FBODaily.com | FedBizOpps: PRESOL | 66 | Coagulation Analyzer CPRR

FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 16, 2018 FBO #6049
SOLICITATION NOTICE

66 -- Coagulation Analyzer CPRR

Notice Date: 6/14/2018
Notice Type: Combined Synopsis/Solicitation
NAICS: 334516 — Analytical Laboratory Instrument Manufacturing
Contracting Office: Department of the Army, U.S. Army Medical Command, REGIONAL HEALTH CONTRACT OFF CENTRAL, ATTN: MCAA GP L31 9V, 2539 GARDEN AVENUE, JBSA FT SAM HOUSTON, Texas, 78234-0000, United States
ZIP Code: 78234-0000
Solicitation Number: W81K0018Q0079
Archive Date: 7/7/2018
Point of Contact: MaryAnn Teniente, Phone: 2102213057
E-Mail Address: maryann.i.teniente.civ@mail.mil
(maryann.i.teniente.civ@mail.mil)
Small Business Set-Aside: N/A
Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 and FAR Part 13 Simplified Acquisition Procedures, 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 solicitation number is W81K0018Q0079 and is issued as a Request for Quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-97 and Defense Federal Acquisition Regulation Supplement Publication Notice (DPN) 20180530. This solicitation is for a Coagulation Analyzer and Reagents (CPRR) for Raymond W Bliss Army Health Clinic, Fort Huachuca, Arizona. The Period of Performance is 1 October 2018 through 30 September 2019 plus 4 option years. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516, with a size standard of 1,000 employees. This procurement is being conducted as a full and open competition. All eligible businesses may submit an offer, which will be considered. Offers are due by 22 June 2018, at 10:00 AM, Central Standard Time. The point of contact is MaryAnn Teniente at (210) 221-3057 or maryann.i.teniente.civ@mail.mil. Offers shall be submitted via e-mail. Questions shall be submitted via e-mail not later than 20 June 2018. No questions will be entertained after this date. This is a "brand name or equal" solicitation. The brand name description of the products are based on STA Satellite #58104 or equal product. The salient characteristics are as follows: Must provide fully automated coagulation analyzer Must provide reagents Must perform Prothrombin Time (PT) and calculation International Normalized Ratio (INR) Must perform Partial Tromboplastin Time (PTT) Must perform calculation International Normalized Ratio (INR) Must include Preventive and Emergency Maintenance Must include delivery, installation Must be FDA approved ITEM SUPPLIES/SERVICES QTY UNIT PRICE AMOUNT NO 0001 Leased Analyzer & Reagents 12 Months ________ ________ Coagulation Analyzer & Reagents, STA Satellite #58104, Cost Per Reportable Results. If providing other than Brand Name bidder must address and meet all salient characteristics in accordance with Addendum 52.212-2. Provide pricing for 800 PT INR test and 300 APTT test annually in accordance with Statement of Work. Base Year, Period of Performance: 1 October 2018 through 30 September 2019 0002 Contractor Manpower Report (CMR) 1 Each ________ _________ 1001 Leased Analyzer & Reagents 12 Months ________ ________ Coagulation Analyzer & Reagents, STA Satellite #58104, Cost Per Reportable Results. If providing other than Brand Name bidder must address and meet all salient characteristics in accordance with Addendum 52.212-2. Provide pricing for 800 PT INR test and 300 APTT test annually in accordance with Statement of Work. Option Year 1, Period of Performance: 1 October 2019 through 30 September 2020 1002 Contractor Manpower Report (CMR) 1 Each ________ ________ 2001 Leased Analyzer & Reagents 12 Months ________ ________ Coagulation Analyzer & Reagents, STA Satellite #58104, Cost Per Reportable Results. If providing other than Brand Name bidder must address and meet all salient characteristics in accordance with Addendum 52.212-2. Provide pricing for 800 PT INR test and 300 APTT test annually in accordance with Statement of Work. Option Year 2, Period of Performance: 1 October 2020 through 30 September 2021 2002 Contractor Manpower Report (CMR) 1 Each ________ ________ 3001 Leased Analyzer & Reagents 12 Months ________ ________ Coagulation Analyzer & Reagents, STA Satellite #58104, Cost Per Reportable Results. If providing other than Brand Name bidder must address and meet all salient characteristics in accordance with Addendum 52.212-2. Provide pricing for 800 PT INR test and 300 APTT test annually in accordance with Statement of Work. Option Year 3, Period of Performance: 1 October 2021 through 30 September 2022 3002 Contractor Manpower Report (CMR) 1 Each ________ ________ 4001 Leased Analyzer & Reagents 12 Months ________ ________ Coagulation Analyzer & Reagents, STA Satellite #58104, Cost Per Reportable Results. If providing other than Brand Name bidder must address and meet all salient characteristics in accordance with Addendum 52.212-2. Provide pricing for 800 PT INR test and 300 APTT test annually in accordance with Statement of Work. Option Year 4, Period of Performance: 1 October 2022 through 30 September 2023 4001 Contractor Manpower Report (CMR) 1 Each ________ ________ TOTAL COST $ ___________________ CLAUSES INCORPORATED BY REFERENCE 52.212-4 Contract Terms and Conditions--Commercial Items JAN 2017 52.212-4 ADDENDUM (w) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 herein for locations where full text can be found. (End of Clause) CLAUSES INCORPORATED BY REFERENCE 52.222-3 Convict Labor JUN 2003 52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEP 2016 52.222-36 Equal Opportunity for Workers with Disabilities JUL 2014 52.222-50 Combating Trafficking in Persons MAR 2015 52.223-18 Encouraging Contractor Policies To Ban Text Messaging AUG 2011 While Driving 52.225-13 Restrictions on Certain Foreign Purchases JUN 2008 52.232-18 Availability Of Funds APR 1984 52.232-33 Payment by Electronic Funds Transfer--System for Award JUL 2013 Management 52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 252.203-7000 Requirements Relating to Compensation of Former DoD SEP 2011 Officials 252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.225-7048 Export-Controlled Items JUN 2013 252.232-7003 Electronic Submission of Payment Requests and Receiving JUN 2012 Reports 252.232-7010 Levies on Contract Payments DEC 2006 CLAUSES INCORPORATED BY FULL TEXT 52.209-10 Prohibition on Contracting With Inverted Domestic Corporations. (NOV 2015) Definitions. As used in this clause-- Inverted domestic corporation means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c). Subsidiary means an entity in which more than 50 percent of the entity is owned-- Directly by a parent corporation; or Through another subsidiary of a parent corporation. If the contractor reorganizes as an inverted domestic corporation or becomes a subsidiary of an inverted domestic corporation at any time during the period of performance of this contract, the Government may be prohibited from paying for Contractor activities performed after the date when it becomes an inverted domestic corporation or subsidiary. The Government may seek any available remedies in the event the Contractor fails to perform in accordance with the terms and conditions of the contract as a result of Government action under this clause. Exceptions to this prohibition are located at 9.108-2. In the event the Contractor becomes either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation during contract performance, the Contractor shall give written notice to the Contracting Officer within five business days from the date of the inversion event. (End of clause) 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days. (End of clause) 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) The Government may extend the term of this contract by written notice to the Contractor within 30 days provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension. If the Government exercises this option, the extended contract shall be considered to include this option clause. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months. (End of clause) 52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (JULY 2013) Definitions. As used in this clause-- Long-term contract means a contract of more than five years in duration, including options. However, the term does not include contracts that exceed five years in duration because the period of performance has been extended for a cumulative period not to exceed six months under the clause at 52.217-8, Option to Extend Services, or other appropriate authority. Small business concern means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of this clause. Such a concern is ``not dominant in its field of operation'' when it does not exercise a controlling or major influence on a national basis in a kind of business activity in which a number of business concerns are primarily engaged. In determining whether dominance exists, consideration shall be given to all appropriate factors, including volume of business, number of employees, financial resources, competitive status or position, ownership or control of materials, processes, patents, license agreements, facilities, sales territory, and nature of business activity. If the Contractor represented that it was a small business concern prior to award of this contract, the Contractor shall rerepresent its size status according to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon the occurrence of any of the following: Within 30 days after execution of a novation agreement or within 30 days after modification of the contract to include this clause, if the novation agreement was executed prior to inclusion of this clause in the contract. Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition occurred prior to inclusion of this clause in the contract. For long-term contracts-- Within 60 to 120 days prior to the end of the fifth year of the contract; and Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter. The Contractor shall rerepresent its size status in accordance with the size standard in effect at the time of this rerepresentation that corresponds to the North American Industry Classification System (NAICS) code assigned to this contract. The small business size standard corresponding to this NAICS code can be found at http://www.sba.gov/content/table-small-business-size-standards. The small business size standard for a Contractor providing a product which it does not manufacture itself, for a contract other than a construction or service contract, is 500 employees. Except as provided in paragraph (g) of this clause, the Contractor shall make the representation required by paragraph (b) of this clause by validating or updating all its representations in the Representations and Certifications section of the System for Award Management (SAM) and its other data in SAM, as necessary, to ensure that they reflect the Contractor's current status. The Contractor shall notify the contracting office in writing within the timeframes specified in paragraph (b) of this clause that the data have been validated or updated, and provide the date of the validation or update. If the Contractor represented that it was other than a small business concern prior to award of this contract, the Contractor may, but is not required to, take the actions required by paragraphs (e) or (g) of this clause. If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed: The Contractor represents that it ( ) is, ( X ) is not a small business concern under NAICS Code 334516- assigned to contract number. (Contractor to sign and date and insert authorized signer's name and title). (End of clause) 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): HTTPS://FARSITE.HILL.AF.MIL (End of clause) 52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause. The use in this solicitation or contract of any DoD FAR Supplement (48 CFR Chapter 2) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation. (End of clause) 252.204-7012 SAFEGUARDING COVERED DEFENSE INFORMATION AND CYBER INCIDENT REPORTING (OCT 2016) Definitions. As used in this clause-- Adequate security means protective measures that are commensurate with the consequences and probability of loss, misuse, or unauthorized access to, or modification of information. Compromise means disclosure of information to unauthorized persons, or a violation of the security policy of a system, in which unauthorized intentional or unintentional disclosure, modification, destruction, or loss of an object, or the copying of information to unauthorized media may have occurred. Contractor attributional/proprietary information means information that identifies the contractor(s), whether directly or indirectly, by the grouping of information that can be traced back to the contractor(s) (e.g., program description, facility locations), personally identifiable information, as well as trade secrets, commercial or financial information, or other commercially sensitive information that is not customarily shared outside of the company. Controlled technical information means technical information with military or space application that is subject to controls on the access, use, reproduction, modification, performance, display, release, disclosure, or dissemination. Controlled technical information would meet the criteria, if disseminated, for distribution statements B through F using the criteria set forth in DoD Instruction 5230.24, Distribution Statements on Technical Documents. The term does not include information that is lawfully publicly available without restrictions. Covered contractor information system means an unclassified information system that is owned, or operated by or for, a contractor and that processes, stores, or transmits covered defense information. Covered defense information means unclassified controlled technical information or other information, as described in the Controlled Unclassified Information (CUI) Registry at http://www.archives.gov/cui/registry/category- list.html, that requires safeguarding or dissemination controls pursuant to and consistent with law, regulations, and Governmentwide policies, and is-- Marked or otherwise identified in the contract, task order, or delivery order and provided to the contractor by or on behalf of DoD in support of the performance of the contract; or Collected, developed, received, transmitted, used, or stored by or on behalf of the contractor in support of the performance of the contract. Cyber incident means actions taken through the use of computer networks that result in a compromise or an actual or potentially adverse effect on an information system and/or the information residing therein. Forensic analysis means the practice of gathering, retaining, and analyzing computer-related data for investigative purposes in a manner that maintains the integrity of the data. Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information. Malicious software means computer software or firmware intended to perform an unauthorized process that will have adverse impact on the confidentiality, integrity, or availability of an information system. This definition includes a virus, worm, Trojan horse, or other code-based entity that infects a host, as well as spyware and some forms of adware. Media means physical devices or writing surfaces including, but is not limited to, magnetic tapes, optical disks, magnetic disks, large-scale integration memory chips, and printouts onto which covered defense information is recorded, stored, or printed within a covered contractor information system. Operationally critical support means supplies or services designated by the Government as critical for airlift, sealift, intermodal transportation services, or logistical support that is essential to the mobilization, deployment, or sustainment of the Armed Forces in a contingency operation. Rapidly report means within 72 hours of discovery of any cyber incident. Technical information means technical data or computer software, as those terms are defined in the clause at DFARS 252.227-7013, Rights in Technical Data--Noncommercial Items, regardless of whether or not the clause is incorporated in this solicitation or contract. Examples of technical information include research and engineering data, engineering drawings, and associated lists, specifications, standards, process sheets, manuals, technical reports, technical orders, catalog-item identifications, data sets, studies and analyses and related information, and computer software executable code and source code. Adequate security. The Contractor shall provide adequate security on all covered contractor information systems. To provide adequate security, the Contractor shall implement, at a minimum, the following information security protections: For covered contractor information systems that are part of an information technology (IT) service or system operated on behalf of the Government, the following security requirements apply: Cloud computing services shall be subject to the security requirements specified in the clause 252.239-7010, Cloud Computing Services, of this contract. Any other such IT service or system (i.e., other than cloud computing) shall be subject to the security requirements specified elsewhere in this contract. For covered contractor information systems that are not part of an IT service or system operated on behalf of the Government and therefore are not subject to the security requirement specified at paragraph (b)(1) of this clause, the following security requirements apply: Except as provided in paragraph (b)(2)(ii) of this clause, the covered contractor information system shall be subject to the security requirements in National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171, ``Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations'' (available via the internet at http://dx.doi.org/10.6028/NIST.SP.800-171) in effect at the time the solicitation is issued or as authorized by the Contracting Officer. (ii)(A) The Contractor shall implement NIST SP 800-171, as soon aspractical, but not later than December 31, 2017. For all contracts awarded prior to October 1, 2017, the Contractor shall notify the DoD Chief Information Officer (CIO), via email at osd.dibcsia@mail.mil, within 30 days of contract award, of any security requirements specified by NIST SP 800-171 not implemented at the time of contract award. The Contractor shall submit requests to vary from NIST SP 800-171 in writing to the Contracting Officer, for consideration by the DoD CIO. The Contractor need not implement any security requirement adjudicated by an authorized representative of the DoD CIO to be nonapplicable or to have an alternative, but equally effective, security measure that may be implemented in its place. If the DoD CIO has previously adjudicated the contractor's requests indicating that a requirement is not applicable or that an alternative security measure is equally effective, a copy of that approval shall be provided to the Contracting Officer when requesting its recognition under this contract. If the Contractor intends to use an external cloud service provider to store, process, or transmit any covered defense information in performance of this contract, the Contractor shall require and ensure that the cloud service provider meets security requirements equivalent to those established by the Government for the Federal Risk and Authorization Management Program (FedRAMP) Moderate baseline (https://www.fedramp.gov/resources/documents/) and that the cloud service provider complies with requirements in paragraphs (c) through (g) of this clause for cyber incident reporting, malicious software, media preservation and protection, access to additional information and equipment necessary for forensic analysis, and cyber incident damage assessment. Apply other information systems security measures when the Contractor reasonably determines that information systems security measures, in addition to those identified in paragraphs (b)(1) and (2) of this clause, may be required to provide adequate security in a dynamic environment or to accommodate special circumstances (e.g., medical devices) and any individual, isolated, or temporary deficiencies based on an assessed risk or vulnerability. These measures may be addressed in a system security plan. Cyber incident reporting requirement. When the Contractor discovers a cyber incident that affects a covered contractor information system or the covered defense information residing therein, or that affects the contractor's ability to perform the requirements of the contract that are designated as operationally critical