Attachment 2 - Statement of Work.pdf

Statement of Work

1.0 TITLE

Surveillance Epidemiology and End Results (SEER) Electronic Data Capture Software Support and Installations

2.0 BACKGROUND

The SEER Program of the National Cancer Institute is an authoritative source of information on cancer incidence and survival in the United States. Case ascertainment for SEER began on January 1, 1973, in the states of Connecticut, Iowa, New Mexico, Utah, and Hawaii and the metropolitan areas of Detroit and San Francisco-Oakland. In 1974-1975, the metropolitan area of Atlanta and the 13-county Seattle-Puget Sound area were added. In 1978, 10 predominantly black rural counties in Georgia were added, followed in 1980 by the addition of American Indians residing in Arizona. In 1992, the SEER Program was expanded to include the Alaska Native population in the State of Alaska as well as to increase coverage of the minority populations, especially Hispanics, in Los Angeles County and four counties in the San Jose- Monterey area south of San Francisco. In 2001, the SEER Program expanded its coverage to include Kentucky, the remainder of the State of California, New Jersey, and Louisiana. In 2010 the remainder of the State of Georgia also entered the program. On May 1, 2018, four state registries were added to the SEER program: Idaho, Massachusetts, New York, and Wisconsin. The Detroit and New Jersey registries left the program as of May 1, 2018. Additional registries are expected to join the program in November of 2021.

The SEER Program currently collects and publishes cancer incidence and survival data from population-based cancer registries covering approximately 35 percent of the US population. Information on more than 9.7 million in situ and invasive cancer cases are included in the SEER database, and approximately 494,000 2015 cases were accessioned within the SEER catchment areas. The SEER registries routinely collect data on patient demographics, primary tumor site, morphology, and stage at diagnosis, first course of treatment, and follow-up for vital status. The SEER Program is the only comprehensive source of population-based information in the United States that includes stage of cancer at the time of diagnosis and survival rates within each stage.

2.1 OBJECTIVE

Generally, about 95% of cancers are definitively diagnosed by pathology. As a result, cancer registries rely heavily on pathology reports to identify new cases of cancer and to determine key characteristics of the cancer required for its classification. Historically, this pathology data gathering has been performed manually, either by cancer registrars who travel to laboratories and review histopathology reports, or by relying on laboratories to voluntarily identify and forward reports to a central registry. Both methods can be labor-intensive and may result in data of varying quality and completeness.

Utilizing information technology to automate this process is both labor saving and error eliminating when compared to hands-on methods. Referred to as "Electronic Pathology" or ePath, the software to accomplish such automation requires the following capabilities:

• Pre-existing pathology reports, consisting of both text-based and coded portions of the overall report, must be searched to select the potential cancer cases. Text-based portions of the report are parsed, and the potential cancer cases selected through comparisons to an appropriate dictionary of reportable terminology. Coded portions of the report are selected using a rules-based process. No standard report format exists for pathology laboratories to follow, so the software must also be flexible enough to accommodate a variety of report formats.

• Selected cases are then transmitted from the pathology laboratory to the registry. This must include complete tracking and an audit trail. The transmission system must be secure and conform to all HIPAA requirements.

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• Once received, the information must be easily incorporated into the registry's data management operation.

• The increasing implementation of electronic medical record systems has opened and will continue to open additional options for electronic data capture. These include but are not limited to electronic records from radiation oncology, surgical and medical notes, and diagnostic imaging reports. The NCI SEER Program has identified diagnostic imaging as the next source to pursue. This is due to the increased capture of malignant and benign brain cases provided by diagnostic imagining.

3.0 SCOPE

The overall scope of this requirement is to support and maintain the current electronic pathology reporting infrastructure, including maintaining continuity of electronic pathology reporting licenses for the facilities listed in Exhibit 1 “SEER ePath Sites” and to install and maintain new license installations as required by the NCI to support the SEER program.

This requirement is not related to the Request for Information HHS-NIH-NCI-RFI-PCPSB-SRP-MB titled “Tools and Solutions for Improving the Acquisition of Electronic Pathology and Radiology Reports for National Cancer Surveillance” that is specifically focused on identifying sources with innovative technologies that may improve the acquisition of electronic pathology and radiology reporting in the future. A separate solicitation for this requirement may be posted at a later date.

4.0 CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS

4.1 TASK 1: OPERATIONAL SUPPORT AND CONFIGURATION CHANGES

The Contractor shall:

4.1.1 Provide IT services for system maintenance and include the following:

4.1.1.1 Maintenance of the existing SEER ePath network;

4.1.1.2 Changes to ePath implementations resulting from changes to servers, networks, laboratory and EMR systems as appropriate;

4.1.1.3 Resolving transmission problems;

4.1.1.4 Maintaining functionality as clients upgrade their systems (including alterations to reporting styles);

4.1.1.5 Other IT services as necessary;

4.1.1.6 Convert existing stand-alone ePath sites to a system set up where the reportability assessment application will call an artifact knowledge file stored on an external server. This will facilitate updates to the reportability list without having to go through the facility or lab IT security.

4.1.1.7 Convert existing ePath installations to the “cloud” configuration, whenever possible.

4.1.1.8 Triage IT requests to determine which are in scope for this contract.

4.1.1.8.1 In scope requests are related to the following general categories:

• Regular software maintenance

• Version upgrade services

• Help and diagnostic services

4.1.1.8.2 Requests that may be out of scope are related to Major IT projects, system changes and upgrades.

4.1.2 Meet weekly with the NCI Contracting Officer’s Representative to perform the following tasks:

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4.1.2.1 Discuss new requests for IT services and progress on software maintenance and version upgrades;

4.1.2.2 Report on troubleshooting and corrective actions taken in support of pathology laboratories;

4.1.2.3 Inform NCI on availability of software and lexicon updates;

4.1.2.4 Plan and monitor the software and lexicon updates;

4.1.2.5 Discuss and plan updates to reportability criteria; requests for IT services should be first approved by the responsible registry, and then presented to and approved by the COR at a weekly SEER project meeting. Meeting minutes should reflect the requests for IT services presented to and approved by the COR.

4.2 TASK 2: EPATH INSTALLATIONS

The Contractor shall:

4.2.1 Provide installation of the ePath application and related software in laboratories and/or registries selected under the direction of the NCI COR in consultation with SEER registries representatives

4.2.1.1 Use a system set up where the reportability assessment application will call an artifact knowledge file stored on an external server. This will facilitate updates to the reportability list without having to go through the facility or lab IT security.

4.2.1.2 Use the “cloud” configuration whenever possible for new installations

4.2.2 Provide renewal of all existing site licenses previously purchased by the National Cancer Institute and installed within SEER Program registries.

4.2.3 EPath software Maintenance and Version Upgrade Services (SMVU). These services shall include:

4.2.3.1 Updating previously installed pathology laboratories to the latest version of TransMed 2 or equivalent software at least twice per year;

4.2.3.2 Updating Aut)ocode or equivalent software at least twice per year;

4.2.3.3 Troubleshooting and correcting laboratory reporting issues;

4.2.3.4 Diagnosis of errors and/or malfunctions with respect to the Software;

4.2.3.5 Suggesting corrective action with respect to errors and/or malfunctions of the Software and/or issuing new builds of the Software to correct identified deficiencies where applicable;

4.2.3.6 Contacting the Licensee on a proactive basis to report known problems with the Software (if any) and suggestions for workarounds;

4.2.3.7 Contacting the Licensee on a proactive basis about the availability of new builds or versions of the Software.

6.0 PERIOD OF PERFORMANCE

The period of performance shall be from September 26, 2020 to September 25, 2023 consisting of a 12-month Base period and two Option Periods.

7.0 PLACE OF PERFORMANCE

Contractor’s place of business and installation sites (as necessary).

8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

8.1 Deliverables

8.1.1 Weekly calls with COR, followed by delivery of meeting minutes;

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8.1.2 Quarterly Report of activities performed during the period, which shall include a narrative of main activities and:

8.1.2.1 Detailed (installation site-level) listing of licensing fees;

8.1.2.2 Current list of software installations by SEER registry and facility;

8.1.2.3 Cumulative listing of Software Update and Version Upgrade services provided by the Contractor;

8.1.2.4 Cumulative listing of IT System Maintenance services requested, approved and completed by the Contractor including estimated IT service hours and actual IT service hours. (for each requested service)

9.0 PAYMENT

9.1 Payment shall be made upon completion of the following Tasks:

Task 1: Completed IT hours will be paid upon receiving invoice for completed hours Task 2: Licenses

• Renewal of existing licenses will be paid upon receiving invoice for completed license renewals

• Newly installed licenses will be paid upon receiving invoice for completed license installations (the license is operational and functioning).

9.2 Additional Provisions for Payment of Licenses

9.2.1 License payments to be made on a fixed-price basis per year.

9.2.2 Optional quantities will be established as separately priced line items to allow purchase of additional licenses within separate quantity ranges at discounted price. (See

10.0 Provision and Clauses)

9.2.3 Licenses will be pro-rated if purchased during a licensing year to allow all licenses to start/stop on the same day.

9.2.4 Licenses will not be effective/billable until installed.

9.3 Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with established NIH payment provisions.

10.0 PROVISION AND CLAUSES

52.217-7 OPTION FOR INCREASED QUANTITY-SEPARATELY PRICED LINE ITEM (MAR 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor anytime during contract performance. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

The applicable Section 508 accessibility standards listed below have been included in the SOW to ensure that Federal employees or members of the public with disabilities have access to, and use of, information and data comparable to the access and use by people without disabilities.

• Software Applications and Operating Systems (1194.21)

• Web-based Intranet and Internet Information and Applications (1194.22)

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