SOW TBESCIII DRAFT.docx

Statement of Work Procurement Request #: 00HCVJEG-2021-52688 Period of Performance: September 29, 2021–September 28, 2026 Title: Tuberculosis Epidemiologic Studies Consortium III

SECTION 1 – BACKGROUND

Thirty-one years ago, the Advisory Committee (now Council) for the Elimination of Tuberculosis adopted a strategic plan to eliminate tuberculosis (TB) by 20101. This strategic plan focused on interruption of TB transmission through rapid identification and appropriate treatment of persons with infectious TB and their close contacts. This approach was highly effective, resulting in a >60% decline in the U.S. TB incidence rate during 1989–2010. However, the 2010 incidence rate remained 10 times the TB elimination threshold, and the annual pace of decline in TB incidence significantly slowed in the second half of the 2010s2. Epidemiologic modeling has demonstrated that the main driver of U.S. TB incidence is no longer recent transmission, but rather the large reservoir of individuals, disproportionally non-U.S.–born persons, with latent TB infection (LTBI) who live in the United States3. In 2016, the U.S. Preventive Services Task Force (USPSTF) issued an updated recommendation calling for screening of asymptomatic adults aged ≥18 years who are at increased risk of TB infection. In its recommendation, the USPSTF defined those at higher risk of TB infection as including “persons who were born in, or are former residents of, countries with increased tuberculosis prevalence and persons who live in, or have lived in, high-risk congregate settings (e.g., homeless shelters and correctional facilities).”4. Subsequently in 2017, the directors of the Centers for Disease Control and Prevention (CDC)’s Division of Tuberculosis Elimination and National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention called for a major new effort to conduct public health surveillance for LTBI, scale up targeted testing for LTBI in at-risk populations, deploy newer, less toxic short-course LTBI treatment regimens, engage with affected communities and medical providers who serve those communities, and increase public health staffing for implementation and oversight of LTBI-related programs5.

As the effort to eliminate TB in the United States enters its fourth decade, TB epidemiologic research efforts need to focus on how to most efficiently and effectively implement TB prevention programs that detect LTBI among persons living in the United States and successfully and completely treat persons with LTBI to reduce their risk of developing TB disease in the future. To that end, though the authority granted by section 317E of the Public Health Service Act (42 USC § 247b–6) to the Secretary of the U.S. Department of Health and Human Services to conduct research “with respect to the prevention, treatment, control, and elimination of tuberculosis,” CDC is soliciting proposals for a five-year epidemiologic research studies consortium that will focus on applying the principles of implementation science to identify the best approaches that will result in decreasing the prevalence of untreated LTBI among non-U.S.–born persons living in the United States and ultimately accelerate progress toward the national goal of TB elimination.

SECTION 2 – PURPOSE

The purpose of this requirement is to gain a better understanding of how LTBI screening, testing, and treatment is offered to at-risk patients in primary care settings, as well as the impact of interventions to improve performance across the LTBI Care Cascade.

CDC, through its TB Epidemiologic Studies Consortium (TBESC), aims to 1) identify primary care systems/settings that serve non-U.S.–born persons at risk for LTBI and TB disease, 2) collect retrospective and prospective electronic medical record data, 3) design and implement clinical care-based interventions to improve performance measures across the LTBI care cascade, and 4) monitor and evaluate intervention performance over time to identify efficient and effective strategies.

SUBSECTION A – PARTIES THE PROJECT INVOLVES

The TB Epidemiologic Studies Consortium (TBESC) will consist of CDC program staff and any principal investigators contracted to perform the tasks included in this requirement. TBESC is managed by the Surveillance, Epidemiology, and Outbreak Investigations Branch (SEOIB) of CDC’s Division of Tuberculosis Elimination (DTE). An SEOIB staff member will serve as the chair of the consortium, leading discussions and making final study protocol decisions considering input from consortium members.

SUBSECTION B – OVERALL OBJECTIVES

The first objective of the consortium will be to identify non-U.S.–born subpopulations within the broader population that are at risk for LTBI for which to prioritize scaling up LTBI targeted testing and treatment in primary care settings. USPSTF and CDC guidelines identify broad population groups that are considered at greater risk of LTBI, chiefly, persons who have lived in countries with greater TB incidence than the United States. However, in 2019, an estimated 44.9 million (13.7%) U.S. residents were born outside of the United States6, and the effectiveness and efficiency of LTBI targeted testing and treatment is not expected to be uniform across the entire non-U.S.–born population.

