finalsyndromicSOW.docx

PERFORMANCE WORK STATEMENT

Developing Business and Infrastructure Requirements for Syndromic Surveillance using Clinical Data from Health Information Exchanges (DBIRSSCDHIE)

C.1 Background and Needs

A major component of the Health Information Technology for Economic and Clinical Health (HITECH) Act under the 2009 national economic stimulus legislation is the Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs. Implementing these “Meaningful Use” programs is of immediate importance for public health authorities (PHA). This creates an opportunity to identify messaging standards and information interchange architectures (e.g., health information exchanges or HIE) for public and population health using clinical data from an EHR. In particular, there is a need for practice and technical standards that support syndromic surveillance using primary and inpatient care health data. Furthermore, such standards need to meet business requirements that accommodate the full range of stakeholder organizational capabilities without barring or impeding innovation. Given the fiscal challenges that health departments are facing, improving public and population health through Meaningful Use demands business requirements that support extensible EHR solutions and building efficiencies with existing assets.

C.2 Definitions and Standards C.2.1 Definitions Biosurveillance: “The science and practice of managing health-related data and information so that effective action can be taken to mitigate adverse health effects from urgent threats” [National Biosurveillance Strategy for Human Health (NBSHH), version 2.0 February 2010, http://www.cdc.gov/osels/pdf/NBSHH_V2_FINAL.PDF] Public Health Constituent: Public health authority personnel at the State or local health department or CDC.

Public Health Authority: A public health authority is broadly defined as including agencies or authorities of the United States, states, territories, political subdivisions of states or territories, American Indian tribes, or an individual or entity acting under a grant of authority from such agencies and responsible for public health matters as part of an official mandate. Public health authorities include federal public health agencies (e.g., CDC, National Institutes of Health [NIH], Health Resources and Services Administration [HRSA], Substance Abuse and Mental Health Services Administration [SAMHSA], Food and Drug Administration [FDA], or Occupational Safety and Health Administration [OSHA]); tribal health agencies; state public health agencies (e.g., public health departments or divisions, state cancer registries, and vital statistics departments); local public health agencies; and anyone performing public health functions under a grant of authority from a public health agency [45 CFR § 164.501].

Contracting Officer’s Technical Representative (COTR): A Federal employee whom a Contracting Officer has designated in writing to act as the Contracting Officer's representative in monitoring and administering specified aspects of contractor performance after award of a contract or order

Electronic Health Records (EHR): The Electronic Health Record (EHR) is a longitudinal electronic record of patient health information generated by one or more encounters in any care delivery setting. Included in this information are patient demographics, progress notes, problems, medications, vital signs, past medical history, immunizations, laboratory data and radiology reports. The EHR automates and streamlines the clinician's workflow. The EHR has the ability to generate a complete record of a clinical patient encounter - as well as supporting other care-related activities directly or indirectly via interface - including evidence-based decision support, quality management, and outcomes reporting. [Source: http://www.himss.org/ASP/topics_ehr.asp]

Health Information Exchange (HIE): “mobilization of health information electronically across organizations within a region or community.” [Kass-Hout, et., al, NHIN, RHIOs, and Public Health, J Public Health Management Practice, 2007, 13(1), 31–34.]

Meaningful Use Notice of Proposed Rule: “The American Recovery and Reinvestment Act of 2009 (Recovery Act) authorizes the Centers for Medicare & Medicaid Services (CMS) to provide reimbursement incentives for eligible professionals and hospitals who are successful in becoming “meaningful users” of certified electronic health record (EHR) technology. The Medicare EHR incentive program will provide incentive payments to eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) that are meaningful users of certified EHR technology. The Medicaid EHR incentive program will provide incentive payments to eligible professionals and hospitals for efforts to adopt, implement, or upgrade certified EHR technology or for meaningful use in the first year of their participation in the program and for demonstrating meaningful use during each of five subsequent years.” [http://healthit.hhs.gov/portal/server.pt?open=512&objID=1325&mode=2]

Nationwide Health Information Network (NHIN): “support communication and ensure secure, interoperable information exchange among these organizations.” [Kass-Hout, et., al, NHIN, RHIOs, and Public Health, J Public Health Management Practice, 2007, 13(1), 31–34.] The Nationwide Health Information Network (NHIN) is being developed to provide a secure, nationwide, interoperable health information infrastructure that will connect providers, consumers, and others involved in supporting health and healthcare. This critical part of the national health IT agenda will enable health information to follow the consumer, be available for clinical decision making, and support appropriate use of healthcare information beyond direct patient care so as to improve health. [Source: http://www.hhs.gov/healthit/healthnetwork/background]

