Combine Solicitation – RF Nitinol Probe
Notice Type: Combine Solicitation
Posted Date:
Office Address:
Subject: RF Nitinol Probe
Classification Code: 65 - Medical, dental & veterinary equipment & supplies
Solicitation Number: N0025917Q0156
Contact:
Setaside: N/AN/A
Place of Performance (address):
Place of Performance (zipcode): 91913-5000
Place of Performance Country: US
Description:
Naval Medical Center San Diego
NOTICE TO CONTRACTOR 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; quotations are being requested and a written solicitation will not be issued. The solicitation number is N0025917Q0156. It is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95. The North American Industry Classification System (NAICS) Code for this acquisition is 339112. The size standard is 1000. It is the contractor's responsibility to be familiar with the applicable clauses and provisions.
NMCSD requires the following brand name item as identified. See attached brand name justification. Vendors quotes shall include documentation and literature specifying performance parameters of the product being offered to include: manufacturer name, part number, and specifications.
Items required:
CLIN 0001: RF NITINOL PROBE (5cm length) RF-NE-5 Quantity: 12 Unit of Issue: Each Price: __________ Date Material Required:
Shipping: Please include shipping in the price of the units.
Delivery/Acceptance location is 34800 Bob Wilson Drive
DEFENSE BIOMETRIC IDENTIFICATION SYSTEM (DBIDS) (a) In accordance with CNICMEMO dated
(b) NCACS users may visit the local
(c) Individuals who apply for NCACS credentials during the period of 17 April through
(d) DBIDS guidance for Vendors/Contractors to obtain a pass is accessible through the following website:
https://www.cnic.navy.mil/om/dbids.html
For more information or to enroll in the DBIDS Program call: 1.202.433.4784. For
(c) Vendors, contractors, suppliers and other service providers shall present their pass upon entry at ECP.
This acquisition incorporates by reference the following FAR provisions and clauses:
52.212-3 -- Offeror Representations and Certifications -- Commercial Items (
52.212-4 -- Contract Terms and Conditions -- Commercial Items (
Additional contract terms and conditions applicable to this procurement are:
252.203-7000 Requirements Relating to Compensation of Former DoD Officials (
The following clauses incorporated by full text apply to the solicitation:
The provision at FAR 52.212-1 applies to this acquisition. Addendum to FAR 52.212-1: FAR 52.212-1 is replaced in its entirety by this addendum: Instructions to Quoters-Commercial Items (a) North American Industry Classification System (NAICS) code and business size standard. The NAICS code and business size standard for this acquisition appear in the first paragraph of this combined synopsis/solicitation. However, the business size standard for a concern which submits a quotation in its own name, but which proposes to furnish an item which it did not itself manufacture, is 1000 employees. ( b ) Submission of quotations. Submit quotations to the office specified in this solicitation at or before the exact time specified in this solicitation. Quotations must be submitted as specified in the solicitation. As a minimum, quotations must show- (1) The solicitation number; (2) The time specified in the solicitation for receipt of quotations; (3) The name, address, and telephone number of the quoter; (4) A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary; (5) Terms of any express warranty; (6) Price and any discount terms; (7) "Remit to" address, if different than mailing address; (8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3( b ) for those representations and certifications that the quoter shall complete electronically); (9) Acknowledgment of Solicitation Amendments; (10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and (11) Quotation must include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotations that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration. ( c ) Reserved. (d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of quotations. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during testing. (e) Multiple quotations. Quoters are encouraged to submit multiple quotations presenting alternative terms and conditions or commercial items for satisfying the requirements of this solicitation. Each quotation submitted will be evaluated separately. (f) Late submissions. (1) Quoters are responsible for submitting quotations so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is
52.212-2 -- Evaluation -- Commercial Items (
FACTOR 1: Technical Capability; defined as the ability of the products to meet the salient characteristics needed. FACTOR 2: Delivery Schedule; defined as the lead time necessary to receive the product. FACTOR 3: Price; the government shall conduct a price evaluation of all technically acceptable offers with acceptable delivery schedules.
