JEFO NCI Biomedical Computing_Final_Redacted.pdf

State laws. The program is responsible for reporting rates of cancer incidence, mortality, and cancer-related statistics in diverse regions and populations of the United States. The SEER Program, a major component of the SRP, collects Congressionally mandated cancer data on a routine basis from designated, State mandated and legally regulated, population-based cancer registries in various areas of the country. Information Management Services, Inc. (IMS), the current contractor follows all required federal and state regulations and provides the required highest level of security, and they developed and maintain the data collection software SEER Data Management System (SEER*DMS). SEER*DMS, an NCI system, supports all the core functions of a central cancer registry such as importing, editing, linking, and consolidating data and producing reports. Data editors and coders view and update cancer data though an intuitive graphical user interface. This system supports data collection of over 950,000 cancer cases per year from 17 central cancer registries (Core registries) and 11 additional Research Support Registries (RSR) covering nearly 50% of the U.S. population.

Throughout SEER program’s 50 years, more than 21,000 publications have used SEER data, and there are 105,000 publications referencing SEER data, and 2,400 using SEER-CMS (Centers for Medicare & Medicaid Services) linkages. The contractor provides public use datasets and generates customized data sets in support of requests from researchers to conduct these analyses.

As of May 2018, migration to and use of SEER*DMS was contractually required by all SEER Core registries and those Research Support registries under a task order to provide data for projects such as the National Childhood Cancer Registry (NCCR) to collect and submit their data to NCI. In addition to developing the data collection system, successful data collection relies on linkages to other data sources. These other sources provide complimentary data to improve the breadth, depth, and quality of cancer surveillance data. Linkages are conducted with other government agencies such as:

Social Security Administration, Department of Motor Vehicles and National Death Index as well as industry partners such as pharmaceutical or genomic data firms. These linkages depend on legal agreements between the Biomedical Computing Support Services contractor (currently IMS) and the cancer registries. These agreements have been established with IMS which allow for data transmissions to the SEER central cancer registries which then uses this data to improve the quality and completeness and then includes it as part of the annual SEER data submission. IMS currently has legal agreements in place with many entities to facilitate receiving the data to be linked and manages the data linkage process. While it is possible that another contractor could make these legal agreements, the process is time-consuming, and work would be stopped until they are established. For example, some agreements are between IMS and a state public health agency. The speed of the agreement is driven by the state, not IMS or NCI. In some cases, it took up to 8 years to establish an agreement. More details are given below.

IMS also develops and maintains online statistical tools for use by SRP staff including program managers and statisticians. These tools are customized to utilize the SEER data and to perform common statistical analyses for cancer surveillance data. IMS has developed and maintained these tools, both the software and updated statistical methodology used by the tools. Some examples include Joinpoint which is software to estimate cancer incidence or mortality trends over time (5,318 downloads), SEER*Stat which is software to estimate incidence, mortality, and survival by other factors available in the SEER data such as cancer type, tumor, and demographic characteristics (304,856 analyses performed). CI*Rank is a software tool that provides estimated rankings to examine which states have highest cancer incidence. Other highly used tools include:

DevCan, CP*Trends, COMPREV, HD*Calc, ProjPrev NCI GIS Portal, NCI Cancer Atlas, Cancer Map Stories, Tobacco Policy Viewer, etc. Providing tools along with the SEER data is a significant and important way to increase the utility of the SEER and other cancer data and to advance the science of cancer surveillance. Releasing user friendly tools and software provides more easy access of sophisticated analytical tools for less technically savvy researchers that are not able to do their own statistical programming.

The tools promote rigorous and reproducible research.

2. Health Care Delivery Research Program (HDRP) seeks to improve health for individuals and populations by supporting innovative health care delivery research, which is conceptualized as the study of cancer care, factors influencing care, and the outcome of care. To support health care delivery research, IMS creates and maintains data resources, which are made available to the research community. Many of these initiatives rely on linking the SEER data collected using SEER*DMS and other data sources. One example of a data linkage is the congressionally-mandated annual Patterns of Care studies to evaluate the dissemination of state-of-the-art cancer therapy and diagnostics into community oncology practice. Collection of these data rely on an abstracting system developed and maintained by IMS (POC*Abs). This is a custom tool to abstract the medical charts of cancer patients. IMS tailors the tool each year to the current POC study specifications.

