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Safe Health Systems, Inc. - Connected Diagnostics Platform
Can you tell me more about how your approach will allow patient performed results (i.e. Lucira EUA, Antigen or Antibody "assay cards") to be collected/interpreted, encoded with appropriate codes (LOINC, SNOMED CT, IVD UDIs, etc.) and then transmitted to the provider and public health according to regulatory requirements. If used in POCT scenario with LISs that lack API functionality(not aware of any with CLIA compliant FHIR/API functionalities at this time), what approaches do you have? Can your system be used with any IVD vendor? How are CLIA testing requirements met in your system?
Looks like you have robust EHR/LIS and patient app capabilities. Interested in the how you'd collect and manage the data in both traditional lab and non traditional testing (including patient performed) settings and report to providers and public health?
Looks like you have robust EHR/LIS and patient app capabilities. Interested in the how you'd collect and manage the data in both traditional lab and non traditional testing (including patient performed) settings and report to providers and public health?
COVID-19 Immutable Test Results Submission and Visualization
Since you mentioned Navica, it appears to be connected to a LIS or LIMS for ELR and/or eCR reporting. Would your app be downloaded by patients and then used with any IVD patient collected or performed test? How are the UDIs, LOINCs, SNOMED CT codes applied for each? Glad to hear you can interpret an image (as that is one challenging aspect of patient performed testing to know it's reported correctly). Would it work with the Lucira device described in their EUA as first patient performed test? It has a light that is green or red instead of traditional "card" based line result values.
How would these data used in point of care setting like Abbott Ag or Ab tests, Lucira or other IVD vendors that are lab managed and need to be integrated into the LIS as many do not have API functionality (not aware of any with FHIR functionality, especially CLIA compliant). One integrated, they likely can use traditional ELR, or EHR eCR reporting to public health.
Trying to understand workflows/functionality scope, etc. Thanks for the info!
How would these data used in point of care setting like Abbott Ag or Ab tests, Lucira or other IVD vendors that are lab managed and need to be integrated into the LIS as many do not have API functionality (not aware of any with FHIR functionality, especially CLIA compliant). One integrated, they likely can use traditional ELR, or EHR eCR reporting to public health.
Trying to understand workflows/functionality scope, etc. Thanks for the info!
Early Signal Detection on Patient Level Data During Data Capture Phase
Sounds like you don't allow for laboratory/IVD test data acquisition such as patient performed testing as COVID testing as you know is not continuous, but based upon a specimen in a "point in time" (also as reflected in the LOINC codes). Seems like your approach would be valuable for vitals, ventilator settings (i.e. O2sats) and other non lab observations though.
Smart Diagnostics Ecosystem for COVID-19 Disease Management
Trying to understand if there are preconditions met by other software. (In general) 1. How to collect AOEs, from ordering provider/patient/specimen collector 2. Integrate into app/LIS or other information source for patient to be married to results of IVD test device/system 3. All transmitted to public health (ELR) 4. All transmitted to HHS (may be met by 3).
Will your approach support all 4 or only portions of above for "tracking lab results"? (Looks like you may have capabilities for some of these)
Do you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? How would your approach support LISs or labs that don't have API functionality?
Are LOINC, SNOMED CT and other codes systems supported at the point of origin or downstream as in your diagram to meet requirements? How are test kit/system UDIs captured and reported
How are CLIA testing requirements met in your system?
Curious about how your approach would "automatically" collect patient performed test results like the recent Lucira EUA? How about for Antigen or Antibody card (like pregnancy tests). How are result values read and assigned appropriate LOINC and SNOMED CT codes depending on the results/values for appropriate transmission to the provider and public health? How are AOEs and other patient provided info collected and married with result values? How is it used in laboratories/Point of Care testing scenarios as in the Lucira EUA?
Looks like you have a great clinical decision support/AI predictor, but interested in the how you'd collect and manage the data in both traditional lab and non traditional testing (including patient performed) settings and report to providers and public health?
Will your approach support all 4 or only portions of above for "tracking lab results"? (Looks like you may have capabilities for some of these)
Do you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? How would your approach support LISs or labs that don't have API functionality?
