P03-Maletta Signed-Brand Name Justification-Fabius Tiro (2).pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:36C247-21-AP-2226

1. Contracting Activity: Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 7, Ralph H. Johnson Charleston Ralph H. Johnson VA Medical Center(VAMC), 109 Bee Street, Charleston, SC 29401-5703.

The Purchase Request # for this requirement is 534-21-4-783-0108

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

The facility is requesting award of a new firm fixed-price contract to purchase upgrades to the Draeger integrated anesthesia workstations that are currently in use.

The anticipated award date is May 17, 2021 and delivery of all items shall be completed by September 20, 2021.

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

The Draeger integrated anesthesia workstation is composed of an anesthesia machine, anesthesia monitor and ARK. The current Draeger systems are approaching or have already reached VA end of life. Therefore, two of the three components – anesthesia machine and anesthesia monitor - are due to be upgraded to the most recent model.

Charleston VAMC is also looking to upgrade eight (8) existing Draeger integrated anesthesia workstations to include, the Draeger Perseus anesthesia machine and the latest version of Physiologic monitor. The upgrade will also include one (1) Draeger integrated anesthesia workstation w/ Fabius Tiro anesthesia machine, (1) Fabius MRI Anesthesia machine, and six (6) standalone anesthesia monitors, all of which must integrate with the Draeger Innovian ARK.

The estimated value of this procurement is $1,133,686.79.

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

(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 ( ) (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;

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36C247-21-AP-2226

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The brand name Draeger is required for each component of the integrated system to ensure ongoing interoperability. Software releases for all of these Draeger anesthesia components are synchronized and tested prior to general market release assuring compatibility and interoperability.

Interoperability of the existing systems is a critical element that ensures the reliable delivery of health care services to our Veterans. In addition, Charleston VAMC anesthesia personnel are already proficient at using the Draeger anesthesia systems. Further, the facility has retained some of the existing fleet of Draeger integrated anesthesia workstations to use in transition. All models of the Draeger anesthesia machines use the same user interface;

therefore, changing the brands would require clinical staff throughout the hospital to learn how to use two different brands of Anesthesia units, which is a patient safety risk. Moreover, the VAMC Charleston Biomedical Engineering department would need to train biomedical support specialists on how to maintain/repair another manufacturer’s anesthesia system.

Therefore, it is essential to the Government's requirement to include the brand name description, Draeger in this particular requirement, thereby precluding consideration of a product manufactured by another company.

Draeger has provided two SDVOSB authorized distributors, Janz Corporation and Sierra 7 Inc.

There is a reasonable expectation that both will submit quotations with fair and reasonable pricing; therefore, this procurement will be set-aside for SDVOSB concerns.

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

The Contract Specialist communicated with the OEM to identify any and all authorized distributors of the Draeger System required for this requirement. Market research was also conducted through queries of VIP,GSA, SBA Dynamic Small Business Search (DSBS) and a Google Internet search. Through all searches, no vendors other than Draeger were located.

Draeger provided a listing of all authorized SDVOSB’s, and this has been included in the contract file.

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

Costs will be determined as fair and reasonable based on similar awards found in queries of FPDS and BetaSam. Although a query of the National Acquisition Center Med-Surg Catalog returned Fabius Tiro brand items, none of the items are those required for this order and can’t be used for price reasonableness determination.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Draeger, Inc. is the only manufacturer of the Integrated Anesthesia Workstation including;

Draeger Perseus, Fabius Tiro and Fabius MRI Anesthesia machines and monitors and the

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36C247-21-AP-2226

Draeger Innovian ARK Integration. The system is proprietary and available only through Draeger Inc. or through one of Draeger’s SDVOSB vendors; The Janz Corporation or Sierra 7.

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

N/A

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

Janz Corporation 6950F Americana Parkway Reynoldsburg, Ohio, 43068-4127 VIP Verified SDVOSB

Sierra7, Inc.

11951 Freedom Drive, Suite 1300 Reston, VA 20190 VIP Verified SDVOSB

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:

Continuous market research will be conducted to determine alternative products that can be used in conjunction with existing equipment and allow for maximum competition.

Regular communication will be conducted with the manufacturer to obtain any additional authorized vendors in the event that no other products are compatible with the existing equipment.

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.

Allen D. Miller Administrative Officer Ralph H. Johnson VAMC

Allen D Miller 126614

Digitally signed by Allen D Miller 126614 Date: 2021.04.26 13:53:14 -04'00'

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36C247-21-AP-2226

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.

LaToyer Furbush Contracting Officer

VISN 07-Charleston Site Team

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.

Maurice D. Ross Division Chief, Services and Commodities Network Contracting Office – 7 (NCO 7)

c. 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 recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition.

Joseph P. Maletta Executive Director, RPO-East VHA Head of Contracting Activity (HCA)