36C26119Q0490-001.doc

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>$250K) Acquisition Plan Action ID: 36C261-19-AP-2076

1. Contracting Activity: Department of Veterans Affairs, VISN 21, San Francisco VA Medical Center

PR #: 662-19-2-296-0011

2. Nature and/or Description of the Action Being Processed: San Francisco VAMC located at 4150 Clement Street, San Francisco, CA 94121 has a new requirement for Medtronic -brand name only- StealthStation S8 Surgical Navigation System. A Firm Fixed Price type contract will be awarded. The estimated value of the proposed action is $410,000.00.

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

Part number Description

Qty

M072707M014 STEALTHSTATION™ S7 to S8 System Trade In

1 EA

9735955

STEALTHSTATION™ EM KIT S8 CRANIAL ACCESSORIES

1 EA

9735740

STEALTHSTATION™ SPINE SOFTWARE

1 EA

9735737

STEALTHSTATION™ CRANIAL SOFTWARE

1 EA

9735921

STEALTHSTATION™ DBS + STEREOTAXY SOFTWARE

1 EA

9733936

VERTEK PASSIVE BIOPSY KIT

9735745

STEALTHSTATION™ MERGE SOFTWARE

9735959

STEALTHSTATION™ EM KIT S8 FLAT EMITTER

1 EA

EK200N

BUNDLE STEALTH-MIDAS STYLUS MOTOR W/IFU

Trade In

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 FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4

( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

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 Medtronic StealthStation S8 System aids in precisely locating anatomical structures in either open or percutaneous surgical procedures during neurosurgery. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR- based model, fluoroscopy images, or digitized landmarks of the anatomy. The S8 will work with the cranial and spinal software for neurosurgical and orthopedic procedures. For cranial procedures, it is required for tumor resections, cranial biopsies, general ventricular catheter placement, depth electrode, lead and probe placement, and general localization. For spine or pelvis procedures, it is required for pedicle screw placement, iliosacral screw placement, and interbody device placement.

The existing StealthStation S7 currently being used at SFVAMC is over nine years-old and is considered end-of-life. This system provides speed and safety to these crucial procedures and requires an upgrade to S8 as Medtronic will no longer support S7 making it obsolete at the end of 2019. If the replacement/upgrade is not procured, this will be detrimental to patient care requiring these surgeries, and any malfunctions or technical breadowns of the existing S7 device will severely hinder quality care. Additionally, cases will need to be fee-based out estimating approximately 230 cases per year. Cases are sourced from inside and outside the VISN at the SFVAMC.

The StealthStation S8 is compatible with the existing Medtronic O-Arm already in use by the SFVAMC. All surgery and other staff are already trained on the StealthStations manufactured by Medtronic. As a part of standardization and to avoid human error, it is imperative to continue using this equipment currently in use at the medical center and compatible with equipment already owned by the VA. Switching brands will not be cost effective as procuring a new brand will require additional new parts to be procured and would create compatibility issues as software, system, and parts must be compatible in form, fit, and function. Additionally, the StealthStation S8 is an upgrade to S7 and includes a trade‐in which other contractors may not accept. Upgrading from the existing S7 to S8 will not require any additional re‐testing/re‐training for staff, therefore, will not cause any unnecessary delays in order to ensure continued quality care for service members.

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

A sources sought notice, 36C26119Q0490, was posted to FBO on March 27, 2019. One response was received timely on March 28, 2019 from Veterans Healthcare Supply Solutions (VHSS), and SDVOSB. A letter from Medtronic confirmed that VHSS is an authorized distributor. VHSS was searched in VIP and SAM, and results indicated that VHSS is active in both systems. An FPDS search showed that both Medtronics and VHSS have supplied the same/similar requirement several times to the VA.

On May 10, 2019, a response was received from Red One Medical, an SDVOSB, via email suggesting that they can offer a functionally “equal” alternative to the StealthStation S8. On 14 MAY 2019, the response from Red One Medical including all attachments (capability statement, Brainlab Curve brochure, and Brainlab Curve link) was forwarded to the program office/customer to determine if it meets the requirement and is functionally “equal” to the Medtronic StealthStation. It was determined by the customer that although the Brainlab Curve may meet the definition of “equivalent,” it does not work with other existing Medtronic O‐arms and ancillary equipment already owned and in use by the SFVAMC. Switching brands will not be cost effective as procuring a new brand will require additional new parts to be ordered otherwise creating compatibility issues as software, system, and parts must be compatible in form, fit, and function. Additionally, the StealthStation S8 is an upgrade to S7 and includes a trade‐in which other contractors may not accept. Upgrading from the existing S7 to S8 will not require any additional re‐testing/re‐training for staff, therefore, will not cause any unnecessary delays in order to ensure continued quality care for service members. The program office/customer deemed Brainlab Curve to be unacceptable to support the needs of the government.

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

Price reasonableness will be determined by comparison to similar items, historical information, and the Independent Government Cost Estimate (IGCE).

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 via GSA, Mandatory NAC, VIP, FPDS, historical information, and FBO. The requirement is unavailable on a mandatory NAC or on GSA. VIP was queried and indicated that 55 SDVOSB/VOSB may possibly respond to a solicitation under NAICS 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing. As described in Section 6 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. A sources sought notice was posted to FBO on March 27, 2019 and received one timely response from an acceptable and capable source that can meet the requirement. As a result of the sources sought notice and additional market research, the rule of two SDVOSB/VOSB could not be met; therefore, it was determined to award this brand name only FFP requirement to Veterans Healthcare Supply Solutions as an authorized distributor of Medtronics, the large business manufacturer.

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:

Veterans Healthcare Supply Solutions 13949 Alvarez Road, Suite 300 Jacksonville, FL 32218 Red One Medical Devices, LLC

513 East Oglethorpe Avenue Unit G

Savannah, GA 31401

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:

For future acquisitions, VA contracting and other staff will continue to conduct appropriate market research to determine if sources capable of meeting the agency’s requirement(s) become available in the marketplace.