support and identified in the contract, the Contractor shall-- Conduct a review for evidence of compromise of covered defense information, including, but not limited to, identifying compromised computers, servers, specific data, and user accounts. This review shall also include analyzing covered contractor information system(s) that were part of the cyber incident, as well as other information systems on the Contractor's network(s), that may have been accessed as a result of the incident in order to identify compromised covered defense information, or that affect the Contractor's ability to provide operationally critical support; and Rapidly report cyber incidents to DoD at http://dibnet.dod.mil. Cyber incident report. The cyber incident report shall be treated as information created by or for DoD and shall include, at a minimum, the required elements at http://dibnet.dod.mil. Medium assurance certificate requirement. In order to report cyber incidents in accordance with this clause, the Contractor or subcontractor shall have or acquire a DoD-approved medium assurance certificate to report cyber incidents. For information on obtaining a DoD-approved medium assurance certificate, see http://iase.disa.mil/pki/eca/Pages/index.aspx. Malicious software. When the Contractor or subcontractors discover and isolate malicious software in connection with a reported cyber incident, submit the malicious software to DoD Cyber Crime Center (DC3) in accordance with instructions provided by DC3 or the Contracting Officer. Do not send the malicious software to the Contracting Officer. Media preservation and protection. When a Contractor discovers a cyber incident has occurred, the Contractor shall preserve and protect images of all known affected information systems identified in paragraph (c)(1)(i) of this clause and all relevant monitoring/packet capture data for at least 90 days from the submission of the cyber incident report to allow DoD to request the media or decline interest. Access to additional information or equipment necessary for forensic analysis. Upon request by DoD, the Contractor shall provide DoD with access to additional information or equipment that is necessary to conduct a forensic analysis. Cyber incident damage assessment activities. If DoD elects to conduct a damage assessment, the Contracting Officer will request that the Contractor provide all of the damage assessment information gathered in accordance with paragraph (e) of this clause. DoD safeguarding and use of contractor attributional/proprietary information. The Government shall protect against the unauthorized use or release of information obtained from the contractor (or derived from information obtained from the contractor) under this clause that includes contractor attributional/proprietary information, including such information submitted in accordance with paragraph (c). To the maximum extent practicable, the Contractor shall identify and mark attributional/proprietary information. In making an authorized release of such information, the Government will implement appropriate procedures to minimize the contractor attributional/proprietary information that is included in such authorized release, seeking to include only that information that is necessary for the authorized purpose(s) for which the information is being released. Use and release of contractor attributional/proprietary information not created by or for DoD. Information that is obtained from the contractor (or derived from information obtained from the contractor) under this clause that is not created by or for DoD is authorized to be released outside of DoD-- To entities with missions that may be affected by such information; To entities that may be called upon to assist in the diagnosis, detection, or mitigation of cyber incidents; To Government entities that conduct counterintelligence or law enforcement investigations; For national security purposes, including cyber situational awareness and defense purposes (including with Defense Industrial Base (DIB) participants in the program at 32 CFR part 236); or To a support services contractor (``recipient'') that is directly supporting Government activities under a contract that includes the clause at 252.204-7009, Limitations on the Use or Disclosure of Third-Party Contractor Reported Cyber Incident Information. Use and release of contractor attributional/proprietary information created by or for DoD. Information that is obtained from the contractor (or derived from information obtained from the contractor) under this clause that is created by or for DoD (including the information submitted pursuant to paragraph (c) of this clause) is authorized to be used and released outside of DoD for purposes and activities authorized by paragraph (i) of this clause, and for any other lawful Government purpose or activity, subject to all applicable statutory, regulatory, and policy based restrictions on the Government's use and release of such information. The Contractor shall conduct activities under this clause in accordance with applicable laws and regulations on the interception, monitoring, access, use, and disclosure of electronic communications and data. Other safeguarding or reporting requirements. The safeguarding and cyber incident reporting required by this clause in no way abrogates the Contractor's responsibility for other safeguarding or cyber incident reporting pertaining to its unclassified information systems as required by other applicable clauses of this contract, or as a result of other applicable U.S. Government statutory or regulatory requirements. Subcontracts. The Contractor shall-- Include this clause, including this paragraph (m), in subcontracts, or similar contractual instruments, for operationally critical support, or for which subcontract performance will involve covered defense information, including subcontracts for commercial items, without alteration, except to identify the parties. The Contractor shall determine if the information required for subcontractor performance retains its identity as covered defense information and will require protection under this clause, and, if necessary, consult with the Contracting Officer; and Require subcontractors to-- Notify the prime Contractor (or next higher-tier subcontractor) when submitting a request to vary from a NIST SP 800-171 security requirement to the Contracting Officer, in accordance with paragraph (b)(2)(ii)(B) of this clause; and Provide the incident report number, automatically assigned by DoD, to the prime Contractor (or next higher-tier subcontractor) as soon as practicable, when reporting a cyber incident to DoD as required in paragraph (c) of this clause. (End of clause) 252.204-7015 NOTICE OF AUTHORIZED DISCLOSURE OF INFORMATION FOR LITIGATION SUPPORT (MAY 2016) Definitions. As used in this clause-- Computer software means computer programs, source code, source code listings, object code listings, design details, algorithms, processes, flow charts, formulae, and related material that would enable the software to be reproduced, recreated, or recompiled. Computer software does not include computer data bases or computer software documentation. Litigation support means administrative, technical, or professional services provided in support of the Government during or in anticipation of litigation. Litigation support contractor means a contractor (including its experts, technical consultants, subcontractors, and suppliers) providing litigation support under a contract that contains the clause at 252.204-7014, Limitations on the Use or Disclosure of Information by Litigation Support Contractors. Sensitive information means controlled unclassified information of a commercial, financial, proprietary, or privileged nature. The term includes technical data and computer software, but does not include information that is lawfully, publicly available without restriction. Technical data means recorded information, regardless of the form or method of the recording, of a scientific or technical nature (including computer software documentation). The term does not include computer software or data incidental to contract administration, such as financial and/or management information. Notice of authorized disclosures. Notwithstanding any other provision of this solicitation or contract, the Government may disclose to a litigation support contractor, for the sole purpose of litigation support activities, any information, including sensitive information, received- Within or in connection with a quotation or offer; or In the performance of or in connection with a contract. Flowdown. Include the substance of this clause, including this paragraph (c), in all subcontracts, including subcontracts for commercial items. (End of clause) 252.244-7000 SUBCONTRACTS FOR COMMERCIAL ITEMS (JUN 2013) The Contractor is not required to flow down the terms of any Defense Federal Acquisition Regulation Supplement (DFARS) clause in subcontracts for commercial items at any tier under this contract, unless so specified in the particular clause. While not required, the Contractor may flow down to subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligation. The Contractor shall include the terms of this clause, including this paragraph (c), in subcontracts awarded under this contract, including subcontracts for the acquisition of commercial items. (End of clause) 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (DEVIATION 2013-O0019) (JAN 2018) (a) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph 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. 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. 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. 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. Notwithstanding the requirements of any other clause in this contract, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (b)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509). 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17. 52.222-21, Prohibition of Segregated Facilities (Apr 2015). (v) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246). 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212). 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706). 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212). 