19-R-0016_Atch03_JA19-0085_MHS-Cancer-Tumor-Registry_Redact.pdf

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

Justification and Approval for Other than Full and Open Competition

J&A Tracking No. 19-0085

1. Identification of the agency and contracting activity: Defense Health Agency (DHA), Health Information Technology-Contracting Division (HIT-CD), Enterprise Medical Contracting

Office, Building 1000, Suite 208, JBSA Ft. Sam Houston, TX 78234.

2. Nature and/or Description of Action being approved: The Government intends to negotiate a firm fixed price contract under FAR 6.3 with a vendor who shall supply hosting, software, training, and data conversion for support of the Military Health System (MHS)

Cancer/Tumor Registry program for 24 Medical Treatment Facilities (MTFs), and all associated

MTFs that identify cancer patients.

3. Description of Supplies/Services: The DHA-Medical Affairs Clinical Support Division, Oncology/Tumor Registry, via the DHA’s Solutions Delivery Division (SDD) Program Office, requires the purchase of software, support, hosting, and upgrade/technical assistance to replace the Automated Central Tumor Registry (ACTUR) application, currently hosted at the Defense

Manpower Data Center (DMDC). ACTUR replacement is urgent; patient safety, documented multiple outages, a lack of Certified Tumor Registrars (CTRs) on staff with the programmers, manual configuration of required reports and other issues place multiple cancer treatment centers at risk for decertification of their programs.

It is critical that DHA procure an established tool for cancer program analysis, administrative and clinical reporting and other day to day tasks in cancer data management. This system’s capabilities should include the following:

Security/ability to accommodate Common Access Card software

Health Information and Portability Accountability Act compliant

Risk Management Framework (National Institute of Standards and Technology (NIST)

800-53) compliance

Centralized hosting capability

Data interoperability/interfacing capabilities with MHS GENESIS and legacy systems

Integrated, scalable system architecture accommodating variance in facility size, treatment modalities, CONUS and OCONUS locations

System reliability; ability to accommodate multiple users concurrently without impact to functionality

System availability 24/7 with sustainment exceptions

Hosting by vendor or by government infrastructure

Multi-hospital data integration into shared database (DoD cancer data repository)

Data repository security and access options

Ability for multiple users to view common abstract data on patients treated for same encounter at multiple DoD facilities

DHA PGI 206.3, Attachment 1 (06-21-2018)

Clustering, event/exposure trac in order to get a timely submission and. We will need to go back to the RSP king, research capabilities

Data extraction and export capability IAW standard setter requirements

Application(s) to support central cancer registry operations and processes

Timeliness in response to updates and mandated changes: data inclusions, exclusions in compliance with standard setters: American College of Surgeons-Commission on Cancer

(ACS-CoC); Surveillance, Epidemiology, and End Results program; North American

Association of Central Cancer Registries; National Program of Cancer Registries

Report generation capacity, both internal and external

Ability to share report design across network

Additional module availability: patient navigation; protocol manager, expedited case finding, survivorship plan generation

Technical assistance – hours provided, weekend availability, turn-around time

Customer support – hours provided, weekend availability, turn-around time

User product training

Continuing education for CTRs

Ability to customize and create user defined fields, both Enterprise- and facility-specific

Follow-up and follow up management: creation of patient lists, letters, and labels

Inclusion of National Quality Programs data standards

User friendly ad hoc report writer; available pre-defined reports

Ability to restrict user access; view only or follow-up only

Ease of use; streamline data design

Embedded user resources (manuals); error correction assist

Data quality checks with edit modules

Ease of creating charts and graphs for outcomes analysis, etc.

Ability to track adverse events and disease response

National Provider Identifier number registry

Real-time correction or changes to abstract

Data conversion process and associated costs

The vendor shall supply the cancer registry software with the same modules and functional profile as is currently deployed with the Oncolog application hosted at Brooke Army Medical

Center within 30 days of contract award. The vendor shall supply the capability for government or off-site hosting, security, software, and functionality updates, and transition of existing data from BAMC and ACTUR. The vendor shall additionally supply on-site training to personnel at cancer center locations. Coordination and transfer of data from the legacy ACTUR application shall be required between DMDC, Joint Pathology Center (JPC) and DHA Clinical Support

Division as they determine the schedule & methodology for data transfer. Technical assistance for the software at MHS MTFs will be rendered by the contractor in response to trouble calls placed by the DHA Help Desk. The contractor will provide updates and upgrades to the software.

The total estimated value of this effort, including all options, is $3,907,400. FY19 O&M funds will be utilized for the base period of this procurement.

