-13727.pdf

Chapter VI: Other Than Full and Open Competition (OFOC) SOP Attachment 4: Single Source Justification for SAP under $150K

OFOC SOP Revision 05 Page 1 of 3 Original Date: 03/22/11 Revision 05 Date: 05/02/2016

JUSTIFICATION FOR SINGLE SOURCE AWARDS IAW FAR 13.106-1

(OVER MICRO-PURCHASE THRESHOLD($3.5K) BUT NOT EXCEEDING THE SAT ($150K))

IAW FAR13.104, COs must promote competition to the maximum extent practicable to obtain supplies and services from the source whose offer is the most advantageous to the Government, considering the administrative cost of the purchase. When competition is not practicable, IAW FAR13.106-1(b), COs solicit from a single source for purchases not exceeding the simplified acquisition threshold. COs may solicit from one source if the CO determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). IAW FAR13.106-3(b)(3),COs are required to include additional statements explaining the absence of competition (see 13.106-1 for brand name purchases) if only one source is solicited and the acquisition does not exceed the simplified acquisition threshold (does not apply to an acquisition of utility services available from only one source) or supporting the award decision if other than price-related factors were considered in selecting the supplier. This template when completed can be used to document single source awards IAW FAR13.106-3(b)(3). Note: Statements such as "only known source" or "only source which can meet the required delivery date" are inadequate to support a sole source purchase.

1. ACQUISITION PLAN ACTION ID:

VA263-17-AP-11456

1A. PROJECT/TASK

No. DAT EQ043

1B. ESTIMATED AMOUNT:

$101,859.39

2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE:

This is for a Brand Name Justification in accordance with FAR 13.106-1(b)(1) where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification.

This acquisition is for a TruSystem 7000dv operating table with dV SmartCare and advanced robotics positioning package. This operating table works in conjunction with the daVinci Surgical System which is in equipment inventory.

3. UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO

OTHER SUPPLIES OR SERVICES CAN BE USED:

3.1. The Hill-Rom 7000dv surgical table is the only table available that has been specifically designed to connect to the FDA-approved Intuitive Surgical daVinci robot and is the only table Intuitive has built a proprietary interface for (see Hill-Rom/Trumpf Medical market research section below and reference Attachment – Intuitive Surgical Sole Source Letter). The interface allows automatic/easier patient positioning that works in conjunction with the robot’s arm to allow for less invasive patient cavity entrance reducing trauma and decreasing patient recovery time. The Hill-Rom TruSystem 7000dV OR table allows movement of the patient while the robot is docked (in patient). When the patient is in extreme trendelenberg position (extreme head down) the blood pressure can change because of the pressure on the diaphragm. The table can be adjusted without removing laparoscopic instrumentation attached to the robot. On a regular operating room (OR) table all instrumentation must be removed and the robot detached. The bed is adjusted and then the instrumentation must be reinserted and the robot arms reattached.

This is time consuming adding to the surgical length of the anesthesia time. There can be unexpected bleeding which cannot be observed when the position is changed. The air pressure must be reestablished and takes up more operative time.

https://www.acquisition.gov/?q=/browse/far/13 https://www.acquisition.gov/?q=/browse/far/13 https://www.acquisition.gov/?q=/browse/far/13

OFOC SOP Revision 05 Page 2 of 3 Original Date: 03/22/11 Revision 05 Date: 05/02/2016

4. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND RESULTS OR STATEMENT WHY IT WAS NOT

CONDUCTED:

Internet searches were performed to find out if there were other sources available for daVinci integrated tables.

In addition, Intuitive Surgical was contacted and their sales team stated that they have not approved any other integrated table for use with their robot. The TruSystem 7000dv is a medical device and falls under FDA rules as the only approved table programmed to work with the daVinci Surgical System.

Further, the following additional market research was conducted:

Medical Surgical Prime Vendor (MSPV) Contracts: A search was conducted on the National Acquisition Center’s MedSurg Catalog search located at http://www.va.gov/nac/MedSurg/List for a list of nationally awarded contractors and/or prime vendor contracts. A search using “trusystem”, “trumpf”, and “intuitive medical” were each separately conducted and provided no results. A search for “Hill-Rom” and “surgical” was also conducted. The results were for surgical stretchers. This requirement is not on the MSPV contract.

GSA eLibrary: https://www.gsaelibrary.gsa.gov/ElibMain/home.do. On April 3, 2018, searches were conducted using the following keywords “trumpf”, "trusystem”, and “intuitive medical” producing no results. A search using “Hill-Rom” produced contract V797P-4434B for the schedule 65 II A, however this contract is limited to A-69 (beds and mattresses), A-74 (flotation pads/mattresses) and A-77 (transportation units). Another search using keywords “surgical table” produced results for schedule 65 II A Category A-87 (Instruments Stands/Tables (Surgical)).

Applying SDVOSB and VOSB filters and verifying this provided nine (9) results. From these results, all vendors were contacted via email (Attachment GSA Email). Zero (0) vendors responded as being able to meet the specifications of the requirement.

GSAXcess: https://gsaxcess.gov/. A search using any words “trusystem”, “trumpf”, “intuitive” and “Hill-Rom” produced zero results for this equipment. This is not an appropriate source at this time. (Attachment – GSAxcess).

ECAT: https://www.medical.dla.mil/WAM/Home/consent/. A search using “Hill-Rom”, Hill-Rom’s part number “112011” and “trusystem” produced no results. This is not an appropriate source at this time. (Attachment –

ECAT).

