65--Neurostimulation Therapy Equipment (Brand Name or Equal)
Department of Veterans Affairs, Orlando VAMC | Published June 16, 2016 - Deadline June 30, 2016
(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Department of Veterans Affairs, Lake Nona VA Medical Hospital Orlando, Florida has a need to procure InterStim II Neurostimulator, brand name or equal for the Urogynecology Department.
(ii) The combined synopsis solicitation number is VA248-16-Q-0806. It's issued as a Request for Quotation (RFQ).
(iii) This combined synopsis solicitation RFQ and the provisions and clauses incorporated are those in effect through Federal Acquisition Circular 2005-88 / 05-16-2016.
(iv) The combined synopsis solicitation is Set-Aside for Service Disable Veteran Owned Small Business (SDVOSB). The NAICS is 339112. Business size standard is 500 employees. Note, Interested Service Disabled/Veteran Owned Small Business [SDVOSB/VOSB] Offerors must be listed and registered in Vetbiz.gov to be considered for Award.
(v) This combined synopsis solicitation is for the purchase of InterStim II Neurostimulator. Any "or equal" response shall identify manufacturer and include parts list, along with details on how such item(s) match or exceed the salient characteristics.
ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0001 InterStim II Neurostimulator
LOCAL STOCK NUMBER: 3058
0002 Patient Programmer
LOCAL STOCK NUMBER: 3037
0003 Lead Kit (28 cm)
LOCAL STOCK NUMBER: 3889-28
0004 Introducer Kit
LOCAL STOCK NUMBER: 355018
0005 Programmer Antenna
LOCAL STOCK NUMBER: 37092
0006 Verify External Neurostimulator
LOCAL STOCK NUMBER: 3531
0007 Twist-Lock Cable (64 cm)
LOCAL STOCK NUMBER: 357664
0008 Test Simulation Cable
LOCAL STOCK NUMBER: 357501
0009 Operational and Maintenance Manual
0011 Operator Training (onsite only)
(vi) A description of the items to be acquired, and/or applicable salient characteristics/minimum Government need(s) follows:
1. The InterStim® Therapy System is a surgically implanted device used to help a patient reduce the number of bowel accidents (fecal incontinence). The InterStim® Therapy System has several components: A neurostimulator which delivers an electrical pulse to the sacral nerve; an electrical lead that is implanted on a sacral nerve, and a programmer that is used to control the electrical pulse delivered by the neurostimulator. The neurostimulator and the lead are permanent implants. The programmer is a handheld device that is not implanted. This device is identical to a device already approved for the treatment of urinary incontinence.
2. The InterStim® Therapy System applies a small electrical stimulation to the sacral nerve that controls the anal sphincter. In order to see if the device will work, a patient first undergoes test stimulation. The lead is implanted on the sacral nerve and an external test stimulator (that is not implanted) is used to deliver the electrical pulse.
3. Treatment with the InterStim® Therapy System can reduce the number of bowel accidents that a patient experiences, and in some cases, the patient becomes totally continent (does not have any more bowel accidents.
4. The VHA NCO 08 - 675 - Orlando, Florida requires these items, Brand Name or Equal. The InterStim® Therapy System is required to support the Urology Department at Lake Nona VA Medical Hospital Orlando, Florida.
" The Therapy System device must be able to connect directly to the lead, eliminating need for an extension.
" The Therapy System device must be able to accommodate three lead sizes - 28 cm, 33 cm, and 41 cm.
" The Therapy System device must be compatible with a lead insertion indicator in the lead.
" Therapy System device must integrate strain relief in the header.
" The Therapy System device must incorporate radiopaque identification of the manufacturer and neurostimulator model number.
" The Therapy System device must allow 1-screw implantation.
" The Therapy System device must be FDA approved.
(vii) Item(s) are to be delivered on or before August 1, 2016, or e.g. 30 Days after Receipt of order (ARO), FOB destination to Lake Nona VA Medical Center 13800 Veterans Way, Orlando, FL 32827
(viii) Provision 52.212-1, Instructions to Offerors - Commercial (Oct 2015), applies to this acquisition.
