Dependencies

Owned by Anonymous
Last updated: Dec 04, 2023 by Anonymous
2 min read

Data Hub Dependencies

 

  1. Define the role and responsibilities of each party in building the IVD Data Hub:

a.     Data creators/collectors

                                          i.    Laboratories

                                         ii.    IVD vendors

                                        iii.    Laboratory information and EHR system vendors, middleware vendors

                                        iv.    Standards development organizations

b.     Data sources (e.g. hospitals, laboratories, registries …)

c.     Data Hub users (e.g. researchers, clinicians, patients, public health reporting, IVD vendors, regulatory agencies…)

d.     Data collection/sharing responsibilities and restrictions

  1. Successful completion and implementation of the LIDR standard:

a.     Build out of the LIDR infrastructure.

b.     Build out of LIDR content.

c.     Finalization and definition of some of the other data elements being proposed:  Harmonization indicator, UDI (instrument vs kit vs reagent systems)

                                          i.    Create a master catalog mapping between each of the tests/assays/reagents names, unit, harmonization indicator and UDI to LOINC/SNOMED codes

d.     Define the process for additions/expansion to the LIDR

e.     Determine if LIDR is a new SDO and who oversees/curates it.

f.      Eliminate the opportunities for labs to create variability in the LIDR elements they utilize.

g.     Funding for LIDR. Staffing required to manage it as well as curate it and ensure its’ entries are correct and if not communicate back to IVD vendors.

h.     Determine if existing LOINC/SNOMED codes are sufficient or can be used interchangeably.

i.      Interface developed between LIS and LIDR

j.      Interface developed between IVD Vendors and LIDR

  1. Implementation of LIDR content in the IVD vendor platforms

a.     IVD Vendors must be ardent in pursuing correct codes which may mean hiring the correct type of staff to dedicate to determining them based on methods. A strong knowledge of lab methods will be required.

  1. Implementation of LIDR content in the LIS vendor platforms

a.     Development of interfaces and logic/rules which can digest the encoded lab results and utilize appropriately within the LIS/EMR so that all required elements are evaluated and compared to existing test records to determine if they are the same tests and should be trended together or utilized in best practice advisories.

  1. Education and training on LIDR, Interoperability and Standards for Labs, LIS teams and IVD vendors

a.     Including general marketing and communication about the importance of this endeavor and what goals are trying to be achieved.

b.     Publications in ASCP, AMIA, etc.

  1. Availability of required data elements from the sending source

  1. Data use/sharing agreements in place from the sending source

  1. Transmission interface from Lab to Data Hub in a structured and standardized way

a.     Completion of any work that may need to be done by HL7, FHIR, etc.

  1. Determination of an entity to create, manage and maintain the Datahub.

a.     Including the necessary staff, expertise, and budget

10)  Determination of patient identity

11)  Will this be de-identified patient data?

a.     If not, the necessary HIPAA measures and considerations will need to be taken.

12)  Security and Access