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. 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). X (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627). 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.) 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) 52.222-54, Employment Eligibility Verification (Oct 2015). 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658). 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). 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. 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. 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) STATEMENT OF WORK GENERAL REQUIREMENTS: SCOPE OF WORK: The Contractor shall provide a coagulation analyzer and reagents including equipment, maintenance, and support at no extra cost to the Government in support of Raymond W Bliss Army Health Center, Fort Huachuca, AZ. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition. The Contractor shall perform to the standards of this Statement of Work (SOW). QUALITY CONTROL (QC) and QUALITY ASSURANCE (QA): 1.2.. The Contractor shall provide a Quality Control (QC) Plan that contains, at a minimum, the items listed in 1.2.2 (below) to the Contracting Officer and Government Point of Contact (GPOC) for acceptance not later than 10 days AFTER the start of the contract (see table 5.2). The Contracting Officer will notify the Contractor of acceptance or required modifications to the plan. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the Contracting Officer. The QC Plan shall include: A description of the inspection system to cover all incidental support and maintenance services listed on the Performance Requirements Summary (PRS) listed in table 5.2. Description shall include specifics as to the areas to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors. Additionally, control procedures for any Government provided keys or lock combinations shall be included. A description of the methods to be used for identifying and preventing equipment failure and/or defects. A description of the records to be kept to document inspections and corrective or preventive actions taken. NOTE: The records of inspections shall be kept and made available to the Government throughout the contract performance period and for the period after contract completion until final settlement of any claims, if any, under this contract. Quality Assurance (QA). Government personnel will record surveillance observations, as needed, and provide to the Contractor. The receipt of the observation does not necessarily constitute concurrence with the observation, only acknowledgment that the Contractor has been made aware of the unacceptable performance. Such surveillance will be done according to standard inspection procedures or other contract provisions. Any action taken by the Contracting Officer as a result of surveillance will be according to the terms of this contract. Equipment Troubleshooting. When the Government performs troubleshooting with the Contractor, the Contractor shall replace all reagents, calibrators, controls and any other materials used at no additional cost to the Government IAW Paragraphs 5.4.2.1 and 5.4.2.2 (below). Performance Evaluation Meetings. The Contracting Officer may require the Contractor to meet with the Contracting Officer and/or Government Point of Contact, as deemed necessary. The Contractor may request a meeting with the Contracting Officer, when the Contractor believes such a meeting is necessary. If required, written minutes of any such meetings shall be recorded in the contract and signed by the Contractor and the Contracting Officer. If the Contractor does not concur with any portion of the minutes, such non concurrence shall be provided in writing to the Contracting Officer within 10 calendar days following receipt of the minutes. HOURS OF OPERATION: Normal Hours of Operation, Monday through Friday between the hours of 0700- 1600. Holidays. Routine equipment servicing and reagent delivery will not be required on standard Federal Holidays. If an emergency arises, equipment servicing and reagent delivery will be provided in accordance with Section 5.4.3 of this SOW. The Contractor shall provide equipment maintenance service/direct customer service and support, Monday thru Friday, to include hotline telephone service. Legal Holidays. The following legal holidays will be observed by the Government: New Year's Day 1 January Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Independence Day 4 July Labor Day First Monday in September Columbus Day Second Monday in October Veteran's Day 11 November Thanksgiving Day Fourth Thursday in November Christmas Day 25 December NOTE: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. CONSERVATION OF UTILITIES. During maintenance, the Contractor shall make sure employees practice utilities conservation. The Contractor shall be responsible for operating under conditions that prevent the waste of utilities to include: Lights shall be used only in areas where work is actually being performed. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning systems. Water faucets or valves shall be turned off when not in use. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the analyzers cannot be safely dumped into each of the facility's drain system, the Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines. RECORDS. The Contractor shall maintain all records necessary to comply with regulatory requirements and Food and Drug Administration (FDA) standards. The Contractor shall be responsible for creating and maintaining those Government required records that are specifically cited in this SOW or required by the provisions of a mandatory directive listed in section 5.4, Applicable Publications and Forms. If requested by the Government, the Contractor shall provide the original record or a reproducible copy of any such record within 5 working days of receipt of the request. REMOVAL OF EQUIPMENT. The Contractor shall not remove any equipment from the Government work site without prior approval of the Contracting Officer or his/her designated representative. UPGRADE OF EQUIPMENT. Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the contract as new technology may become available. Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents or equipment shall be mutually agreed upon by the contractor and the Government through a bilateral modification. SPECIAL WORKING CONDITIONS. All equipment, parts, materials, and incidental services supplied by the Contractor shall conform to the applicable Safety and Health Standards as indicated in the current code of federal Regulations, Title 29, Chapter XVII, paragraph 1910, Occupational Safety Health Act of 1970. CONTRACTOR PERSONNEL. Contractor Employees. The Contractor shall not employ persons for work on this contract if such employee is identified to the Contractor by the Contracting Officer as a potential threat to the health, safety, security, general well-being or operational mission of the installations and their population. Contractor employees shall present a neat appearance and be easily recognized as Contractor employees. Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any Government facility. The Contractor shall not employ any person who is an employee of the US Government. Additionally, the Contractor shall not employ any person who is an employee of the Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7R, "Joint Ethics Regulation". The Contractor shall not employ any person who is an employee of the Department of Defense, if such employment would be contrary to local policies. DEFINITIONS/ACRONYMS. DEFINITIONS. Following is a list of basic definitions.. CONTRACTING OFFICER: The ONLY person with the authority to enter into, administer, change, and/or terminate contracts and make related determinations and findings. GOVERNMENT POINT OF CONTACT (GPOC): A Government employee selected and designated in writing by the Contracting Officer to act as his/her designated representative in administering a contract. NOTE: The GPOC is not authorized to make any changes to the terms and conditions of the contract. QUALITY ASSESSMENT AND IMPROVEMENT. Those actions taken by the Government to check services to determine if they meet the requirements of the CLIA/DoD CLIP '88 & '03, CAP, JCAHO, U.S. Army Medical Command quality assurance and risk management programs, and ensure compliance with the terms and conditions of the contract QUALITY CONTROL. Those actions taken by a Contractor to control the performance of services to ensure that they meet the requirements of the contract. SERVICES: Includes incidental maintenance services and support performed and materials furnished or utilized to maintain the equipment. QUALITY IMPROVEMENT (QI): Those actions taken by the Government, in accordance with BJACH, Quality Plan, relevant CSLI standards for quality, AR 40-68, to assure services meet the requirements of the SOW. 2.2. ACRONYMS/ABBREVIATIONS. Following is a list of basic acronyms/abbreviations used in the contract. AR Army Regulation COR Contracting Officer's Representative CAP College of American Pathologists DA Department of the Army DOD CLIP Department of Defense Clinical Laboratory Improvement Program GPOC Government Point of Contact HIPAA Health Insurance Portability & Accountability Act of 1996 MAS Minimum Acceptable Standards MEDCOM U.S. Army Medical Command JC Joint Commission OSHA Occupational Safety and Health Administration PMS Preventive Maintenance Services PRS Performance Requirements Summary QA Quality Assurance QA&I Quality Assessment & Improvement QC Quality Control SOW Statement of Work GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES. The Government will provide, without additional cost to the Contractor, the facilities, equipment, materials, and services listed below. 