SAMDaily.us | PRESOL | 65 | Sacral Neutostimulation (Neuromodulation) System

SAMDAILY.US - ISSUE OF DECEMBER 13, 2019 SAM #6588
SOLICITATION NOTICE

65 -- Sacral Neutostimulation (Neuromodulation) System

Notice Date: 12/11/2019 1:46:53 PM
Notice Type: Combined Synopsis/Solicitation
NAICS: 339112 — Surgical and Medical Instrument Manufacturing
Contracting Office: NAVAL MEDICAL CENTER SAN DIEGO CA SAN DIEGO CA 92134 USA
ZIP Code: 92134
Solicitation Number: N0025920Q0013
Response Due: 12/30/2019 5:00:00 AM
Archive Date: 01/14/2020
Point of Contact: John E. Freeman, Phone: 6195328098, Renier S. Valdez
E-Mail Address: john.e.freeman14.civ@mail.mil, renier.s.valdez.civ@mail.mil
(john.e.freeman14.civ@mail.mil, renier.s.valdez.civ@mail.mil)
Description: NOTICE TO CONTRACTORThis 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 N0025920Q0013. 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 2020-01. The North American Industry Classification System (NAICS) Code for this acquisition is 339112. The size standard is 1000 employees. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. This is an unrestricted acquisition.LOCATION: Naval Medical Center San Diego, 34800 Bob Wilson Dr., San Diego, CA 92134-5000.Naval Medical Center San Diego (NMCSD) requests responses from qualified sources capable of providing the following:Sacral Neurostimulation (Neuromodulation) System, four (4) each, (4 patients) Required to be full-body MRI 1.5T conditionally safe and Head Scan 3T conditionally safe. Contractor representative must be present during surgical procedures. CLIN 0001: Patient Remote ControlQuantity: 5 Unit of Issue: each Price each: $__________ Total Cost $____________Date of Delivery: 15 Jan 2020CLIN 0002: NeurostimulatorQuantity: 4 Unit of Issue: each Price each: $__________ Total Cost: $__________Date of Delivery: 15 Jan 2020CLIN 0003: Charging SystemQuantity: 4 Unit of Issue: each Price each: $__________ Total Cost: $__________Date of Delivery: 15 Jan 2020CLIN 0004: External StimulatorQuantity: 4 Unit of Issue: each Price each: $__________ Total Cost: $__________Date of Delivery: 15 Jan 2020CLIN 0005: Tined Lead Implant KitQuantity: 4 Unit of Issue: each Price each: $__________ Total Cost: $__________Date of Delivery: 15 Jan 2020CLIN 0006: Tined Lead Kit with Percutaneous ExtensionQuantity: 4 Unit of Issue: each Price each: $__________ Total Cost: $____________Date of Delivery: 15 Jan 2020CLIN 0007: Foramen Needle, LongQuantity: 1 Unit of Issue: box Price each: $__________ Total Cost: $__________Date of Delivery: 15 Jan 2020CLIN 0008: Foramen Needle, ShortQuantity: 1 Unit of Issue: box Price each: $__________ Total Cost: $__________Date of Delivery: 15 Jan 2020CLIN 0009: Stimulation Ground CableQuantity: 1 Unit of Issue: box Price each: $__________ Total Cost: $__________Date of Delivery: 15 Jan 2020Delivery/Acceptance location is 34800 Bob Wilson Drive San Diego, CA 92134. FBO Destination: unless otherwise specified in the order, the supplier is responsible for the performance of all inspection requirements and quality control. DEFENSE BIOMETRIC IDENTIFICATION SYSTEM (DBIDS)(a) In accordance with CNICMEMO dated May 5, 2017, individuals currently using an NCACS credential for Installation access are required to switch to a DBIDS no later than 14 August 2017. After 14 August 2017, the NCACS credential will no longer be valid for access to Navy Installations.(b) NCACS users may visit the local Navy Installation Visitor Control Center to obtain a DBIDS credential. To ensure uninterrupted Installation access, current NCACS credential holders are encouraged to shift to the DBIDS credential as soon as possible as Navy does not have the ability to extend this deadline. There are no fees incurred by the contractor, vendor, or supplier to obtain a DBIDS credential.(c) Individuals who apply for NCACS credentials during the period of 17 April through 31 May 2017 must also obtain DBIDS credentials. NCACS credentials issued after 17 April 2017 will no longer be accepted without an accompanying DBIDS credential for Navy Installation access.(d) DBIDS guidance for Vendors/Contractors to obtain a pass is accessible through the following website:https://www.cnic.navy.mil/om/dbids.htmlFor more information or to enroll in the DBIDS Program call: 1.202.433.4784.For Naval Base San Diego Pass and Decal Office, call: 1.619.556.1653(c) Vendors, contractors, suppliers and other service providers shall present their pass upon entry at ECP.PRIVACY AND SECURITY OF PROTECTED HEALTH INFORMATION (SEP 2012)IntroductionIn accordance with DoD 6025.18-R “Department of Defense Health Information Privacy Regulation,” January 24, 2003, the Contractor meets the definition of Business Associate. Therefore, a Business Associate Agreement is required to comply with both the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the Contractor agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and in DoD 6025.18-R and DoD 8580.02-R, as amended. Additional requirements will be addressed when implemented. (a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DoD 6025.18-R or DoD 8580.02-R. Individual has the same meaning as the term “individual” in 45 CFR 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g). Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E. Protected Health Information has the same meaning as the term “protected health information” in 45 CFR 160.103, limited to the information created or received by the Contractor from or on behalf of the Government pursuant to the Contract. Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103. Required by Law has the same meaning as the term “required by law” in 45 CFR 164.103. Secretary means the Secretary of the Department of Health and Human Services or his/her designee. Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160, 162 and part 164, subpart C. Terms used, but not otherwise defined, in this Clause shall have the same meaning as those terms in 45 CFR 160.103, 160.502, 164.103, 164.304, and 164.501. (b) The Contractor shall not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law. (c) The Contractor shall use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract. (d) The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract. (e) The Contractor shall, at their own expense, take action to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Clause. These mitigation actions will include as a minimum those listed in the TMA Breach Notification Standard Operating Procedure (SOP), which is available at: http://www.tricare.mil/tmaprivacy/breach.cfm (f) The Contractor shall report to the Government any security incident involving protected health information of which it becomes aware. (g) The Contractor shall report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Contractor becomes aware. (h) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information. (i) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it. (j) The Contractor shall provide access, at the request of the Government, and in the time and manner reasonably designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under 45 CFR 164.524. (k) The Contractor shall make any amendment(s) to Protected HealthInformation in a Designated Record Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government, and in the time and manner reasonably designated by the Government. (l) The Contractor shall make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner reasonably designated by the Government or the Secretary, for purposes of the Secretary determining the Government’s compliance with the Privacy Rule. (m) The Contractor shall document such disclosures of Protected Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528. (n) The Contractor shall provide to the Government or an Individual, in time and manner reasonably designated by the Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.General Use and Disclosure Provisions Except as otherwise limited in this Clause, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the HIPAA Privacy Rule, the HIPAA Security Rule, DoD 6025.18-R or DoD 8580.02-R if done by the Government.Specific Use and Disclosure Provisions (a) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor. (b) Except as otherwise limited in this Clause, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached. (c) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information to provide Data Aggregation services to the Government as permitted by 45 CFR 164.504(e)(2)(i)(B). (d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1).Obligations of the Government Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions (a) The Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520. (b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected HealthInformation, if such changes affect the Contractor’s permitted or required uses and disclosures. (c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522.Permissible Requests by the Government The Government shall not request the Contractor to use or discloseProtected Health Information in any manner that would not be permissible under the HIPAA Privacy Rule, the HIPAA Security Rule, or any applicable Government regulations (including without limitation, DoD 6025.18-R and DoD 8580.02-R) if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause.Termination (a) Termination. A breach by the Contractor of this clause, may subject the Contractor to termination under any applicable default or termination provision of this Contract. (b) Effect of Termination. (1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below (2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information. (3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health Information is infeasible, the Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Contractor that return or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information.Miscellaneous (a) Regulatory References. A reference in this Clause to a section in DoD 6025.18-R, DoD 8580.02-R, Privacy Rule or Security Rule means the section currently in effect or as amended, and for which compliance is required. (b) Survival. The respective rights and obligations of Business Associate under the “Effect of Termination” provision of this Clause shall survive the termination of this Contract. (c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with DoD 6025.18-R, DoD 8580.02-R, the HIPAA Privacy Rule or the HIPAA Security Rule.This acquisition incorporates by reference the following FAR provisions and clauses: 52.204-7 - System for Award Management (Oct 2018)52.204-13 - System for Award Management Maintenance (Oct 2018)52.204-16 Commercial and Government Entity Code Reporting (Jul 2016)52.204-18 Commercial and Government Entity Code Reporting (Jul 2016)52.212-3 -- Offeror Representations and Certifications -- Commercial Items (Oct 2018)Contractors are reminded to either include a completed copy of 52.212-3 and its ALT I with Offers, or alternatively, the provision can also be submitted at https://www.sam.gov. 52.212-4 - Contract Terms and Conditions -- Commercial Items (Oct 2018)52.232-40 - Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)Additional contract terms and conditions applicable to this procurement are: 252.203-7000 Requirements Relating to Compensation of Former DoD Officials (Sep 2011)252.203-7005 Representation Relating to Compensation of Former DoD Officials (Nov 2011)252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support (May 2016)252.211-7003 Item Unique Identification and Valuation (MAR 2016)252.211-7008 Use of Government-Assigned Serial Numbers (SEP 2010)252.223-7008 Prohibition of Hexavalent Chromium (JUN 2013)252.225-7000 Buy American--Balance of Payments Program Certificate—Basic (Nov 2014)252.225-7001 Buy American and Balance of Payments Program—Basic (Dec 2017)252.225-7002 Buy American Qualifying Country Sources as Subcontractors (Dec 2017)252.225-7035 Buy American--Free Trade Agreements--Balance of Payments Program Certificate—Basic (Nov 2014)252.225-7036 Buy American—Free Trade Agreements--Balance of Payments Program—Basic (Dec 2017)252.232-7003 Electronic Submission of Payment Requests and Receiving Reports (Dec 2018)252.232-7006 Wide Area WorkFlow Payment Instructions (Dec 2018)252.232-7010 Levies on Contract Payments (Dec 2006)252.244-7000 Subcontracts for Commercial Items (Jun 2013)252.246-7003 Notification of Potential Safety Issues (Jun 2013)252.246-7008 Sources of Electronic Parts (May 2018)252.247-7023 Transportation of Supplies by Sea—Basic (Feb 2019)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 (Oct 2018)(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code and small business size standard for this acquisition appear in Block 10 of the solicitation cover sheet (SF 1449). However, the small business size standard for a concern which submits a quote in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.(b) Submission of quotes. Submit signed and dated quotes to the office specified in this solicitation at or before the exact time specified in this solicitation. Quotes may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, quotes must show—(1) The solicitation number;(2) The time specified in the solicitation for receipt of quotes;(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) If the quote is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotes that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.(c) Period for acceptance of quotes. The quoter agrees to hold the prices in its quote firm for 30 calendar days from the date specified for receipt of quotes, unless another time period is specified in an addendum to the solicitation.(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of quotes. 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 preaward testing.(e) Multiple quotes. Quoters are encouraged to submit multiple quotes presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with subpart 4.10 of the Federal Acquisition Regulation), or alternative commercial items for satisfying the requirements of this solicitation. Each quote submitted will be evaluated separately.(f) Late submissions, modifications, revisions, and withdrawals of quotes. (1) Quoters are responsible for submitting quotes, and any modifications, revisions, or withdrawals, 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 4:30 p.m., local time, for the designated Government office on the date that quotes or revisions are due.(2) (i) Any quote, modification, revision, or withdrawal of a quote received at the Government office designated in the solicitation after the exact time specified for receipt of quotes is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late quote would not unduly delay the acquisition; and-(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of quotes; or(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of quotes and was under the Government’s control prior to the time set for receipt of quotes; or(C) If this solicitation is a request for proposals, it was the only proposal received.(ii) However, a late modification of an otherwise successful quote, that makes its terms more favorable to theGovernment, will be considered at any time it is received and may be accepted.(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the quote wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.(4) If an emergency or unanticipated event interrupts normal Government processes so that quotes cannot be received at the Government office designated for receipt of quotes by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of quotes will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.(5) Quotes may be withdrawn by written notice received at any time before the exact time set for receipt of quotes.Oral quotes in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile quotes, quotes may be withdrawn via facsimile received at any time before the exact time set for receipt of quotes, subject to the conditions specified in the solicitation concerning facsimile quotes. A quote may be withdrawn in person by a quoter or its authorized representative if, before the exact time set for receipt of quotes, the identity of the person requesting withdrawal is established and the person signs a receipt for the quote.