Combine Solicitation – 65– Endoscope Forceps

MTR 5 Offers either an oval or round cup Physical Inspection/Literature Review

MTR 6 Must offer jaws with and without spike/needle options Physical Inspection/Literature Review

MTR 7 Must be sterile single-use cold forceps Physical Inspection/Literature Review

MTR 8 Forceps with coating or sheathing must be latex free Physical Inspection/Literature Review

MTR 9 Surgical grade steel cup, jaw, and hinge construction Physical Inspection/Literature Review

MTR 10 Packaging states that the device is sterile Physical Inspection

MTR 11 Packaging states that the device is single use Physical Inspection

MTR 12 Packaging states expiration date Physical Inspection

MTR 13 Packaging states the lot number Physical Inspection

MTR 14 Must be FDA approved Literature Review

Intended Use: Devices used to collect tissue endoscopically primarily from the rectum and colon.

ENDOSCOPIC FORCEPS

TECHNICAL SPECIFICATIONS: METHOD OF EVALUATION:

Item: GI GASTROSCOPY BIOPSY SAMPLES REQUIRED

MTR 1 Minimum working length 150 cm Physical Inspection/Literature Review

MTR 2 Maximum outside dimension (jaw O.D.) 1.8 mm (for use with pediatric gastroscopes with minimum channel size of 2.0 mm) Physical Inspection/Literature Review

MTR 3 Maximum outside dimension (jaw O.D.) 2.4 mm (for use with gastroscopes with minimum channel size of 2.8 mm) Physical Inspection/Literature Review

MTR 4 Maximum outside dimension (jaw O.D) 3.3 mm (used for therapeutic gastroscopes with large channel size of 3.8 mm minimum) Physical Inspection/Literature Review

MTR 5 Must offer both smooth(e.g., non-serrated jaws) and serrated jaw options on the forcep cup Physical Inspection/Literature Review

MTR 6 Offers either an oval or round cup Physical Inspection/Literature Review

MTR 7 Must offer jaws with and without spike/needle options Physical Inspection/Literature Review

MTR 8 Are sterile single-use cold forceps Physical Inspection / Literature Review

MTR 9 Forceps with coating or sheathing must be latex free Physical Inspection/Literature Review

MTR 10 Surgical grade steel cup, jaw, and hinge construction. Physical Inspection/Literature Review

MTR 11 Packaging states that the device is sterile Physical Inspection

MTR 12 Packaging states that the device is single use Physical Inspection

MTR 13 Packaging states expiration date Physical Inspection

MTR 14 Packaging states the lot number Physical Inspection

MTR 15 Must be FDA approved Literature Review

Intended Use: Devices used to collect tissue endoscopically primarily from the stomach, duodenum, and esophagus.

ENDOSCOPIC FORCEPS

TECHNICAL SPECIFICATIONS: METHOD OF EVALUATION:

Item: PULMONARY BIOPSY

SAMPLES REQUIRED

MTR 1 Minimum working length of 100 cm Physical Inspection/Literature Review

MTR 2 Maximum outside dimension (jaw O.D.) 1.8 mm (for typical biopsy forcep for bronchoscope with minimal channel size of 2.0 mm) Physical Inspection/Literature Review

MTR 3 Maximum outside dimension (jaw O.D.) 2.2 mm (used for therapeutic bronchoscopy scopes with minimal channel size of 2.8 mm) Physical Inspection/Literature Review

MTR 4 Must offer both smooth(e.g., non-serrated jaws) and serrated jaw options on the forcep cup Physical Inspection/Literature Review

MTR 5 Offers either an oval or round cup Physical Inspection/Literature Review

MTR 6 Must offer jaws with and without spike/needle options Physical Inspection/Literature Review

MTR 7 Are sterile single-use cold forceps Physical Inspection / Literature Review

MTR 8 Forceps with coating or sheathing must be latex free Physical Inspection/Literature Review

MTR 9 Surgical grade steel cup, jaw, and hinge construction. Physical Inspection/Literature Review

MTR 10 Packaging states that the device is sterile Physical Inspection

MTR 11 Packaging states that the device is single use Physical Inspection

MTR 12 Packaging states expiration date Physical Inspection

MTR 13 Packaging states the lot number Physical Inspection

MTR 14 Must be FDA approved Literature Review

Intended Use: Devices used to collect tissue endoscopically primarily from the lungs and bronchus.

Pricing: Offerors shall complete the pricing schedule with its unit price on forceps for all five years. An offeror may quote on one, two, or all three categories of forceps. Offeror does not have to quote on all three categories of forceps to receive a BPA. Quotes shall only be submitted for one forceps for each category. For evaluation purposes, the total price for all five years shall be used to determine the lowest price in each category of forceps.