The second objective of the consortium is to identify and provide primary care interventions that increase LTBI targeted testing and treatment and are effective and efficient at minimizing losses at each of the steps of the LTBI care cascade. The LTBI care cascade (Figure 1) is the process of identifying persons with LTBI and ensuring that they complete treatment to prevent progression to TB disease.

This conceptual framework is referred to as a “cascade” because each step in the process is completed by a progressively smaller number of persons as individuals are lost to follow-up. In an ideal scenario, screening criteria would yield a very high percentage of persons with LTBI (TB test positivity expected to be 15% or higher among at-risk non-U.S.–born populations). Similarly, every person who meets screening criteria would be tested for TB infection, and those found to have LTBI would be recommended/offered LTBI treatment, start treatment, and complete the entire course of treatment. Scaling up this approach nationwide would prevent and ultimately eliminate TB disease in the United States.

However, previous studies have demonstrated that there are major weaknesses and gaps in the LTBI care cascade, as implemented in the United States. Weaknesses and gaps include (1) identifying persons that meet TB infection screening criteria who present for medical care, (2) testing with recommended diagnostics (interferon-gamma release assays), (3) recommending and prescribing treatment for persons who are diagnosed with LTBI, and (4) ensuring that persons who start treatment are compliant and ultimately complete treatment7,8.

SECTION 3 – SCOPE OF WORK

The contractor, under CDC’s supervision and the auspices of the consortium, shall conduct a multicenter epidemiologic research study using the principles of implementation science to identify the characteristics of LTBI targeted testing and treatment programs that are associated with the greatest effectiveness (maximizing number of LTBI cases detected and completely treated according to CDC guidelines9,10) and efficiency (minimizing the cost per LTBI case detected and completely treated). The design of the study will be determined by CDC and approved by the CDC Institutional Review Board (IRB).

The study requires the contractor to implement an LTBI targeted testing and treatment program at their respective institution(s) in a primary healthcare setting. The contractor shall collect and provide CDC-specified data elements, including deidentified patient-level data, to address the consortium objectives as described above.

The consortium’s multicenter epidemiologic research study will be comprised of three phases:

· In phase one, which shall last approximately 1 year, the contractor shall work with CDC to establish baseline measurements of the LTBI care cascade in the targeted subpopulations they serve.

· In phase two, which will last approximately 3 years, the contractor shall implement their proposed testing and treatment interventions targeting the at-risk non-U.S.–born population(s) they serve and collect data to evaluate effectiveness and efficiency.

· In phase three, the final year of the study period, the contractor shall report study results, complete manuscripts for publication, and finalize deliverables.

SECTION 4 – TASKS TO BE PERFORMED

The contractor shall, independently and not as the agent(s) of the Government, furnish all the necessary services, qualified personnel, material, equipment, and facilities to develop, implement, and evaluate intervention studies to improve identification of LTBI and completion of LTBI treatment for high-risk non-U.S.–born populations in primary care settings. If the contractor operates LTBI targeted testing and treatment programs in multiple primary care settings (e.g., community health clinics, private physician practices, hospital outpatient clinics), the contractor shall limit their intervention(s) to one such primary care setting. However, the intervention(s) may include multiple practice or clinic locations, or a network of practices/clinics, as long as the practices/clinics operate in the same type of primary care setting and the contractor, directly or through partnerships, manages all locations or the network.

Task 1: Conduct Start-up Activities Subtask 1.1 Establish Memoranda of Understanding and Data Use Agreements (Base Year)

1.1.1 Contractor shall establish any necessary Memoranda of Understanding (MOUs) with primary care partners and submit copies to Contracting Officer's Representative (COR) within 2 months of contract award.

1.1.2 Contractor shall establish any necessary Data Use Agreements (DUAs) with partners and submit copies to COR within the first 4 months of contract award. As part of the contract award, CDC retains ownership of any and all data collected as part of this contract.

1.1.3 Contractor shall rely on CDC as the single IRB (sIRB). Under Revised Common Rule §46.114(b), all cooperative research initiated on or after January 20, 2020 requires reliance on an sIRB and applies to all U.S. institutions engaged in collaborative research supported by a Federal department.

Subtask 1.2 Plan and Conduct Kick-off Meeting (Base Year) Contractor shall coordinate and host kick-off/planning meeting between their project team and CDC staff within 30 days of the award. The contractor’s key personnel must attend, and any travel-related arrangements and costs for contractor personnel are the responsibility of the contractor. CDC anticipates attending this meeting virtually using web-based video conferencing software. Contractor shall plan, schedule, and manage all logistics related to the kick-off meeting including meeting space, agenda, audio-visual support, printed materials, and communications. Contractor shall be responsible for hosting web-based video conference capabilities for CDC members and others to be able to participate remotely.