Population Health (everyone’s responsibility): Population health is an approach to health that aims to improve the health of an entire population. One major step in achieving this aim is to reduce health inequities among population groups. Population health seeks to step beyond the individual-level focus of mainstream medicine and public health by addressing a broad range of factors that impact health on a population level, such as environment, social structure, resource distribution, etc. An important theme in population health is importance of social determinants of health and the relatively minor impact that medicine and healthcare have on improving health overall. [Source: http://www.health.state.mn.us/e-health/phphin/phmodel2008.pdf]

Public Health (governmental responsibility): Public health is concerned with threats to the overall health of a community based on population health analysis. Governmental public health agencies provide the backbone to the public health infrastructure, but this infrastructure is also dependent on other entities such as the health care delivery system, the public health and health sciences academia, and other sectors that are heavily engaged and more clearly identified with health activities. Public health also plays a legal regulatory role (e.g., conducting restaurant inspections) [Source: http://www.health.state.mn.us/e-health/phphin/phmodel2008.pdf]

Public Health Surveillance: Public health surveillance is the ongoing systematic collection, analysis, and interpretation of health data essential to the planning, implementation, and evaluation of public health practice, closely integrated with the timely dissemination of these data to those who need to know. The final link in the surveillance chain is the application of these data to prevention and control. A surveillance system includes a functional capacity for data collection, analysis, and dissemination linked to public health programs.” [Thacker, S.B., and Berkelman, R.L. "Public Health Surveillance in the United States." Epidemiology Reviews 10 (1988): 164-90.]

Stakeholder: A person, group, organization, or system who affects or can be affected by this project; including but not limited to: community-based hospitals, community groups, public health constituents at the state and CDC, primary care providers, insurers, etc.

Syndromic Surveillance: US CDC defines syndromic surveillance as “surveillance using health-related data that precede diagnosis and signal a sufficient probability of a case or an outbreak to warrant further public health response.”

The Joint Public Health Informatics Taskforce (JPHIT): JPHIT provides a common voice in public health informatics for a more robust enterprise capable of better protecting the population. JPHIT consists of an Executive Board made up of elected representatives and alternates from the following core organizations:

· The Association of Public Health Laboratories (www.aphl.org)

· The Association of State and Territorial Health Officials (www.astho.org)

· The Council of State and Territorial Epidemiologists (www.cste.org)

· The National Association of County and City Health Officials (www.naccho.org)

· The National Association of Health Data Organizations (www.nahdo.org)

· The National Association of Public Health Statistics and Information Systems (www.naphsis.org)

· The Public Health Data Standards Consortium (www.phdsc.org) JPHIT seeks to unify the public health message in the context of growing and moving towards accrediting public health departments with specific capabilities and to provide measured performance improvement in the area of health information exchange.

C.2.2 Standards C.2.2.1. Meaningful Use The contractor shall maintain consistency with the policy priorities and standards required by the CMS EHR Reimbursement Program, a provision of the HITECH Act, part of the America Reinvestment and Accountability Act of 2009.

C.2.2.2 Interoperability Standards The contractor shall implement the relevant HHS recognized interoperability standards accepted by the Secretary of Health and Human Services in December 2006. See the Executive Order: Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs at http://www.whitehouse.gov/news/releases/2006/08/20060822-2.html and standards at http://www.hhs.gov/healthit/standards.html

· AHIC Biosurveillance Use Case: The Biosurveillance Use Case is available at the Office of the National Coordinator for Health Information Technology. Harmonized Use Case for Biosurveillance (Visit, Utilization and Lab Results Data). 2006; Available from: http://www.hhs.gov/healthit/usecases/

· Biosurveillance Data Steering Group Preparedness Functional Area Matrix: http://www.hhs.gov/healthit/ahic/materials/meeting10/bio/BDSG_Functional_Areas_Matrix.xls

· Health Informatics Technology Standards Panel Interoperability Specifications (http://www.ansi.org/standards_activities/standards_boards_panels/hisb/hitsp.aspx?menuid=3

· 2007 table of nationally notifiable infectious diseases http://www.cdc.gov/ncphi/disss/nndss/phs/infdis.htm ()

· Listing of jurisdictions funded for Bioterrorism Preparedness through the Cities Readiness Initiative http://www.ncsl.org/statefed/health/BioFunds.htm

· The qualities and operating characteristics of earned value management systems are described in American National Standards Institute (ANSI)/Electronic Industries Alliance (EIA) Standard-748-A-1998, Earned Value Management Systems, approved: May 19, 1998, Reaffirmed: August 28, 2002 The contractor shall comply with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and CDC levels. At the government-wide level these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at http://www.cio.gov. HHS documents are found at http://www.hhs.gov/orim

