Title: Medtronic Situate Detection System X l Actionable Package 11/21/2017 l Current Phase: 1 Requirement l Proposed Posting: 12/20/2017 l Proposed Award: 1/15/2018 l Comments:11/28-Sources sought on FBO.

Attachment 2: Combined Synopsis/Solicitation for Commercial Items

VHAPM Part 813.106-1/2 SAP: Soliciting Competition & Evaluation of Quotations/Offers Page 4 of 5

Original Date: 10/12/17

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS



General Information

Document Type:

Combined Solicitation/Synopsis

Solicitation Number:

36C24218Q0112

Posted Date:

12/11/2017

Original Response Date:

12/14/2017

Current Response Date:

12/14/2017

Product or Service Code:

6515

Set Aside (SDVOSB/VOSB):

SDVOSB

NAICS Code:

339112

Contracting Office Address

Department of Veterans Affairs

James J. Peters VAMC

130 West Kingsbridge Road

Bronx, NY 10468

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; Quotes are being requested, and a written solicitation document will not be issued.



This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular.



The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 with a small business size standard of 1000 Employees.



The New York Harbor Healthcare System Brooklyn and Manhattan Campuses are seeking to purchase a Situate Detection System.



All interested companies shall provide quotations for the following:











Supplies



Line Item

Description

Quantity

Unit Price

Total Price

1

Item number 01-0047 Medtronic Situate Detection System X(console, Body, Room Scanner)

10





2

Service Manuals

2







Equipment Statement of Work (SOW)

Medtronic Situate Detection System X 630-18-1-3086-0005



1. Background



The New York Harbor Healthcare System has a need for brand name or equal Situate Detection System X (Console X, Body, Room Scanner). The system detects and monitors sponges, using RF, during surgical procedures, this reduces the risk of sponges being left in patients after surgery. Manual counting has been proven to be only 77% accurate. Miscounts occur 1 in 64 procedures. Our Facility currently does not use adjunct technology to support manual counting. NYHHS is seeking to purchase 10 situate detection systems, 7 for the Manhattan Campus operating rooms and 3 for the Brooklyn Campus operating rooms. Patients who need surgery require this procurement to maximize patient safety. Situate Detection System is a technology developed to overcome the difficulty of finding surgical sponges in-vivo and in the surrounding operating room environment. It employs detection devices to transmit reliable, non-ionizing, low frequency radio waves to detect tagged cotton disposables. When the tagged cotton is stimulated by the device s signal, it transmits its own signal back to the detector, identifying its presence. It s the reliable communication between the detector and the tag that enables the quick and effective resolution of missing sponges.





Specifications/salient characteristics:



Must use RF to detect sponges

Ability to detect sponges from at least 15 inches away in vivo

Must detect sponges in vivo

Must detect sponges in areas of the OR outside of the sterile field

Filters electrical noise found in Operating Rooms

Transmits non-ionizing, low frequency radio waves

This system does not require installation. Company will provide training before and during first day of use.





Brand Name Item: Medtronic Situate Detection System X (Console X, Body, Room Scanner)



Complete generic identification RF Surgical Detection system



Applicable model/make/catalog number Item # 01-0047



Manufacturer name Medtronic. Covidien Sales LLC, a Medtronic Company



Technology has 3 unique features that make it a sponge detection solution for the OR:

Low energy radio frequency: Maintains its signal strength through dense tissue, blood, and bone as well as near metal making it a solution for in vivo detection

Environmental compatibility: Filters electrical noise in ORs and meets IEC medical electrical equipment general requirements for basic safety for electromagnetic compatibility.

Extended reach: Allows for detection outside the patient and across the OR with complementary scanning components



2. Objectives

This equipment is essential for the Surgical program at the New York Harbor Healthcare System. This equipment is needed for immediate patient care.



3. Period of Performance

Time of delivery: Due to patient safety issues, delivery is needed ASAP, no later than 30 days after receipt of order. This is a onetime purchase.



4. Place of Performance / Place of Delivery

This equipment is to be delivered to New York and Brooklyn Campus of the New York Harbor Healthcare System.



Manhattan Campus: 7 RF Surgical Detection system

Attn: NY Harbor Manhattan Campus Warehouse/Surgical Service

423 East 23rd Street

New York, NY 10010



Brooklyn Campus: 3 RF Surgical Detection system

Attn: NY Harbor Brooklyn Campus Warehouse/Surgical Service

800 Poly Place

Brooklyn, NY 11209



5. Scope or Tasks

Delivery should be ASAP, NLT 30 days and all parts are to be operational.



6. Security

This equipment does not store patient information.

This equipment does require bio medical processing once it is received.



9. Warranty/Maintenance

Equipment will be free from defects in material and workmanship under normal use and operation for a period of one year.



Delivery shall be provided as soon as possible or no later than 30 days after receipt of order/award of contract. FOB origin or destination. The contractor shall deliver line item(s) 1-2 to Brooklyn VA and Manhattan VA.



Place of Performance

Address:

Manhattan Campus

423 East 23rd Street

New York, NY 10010



Brooklyn Campus

800 Poly Place

Brooklyn, NY 11209

Country:

UNITED STATES



Award shall be made to the offeror whose quotation offers The Lowest Price Technically Acceptable. The government will evaluate information based on the following evaluation criteria: Lowest Price Technically Acceptable.







The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.



The following solicitation provisions apply to this acquisition:

FAR 52.212-1, Instructions to Offerors Commercial Items [JAN 2017]

FAR 52.212-3, Offerors Representations and Certifications Commercial Items [JAN 2017]



Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required.



The following contract clauses apply to this acquisition:

FAR 52.212-4, Contract Terms and Conditions Commercial Items [JAN 2017]

End of addendum to FAR 52.212-4

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders [JAN 2017]

VAAR 852.211-70, Service Data Manuals(technical/medical equipment only)

VAAR 852.246-70, Guarantee (Equipment Only)



The following subparagraphs of FAR 52.212-5 are applicable: 52.203-19, 52.209-10, 52.225-1, 52.203-13, 52.219-8, 52.222-35, 52.232-33, 52.225-13, 52.222-50, 52.222-36, 52.222-21, 52.222-19, 52.222-3, 52.219-27.





All quoters shall submit the following: Certificate of Competency, Quote with DUNS number, Solicitation number, phone number, and fax number, point of contact, VIP certification and proposed delivery date for equipment.



All quotations shall be sent to Tina.Cavalieri@va.gov.



(a) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical equipment only for VA Medical Centers.  No remanufactures or gray market items will be acceptable.





This is an open-market combined synopsis/solicitation for Situate Detection System as defined herein.  The government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoter shall list exception(s) and rationale for the exception(s).



Submission shall be received not later than Thursday, December 14, 2017 @8AM at email address listed above. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). E-mailed quotes will be accepted.



Point of Contact

Tina Cavalieri

Fax: 914-788-4878

Email Address: Tina.Cavalieri@va.gov