Subtask 1.3 Develop Intervention(s) Protocol (Base Year)

1.3.1 Contractor shall develop and submit draft intervention protocol to COR within 6 months of contract award. Protocols shall fulfill and address the following requirements:

a. The healthcare setting in which the targeted testing and treatment program is implemented must align with the Institute of Medicine’s definition of primary care: “the provision of integrated, accessible health care services by clinicians who are accountable for addressing the large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community”11.

b. The targeted testing and treatment program implemented by the contractor shall reach one or more subpopulation(s) of non-U.S.–born persons at risk for LTBI. The contractor shall propose at least one target subpopulation that meets the following requirements:

i. The targeted subpopulation(s) shall include individuals whose countries of birth have a TB disease case rate among their expatriates living in the United States of at least 10 cases per 100,000 persons (See Appendix A for this list of 52 countries of birth that meet this criterion as defined by Tsang et al.)12.

ii. The contractor, either directly or through partnerships, shall provide primary healthcare services to at least 10,000 patients within the targeted subpopulation(s) each year.

iii. The contractor shall provide justification for the chosen target subpopulation(s), including documentation of the following:

a. Demographics (e.g., race/ethnicity, country of birth)

b. Defined geographic area

c. TB morbidity data

d. Level of risk for TB infection, as well as progression to TB disease (based on published literature)

e. Estimation of the total number of persons with LTBI

c. Interventions must improve adoption of CDC’s most recent LTBI recommendations,9,10,13 including:

i. Increased targeted testing for chosen target population

ii. Use of interferon-gamma release assays (IGRAs) for TB infection testing (interventions shall not include the use of the tuberculin skin tests except for children aged ≤5 years as described in the 2016 Clinical Practice Guidelines for Diagnosis of Tuberculosis in Adults and Children14)

iii. Use of one or more of the “preferred” rifamycin-based short-course LTBI treatment regimens described in the 2020 CDC Guidelines for the Treatment of LTBI9

d. Interventions may include, but are not limited to electronic health alerts, electronic medical record systems improvements, trainings, community outreach, or patient navigators/social workers. The contractor shall also consider other interventions to improve LTBI targeted testing and treatment in primary care settings.

e. LTBI care cascade intervention(s) may be implemented in stages, starting with interventions to improve patient screening, followed by a phasing-in of additional interventions to address gaps in the care process, ranging from at-risk patient identification to the end point of LTBI treatment completion.

f. The protocol must include a description of how:

i. the target population will be identified in the primary care clinical setting,

ii. diagnostic testing will be ordered and performed,

iii. test results will be communicated to patients, and

iv. patients will be linked to LTBI treatment/care.

1.3.2 Contractor shall submit finalized intervention(s) protocol to COR within 30 days from receipt of COR approval of their draft intervention protocol.

Subtask 1.4 Participate in Consortium Activities (Base Year + All Option Years)

1.4.1 Contractor’s key personnel shall participate in monthly consortium-wide video/audio conference calls. The primary purpose of monthly calls is for consortium members to provide research/study-related updates, identify potential issues and discuss resolutions as a group, and share success stories and strategies. Monthly calls shall be coordinated by CDC staff.

1.4.2 Contractor shall, within reason, be available in-person for site visits upon request by COR. The purpose of site visits is to monitor study implementation and progress, address data quality assurance and controls, and for CDC to provide technical assistance. Contractor shall plan for one to two site visits per year; however, additional site visits may occur as part of CDC’s contract oversight responsibilities, as needed. Contractor shall be responsible for planning and hosting site visits, with input from the COR.

1.4.3 Contractor’s key personnel shall attend in-person at least one TBESC meeting annually, which are generally held in Atlanta, for a total of 5 annual meetings if all option years are exercised. The first annual meeting will not occur until 2022. The primary purpose of these meetings is to review progress and implementation of current intervention projects, learn from outside experts, and conduct discussions about possible new studies or modifications. Any travel-related arrangements and costs for contractor personnel are the responsibility of the contractor.