C.2.2.3. Clinical Laboratory Improvement Amendments (CLIA): “The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 200,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program. The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.” [For more information on CLIA, please visit the CMS web site: http://www.cms.hhs.gov/CLIA and CDC at: http://wwwn.cdc.gov/clia/default.aspx]

C.2.2.4. Public Health Information Network: The contractor shall, where applicable, comply with standards promoted by the NHIN and PHIN, such as the PHIN Vocabulary and Access Distribution System (PHIN VADS); other health IT vocabularies and terminology standards; secure, nationwide, interoperable health information infrastructure; industry data standards (i.e., LOINC, SNOMED, IHE, HL7 and HITSP), and Public Health Information Network Implementation Guide for Syndromic Surveillance, HL72.3.1 and 2.5.1

C.2.2.5 Public Health Syndromic Surveillance Business Requirements: The contractor shall maintain consistency with community-consensus statements regarding the business process and technological requirements of the current state of public health syndromic surveillance practice: The ISDS Meaningful Use Workgroup, Final Recommendation: Core Processes and EHR Requirements for Syndromic Surveillance, www.syndromic.org/projects/meaningful-use C.3 Scope of Work

Independently, and not as an agent of the government, the Contractor will identify messaging standards and information interchange architectures (e.g., HIE) for syndromic surveillance using clinical data. The Contractor must furnish all the necessary personnel, facilities, supplies, equipment and travel required to recommended business requirements for ambulatory and inpatient care syndromic surveillance. A graphical depiction of the Government’s concept of the work breakdown structure required of this project is provided below:

C.3.1 Specific Tasks to be performed:

Task 1 - Administration and Operational Management

The contractor will furnish a project plan, schedule (including milestones and deliverables), client progress calls, and publish monthly reports; and the contractor shall coordinate with and support the Government staff. The contractor’s Project Director will oversee the tasks and be responsible for the following specific tasks:

· Initial Meeting – Prior to the kickoff meeting, the contractor shall schedule a meeting with the government for planning purposes within seven (7) calendar days following the date of award.

· Prepare Agenda for Kick-Off Meeting – The contractor shall prepare an Agenda for the Kick-Off meeting and shall submit the Agenda to the COTR at least 3 business days prior to the Kick-Off meeting.

· Participate in Project Kick-Off Meeting – The contractor shall provide one (1) – two (2) key personnel to participate in a kick-off meeting in Atlanta, GA at the beginning of the project. The kick-off meeting will be scheduled to occur on or before fourteen (14) calendar days following the date of award.

· Prepare Project Plan – The contractor shall prepare a project plan, including a milestone(s) chart, for review and approval by the COTR. The Project Plan shall be submitted as part of the contractor proposal.

· Attend Project Meetings – The contractor shall attend all project meetings and prepare and submit summary minutes for review and approval by the COTR. The summary minutes must be delivered within 2 business days following the meeting.

· Progress Reports – The contractor shall provide a monthly report, due on the 15th of each month for the prior month, containing the progress for each task, deliverables, expected work and deliverables for the following month, barriers or issues to be resolved, costs expended (to include: monies spent prior month, monies spent-to-date, and remaining balance for), and information describing any anticipated staff changes of key personnel.

· Prepare Final Findings Summary Report – The contractor shall, within 60 days following the end of the contract period, prepare a final summary report at the end of the project in a PowerPoint and MS Word format on the findings of developing business and infrastructure requirements for syndromic surveillance with clinical data. The report must detail the study methodology, the requisite business process and data elements.

Prepare Final Close-Out Report – The contractor shall prepare one (1) final close-out report at the end of the project. The report shall summarize outcomes; the entire time period covered in this contract; milestones, timeline and deliverables; and resolution of any issues or barriers.

Task 2 – Developing business and infrastructure requirements for syndromic surveillance using clinical data

The Contractor will:

1. Recruit Subject Matter Experts - Within one (1) month following the date of award, identify and recruit subject matter experts (SME) that have sufficient knowledge and background in: health information exchanges, primary and inpatient health care providers, EHR technology vendors, syndromic surveillance experts from local and state health authorities and CDC, representatives of key public health partner organizations (e.g., CSTE, NACCHO), leading public health surveillance and informatics researchers, etc.