IMS also plays a critical role in linking SEER data to data from other agencies. IMS links the SEER cancer registry data to Centers for Medicare & Medicaid Services (CMS) data to produce four data sources (SEER-Medicare, SEER-MHOS, SEER-CAHPS and SEER-Medicaid). The SEER-CMS linkages allow researchers to assess an array of epidemiological and health services research, such as patterns of care, access to care, cost of care, quality of life, and healthcare experiences among cancer patients. IMS also links SEER data to data from the Department of Housing and Urban Development (HUD). SEER-HUD will allow researcher to assess the impact of receipt of housing assistance on cancer presentation, treatment, and health outcomes. Each of these data linkages requires agreements between IMS and the respective agency.

3. Behavioral Research Program (BRP) initiates, supports, and evaluates a comprehensive program of research ranging from basic behavioral research to the development, testing, and dissemination of interventions in areas such as tobacco use, screening, dietary behavior, and sun protection. The goal is to increase the breadth, depth, and quality of behavioral research in cancer prevention and control. IMS has developed data quality control assessment, testing of computer-assisted personal interviewing (CAPI) and other instruments.

4. Epidemiology and Genomics Research Program (EGRP) supports research in human populations to understand determinants of cancer occurrence and outcomes.

EGRP fosters interdisciplinary collaborations and the development and use of resources and technologies to advance cancer research and its translation to serve as the basis for clinical and public health interventions. The vision is to reduce the cancer burden in human populations by identifying determinants of cancer risks and improving outcomes.

IMS has been critical in developing data harmonization schemes, creating and managing databases over many years of these projects.

This work is a recompete to an ongoing contract for Biomedical Computing Support Services held by Information Management Services, Inc. (IMS) under Contract No.

75N91021D00017 Task Order No. 75N91023F00002. This task order period of performance is 7/3/2023 – 6/20/2025. Total Obligated to Date:

Contract is a Cost-Plus Fixed-Fee type. The procurement was competitive by giving fair opportunity to the multiple award IDIQ contracts holders Westat, Inc. (under Contract # 75N91021D00023), ICF Incorporated (contract number 75N91021D00022), and IMS (contract number 75N91021D00017).

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Division of Cancer Control and Population Sciences Biomedical Computing Support Services

b. Project description.

See Attachment 2: Task Order Statement of Work

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on:

Other (specify): __Recompete of 75N91021D00017/ 75N91023F00002

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, Developed and continue to develop several key software products, such as SEER*DMS, customized to collect surveillance data. Thes data management software products are critical to the collection of Congressionally mandated annual cancer incidence data and its timely reporting;

Developed and continue to develop software products specialized to link and manage cancer surveillance data;

Developed software and web-based tools to display and analyze cancer surveillance data;

Have all necessary legal arrangements with entities essential for the SEER mission that enable efficient, accurate and timely work performed by DCCPS to meet its mission requirements.

Details for each item are described below:

1. A mission of the Division is to fulfill a Congressional mandate to report annually on cancer incidence. Switching to a different Contractor would jeopardize this mandate because the NCI would not have an operational data collection software and it is estimated that it would be delayed 5+ years. Details of the data collection software are as follows:

A. SEER*DMS was developed under NCI direction to improve quality of SEER data collection at the central cancer registries. IMS is the sole developer of the SEER*DMS system which is the primary key system for registry operations that fulfill SEER requirements. No other market systems align with these specific levels of data processing requirements.

The system holds SEER-wide standard base algorithms and functionalities across all central cancer registries as well as registry specific functionalities and algorithms that manage registry specific workflows.