Task 2: Collect, Manage, and Submit Electronic Data Subtask 2.1 Develop Data Collection Procedures (Base Year)

2.1.1 Contractor shall develop and submit draft data collection procedures documentation to COR within 3 months of contract award.

a. Documentation shall include, but is not limited to descriptions of:

i. existing electronic data sources and electronic medical record (EMR) software in use (e.g., Epic, NexGen, Cerner),

ii. methods and requirements for data extraction from the source(s) (e.g., data request costs),

iii. the format of data when extracted from existing EMR,

iv. how data will be converted to the structure and format required,

v. any data transformations required and how each will be performed,

vi. any data quality control and assurance practices performed,

vii. which key personnel will submit data, and

viii. methods for secure data submission.

b. Contractor shall have electronic medical record (EMR) systems with the capability to query and extract data that can be submitted to COR. EMR systems used in the intervention setting must be able to be modified as part of this contract, including but not limited to the addition of data capture variables, workflows in the system interface, and implementation of EMR-based clinical decision support tools.

2.1.2 Contractor shall submit finalized data collection procedure documentation that addresses all COR comments to COR within 30 days from receipt of COR approval of their draft version.

Subtask 2.2: Develop Data Documentation and Mapping Guide, and Submit Test Dataset (Base Year)

2.2.1 Contractor shall develop and submit draft data documentation to COR within 4 months of contract award. Documentation must include a data dictionary with standardized variables and mapping to CDC-required data elements. COR will provide a list of required data elements and format for data submission.

2.2.2 Contractor shall submit the final data dictionary and mapping guide that addresses all COR comments to COR within 30 days following acceptance and approval of drafts.

2.2.3 Contractor shall submit a sample/test dataset that is the product of the mapped variables and in the data format required to COR within 6 months of contract award. Within 30 days after submission, COR will provide contractor a data submission report that highlights any errors related to data format and missing variables, as well as other issues that shall be rectified by the contractor within 30 days of receiving the report from COR. This process will be iterative until final approval by COR, so that contractor may proceed to Subtask 2.3.2 (submission of complete baseline data).

Subtask 2.3: Define Baseline Period and Submit Baseline Data and Report (Base Year)

2.3.1 Contractor shall develop and submit documentation of their proposed baseline period, which shall include a narrative regarding the methods for defining and extracting the 12-month cohort period data (pre-intervention), to COR within the first 6 months of contract award. COR will evaluate and determine a final version that shall be considered the standard.

2.3.2 Contractor shall successfully submit at least 12 months of electronic data for the above-defined period, which shall be considered baseline data (before implementation of any interventions), including all required variables and following the methods outlined in Subtask 2.2 to COR within 12 months of contract award.

2.3.3 Contractor shall perform analysis of baseline data submitted to create an LTBI care cascade and collaborate with CDC team to create a COR-approved baseline summary during the base year of funding within 12 months of contract award.

Subtask 2.4: Perform Quality Control and Submit Quarterly Datasets with Documentation (Option Years 1-4)

2.4.1 Contractor shall transmit quarterly datasets to COR that include the required minimum data elements; additional data elements may be added over time, as data collection improves, or if intervention implementation is changed based on progress reports.

a. Contractor shall perform data quality control and assurance practices before each data submission and highlight those results and any changes in their updated quarterly data documentation (see Subtask 2.4.2).

b. Contractor shall quarterly (or upon request from COR) conduct chart reviews (in a subset of charts) to verify unusual findings and data inconsistencies, as well as to supplement or validate risk indicator records or LTBI screening and status history.

c. Upon quarterly data submission, COR will conduct additional data quality control checks and verification within 30 days of receiving data. A report highlighting issues and required corrections will be returned to contractor, and a revised data submission may be required within 30 days of receiving error notification from COR.

2.4.2 Contractor shall update and submit their data documentation (originally created under Subtask 2.2.1–2.2.2) with each new quarterly data submission, ensuring that changes are clearly identified. Significant changes to data structure or variables may require the contractor to repeat data onboarding process tasks (all of subtask 2.2). These types of changes are likely to occur, as proposed interventions will improve data collection and, over time, additional variables (e.g., treatment completion) may be added to the routine data collection list. Quarterly data documentation shall at least:

a. Identify any changes in data collection (e.g., new variables, changes in mapping, new EMR platforms used, or updates or releases to existing platforms),

b. Identify any expansion of data collection and procedures conducted to harmonize, if necessary, variations of data collection across clinics within the primary care setting, and

c. Include reports of results from quality assurance and quality control procedures.