52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS (
(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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (
(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).
(3) 52.233-3, Protest After Award (
(4) 52.233-4, Applicable Law for Breach of Contract Claim (
(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: (Contracting Officer check as appropriate.)
___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (
____ (2) 52.203-13,
____ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (
_ __ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (
___ (5) [Reserved]
___ (6) 52.204-14, Service Contract Reporting Requirements (
___ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (
____ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (
____ (10) [Reserved]
____ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (
____ (ii) Alternate I (
____ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (
____ (13) [Reserved]
____ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (
____ (ii) Alternate I (NOV 2011).
____ (iii) Alternate II (NOV 2011).
____ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (
____ (ii) Alternate I (
____ (iii) Alternate II (
____ (16) 52.219-8, Utilization of Small Business Concerns (
____ (17)(i) 52.219-9, Small Business Subcontracting Plan (
____ (ii) Alternate I (
____ (iii) Alternate II (
____ (iv) Alternate III (
____ (v) Alternate IV (
____ (18) 52.219-13, Notice of Set-Aside of Orders (
____ (19) 52.219-14, Limitations on Subcontracting (
____ (20) 52.219-16, Liquidated Damages-Subcon-tracting Plan (
____ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (
__X__ (22) 52.219-28, Post Award Small Business Program Rerepresentation (
____ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (
__X__ (25) 52.222-3, Convict Labor (
__X__(26) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (
__X__ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
__X__ (28) 52.222-26, Equal Opportunity (
____ (29) 52.222-35, Equal Opportunity for Veterans (
__X__ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (
____ (31) 52.222-37, Employment Reports on Veterans (
____ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (
__X__ (33)(i) 52.222-50, Combating Trafficking in Persons (
____ (ii) Alternate I (
____ (34) 52.222-54, Employment Eligibility Verification (
____ (35) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (
Note to paragraph (b)(35): By a court order issued on
____ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (OCT 2016).
____ (37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (
____ (ii) Alternate I (
____ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (June, 2016) (E.O. 13693).
____ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (June, 2016) (E.O. 13693).
____ (40) (i) 52.223-13, Acquisition of EPEAT(R) Registered Imaging Equipment (
____ (ii) Alternate I (
____ (41)(i) 52.223-14, Acquisition of EPEAT(R) Registered Televisions (
____ (ii) Alternate I (
____ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (
____ (43)(i) 52.223-16, Acquisition of EPEAT[supreg]-Registered Personal Computer Products (
____ (ii) Alternate I (
__X__ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (
____ (45) 52.223-20, Aerosols (June, 2016) (E.O. 13693).
____ (46) 52.223-21, Foams (June, 2016) (E.O. 13693).
____ (47)(i) 52.224-3, Privacy Training (
____ (ii) Alternate I (
____ (48) 52.225-1, Buy American'upplies (
____(49) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (
____ (ii) Alternate I (
____ (iii) Alternate II (
____ (iv) Alternate III (
____ (50) 52.225-5, Trade Agreements (
__X__ (51) 52.225-13, Restrictions on Certain Foreign Purchases (
____ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (
____ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (
____ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (
____ (55) 52.232-29, Terms for Financing of Purchases of Commercial Items (
____ (56) 52.232-30, Installment Payments for Commercial Items (
__X__ (57) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (
____ (58) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (
____ (59) 52.232-36, Payment by Third Party (
____ (60) 52.239-1, Privacy or Security Safeguards (
____ (61) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(12)).
____ (62)(i) 52.247-64, Preference for Privately Owned
____ (ii) Alternate I (
(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: (Contracting Officer check as appropriate.)
_____(1) 52.222-17,
_____ (2) 52.222-41, Service Contract Labor Standards (
_____ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (
_____ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (Multiple Year and Option Contracts) (
_____ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (
_____ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (
_____ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (
_____(8) 52.222-55, Minimum Wages Under Executive Order 13658 (
_____ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (
_____ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (
_____ (11) 52.237-11, Accepting and Dispensing of
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records--Negotiation.
(1) The Comptroller General of
(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.
