36C24419Q1116-003.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: ___36C224-19-AP-3031________________________________________

1. Contracting Activity: Department of Veterans Affairs, VISN 4, PITTSBURGH Medical Center

646-19-3-233-0267

2. Nature and/or Description of the Action Being Processed:

Request for other than full and open competition - use of brand name only specification for the acquisition of Karl Storz 4k Video Equipment to integrate and update all of the Storz video equipment that currently lives in the Operating room. Total cost of brand name only Karlz Storz video equipment is $2,004,700.17.

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

It is in the best interest of the Government to procure the Karl Storz equipment via brand name only procurement.

A total replacement of this equipment will cost over $3.5M. This does not cover the cost for the retraining of personnel, service interruptions, down time to equipment / software that connects to this systems, maintenance costs, and overall operational expenses.

This upgrade would include the integration that currently lives in OR 1,5,12 and upgrade to all the Video equipment used in those OR’s as well as the 7 Mobile video Carts. The upgrade will also consist of trading in older equipment.

This equipment is used for Minimally Invasive surgery that is wide stream between General Surgery, ENT, Thoracic Surgery, Plastics, Orthopedics. Over 50% of procedures done in the OR is minimally invasive which requires the most up to date equipment with the best image, so the surgeons can perform the surgery to the best of their ability. Minimally invasive is the preferred way to go for the patient allowing for reduction in tissue trauma, less post-op pain, faster recovery, and better cosmetic rate.

The VA personnel are familiar with the touch panel control to allows video, audio and control of devices in the OR. These are the same features, but upgraded, that are installed in Current ORs, Cath and EP labs at the VA Pittsburgh.The user interface KARL STORZ uses is consistent across all the ORs and EP /Cath labs, and other devices, such as the AIDA image capture solution. Identical user interface for the ORs allows for easy transition to the latest integration solution and virtually no training to go live with new ORs. As well as a familiar control system, our latest NEO IP provides diagnostic details for improved access by Bio-Med or first responder support.

The Karl Storz integration allows for improved serviceability and diagnostics to the integration solution. The NEO IP solution provides diagnostics for any connected device. IP, MAC address, device temperature and connection status are all displayed via the internal service report for the NEO IP.

Additionally, new system health check and diagnostics will be available with the NEO IP using the existing Stream-Connect application allowing increased service diagnosis and efficiencies through the existing deployed Stream-Connect application. All upgrades will only require a software update to allow for these features (Included in the Karl Storz System Warranty).

Storz video equipment for upgrade would consist of 4k compatible:

Video monitors 32” boom mounted and mobile carts Processors boom mounted and mobile carts Light sources boom mounted and mobile carts Printers boom mounted and mobile carts HD Camera heads Mobile carts All cabling accessories and licenses Ceiling wall mounted camera with pan, tilt and zoom

Integration:

4k integration solution 48-72 Inputs (NEO IP) 4 in 1 video aux plates PC connections Ceiling wall mounted camera integration Quad/pip Audio Control Boom upgrade and integration to hold the larger 32” display monitors Stream Connect

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;

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 acquisition is authorized pursuant to FAR 6.302-1(c), only one responsible source and no other supples or services will satisfy agency requirements. The VA Pittsburgh Currently runs off of Karl Storz’s Video equipment and integration system. This is an upgrade to some of the equipment and integration to a 4k System. No other system would be compatible with the existing video equipment. Purchasing through another company would require a complete Equipment and Integration replacement which would cost the VA a minimum of $3.5M. This cost does not include retraining of personnel, service interruptions, down time to equipment / software that connects to this systems, maintenance costs, and overall operational expenses. The Karl Storz integration allows for improved serviceability and diagnostics to the integration solution. Damage which might arise or be caused, whether by the Customer or by any of the users of the products provided by KARL STORZ, as a result of, in connection with, or otherwise attributable to the following items is excluded from coverage: (a) misuse, abuse, mishandling and/or improper operation and/or storage, (b) repairs, servicing, modifications and/or alterations performed by any person or entity, other than KARL STORZ or an authorized repair facility of KARL STORZ, (c) use in combination with adaptors, accessories and/or equipment from other manufacturers unless authorized or recommended by KARL STORZ. These quoted items in the Market Research and the items currently installed at Pittsburgh VAMC are proprietary in their ability to communicate with one another and there are no other manufactures that provide equipment that can achieve the same level of connectivity and communication. Karl Storz is the sole service provider of these items and our warranties are voided when worked on by non approved third party vendors.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This is a brand name only procurement, due to compatibility of existing equipment. No other manufacture would be sufficient or compatiable with current equipment. A notice of intent to procure brand name only Storz equipment or compatible with Storz equipment was posted on GSA for all small business. This action resulted in “no bids” from SBs, supporting the decision to procure this equipment as a Open Market. This brand name only requirement will also be posted on FBO with the solicitation. Offerors will be able to obtain the Storz equipment from the manufacturer or other distributors and sources available on the open market. There are two authorized vendors that sell Storz equipment as authorized vendors. They are American Medical Depot (SB) and L1 Enterprises (SDVOSB). Neither one replied with interest to the published RFI.

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

Reasonable: This item is brand name only and will be a full and open procurement. Offerors will be able to obtain the Storz equipment from qualified vendors. Competition is anticipated when competing on the open market, which will better enable a fair and reasonable price. Market Research states Storz will give Government credits for equipment upgraded in this procurement.

The quote involves the trade-in of the item(s) listed below and a discount is being applied to the quote in consideration of the trade-in item(s) being returned. If the trade-in item(s) are not returned within 60 days after order ships, the discount will be reversed and Karl Storz will invoice for the full value of the product(s). The following item(s) should be returned to complete the transaction and to avoid additional billing. Line Product Quoted Qty | Product to be returned Qty 7 P-UI500-UP501S1- TR 10 | KARL STORZ Trade 10, 9 P-TH120-TRADE 15 | KARL STORZ Trade 15.

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 by placing an RFI on GSA with the intent to purchase Storz equipment. The RFI stated Brand Name or Equal but shall be compatible with Storz equipment. The RFI was published for just over a week to to inquire if there was any interest. RFI closed with no interest. In reviewing the Market Research, Storz stated that they would not honor any other manufactur’s warranty and that having anyone other than Storz equipment would void any warranty currently covering existing equipment. Storz also said that the pricing reflecting in the Market Research included trade in value of many of the current equipment to the new upgraded equipment. Market Research also concluded that there are two Small Business partners that resell Storz equipment (authorized vendors). They are American Medical Depot (SB) and L1 Enterprises (SDVOSB). Neither one replied with interest to the published RFI. When soliciting for Open Market on FBO, there will be an additional effert to contact these two vendors to help ensure a minimum of 2 quotes.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: All of the descriptions associated with this project are based on the Storz equipment. Other video equipment would not be able to provide the same ease of use and compatibility as the Storz equipment allows.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: N/A

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: N/A

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and 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.

Name Date Title Facility

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name Date Contracting Specialist

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Shawn Smith Date Branch Chief

NCO4 – Commities Team 3

c. VHA SAO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

08/09/2019

Joseph P. Maletta Date VHA Head of Contracting Activity (HCA)