Task 3. Design, Monitor, and Report on Implementation of Intervention(s) Subtask 3.1 Develop Implementation Plan (Base Year)

3.1.1 Contractor shall develop and submit a draft implementation plan to COR within 6 months of contract award.

a. Contractor shall select and describe a suitable implementation framework(s) (e.g. evidence-based practice (EBP), Capability, Opportunity, Motivation (COM-B), Reach Effectiveness Adoption Implementation (RE-AIM).

b. The implementation plan must describe in detail how the intervention protocol will be carried out in the primary care clinical practice setting. The implementation plan must at least identify:

i. Key primary care setting personnel roles,

ii. Fidelity measures,

iii. Training procedures,

iv. Indicators and actions that will be taken to identify and rectify implementation problems as they arise, and

v. Proposed timelines for achieving intervention milestones for various phases of implementation.

c. As part of the implementation plan, contractor shall use and complete a “Capacity Assessment Tool” provided by CDC to assess organization readiness for implementation.

3.1.2 Contractor shall submit a finalized implementation plan that addresses all COR comments within 30 days from receipt of COR approval of their draft implementation plan.

Subtask 3.2 Conduct and Oversee Implementation (Base Year + All Option Years) The contractor shall be responsible for conducting and overseeing implementation of all phases of intervention(s) in the proposed primary care setting throughout the entire five-year period of performance if all option years are exercised. Implementation activities include but are not limited to:

a. Engagement and communication with stakeholders to increase engagement in the implementation process with primary care stakeholders through routine meetings and discussions.

b. Clinic-based training activities for clinic leadership and staff:

i. Training on procedures and policies,

ii. Education on objectives and monitoring process, and

iii. Training activities related to carrying out the intervention.

c. Evaluation of implementation including measures of implementation processes (e.g., number of trainings, number of training attendees, number of planning meetings, number of stakeholder meetings, fidelity measures, check-ins to measure intervention activities).

d. Policy and procedures including description of the standard processes or rules for operation as part of the intervention implementation (e.g., clinic policies).

Subtask 3.3 Monitor Changes and Submit Quarterly Implementation Reports (Base Year + All Option Years)

3.3.1 Contractor shall develop and submit a proposed quarterly implementation report template/shell to COR within 6 months of contract award. COR will evaluate the merits of each submitted template and determine a final version that shall be considered the standard that must be used by the contractor. Quarterly implementation reports shall include but are not limited to following information.

a. Qualitative section

i. Summary of changes in intervention implementation over time, and including dates and modifications made. This is critical for determining the impact of changes/improvements to interventions on desired health outcomes.

ii. Barriers or facilitators to intervention implementation, which shall be periodically solicited from leadership, providers, clinic staff, and patients using either surveys, key informant interviews, or focus groups.

b. Quantitative section

i. Number of stakeholder meetings

ii. Number of trainings conducted

iii. Number of EMR alerts acted on/ignored

iv. Number of tests ordered by test type

v. Number of tests ordered by clinician type (e.g., physician, nurse, mid-level provider)

vi. Number of unique clinicians by clinician type (if relevant) ordering LTBI treatment and number of times each unique clinician ordered treatment

3.3.2 Contractor shall submit a finalized implementation quarterly report template/shell, based on the standards set by the COR under 3.3.1, that addresses all COR comments within 30 days from receipt of COR approval of their initially submitted report. Quarterly reports are due to COR by the 15th day within the quarterly month for Option years 1–4.

3.3.3 Contractor shall submit quarterly implementation reports using the established standard template to COR based on contractor’s implementation plan that was developed and approved by COR during the base year. Quarterly implementation reports are due to COR by the 15th day within the quarterly month for Option years 1–4. Changes in implementation are likely to occur based on patient outcomes and feedback from clinicians, patients, trainers, etc. Contractor shall document the monitoring of changes, improvements, and successes by collecting and reporting both qualitative and quantitative measures. Data from these reports will be used in conjunction with electronic data received to evaluate the impact of intervention(s) and improvements over time.

Task 4: Design, Conduct, and Report on Evaluation Activities Subtask 4.1: Develop Evaluation Plan (Base Year)

4.1.1 Contractor shall develop and submit a draft evaluation plan including draft quarterly evaluation report template to COR within 6 months of contract award.

4.1.2 Contractor shall submit a finalized evaluation plan with quarterly evaluation report template that addresses all COR comments within 30 days from receipt of COR approval of their draft evaluation plan.

