Table of Contents

1          Introduction. 1

2          Background [Greg R.] 1

2.1       SHIELD. 2

2.2       Highly Reliable Data/Patient Safety. 3

3          The SHIELD Strategic Planning Process[Greg R.] 3

4          Current State: Barriers to Laboratory Interoperability [Greg R.] 5

5          Future State: US Laboratory Interoperability[Greg R.] 5

5.1       Clinical Interoperability. 6

5.2       Expanded LIVD File (perhaps too granular for a heading 2? , GR) 6

5.3       Supporting HIE, Public Health Surveillance and other aggregations. 6

6          Steps Towards the Future State:  How to Transform the Clinical Laboratory System in the US. 7

6.1       Strategy 1:  Expanded LIVD File [how from LIVD Comm] 7

6.2       Strategy 2:  Laboratory System Transformation [how from Implementation Comm] 7

6.3       Strategy 3:  Strategic Alignment 7

6.4       Strategy 4:  Tools and Knowledge Management 9

6.5       Strategy 5:  Communication and Training. 9

6.6       Strategy 6:  Working with Industry. 9

7          Roadmap. 9

8          Monitoring and Evaluation. 9

8.1       Key Performance Indicators. 10

9          Risk and Mitigation Strategies. 11

10        Budget 12

11        Appendixes. 0

Executive Summary

1       Introduction

2       Background [Greg R .]

What is SHIELD? The Food and Drug Administration’s (FDA) Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) is a public-private partnership that was assembled with a singular focus on improving the interoperability and utility of in-vitro diagnostic (IVD) test data through the harmonized implementation of semantic data standards that have been appropriately qualified by a sole authoritative source. Codes for laboratory data should be interoperable; “Describe the same test same way, every time”.

Laboratory in vitro diagnostics (IVD) testing makes up a significant portion of Electronic Health Record (EHR) data and these test results are used in approximately 70% of decisions made that influences patient care. The misrepresented or loss of IVD test data due to interoperability failures have had critical consequences including duplicate testing, lost provider productivity and, most importantly, patient safety issues. IVDs are used to gain insight into patient’s physiologic status (e.g., glucose levels, disease presence/absence), which helps guide clinical decisions and subsequent therapeutic actions. Semantic interoperability is essential to ensuring that the IVD test results are accurately and consistently described within EHRs.

By improving the semantic interoperability of laboratory data within and between institutions, diagnostic information can be used to better support clinical decisions, improve public health and improve quality through Real World Evidence (RWE). SHIELD supports the provision of vetted and harmonized codes from manufacturers/industry to laboratories to enable consistent representation of laboratory data in Laboratory Information Systems (LIS) and EHR systems, achieving cross-institutional semantic interoperability.

Benefits of SHIELD:

·        Eases administrative and clinical burden for all stakeholder groups through a unified approach

·        Establishes and Advances standards-based information exchange across laboratories and healthcare institutions

·        Lays the foundation for semantic interoperability by implementing infrastructure that directly harmonizes the process of how laboratory data standards are practically applied to IVD test data

SHIELD’s Pandemic Response: The COVID-19 pandemic required a rapid SHIELD focus on SAR-CoV-2 testing. AEUA (Emergency use authorized) assays for COVID-19 testing were being authorized without the necessary laboratory codes needed for laboratory interoperability and reporting. This ‘tragic data gap’ exposed by the COVID-19 pandemic has undermined the national response to the emergency. The challenges experienced to establish an adequate COVID-19 diagnostic test surveillance system in 2020 made clear the importance of lab test result data interoperability as a condition of pandemic preparedness.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act required “every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19” to report the results from each test to HHS.  On June 4, 2020, the HHS announced new laboratory data reporting guidance for standardized COVID-19 testing data elements of LOINC test order, LOINC test result, SNOMED CT test description, SNOMED CT specimen source, and Device Identifier. These requirements posed many challenges for laboratories, one of which being unable to report COVID Data. This is amid overarching supply shortages and other difficult labs faced during the pandemic.  As a result, SHIELD developed the pandemic-specific LIVD specification for SARS CoV-2 Tests that specifically defined the proper LOINC, SNOMED CT and Device Identifer to be communited for all SARS CoV-2 tests performed on a particular IVD platfrom. SHIELD creates and maintains the LIVD specification which provided the authoratitative source of coding for SARs-CoV-2 testing and is promulgated through CDC for purposes of standardizing reporting SARS-CoV-2 test results.