Solutions for Enterprise-Wise Procurement (SEWP): https://www.sewp.nasa.gov//. A search was conducted for “trumpf” and “intuitive” as a provider. The search produced zero (0) results. A search using “Hill-Rom” produced one verified SDVOSB result (4 Points Technology). However, after reviewing their contract, NNG15SD22B, SEWP is not an appropriate source for this requirement at this time. The contract above is for computer related services.

The conclusion of this search effort is that SEWP does not have the provider and is not a source for acquiring the TruSystem 7000dv with dV SmartCare and advanced robotics positioning package at this time. (Attachment –

SEWP).

SDVOSB/VOSB Sources via VetBiz (VIP): In Accordance with VAAR Subpart 819.7004, 819.7005, 819.7006 -https://www.vip.vetbiz.gov/. A search on Vetbiz.gov was conducted in an attempt to locate Service-Disabled- Veteran-Owned-Small-Business (SDVOSB) and Veteran-Owned-Small Business (VOSB) concerns utilizing NAICS code 339112 (this search provided 226 SDVOSB and 159 VOSB results). From these results, all vendors were contacted via email (Attachments SDVOSB Email and VOSB Email). One (1) SDVOSB vendor responded stating they were capable and provided a letter of authorization as a reseller for Hill-Rom (Attachment – Janz LOA). This information was conflicting with the letter from Hill-Rom (see Hill-Rom/Trumpf Medical section below). Hill-Rom was contacted again to clarify this inconsistency (Attachment – Hill-Rom Authorized Distributors). This SDVOSB vendor followed up and stated they are not authorized for the TruSystem 7000dv and to disregard their previous email (Attachment http://www.va.gov/nac/MedSurg/List https://www.gsaelibrary.gsa.gov/ElibMain/home.do https://gsaxcess.gov/ https://www.medical.dla.mil/WAM/Home/consent/ https://www.gsaelibrary.gsa.gov/ElibMain/home.do https://www.vip.vetbiz.gov/

OFOC SOP Revision 05 Page 3 of 3 Original Date: 03/22/11 Revision 05 Date: 05/02/2016

– Janz - Disregard). This SDVOSB is not a viable source to provide this product. 0 other vendors responded as being able to meet the specifications of the requirement. Zero (0) other vendors responded as being able to meet the specifications of the requirement.

Small Business Administration (SBA) – Dynamic Small Business Search (DSBS):

http://dsbs.sba.gov/dsbs/search/dsp_dsbs.cfm. SBA DSBS market research was conducted utilizing NAICS code 339112 and the keyword “TruSystem” and produced zero (0) results. Another search using NAICS code 339112 and the keyword “surgical table” produced one (1) result; “Hill-Rom” and produced three (3) results; “trumpf” and produced one (1) result (duplicate of Hill-Rom search); “intuitive” and produced one (1) result, but this was for plastic surgery and not appropriate for this requirement. These vendors were contacted via email (Attachment SBA Email). Zero (0) vendors responded as being able to meet the specifications of the requirement.

FBO Intent to Sole Source Notice: A Notice of Intent to Sole Source 36E77618Q9039 was published to Federal Business Opportunities (FBO) on April 4, 2018 (Attachment – S03 - FBO - 36E77618Q9039). Zero (0) vendors responded as being able to meet the specifications of the requirement.

Hill-Rom/Trumpf Medical: Hill-Rom medical was contacted via email. The vendor confirmed the TruSystem 7000dv is a sole proprietary product to Hill-Rom, Inc and the product is a registered trademark exclusive to Hill-Rom (Attachment – Hill-Rom TruSystem 7000dv), Inc. Further, Hill-Rom, Inc. does not have authorized distributors of their product. Hill-Rom was previously doing business as Trumpf Medical (see FPDS results below and Hill-Rom Email Attachment). Intuitive Surgical is the sole source of the daVinci Surgical Systems and provided a letter (Attachment – Intuitive Surgical Sole Source Letter) stating Trumpf Medical (now Hill-Rom) is the only connective table to the da Vinci Surgical Systems.

Federal Procurement Data System: A search for “TruSystem 7000dv” produced ten (10) results. Five (5) of these results are for the Department of Veterans Affairs were for the purchase of the TruSystem 7000dv package [one (1) for $94,222.68, two (2) for $100,534.00 (one (1) ea TruSystem 7000dv with dV SmartCare and advanced robotics positioning package), one (1) for $88,520.00, one (1) for $92,111.20]. One (1) result for the Department of Veterans Affairs for $9,150.00 was for a change order. One (1) result was for the Department of Army for $99,398.15). One (1) result was for the Department of Air Force for $88,520.00. One (1) result was for the Defense Health Agency for $100,534.00. The vendor is recognized as Trumpf Medical Systems Inc/Hill-Rom DBA Trumpf Medical. (Attachment – FPDS - TruSystem).

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Note: COs are required to make a determination of price reasonableness IAW FAR 13.106-3. See the Commercial Supply and Service SOP for Price Reasonableness templates.

Signature: ______________________________ Date:____________________ Name: Michelle Rhodes Title: Contracting Officer NCO: Program Contracting Activity Central (PCAC)

04/27/2018 http://dsbs.sba.gov/dsbs/search/dsp_dsbs.cfm https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466 http://vaww.pclo.infoshare.va.gov/PMWeb/Vol6Chapter5.aspx