A03-J&A_da_Vinci_redacted.pdf

Control No. NCD-18-34

Justification and Approval For Other Than Full and Open Competition

For actions over

Program/Equipment: da Vinci Xi Robotic Surgical System

Authority: FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items

Amount

Prepared By:

Typed Name:

DSN:

Title:

Date: 17 May 2018

Contracting Officer:

Typed Name:

DSN:

Date Reviewed: 17 May 2018

Technical Representative:

Typed Name:

DSN:

Title:

Date Reviewed: 17 May 2018

Requirements Representative:

Typed Name:

DSN:

Title:

Date Reviewed: 17 May 2018

Reviews:

I have reviewed this justification and find it adequate to support other than full and open competition.

Typed Name:

DSN:

Signature:

Date:

Legal Counsel:

Typed Name:

DSN:

Signature:

Date:

5/18/18

5/23/18

256-5971

Justification and Approval For Other Than Full and Open Competition

For actions over

1. CONTRACTING ACTIVITY

Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division, ATTN:

CCAP-SCN, General Greene Avenue, Natick, MA 01760

2. DESCRIPTION OF ACTION

Approval is requested to solicit on the basis of other than full and open competition for a:

New Contract.

The contract is in support of:

Clinical Investigations and Research at the 59th Medical Wing

Type of contract contemplated:

Firm Fixed Price, Supply

Reason for type of contract:

This is a 1 year contract for the procurement of commercial medical equipment. In accordance with FAR 16.103(b) a firm-fixed-price contract shall be used when the risk involved is minimal or can be predicted with an acceptable degree of certainty. A FFP type contract is consistent with the procurement of the da Vinci Xi robotic surgical system, as there is minimal risk to the contractor providing the equipment.

Funding information:

Funded with Procurement dollars from the Air Force Medical Modernization Panel

Fiscal Year: 18

Type of Money to be used:

Procurement.

3. DESCRIPTION OF SUPPLIES/SERVICES

One (1) da Vinci Xi Dual Console System; a state-of-the-art robotic surgical system that includes two surgeon’s consoles, a surgical cart, a video cart, endoscope system, system software, system accessories, installation, training, and procedure-specific instrument sets.

Total Estimated Amount:

4. AUTHORITY CITED

The statutory authority permitting other than full and open competition is FAR Subpart 13.5 Simplified

Procedures for Certain Commercial Items.

5. REASON FOR AUTHORITY CITED:

The 59th Medical Wing, Clinical Research Division (59 CRD), which is a part of the San Antonio Military Health System (SAMHS), has become a robotic surgery training center for the Graduate Medical Education (GME) program to assist students, residents, and fellows in obtaining their official robotic surgery credentials. SAMHS also includes Brooke Army Medical Center and Wilford Hall Ambulatory Surgical Center. These two centers are already using the da Vinci Xi robotic surgical system. 59 CRD has a da Vinci S Model surgical robot set up as part of the GME Robotic Surgical Education Program to assist surgeons in getting their official robotic surgery credentials; however, the S Model is outdated and needs to be replaced with the more technologically advanced Xi system for training to perform general surgical procedures. The da Vinci S model no longer reflects the instrumentation being used for patient care, has become obsolete, and is no longer sold or serviced by the original equipment manufacturer (OEM), Intuitive Surgical, Inc. In order to facilitate continuity throughout the SAMHS and DoD, training with the same advanced robotic da Vinci Xi robotic surgical system is essential to the Government's requirements. In order to support 59th Medical Wing (59 MDW) approved training protocols FWH20170021A, General Surgery Robotic Surgical Skills Training Lab and FWH20170102A, Urology Laparoscopic Surgery Skills Training, and to facilitate training and certification continuity throughout SAMHS, 59 CRD requires their robotic surgical equipment be upgraded to the da Vinci Xi model to meet 59 MDW mission requirements.

Intuitive Surgical is the original equipment manufacturer (OEM) and sole distributor of the da Vinci Xi model Surgical System and instrumentation. They have no distributors or resellers.

This item is peculiar to one manufacturer and sold in the commercial open marketplace.