Knowledge and experience obtained by the SHIELD team during the Sars-CoV-2 pandemic provides the basis and the foundation on which to address the national issue of laboratory data interoperability.  SHIELD success will improve the national capacity to respond to future health care emergencies, elevate quality of healthcare, reduce healthcare costs and enhance patient safety.  

2.1        SHIELD

Vision: Shared vision of laboratory interoperability across the US to advance innovation and reduce burdens to the healthcare knowledge workers, increase patient safety and streamline knowledge management.

Mission: Aim to provide highly reliable laboratory knowledge to public, private, and professional organizations.

SHIELD’s goal is cross institutional laboratory data Interoperability by developing a publicly available infrastructure to improve the quality, interoperability and portability of laboratory data within and between institutions for enabling public health reporting, healthcare research and innovation, Clinical Decision Support (CDS), regulatory decisions, outbreak monitoring, signal detection and RWE.

SHIELD will accomplish this by:

·        Conducting an exploratory analysis of healthcare terminology data to identify differences that exist within laboratory code data in EHRs and LIS’s

·        Assessing electronic healthcare system interoperability pre- and post-implementation, including comparative associations with ICD codes and CPT codes, used for diagnosis and reimbursement claims

·        Compiling and preparing findings for dissemination/publication by SHIELD and IHIs[CWS1] 

·        Increasing semantic interoperability at each IHI and be an example to share with other healthcare systems to improve regulatory decisions, realize real-time epidemiology, enhance clinical decision support and enable research related to key diseases

2.2        Highly Reliable Data/Patient Safety

3       The SHIELD Strategic Planning Process [Greg R.]

The purpose for the development of a strategic plan for SHIELD is to connect its mission and vision by addressing three questions:

1. What is the purpose (Mission)?

2. What do we want to achieve (Vision)?

3. How are we going to get there? (Plan)?

The strategic plan establishes the roadmap for laboratory data interoperability within a 3-5 year timeline.  The plan inlcudes the key stakeholders and partners necessary to move the US laboratory systems to interoperability throughadoption of harmonized coding. The strategic plan sets the guiding principles of SHIELD’s approach by:

·        Articulating a clear mission and vision in a written document: SHIELD’s mission provides the organization with a clear and effective guide for making decisions, while its vision ensures that all the decisions made are properly aligned with what the organization hopes to achieve.

·        Driving organizational alignment: a strategic plan isn’t just a document to keep everyone on track. Having everyone participate in the strategic planning process fosters collegiality and creates an opportunity for discussion on the direction of the organization, which is why strategic planning often results in cultural transformation. In addition, the process promotes the open and creative exchange of ideas, including resolving disputes and working out effective solutions.

·        Enhancing Execution: confusion and day-to-day organizational fires are often reasons why strategic planning yields little results, but these risks can be mitigated by having a plan that is written down, with clear assignments, dues dates, and deliverables, so that all stakeholders know what must be executed by when.