A new contractor would need to have expert and proven understanding of the base code, the registry specific variations and understand how each variation impacts registry operations. This initial transition phase by a new contractor would cause a major disruption to registries being able to perform their work and fulfill federal requirements under existing SEER contracts.

There are several components to this transition.

Migration of all 17 Core registry instances: Each Core registry and Research Support (RSR) registry submitting National Childhood Cancer Registry (NCCR) data currently funded under the SEER contract utilizes SEER*DMS and would need to migrate their system. To have a new contractor migrate all the current SEER Cancer Registry contract holders to a new instance of SEER*DMS would require the government to invest an estimated $5.1 million and take an estimated 5.6 years just for the migration of 17 Core registry system Instances from the current IMS contract to a new one. This would result in major duplicative effort and cause extreme disruption to the program and the central cancer registries. See “Attachment 1:

Additional Supporting Documentation.”

Data center infrastructure: IMS currently houses all registry SEER*DMS system instances in two data centers for security. They maintain the infrastructure and security of the environment for SEER*DMS and all other systems that provide support for the SEER Program. A new contractor would have to replicate and duplicate this same environment with two data centers and then migrate all SEER registries onto new SEER*DMS systems that they would support. This would be a major and disruptive duplication process for the government. The new vendor would need to ensure they: 1) either have the right data centers or purchase the necessary types of data center space; 2) ensure they set up the right data system infrastructure that has a federal ATO for a moderate risk system and aligns with state security requirements; 3) ensure correct partitioning of registry data; and

4) then migrate all systems, data, system workflows, data workflows, business workflows from the IMS data centers and the individual registry enclaves on those centers to the new vendors data center infrastructure. Testing would also have to happen, and this may take anywhere from 3-4 months per registry to ensure their data is migrated well from one data center infrastructure to the next.

Legal agreements: The process by which the registries use SEER*DMS in the enclave required years of discussions and legal work to develop agreements with each of the 17 registries in the SEER program. Each of these agreements is slightly unique as each state has different reporting regulations and laws. For example, it took eight (8) years of discussion to enable the California registries to migrate to SEER*DMS because of complex state laws, existing systems for surveillance data capture and unique processes for data collection that had to be negotiated.

IMS is continuously updating the SEER*DMS system with new requirements for data (e.g., pharmacy, genomics, treatment etc.). The use of a single central system managed by IMS supports efficiencies and reduces cost of data delivery from external partners.

Instead of needing 17 different feeds to send pharmacy data from Consumer Value Store (CVS) to the registries, IMS and the SEER*DMS enclave enables a single data conduit that can then be separated centrally to go to the appropriate registry virtual database.

Without these agreements, the registries cannot share their data with the SEER program. If SEER does not have the registry data, then they are unable to provide data and reports such as the Annual Report to the Nation that fulfill the requirements of the National Cancer Act and the fulfillment of Program’s mission to collect and release cancer registry data is put at risk. Failure of this mission also deprives the national and international research community of up-to-date cancer surveillance data. There is no other mechanism by which registries can share data with SEER.

While NCI owns the base code to SEER*DMS, NCI does not own the cancer incidence data nor does it own the instances of SEER*DMS that were deployed for each registry. The cancer registries always maintain ownership of the data and instance. This is akin to how Microsoft owns the base code of Microsoft Access but does not own the private data or the instance of MS Access that is purchased by an individual business that is installed and used at the individual business organization data center.

When a SEER Core Registry transitions to SEER*DMS, they are working with IMS to deploy an instance of SEER*DMS on registry servers (that are maintained and managed by IMS). They migrate all data, logic workflows, and business workflows from their registry legacy system to the new SEER*DMS system. This migration process is complicated since it requires in-depth analysis of existing registry operations, data, business and logic workflows and then translating and building that into the brand-new SEER*DMS instance that the registry sets up. This is similar to how a normal business organization who chooses to purchase and use MS Access would spend time setting up a brand-new instance of MS Access in their organization. The business would use their technical team to move all data, reports, formulas that may have been developed in the organization's individual legacy system onto their now purchased "out of the box" new MS Access system. This new MS Access system would not contain the logic and formulas and would require the technical team to customize the new MS Access system and implement logic workflows, formulas, and import data.