Additionally, Intuitive Surgical is the sole provider of services and maintenance for the equipment; there are no authorized service providers except for the OEM. The da Vinci is the standard robotic system utilized in Department of Defense Medical Treatment facilities. The training of residents, fellows and staff surgeons allows these medical professionals to go to other DoD facilities and be fully qualified to perform robotic surgery. The loss of this training capability will have a significant negative effect across the military medical system and will lead to the inability of our surgeons to perform required patient care procedures. The incorporation of the da Vinci Xi system allows for standardization of training for all military residents, fellows and staff assigned to the largest Graduate Medical Education Program in the Department of Defense. This standardization is based on the use of da Vinci Xi Systems throughout the DoD system. This capability is vital to the successful completion of surgical residencies and fellowships and is invaluable to the current training of staff surgeons. With approximately 20 da Vinci Xi Systems across the DoD valued at approximately , the loss of skilled surgeons to use these systems would require standard of care surgeries to be canceled due to lack of trained surgeons. The acquisition of the da Vinci advanced Xi system is essential to the Government's requirements and allows the largest surgical residency program in the DoD to produce fully trained surgeons to use advanced surgical robotic systems currently in the DoD inventory. Sending staff surgeons out to training once assigned to surgical centers would have a devastating effect on unit readiness and would have an immediate impact on the medical mission of the sites. To replace the existing network of da Vinci systems in DoD with any other surgical robotic system would require an investment of and additional dollars to retrain surgeons in the use of a new system. The cost in failed mission and readiness of the surgical staffs would be substantial in that it costs approximately to train and certify one

(1) surgeon to operate the surgical robotic system. The SAMHS has at least 40-50 residents at one time being trained in the system. To train this group on an annual basis would cost approximately and any retraining on a new or different surgical robot would require retraining surgeons at the same or higher costs.

6. EFFORTS TO OBTAIN COMPETITION:

This requirement will be synopsized as a sole source requirement in FBO utilizing FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items. Market research has identified Intuitive Surgical, Inc. as the OEM and sole source for the da Vinci Xi surgical system.

7. ACTIONS TO INCREASE COMPETITION:

Literature reviews, trade shows, and industry notices will continue to be investigated to seek out any potential future competitors. As technology evolves it is possible that another system will be able to meet the requirements of the 59th Medical Wing in the future. As such, it is anticipated that if a more advanced surgical system is discovered that satisfies the agency’s requirements, then full and open competition will take place at that time pending agency needs and availability of funds.

The brand name justification will be posted in accordance with FAR 5.102(a)(6) with the solicitation.

8. MARKET RESEARCH

Market Research was conducted by:

59th Clinical Research Division, 59th Medical Wing

The results of the market research identified Intuitive Surgical, Inc. as the original equipment manager (OEM) and sole distributor of this type of equipment. Market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency’s needs. Based on our market research no other products are available, nor can be modified, to provide the surgical system needed to fulfill this requirement for the 59th Medical Wing’s, Clinical Research Division. Other Robotic Surgery systems currently on the market that are FDA approved for robotic surgeries were evaluated. Some of these systems include.

– Reviewed 1/15/2018

This system is designed specifically to assist in brain surgery. It is not approved nor designed to perform general surgical procedures like prostate surgery, colon surgery, bladder surgery, etc. It is only designed and FDA approved to assist in brain surgery. Because of these limitations the does not meet agency requirements.

– Reviewed 1/15/2018

Similar to the is specifically designed to assist in brain surgery. It has not been approved nor has the capability to perform general surgery procedures including laparoscopic procedures on prostate, colon, bladder, lung or other general surgery procedures.

Because of these limitations it does not meet agency requirements.

– Review 2/5/2018

This is a system specifically designed for joint replacement surgery and not general surgical procedures such as prostate, colon, bladder, lung or other laparoscopic surgical procedures. This device is not designed or approved for general surgical use and cannot meet the agencies requirements.

– Review 3/5/2018

This is a robotic surgery system that has recently received FDA clearance. This system can perform procedures equivalent to the da Vinci System, however, it uses a completely different technology and does not meet the requirement as a training platform for the da Vinci System.

The surgeon interaction with the patient is completely different using the and using it as a training platform will not provide acceptable training or certification to allow performance of patient surgery using the da Vinci Xi Robotic Surgical System. One of the major requirements for the da Vinci Xi is to train and certify surgeons on the da Vinci so that they can perform patient surgeries. Training on a dissimilar technology will not allow them to use the da Vinci to perform patient procedures. The Robotic Surgery System does not meet agency requirements.

A search of the GSA website utilizing the keywords “da Vinci Xi”, “surgical robotic systems”, and “Intuitive Surgical” provided no results. Additionally, no results were identified when a search for contract SPE2D1-15-D-8301 (see section 10a Procurement History below) was performed.

9. INTERESTED SOURCES:

The only source identified for this acquisitions is:

Intuitive Surgical, Inc. - 1020 Kifer Road, Sunnyvale, CA 94086-5304, Phone: (800) 876-1310. Intuitive Surgical is the manufacturer of the da Vinci Xi Robotic System, they do not have distributors and do not allow reselling of the da Vinci Xi system through other vendors.

The San Antonio Military Health System uses 4 da Vinci Xi systems to perform surgical procedures on DoD patients in the largest DoD Health System. Surgeons must be trained and certified on the da Vinci Xi System prior to performing surgery on patients. There is no other robotic surgical system that can provide the training required to certify surgeons to operate on human patients. The da Vinci Xi is the only system that meets the 59th Medical Wing requirements and it is only available from Intuitive Surgical Inc.

10. OTHER FACTS:

Discuss any other facts supporting use of other than full and open competition, such as the following:

a. Procurement History In March 2015 DLA Troop Support awarded contract SPE2D1-15-D-8301, a multi-year indefinite quantity-indefinite delivery type contract, to Intuitive Surgical, Inc. The pricing information provided in contract SPE2D1-15-D-8301 lists the da Vinci Xi surgical system at

59 CRD seeks a sole source stand-alone contract in lieu of ordering from SPE2D1-15-D-8301 due to for use of SPE2C1-15-D-8301, which equates to 59 CRD currently has a support agreement in place with Natick Contracting Division for contracting services during FY18.

b. Acquisition Data Availability This commercial acquisition is to update 59 CRD’s technical capabilities with existing capabilities currently in use within the SAMHS and DoD. The da Vinci Xi System is only available from one source, Intuitive Surgical Inc., which is the OEM. In order to facilitate standardization and continuity in training and use of robotic surgical equipment throughout the SAMHS and DoD, 59 CRD requires this specific system. As surgical procedures and technology evolve, there may eventually be a need to replace the da Vinci surgical system as the standard robotic system used within the SAMHS and DoD, at which point technical data packages, specifications, engineering descriptions, statements of work, and/or purchase descriptions will be developed that are suitable for full and open competition.

c. Unusual and Compelling Urgency Not Applicable

d. Subcontracting Competition

Subcontracting opportunities will be identified by the vendor.

e. Follow-on Contracts It is not anticipated that a follow-on requirement will be necessary in the near future. As technology evolves, there may eventually be surgical systems that replace the da Vinci as the standard robotic system in the SAMHS and DoD.

11. TECHNICAL CERTIFICATION:

I certify 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.

Typed Name:

Date:

Title: 59th Clinical Research Division

Signature:

12. REQUIREMENTS CERTIFICATION:

I certify 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.

Typed Name:

Date:

Title: , 59th Clinical Research Division

Signature:

13. FAIR AND REASONABLE COST DETERMINATION:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable

The techniques to be used to determine fair and reasonable prices are: Price analysis in accordance with FAR 15.404-1(b)(2)(ii); comparison of proposed prices to historical prices paid, whether by the Government or other than the Government, for the same or similar items.

Certified cost or pricing data will not be required. Per FAR 15.403-1(c)(1)(iii), Price analysis clearly demonstrates that the proposed price is reasonable in comparison with current or recent prices for the same or similar items, adjusted to reflect changes in market conditions, economic conditions, quantities, or terms and conditions under contracts that resulted from adequate price competition.. .

Name:

Date:

Title: Contracting Officer

Signature:

14. CONTRACTING OFFICER CERTIFICATION:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name:

Date:

Title: Contracting Officer

Signature:

APPROVAL

Based on the foregoing justification, I hereby approve the procurement of the da Vinci Xi Surgical System on an other than full and open competition basis pursuant to the authority of FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature:

Date:

Advocate for Competition

3/22/18

3/22/18

7/12/18