2. Define Business Processes - Within six (6) months following the date of award:

a. Define business processes that:

i. Are generalizable to all stakeholder entities throughout the healthcare information enterprise for the purposes of syndromic surveillance as an EHR Meaningful Use

ii. Balance the current range of stakeholders’ technical and resource capabilities

iii. Leverage existing infrastructure assets or investments

iv. Identify areas for innovation and quality improvement

v. Detail the implications for data sharing

b. Define business processes for:

i. Syndromic surveillance with inpatient care data from an EHR

ii. Syndromic surveillance with primary care data from an EHR

3. Define Data Elements - Within seven (7) months following the date of award:

a. Define the data elements which include

i. Elements from the minimum dataset recommended for emergency-department based syndromic surveillance (www.syndromic.org/projects/meaningful-use)

ii. Elements that extend the capability of state and local health departments and CDC to provide timely intelligence and data on public health threats or health conditions of interest (e.g., the prevalence and severity of chronic disease conditions)

b. Identify message specifications and standards (e.g., HL7 2.5.1, ICD-9-CM) to be exchanged with a state health department and CDC as recommended by NHIN and the standards community

4. Describe and Assess Information Interchange Architectures – Within seven (7) months following the date of award:

a. Describe information interchange architectures (e.g., HIE) that may or currently support syndromic surveillance using clinical data

b. Assess each information interchange architectural scheme for capability to support the SME defined business processes, data elements, and messaging specification and standards for syndromic surveillance using clinical data

5. Solicit and Gather Input from the Full Stakeholder Community - Within nine (9) months following the date of award, solicit and gather input from the broad stakeholder community. Communication and input media should be accessible to individuals as well as stakeholder associations or corporations. Input should be analyzed and reported upon using quantitative and qualitative scientific methods.

6. Revise the Business Processes and Data Elements Based on Stakeholder Input - Within eleven (11) months following the date of the award, based on stakeholder input and in consultation with CDC and subject matter experts, revise the business processes and data elements to better support extensible EHR solutions and build efficiencies with existing assets.

C.3.2. Performance-Based Matrix

Degree to which deliverables meet relevant stakeholder needs

Group representation of stakeholders that provide input All deliverables met per contract requirements (i.e., timeliness and content)

Minimum of 50% polled stakeholders ‘Agree’ or ‘Strongly Agree’ that deliverables met guidance needs

At a minimum, 80% of all key stakeholder organizations or associations provide input

A. The evaluation will be considered when future AGENCY contract selections are made.

2. Payment is linked to quality through FAR 52.246-5 Inspection of Services – Cost Reimbursement.

A. The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

B. The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all places and times during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

C. If any of the services performed do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, for no additional fee. When the defects in services cannot be corrected by performance, the Government may—

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce any fee payable under the contract to reflect the reduced value of the services performed.

D. If the Contractor fails to promptly perform the services again or take the action necessary to ensure future performance in conformity with contract requirements, the Government may—

(1) By contract or otherwise, perform the services and reduce any fee payable by an amount that is equitable under the circumstances; or

(2) Terminate the contract for default.

Degree to which deliverables meet relevant stakeholder needs

Group representation of stakeholders that provide input

All deliverables met per contract requirements (i.e., timeliness and content)

Minimum of 50% polled stakeholders ‘Agree’ or ‘Strongly Agree’ that deliverables are accessible/applicable and, if implemented, will result in minimal or no loss of business capability

At a minimum, input is gathered from JPHIT member organizations, and EHR Associations (EHRA)

COTR and Contracting Officer

1.3 Developed guidelines support extensible EHR solutions

Group representation of stakeholders that provide input

Minimum of 50% polled stakeholders are EHR vendors ‘Agree’ or ‘Strongly Agree’ that technical guidelines support extensible EHR solutions within the constraints of Meaningful Use

At a minimum, input is gathered from PHDs and EHRA

Information interchange architectures includes HIE model

COTR and Contracting Officer

Incentives and Payment-Quality Link

1. Positive incentives:

a. The evaluation will be considered when future AGENCY contract selections are made.

2. Payment is linked to quality through FAR 52.246-4 Inspection of Services – Fixed Price.

a. The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

b. The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all places and times during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

c. If any of the services performed do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, for no additional fee. When the defects in services cannot be corrected by performance, the Government may—

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce any fee payable under the contract to reflect the reduced value of the services performed.

If the Contractor fails to promptly perform the services again or take the action necessary to ensure future performance in conformity with contract requirements, the Government may—

(1) By contract or otherwise, perform the services and reduce any fee payable by an amount that is equitable under the circumstances; or

(2) Terminate the contract for default.

C.4. Technical Requirements

C.4.1 - The contractor shall, during the contract period, recruit, convene, work with and build consensus among an interdisciplinary workgroup of subject matter experts (i.e., in the fields of clinical practice, syndromic surveillance practice, and health information exchanges, and research), and elicit and analyze feedback from key stakeholder groups.

