P03. PM_Part813.5_Atch1_FAR13.5_JA_OVER_SAT DC.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 3 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C263-21-AP-3849

1. Contracting Activity: Department of Veterans Affairs, VISN 23, NCO23, Supply Team 1

2. Nature and/or Description of the Action Being Processed: This procurement is for a document control system in accordance with FAR 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. Pathology and Laboratory Medical Service (PLMS) needs a document control system to warehouse, catalog, manage and provide employee access to standard operating procedures and related documents which does not contain any form of patient identification or patient health Information.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The software will provide easy and accurate auditing of laboratory documents during accreditation inspections and will provide tracking of staff training, compliance, and continuing education. The document control system will also provide a paperless alternative to reporting and tracking deviations from standard operating procedures. The new document control package replaces current outdated system and must meet VA directives to divest from the current version and move forward with modernization of the VA. Delivery would be expected to be within 90 days of award. This will be a 5 year IDIQ with ordering periods. Total estimated Value of all five years is $283,252.05. Electronic document control is critical and necessary for maintaining effective compliance with industry standards, CAP, CLIA, Joint Commission, FDA, EPA, and 21 CFR Part 11 standards, as well as meeting VHA Patient Safety and Quality initiatives.

4. Statutory Authority Permitting Restricted 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) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3

Revision 03 Date: 02/11/2021

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Although there are many companies that provide document control, in order to install in the VA, the system must be FedRamp approved. Medial Lab is the only vendor vendor with this.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The market was surveyed and no other products were found to be FedRamp approved. The item is proprietary and we have a letter staing such.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Market research has determined through FPDS that other VISN’s within the Department of Veteran’s Affairs are paying the same amounts for this product. Those prices have been deemed fair and reasonable by other contracting Officers.

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

Market Research Was Not Conducted: Market research was conducted and other companies provide similar products but they are not FedRamp approved, a requirement for this acquisition.

MediaLab is a proprietary item and I have a latter stating there are no other authorized distributors of the product.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The time required to get FedRamp approval is anywhere from 9-12 months. The current software is no longer supported by the VA internet. There is an immediate need for this acquisition.

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

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: No actions are planned as we have no control over whether a vendor seeks approval from FedRamp, a required approval for this product. If in the future there are other companies that do have approval we would compete this requirement.

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.

Jill Johnson Date Health Systems Specialist

VISN 23

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

JILL M JOHNSON

531094

Digitally signed by JILL M

JOHNSON 531094

Date: 2022.02.09 08:55:03 -06'00'

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 3

Revision 03 Date: 02/11/2021

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.

Harry R. Grambo III Date Branch Chief Supply Team 1 Network 23 Contracting Office

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.

Scott Petrin Date Division Chief, Division I

Network 23 Contracting Office

2/9/22 Harry R.

Grambo 941663

Digitally signed by Harry R.

Grambo 941663 Date: 2022.02.09 09:01:00 -06'00'

2/9/22 Scott J. Petrin 1494019

Digitally signed by Scott J.

Petrin 1494019 Date: 2022.02.09 11:23:05 -06'00'