P03 - J and A - StatDx -Redacted AA_Redacted.pdf

Attachment 7: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 8 Revision: 01 Effective Date: 04/01/23

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C776-23-AP-0868

1. Contracting Activity: Department of Veterans Affairs (VA), Program Contracting

Activity Central (PCAC), 6100 Oak Tree Blvd., Suite 490, Independence, OH 44131 Purchase Request: 776-23-3-8551-0051

2. Nature and/or Description of the Action Being Processed:

The Department of Veterans Affairs (VA) Veterans Health Administration (VHA) Office of Health Informatics (OHI) requires an existing commercial off the shelf web based, Point of Care Radiology Diagnostic Clinical Decision Support brand name product (StatDX), that will be made available throughout the VHA healthcare system.

VHA continuously researches available products to find the most well-rounded intellectual property products that encompass the needs of the VA. The information is proprietary and contributed to by recognized experts in all fields of healthcare.

VHA approves the selection of certain products based on relevancy and appropriateness by consulting with the field and confirming the needs are current and ongoing.

VHA’s goal is to ensure uniform availability to a purchase-based collection of high quality, clinical online resources in the VHA system to improve clinical decision making at the point of care. This requirement was previously awarded to WT Cox, contract number 36C77622P0197, as unrestricted, in the amount of

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Veteran’s Health Administration (VHA) medical center libraries, VA Central Office Staff (VACO), and the staff at the all-VA Medical Centers (VAMCs), Community Based Outpatient Clinics (CBOCs), and other affiliated programs and offices require continued access to StatDX subscription. The StatDX subscription is used heavily by Radiologists to aid in the diagnosis and analysis of complex and simple imaging examinations. StatDx subscription is an online tool, product is 508 compliant, and a resource that will help narrow the causes of an injury or illness is required. The VA needs an online product that will ensure that the diagnosis is accurate. These necessary techniques should, at a minimum, include X-rays, computed tomography (CT) scans, and magnetic resonance imaging (MRI) scans.

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Radiologists need to have several medical imaging tools available to them. These tools, called diagnostic imaging tests, can be of several different types. Each of them uses a different technology to create images and detect different types of medical problems. Making this Point of Care Radiology Diagnostic Decision Support Product available through CPRS (Computerized Patient Record System), the VA’s Electronic Health Record, nationwide to insure consistent access at the bedside for all VHA health professionals and staff.

Radiology's role is central to disease management and diagnosis, with a wide choice of tools and techniques available for the detection, staging and treatment are needed. Diagnostic imaging must provide detailed information about structural or disease related changes. The VA needs an online product to prepare and achieve the diagnosis of a wide variety of diseases and injuries with evidence-based decision support to help radiologists check diagnoses and analyze complex or unusual cases.

Providing access nationwide to standard knowledge based clinical information resources available at the point of care.

Estimated Dollar Value: (Base Year), Total w/ Four (4) Option Years =

Period of Performance: One (1) year from date of award, plus four (4), one (1) year options, to be exercised at the discretion of the Government.

Base Year: 6/30/2023 through 6/29/2024 = Option Year 1 of 4: 6/30/2024 through 6/29/2025 = Option Year 2 of 4: 6/30/2025 through 6/29/2026 = Option Year 3 of 4: 6/30/2026 through 6/29/2027 = Option Year 4 of 4: 6/30/2027 through 6/29/2028 =

4. Statutory Authority Permitting Other than Full and Open Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

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( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

STATdx (http://www.statdx.com/) is an existing, commercial, off-the-shelf, web-based, point-of-care radiology diagnostic clinical support product currently utilized by clinicians throughout the VA. What distinguishes these products from other sources such as electronic textbooks or bibliographic citations databases is that StatDx subscription includes a mechanism to support and provide clinical Radiology decision support knowledge at the point-of-care.

Product is 508 compliant

The desired goals of the nationwide provision of a commercial Point of Care Radiology Diagnostic Decision Support Products are as follows:

• Providing access nationwide to standard knowledge based clinical information resources available at the point of care.

• Initiating a nationwide, centralized purchase to capitalize on the economies of scale offered by vendors.

• Negotiating one license/contract to decrease the current contracting and reviewing efforts that are required at the facility and/or VISN level and thereby avoid the costs and workload associated with multiple procurements.

• Making this Point of Care Radiology Diagnostic Decision Support Product available through CPRS (Computerized Patient Record System), the VA’s Electronic Health Record, nationwide to insure consistent access at the bedside for all VHA health professionals and staff.