Addendum to FAR 52.212-1 Instructions to Offerors - Commercial Items:
(a) Offerors are to e-mail complete quotes to Alberto.Velazquez-Santiago@Va.Gov no later than 1 PM EST on 24 June, 2016.. All provisions and clauses applicable to this solicitation can be viewed in full text using the following web addresses: http://www.acquisition.gov/far/index.html and http://www.va.gov/oal/library/vaar/
(b) Subsection (b): Submission of offers: Offerors submitting brand name item(s) shall be an authorized distributor of brand manufacturer, and shall substantiate this by including letter from manufacturer on manufacturer letterhead verifying this.
(c) Subsection (c): Period for acceptance of Offers, is changed from 30 calendar days to 60 calendar days.
(d) Responses shall be on an all or none bases, no partial submission. No grey market or refurbished item(s). The Government reserves the right to make no award at all.
(ix) Provision 52.212-2, Evaluation - Commercial Items (OCT 2014), applies to this acquisition.
(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors will be used to evaluate offers: Price and technical acceptability. Technical and past performance, when combined, are Equal__. A best value award will be made utilizing the lowest price technically acceptable.
(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).
(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.
(x) 52.212-3 Offeror Representations and Certifications - Commercial items (MAY 2014) applies to this acquisition. Offerors shall provide with their offer a completed copy of their Representations and Certifications per 52.212-1(b)(8). Offeror Representations and Certifications can be accessed electronically at the following web address: http://www.acquisition.gov/far/index.html
(xi) Clause 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition.
(xii) Clause 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (APR 2015) applies to this acquisition.
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014)
(2) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(3) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
 (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).
 (2) 52.203-13, Contractor Code of Business Ethics and Conduct (APR 2010)(41 U.S.C. 3509).
 (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)
[x] (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).
 (5) [Reserved]
 (6) 52.204-14, Service Contract Reporting Requirements (JAN 2014) (Pub. L. 111-117, section 743 of Div. C).
 (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (JAN 2014) (Pub. L. 111-117, section 743 of Div. C).
[X] (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Aug 2013) (31 U.S.C. 6101 note).
 (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).
 (10) [Reserved]
 (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (NOV 2011) (15 U.S.C. 657a).
 (ii) Alternate I (NOV 2011) of 52.219-3.
 (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).
 (ii) Alternate I (JAN 2011) of 52.219-4.
 (13) [Reserved]
 (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644).
 (ii) Alternate I (NOV 2011).
 (iii) Alternate II (NOV 2011).
 (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).
 (ii) Alternate I (Oct 1995) of 52.219-7.
 (iii) Alternate II (Mar 2004) of 52.219-7.
 (16) 52.219-8, Utilization of Small Business Concerns (OCT 2014) (15 U.S.C. 637(d)(2) and (3).
 (17)(i) 52.219-9, Small Business Subcontracting Plan (OCT 2014) (15 U.S.C. 637(d)(4)).
 (ii) Alternate I (Oct 2001) of 52.219-9.
 (iii) Alternate II (Oct 2001) of 52.219-9.
 (iv) Alternate III (OCT 2014) of 52.219-9.
[X] (18) 52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)).
 (19) 52.219-14, Limitations on Subcontracting (NOV 2011) (15 U.S.C. 637(a)(14)).
 (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).
[X] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (NOV 2011) (15 U.S.C. 657f).
[X] (22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C 632(a)(2)).
 (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).
 (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).
[X] (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).
[X] (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN 2014) (E.O. 13126).
[X] (27) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
[X] (28) 52.222-26, Equal Opportunity (APR 2015) (E.O. 11246).
 (29) 52.222-35, Equal Opportunity for Veterans (JUL 2014) (38 U.S.C. 4212).
[X] (30) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).
 (31) 52.222-37, Employment Reports on Veterans (JUL 2014) (38 U.S.C. 4212).
 (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).
[X] (33)(i) 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627).
 (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
 (34) 52.222-54, Employment Eligibility Verification (AUG 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)
 (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
 (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
[X] (36)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).
 (ii) Alternate I (JUN 2014) of 52.223-13.
 (37)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).
 (ii) Alternate I (JUN 2014) of 52.223-14.
 (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007)(42 U.S.C. 8259b).
 (39)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (JUN 2014) (E.O.s 13423 and 13514).
 (ii) Alternate I (JUN 2014) of 52.223-16.
[X] (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)
[X] (41) 52.225-1, Buy American-Supplies (MAY 2014) (41 U.S.C. chapter 83).
 (42)(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (MAY 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.
 (ii) Alternate I (MAY 2014) of 52.225-3.
