J A_-_Redacted.pdf

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS/NIH

b. Sponsoring organization. NCI/Division of Cancer Control and Population

Sciences Surveillance Research Program/Office of the Associate Director

c. Contracting Officer Representative (COR) information.

Carol L. Kosary

9609 Medical Center Drive

Room 4E448

Bethesda, MD 20892-9765

Phone: 240-276-6732

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The purpose of this acquisition is to award a 5-year follow-on contract with

Artificial Intelligence in Medicine Inc. (AIM) to: 1) maintain and update the existing Surveillance Epidemiology and End Results (SEER) ePath network; 2) expand the SEER network to additional pathology laboratories; 3) expand electronic data capture to include electronic reports from diagnostic imaging, and

4) install cancer data forwarding module in previously installed ePath laboratories. This contract will consist of the EPath Application Support &

Version Upgrade Fee. The objectives consist on: (1) the number of hours providing operational support and configuration changes, (2) EPath installations,

(3) Diagnostic Imaging installations, and (4) Cancer Data Forwarding Module installations.

b. Project background.

The Surveillance Epidemiology and End Results (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.

During 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

The SEER Program currently collects and publishes cancer incidence and survival data from 20 population-based cancer registries covering approximately

28 percent of the US population. Information on more than 8.6 million in situ and invasive cancer cases is included in the SEER database, and approximately

450,000 new cases are accessioned each year 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.

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 saves labor and eliminates error when compared to current hands-on methods. The software to accomplish such automation, referred to as "Electronic Pathology," or ePath, requires the following capabilities:

a) Pre-existing pathology reports, consisting of both text-based and coded portions of the overall report, must be searched in order 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.

b) Selected cases are 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.

c) Once received, the information must be easily processed and incorporated into a Registry’s operations and data management workflows.

The ePath automated cancer identification and reporting application consists of two Artificial Intelligence in Medicine’s products:

1) AutoCode – A semantic text analyzer which reads digital text and identifies, extracts, and codifies knowledge-specific concepts from text regardless of the wording use to express the concepts. This is accomplished using an ICD-O-3 dictionary and rule-based report selection based on coded report content.

2) TransMed – An integration platform based on the Microsoft .NET framework; TransMed ensures that once the cases are selected, they are transmitted from the pathology laboratory to the registry. It incorporates a variety of fail-safe mechanisms and maintains audit logs. The system also generates records of all pathology reports that have been transmitted from the institution. TransMed is HIPAA compliant.

To date the ePath automated cancer identification and reporting application has been installed in 340 laboratories throughout the SEER program. The SEER registries currently receive approximately 1.8 million electronic records related to newly diagnosed cancer cases through the network of ePath installations annually. Additionally, the increasing implementation of electronic medical record systems has opened 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 reports as the next source to pursue due to its ability to identify previously missed cases of malignant and benign brain cancers. This will be accomplished through the installation of the AIM developed Diagnostic Imaging module within Radiology

Department Electronic Medical Record (EMR) of diagnosing medical facilities.

The Diagnostic Imagining module utilizes the previously installed TransMed platform.

The NCI SEER Program will also install the AIM developed Cancer Forwarding

Modules in a number of its previously installed pathology laboratories. This module identifies and submits subsequent pathology reports from previously reported cancer cases. These reports may contain information pertinent to cancer recurrence.

Finally, this contract will provide for continued operational support and configuration changes to the existing NCI-SEER ePath network.

Previous Contracts

1. 263-MQ-416368/HHSN261200700460P -Artificial Intelligence in Medicine

(AIM), Inc.

September 26, 2003 – September 25, 2008

$3,106,900

Non-Competitive

2. HHSN261200800801P- Artificial Intelligence in Medicine (AIM), Inc.

September 26, 2008-September 25, 2013

$4,208,771

Non-Competitive

3. HHSN261201300374P Artificial Intelligence in Medicine (AIM), Inc.

September 26, 2013-September 25, 2015

$1,879,704

Non-Competitive

3. Description of the supplies or services required to meet the agency’s needs

(including the estimated value).

a. Project title. Surveillance Epidemiology and End Results (SEER) Electronic

Data Capture Software Support and Installations

b. Project description. See 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 -- HHSN261201300374P

Other (specify): ______________________

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, definite quantity, or requirements): _IDIQ__

Other (specify): ___________

Completion Form Term form

Acquisition identification number. N02PC52605-57

c. Total estimated dollar value and performance/delivery period.