4.1.3 Contractor shall develop the evaluation plan and monitoring activities in collaboration with CDC and the consortium.

a. The plan must include, but is not limited to, the following.

i. Descriptions of specific, measurable, achievable, realistic, and time-phased (SMART15) objectives for each proposed activity;

ii. Benchmarks for LTBI case detection and access to treatment services among the targeted high-risk group;

iii. Indicators that are based on local program objectives and activities; and

iv. Indicators that focus on project sustainability (e.g., enhanced partnerships, communication with target population, education and training of staff).

b. The evaluation plan must describe in detail the measures to be collected and evaluated, in order to reach target outcomes related to improved targeting, testing, and treatment of LTBI to prevent TB disease. Evaluation plans must include the following standard LTBI care cascade measures to identify changes in outcomes:

i. Number of patients meeting screening criteria as defined by study protocol

ii. Number of patients tested by TB diagnostic test type and brand (e.g., QuantiFERON or T-Spot.TB)

iii. Number of results by test outcome

iv. Number of patients with chest radiographs performed

v. Chest radiograph results

vi. Number of TB/LTBI diagnoses based on ICD-10 code

vii. Number of unique patients offered treatment by treatment regimen

viii. Number of unique patients starting treatment by treatment regimen

ix. Number of unique patients completing treatment by treatment regimen

c. Contractor shall also develop additional evaluation methods for programmatic indicators that cannot be measured with electronic medical record data alone, such as increases in testing and treatment acceptance among the target population and better understanding of implementation barriers.

Subtask 4.2 Conduct Evaluation Activities (Base Year + All Option Years) Contractor shall perform systematic and formal evaluation of project activities and monitor evaluation criteria on an ongoing basis, including:

a. Reviewing progress in meeting indicators and objectives on monthly basis;

b. Disseminating evaluation findings among TB stakeholders for increased programmatic accountability, awareness, and engagement; and

c. Collaborating with CDC and the consortium to assess basic cost-effectiveness of enhanced LTBI testing and treatment.

Subtask 4.3: Submit Quarterly Evaluation Reports (Option Years 1–4) Contractor is required to develop and submit quarterly evaluation reports based on evaluation template report submitted to and approved by COR during the base year (per subtask 4.1.)

Task 5: Design, Conduct, and Report on Cost-Effectiveness Analysis (Base Year + Option Years 1–4) Subtask 5.1: Develop Plan for Cost-Effectiveness Analysis (Base Year)

5.1.1 Contractor shall submit a draft plan for cost-effectiveness analysis to COR within the 9 months of contract award.

a. Contractor shall develop measures to evaluate both the effectiveness and efficiency of interventions that utilizes measures of time, costs, target population reach, scalability, and sustainability.

b. The plan shall include a mixed-methods design with surveys, interviews, and other data collection methods to obtain high-quality data measures.

c. The plan shall also outline the frequency of collection of each measure.

d. Efficiency and cost-effectiveness analysis plans must include, but are not limited to, capturing the following data elements throughout the 5-year contract performance period.

i. Pre-project and start-up costs[effort]

ii. Clinic staff level of effort, labor costs, and specific activities

iii. Community engagements (dates, duration, estimates of staff and community attendance)

iv. Costs associated with information technology/informatics support and EMR update costs

v. Time and effort spent on data management and linking data

vi. Costs associated with IGRA tests via contract rates

vii. Costs associated with TB drugs

viii. Patient incentives reported on at least a monthly basis by the number and type given to patients (if used)

ix. Any reimbursements for clinic services (if available)

x. Fixed/initial costs to implement changes to EMR system, including

a. The costs to upgrade software or hardware

b. The costs of contracting for security and maintenance

c. Clinic staff time needed to create the proposal for modifying the EMR

xi. Staff time spent in planning and coordinating the start-up of LTBI targeted testing and treatment, including communication time, outreach time, and coordination meetings

xii. Ongoing staff time spent on tasks related to project

xiii. Travel costs

xiv. Drug and testing costs

xv. Costs to patients for:

a. Out-of-pocket costs

b. Estimated from claims data

c. Lost work time (lost productivity)

d. Travel costs (estimated by observation and via interviews)

5.1.2 Contractor shall submit a finalized cost-effectiveness analysis plan that addresses all COR comments to COR within 30 days from receipt of COR approval of their draft evaluation plan.

Subtask 5.2: Collect and Analyze Cost Effectiveness Data (Base Year + Option Years 1–4)

5.2.1 Contractor shall collect cost-effectiveness data based on the final list of data elements and collection interval(s) will that are defined in the COR-approved cost-effectiveness plan (Subtask 5.1).

5.2.2 Contractor shall conduct cost-effectiveness analyses using COR-approved software that can perform cost-effectiveness analyses, including analysis of uncertainty (e.g., Monte Carlo sensitivity analysis).