(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate quotes and award a contract without discussions with quoters. Therefore, the quoter’s initial quote should contain the quoter’s best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all quotes if such action is in the public interest; accept other than the lowest quote; and waive informalities and minor irregularities in quotes received.(h) Multiple awards. The Government may accept any item or group of items of a quote, unless the quoter qualifies the quote by specific limitations. Unless otherwise provided in the Schedule, quotes may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity quoted, at the unit prices quoted, unless the quoter specifies otherwise in the quote.(i) Availability of requirements documents cited in the solicitation.(1) (i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to-GSA Federal Supply Service Specifications SectionSuite 8100 470 East L’Enfant Plaza, SWWashington, DC 20407Telephone (202) 619-8925Facsimile (202) 619-8978.(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision. Additional copies will be issued for a fee.(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:(i) ASSIST (https://assist.dla.mil/online/start/).(ii) Quick Search (http://quicksearch.dla.mil/).(iii) ASSISTdocs.com (http://assistdocs.com).(3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point(DoDSSP) by-(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone(215) 697-2667/2179, Facsimile (215) 697-1462.(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.(j) Unique entity identifier. (Applies to all quotes exceeding $3,500, and quotes of $3,500 or less if the solicitation requires the Contractor to be registered in the System for Award Management (SAM).) The Quoter shall enter, in the block with its name and address on the cover page of its quote, the annotation “Unique Entity Identifier” followed by the unique entity identifier that identifies the Quoter's name and address. The Quoter also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Quoter to establish additional SAM records for identifying alternative EFT accounts (see subpart32.11) for the same entity. If the Quoter does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Quoter should indicate that it is a quoter for a Government contract when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.(k) [Reserved](l) Debriefing. If a post-award debriefing is given to requesting quoters, the Government shall disclose the following information, if applicable:(1) The agency’s evaluation of the significant weak or deficient factors in the debriefed quoter’s quote.(2) The overall evaluated cost or price and technical rating of the successful and the debriefed quoter and past performance information on the debriefed quoter.(3) The overall ranking of all quoters, when any ranking was developed by the agency during source selection.(4) A summary of the rationale for award;(5) For acquisitions of commercial items, the make and model of the item to be delivered by the successful quoter.(6) Reasonable responses to relevant questions posed by the debriefed quoter as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.(End of provision)52.212-2 -- Evaluation -- Commercial Items (Oct 2014)(a) The Government will award a contract resulting from this solicitation to the responsible quoter whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: Technical Capability, Delivery Schedule, and Price.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 quotes.52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS (OCT 2019)(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 (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).(6) 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: (Contracting Officer check as appropriate.) ___ (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 (Oct 2015) (41 U.S.C. 3509).____ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)XX (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).___ (5) [Reserved]___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C). ___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).XX (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).____ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (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.XX (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 2018) (15 U.S.C. 637(d)(2) and (3)).____ (17)(i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637(d)(4)).____ (ii) Alternate I (Nov 2016) of 52.219-9.____ (iii) Alternate II (Nov 2016) of 52.219-9.____ (iv) Alternate III (Nov 2016) of 52.219-9.____ (v) Alternate IV (Aug 2018) of 52.219-9.____ (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 (JAN 2017) (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)).____ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (NOV 2011) (15 U.S.C. 657f).XX (22) 52.219-28, Post Award Small Business Program Rerepresentation (July 2013) (15 U.S.C. 632(a)(2)).____ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)). ____(24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).XX (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).XX(26) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (Oct 2019) (E.O. 13126).XX (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).XX (28)(i) 52.222-26, Equal Opportunity (SEPT 2016) (E.O. 11246).____ (ii) Alternate I (Feb 1999) of 52.222-26. ____ (29)(i) 52.222-35, Equal Opportunity for Veterans (OCT 2015)(38 U.S.C. 4212). ____ (ii) Alternate I (July 2014) of 52.222-35. XX (30)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793). ____ (ii) Alternate I (July 2014) of 52.222-36.