. Taylor advised that developing a test case that would support the ONC plus is what they are working on. Nothing else is outside of the scope. If ONC restricts the data elements to 7, it does not mean that this test plan will. This test plan is meant to be broader than that. Still waiting on ONC to see what the stage 2 cert criteria will be. Once the PRM has been posted in December, the writer of the stage 2 procedures for ONC certification process will be able to determine if more than the 7 data elements will be required.

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Dr. Coli advised that the LRI pilots echo system is filling in rapidly and currently has 5-6 teams. He asked if it may be necessary that someone from each of those teams attend these meetings. Mrs. Taylor advised that if time permits, it would be a good idea and Mrs. DuHaime (LM) advised that participation is always encouraged.


 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">CLIA testing **

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Requirements have been provided to the team to review. These are the requirements as we see them. If there are any questions, please present them!

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Ms. Sawchuck advised that her team has a couple of observations. The fields in CLIA may not be sufficient for public safety. The 2nd piece, when you look at oversight of EHR it will mostly be accrediting agencies. Their requirements are more stringent than CLIA. If people only followed CLIA, they will not be compliant with their agency

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Another concern announced by Nancy is the report layout and the location of the elements. Currently, the vendors have them set up different ways. The layout is critical for interpretation. A suggestion was made to format the reports in a way that would be easily translated. Many clinicians work in a number of institutions and the forms are done differently, it gets very confusing. Mrs. Hall acknowledges and agrees with the suggestion but, advised the team that the scope report currently being done is defining the information that will be exchanged and not designing the output of the report. That would take collaboration of the report. This is out of the scope and would have to be a future effort.

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Ms. Johns advised that EHR usability may be an issue regarding the format of the report not the way that it is in regards to location but, in regards to the context of the report and the use of LOINC vocabulary. If a standard vocabulary is used and has a test description that is not matching the way the lab reports it, how will the accrediting agencies view this? Megan advised that the labs have been implementing computers since the 70s and it is not unusually for a doctor to advise that reports are too cluttered. The idea is to ensure that we don’t lose the progress. The accreditors will not look at structure from a compliance perspective, they will hone in on info. All the acreditores will have a standardized language that will have to be used. But some may deviate which may cause non compliance. Megan advised that she will look into this issue further and provide additional information at a later date.


 * <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">EHR testing (Juror Document) – Inspection Testing **

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Mrs. Taylor presented the team with a sample Juror Document to review. <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">This document is based on the requirements from the NIST team based where you expect to find the data.This view of the data elements take you in sequence. The color coding is to tell you where we think the data may show up. There is no standard way to display lab results on a screen. There are a core set of data elements that are displayed. On this document, if we are sure that the data element will be viewable from the clinician screen, it is marked in green. If it only may be, it will highlight in yellow. Blue is only in the database. This is so that we can design the tester to look at the data that needs to be validated and find out where it will be expected to be located. The other document then organizes these elements into categories according to where you will see them.

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">The first cluster is all of the items expected to be seen <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">The 2nd category will be the yellow highlighted items <span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">The 3rd will be the blue highlighted items

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Feedback is welcomes and should be posted to the Wiki page.

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Mr. Robinson asked if there were optional elements shown on this document. Mrs. DuHaime (LM) advised that optional items were not included but, will re-review to make sure.

<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 13px;">Request from the team to define stored information was made. Is it defined as data that cannot be changed? Previous discussions determined that the definition of stored was defined as out of the scope.

Next Meeting
Tuesday, 11/08/2011 1:00 p.m. EDT
 * Date:**
 * Time:**
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 * <span style="color: blue; font-family: 'Arial','sans-serif'; font-size: 13px;">WebEx link: **[|**siframework2.webex.com**]**<span style="color: blue; font-family: 'Arial','sans-serif'; font-size: 13px;">Dial-in: 1-408-600-3600 Passcode: 664 208 0504 **

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