Are LOINC, SNOMED CT and other codes systems supported at the point of origin or downstream as in your diagram to meet requirements? How are test kit/system UDIs captured and reported
How are CLIA testing requirements met in your system?
Curious about how your approach would "automatically" collect patient performed test results like the recent Lucira EUA? How about for Antigen or Antibody card (like pregnancy tests). How are result values read and assigned appropriate LOINC and SNOMED CT codes depending on the results/values for appropriate transmission to the provider and public health? How are AOEs and other patient provided info collected and married with result values? How is it used in laboratories/Point of Care testing scenarios as in the Lucira EUA?
Looks like you have a great clinical decision support/AI predictor, but interested in the how you'd collect and manage the data in both traditional lab and non traditional testing (including patient performed) settings and report to providers and public health?
Interpret-COVID Consumer Dx Test App
Trying to understand if there are preconditions met by other software. (In general) 1. How to collect AOEs, from ordering provider/patient/specimen collector 2. Integrate into app/LIS or other information source for patient to be married to results of IVD test device/system 3. All transmitted to public health (ELR) 4. All transmitted to HHS (may be met by 3).
Will your approach support all 4 or only portions of above for "tracking lab results"? (Looks like the you are able to collect 1, but you have determined them and unclear if they include the HHS required elements?)
Do you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? How would your approach support LISs or labs that don't have API functionality?
Are LOINC, SNOMED CT and other codes systems supported at the point of origin or downstream as in your diagram to meet requirements?
How are CLIA testing requirements met in your system?
Curious about how your approach would "automatically" collect patient performed test results like the recent Lucira EUA? How about for Antigen or Antibody card (like pregnancy tests). How are result values read and assigned appropriate LOINC and SNOMED CT codes depending on the results/values for appropriate transmission to the provider and public health? How are AOEs and other patient provided info married with results before required reporting?
While it's true, Quest, LabCorp,, Costco and other laboratories/entities have patient COVID specimen collection kits that are sent to a CLIA lab for performance and reporting of testing, how would your approach work with Lucira as the only EUA for patient performed testing?
Will your approach support all 4 or only portions of above for "tracking lab results"? (Looks like the you are able to collect 1, but you have determined them and unclear if they include the HHS required elements?)
Do you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? How would your approach support LISs or labs that don't have API functionality?
Are LOINC, SNOMED CT and other codes systems supported at the point of origin or downstream as in your diagram to meet requirements?
How are CLIA testing requirements met in your system?
Curious about how your approach would "automatically" collect patient performed test results like the recent Lucira EUA? How about for Antigen or Antibody card (like pregnancy tests). How are result values read and assigned appropriate LOINC and SNOMED CT codes depending on the results/values for appropriate transmission to the provider and public health? How are AOEs and other patient provided info married with results before required reporting?
While it's true, Quest, LabCorp,, Costco and other laboratories/entities have patient COVID specimen collection kits that are sent to a CLIA lab for performance and reporting of testing, how would your approach work with Lucira as the only EUA for patient performed testing?
Net Medical's Telemed for COVID-19 Wireless Data
Trying to understand if there are preconditions met by other software. (In general) 1. How to collect AOEs, from ordering provider/patient/specimen collector 2. Integrate into app/LIS or other information source for patient to be married to results of IVD test device/system 3. All transmitted to public health (ELR) 4. All transmitted to HHS (may be met by 3).
Will your approach support all 4 or only portions of above for "tracking lab results"? (Looks like you are familiar with 1, 3 and 4, and CLIA requirements)
Looks like you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? How would your approach support LISs or labs that don't have API functionality?
Are LOINC, SNOMED CT and other codes systems supported at the point of origin or downstream as in your diagram to meet requirements? How are the UDIs for different devices/platforms/reagent kits collected and transmitted. Are these codes applied at point of origin before transmission?
How would your approach record patient performed results like in the Lucira EUA? How would these reported to provider and public health?
Interesting approach!
Will your approach support all 4 or only portions of above for "tracking lab results"? (Looks like you are familiar with 1, 3 and 4, and CLIA requirements)
Looks like you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? How would your approach support LISs or labs that don't have API functionality?