Proposal Submission:

1. Proposals shall consist of three (3) volumes in electronic format: Volume I - Technical, Volume II - Price, and Volume III - Solicitation.

a. Volume I - Technical. Offerors shall provide product literature as follows:

i. A list of all forceps being quoted on to include all MTRs.

ii. Descriptive product literature of proposed forceps to demonstrate compliance with all MTRs set forth in the solicitation. The descriptive literature shall identify and highlight the appropriate model and type for the items proposed.

iii. If the descriptive product literature (e.g., cuts, illustrations, drawings, and brochures) provided does not reference each MTR and show how the product complies with each of the MTRs, then the offeror may supplement the descriptive literature with a written technical narrative or other documentation to demonstrate that the product complies with all the MTRs.

iv. Product sample(s) for physical inspection to demonstrate compliance with all of the MTRs. Product samples shall be submitted by the date and time and at the location established in the solicitation.

b. Volume II - Price. Offerors shall insert the unit price in the price column for the category(ies) of forceps quoted on in the Price Schedule (Attachment A).

c. Volume III - Solicitation. Offeror shall submit the following:

i. Any proposed exceptions to solicitation terms and conditions. Offerors are advised that any proposed exceptions may render the offeror's proposal unacceptable and ineligible for award.

ii. Provide the following additional information:

ADDITIONAL OFFEROR'S INFORMATION: (Please Complete)

Ordering Address: ________________________________________

Ordering Phone #: _________________ Fax: __________________

Tax I.D. Number: ________________________________________

DUNS Number: ________________________________________

Payment Terms: ____________________

Delivery: ____________________ (Shall not exceed 10 Calendar Days)

Emergency Delivery Terms: _________________________________________

Emergency Order contact Person: _______________________________

Phone: _______________________________

Is your company EDI capable Yes__________ No__________

(If yes, please provide registration number) ___________________________________

Company website:_______________________________________________________

2. Format. The submission shall be clearly indexed and logically assembled. Each volume shall be clearly identified and shall begin at the top of a page. All pages of each volume shall be appropriately numbered and identified by the complete company name, date and solicitation number in the header and/or footer. Page limitations are applicable to this procurement. All files will be submitted as either a Microsoft Excel (.XLS) file or an Acrobat (PDF) file as indicated in the table. Page size shall be no greater than 8 1/2" x 11" with printing on one side, only. The top, bottom, left and right margins shall be a minimum of one inch (1") each. Font size shall be no smaller than 12-point. Arial or Times New Roman fonts are recommended. Characters shall be set at no less than normal spacing and 100% scale. Tables and illustrations may use a reduced font size not less than 8-point and may be landscape. Line spacing shall be set at no less than single space. Each paragraph shall be separated by at least one blank line. Page numbers, company logos, and headers and footers may be within the page margins ONLY, and are not bound by the 12-point font requirement. Footnotes to text shall not be used. All proprietary information shall be clearly and properly marked.

3. File Packaging. All of the files may be compressed (zipped) into one file using WinZip version 6.2 or later version or the quote files may be submitted individually.

4. Content Requirements. All information shall be confined to the appropriate file. Offerors are responsible for including sufficient details to permit a complete and accurate evaluation of each offer. The titles for each file are shown in the Table below:

Volume Number Volume Type File Type Maximum Pages

Volume I Technical PDF 20

Volume II Price XLS 3

Volume III Solicitation/Offer PDF 10

Proposal Due Date: Proposals are due by 12:00 noon EST on Monday, July 14, 2014; however, samples are due earlier on Thursday, July 10, 2014. All interested Offerors must be registered in the System for Award Management (SAM) prior to receiving an award. You may access SAM at https://www.sam.gov/portal/public/SAM/.

Award will be made to the lowest priced technically offeror in each category of forceps. The Government intends to award without discussions based upon the initial evaluation of proposals. A BPA will be issued to the offeror whose price is lowest among all proposals that were deemed to be technically acceptable. If one offeror is not determined to be the lowest priced technically offeror for all three categories of forceps, multiple awards may be made, not to exceed three BPAs.

Point of contact:

Simone Jackson, Contract Specialist

[email protected]

BLANKET PURCHASE AGREEMENT

TERMS AND CONDITIONS

Endoscopic Biopsy Forceps

1. GENERAL TERMS

The BPA, including product, prices, and other terms and conditions, is public information and is releasable under the Freedom of Information Act (FOIA). Procurement related information, including negotiations, shall be treated as confidential and shall not be disclosed except as required by applicable laws and regulations.