·        Creating a roadmap and justify funding for leading US labs to interoperability: a roadmap allows for decision makers and leaders to be strategic when they evaluate initiatives. The overall strategic plan for SHIELD will be used to evaluate, assess and execute on key success factors and outcomes to achieve SHIELD’s goals and make it clear to key funders why this particular mission is important. The roadmap will justify SHIELD’s long term vision on three fronts: 1) public value to be created 2) sources of legitimacy and support 3) operational capacity to deliver the value

The Strategic Plan will focus on updating laboratory systems and IVD data at demonstration sites to adhere to best practices from the FDA SHIELD IVD Semantic Interoperability Working Group. The Strategic Plan is the byproduct of collaboration from 8 committees; comprising of co-chairs, and members.  The formation of committees started during the week of April 29^th into the first few weeks of May. By May 14^th, all committees and committee co-chairs were identified. Simultaneously, during that second week of May Committee members were recruited, on a volunteer basis through a survey.  According to the survey responses, approximately 45 SHIELD members were ready to participate in these 8 different committees. Member profiles represented various health care and, life science industries and thought leaders in laboratory interoperability to ensure a strong representation from a variety of stakeholders and breadth of knowledge/ideas. The 8 committees were made up of the following, also depicted in Figure 1:

1. Coordination Committee

2. Communication Committee

3. Strategic Alignment Committee

4. LIVD File Expansion Committee

5. Implementation Committee

6. Tooling, Technology and Knowledge Management (KM) Committee

7. Industry Committee

8. Effectiveness Committee (Program Evaluation)

To formally kick-off this 12-week strategic planning process, committee co-chairs held initial meetings to align on standard operating procedures and approach for completing this strategic plan. These meetings were then followed by committee wide membership meetings to address the most pressing strategies that aligned with the vision and mission of SHIELD.  Under the leadership of committee co-chairs, and voluntary dedicated time of committee members, each committee was asked to identify at least 3 strategies,  categorize action items for each and provide a roadmap for implementation within the 3-5 year timeline that tied to a specific budget or funding amount. These committee-level strategic plans were aggregated to create the SHIELD strategic plan.

4       Current State: Barriers to Laboratory Interoperability [Greg R .]

According to Office of National Coordinator for Health Information, there are currently 6 barriers to health care interoperability[i]

1. Landscape Analysis [CAP?]

1. Technical barriers - "These limit interoperability through — for example — a lack of standards development, data quality, and patient and healthcare provider data matching."

For example, in order for systems to be interoperable, there must be a shared understanding of what certain concepts mean. In the laboratory domain, there are many examples related to how tests are defined that emphasize this point. For instance, if a printed report says that the glucose level is 100 mg/dL, and does not give any more information, most clinicians would automatically assume that this was a serum/plasma sample, as opposed to a urine sample or a sample drawn as part of a glucose tolerance test. However, electronic systems don’t have this ability to draw inferences; so, in order to transmit test results successfully, we need to have a system for ensuring that both the sending and receiving system know how to interpret and file a given result. Another example is a therapeutic drug level, such as gentamicin. If the laboratory system has only a generic definition of a gentamicin, but the receiving system has separate results choices for “gentamicin, peak,” “gentamicin, trough” and “gentamicin, random,” then it is hard to know how to link the tests between the two systems[ii].

2. Financial barriers - "These relate to the costs of developing, implementing and optimizing health IT to meet frequently changing requirements of healthcare programs," including lack of incentives for sharing information and need for business models for secondary uses of data.

3. Trust barriers - "Legal and business incentives to keep data from moving present challenges. Health information networks and their participants often treat individuals' electronic health information as an asset that can be restricted to obtain or maintain competitive advantage."

4. Administrative requirements - "Federal documentation and administrative requirements (including billing requirements) contribute to health IT burden due to outdated guidelines for evaluation and management codes that unnecessarily link payment to documentation."

5. Reporting requirements - "Federal reporting requirements in some cases add burden to healthcare providers by requiring them to report on quality measures that are not relevant or meaningful."

6. IT usability - "Health IT system design and usability barriers identified by stakeholders include ... variations in the design [of user-interfaces] that make day-to-day use complicated when a healthcare provider uses multiple systems and the lack of developer engagement with end users of health IT regarding design needs."