The period of performance will be from September 26, 2015 thru September

25, 2020.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States

Code (U.S.C.) 253(c)(__) as set forth in Federal Acquisition Regulation

(FAR) 6.302- __.

This acquisition is conducted under the authority of section 4202 of the

Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services

Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Artificial Intelligence in Medicine (AIM), Inc.

Berkeley Street, Suite 403

Toronto, Ontario, Canada M5A 2W3

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Artificial Intelligence In Medicine, Inc. (AIM) is the sole-source provider of the software developed to automate the review of pathology and diagnostic imaging reports for cancer case findings and the forwarding of those reports deemed to meet the requirements for reporting to the cancer registry. AIM is also the sole-source provider of both a Diagnostic Imaging Module, which operates through the existing TransMed infrastructure and a Cancer Data Forwarding Module which works in conjunction with the previously installed AIM ePath. These products are proprietary to AIM, Inc. and are unavailable through any other distributor.

There have been no other products located that could automate the review of the pathology or diagnostic imaging reports and forward these records to the SEER cancer registries at the level of production required. Currently the SEER ePath network consists of 340 pathology laboratories reporting approximately 1.8M records yearly. There are some cancer centers with “home grown” systems which can conduct automatic retrieval and data extraction but these applications are cancer center specific and often even study specific applications. None of these are capable of supporting this level of production required.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under

FAR 5.202 applies.

A small business sources sought was posted on FedBizOps on June 2, 2015 with a response date of June 9, 2015. No responses were received.

A pre-solicitation notice was posted on FedBizOpps June 12, 2015 with a response date of June 26, 2015. No capability statements were received.

7. Determination by the Contracting Officer that the anticipated cost/price to the

Government will be fair and reasonable.

The NCI contract specialist will consider the independent government estimate and previous purchase order prices as a determining factor for price reasonableness. Based on the aforementioned, there is no reason to believe that the proposed price will not be fair and reasonable to the government. An award will only be made, if during negotiations, it is shown that the anticipated cost to the Government is fair and reasonable.

A final determination will be made prior to the award of this contract.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The NCI and SEER cancer registry staff has been exploring the electronic data capture needs and requirements for many years. Vendor support for population-based central registries is a very small market. The vast majority of the software is either “home grown” by individual registries or directly developed and maintained by either the

National Cancer Institute (Surveillance, Epidemiology, and End Results (SEER)) or the

Centers for Disease Control (National Program for Cancer Registries (NPCR)) and shared with the central registry community. Over the past several years the CDC’s

National Program of Cancer Registries (NPCR) program has made an attempt to develop a similar application, with limited success. Internet searches as well as searches of the literature yield no viable vendors capable of fulfilling the specific requirements of the

NCI SEER program in this area. Previous FedBizOps postings of earlier acquisitions have not been successful in yielding additional vendors.

NCI and SEER cancer registry staff have been exploring its electronic data capture needs and requirements for a number of years. This requirements gathering has included: (a) monitoring of a number of journals which are relevant to this field, particularly those related to the American Health Information Management Association (AHIMA), (b) monitoring ongoing work in natural language processing of large text based documents at such centers as Stanford’s Natural Language Processing Group, (c) attendance at conferences where a number of vendors display their products such as the American

Society of Clinical Oncologists (ASCO), the American Public Health Association

(APHA), and Cancer Informatics for Cancer Centers (CI4CC). Requirements gathering have also been explored through efforts ongoing within the North American Association of Central Cancer Registries (NAACCR). The NAACCR mission is to coordinate and encourage the development, enhancement and application of cancer registration techniques in population-based groups, so that quality data will be available for cancer control and epidemiologic research, public health programs, and improved patient care to reduce the burden of cancer. The NAACCR has established a network of committees to achieve the organization’s goals and mission. The NAACCR also holds annual meetings in which central cancer registry professionals, researchers in the field of epidemiology and public health, cancer control and prevention specialists, hospital registrars, and representatives from related organizations from within the U.S. and internationally, participate. Vendors, such as AIM, are welcome to attend this annual meeting to showcase products. AIM is the only vendor which has participated in this event and is the only known contractor capable of providing the necessary software as it is proprietary to them.

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

None

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources expressed interest in writing to the acquisition

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

There will be a future ongoing need for this requirement, which will be synopsized in

FedBizOpps.