The BPA holder shall provide written notice to the Strategic Acquisition Center (SAC) BPA administrator, of any changes related to the company or the products offered under its BPA. Changes include, but are not limited to, change in company information, including contract administrator, company name, address and phone number.

2. AS214 PRODUCT MODIFICATION, REMOVAL OR RECALL (JAN 2008)

If any product awarded under this solicitation requires modification, is removed or recalled by the contractor or manufacturer due to defects in the product or potential dangers to patients, or if any required modification, removal or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the contractor or manufacturer:

a. Notify the Contracting Officer, VA Strategic Acquisition Center, 10300 Spotsylvania Avenue, Suite 400 Fredericksburg, VA 22408, in writing, by the most expeditious manner possible. The notification shall include, but not be limited to the following:

(1) Complete item description and/or identification, call numbers from customers, and the BPA number assigned as a result of an award on this solicitation.

(2) Reasons for modifications, removal or recall.

(3) Necessary instructions for return for credit, replacement or corrective action.

b. A copy of the notification in a. above shall be provided to:

Manager, Product Recall Office

National Center for Patient Safety

Veterans Health Administration

24 Frank Lloyd Wright Drive, Lobby M

Ann Arbor, MI 48106

c. Provide the information in (a) above to all agencies and VA Facilities who purchased the product.</p>

3. EXTENT OF OBLIGATION:

This BPA ordering period expires sixty (60) months after award. The Government is obligated only to the extent of authorized purchases actually made under the resultant BPA. This BPA does not obligate any funds, nor is the Government obligated to make any purchases under this BPA. The Government does not guarantee any volume of purchases through a BPA.

The terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the BPA Holder's invoice, the provisions of this BPA will take precedence.

The Government intends to utilize awarded BPAs to maintain medical centers supplies. The resultant BPAs may be used on a daily basis.

4. INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE BPA:

Government Participants - The contractor shall provide delivery of United States Food and Drug Administration (FDA) approved Endoscopic Biopsy Forceps as specified in the BPA. Individual VAMCs shall issue BPA Calls to the contractor which shall indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures.

Any individual who has ordering/contracting authority, on behalf of VA (as authorized below), to place BPA Calls, may use this BPA up to the dollar limits of their ordering authority.

Authorized Federal Agencies:

US Department of Veterans Affairs, Medical Centers

POINT(S) OF contact:

VA Program Manager:

Name: Will be determined upon award of BPA

Address:

Voice:

Email:

VA Project Manager:

Name: Will be determined upon award of BPA

Address:

Voice:

Email:

5. DELIVERY AND ORDERING REQUIREMENTS:

The delivery time offered for all calls placed against the resultant BPA shall not exceed 10 calendar days after receipt of order (ARO). Awardees shall deliver to all U.S. facilities and U.S. territories. Calls will be placed against this BPA in writing, by phone, or via facsimile.

6. DELIVERY TICKETS:

At a minimum, delivery tickets or sales slips must contain the following information and must accompany all deliveries under this BPA, unless otherwise agreed to:

Name of the contractor

BPA Number

Model Number or National Stock Number (NSN)

BPA Call Number

Date of purchase and shipment

Quantity, unit price, and extension of each item less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided that the invoice is itemized to show the information)

7. PURCHASE CARD:

(a) Definitions.

"Government wide commercial purchase card" means a uniquely numbered credit card issued by a contractor under GSA's Government wide Contract for Fleet, Travel, and Purchase Card Services to named individual Government employees or entities to pay for official Government purchases.

"Oral order" means an order placed orally either in person or by telephone, which is paid for by Government wide commercial purchase card.

(b) The Contractor shall accept payments for oral or written BPA Calls made using the Government wide commercial purchase card in the amount of $3,000.00 or less.

(c) The Contractor shall not process a transaction for payment through the purchase card clearinghouse until the purchased supplies have been shipped or services performed. Unless the cardholder requests correction or replacement of a defective or faulty item in accordance with other BPA requirements, the Contractor shall immediately credit a cardholder's account for items returned as defective or faulty.

8. INVOICES:

An itemized invoice shall be submitted to the VA billing address listed on each BPA Call placed. The itemized invoice shall identify the delivery ticket or packing list, ship-to-address of supplies, the BPA number, and the delivery/purchase call number assigned by the individual facility at the time of ordering.

9. CANCELLATION:

Either party may terminate this agreement at any time upon 30 days prior written notice to the other party. The cancellation will take effect 30 calendar days after the other party receives the notice of cancellation.

10. UNIVERSAL PRODUCT NUMBERS (UPNs):

The Supplier that receives a BPA shall utilize Universal Product Numbers (UPN) as product identifiers and UPN bar code compliant labels on all packaging sizes down to the unit of measure, as they become available from manufacturers of medical and surgical supplies.