Insert USE CASE scenarios[

5. Future State: US Laboratory Interoperability [Greg R.]

It is understandable that health systems, payers, providers and hospitals are all on-board with seeking innovative yet, manageable approaches to interoperability in healthcare. Some advances in analytics, such as intelligent organization of claims, accurate diagnosis, computer assisted coding and patient insight using artificial intelligence, NLP technology and medical Machine Learning will be at the forefront of methods that will drive these endeavors forward.  Real-time data exchange of relevant healthcare information during each step of the information chain will not only improve quality of care but the efficiency in which it is delivered will be the center of value-based healthcare. Therefore, it is important to work with thought leaders in the world of interoperability in an effort to adopt SHIELD’s approach to improve their internal interoperability.

Additionally,[BZ13]  the COVID-19 pandemic has woken the healthcare system to the reality that the US does not have a uniform health system and that healthcare in the United States is provided by many distinct organizations. As a result, the healthcare delivery system is not as reliable as other industries. Thus, increasing the need for strong business and clinical requirements to achieve a High Reliability Organization (HRO) status and to generate reliable performance results in healthcare. An HRO model is an environment of “collective mindfulness” where all physicians, caregivers, employees, management, and key stakeholders look for, and report, small problems or unsafe conditions before they pose a substantial risk to their patients and when they are easy and affordable to fix[iii]. Especially, in recent years, healthcare consumers, providers, payers, and other key stakeholders have demanded better patient care, heightened patient safety and improved business outcomes. And, implementing an effective HRO model helps physician practices’ leaders and practitioners design their organizations around anticipating and preventing problems. Therefore, achieving interoperability across the U.S laboratories will put SHIELD as the driving force and center of this shared vision and common goal of achieving consistent and reliable patient care outcomes and sustainable business performance results for many healthcare entities/organizations.

Scenarios are a good place to strategic plan to end.  There are difference potential scenarios that will bring in various parts of a very large system.

·        Creation of the LIVD coding on routine base

·        Repository and authority

·        Use scenarios that sustain the ecosystem?

·        CAP xxx

·        IVQ Data Hub

5.1. Clinical Interoperability

5.2. Expanded LIVD File (perhaps too granular for a heading 2? , GR)

5.3. Supporting HIE, Public Health Surveillance and other aggregations.

Notes

SHIELD in the Steady State [what are the functions of SHILED in the future state]

·        Convene stakeholders

·        Ensure ongoing Quality of data

·        Accommodate new data needs

·        Accommodate new technology needs

·         

6. Steps Towards the Future State:  How to Transform the Clinical Laboratory System in the US[DS(17] .

6.1. Strategy 1:  Expanded LIVD File [how from LIVD Comm]

6.2. Strategy 2:  Laboratory System Transformation [how from Implementation Comm]

Laboratory system transformation (implementation committee) items describe the specific elements of the laboratory systems, data standards and policy that must be addressed to achieve the objectives of SHIELD.  To the extent possible or reasonable, specific action items are proposed.

6.3.2    Establish explicit definition of levels of laboratory data interoperability. 

Laboratory data interoperability as introduced, “Describe the same test same way, every time”, is complex and achieved in phases.  The ultimate final objective for laboratory data interoperability is realized when a specific laboratory test result performed on one IVD platform and the same laboratory test performed on a different IVD platform can be viewed as performed on the identical IVD platform.  In other words, the data are precisely equivalent and safely intermingled.  This is referred to as “Complete Interoperability”.  A more limited, but necessary, stage of laboratory data is that laboratory test data performed on a particular IVD platform can be associated electronically with laboratory test data performed on the same IVD platform at any single healthcare institution with 100% accuracy.  This will be referred to “Limited Interoperability”.

Complete interoperability requires the normalization of laboratory test results on an international scale which includes IVD maker, clinician, and laboratorian involvement.  This level of laboratory test data interoperability is present in less than 100 tests worldwide.  The US along with the international health care community is engaged in this effort, and SHIELD should both support the effort and employ its products.  Limited interoperability is a necessary and attainable step towards laboratory data interoperability and forms the basis of the implementation strategy objectives.  However, it must be clearly understood by HHS, subsidiary departments (FDA, CDC, ONC), that Complete interoperability is critical to pursue for the safety of patients, public health objectives and overall healthcare operational efficiencies.

6.3.3    Data and data exchange standards

To realize Limited, and eventually Complete, laboratory data interoperability, standards for data representation and data exchange within the laboratory environment and electronic health record domains must be clearly stated and strictly adhered to by all stakeholders – IVD makers, software vendors and laboratories. 

6.3.3.1 Data elements required for laboratory data interoperability

Data elements included in SHIELD’s pandemic LIVD file represent the bare minimum data elements necessary to include in any electronic exchange of laboratory data to approach Limited interoperability.  Additional data elements as identified as part of the LIVD file expansion must be considered and included in future laboratory data exchange to achieve consistent Limited interoperability, and eventually, Complete interoperability.  Critical data elements include unique device identifiers for IVD platforms and unique identifiers associated with test kits used on a particular IVD platform.  When available, an indicator for Complete interoperability for a particular test should also be included.  All data elements describing test orders, test results, specimens used and test results should be represented using the appropriate data standard and standard development organization source.

6.3.3.2 Data exchange standards

6.3.3.2.1          IVD platform to Laboratory Information System

The Integrating the Healthcare Environment Laboratory Information Workflow (IHE LAW) data exchange standard provides direction to IVD maker and software vendors regarding the data elements necessary to electronically exchange between IVD platform and information system including device identifiers and test kit identifiers.  However, very few device manufactures or LIS vendors have developed the capability to adhere to this standard.  These vendors are reluctant to invest in such product development due to cost, apparent disinterest by clients and protection of “proprietary” product features. 

SHIELD will not realize its objectives without vendor adherence to IHE LAW.  Therefore, a primary implementation objective is the broad adoption and adherence to IHE LAW by the vendor community.  Possible approaches to promote IHE LAW are described later in this section.

6.3.3.2.2          Laboratory Information System to EHR, and EHR to EHR data exchange

Laboratory data exchange between clinical information systems is defined and promoted by HL7 and ONC.  These exchange standards are widely accepted and employed.   Including data elements necessary for Limited and Complete laboratory data interoperability into the HL7 exchange standards and by ONC directive will provide the necessary structure and guidance to meet this component of laboratory data interoperability.

6.3.3.2.3          Data element standards

Data element standards that represent the required data elements defined in the LIVD files include LOINC, SNOMED CT, and RxNorm.  To achieve SHIELD objectives, these data standards must be harmonized, integrated, and disseminated into a unified format.  Integration efforts between SDO’s in the US domain must be completed and deployed. 

6.3.4    Implementation Vectors

6.3.4.1 Step 1 - Pilot Site and Prototype Approach

Due to limits in IVD maker and software developer interest and capacity to support IHE LAW, initial implementation efforts must focus on changing this industry inertia.  This can be done legislatively, but such approaches will likely result in prolonged negotiations or resistance.  In addition, specific data elements, data element representation and exchange standards are still in development.  A pilot set of implementation sites focused on vetting the tractability and plausibility of SHIELD strategies is recommended to support stable standards definitions and use (Section 6.2), provide a test environment for tooling development (Section 6.4), engage vendors at sites, and demonstrate functioning, scalable prototype implementations. 

6.3.4.2 Pilot site selection

SHIELD pilot implementation will be developmental in nature and require access to substantial resources committed to the SHIELD mission and vision.  Approached as a standalone effort, resource allocation of personnel and funding will be large.  However, SHIELD compliments ongoing national efforts that rely on the use of clinical and laboratory data to achieve their objectives.  These national efforts center on national biosecurity and ability to respond to future regional, national and/or international health emergencies.  Aligning SHIELD pilot site efforts with these other efforts of national importance will provide SHIELD with pilot sites already committed to the objectives of SHIELD as part of their specific charters.  These sites include the Veterans Administration and the University of Nebraska Medical Center.  Both the VA and UNMC operate expansive laboratories, as well as, deliver health care in the inpatient and outpatient settings. Likewise, the VA and UNMC are extensively involved in multiple biosecurity and surge capacity pilots funded by the CDC, ASPR and DoD.  These sites have committed to participation in SHIELD pilots.  Further, each site uses IVD platforms, LIS and EHR systems that are used broadly in the US, and as such, provide the vendors an opportunity to collaborate in SHIELD development without legislative pressure.

6.3.4.3 Laboratory Test Prioritization for Implementation

Development and deployment of SHIELD protocols for laboratory data interoperability will be a significant undertaking and application for the entire US laboratory test compendium simultaneously is not advised.  Prioritization for implementation should focus on those laboratory tests for which there are: a) patient safety implications which SHIELD will address; b) testing volume is sufficiently large to be impactful; and c) some IVD maker capacity to support SHIELD is present.  Based on COVID pandemic efforts and HHS requirements, an initial focus on respiratory pathogens provides an area of laboratory tests that are widely employed in the US throughout the entire calendar year ranging for Sars-CoV-2, influenza, RSV, pneumonia, and other various respiratory illnesses.  Further, many of the IVD platforms employed for Sars_CoV-2 under EUA provisions are used to identify these other pathogens.  Information technologies developed during the pandemic by IVD makers and software platforms can be extended and enhanced.  Further, pilot sites noted in Section 6.3.4.2 have IVD maker and LIS/EHR software platforms with basic SHIELD functionality to support this area and will reduce barriers of implementation related to vendor capabilities and inertia.

6.3.4.4 Professional Association Engagement

Professional associations, specifically the College of American Pathologists, ASCP and AACC, have extensive knowledge in laboratory medicine and are heavily investing in patient safety.  Representatives of these organization should be engaged and involved with pilot site implementation, as well as, overall strategy, implementation, training and oversite development.  In addition to primary missions of patient safety, these organizations represent the stakeholders who ultimately will be the workforce to implement and maintain any SHIELD directive.  These bodies will have specific insights and knowledge regarding the pitfalls and implications of SHIELD recommendations.  Such pitfalls and unintended, unnecessary burdens placed upon the laboratories can be avoided with proper involvement of these organizations and their constituents.

6.3.4.5 Implementation Expert Guidance and Oversight

{Engage key industry and professional experts to serve as expert panel to guide implementation and ongoing SHIELD development} 

6.3. Strategy 3:  Strategic Alignment

Strategic Alignment Committee

·        [How to] Identification of alignment partners

a.      Prepare package for Micky to speak with Agency Heads

                                i.          Schedule meetings for Micky

                               ii.          Propose that Agencies spin up teams within the Agency

1. What are the agency barriers, review and analysis of agency policies related to SHIELD

2. Plans to reform

3. Presentations at major forums and publications

b.      Phase II Strategy Development  (based on assessment and engagement by agencies)

                                i.          Starts Year 2

c.      Metrics:  (1) committees Formed and (2) plans made

d.      Tools:  Planning tool for alignment

e.      Phase 3:  Development of Mature SHILED governance and authority/Future State

Notes:

The Strategic Plan will also propose clearly defined lines of authority and roles and responsibilities across the SHIELD program team. SHIELD leadership works with CDRH counterparts to translate the program’s high-level strategy and priorities into actionable plans and execution at the working-level. A governance body, perhaps driven by the implementation committee can provide technical assistance and disseminate best practices and other information to support and accelerate efforts. This is essential for rapid and successful implementation of HHS data reporting requirements. Additionally, support services, targeted outreach, and a small grants program are proposed to support implementation of coding standards. This section can also contain details around the following:

ü  Analyze and identify recommendations to improve program governance

ü  Update the program governance plan

ü  Create and maintain a decision authority matrix by building upon the current decision-making processes

ü  Track and monitor decisions in the SHIELD decision log and identify impacts to communicate decisions to committee stakeholders.