(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1)in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-
(i) 52.203-13,
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (
(iii) 52.219-8, Utilization of Small Business Concerns (
(iv) 52.222-17,
(v) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(vi) 52.222-26, Equal Opportunity (
(vii) 52.222-35, Equal Opportunity for Veterans (
(viii) 52.222-36, Equal Opportunity for Workers with Disabilities (
_____ (B) Alternate I (
(xvi)52.222-55, Minimum Wages Under Executive Order 13658 (
Note to paragraph (e)(1)(xvii): By a court order issued on
(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.
(End of clause)
52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (
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): http://farsite.hill.af.mil/vmfara.htm https://www.acquisition.gov/browsefar (End of provision)
52.252-2 CLAUSES INCORPORATED BY REFERENCE (
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):
FAR Clauses: http://farsite.hill.af.mil/vmfara.htm DFAR Clauses: http://farsite.hill.af.mil/vmdfara.htm
(End of clause)
The Government will only consider firm fixed price (FFP) quotations.
Electronic submission of Quotes: Quotations shall be submitted electronically by email to [email protected]. Quotations must be received by
All quotes shall include price(s), FOB point, a point of contact, name and phone number, GSA contract number if applicable, business size, and payment terms. Each response must clearly indicate the capability of the Offeror to meet all specifications and requirements. ******* End of Combined Synopsis/Solicitation ***
BRAND NAME JUSTIFICATION
1. Description of the supplies and/or services required to meet the end-user's minimum needs:
The Radio Frequency Ablation is a process that burns a nerve in the patient's spine. This gives the patient temporary relief of pain lasting 9-12 months on average. There are three components that are utilized to produce the lesion. The Generator which converts the energy and produces the burn, it also monitors the temperature and time of the lesion. We currently own 2 different manufacturers machines. The probe, this connects to the machine using unique connectors which are specific for each company. The probe is the actual item that produces the burn in the patient's body. These are a multi-use item and need to be sterilized between uses. In order for the probes and the machine to function properly the probe needs to fit into the receptacle on the machine, additionally the machine needs to be able to read the temperature on the probe to ensure it is burning at the proper temperature. The final component is the needle. This is what actually pierces the patient's skin and is in direct contact with the body. The needle needs to be designed to work with the probe to produce the correct size lesion.
12-Each RF Nitinol Probe (5cm length) RF-NE-5
2. Estimated value of the requirement:
3. Contractor's unique qualifications which make him/her the ONLY source that can truly satisfy the Government's minimum requirements: Currently we use Neurotherm machines daily and for the different aspects the machines produce. The Neurotherm machine can only use probes designed for the Neurotherm machine. This is due to the connector that connects to the end of the machine. Neurotherm will not guarantee any outcome of patients if we use a device that is not compatible and may cause damage to the patient. Neurotherm does produce adaptors to use their probes on other machines but not vice-versa. Using probes that cannot be monitored by the machine correctly may cause serious and irreparable harm to the patient. The needles are made in different lengths and widths. The inner circumference of the needle needs to correspond with the outer diameter of the probe. If the inner circumference is too small then the needle will not fit. If the outer circumference is too small then the probe will not be able to conduct the burn through the needle. This can cause a couple of conditions first it may cause the machine to fail as the machine detects it is not conduction the charge correctly. Second it may cause the procedure to fail, the patient does not receive the correct burn and the pain will not be relieved causing either additional RFA procedures or escalation to invasive surgery. Finally it could cause an unwanted burn on the patient. The company will not guarantee the outcome if we do not use compatible probes and needles and any damages that are caused will fall to the hospital.
The only solution is to purchase the correct probes and needles from the manufacturer to guarantee that all three components work together and properly is to purchase all items from the manufacturer. Other companies do produce needles that are compatible with all machines but there is an inherent risk with using these needles because of the differing diameters of the probes being used. The risk will fall to the patient and it will not be noticed until after more harm has been produced on the patient. So due to safety concerns for the patient the best option is to buy manufacturer produced needles and probes.
Link/URL: https://www.fbo.gov/spg/DON/BUMED/N00259/N0025917Q0156/listing.html


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