A UPN uniquely identifies healthcare products. It is derived from either the HIBCC-LIC or UCC/EAN bar code labeling data structures. The HIBCC-LIIC format is variable in length, alpha-numeric and consists of manufacturer LIC assigned by HIBCC, the labeler's products or catalog number, and the package level (or inventory unit) indicator.

The UCC/EAN format is fixed length, all numeric and consists of the UCC/EAN assigned manufacturer number (company prefix), numeric item number, a package level (or inventory unit) indicator, and a calculated check character.

When available, the contractor shall use UPNs as the key product unit identifier in its electronic product catalogs, order-processing systems, all product recalls, business documents, and reports called for under the terms of the contract.

11. CONTRACT CLAUSES

FAR Clauses Incorporated by Reference:

52.202-1

52.203-5

52.203-6

52.203-7

52.203-17

52.211-5

52.225.25

52.232-1

52.232-39

52.233-3

FAR Clauses

52.216-1 -- Type of Contract.

As prescribed in 16.105, complete and insert the following provision:

Type of Contract (Apr 1984)

The Government contemplates award of a firm fixed price contract resulting from this solicitation.

(End of Provision)

52.233-2 -- Service of Protest.

As prescribed in 33.106, insert the following provision:

Service of Protest (Sep 2006)

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from Strategic Acquisition Center, 10300 Spotsylvania Ave, Suite 400, Fredericksburg, VA 22408.

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

(End of Provision)

VAAR CLAUSES:

MANDATORY WRITTEN DISCLOSURES

Mandatory written disclosures required by FAR clause 52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at http://www.va.gov/oig/contacts/hotline.asp and clicking on "FAR clause 52.203-13 Reporting." If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

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)

VAAR 852.203-71 DISPLAY OF DEPARTMENT OF VETERAN AFFAIRS HOTLINE POSTER (DEC 1992)

(a) Except as provided in paragraph (c) below, the Contractor shall display prominently, in common work areas within business segments performing work under VA contracts, Department of Veterans Affairs Hotline posters prepared by the VA Office of Inspector General.

(b) Department of Veterans Affairs Hotline posters may be obtained from the VA Office of Inspector General (53E), P.O. Box 34647, Washington, DC 20043-4647.

(c) The Contractor need not comply with paragraph (a) above if the Contractor has established a mechanism, such as a hotline, by which employees may report suspected instances of improper conduct, and instructions that encourage employees to make such reports.

(End of Clause)

VAAR 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.

(End of Clause)

PLEASE NOTE: The correct mailing information for filing alternate protests is as follows:

Deputy Assistant Secretary for Acquisition and Logistics,

Risk Management Team, Department of Veterans Affairs

810 Vermont Avenue, N.W.

Washington, DC 20420

Or for solicitations issued by the Office of Construction and Facilities Management:

Director, Office of Construction and Facilities Management

811 Vermont Avenue, N.W.

Washington, DC 20420

852.211-72 TECHNICAL INDUSTRY STANDARDS (JAN 2008)

The supplies or equipment required by this invitation for bid or request for proposal must conform to the standards of the IEC 60601-1 - Medical equipment medical electrical equipment and NFPA 99: Health Care Facilities Code as to N/A. The successful bidder or offeror will be required to submit proof that the item(s) he/she furnishes conforms to this requirement. This proof may be in the form of a label or seal affixed to the equipment or supplies, warranting that they have been tested in accordance with and conform to the specified standards. Proof may also be furnished in the form of a certificate from one of the above listed organizations certifying that the item(s) furnished have been tested in accordance with and conform to the specified standards.

(End of Provision)

VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)

The contracting officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee's authority. A copy of the designation shall be furnished to the contractor.

(End of Provision)

VAAR 852.273-74 AWARD WITHOUT EXCHANGES (JAN 2003)

The Government intends to evaluate proposals and award a contract without exchanges with offerors. Therefore, each initial offer should contain the offeror's best terms from a cost or price and technical standpoint. However, the Government reserves the right to conduct exchanges if later determined by the contracting officer to be necessary.

(End of Provision)

VAAR 852.273-70 LATE OFFERS (JAN 2003)

This provision replaces paragraph (f) of FAR provision 52.212-1. Offers or modifications of offers received after the time set forth in a request for quotations or request for proposals may be considered, at the discretion of the contracting officer, if determined to be in the best interest of the Government. Late bids submitted in response to an invitation for bid (IFB) will not be considered.

(End of Provision)

Link/URL: https://www.fbo.gov/notices/8c7a89aad320ad88632474913c673dcb