Strategic alignment between the many government and non-governmental stakeholders of SHIELD and is critical to the transformation needed to bring about laboratory data interoperability.  The steps proposed in this Strategic Plan must happen at many points in the clinical laboratory starting with manufacturing, ordering of tests, laboratory processing, and the many down stream uses of the data from clinical reporting, billing, surveillance, and research.

Table x below lists SHIELD stakeholders and the alignment that this strategic plan recommends. These range from policy changes, to investment and programmatic action. Both government agencies (federal and state) and non-government stakeholders (manufacturers, coding organizations, laboratories, and professional society) need to act to move the national laboratory system towards interoperable, efficiency and improved patient safety.

Strategic alignment of stakeholders is proposed in three phases. The first phase will work to engage the leadership of the many stakeholders and develop more specific analysis of barriers to reform.  The second phase will be to develop and implement a plan to help the partner stakeholders to update and develop their procedures and process to support interoperability.  The third phase is to evaluate the efforts.  This would take place over a three-year period.

The strategic alignment works with each stakeholder organization separately but also works to build a body that will provide governance and authority for interoperability in the future.  This body will coordinate across the many government agencies and private sector organizations that play a role in interoperablity.

Phase one – Engagement and assessment

·        Develop a case and value proposition for each stakeholder

·        Work with Deloitte consultants to inform agencies about potential role in SHIELD in advance of formal contact.

·        Propose that ONC director meet with agency and organization heads meet with stakeholder leaders with a plan for collaboration

·        Form collaborative committee (SHIELD and agency members) for each stakeholder

·        Develop work plan for committee to continue work and implement as planned

·        Publication

·        First develop a draft plan for interagency governance of interoperability and hold first meeting of all agencies consider structure, functions and agents that would do this work.  An possible convener could be ONC or ASPE/

Phase 2- Implementation

·        Agency/organization specific commitees begin work to move forward policy and process reform

·        Second meeting of all stakeholder leadership to review reports of Phase one and  develop terms of reference of a coordination body

·        Publications

Phase 3 – Evaluation

·        Evaluate implementation including potential pilots to be able to view data flow for each part of process

·        Establishment of interoperability governance body for ongoing and authority to coordinate interoperability into future

·        Publications

Table X. Strategic Alignment Map

6.4. Strategy 4:  Tools and Knowledge Management

6.5. Strategy 5:  Communication and Training

The communication committee will work to operationalize coordination, planning, management, and execution of multiple related initiatives across organizations utilizing appropriate level of support to realize shared vision of laboratory interoperability. The committee will contribute a Strategic Communications plan to build a transparent targeted, stakeholder- and data-informed communication campaign with clear channels of engagement and purposeful knowledge sharing. The communication plan will incorporate the following:

ü    A plan to build the system

ü    A plan to sustain the future state

6.6. Strategy 6:  Working with Industry

7. Roadmap

8. Monitoring and Evaluation

Monitoring the implementation of coding standards and reporting will be used to guide the implementation work of the project and better understand the needs of those doing the implementation. The extent and quality of implementation of the coding standards and resultant reporting are critical sustainability of HHS Protec. The Effectiveness Committee will deploy evidence-based evaluation methodologies to support the rigorous measurement of performance effectiveness and the interpretation of data to achieve results-driven improvements for semantic interoperability of laboratory data while promoting operational efficiencies. Monitoring and evaluation of the national implementation of SHIELD harmonized standards and maintenance over time is essential.

It’s important that SHIELD is able to align the strategic objectives with actional goals, and measurable outcomes. For example, the Balanced Scorecard (BSC) methodology can be applied to identify specific metrics, and measures (KPIs) that tie directly to the vision and strategy of SHIELD as outlined by SHIELD members. The balanced scorecard measures an organization’s performance from four different perspectives: financial, internal business processes, customers, and learning & growth, all through the lens of the organization’s Vision and Strategy. This process addresses a concern many organizations have about the difficulty of linking their long-term strategies with short-term actions. The balanced scorecard gives the organization a mechanism to look beyond short-term financial measures as sole indicators of the organization’s performance.