3.1. FACILITIES. The Government will furnish the facilities for set-up and operation of the Contractor equipment analyzers required in support of the SOW. Contractor shall not alter the facility without prior approval from the contracting officer. The Contractor shall return the facilities to the Government in the same condition as received, fair wear and tear and approved modifications excepted. These facilities shall be used for performance of this contract only. 12. EQUIPMENT. N/A MATERIALS. No materials will be provided. SERVICES. The Government will provide the following services at no cost to the Contractor: The Government will provide the normal range of facility utilities (e.g. electricity, water, heating, refuse collection, etc.) and other utilities necessary for the full functionality of the equipment/instrumentation. Security: Police and Fire Protection, as is provided other personnel. Emergency Healthcare for Contractor employees. The MTF will provide emergency health care for injuries or life threatening medical emergencies occurring while on duty. The Contractor shall reimburse the Government for such services as billed by the MTF, unless the Contractor employee is otherwise authorized to receive such services at no cost (e.g., is retired military or is a military dependent). CONTRACTOR FURNISHED PROPERTY General. Except for those Government-furnished items and services specified in section 3, the contractor shall furnish all items, equipment, and incidental support and maintenance services required under this contract. Transportation. Transportation in support of any equipment and incidental support and maintenance services is the responsibility of the Contractor. The Government will not provide transportation. Nametags. The Contractor shall furnish a nametag for each contract employee. The nametag will contain the name of the company and the employee. SPECIFIC TASK DESCRIPTION The Contractor shall provide a fully automated coagulation analyzer system capable of performing Prothrombin Time (PT), Partial Thromboplastin Time (PTT) and calculation International Normalized Ratio (INR). The analyzer systems will be from a single Contractor. The Contract for the analyzer will be 1 year and 4 optional years beginning 1 October 2018, for a total of 5 years. The system shall provide redundancy (to ensure continuous operations), training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. All equipment displays and supporting literature must be in the English language. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per CLSI QM guidelines and analyzer removal at the termination of the contract. All costs will be calculated on a monthly payment. For the purposes of this SOW the analyzer system includes at a minimum: Any and all analyzers Peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computer terminals and CPUs, etc) The analyzer system will be located at: Raymond W Bliss Army Health Center Department of Pathology 2240 E Winrow Ave Fort Huachuca, AZ 85613 Within 10 working days after contract award, Contractor shall coordinate and conduct a post award site visit for the purpose of coordinating schedule for equipment installation. Method Validation will be conducted in accordance with method validation protocols established by the Laboratory's Quality Management Program (these protocols are in concordance with applicable standards as described by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP). Relevant guidelines listed in Appendix 2 (below) are the minimum guidelines that will be referenced when conducting method validation. Additional guidelines may be required, depending on regulatory requirements. Method Validation will include but not be limited to, normal range verification, demonstration of linearity with limit of quantitation verification (LOQ), limit of detection verification (LOD), reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of clinical reportable range (CRR), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using control materials, to include third party controls, as designated by the Laboratory Director. The Method Validation will be completed and approved by the Laboratory Director prior to reporting of patient results. Payment for services will not begin until the analyzer system has been approved for reporting of patient results estimated 1 Oct 2018. The Contractor shall provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software as determined by the Laboratory Director (e.g. EP Evaluator®), to provide technical assistance for the method validation studies. The assigned Technical Service Representative will be responsible for the entire Method Validation. All reagents, calibrators and linearity materials used in the Method Validation Study will be provided by the Contractor at no additional cost to the Government. These materials will not be used in the analysis of specimens for patient care The Government's Technical Supervisor will obtain patient specimens for use in the Method Validation. In the event that specimen requirements for correlation studies cannot be met (e.g., insufficient number of patients to challenge the extremes of a curve), the Contractor shall assist in procuring additional specimens. These specimens may be obtained from other laboratories or from Contractor sources. Both the Contractor and Contractor personnel at each location shall abide by all Health Insurance Portability & Accountability Act of 1996 (HIPAA) rules and regulations when conducting the Method Validation Study. The Contractor shall provide two (2) paper and two (2) CD copies of the Operator's and Maintenance manuals and a statement of the warranty terms in the English language. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified is non-Government owned leased equipment that is serviced and maintained by the Contractor. The Contractor shall provide the reagents and shall coordinate exact quantities and shipment schedule with the GPOC prior to shipment IAW Section 5.3.13, Deliveries (below). The Contractor shall be responsible for the collection and transportation of equipment upon termination of the contract. ANALYZERS: Individual analyzer shall be a FDA approved automated coagulation, walk away analyzer for plasma samples to perform PT, PTT & INR. There shall be a single aspiration pathway used for automated and manual sample pipetting on Becton-Dickinson and Greinier tubes and manual pour off tubes. The analyzer must be a digital bar code technology, to read labeled samples tubes and positive tube identification and positive position identification. The analyzer systems shall provide users with rapid, reliable test results that are critical for patient care. These analyzer systems shall (must) be capable of performing in low, medium, and high volume work periods to produce results that are accurate and precise throughout the manufacturer's stated linearity/analytic measurement range. The analyzer system shall offer customizable repeat/reflex testing automatically, without operator intervention. The system shall be capable of on-board decision rules customized to give operators with "if, then" statements to standardize actions for various result scenarios. All analyzer/data management system displays and supporting literature shall be in the English language. The system shall be capable of onboard reagent tracking to monitor lot numbers, expiration dates and volumes. The system provides on board documentation of QC results and actions taken for outliers with electronic archiving and the ability to store multiple lots of QC. Ability to run new and old lot numbers of QC concurrently for parallel testing. Ability to print and evaluate QC data and provide peer evaluations. The analyzer system shall have detector system for bubbles, clots, incomplete sample aspirations, and interfering substances. The analyzer system shall be totally self-contained excluding waste and will not require external water, pressure or vacuum. Vendor shall provide a waste stream analysis and inform the government if any waste requires special handling before disposal. Initial startup from the shutdown state shall (must) not exceed 20 minutes. Each analyzer system shall (must) come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system for 15 to 20 minutes. The analyzer systems and all reagents shall be approved by the Food & Drug Administration (FDA). All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time. 5.2.9 The Government will provide an existing space. 5.3. REAGENTS. The analyzer shall (must) have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed above. All assays must be FDA approved for plasma. The workload listed in Appendix 1 is an estimate based on projected patient workload. Actual workload may vary. The workload numbers represent patient reportable results, and do not include controls or reruns due to troubleshooting or specimen dilutions. The actual workload may fluctuate in the first year of the contract due to changes in the distribution of patient care. In addition, workload may expand in subsequent option years due to fluctuations in patient volume. Appendix.1 provides the estimated workload for Contract Year 1 as well as an estimated workload for each option year. All workload numbers represent total estimated patient reportable/billable results for the indicated year. All Reagents will require minimal preparation. The Contractor shall (must) ensure that all required reagents/reagents packs are accounted for in the loading plan for the assays that are routinely maintained on the analyzer (assays to be routinely maintained on the analyzers will be specified at the time of installation). The Contractor shall provide an estimate of the yearly quantities of reagent, required to perform the volume of patient reportable tests for each assay as provided in Appendix 1. The reagents will be all be shipped in one shipment at the beginning of the period of performance with all reagents expiration dates at least greater than 15 months. The Contractor shall provide quality control materials IAW requirements outlined in the Laboratory QA program and approved by the Laboratory Director. The Contractor shall ensure that requirements for routine quality control runs (as defined by the Laboratory Director and outlined in the Laboratory QA program), specimen dilutions, and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements. The Contractor shall estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at the level of use specified in Appendix 1. An operator level maintenance tool/spare parts kit will be provided and replenishment of all expended items will be made by the contractor, at no additional cost to the Government. Replenishment shall be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle. Reagents shall (must) have a minimum shelf life of six (15) months upon receipt by the Government, or, if this shelf life requirement cannot be met, the Contractor shall (must) identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Proposal. The Contractor shall provide one shipment and one lot of reagents for the entire period of performance. The shipment will be sent at the government's request. During the current period of performance only one lot verification, geometric mean and ISI will be required. All reagents provided shall be identical to those used in the FDA 510K approval application. All reagents shall be provided as follows: Be provided by the manufacturer of the equipment. Be marked with the required storage temperature. Be maintained at the proper storage temperature during transportation from the Contractor's storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature. The Contractor shall provide the reagents, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies as outlined in the Schedule of Supplies/Services. Deliveries. Deliveries of required items shall be annually upon government's request. Orders shall arrive within one week of requested date of delivery. Any supplies that are placed on back order shall be clearly identified on the shipping documents and shall be delivered in a timely manner, not to exceed ten (10) working days. Emergency orders shall be delivered within 24 hours after the order is placed and be of the same lot number of reagents currently in use for the assay(s) for which supplies are being requested. 5.3.14. Preservation and packing - Preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination. All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box. All deliveries will be made Monday through Friday, to exclude Federal Holidays. Deliveries will be sent to Raymond W Bliss Army Health Center ATTN: Laboratory 2240 E Winrow Ave BLDG 45001 Fort Huachuca, AZ 85613 ANCILLARY MAINTENANCE AND SERVICE, ANCILLARY MAINTENANCE. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition. The Contractor shall maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor service personnel in accordance with requirements as specified in the Contractor's instrument maintenance manual. Completion of installation of the analyzers will establish time zero for determination of time frames for performance of the above periodic services. The Contractor shall provide a full unscheduled and preventive maintenance service for the lease period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer's maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems in accordance with section 5.4.3.1 of this PWS. REPAIR. Upon notification of equipment failure, the Contractor's qualified service technician shall establish telephonic contact within 60 minutes of the Government notification to the Contractors Customer Service "Hotline" and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within 24 hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor. The Contractor shall provide replacement parts as necessary for operator level maintenance. The Contractor shall provide all reagents and controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost. The Contractor shall replace all reagents and controls and any other materials used by the Government to trouble shoot the instrument failure prior to notification of the contractor. All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the Contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government. All correspondence, service reports, and invoicing shall be in English. Preventive maintenance services shall be performed in accordance with the manufacturer's standards/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation. 5.4.2.4.1. The Contractor shall notify the GPOC or AGPOC of the exact date and time for performance of a preventive maintenance service within ten (10) days prior to the scheduled preventive maintenance services. Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the Contractor's representative shall report to the laboratory at Raymond W Bliss Army Health Center and then be escorted to Security to get a visitors badge and then to Medical Maintenance to notify them what maintenance is being completed. The badge must be returned to security prior to departing the MTF. Within one (1) working day after completion of a repair, the Contractor's representative shall furnish the chemistry supervisor, laboratory representative or GPOC one (1) copy of a service report for all services performed. The report shall be in English and shall contain, as a minimum, the following information: Nomenclature and serial number Date Description of services performed (i.e., preventive maintenance service, or unscheduled repair service) Location of services performed Duration of performance (hours) List of parts replaced or other actions taken to restore operability of the instrument Name of technician The Government and the Contractor shall exchange hazard communication information before the commencement of any repair. When required, the Contractor shall comply with the Occupational Safety and Health Administration lockout and tag out procedures while performing maintenance on electrical equipment. Safety Inspections shall be performed at least annually in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text on line. Preventive maintenance inspections and calibrations shall be performed in accordance with Contractor's guidance as specified in the Contractor's instrument maintenance manual. When appropriate, the Contractor's representative shall notify Medical Maintenance so a complete DD Form 2163 (sticker), entitled "Medical Equipment Verification/Certification", can be attached to the equipment upon completion of calibration services. If the DD Form 2163 is already attached to the equipment, Medical maintenance shall update the existing DD Form 2163. Procedures for updating the 2163 will be provided by medical maintenance. SERVICE: The Contractor shall provide direct customer service and support, Monday thru Friday, 0700 - 1600 to include hotline telephone service (provided in English) and on-call emergency repair service support, to assist operators in correcting equipment operation problems. The Contractor shall perform Preventive Maintenance Services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment. The Contractor shall provide a full unscheduled and PMS throughout the contract. PMS shall be at no additional cost to the Government inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor's instrument maintenance manuals), unscheduled maintenance and repair of the analyzer and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services. Scheduled routine services shall be performed between 0700-1600 Monday-Friday, excluding Federal Holidays. The Contractor's qualified service technician shall be on site to provide routine services; service requiring immediate repair; and one (1), two (2) or four (4) scheduled services for preventive maintenance (as specified in the Contractor's instrument maintenance manual), safety and calibration as required by this statement of work. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor. Upon analyzer failure, the Contractor's qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement). The Contractor's qualified service technician shall establish telephonic contact within 60 minutes of the Government notification to the Contractors Customer Service "Hotline" and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within four (24) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost. The Contractor shall replace all reagents, calibrators, controls and any other materials used by the Government to trouble shoot the instrument failure prior to notification of the Contractor. The Contractor's qualified service technician shall ensure all repairs are completed and the analyzer is fully operational prior to departing the lab. In addition the service technician or Customer Service "Hotline" will verify the repairs corrected the problem and the analyzer is operational in a follow-up call. This call will be made in a timely fashion (not to exceed 48 hours) after the service technician departs the lab. Should the analyzers become inoperable, the technical repair specialist shall be on-site as described in 5.4.3.6. The Contractor's qualified service technician shall be on-site to provide unlimited emergency service as described in 5.4.3.6. 5.4.3.8.2. The repair of the analyzer must be completed within one business day of initial notification. If deemed necessary after consultation with the GPOC, if the analyzer cannot be repaired within two business days of the initial notification, the Government will ship all patients specimens to a College of American Pathologists accredited clinical laboratory and all additional costs will be reimbursed by the Contractor. If the equipment is out of service for longer than two business days hours (from the time of service technician's arrival on site), the Contractor shall notify the GPOC in writing as to the reason(s) (i.e., non-availability of parts, etc.) for non-compliance. The Contractor shall provide all necessary user-replaceable maintenance items required to support the analyzer and any analyzer specific tools/supplies necessary to perform operator- level periodic maintenance tasks, at no additional cost to the Government. The Government will make the equipment available to the Contractor for servicing at such time and duration necessary to perform needed repairs. TRAINING: The Contractor shall provide initial on-site operator training to all technicians assigned to the Government site (i.e., RWBAHC Laboratory staff) prior to initiation of use of the analyzer for patient testing. In addition, the Contractor shall provide training for two (2) primary operators for the analyzer at the Contractor's training site, prior to delivery and installation of the analyzer at no cost to the Government 5.5.1.1 The on-site operator training shall be provided by qualified Contractor trained personnel. The training shall encompass basic operation, maintenance and troubleshooting. The Contractor shall provide one training slot per contract year, after the first base year of two slots at the Contractor's training site, at no additional cost (including transportation airfare, rental car, per diem, etc.) to the Government. All training manuals/guides, instructional literature, and any other related written/electronic material shall be in the English language. Training shall include basic operation of the analyzers, troubleshooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software. INFORMATION MANAGEMENT. The analyzer system shall (must) be capable of interfacing with the military hospital computer system, i.e., the Composite Health Care System (CHCS). The Contractor shall (must) have an established driver compatible for interfacing the analyzer with the CHCS. The interface between CHCS and the analyzer shall (must) be bidirectional. The analyzer system shall (must) include a data management system for control of the operation of the analyzer system, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer system's data management system. The Data Management system shall have a comprehensive, fully-integrated Quality Control (QC) software module that stores and evaluates quality control results. Results can be viewed in a variety of formats including Levy-Jennings charts, moving patient averages, and statistical summaries. The application shall validate QC results by checking them against user selected rules and automatically alert the operator when a rule violation has occurred. Data Management system shall (must) have a user friendly "Windows Based" interface that shall include a data management system for operational control of the analyzer system, management of the QC program, on-instrument useful life of the reagents/reagent packs, and management of patient results. The software shall provide a single operator interface for workload management, data management, and instrument operational status monitoring. The software controls the operations of the analyzer, monitors the lot number expiration date of on-board reagents and control materials. This shall be accomplished via communication connections between the automation, analyzers, and hospital Laboratory Information System (LIS). The results management application shall manage patient data, sample and QC results by offering archiving, status, calculation of results and long-term results storage. 5.6.3.3 The software shall provide proactive monitoring of key instrument parameters to allow for predictive diagnostics. DELIVERY OF EQUIPMENT: The Analyzers will be delivered to the location as indicated below within 30 calendar days after contract award. Equipment setup, on-site training, method validation studies, and analytical measurement range/linearity verification, shall (must) be completed by Contractor personnel within a period of time to ensure that equipment is fully operational by 1 October 2018. During the initial implementation, a dedicated technical representative must be available on site throughout the entire implementation period. Substitutions must be coordinated with the GPOC. PRIMARY LOCATIONS OF COMPLETE SYSTEMS: The system shall be delivered to: Raymond W Bliss Army Health Center ATTN: Laboratory 2240 E Winrow Ave BLDG 45001 Fort Huachuca, AZ 85613 The system shall be installed at Raymond W Bliss Army Health Center Dept. of Pathology 2240 E Winrow Ave BLDG 45001 Fort Huachuca, AZ 85613 Exact installation locations at the primary location shall be coordinated by the Contractor with the point of contacts listed below: Hematology Supervisor Raymond W Bliss Army Health Center Tel: 520-533-3500 SAFETY DATA SHEETS (SDS) The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the English language and shall contain as a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident. INFORMATION SECURITY TELECOMMUNICATION All Contractor systems that communicate with Department of Defense (DoD) systems shall interconnect through the established Military Healthcare System (MHS) Virtual Private Network (VPN) Business to Business (B2B) gateway. For all Web applications, Contractors shall connect to a Defense Information Systems Agency (DISA)-established Web Demilitarize Zone (DMZ). All software must be able to pass MITC testing and review and be awarded a Certificate of Networthiness (CoN) from NETCOM. Submission of the CoN must be completed within six (6) months of contract award. The Contractor shall follow Army Regulation 25-1, "Army Knowledge Management and Information Technology, AR 25-2, "Information Assurance (IA)", and DoD 6025.18-R, DoD Health Information Privacy Regulation. In accordance with contract requirements, Contractors shall connect to the B2B gateway via a Contractor procured Internet Service Provider (ISP) connection. The Contractor shall assume all responsibility for establishing and maintaining their connectivity to the B2B gateway. This shall include acquiring and maintaining the circuit to the B2B gateway and acquiring a Virtual Private Network (VPN) device compatible with the MHS VPN device. The Contractor shall comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies and will provide, maintain and configure VPN concentrator that complies with DoD security standards. All costs for VPN hardware and software shall be incurred by the Contractor. DEPARTMENT OF DEFENSE INFORMATION ASSURANCE CERTIFICATION AND ACCREDITATION PROCESS (DIACAP) IMPLEMENTATION PLAN The Contractor shall provide all required information to support and initiate the DIACAP Implementation Plan. This shall include the required information for the System Identification profile. The Contractor shall provide information for the Risk Assessment Analysis to the Government for all networking IT applicability. ELECTRONIC SECURITY. Contractor Information Systems (IS)/networks that are involved in the operation of systems in support of MAHC shall operate in accordance with controlling laws, regulations, DoD, and local policy. Certification & Accreditation (C&A) requirements apply to all DoD and Contractor's IS/networks that receive, process, display, store or transmit DoD information. The Contractor shall comply with the C&A process for safeguarding IS. Certification is the determination of the appropriate level of protection required for IS/networks. Certification also includes a comprehensive evaluation of the technical and non-technical security features and countermeasures required for each system/network. Accreditation is the formal approval by the Government to operate the Contractor's IS/networks in a particular security mode using a prescribed set of safeguards at an acceptable level of risk. In addition, accreditation allows IS/networks to operate within the given operational environment with stated interconnections; and with appropriate level of protection for the specified period. The Contractor shall comply with C&A requirements, as specified by the Government that meet appropriate DoD Information Assurance requirements. The C&A requirements shall be met before the Contractor's system is authorized to access DoD data or interconnect with any DoD IS/network that receives, processes, stores, displays or transmits DoD data. The Contractor shall ensure the proper Contractor support staff is available to participate in all phases of the C&A process. They include, but are not limited to: Attending and supporting C&A meetings with the Government Supporting/conducting the vulnerability mitigation process Supporting the C&A Team during system security testing Contractors shall (must) confirm that their networks are locked down prior to initiating testing. Conformation of system lock down shall be agreed upon during the definition of the C&A boundary and be signed and documented as part of the System Security Authorization Agreement (SSAA). Locking down the system means that there shall be no changes made to the configuration of the system (within the C&A boundary) during the C&A process. Any re-configuration or change in the system during the C&A testing process shall require a re-base lining of the system and documentation of system changes. Information Assurance (IA) mitigation strategies include security updates, service packs, and changes to operating procedures as physical and cyber vulnerabilities are detected. Operating system, routers, servers, development platforms and the application being delivered to the Government shall be in compliance with all known applicable Department of Defense Computer Emergency Response Team (DoD-CERT) Alert, Bulletin, and Technical Advisory Notices published during the past 36 months. Disposing of Electronic Media. Contractor shall follow the DoD standards, procedures, and use approved products to dispose of unclassified hard drives and other electronic media, as appropriate, in accordance with DoD Memorandum "Disposition of Unclassified Computer Hard Drives," June 4, 2001. Contractor is required to also follow DoD guidance on sanitization of other internal and external media components in DODI 8500.2 "Information Assurance (IA) Implementation," 6 Feb 2003 (see PECS-1 in enclosure 4 Attachment 5) and DoD 5220.22-M "Industrial Security Program Operating Manual (NISPOM)," (Chapter 8). Information Assurance Vulnerability Management (IAVM). The Contractor shall implement an information assurance vulnerability management program for all AIS and corresponding subnets that are connected to or intermittently connect to DoD networks. The program shall meet the scope and intent of AR25-2 and MAHC IA policies to provide protection against known threats and vulnerabilities. Compliance with DoD IAVM alerts and bulleting is required for these systems and shall be completed within the specified timeframe. INFORMATION SYSTEMS (IS)/NETWORKS PHYSICAL SECURITY. The Contractor shall employ physical security safeguards for IS/Networks involved in processing or storage of Government Data to prevent the unauthorized access, disclosure, modification, destruction, use, etc., and to otherwise protect the confidentiality and ensure use conforms with DoD regulations. In addition, the Contractor shall support a Physical Security Audit performed by the Government of the Contractor's internal information management infrastructure. The MHS Physical Security Audit Matrix is available at: http://www.tricare.osd.mil/tmisnew/Policy/PSAMatrix%20012304%200930%20clean%20versio n.xls. The Contractor shall correct any deficiencies identified by the Government of the Contractor's physical security posture. SPECIAL REQUIREMENTS FOR PROTECTED HEALTH INFORMATION. Whenever a contract is awarded that requires the vendor to collect, use, copy, access or store Protected Health Information (PHI) in commercial office space, the Contractors shall (must): 6,7.2. Notify the MTF HIPAA Security Manager. 