Are LOINC, SNOMED CT and other codes systems supported at the point of origin or downstream as in your diagram to meet requirements? How are the UDIs for different devices/platforms/reagent kits collected and transmitted. Are these codes applied at point of origin before transmission?
How would your approach record patient performed results like in the Lucira EUA? How would these reported to provider and public health?
Interesting approach!
VirusIQ Screening Platform > Virtual Lab Module
Trying to understand if there are preconditions met by other software. (In general) 1. How to collect AOEs, from ordering provider/patient/specimen collector 2. Integrate into app/LIS or other information source for patient to be married to results of IVD test device/system 3. All transmitted to public health (ELR) 4. All transmitted to HHS (may be met by 3).
Will your approach support all 4 or only portions of above for "tracking lab results"? (Looks like the chip runs in parallel to some of these)
Looks like you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? How would your approach support LISs or labs that don't have API functionality?
Are LOINC, SNOMED CT and other codes systems supported at the point of origin or downstream as in your diagram to meet requirements?
How are CLIA testing requirements met in your system?
Curious more about the chip and how it would "automatically" collect patient performed test results like the recent Lucira EUA? How about for Antigen or Antibody card (like pregnancy tests). How does the chip read the result values and assign appropriate LOINC and SNOMED CT codes depending on the results/values for appropriate transmission to the provider and public health? How are AOEs and other patient provided info collected on the chip? How is the chip CLIA validated for use in laboratories/Point of Care testing scenarios as in the Lucira EUA?
Intriguing proposal!!
Will your approach support all 4 or only portions of above for "tracking lab results"? (Looks like the chip runs in parallel to some of these)
Looks like you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? How would your approach support LISs or labs that don't have API functionality?
Are LOINC, SNOMED CT and other codes systems supported at the point of origin or downstream as in your diagram to meet requirements?
How are CLIA testing requirements met in your system?
Curious more about the chip and how it would "automatically" collect patient performed test results like the recent Lucira EUA? How about for Antigen or Antibody card (like pregnancy tests). How does the chip read the result values and assign appropriate LOINC and SNOMED CT codes depending on the results/values for appropriate transmission to the provider and public health? How are AOEs and other patient provided info collected on the chip? How is the chip CLIA validated for use in laboratories/Point of Care testing scenarios as in the Lucira EUA?
Intriguing proposal!!
VirusIQ Screening Platform > Virtual Lab Module
Trying to understand if there are preconditions met by other software. (In general) 1. How to collect AOEs, from ordering provider/patient/specimen collector 2. Integrate into app/LIS or other information source for patient to be married to results of IVD test device/system 3. All transmitted to public health (ELR) 4. All transmitted to HHS (may be met by 3).
Will your approach support all 4 or only portions of above for "tracking lab results"? (Looks like the chip runs in parallel to some of these)
Looks like you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? How would your approach support LISs or labs that don't have API functionality?
Are LOINC, SNOMED CT and other codes systems supported at the point of origin or downstream as in your diagram to meet requirements?
How are CLIA testing requirements met in your system?
Curious more about the chip and how it would "automatically" collect patient performed test results like the recent Lucira EUA? How about for Antigen or Antibody card (like pregnancy tests). How does the chip read the result values and assign appropriate LOINC and SNOMED CT codes depending on the results/values for appropriate transmission to the provider and public health? How are AOEs and other patient provided info collected on the chip? How is the chip CLIA validated for use in laboratories/Point of Care testing scenarios as in the Lucira EUA?
Intriguing proposal!!
Will your approach support all 4 or only portions of above for "tracking lab results"? (Looks like the chip runs in parallel to some of these)
Looks like you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? How would your approach support LISs or labs that don't have API functionality?
Are LOINC, SNOMED CT and other codes systems supported at the point of origin or downstream as in your diagram to meet requirements?
How are CLIA testing requirements met in your system?