Regular evaluation of the extent of implementation of evaluation SARS LIVD mapping by clinical laboratories is needed. Those clinical laboratories that implemented LIVD mapping should be evaluated further to understand the impact on the quality of data improved received when transmitted to public health or other entities. It should also include an assessment of the capabilities of clinical laboratories and public health laboratories to collect, send and receive the data elements named in the HHS guidance as well as assessing the validity of being included in the lab data exchange stream.

8.1. Key Performance Indicators

A SHIELD roadmap can be inserted here to show how strategy will meet execution. It will outline key outcomes that must be delivered over the duration of the project timeline in order to achieve the organization’s strategic vision.

Table below describes artifacts and documents to be delivered by each Committee. Each document was given an ID number which is used in the Project Timeline.

9. Risk and Mitigation Strategies

Implement a risk management program that brings risk identification and mitigation to the forefront for team members and stakeholders to improve the program’s ability to anticipate and mitigate obstacles.

Implement and Maintain Risk Management Program:

(1)   Evaluate the existing (or create) Risk Management Plan to determine how to simplify the existing processes and to remove barriers to adoption and redesign the risk management process (2) Facilitate initial risk elicitation workings sessions with stakeholders to develop proposed mitigation strategies (3) Perform proactive risk management at the program and committee levels supported by recurring working group meetings (4) Provide a bi-weekly risk report to include the Risk Register and status of all risk mitigation activities.

Continuously Capture Lessons Learned:

(1)  At the end of every increment, develop and maintain a Lessons Learned (LL) Log by leveraging retrospective information and interviewing the work stream leads to detail by work stream what worked well, what didn’t work well, challenges and recommendations for going forward (2) At the end of every initiative, develop a comprehensive lessons learned by work stream and publish the report to the entire program to facilitate integration (3) Work with the work stream leads to implement agreed upon recommendations going forward and monitor progress to implement.

10. Budget[BZ18] [DS(19]

As part of this effort, budget estimates will need to be developed for the purposes of requesting allocation of government funds in order to perform the work of SHIELD.  Therefore, each committee should generate an “execution plan”, in other words a Statement of Work (SOW), to be performed over a three-year time frame order to achieve the objectives of the committee.  A statement of work (SOW) is a narrative description of a committee’s goals/agenda.  Scope of works include:

·        Objectives – Well defined statements of the results to be achieved for the overall mission of the work to be accomplished.

·        Scope - What the scope of work does and does not cover.

·        Tasks - Activities and milestones that need to be completed to accomplish the objectives. Tasks can be structured by milestones, deliverables, or processes.

·        Time Frames and Deliverables

A statement of work will allow us to arrive at budget estimates and is the first step in the process.  With a SOW, the Coordination Committee can then work with the committee to help create a Basis of Estimate (BOE) and cost estimate.  For a reference point, Figure 2 shows the suggested funding allocation articulated in the SHIELD whitepaper.²  Guidance is for the committees to start with describing what is the right thing to do to accomplish the goals and overcome the challenges for work that needs to be done.

11. Appendixes

1. Laboratory Data Interoperability Strategy for the COVID-19 Response and Pandemic Preparedness White Paper

2. SHIELD Strategic planning process document

3. Committee reports (this could include committee materials, meeting minutes, reports and committee purpose/charter/background statements)

[i] ​https://www.beckershospitalreview.com/ehrs/6-barriers-to-healthcare-interoperability-according-to-onc.htmlOpen

[ii] https://documents.cap.org/documents/laboratory-interoperability-best-practices.pdf

[iii]​https://symbiosisonlinepublishing.com/nursing-healthcare/nursing-health-care31.phpOpen

 [CWS1]What is this?