Using SEER*DMS, NCI ensures the accuracy and quality of the statistics and data that are released to the nation and the government’s federally mandated goal of producing and releasing national cancer surveillance data.

Pipeline solution for direct transfer of data from healthcare facilities to central cancer registry enclaves. This pipeline includes, but is not limited to, creating the necessary legal agreements directly with healthcare facilities (responsible for reporting data locally up to the central registry), implementing technical solutions through tools and secure file transfer protocols to transfer data directly from the facility to the registry enclaves, and ensuring ongoing maintenance and security of all direct data transfer pipelines. This is a crucial process and technical solution that IMS provides for central cancer registries that ensures an efficient and improved process of registry data collection. Without this process, registries would have a break in their current data processing operations.

Authority to Operate: IMS has worked with the National Cancer Institute’s Center for Biomedical Informatics and Information Technology (CBIIT) to secure an ATO for SEER*DMS as a moderate system. This certifies that IMS meets all federal security requirements for the system and technical infrastructure. If the award went to any other contractor other than IMS, then a new ATO would be required for the system by the winning contractor. Even if a new contractor has an existing ATO, the ATO may not cover this specific work and requirements. This work requires a moderate-level system, and this is unusual for work conducted by NCI. The process to secure a new ATO with a new contractor would pose an increased cost to the government in money and increased time that could not be recovered.

SEER*DMS Lite: This was developed for the National Childhood Cancer Registry (NCCR), a critical component of the Childhood Cancer Data Initiative (CCDI). In addition, all research support registries, currently 3 funded, must use SEER*DMS Lite if not already using SEER*DMS. SEER*DMS Lite facilitates collection of data from nearly all childhood cancer patients in the US into a central system that will enable linkages with critical new data sources. As for the larger SEER program, having a centralized and single process improves accuracy of linkages and better supports both the registries and the external partners submitting their data. IMS is responsible for developing SEER*DMS Lite and the interconnection agreements has enabled the sharing of these data. Without the centralized process and availability of SEER*DMS Lite, this initiative would be at risk thereby not having timely data on childhood cancer cases.

2. IMS has developed about 40 software products for data organization, data visualization, statistical methods, and registry operations. One example is Match*Pro. This is software for consistent linkages and is available through an NCI-funded central website that has multiple common processes such as templated Institutional Review Boards (IRBs) Data Use Agreements (DUA) and tracking systems that efficiently allow participating investigators to capture more complete data on cancer and its outcomes among their subjects. Also used for initiatives such as the Virtual Pooled Registry and for routine linkages. Match*Pro has a module using privacy preserving record linkage (PPRL) which enables SEER and its partners to manage data without releasing PII.

Since these tools are proprietary to IMS, NCI would not have access to them under a new contractor and processes for SEER would be at risk including: The data release process, development of any data products would be delayed, or compromised data quality. The downstream consequence is that both the government and external researchers would be unable to access timely cancer surveillance data - a primary mission of NCI as required by the National Cancer Act of 1973. As the SEER Program is a main contributor to the United States Cancer Statistics (USCS), inability to continue to collect and analyze data to the degree conducted currently would imperil NCI’s ability to provide current and correct information to the USCS.

Due to the scope and magnitude of the other software products, transfer of these to a new contractor would incur major delays and risk to the SEER data submissions and public release.

IMS has developed critical websites and software integrated with the SEER data.

Data submission guidelines. These guidelines are developed with IMS since they understand the technical requirements of the data submission. IMS also works collaboratively with other organizations such as NAACCR and the International Association of Cancer Registries (IACR) who update data submission guidelines and reporting requirements. Since IMS manages the website, they can seamlessly update and maintain these webpages in an accurate and timely manner. Both registries and researchers rely on the accuracy and timeliness of this information.

