Notice_of_Intent_to_Sole_Source-final.pdf

Notice of Intent to Sole Source

Date: August 12, 2019

Subject: “Order for Implementation of SHIELD-Harmonized Laboratory Data Standards in Public Health Laboratories”

This is a notice that the U.S. Food & Drug Administration intends to issue a Sole Source award to Association of Public Health Laboratories (APHL). The Government intends to issue a sole source award in accordance with FAR 6.302-1, only one responsible source and no other will satisfy the agency requirements for the above stated service. APHL is a unique, non-profit organization that represents state and local governmental health laboratories in the United States. Its members, known as “public health laboratories,” monitor, detect and respond to health threats. APHL works closely with federal agencies to develop and execute national health initiatives. During public health emergencies, it operates as a coordinating center for laboratory response. Federal Liaison/Policy: APHL serves as a conduit of information between US public health laboratories and federal agencies. APHL issues statements on pending legislation and regulations, and disseminates educational materials on priority issues.

This requirement can be satisfied by one responsible source, as APHL is the only known entity with the access, knowledge and extensive experience to update informatics systems in multiple public health laboratories across the United States. Success of this award requires the ability to implement the same infrastructure across multiple public health labs and send reports to the Centers for Disease Control. No other organization is currently known to be capable of fulfilling these requirements.

This will be a firm fixed price award.

The NAICS Code is: 621491 Health maintenance organization (HMO) medical centers and clinics.

APHL address is:

Association of Public Health Laboratories (APHL) 8515 Georgia Avenue, Suite 700 Silver Spring, MD 20910

The requirement employs standardized ways to describe the same device the same way each time to enable similar data to be pooled and evaluated. Then, by using standardized transmission formats, test data will be pooled and analyzed. All standards and approaches leveraged in this project are approved by the SHIELD (Systemic Harmonization and Interoperability Enhancement for Laboratory Data) initiative.

SHIELD is a multi-agency/stakeholder collaborative initiative to accelerate lab data digitization and improve the quality and harmonization of in vitro diagnostic (IVD) data sources.

Fundamentally, all IVDs ask a question of a specimen to get an answer; to achieve IVD semantic interoperability it is key that the same type of question and the associated answer be described the same way. This requirement will help ensure that the IVD descriptive information is consistent and unambiguous, hence expanding its potential for utility in downstream analyses and applications.

Appropriate application of these semantic standards and identifiers that can be used across heterogeneous computing environments are essential for facilitating the storage, exchange, and pooling of results for clinical care, outcomes management, and research

The purpose of this procurement is to sponsor an interoperability upgrade to existing public health laboratory (PHL) LISs by incorporating high-quality, industry-supported and 3rd party vetted, standardized descriptive coding for IVDs through LIVD and FHIR (as appropriate). Largely digitized, IVD data is often represented differently between institutions (or even within an institution) leading to ambiguity and incapacitating its utility in research or other purposes. Semantic interoperability failures for IVDs has been frequently cited as a significant impediment to patient care and public healthcare overall. Maintaining electronic health record systems that lack harmonized, semantically interoperable coding is costly and encumbers healthcare professionals whose time could be put to much better use.

This requirement will ‘pressure test’ the implementation of SHIELD-approved infrastructure prior to roll-out on a national scale. Electronic healthcare system interoperability will be assessed pre- and post-implementation, to include an evaluation of efficiency when reporting IVD test data (e.g., to the CDC).

This effort is expected to also have a significant impact on the ability to use Real-World Evidence (RWE) in regulatory decisions, realize real-time epidemiology, enhance clinical decision support and enable research related to infectious disease an antimicrobial resistance.

The requirement will implement SHIELD-vetted data interoperability standards and tools (as appropriate/feasible) for infectious disease tests and evaluate the benefits of this infrastructure and identify opportunities for improvement, prior to national and/or international dissemination. The following tasks are examples of the requirement that will outline the required actions (as possible/appropriate) for each laboratory (and associated implementation team) undergoing semantic interoperability enhancement: Identify lab tests and test codes with CDC associate to use in trial across and associated answer sets with SHIELD help, Obtain LOINC mappings in LIVD and answer sets from authoritative source w/SHIELD help and compare to data dictionary mappings of lab, Standards, vocab and technical integration, Database development, administration and modeling, APHL Informatics messaging services, and Collect poolable, high-quality, harmonized infectious disease IVD RWE from multiple laboratories, suitable for regulatory consideration, surveillance reporting (e.g., to the CDC Laboratory Response Network), and note any other associated benefits/challenges.

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement to Sarah Hussain, sarah.hussain@fda.hhs.gov in writing and must be within seven (7) days after date of publication of this notice which may be considered by the agency. A determination by the Government not to compete as a result of information received is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

No phone calls will be accepted.