Subtask 5.3: Submit Annual Cost-Effectiveness Analysis Plan Monitoring Reports and Final Overall Cost-Effectiveness Analysis (Base Year + Option Years 1–4)

5.3.1 Contractor shall develop and submit a proposed cost-effectiveness analysis plan monitoring report template/shell to COR within 12 months of contract award. The template/shell shall include sections that report on the descriptive statistics for cost measures outlined in the COR-approved analysis plan and track progress towards overall cost-effectiveness analysis goals (Subtask 5.1).

5.3.2 Contractor shall submit a finalized cost-effectiveness analysis plan monitoring report template/shell that addresses all COR comments to COR within 30 days from receipt of COR approval of their draft cost-effectiveness analysis plan monitoring report template/shell.

5.3.3 Contractor shall submit an interim cost-effectiveness analysis monitoring report (using the template developed and approved in 5.3.1 and 5.3.2) covering the preceding contract year to COR annually at the start of each contract year (Sept 30th of each option year).

5.3.4 Contractor shall submit the final detailed results of their overall cost-effectiveness analysis, along with conclusions (using the template developed and approved in 5.3.1 and 5.3.2) to COR during the third quarter of option year 4.

Task 6. Report and Disseminate Post-Intervention Results Subtask 6.1: Produce and Submit Comprehensive Post-Intervention Report (Option Year 4) The contractor shall produce and submit a single comprehensive report to COR during the fourth quarter of option year 4 that addresses the overall impact of the implemented intervention(s) on LTBI and TB disease outcomes. This report must include the following:

a. Overall statistics including target population reach, number of IGRAs performed, and number of patients initiating treatment and completing treatment

b. Assessments of ability to implement intervention(s) long-term in current setting

c. Feasibility of expanding intervention(s) to similar and alternative settings

d. Summary of successful strategies and requirements needed for implementation

e. Summary of major challenges and solutions identified

f. Report on completed cost effectiveness studies, along with major results

g. Summary of contractor’s contribution to scientific literature as a result of this contract Subtask 6.2: Publish/Contribute to the Scientific Literature (Option Year 4)

6.2.1 Contractor, as first author, shall produce at least one scientific manuscript that is appropriate for a peer-reviewed journal, which must be approved and cleared through the CDC scientific clearance chain by the beginning of the fourth quarter of option year 4. The manuscript shall include CDC and consortium co-authors and describe findings and results that are products of the research conducted under this contract.

6.2.2 Contractor shall contribute as a co-author to at least one scientific manuscript appropriate for peer-reviewed journal, which must be approved and cleared through the CDC scientific clearance chain by the beginning of the fourth quarter during option year 4. The manuscript shall include CDC and consortium co-authors and describe findings and results that are products of the research conducted under this contract. (If the contractor has already satisfied the requirements of 6.2.1 and has more than one first-authored publication related to this contract, then the additional first-author publication(s) may be used to satisfy this requirement.)

SECTION 5 – GOVERNMENT-FURNISHED MATERIALS

No government-furnished materials will be included as part of this contract.

SECTION 6 – PERIOD OF PERFORMANCE

The contract shall be performed over a 5-year period in one 12-month base period and four 12-month option periods, if exercised by CDC.

Base Year: September 29, 2021–September 28, 2022 Option Year One: September 29, 2022–September 28, 2023 Option Year Two: September 29, 2023–September 28, 2024 Option Year Three: September 29, 2024–September 28, 2025 Option Year Four: September 29, 2025–September 28, 2026

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

Contractor shall provide the following deliverables by the end of the 5-year performance period.

BASE YEAR

Option years 1–4

Option year 4

SECTION 8 – REFERENCE MATERIALS

SECTION 9 – POINT OF CONTACT INFORMATION

The Point of Contact (POC) for this procurement is:

Sherrie N. Randall, CFCM Lead Contracting Officer Centers for Disease Control and Prevention 4770 Buford Hwy, Mail Stop TCU-4 Atlanta, Georgia 30341-3717

Telephone Number: 770.488.2866 Fax Number:

E-mail Address: srandall@cdc.gov

Preferred method of communication: Email

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

Key personnel include:

1. Principle Investigator

a. Roles and responsibilities

b. Minimum qualifications

2. Project Coordinator

a. Roles and responsibilities

b. Minimum qualifications

3. Data Manager

a. Roles and Responsibilities will include:

· Design and develop database and ETL (Extract, Transform, and Load) processes and scripts to support data extraction from the local Electronic Medical/Health Record system and transform and process it for secure submission to CDC

· Complete necessary documentation to support the data submission process, including but not limited to: data management process documentation, data mapping guide, data dictionary, data models, database documentation and metadata registries

· Work closely with the CDC DTBE team (epidemiologists, statisticians, programmers, medical officers, and project managers) to ensure that the data sets conforms to the specifications and data quality standards

· Handle inquiries, perform data management, validation and cleaning

· Monitors data quality, Conduct analysis and share data per CDC DTBE requirements

· Perform data management and cleaning, including analyses to assess data quality.

