0178 - Brand Name Justification - Hines-Best.pdf

Brand Name Justification

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C246-23-AP-2224

1. Contracting Activity: Department of Veterans Affairs, Network Contract Office 6 (NCO 6) for Hampton VA Medical Center 2237: 590-23-2-985-0178

2. Nature and/or Description of the Action Being Processed: Draeger Anesthesia Scheduling Equipment

The proposed action is for a Brand Name Only award of a FFP contract to procure the line items that complete the Draeger Anesthesia Scheduling system. ARK replaces paper anesthesia records used in VA Operating Rooms (OR) and other anesthetizing or moderate sedation locations to manage patient information in the OR, pre- and post-procedural, and for critical information during OR procedures. CO will proceed with a SB set-aside.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Innovian Anesthesia software is an ARK system with an Innovian-end Veterans Health Information Systems and Technology Architecture (VistA) interface that enables real time bi-directional exchanges of data in Vista both in batch and real time. The software provides end-users with important data, such as patient demographics, text integration, patient allergies, problem lists, care status and delivery, laboratory results, medication administration, and information regarding surgeries. ARK replaces paper anesthesia records used in VA Operating Rooms (OR) and other anesthetizing or moderate sedation locations to manage patient information in the OR, pre and post-procedural, and for critical information during OR procedures. In addition, telephone and online support shall be provided 24-hours per day, 7 days a week. These critical maintenance services will ensure the current software remains operational in anesthesiology environments.

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

Effective Date: 02/01/2022 Page 2 of 4

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority: This action is for the procurement of a Draeger Innovian ARK system currently used in 57 other VA Medical Centers throughout the VHA. To ensure these anesthesiology environments are operating at optimum patient safety capabilities the ARK must meet the following specifications/requirements:

- System must be ERA certified

- System must meet the requirements of the VA National ARK specifications.

- System must incorporate the VA Standard Terminology for ARK.

- The ARK terminology database must be standardized for both intra and inter VISN requirements for consistency in reporting at local and national levels.

- ARK system architecture must include a direct connect so if Network services go down, the ARK can continue to collect vital signs and the clinician can continue to chart.

- ARK must comply with DSS requirements for integration with Vista and must be certified by DSS.

- ARK must have met the requirements of DSS for interfacing with Vista, including all standard interfaces such as ADT, Labs, Vista Imaging, Text Imaging Utilities, etc.

- ARK must also be capable of sending data to both the VA’s Vista Surgery package and DSS Period package. (The interface between Innovian and DSS Periop package is included as part of Draeger’s proposal.)

- ARK must be capable of scanning waveforms, images and other documentation to include in the ARK EHR. (Draeger will “turn on” that capability during the implementation and will provide you with information on how to acquire the correct validated scanners.)

- ARK must be capable of providing analytic reports and discrete data for both local and national use.

- ARK software and hardware must be warrantied for at least one year. Additional years of ARK support must be contractually available.

- Post Go Live support of the ARK must be provided on a 24 by 7 basis, 365 days a year via remote services

- Proactive maintenance and support must be a component of the ARK maintenance and support contract.

- ARK software must have been developed in conjunction with the VA Build group and in conjunction with the VA User Group.

- ARK must possess a module for Moderate Sedation in order to comply with National Directive 1073. (This is not part of the Innovian proposal but can be purchased at a later date.)

- Only the Draeger Innovian ARK can meet all the above specifications/requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Posted a source sought notice on contract opportunities 36C24623Q0540 (03.07.2023 – 03.13.2023) resulted in interested vendors – two SDVOSB and one LB. The LB was the OEM and both SDVOSB are authorized distributor of the OEM. Draeger Innovian system will satisfy the needs of the government, CO will move forward with SB set-aside.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will determine that the prices will be fair and reasonable based on a comparison of proposed prices to other Medical Centers within VISN 6. Prior to award price analysis of the proposed contract price will be performed and documented to sufficiently determine that the cost to the Government of the proposed acquisition will be fair and reasonable.

Effective Date: 02/01/2022 Page 3 of 4

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 from September 2022 through February 2023 by searching the product websites of General Electric, Picis, iMDsoft, and Phillips Electronics. Based on reviews of these companies’ products and services offered, the Government’s technical experts determined that none of these sources can meet the Government’s requirement for a usable ARK. PICIS had previously been selected by VISN 6, but VA Salem recently replaced PICIS with Innovian ARK, and VA Hampton wishes to do the same. There is precedence for doing so. In March 2023, a Request for Information (Sources Sought) was posted to determined qualified ARK vendors.

- SBAVET Cert database was searched utilizing NAICS code 339112 provided 576 SD/VOSB.

- Posted a source sought notice on contract opportunities 36C24623Q0540 (03.07.2023 –

03.13.2023) resulted in interested vendors – two SDVOSB and one LB.:

- (Large Business): Draeger, Inc., (OEM) offers exact item.

- (SDVOSB): The Janz Corporation., offers exact item

- (SDVOSB): Sierra 7, offers exact item

- NAC searched using keyword “Draeger Anesthesia Equipment” revealed no potential contracts.

- SAC searched using keyword “Draeger Anesthesia” revealed Draeger equipment but none are the items requested.

- FPDS searched using keyword “Draeger Anesthesia Equipment” under department of Veteran

Affairs revealed 517

- SBA DSBS searched using keyword “Draeger Anesthesia” revealed no information or contracts.

- GSA eLibrary search using keyword “Draeger Anesthesia” yielded several results as the items are

GSA contract 36F79718D0369 .

The Brand Name requested procurement items via Open Market from the OEM: Draeger, Inc. (Large Business). Draeger, Inc. has identified (2) SDVOSB as their authorized reseller distributor: The Janz Corporation and Sierra 7

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

Draeger, Inc., The Janz Corporation and Sierra 7

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: NCO 6 will continue to conduct market research to ascertain if there are changes in the marketplace that would enable competition for future actions.

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.

Name: Patrick Bichara Date Title: Registered Nurse Facility: Hampton VA Medical Center

4/12/23

Effective Date: 02/01/2022 Page 4 of 4

12. 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.

Name: John Harmsen Date Title: Contracting Officer Facility: NCO 6

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.

Name: Jerry Mann Date Title: Division Chief

Facility: NCO 6