LIVD File Expansion Committee:
Held on: | Wednesday, 06/16/2021 | ||
Attendees: | Co-Chairs and Members: Riki Merrick, Wendy Rubinstein, John Snyder Members: Samuel McCash, Karre Willis, Kristin Benware, Pam Banning, Ann Phillips, Cornelia Felder, Ed Heierman, Helena Sviglin, Hung Luu, Jerry Sable, Ken Gersing, Matt Rahn, Mckenna Tennant, Nathan Davis, Scott Campbell, Stacey Borenstein, Ana Szarfman and Xavier Gansel Deloitte: Zerina Borhan, Vishal Patel and Victor Landim | ||
Action Items: | · Deloitte will own the meetings moving forward | ||
Agenda / Meeting Notes | |||
Discuss topics Housekeeping: · Action Item: Deloitte will own the meetings moving forward · There was no feedback from the Coordination Committee Meeting LIVD File Purpose · Pre-market data is defined in Clinical Data Interchange Standards Consortium (CDISC) – lab data is part of the submission – but not equipment specific o Helena Sviglin was concerned about defining a pre and post market data. Helena needs more clarification on data that supports pre-market approach o CDISC could be one of the producers of the LOINC to In Vitro Diagnostic (LIVD) file. Riki suggested using the LIVD vocabulary and definition for lab test that helps defines which LOINC code to assign, and put in a LIVD format o As an exercise have the CDISC to Logical Observation Identifiers Names and Codes (LOINC) mapping provided in LIVD format o Ed Heierman said the objective and use of LIVD in this strategic plan is to provide the necessary content to allow the establishment of a common vocabulary for selective attributes associated to a test § LIVD is an attempt to provide the necessary information so that once data is generated (and ultimately will make its way to other EHR systems), the practitioner can used LIVD to make sure you are mapped to the correct LOINC and Systematized Nomenclature of Medicine (SNOMED) · Calibrations are essential to help clinical trials comparison o Scott Campbell said calibration can be part of the process, but the timing as to when to include in the process will be important to articulate · Major Objectives: o LIVD repository = Keith Campbell worked with SOLOR in the past to collect LIVD Files from manufacturers and build their SOLOR infrastructure and system. This may be an important objective that requires cross collaboration with the Tooling Committee to help us understand the requirements o Establishing what is the scope of data for LIVD – Ed Heierman pointed out this objective as key to efficiently achieve success o LOINC for test performed SCT codes for result value sets, specimen type codification and test kit identification o What other data do we need in LIVD format to help the laboratorian to pick the correct LOINC (or other codes) · Potential framework to include traceability (Scott – missed something here) · Ed: Originally designed for chemistry; units of measure, answer lists – we will add on elements we need – chunk it by test classes o Order codes · Scott: Using LOINC on OWL – LOINC classes = SOLOR o Scott Campbell suggested the team to brainstorm a trajectory of where we want to see this in the next 1-5 years, where the various data be added and how we will maintain, and what will we required from Tooling Committee o John Snyder said that if we break down by domain, of by LOINC class type, the missing data elements will start to become obvious., therefore he recommends finding the pain points that haven’t been addressed so far o Looking at core lab: chem, micro, hematology o Scott Campbell said what Keith Campbell is doing with SOLOR will help with the organization of the codes, but he thinks we should pick a particular area and work on in · Need to have consistent naming (LOINC Display name project) can cover some of that already, though not test kit specific, so may not be good enough for trending etc · Helena said there is a disconnect between LOINC and the requirements for pre-market. Helena is willing to meet separately regarding the pre-market data and how the regulatory process work o Hung Luu would like to speak with Helena separately · Pre-market will not have UDI either. o There are ways to handle situations where "gaps" may exist, such as no UDI. We had to address these for COVID-19 Meeting Recording: Additionally, please find the recording of the meeting with audio transcript in here. Passcode: sb4J.nHp This is the full link incase the hyperlink does not work for you: Recording of the call Next Steps
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