____ (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).____ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).XX (33)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (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 (Oct 2015). (E. O. 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.)____ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).____ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).____ (38) (i) 52.223-13, Acquisition of EPEAT® Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).____ (ii) Alternate I (OCT 2015) of 52.223-13.____ (39)(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.____ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).____ (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).____ (ii) Alternate I (Jun 2014) of 52.223-16.XX (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).____ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).____ (44) 52.223-21, Foams (Jun 2016) (E.O. 13693).____ (45)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).____ (ii) Alternate I (JAN 2017) of 52.224-3.____ (46) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).____ (47) (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.____ (48) 52.225-5, Trade Agreements (Oct 2019) 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).XX (49) 52.225-13, Restrictions on Certain Foreign Purchases (JUNE 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).____ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).____ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150____ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).____ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).____ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).XX (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C. 3332).____ (56) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (July 2013) (31 U.S.C. 3332).____ (57) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).____ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).____ (59) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).____ (60)(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. ____ (iii) Alternate II (Feb 2006) 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: (Contracting Officer check as appropriate.)_____ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)._____ (2) 52.222-41, Service Contract Labor Standards (AUG 2018) (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) (AUG 2018) (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 2015) (E.O. 13658)._____ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706). _____ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792).(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 the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.(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, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontractsto small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.(vi) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.(vii) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).(viii) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).(ix) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).(x) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).(xi) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).(xii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.(xiii) 52.222-41, Service Contract Labor Standards (Aug 2018), (41 U.S.C. chapter 67).(xiv) _____ (A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627)._____ (B) Alternate I (March 2, 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).(xv) 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.)(xvi) 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)(xvii) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).(xviii)52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658). (xix) (A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).(B) Alternate I (JAN 2017) of 52.224-3.(xx) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).(xxi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.(xxiii) 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). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.(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)The Government will only consider firm fixed price (FFP) quotations. All questions regarding the RFQ, of a contractual or technical nature, must be submitted electronically by email to john.e.freeman14.civ@mail.mil no later than 1200 Pacific Time, Friday, 13 December 2019. Questions with the Government’s responses will be posted as an attachment to the RFQ. Please be advised that the Government reserves the right to transmit those questions and answers of a common interest to all prospective Quoters.Electronic submission of Quotes: Quotations shall be submitted electronically by email to john.e.freeman14.civ@mail.mil. Quotations must be received by 0500 Pacific time on Monday 30 December 2019. Email submissions are limited to 2MB. The submitter should confirm receipt of email submissions.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 Quoter to meet all specifications and requirements.******* End of Combined Synopsis/Solicitation ********
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Record: SN05514429-F 20191213/191211230307 (samdaily.us)
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65 -- Sacral Neutostimulation (Neuromodulation) System