C.5 Reporting Schedule

The Contractor shall submit monthly progress reports and a final written report and findings summary to the COTR. Reports shall be submitted by email to the COTR by the date requested, in a Word document attachment or appropriate format (e.g., MS PowerPoint slides, MS Project). The monthly progress reports shall document any problems that may have been encountered and have not yet been resolved as well as any items submitted for review by the Government. This would include responses that are due or overdue at time of the report. The monthly report shall also document any contemplated changes to the project plan. Contractor shall submit a final report for the project (MS Word format) and final findings summary (MS PowerPoint format) at the end of the project.

C.6 Deliverables:

The contractor shall provide the following deliverables to the COTR by the dates required:

1 electronic copy (in MS PowerPoint format)

i. Are generalizable to all stakeholder entities throughout the healthcare information enterprise for the purposes of Meaningful Use

ii. Balance the current range of stakeholders’ technical and resource capabilities

iii. Leverage existing infrastructure assets or investments

iv. Identify areas for innovation and quality improvement

v. Detail the implications for data sharing

b. Define business processes for:

i. Syndromic surveillance with inpatient care data from an EHR

ii. Syndromic surveillance with primary care data from an EHR 1 electronic copy (in MS Word format)

i. Elements from the minimum dataset recommended for emergency-department based syndromic surveillance

ii. Elements that extend the capability of state and local health departments and CDC to provide timely intelligence and data on all hazard public health-related threats or health conditions of interest (e.g., the prevalence and severity of chronic disease conditions) b.) Define message specifications and standards (e.g., ICD-9-CM) to be exchanged with a state health department and CDC as recommended by NHIN and the standards community 1 electronic copy (in MS Word format)

b.) Assess each information interchange architectural scheme for capability to support the SME defined business processes, data elements, and messaging specification and standards for syndromic surveillance using clinical data 1 electronic copy (in MS Word format)

Due within seven (7) months following the date of award

COTR and Contracting Officer

Due within nine (9) months following the date of award

COTR and Contracting Officer

The contractor shall deliver, within the time frames specified, Item(s) No. 1.1 through 1.11 to the COTR and the Contracting Officer at the address shown on the face page of the contract.

C.7 Special Considerations

The contractor shall be required to work off site with their own software and equipment and attend meetings at CDC, Century Center, as requested and needed. The government shall provide a “touch-down” space for occasions when office space on site is required.

C.7.1 GOVERNMENT RIGHTS IN DATA

All data, software and supporting materials acquired under this contract become the property of the U.S. Government. Under no circumstances shall an offeror place a copyright that will in any way limit the Government’s use of any of the materials that the vendor develops, provides and/or receives payment for under this contract. The government shall not resell the software or data. The contractor and others that hold rights retain their full rights to their versions of the software and all data, and may resell to any non-Federal Government entity.

C.8 SECURITY

The Contractor shall not provide any government documents, information, or licensed material in any form to sources not authorized by CDC without written approval during the period of performance of this requirement and any time afterwards. Execution of non-disclosure statements shall be required.

C.9 GOVERNMENT FURNISHED PROPERTY –No Government Furnish Property

C.10 REFERENCES – No special references

C.11 Period of Performance: A period of twelve (12) months.

C.12 Travel: Travel shall be required to support various aspects of the contract. Although the exact amount and locations for travel have not been determined. The Contractor shall not exceed the amount established in Section B of the contract. All requests for federally reimbursable travel will be pre-approved by the Contracting Officer and reimbursed to the extent that it is reasonable and supported. Request for travel approval shall be provided within 5 business days of the anticipated trip(s) and shall include the following information:

1. Purpose of Travel

1. Travel Origination

1. Travel Destination

1. Duration of Travel

1. Name of Traveler(s)

1. Estimated Cost (for each traveler)

1. Total Estimated Cost

All travel executed outside of the Contracting Officer’s authorization is at the contactor’s risk. Contractor will be authorized travel expenses consistent with the substantive provisions of the Federal Travel Regulation (FTR). While not wholly applicable to contractors, the Contractor shall limit travel costs to those authorized by the Federal Travel Regulation (FTR) to the maximum extent practicable. The FTR can be located at: http://www.gsa.gov/portal/content/104790.

Developing Business and Infrastructure Requirements for Syndromic Surveillance using Clinical Data (DBIRSSCD)

Task 2 Developing business and infrastructure requirements for syndromic surveillance using clinical data

Task 1 – Administration and Operational Management