4. Statutory and Regulatory Authority Permitting Other Than Full and Open Competition

(see FAR 6.302), or the Specification of the Statutory and Regulatory Provision Providing

Exception to 8(a) Program Competitive Requirements (see FAR 19.805-1): 10 U.S.C.

2304(c)(1) 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will

Satisfy Agency Requirements

5. Rationale Justifying Use of the Statutory Authority Cited: The MHS does not have a

Tumor/Cancer Registry contract. There is a contract, W81XWH-10-1-0435, for ACTUR - a

GOTS product under the Defense Manpower Data Center (DMDC) with funding provided through the JPC. This GOTS application is outdated, unstable, noncompliant with ACS-CoC reporting, and requires significant workarounds to obtain useable data for cancer center certification, research, and reporting.

There are no other known sources that can provide the mandatory requirements listed below:

a. Risk Management Framework compliance (NIST 800.53)

b. Common Access Card software compatibility

c. HIPAA compliance

d. Certified Tumor Registrars and clinicians on staff

e. Centralized hosting capability

f. Ability or current customization for military Tumor Registry needs at no cost

g. ACS-CoC compliance

h. Surveillance, Epidemiology, and End Results program compatibility

i. Survivorship functionality for post treatment physical, psychosocial, and economic issues of cancer patients

j. Surveillance, Epidemiology, and End Results program compatibility for efficacy and research

k. Turnkey capability for installation, deployment, and operationalized solution within 60 days of contract initiation

l. Hosting options government or vendor infrastructure

6. Efforts to Obtain Competition: An open Request for Information (RFI) was posted on the

Federal Business Opportunities (FBO.gov) site in December 2017, along with targeted letters to known Cancer/Tumor Registry vendors. Thirty-three (33) vendors submitted responses, four (4) were accepted for review by the Veteran’s Administration and DHA Oncology Communities of

Interest; however, they could not satisfy current RMF compliance and customization for MHS

MTF use. A Reverse Industry Day vendor review was also held on 24 May 2018, scheduled to coincide with the May 2018 National Tumor Registrar Association’s Conference in New Orleans and held at the Southeast Louisiana Veteran’s Health Care System in New Orleans and competing products were reviewed.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable:

Initial cost estimates by the SDD Investment Management Branch were well over $6.9M for 5 years. Cost of continuing ACTUR would start at $1.2M per year with a 3% inflationary trend over a 5-year period, which would be approximately $6.37M. Costing from vendors should include hosting, data conversion, and training shall be $3.9M over the same time period. During the RFI submission period several vendors did not supply estimates, citing ground up development costs for like or similar products. The anticipated cost will be determined fair and reasonable based a comparison of price of like or similar products and/or requesting other than certified cost and pricing information.

8. Market Research: In accordance with FAR Part 10, market research conducted from

October 2017 to May 2018 with 33 companies submitting information for a Request for

Information (RFI) concerning Cancer/Tumor Registry products. The RFI culminated in a

Reverse Industry Day demonstration in May 2018 from four tumor registry software providers who met the minimum standards of the ACS-CoC requirements for reporting and cancer center certification. Additional market research will be conducted, to determine if competing vendors have authorized resellers of Cancer/Tumor Registry software.

9. Other Facts:

a. Sole-Source: The vendor shall meet the military medical requirements and ACS-CoC stringent reporting requirements. As such, the vendor shall meet RMF requirements, cancer center program certification, federal, and state requirements at the MHS enterprise level in order to meet transitions and continuity of care among our highly mobile population. The application must be customized for military medical use. Due to the niche specialty requirements and relatively small turnkey vendor market, we posted a notice of intent within the FedBizOps website at FBO.gov for five (5) calendar days (between 17 – 22 July 2019) to allow potential competitors the opportunity to advise if they could meet the stringent requirements shown hereon. We received no responses.

b. Historical Data: The Oncolog tumor registry has been in use at BAMC for five years with a proven increase in reporting accuracy, stability, productivity and accurate data/reporting.

The ACTUR application has been in use for the MHS since 1985.

c. Unusual and compelling urgency: Due to legacy system issues, MTF cancer center certifications are at risk for decertification if another replacement system is not brought on-line.

10. Interested Sources: No other sources except as stated within, have expressed an interest in this acquisition.

11. Actions to overcome barriers: The SDD and DHA Medical Affairs, Clinical Support

Division have reviewed data on the industry and commercial products that provide similar software applications. As acceptable sources become known that meet the network and

Government’s unique need, appropriate action shall ensure full and open competition.

COORDINATION: Redacted