Statistical analysis: These products are designed to improve statistical methodology and methods of presentation (see Table 1 of Attachment 1: Additional Supporting Documentation). For many of the interactive websites the data that feeds the output is updated every year and flows from the outputs of other systems such as SEER*DMS.

NCI vitally depends on the use of this software to produce our updates of cancer and cancer related statistics, which are conducted under specified deadlines. One example is SEER*Explorer, which is the primary way the public and researchers access SEER data.

It is an interactive website that displays various cancer statistics and trends. Since SEER*Explorer is updated with current statistics and data directly from SEER*DMS, this pipeline would be disrupted with another contractor taking over the maintenance, continuous updating, and deployment of these websites and software products, and adherence to deadlines would likely be compromised.

National Childhood Cancer Registry/Childhood Cancer Data Initiative: IMS has developed analogous tools (NCCR*Explorer, NCCR SEER*Stat), have worked with both SEER and NPCR (non-SEER program funded by the CDC) registries to collect data within the secure enclave environment, create a consolidated set of data to feed into the applications. In addition, they have been integral to the NCCR Data Platform through data consolidation, data cleaning and linkages across multiple registries and novel data sources.

The Surveillance Research Program (SRP) is mandated to release cancer data to the public and to provide de-identified data. All data collection activities rely on legal agreements between IMS and other parties to meet state data release requirements.

IMS initiates this process and works directly with the registries to develop and execute these agreements. Data collection for cancer registries is a complex effort requiring coordination. For example, a registry first receives data from legally required reporting sources such as doctors, hospitals, pharmacists, etc. A registry also engages in reconciliation between bordering states, linkages with other data sources and the need to edit and re-abstract data over time.

To date, IMS has established:

Interconnection Security Agreements with states to receive data for the National Childhood Cancer Registry Initiative. These took an average of 17 weeks to establish with a maximum time of 42 weeks.

Interconnection Security Agreements with states to establish data transfer into DMS.

These took an average of 37 weeks to establish with one agreement taking 9 months to establish.

Agreements with commercial entities for data acquisition and transfer. These required a range of 3 months to 2 years to establish the necessary legal agreements and infrastructure.

Interagency agreements with Social Security Administration (SSA), National Death Index (NDI), and Department of Energy (DOE).

Key partnerships to provide geocoding and residential history data. These legal agreements have taken longer than one year to obtain residential history data.

In addition to the above:

NCI has other agreements where IMS is listed as the current biomedical computing support services contractor or data coordinator/custodian responsible for completing specified tasks. If a contractor other than IMS was awarded the contract, amendments to the NCI agreements would need to be ratified.

NCI’s MOU with Department of Housing and Urban Development (HUD) would need to be amended to indicate the new contractor with specific staff member’s names who will have access to PII. It is estimated that ratification of an amendment would take 12-24 weeks.

NCI’s Information Exchange Agreement with CMS, would need to be amended to indicate the new contractor’s name with specific staff member’s names who will have access to PII. It is estimated that ratification of an amendment would take 12-24 weeks.

Risk if current agreements were nullified:

Stopped data transmission (including twice annual data submission to the SEER program as well as all linkages with external partners) would be delayed as the Surveillance Research Program (SRP) cannot receive any data without these agreements. IMS s an honest broker/trusted third party to receive and link data on their behalf. That is, IMS has all required data protections in place that includes secure data transfers, no transfer of PII, compliance with state and federal laws.

Compromised data collection such as data linkages with third parties would stop he enclave which stores the data, and the software and data management process would also be at risk. The SEER data submission is a mission critical task and delay of this submission impacts both internal and external consumers of the data which includes other Federal agencies and extramural researchers as well as impairs the ability of the NCI to respond effectively to Congressional requests.

Statistical problems in data: SRP may not be able to release surveillance statistics that are reported under mandate. May lose population-based representation. Any delay in re-establishing new agreements creates a downstream problem for researchers who use our data and rely on its accuracy and completeness for research and analysis.

