Skip to Main Content

Clinical Sample to Answer Platform - multi-modality

BeanStock Ventures is developing a sample to answer platform focused on taking in test and assay data (PCR, NGS, Microarray) providing a standardized interface for native data upload , processing, storage, comparison, review and reporting.

edited on 17th November 2020, 02:11 by Shawnnah Monterrey
You will need to login to post a comment

Andrea Pitkus 8 months ago

How will pre-analytical, analytical and post-analytical laboratory testing aspects play into your approach, as well as CLIA/state laboratory regulations? see https://www.ecfr.gov/cgi-bin/text-idx?SID=124...e42.5.493_11291

Reply 1

Shawnnah Monterrey 8 months ago

Pre-analytical if referring to accessioning will be covered by LIMS integration. Analytical is intended to be integrated. Post analytical will include QC step for approval or lab review prior to be sent to the patient or clinician. Report will comply with CLIA and access controls will be in place to protect patient privacy during analysis using an unique id.

Reply 0

Andrea Pitkus 8 months ago

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?

Reply 1

Shawnnah Monterrey 8 months ago

1) Relies on LIMS or LIS, but will have API interface to obtain info needed for analysis, 2) Will be covered, need to tie patient information info the final report by sourcing from LIMS, 3) Yes - EMR/EHR, etc, 4) Yes

Reply 0

Andrea Pitkus 8 months ago

Thanks for the info. Part of the challenge in #2 and why AOEs have been built as part of lab order requirements is getting the information from those in #1 as the laboratory often doesn't know/have access to the info unless provided by #1. Once received from the EHR or a patient app, the performing laboratory can include the responses/info in their lab report of record (CLIA compliant) and send from the LIS directly to public health for ELR in accord with their requirements by law (and in some cases results sent to the EHR and sent in ELR compliant message to public health).

Paradigm changes a bit with patient performed tests as no LIS/EHR involved. Will patient performed testing be supported by your team too or out of scope? If in scope, interested in how AOE questions/responses are collected, encoded, married with patient performed results, and sent on to public health and HHS.

Reply 1

Shawnnah Monterrey 8 months ago

There are currently patient portal that allow patients to view results, this information already has their details. If we want to consider home testing with self reporting that is a bit different. Is that the main intent of this effort? If so we could develop a phone image capture of the lateral flow device and determine if they are positive or negative and sent via wifi or cellular, but them how do we handle rural areas (no smart phone)that's always a challenge. Is this most beneficial?

Reply 0

Andrea Pitkus 8 months ago

Thank you for the info. Where/how would your approach support LOINC and SNOMED CT encoding of data to meet ELR/HHS reporting requirements?

Reply 1

Shawnnah Monterrey 8 months ago

Typically in healthcare we rely on IHE (with Hl7) to take into account DICOM, HL7, SNOMED etc, without a COVID specific working group it's difficult to get community/industry consensus. Right now I think a good starting point is to provide an API that EHR/EMR and LIMS can connect to and leverage the work HL7 and IHE is doing (see below), as you know until there is some working group driving the standard, the EMR/EHR and LIMS work together to provide connectivity. At least with our platform our interface for EMR and LIMS with be standard per below and we can help drive standardization once we know exactly the major workflows and required and options data elements.
https://www.ihe.net/
For LIMS see:
https://www.ihe.net/resources/technical_frameworks/#laboratory
For public health see:
https://www.ihe.net/resources/technical_frameworks/#qrph
For COVID see:
https://blog.hl7.org/topic/covid-19

Reply 0

Andrea Pitkus 8 months ago

Thank you for the info. I should clarify I was specifically interested in how ELR and HHS reporting requirements for all COVID-19 testing would be met. Further info is on the Design a thon homepage Problem : https://www.hhs.gov/sites/default/files/covid...ng-guidance.pdf LOINC, SCT, UDI reporting are listed for both laboratory and non laboratory COVID-19 testing.

Not sure what is meant by "without a COVID-19 working group?" HL7 Public Health Workgroup oversees ELR and eCR reporting as required by law. ELR was part of Meaningful Use regulations and HL7 2.51 is the standard in those specifications. Non hospital labs (those ineligible for MU) still need to report ELR by law, but can use 2.31 messaging, flatfiles, and other means as those types of labs don't have specific standards requirements.

Furthermore, HL7 Orders and Observations WG convened a special WG that help review the COVID-19 reporting needs and provide guidance on how the data elements should be reported including referencing implementation guides for LRI, ELR, eDOS, LOI, and EHR-S functional guide for receipt of lab results in the EHR.

As you may know, US LISs don't have FHIR functionality, that is CLIA complaint for daily reporting needs. O&O is working on Diagnostic Report resource still and specimen information is discussed on the Specimen DAM calls.

Although some have developed FHIR based apps/APIs downstream on the EHR side for public health reporting and there is a eCR FHIR app, ELR is the main lab reported means of public health reporting.

Appreciate the info as I try to understand your vision and capabilities with your idea.

Reply 0

Share