 (iii) Alternate II (MAY 2014) of 52.225-3.
 (iv) Alternate III (MAY 2014) of 52.225-3.
 (43) 52.225-5, Trade Agreements (NOV 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
[X] (44) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).
 (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
 (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).
 (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).
 (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
 (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
[X] (50) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) (31 U.S.C. 3332).
[X] (51) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).
 (52) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).
 (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
 (54)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).
 (ii) Alternate I (Apr 2003) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
 (1) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495).
 (2) 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67).
 (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
 (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
 (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67).
 (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (MAY 2014) (41 U.S.C. chapter 67).
 (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (MAY 2014) (41 U.S.C. chapter 67).
 (8) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2014) (Executive Order 13658).
 (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792).
 (10) 52.237-11, Accepting and Dispensing of $1 Coin (SEP 2008) (31 U.S.C. 5112(p)(1)).
(End of Clause)
(xiii) Statement regarding any Additional Provisions and Clauses, or other terms and conditions important to the requirement/procurement process consistent with commercial practices:
Provisions in full text:
52.225-18 Place of Manufacture (MAR 2015).
(a) Definitions. As used in this clause-
"Manufactured end product" means any end product in product and service codes (PSCs) 1000-9999, except-
(1) FPSC 5510, Lumber and Related Basic Wood Materials;
(2) Product or Service Group (PSG) 87, Agricultural Supplies;
(3) PSG 88, Live Animals;
(4) PSG 89, Subsistence;
(5) PSC 9410, Crude Grades of Plant Materials;
(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;
(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;
(8) PSC 9610, Ores;
(9) PSC 9620, Minerals, Natural and Synthetic; and
(10) PSC 9630, Additive Metal Materials.
"Place of manufacture" means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.
(b) For statistical purposes only, the offeror shall indicate whether the place of manufacture of the end products it expects to provide in response to this solicitation is predominantly-
(1)  In the United States (Check this box if the total anticipated price of offered end products manufactured in the United States exceeds the total anticipated price of offered end products manufactured outside the United States); or
(2)  Outside the United States.
(End of provision)
52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998).
This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):
(End of provision)
852.252-70 Solicitation provisions or clauses incorporated by reference (JAN 2008).
The following provisions or clauses incorporated by reference in this solicitation must be completed by the offeror or prospective contractor and submitted with the quotation or offer. Copies of these provisions or clauses are available on the Internet at the web sites provided in the provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference, or the clause at FAR 52.252-2, Clauses Incorporated by Reference. Copies may also be obtained from the contracting officer.
(End of provision)
Provisions incorporated by reference are:
- 52.203-11 Certification and Disclosure regarding payments to Influence certain Federal Transactions (SEP 2007);
- 52.204-7 System for award management (JUL 2013)
- 52.204-17 Ownership or Control of Offeror (NOV 2014)
- 52.211-6 Brand Name or Equal (AUG 1999)
- 52.225-25 Prohibition on Contracting with entities engaging in certain activities or transactions relating to Iran - Representation and Certification (DEC 2012)
Clauses in Full Text:
52.252-2 Clauses Incorporated by Reference (FEB 1998).
This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):
(End of clause)
Clauses Incorporated by Reference:
- 52.204-13 System for Award Management Maintenance (JUL 2013)
- 52.204-18 Commercial and Government Entity Code Maintenance (JUL 2015)
- 52.222-20 Contracts for materials, supplies, articles, and equipment exceeding $15,000.00 (MAY 2014);
- 52.232-1 Payments (APR 1984);
- 52.232-8 Discounts for prompt payment (FEB 2002);
- 52.243-1 Changes -Fixed Price (AUG 1987);
- 852.203-70 Commercial Advertising (JAN 2008);
- 852.246-70 Guarantee (JAN 2008);
- 852.246-71 Inspection (JAN 2008)
(xiv) DPAS is N/A
(xv) The RFQ is due on 1 PM EST on 24 June, 2016. by e-mail at Alberto.Velazquez-Santiago@Va.Gov. Offers received after the exact time specified in the solicitation are considered late and may be considered if the action would not unduly delay the acquisition or are deemed to be in the best interest of the Government.
(xvi) For further information contact Alberto Velazquez by phone at 407-646-4021.
Point of Contact(s): Alberto.Velazquez-Santiago@Va.Gov
Contracting Officer: Lisa John