This license will also allow for authorized user access at all Department of Veterans Affairs current and future physical facilities included but not limited to current and future medical centers, community based outpatient clinics, DOMs, vet centers and all other locations where Department of Veterans Affairs employee’s work. The online web-based version of this subscriptions provides unique access to StatDX.

StatDX includes:

• StatDx images and knowledge-based information assists the provider in the identification, diagnosis, and management of common skin disorders. Other

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Effective Date: 04/01/23 resources do not include the combinations of these two important mechanisms for use in direct patient care.

• A diagnostic decision support system is included to assist radiologists’ providers in differential radiological diagnosis.

• Vivid displays of Radiology images showing the variation of disease and injury presentation. Other resources do not.

This requirement falls in line with VA’s mission, goals, and objectives in support of providing Veterans’ care.

VA Library Network Office (LNO) continuously researches available products to find the most well-rounded intellectual property products that encompass the needs of the VA. These subscriptions provide the most up-to-date, state-of-the-art research and peer reviewed medical articles by recognized experts in their field and due to their proprietary nature, copyrighted material and intellectual property are unique and highly specialized and only available from one source. Selection of specific resources is based upon a multitude of criteria:

a. Input from a select group of VA medical librarians

b. Recommendations from the Core Collection Advisory Committee (CCAG)

• This research is conducted continuously throughout the year by the LNO.

Suggestions from medical center staff, librarians and program office officials are received on a routine basis. In 2015, the Library Network Office established a Core Collection Advisory Group (CCAG) to make recommendation regarding the online knowledge-based resources (books, journals, databases) that will be made available enterprise-wide. The CCAG consists of membership from across VHA and are representative of the key stakeholder groups currently using the core Library collection.

Individual members are nominated by their respective program offices and verified annually. This interdisciplinary group makes recommendations as to what will and what will not be provided nationally to all clinicians and program teams as part of the Core Collection. A group of select librarians annually provide their recommendations based upon the available budget.

For each item, a justification for keeping or deleting the resource is noted.

This detailed information is part of the data provided to the CCAG. The CCAG members annually review the current Core Collection and established evaluation criteria collectively and by consensus. The 3 criteria established are listed below.

1. (Learning/Innovation) Resource supports an environment of continuous learning that is essential to modern, high-quality health care.

2. (Widely Used) Resource is so widely used within a discipline or across the Agency that inclusion in the National Core Collection is the best decision for the interest of the Agency. If removed from the National Core Collection, individual facilities would likely decide to purchase it on their own.

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3. (VHA Priorities) Resource directly supports the VHA mission, priorities, initiatives, and focus areas (VHA's Three Priorities for Strategic Action: Restore Trust, Constructing a Learning Organization, Modernizing Systems).

c. Doody’s Review – an authoritative medical review service designed to assist medical librarians and institutions with their purchasing decisions. Resources are reviewed by medical librarians and content specialists.

d. Recommendations/support of authoritative medical organizations suchs as the American Psychiatric Association.

e. Impact factors and other bibliometric data

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

An RFI was published to Contract Opportunities

An SBA VetCert search was completed using the NAICS code 519290 (See Attachment 3).

7. Determination by the CO that the Anticipated Cost to the Government will be

Fair and Reasonable:

The CO will obtain published pricing, pricing awarded on other contracts, or if necessary, other than certified cost and pricing data to determine the price paid to be F&R.

8. Description of the Market Research Conducted and the Results, or a

Statement of the Reasons Market Research Was Not Conducted:

Market research has shown that this requirement was previously awarded to WT Cox, contract number 36C77622P0197. It was awarded as an unrestricted-insufficient small business procurement in the amount of

An RFI was published on 04/18/2023 to Contracting Opportunities, no responses received.

VHAPG Part 806.3 OFOC Page 6 of 8 the solicitation will be released as full and open, and this requirement competed to the maximum extent practicable.

The VA Rule of Two has not been met based on the Contracting Officer not having a reasonable expectation that two or more SD/VOSB companies can provide these services.

dditionally, the representations and certifications were reviewed to verify the small business size in NAICS 519290.

The Contracting Officer will determine the prices to be fair and reasonable prior to award by evaluating the proposed price.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

11. A Statement of the Actions, if any, the Agency May Take to Remove or

Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

VA will continue to perform market research in attempts to find other sources soliciting new awards for the same or similar future acquisitions of the services being acquired.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

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13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

c. DoC Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval for other than full and open competition.

https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

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d. HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

List of Documents:

Attachment 1 – Publisher’s confirmation of authorized reseller Attachment 2 – RFI Attachment 3 - SBA VetCert 519290 Attachment 4 – SAM