C01 - VisualDx and DermExpert Justification and Approval_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

VisualDX/DermDX Subscription

Acquisition Plan Action ID: 36C776-21-AP-3248.

Contracting Activity: Department of Veterans Affairs, VHA, Program Contracting Activity Central

(PCAC), 6150 Oak Tree Blvd, Suite 300, Independence, OH 44131.

2237: 776-21-4-8251-0237.

Nature and/or Description of the Action Being Processed: The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), requires a renewal of a site license subscription, on a sole source, firm fixed price basis, to the online/web edition of VisualDX/DermDX.

Description of Supplies/Services Required Needs: The VisualDX Web Edition resource is an authoritative, up to date, and relevant internet resource necessary for ensuring information is available to staff for patient care. The Department of Veterans Affairs (VA) Veterans Health Administration (VHA) requires an existing commercial off the shelf web based, Visual DX Point of Care Dermatology Diagnostic Clinical Decision Support Product that will be made available throughout the VHA healthcare system.

In accordance with Federal Acquisition Regulations (FAR) Part 13.5, Simplified Procedures for Certain Commercial Items and specifically FAR 13.501, Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

The estimated total value of the acquisition is , for the base, plus two option periods.

The current contract (36C77618P0090) expires on 9/29/2021. The period of performance for the new contract is as follows:

Base Year: 9/30/2021-9/29/2022.

Option Year 1 of 2: 9/30/2022-9/29/2023.

Option Year 2 of 2: 9/30/2023-9/29/2024.

Statutory Authority Permitting Other than Full and Open Competition:

FAR Part 13.5, Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Certain Commercial Items 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:

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

OFOC SOP Revision 11 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

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Revision 11 Date: 02/11/2021 alifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The VA Subject Collection Advisory Committee convened to r knowledge and web searches, and decided on the subscriptions/products the VA requires to meet those needs.

The following are the salient characteristics

a. Images and knowledge-based information to assist the primary care provider in the identification, diagnosis and management of common skin disorders.

b. Vivid displays of dermatology images showing the variation of disease presentation through various ethnic groups and skin types in relation to age and stage.

c. A decision support system to allow the clinicians to enter patient findings in order to dynamically build a differential diagnosis displayed by medical images.

d. A substantial, considerable and exhaustive number of images from sources with a long standing, authoritative history of producing the photographic visual representations of required subjects in clinical medicine.

e. A diagnostic clinical decision support system to enhance diagnostic accuracy, aid therapeutic decisions, and improve patient safety. Includes searching by diagnosis, building a patient-specific differential, and reviewing travel or medication-related events at the point of care, including but not limited to the areas of diagnosing skin conditions, general and emergency medicine conditions, and medication reactions.

f. Provides access to the full spectrum of human diseases across skin types, body location, morphologic variation, and other diagnostic features. To adequately capture the immense variation inherent in disease requires access to hundreds of specialized image collections that span dermatology, ophthalmology, oral medicine, infectious disease, emergency medicine, radiology, and pathology.

g. An established and efficient means for uploading and centralizing images developed by medical experts from around the world; cases that include tropical and rare diseases, as well as common conditions represented within various ethnic groups and skin types.

h. Continuing Medical Education (CME) included: Users shall be able to track CME activity after establishing an account as provided by the contractor. All username/password and account maintenance shall be the responsibility of the contractor. CME credits shall include: AMA PRA Category 1. Credits would primarily be appropriate for physicians in the Family Medicine, Internal Medicine, Emergency Medicine, Hospital Medicine, Dermatology, and other medical specialties.

The SM only subscription that can meet these needs for that accomplishes the following in order to meet the needs of the VA:

Unique Characteristics

VisualDx is the only diagnostic decision support system to assist in the differential diagnosis of over 1,000 visually presenting diagnoses and is illustrated with over 18,000 professionally photographed medical images.

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No other diagnostic decision support system allows the clinician to enter patient findings in order to dynamically build a differential diagnosis displayed by medical images.

No other diagnostic decision support system or organized collection of medical images exists that so vividly displays the variation of disease presentation through age, stage, and skin type.

VisualDx addresses health disparities by providing robust information on the presentation and treatment of disease in dark skin.

VisualDx provides sustainable training in pattern recognition and clinical reasoning through daily use for common diagnostic problems.

No other diagnostic decision support system includes a customizable alert and feedback mechanism that allows you to push local and disease-specific alerts, updates, and reporting information directly to the point-of-care.

VisualDx is the only solution that provides rapid access to information about bioterrorism, chemical warfare, radiation injury, avian flu, SARS (and other emerging diseases), while also providing specialist-level information for diagnosing and treating common, and variants of the common conditions, to help improve care.

The VHA Dermatology Program Office has identified the VisualDX/DermDX as the authoritative, up-to-date, and relevant resource to ensure that a diagnostic clinical decision support product is made available to staff for patient care.

These products may also be referred to as a bedside information tool because they have been information that will directly affect patient care. What distinguishes these products from sources such as electronic textbooks or bibliographic citations databases is that it includes a mechanism to support and provide clinical dermatology decision support knowledge at the point-of-care.

VisualDX (Published by Logical Images, Inc) was also contacted to find out if there were authorized resellers. VisualDX responded stating that the current publisher (Logical Images, INC) is the only authorized seller and there are no authorized resellers.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: In addition to contacting the publisher for resellers, a survey of the market place was accomplished by publicizing a notice of intent to sole source was posted via beta.SAM.gov (https://beta.sam.gov/) on 8/30/2021. There were no responses.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The proposed pricing will be evaluated against the Independent Government Cost Estimate and historical pricing using the previous contract and comparable pricing for similar, web-based resources will be used to ensure the price has been deemed fair and reasonable.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As described in Section above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. There were no qualified responses. Further, a Vendor Information Pages query was completed using NAICS

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519130. None of the vendors generated from the list were contacted due to the understanding that there are no authorized resellers.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No other entities have expressed in writing, or otherwise, an interest in providing a comparable resource to the VA Library Network Office.

10. 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: In order to remove or overcome barriers to competition in future acquisitions for this requirement, the agency will work with the program office to perform additional market research in a timely manner to see if other solutions are feasible and can be considered as a viable alternative.

11. 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.

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

a. 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.

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c. VHA PCAC 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 ($750K to $75 million) for other than full and open competition.

d. VHA RPO 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 ($750K to $75 million) for other than full and open competition.