USAHCA_Sole_Source_Justification_under_13.501_Redacted.pdf

Control Number: 16-HRCO-0012

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: U.S. Army Medical Command (MEDCOM), Health Readiness Contracting Office (Provisional) (HRCO-P).

2. Description of Action: This approval is for a new contract award. The resultant award will be a Firm-Fixed-Price (FFP) contract. The type of funds to be used is Fiscal Year (FY) 16 Defense Health Program (DHP) Appropriation funds.

3. Description of Supplies/Services: The contractor shall provide the required supplies and services for medical training equipment to the Army Reserve (AR), (the Department of Defense (DoD)) through the Medical Readiness Training Command (MRTC). This requirement consists of the purchase and shipment of six (6) new human worn surgical simulators (HWSS) and refurbishment of three (3) previously purchased HWSSs herein referred to as Cut Suits. The purchase of the six (6) new Cut Suits shall also include training for twelve (12) end-users ( two end-users will be designated for each simulator purchased) on the proper operation and maintenance of the equipment and shall include a one (1) year minimum commercial warranty and maintenance against defects in material and workmanship subject to conditions of use.

The anticipated effective date for award is September 29, 2016. All equipment, to include the refurbished equipment, shall be shipped to several different Continental United States (CONUS) military locations. The total estimated amount is $490,182.00 ($400,950 for 6 new Cut Suits and $89,232 for refurbishment of 3 existing cut suits).

4. Authority Cited: It has been determined that only one responsible source and no other supplies or services will satisfy agency requirements and the anticipated solicitation shall be other than full and open competition in accordance with 41 United States Code 1901 as implemented in Federal Acquisition Regulation (FAR) 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: The proposed contractor is Strategic Operations, Inc. (STOPS) (DUNS number 127626724), located at 4705 Ruffin Road, San Diego, CA, 92123-1611. STOPS is a small business that offers hyper-realistic training supplies and services for end users to deploy a high degree of fidelity in the replication of battlefield conditions in a training environment that participants so willingly suspend disbelief that they become totally immersed and eventually stress inoculated. STOPS has a clear understanding of and expertise in, military tactics, techniques, and procedures and most importantly, add to this mix, all the proprietary techniques, methods, procedures, and ideals that enable the effect to be not only extremely realistic, but dynamic, interactive, and repeatable. A large number of military personnel can experience combat situations in a controlled, duplicatable, and dynamic training environment that truly reflects real world conditions. STOPS offers the only human worn surgical simulator, referred to as the Cut Suit, that provides surgical training opportunities from point of injury through roles 1-3 of care (role 1 point of injury care by the medic and/or battalion aid station; role 2 is basic primary care to include forward resuscitative damage control surgical care and role 3 is care provided in a fully equipped medical treatment facility/hospital). Similar surgical

(See FAR 2.101 and 3.104-4)

(25 February 2016)

Human Worn Surgical Simulation Cut Suits, MRTC – San Antonio, TX simulators were reviewed but only came in the form of a manikin, individual body parts of a manikin, or moulage dressings and accessories. In addition, the highly specialized medical training equipment must be compatible in all aspects (form, fit and function) with the existing systems presently owned. Three (3) previously purchased Cut Suits require refurbishment which includes all updates, compatibility with the existing systems and replacement components/equipment from the original manufacturer which presently can only be done by the manufacturer, STOPS.

6. Efforts to Obtain Competition: In accordance with FAR 5.2, both requirements were synopsized individually through the Government Point of Entry (GPE), FedBizOpps. A Request for Information (RFI) for the six (6) new human worn surgical simulators was released on August 9, 2016 with a response date of August 16, 2016. The RFI was to determine available sources for competition and/or other vendors capable of offering a human worn surgical simulator with the known specifications of the requirement. One Contractor identified as Strategic Operations, Inc. (STOPS), submitted a capability package on 16 August 2016, for a HWSS called the Surgical Cut Suit. A separate Presoliciataion Notice to solicit a single source for the refurbishment of the three (3) previously purchased Cut Suits for an estimated $89,232 was issued in accordance with FAR 13.106-1(b) to Strategic Operations, Inc. (STOPS), due to only one source being reasonably capable of providing the required refurbishment. This notice was released on August 10, 2016 with a response date of August 14, 2016; no responses were received.

Due to the lack of vendor response and market research findings for the purchase of the six (6) new human worn surgical simulators, an additional special notice was issued on the Government Point of Entry (GPE), FedBizOpps, as an Intent to Sole Source for the six (6) new human worn surgical simulators referred to as the brand name, Surgical Cut Suits, in accordance with 41 U.S.C. 1901 under the authority of FAR Subpart FAR 13.501 to Strategic Operations, Inc. (STOPS). This notice was released on August 29, 2016 with a response date of September 01, 2016; no responses were received.

a. Effective competition. Only one response was received for the purchase of the six (6) new human worn surgical Cut Suits and there were no contractors identified in the Interested Vendors list

b. Subcontracting competition. Not applicable. The manufacturer of the Cut Suit, Strategic Operations, Inc. (STOPS), has been identified as a small business in association with NAICS code 339112 -- Surgical and Medical Instrument Manufacturing, according to the FAR and DFARS Representations and Certifications Report.