Curious more about the chip and how it would "automatically" collect patient performed test results like the recent Lucira EUA? How about for Antigen or Antibody card (like pregnancy tests). How does the chip read the result values and assign appropriate LOINC and SNOMED CT codes depending on the results/values for appropriate transmission to the provider and public health? How are AOEs and other patient provided info collected on the chip? How is the chip CLIA validated for use in laboratories/Point of Care testing scenarios as in the Lucira EUA?
Intriguing proposal!!
Early Signal Detection on Patient Level Data During Data Capture Phase
Thank you. Was trying to understand if your approach provides a solution to the problem on the homepage and if so, how.
COVID-19 Immutable Test Results Submission and Visualization
Thanks for the reply. How would you collect patient performed testing (i.e. such as meeting Lucira EUA requirements)?
As you may know not aware of any LISs/labs in the US supporting FHIR/APIs for CLIA compliant reporting. In fact, we on O&O are still working on diagnostic report resource to meet lab reporting needs.
As you may know, ELR reporting is typically HL7 v2.51 (some labs are still on 2.31) messaging format. This is for lab reporting.
However, if patients are performing results and sending to their provider, then physician based reporting by law is applicable such as via eCR. Different reporting/different requirements. Can any/all be supported?
As you may know not aware of any LISs/labs in the US supporting FHIR/APIs for CLIA compliant reporting. In fact, we on O&O are still working on diagnostic report resource to meet lab reporting needs.
As you may know, ELR reporting is typically HL7 v2.51 (some labs are still on 2.31) messaging format. This is for lab reporting.
However, if patients are performing results and sending to their provider, then physician based reporting by law is applicable such as via eCR. Different reporting/different requirements. Can any/all be supported?
IBM Digital Health Pass for Citizen Reported COVID-19 Testing Data
Trying to understand if there are preconditions met by other software. (In general) 1. How to collect AOEs, from ordering provider/patient/specimen collector 2. Integrate into app/LIS or other information source for patient to be married to results of IVD test device/system 3. All transmitted to public health (ELR) 4. All transmitted to HHS (may be met by 3).
Will your approach support all 4 or only portions of above for "tracking lab results"?
Do you have app, webportal or EHR based data collection and reporting? How are patient performed tests and data collected and reported?
Do you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? Is FHIR and V2.51 supported depending on where the reporting occurs?
How/where are LOINC, SNOMED CT and other codes systems supported in your messaging to meet requirements?
How are CLIA testing requirements met in your system?
Will your approach support all 4 or only portions of above for "tracking lab results"?
Do you have app, webportal or EHR based data collection and reporting? How are patient performed tests and data collected and reported?
Do you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? Is FHIR and V2.51 supported depending on where the reporting occurs?
How/where are LOINC, SNOMED CT and other codes systems supported in your messaging to meet requirements?
How are CLIA testing requirements met in your system?
Andrea Pitkus voted on a comment on the idea Vote on Nov 29 Midnight Extension
Andrea Pitkus voted on a comment on the idea Vote on Nov 29 Midnight Extension
Andrea Pitkus voted on the idea Vote on Nov 29 Midnight Extension
Andrea Pitkus voted on the idea Mock Data or Real Patient Data
Andrea Pitkus voted on a comment on the idea WATERS overview video
Andrea Pitkus voted on the idea WATERS overview video
Andrea Pitkus voted on the idea Public Voters Must Be a Registered User?
Andrea Pitkus voted on a comment on the idea Public Voters Must Be a Registered User?
Andrea Pitkus voted on a comment on the idea Personal smartphone-integrated virus sensors & app for rapid & accurate saliva self-screening with option to share results before entering common space.
Andrea Pitkus voted on a comment on the idea Personal smartphone-integrated virus sensors & app for rapid & accurate saliva self-screening with option to share results before entering common space.
Andrea Pitkus voted on the idea HUMAN GAS EMISSION BATHROOM FLITERS
Andrea Pitkus
Madison, United States
Joined this community on Nov 16, 2020
Bio https://www.linkedin.com/in/andrea-pitkus-phd-mls-ascp-cm-2a0b748/ Medical Laboratory Scientist with PhD in Health Informatics focused on laboratory data interoperability and clinical decision making
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Interpret-Covid