A.02.04_16RHCOP556_Sole_Source_Justification-redacted.pdf

Control Number: 16-RHCO-P-556

For Official Use Only (See FAR 2.101 and 3.104-4)

(25 February 2016)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: JBLM Health Contracting Cell

2. Description of Action: This Justification and Approval is for a new contract for a one-time acquisition. This will be a firm fixed priced contract using FY16 R&D funding.

3. Description of Supplies/Services: This requirement is for Madigan Army Medical Center, Andersen Simulation Center (ASC). This one-time acquisition would be for an Emergency Obstetrics Cesarean Section Training System manufactured by Operative Experience. This simulator system will be used for the research study, Validation of a Cesarean Section Simulator to Improve Surgical skills during Deployment and at the MTF, and provide Emergency Obstetrics Cesarean Section Skills to OBGYN, General Surgery, and Family Medicine physicians. The value of this acquisition is $316,240.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: This simulator is sold exclusively through Operative Experience. While there are other simulators, according to market research none offer a comprehensive offering which would compare to the value that this one piece of equipment will provide. The purpose of purchasing this specific system is that it will be used in a study to determine the effectiveness of its use as a training system for the Army. Without this system, the study cannot be completed as the system is the focus of the study.

6. Efforts to Obtain Competition: Products from three other vendors were reviewed.

The equipment and consumables for this simulator are sold exclusively by the Operational Experience. In our market research we could not find a comparable simulator with as much realism and found no comparable cesarean section simulators that encompass the entire procedure with the option to include recognition and management of complications and to include cesarean hysterectomy.

A sources sought notice was posted to www.fbo.gov on 15AUG2016 requesting information from any company that can provide a simulator that meets the salient characteristics being requested. There were no responses to the notice.

(See FAR 2.101 and 3.104-4)

(25 February 2016)

Control Number: 16-RHCO-P-556

Cesarean Section Training System for the Anderson Simulation Center at Madigan Army Medical Center, Joint Base Lewis‐McChord, WA

a. Effective competition. In the future, Joint Base Lewis-McChord Health Contracting Cell, Lacey, WA, as well as the ASC will continue to perform market research to monitor any changes in the status of this requirement. As technology becomes available, research will be performed to consider other products that meet or exceed the current requirements.

b. Subcontracting competition. In accordance with FAR 19.702(a)(1), a Subcontracting Plan is not required for negotiated acquisitions under $700K. Additionally this action would be awarded to a Veteran-owned Small Business.

7. Actions to Increase Competition: As technology becomes available, research will be performed to consider other products that meet or exceed the current training requirements. The requested simulator was specifically selected for the completion of the aforementioned study and was reviewed by 38 OBGYN physicians. The Central Simulation Committee (CSC) is MEDCOM’s organization whose primary mission to research new simulators and study their effectiveness in usefulness and applicability in Army medicine. The CSC is constantly reviewing, testing, and researching new products in the marketplace. One of the ways this is done is through the International Meeting for Simulation in Healthcare which is a premiere simulation expo in which vendors from around the world can display and demonstrate their products. The Notice required by FAR 5.201 will be published. No action on the part of this office will decrease this type of barrier to competition available.

8. Market Research: The requested item is new technology and we could not find an adequate comparable simulator on the market that would allow the following: complete cesarean hysterectomy, abdominal incision and repair, uterine incision and repair, fetal extraction, complications trainer, and c-section trainer and with incredible realism . The following vendors were considered for this purchase:

A. Gaumard Scientific Birthing Victoria http://www.gaumard.com/ B. Adam Rouilly Desperate Debra http://www.adamrouilly.com C. CAE Healthcare Fidelis Lucina http://www.caehealthcare.com.

Before the requested vendor was selected, research was performed on-line and at the International Meeting for Simulation in Healthcare. It is an environment where the CSC can get hands-on and evaluate any and all simulators that may meet the training requirement.

(25 February 2016)

Control Number: 16-RHCO-P-556

The Small Business Administration’s Dynamic Small Business Search as well as the Defense Logistics Agency’s Product Data Bank were also searched for similar systems in the market place.

A Sources Sought was posted on 15AUG2016 closing on 19AUG2016. No responses were received as a result of this notice.

9. Interested Sources: Aside from the suggested source, no other vendors have expressed interest in this action. The notice required by FAR 5.201 will be published and bids or proposals received shall be considered.

10. Other Facts:

a. Procurement history.

(1) This product has not been purchased previously by the Army.

(2) N/A

(3) N/A

(4) N/A

(5) N/A

(6) N/A

(7) N/A

b. Other facts.

(1) The whole intent of this acquisition is to obtain several simulators to test their ability to provide the most realistic training simulations to better prepare and train Army doctors.

(2) The requested simulator will be used to support the multi-center study: Validation of a Cesarean Section Simulator to Improve Surgical Skills during Deployment and at the MTF. This simulator and study will be performed at Madigan Army Medical Center (MAMC), Ft. Belvoir Community Hospital (FBCH), and Walter Reed National Military Medical Center (WRNMMC).

(25 February 2016)

Control Number: 16-RHCO-P-556

MARTINEZ.MICHELLE.L.1239588863

Digitally signed by MARTINEZ.MICHELLE.L.1239588863 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=MARTINEZ.MICHELLE.L.1239588863 Date:2016.09.1606:57:38‐07'00'

Digitally signed by MARTINEZ.MICHELLE.L.1239588863

MARTINEZ.MICHELLE.L.1239588863 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=MARTINEZ.MICHELLE.L.1239588863 Date: 2016.09.16 06:58:21 ‐07'00'

(3) If the requested simulator is validated during this study, this type of training may decrease risks to actual patients by providing better initial training for military residents, better preparing physicians to manage hemorrhage complications during the procedure, and allow training of general surgeons prior to deployment to competency.

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.

Signature:

Typed Name: Michelle Martinez Title: Simulation Program Manager

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.

Signature:

Typed Name: Michelle Martinez Title: Simulation Program Manager

(25 February 2016)

Control Number: 16-RHCO-P-556

Signature:.1284448126

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. Based on the Independent Cost Estimate provided by the requiring activity and historical contract pricing available for the same or similar requirements, the anticipated cost to the Government will be fair and reasonable.

Certified Cost or Pricing Data will not be required in accordance with FAR 15.403- 1(b)(3).As part of the basis, indicate that certified cost or pricing data is not required per FAR 15.403-1(b)(3).

YORK.BRANDON.MICHAEL.1

Digitally signed by YORK.BRANDON.MICHAEL.1284448126 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=YORK.BRANDON.MICHAEL.1284448126

Signature: 284448126 Date: 2016.09.19 11:06:35 ‐07'00'

Typed Name: Brandon York Title: Contracting Officer

14. Contracting Officer Certification:

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

Digitally signed by YORK.BRANDON.MICHAEL.1284448126 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=YORK.BRANDON.MICHAEL.1284448126 Date: 2016.09.19 11:06:58 ‐07'00'

Typed Name: Brandon York Title: Contracting Officer

YORK.BRANDON.MICHAEL