7. Actions to Increase Competition: MEDCOM HRCO (P) will continue to conduct market research and will post additional Sources Sought and Requests for Information (RFIs) announcements through the GPE, FedBizOpps, to survey any future competition and programs available within this industry. This justification will also be made publicly available within 14 days after award IAW FAR 13.501(a) (iii).

8. Market Research: Market research was conducted IAW FAR 8.002, FAR 8.004 and FAR Part 10 for this procurement utilizing NAICS code 339112 -- Surgical and Medical Instrument Manufacturing, this U.S. industry comprises establishments primarily engaged in manufacturing medical, surgical, ophthalmic, and veterinary instruments and apparatus (except

(25 February 2016) electrotherapeutic, electro-medical and irradiation apparatus). Other market research tactics conducted ranged from basic internet searches, the Federal Procurement Data System (FPDS), FedBizOpps (FBO) and the SBA Dynamic Small Business Search (DSBS). In accordance with FAR 8.002(a)(1) and 8.002(a)(2) – Priorities for Use of Mandatory Sources, there are no inventories of the requiring agency, excess from other agencies, sources from the Federal Prison Industries, Inc. or supplies or services that are on the Procurement List maintained by the Committee for Purchase From People Who Are Blind or Severely Disabled. In accordance with FAR 8.004(a)(1) –Use of Other Sources, The Federal Supply Schedule (FSS)/General Services Administration (GSA), schedule 00CORP, SIN 874 9, indicated 101 contractors, of which 69 were small business concerns and further research provided only three prospective vendors that carried various medical simulators on their published price lists. After careful research of the various product offerings, it was determined that none of the surgical simulators researched on GSA Schedule 00CORP had wearable features for multi-procedural surgical training. The proposed contract actions were synopsized IAW FAR 5.2 through the GPE, FBO, and only one response was received and no contractors were identified on the Interested Vendors list. In reviewing FBO and FPDS, STOPS has sold the Cut Suit to other Government agencies to include the U.S. Department of Air Force and the U.S. Department of the Navy. An article published in the Gold Standard on March 20, 2014 by the Fort Knox Public Affairs Office, who publishes under guidelines found in AR 360-1, discussed training exercises that incorporated the STOPS Cut Suit and the valuable knowledge and benefits obtained from being able to role play trauma related injuries in casualty drawn scenarios in incorporating the human worn surgical simulators into these critical exercises.

9. Interested Sources: As previously mentioned only one response was received and no contractors were identified in the Interested Vendors list. To date, only one source has expressed interest in supplying the required services for this multi-site requirement, which was Strategic Operations, Inc. (STOPS).

10. Other Facts: Other facts supporting the use of other than full and open competition, such as the following:

a. Procurement history. Reasonable efforts to retrieve the following items from computer records, contract files, competition advocate office files or other sources are expected:

(1) Contract numbers and dates of the last several contracts for these same requirements. STOPS was identified as the awarded contractor on competitive contract award W9124D-13-F-0169 for the amount of $190,451.25. This requirement was administered by the U.S. Army Fort Knox Contracting Office.

(2) The competitive status of these actions. The Paperless Contract File (PCF) documents were inaccessible; however, the Contract Action Report (CAR) processed through the Federal Procurement Data System (FPDS) indicated that the action on this award was solicited as Full and Open Competition, but only one (1) offer was received.

(3) Authority previously cited if less than full and open competition was used. Not Applicable.

(25 February 2016)

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. Not Applicable.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. The Paperless Contract File (PCF) documents were inaccessible; however, the Contract Action Report (CAR) processed through the Federal Procurement Data System (FPDS) indicated that the actions on this award were was solicited as Full and Open Competition, but only one (1) offer was received. Related details of circumstances are not available.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. Not applicable.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. Not Applicable.

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated. There are no other facts to be considered at this time.

(25 February 2016)

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:

Date:

Typed Name: Title: Chief, Clinical Operations

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.

20160901 Signature: Date:

Typed Name: Title: Chief, Clinical Operations

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 in accordance with (IAW) FAR 15.404-1(b)(2) price analysis techniques.As part of the basis, certified cost or pricing data is not required per FAR 15.403-1(b)(3).

20160906 Signature: Date:

Typed Name: Title: ContractingOfficer

20160901

(25 February 2016)

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Date: 20160908

Typed Name: Title: Contracting Officer: