Combine Solicitation – 65– Thermal Indometrial Ablation Device Novasure (Brand Name or Equal)

Notice Type: Combine Solicitation

Posted Date: 01-APR-14

Office Address: Department of Veterans Affairs;Network Contracting Office 22;4811 Airport Plaza Drive;Suite 600;Long Beach CA 90815

Subject: 65-- Thermal Indometrial Ablation Device Novasure (Brand Name or Equal)

Classification Code: 65 - Medical, dental & veterinary equipment & supplies

Solicitation Number: VA26214Q0590

Contact: Omar MajetteContract Specialist 562-766-2249 mailto:[email protected]

Setaside: N/AN/A

Place of Performance (address): VA SAN DIEGO Healthcare System3350 La Jolla Village Dr.;San Diego

Place of Performance (zipcode): 921161

Place of Performance Country: United States

Description: Department of Veterans Affairs

Long Beach VANLO

Department of Veterans Affairs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. The solicitation number is VA262-14-Q-0590 and is issued as an (RFQ) Request For Quotation, unless otherwise indicated herein. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-69. The associated North American Industrial Classification System (NAICS) code for this procurement is 423450 (MEDICAL, DENTAL, AND HOSPITAL EQUIPMENT AND SUPPLIES MERCHANT WHOLESALERS). This requirement is solicited as UNRESTRICTED ACQUISITION (OPEN TO ALL BUSINESS SIZE CLASSIFICATIONS). THE DUE DATE FOR QUOTES IS 04, APRIL, 2014 AT 4:00PM EST

Responses to this notice shall be e-mailed, mailed or faxed to the attention of Omar Majette, Department of Veterans Affairs, VISN 22 Network Contracting Activity, 4811 Airport Plaza, Long Beach, CA 90815. Fax number is (562) 766-2356. E-mail address: [email protected]. Telephone responses will not be accepted. Responses must be received in writing no later than 4:00pm PST, 04/04/2014.

The VHA NCO 22 - San Diego, CA requires the following items (BRAND NAME OR EQUAL):

Item # Description/Part Number* Qty Price Extended Amount

0001 Novasure Endometrial Ablation Device (NS2007US) 1

(Brand Name or Equal)

SUBTOTAL (Products)

This solicitation requires registration with the System for Award Management (SAM) prior to award, pursuant to applicable regulations and guidelines. Registration information can be found at www.sam.gov.

The selected Offeror must comply with the following commercial item terms and conditions, which are incorporated herein by reference: FAR 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition; FAR 52.212-3, Offeror Representations and Certifications - Commercial Items - the selected offeror must submit a completed copy of the listed representations and certifications; FAR 52.212-4, Contract Terms and Conditions - Commercial Items; FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, paragraph (a) and the following clauses in paragraph (b): 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.225-13, 52.232-34. The full text of the referenced FAR clauses may be accessed electronically at https://www.acquisition.gov/far/.

C.1 52.211-6 -- Brand Name or Equal

As prescribed in 11.107(a), insert the following provision:

Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

(b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must-

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by-

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

(c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

Please see the Salient Characteristics in the information below:

Specifications

The NovaSure disposable device does not contain latex.

NovaSure disposable device

1. The NovaSure disposable device is a Class III device by FDA

regulation.

2. The NovaSure disposable device is a Class IIB device according to

the MDD 93/42/EEC.

3. The NovaSure disposable device tip nominal diameter: 7.5 mm.

4. The NovaSure disposable device overall dimensions:

19" x 6" x 12" (48.3 cm x 15.2 cm x 5 cm).

5. The NovaSure disposable device has a voltage rating of 153 V.

NovaSure RF controller

1. The NovaSure RF controller is a Class I, defibrillator-proof Type bf

instrument, according to iec 60601-1.

2. The NovaSure RF controller is a Class III device by FDA regulation.

3. The NovaSure RF controller is a Class IIb device according to the

mdd 93/42/eec .

4. The RF controller has been tested and found to comply with the

limits for medical devices according to iec 60601-1-2. These limits

are designed to provide reasonable protection against harmful

interference in a typical medical installation. This equipment

generates, uses and can radiate radio frequency energy and, if not

installed and used in accordance with the instructions, may cause

harmful interference to other devices in the vicinity. However, there

is no guarantee that interference will not occur in a particular

installation. If this equipment does cause harmful interference to

other devices, which can be determined by turning the equipment off

and on, the user is encouraged to try to correct the interference by

one or more of the following measures:

o Re-orient or relocate the receiving device

o Increase the separation between equipment

o Connect the equipment into an outlet on a circuit different from that

to which the other device(s) is/are connected.

5. The controller meets the requirements of iec 60601-1/ul 60601-1,

iec 60601-2-2 and csa c22.2 no.601.1.

6. Shipment of the controller should be done only in the original Hologic

packaging. Environmental requirements for use, shipping and

storage are indicated below.

7. The absolute maximum peak voltage generated by the

NovaSure RF controller is 153 volts. Accessories used with the RF

controller should have a voltage rating equal to or greater than

153 volts.

8. The absolute maximum peak power generated by the

NovaSure RF controller is 216 watts.

9. NovaSure RF controller weight: 24 lbs (11 kg), unpacked.

10. Height: 12.5"; Width: 7.5"; De Depth: 14.5"

(32 cm x 19 cm x 35.5 cm).

11. The maximum pressure of CO2 delivered from the NovaSure

RF controller and disposable device shall be 90 '' 10 mmhg.

The maximum flow rate of CO2 from the NovaSure RF controller

connected to the disposable device shall be 95 '' 15 ml/min. (The

maximum flow rate of CO2 from the NovaSure RF controller without a

NovaSure disposable device attached is 117 '' 13 ml/ min.)

12. The Novasure RF Generator should be used without a neutral

electrode.

The following VAAR clauses are also applicable to this acquisition:

VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008)

The bidder or offeror agrees that if a contract is awarded to him/her, as a result of this solicitation, he/she will not advertise the award of the contract in his/her commercial advertising in such a manner as to state or imply that the Department of Veterans Affairs endorses a product, project or commercial line of endeavor.

(End of Clause)

852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012)

(a) Definitions. As used in this clause-

(1) Contract financing payment has the meaning given in FAR 32.001.

(2) Designated agency office has the meaning given in 5 CFR 1315.2(m).

(3) Electronic form means an automated system transmitting information electronically according to the

Accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests.

(4) Invoice payment has the meaning given in FAR 32.001.

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA's Electronic Invoice Presentment and Payment System. (See Web site at http://www.fsc.va.gov/einvoice.asp.)

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org) includes additional information on EDI 810 and 811 formats.

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances below, the contracting officer directs that payment requests be made by mail, the contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for:

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(C$END-OF-CLAUSE)

VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

The contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. He/she shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employees fault or negligence, and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of California. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, shall not be the responsibility of the contractor hereunder with the regard to any claims, loss, damage, injury, and liability resulting there from.

(End of Clause)

VAAR 852.246-70 GUARANTEE (JAN 2008)

The contractor guarantees the equipment against defective material, workmanship and performance for a period of, said guarantee to run from date of acceptance of the equipment by the Government. The contractor agrees to furnish, without cost to the Government, replacement of all parts and material that are found to be defective during the guarantee period. Replacement of material and parts will be furnished to the Government at the point of installation, if installation is within the continental United States or f.o.b. the continental U.S. port to be designated by the contracting officer if installation is outside of the continental United States. Cost of installation of replacement material and parts shall be borne by the contractor.

THE ACH VENDOR FORM (attached) shall be filled out upon contract award if vendor is not currently enrolled into the Veteran Administration Electronic Invoicing System:

Link/URL: https://www.fbo.gov/spg/VA/LBVANBC/VAMD/VA26214Q0590/listing.html