· Generate and manage data summaries and feedback reports, data file exchanges and file exchange agreements between partner site and CDC-DTBE

b. Minimum Qualifications:

· Demonstrated experience with data management projects including data extraction, transformation and secure submission, data flows and business rules

· Demonstrated capability of updating data, importing and exporting data in multiple formats, and performing database normalization and indexing.

· Excellent Programming experience in writing Complex Stored Procedures, Queries, Views, User Defined Functions, Cursors and Common Table Expressions using T-SQL.

· Experience working with data modeling and design tools (e.g. ERwin)

· Demonstrated ability to adjust quickly to changing priorities and make quick decisions with limited information.

· Proven ability to integrate with a team and work well with others.

· Strong written and verbal communication skills with the ability to communicate at various levels of the organization.

· Experience in Data Extraction, Transforming and Loading (ETL) using tools and utilities (e.g. Microsoft SQL Server SSIS and Bulk Insert).

· Understanding of Entity-Relationship/Multidimensional Data Modeling

· Proficiency with Microsoft Office Products (Outlook, Word, Excel, Visio and PowerPoint).

SECTION 11 – EVALUATION FACTORS

Offerors proposals will be evaluated in three (3) areas: Technical, Past Performance, and Price.

Technical Evaluation The technical evaluation factors that will be used to assess the merits of individual proposals are described in detail below.

**EF – Evaluation Factor **SF – Sub-Factor EF1—Technical Approach and Understanding of the Requirements SF1.A—Healthcare Setting

a. Provide a detailed description of the offeror’s primary care institution or network, including but not limited to geographic reach, length of time in operation, organizational structure, size of organization, and overall patient population characteristics including insurance status and demography.

b. Provide letters of support from institution/network leadership and affiliated healthcare providers that indicate not only support for the project but also 1) the ability to implement policies and procedures to comply with study protocols, 2) ability to modify EMR system, 3) ability to collect and provide required data, and 4) ability to conduct screening, testing, and treatment for LTBI.

c. Provide a detailed description of the institution/network’s current and past preventive care programs aimed at the detection and treatment of LTBI.

SF1.B—Target Subpopulation

a. Provide a detailed description of the subpopulation that the offeror will target for LTBI testing and treatment, including but not limited to the demographic characteristics of the target subpopulation, the approximate geographic area where the target subpopulation resides, morbidity data for TB in the target subpopulation, level of risk for TB infection and progression of infected persons to TB disease in the target subpopulation, and estimation of the total number and proportion of persons in the target subpopulation who have LTBI.

b. Provide the average annual number of patients from the target subpopulation seen by the institution/network and the proportion of the institution/network’s overall patient population that consists of the target subpopulation.

c. Provide letters of support from community leaders and organizations within the target subpopulation that indicate not only support for the project but also that the offeror’s institution/network is a major provider of healthcare to the target subpopulation and that the offeror’s institution/network has a positive reputation in the communities of the target subpopulation.

SF1.C—Proposed LTBI Intervention Design

a. Provide a detailed description of the intervention that the offeror proposes to implement to improve LTBI care cascade metrics within the offeror’s institution/network after the initial 1-year baseline data collection period, including but not limited to the steps in the LTBI care cascade that will be targeted for improvements, a description of how baseline LTBI testing and treatment protocols will be modified within the institution/network for each LTBI care cascade step that will be targeted, and anticipated outcomes of the intervention.

b. Provide a detailed description of how the baseline and post-intervention implementation data elements will be collected within the offeror’s institution/network, including but not limited to a description of the data elements that will be collected, whether these data are already being routinely collected within the institution/network, and how new data that is not being currently collected will be obtained.

c. Provide a detailed description of how the proposed intervention will adhere to and improve adoption of CDC’s most recent recommendations and guidelines for LTBI testing and treatment.

EF2—Personnel and Management Plan SF2.A—Key Personnel and Staffing:

a. List the name of the Principal Investigator (Project Director) responsible for overall implementation of the contract. Discuss the qualifications, experience, and accomplishments of the Principal Investigator and provide a CV.