The existing infrastructure– i.e., legal documentation, data migration, new ATO, proprietary software being used for enhanced tools, etc. – has taken years to establish and the risk of transitioning would cost the government time and money and a lapse in services regardless of the capabilities of industry competitors. The government has a need for continued uninterrupted service to DCCPS’s registry support and other initiatives. The past acquisition for these services were competed; however, the current Task Order was solicited through limited completion under an existing Indefinite Delivery Indefinite Quantity (IDIQ) mechanism to a small pool of Contractors. Market Research conducted to date has shown that awarding a contract to a new Contractor will increase effort, cost, and risk to NCI that cannot be recovered.

If a new contractor were to receive the award, it would require the government to invest an estimated $5.1 million and would take an estimated 10.6 years in total. This includes 5.6 years just for a new contractor to migrate 17 instances of SEER*DMS, plus all the other legal agreements that would have to be redone See “Attachment 1: Additional Supporting Documentation” for a breakout. Based on the market research completed and the information provided IMS is the only vendor capable of completing the requirements of the statement of work (SOW).

5. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The NCI Contracting Officer’s Representative (COR) completed the Independent Government Cost Estimate (IGCE) by utilizing historical data associated with Task Order 75N91021D00017/ 75N91023F00002. The pricing data (adjusted for inflation) will be used to make a fair and reasonable determination on the resulting award.

In addition, the acquisition will utilize a GWAC on the HHS Mandatory Use List (a best-in-class IT services solutions contract)— the NIH Information Technology Acquisition and Assessment Center (NITAAC) Chief Information Officer- Solutions and Partners 3 (CIO-SP3) Small Business GWAC— to place a task order from a prequalified vendor (and in which IMS is a contract holder). Contracting Officer will ensure the anticipated cost/price will be fair and reasonable to the Government, and will be in accordance with FAR Part 16.505 and FAR Part 8.

The Contracting Officer will also request Certified Cost and Pricing Data due to the dollar value of the task order

For clarification, IMS was considered a small business at the time of award when they received the award for the NITAAC CIO-SP3 (Small Business) GWAC. They have since graduated to large business but can remain on that GWAC and apply for task orders. They just cannot propose on task orders that are exclusively set aside for small business.

6. Any other facts supporting the use of other than full and open competition.

No additional facts.

7. A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

The need for standardized data collection methodologies for the SEER program by all the central cancer registry contractors that report on their annual cancer data trends, necessitates the need for a data management software to be able to collect complete quality data to be able to accomplish the NCI’s statutory mandate to annually report on cancer incidence data and trends and provide reliable quality data sets. The SEER*DMS system code is owned by the

Government. However, having that same data management software that has to then be tailored to each of the 17+ central cancer registries who hold a Core task order or a Research Support task order under the SEER IDIQ contract by also creating “instances” of SEER*DMS which has to be tailored to each registries workflows creates exponential more complexities.

And recreating this many instances by a new contractor would require additional 5+ years, and that is not including all the other legal requirements such as needing an Authority to Operate a moderate security level system. Many legal agreements would be nullified and have to be redone again with a new contractor thus delaying data collection for all 17+ registries for an estimated 10.6 years. It would be difficult or next to impossible to lessen policy and regulations requiring things like ATOs and legal agreements so that data linkages can occur between IMS and those contractors and other places such as CVS. These are legal requirements. And the National Cancer Act of 1971 authorizes collection of cancer registry data and mandates that NCI annually report population-based statistics. This acquisition supports the collection, processing, and reporting of these and other data. SEER Data Management software (SEER*DMS) is the software that is used that enables the NCI to continually be able to meet our congressional mandate annually. If any other contractor had to duplicate this capability, NCI would be at risk of not being able to provide its annual report of population-based statistics for all the 17 registries for at least 5.6 years for just the SEER*DMS registry instances that would need to be complete, and it would cost and estimated $5.1 million dollars. Statutory requirements necessitating an annual reporting of population based cancer incidence without missing any years make it difficult to overcome barriers