6.7.3. Follow all DUA and DoD requirements for secure disposal, destruction, and/or sanitization of all equipment that contained PHI. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (June 2012) In 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. 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. 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. The Contractor shall use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract. 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. 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/trna/nrivacv/breach.aspx. The Contractor shall report to the Government any security incident involving protected health information of which it becomes aware. 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. 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. 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. 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. The Contractor shall make any amendment(s) to Protected Health Information 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. 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. 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. 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 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. 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. 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). 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 The Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520. The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Contractor's permitted or required uses and disclosures. 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 shalt not request the Contractor to use or disclose Protected 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 8580.02-10 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 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. Effect of Termination. 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 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. 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 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. 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. 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. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS. GENERAL. Applicable documents - The latest practicable local and national (US) technical regulations are applicable for the manufacturing of the system. In case of differences between local and national regulations, the regulations containing the most stringent requirements shall govern. Contractor will comply with all U.S. laws pertaining to medical equipment. Contractor will also comply with all Department of Defense (DOD), Department of Army (DA), US Army Medical Command (USAMEDCOM), Western Regions Medical Command and Munson Army Health Center regulations and policies pertaining to medical equipment. Current issues of many DA publications can be accessed at http://www.usapa.army.mil/gils. Current issues of many forms can be accessed at http://www.usapa.anny.mil/forms. Publications and forms not on the intemet can be obtained from the MTF. These regulations include, but are not limited to, the following: The Publications have been coded as mandatory or advisory. The Contractor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance but are not binding for compliance. Publications: 8.3.1. Mandatory: Public Law 91-596 29 Dec 70 Occupational Safety and Health Administration Public Law 104-191 (Aug 1996) Health Insurance Portability and Accountability Act of 1996 Current Edition Joint Commission for Accreditation of Healthcare Organizations (JCAHO) Manual AR 40-1 Composition, Mission, and Functions of the Army Medical Department AR 40-2 Army Medical Treatment Facilities and General Administration AR 40-4 Army Medical Department Facilities/Activities AR 40-68Quality Assurance Administration AR 340-21The Army Privacy Program (05 Jul 85) AR 380-19Information Systems Security AR 380-76The Department of the Army Personnel Security Program AFIP PAMPHLET 40-24; Clinical Laboratory Improvement Program (CLIP) policy mandated by DODI 6440.2 NFPA 99, Chapter 7.7.3.2. Advisory W9 I YU0-15-F-0162 Page 34 of 37 AR 310-25Dictionary of United States Army Terms MEDCOM Pam 25-31Index of Command Administrative Publications (15 AUG 01) (End Performance Based Work Statement) PERFORMANCE MEASUREMENTS REQUIREMENT SUMMARY. The following performance objectives and measures will be used to evaluate Contractor performance and compliance under the contract. This information will be used to prepare annual past performance evaluations. See Attachment 2, Laboratory Continuous Quality Improvement, for additional details. PERFORMANCE REQUIREMENT PERFORMANCE STANDARD PERFORMANCE LEVEL SURVEILLANCE METHOD 1. Method Validation for new assays. SOW section 5.1.3. Method Validation for new assays will be conducted in accordance with method validation protocols established by the Department of Pathology's Quality Management Program Meets - 99% based on the number of new assays implemented each performance period. Review assessment of Method Validation results. GPOC Monitors 2. Contractor shall provide telephone support Mon - Fri. SOW section 5.4.3.1. Provides telephone support 5 days a week as required. Meets - 99% based on the number of calls placed each month. Continuous monitoring. GPOC Monitors 3.Repair service engineer responds with 24 hours after notification for routine/ emergency failures SOW section 5.4.2. & 5.4.3.6. Response for repairs as required. Meets - 99% based on the he number of service visits placed each month Repairs completed. GPOC Monitors 4. The Contractor delivers reagents within one (1) week after delivery is requested. SOW section 5.3.14. Agents delivered as required. Meets - 95% based on the number of reagents delivered each month Review of delivery documents. GPOC Monitors 5. The minimum shelf life of the reagents will be 15 months after the date of delivery. SOW Para 5.3.10. Agent minimum shelf life meets requirements. Meets - 99% based on the number of DA Forms 1974 processed each month Continuous monitoring shelf life dates. GPOC Monitors. 6. The contractor shall provide all data and material to verify analytical measurement range. SOW Para 5.1.3.1 Provides data and for verification of measurements range as required. Meets - 100% based on finished analytical measurement range summary and report. Review of reports. GPOC monitors. 7. Packing and temperature control requirements for all reagents and supplies. SOW Para 5.3.1.2. Meets packaging & temperature controls required. Meets - 99% based on each shipment of supplies and reagents. Inspection upon receipt. The inspection and acceptance point for all services rendered under this contract will be by the Hematology Supervisor, the Laboratory Quality Assurance and the Laboratory Manger. The performance by the Contractor shall be subject to continuous inspection, surveillance and review for acceptance by the Government Point of Contact (GPOC) or designated representative. The purpose of this section is to list the contract requirements considered most critical to acceptable contract performance. Show the maximum allowable degree of deviation from perfect performance for each requirement or Minimum Acceptable Standards (MAS) that will be allowed by the Government before contract performance is considered unsatisfactory. Explain the Quality Assurance methods the Government will use to evaluate the Contractor's performance in meeting the contract requirements. The Government's primary quality assurance procedures are based on variability seen in short- and long-term quality control performance (accuracy and precision of instrument performance), shelf life of reagents (whether the reagents are supplied with the requisite shelf life remaining and whether reagent performance is stable up to the advertised expiration date), proficiency test performance, frequency and duration of instrument downtime, Contractor response to requests for assistance/repair of the instruments, and customer complaints. Criteria for acceptable and unacceptable performance will be based on the MAS for each contract requirement. When the number of defects in the Contractor's performance which are discovered by the GPOC exceeds the unacceptable level, the Contracting Officer may complete a CDR. The CDR requires the Contractor to explain, in writing, why performance was unacceptable, how performance will be returned to acceptable levels and how recurrence of the problem will be prevented in the future. Performance/Quality Standards for the coagulation analytes: The MAS for specific analyte standards required of the Contractor are derived from the Federally mandated DoD CLIP and CLIA '03 Pamphlet 40-24; 42 CFR 493 Chapter 8, Proficiency Test Programs for Coagulation These Proficiency Test Program standards are also used as for MAS for method validation studies and correlation studies between analyzers. Each analyte must perform within these standards to be considered minimally acceptable. Appendix 1 Analyte/Test Projected Annual Volume Prothrombin Time (PT) 800 International Normalized Ratio (INR) 800 Partial Thromboplastin Time 300 Additional Items for surveillance: Analyzer shall be operational 99.9% of the time in a 40 hour week The Contractor responds to all calls in accordance with paragraph 5.4.2. 9.6.5. Quality Control material: Analyzers are monitored each day of use. The analyzer shall perform within historical records established by the performance of the analyzer; performance must also be within the federally accepted limits of performance. If there are known discrepancies with the QC material itself, then an official MEMO stating the exact nature of the material or analyte problem shall be noted. An alternate QC material or method shall be provided by the Contractor which shall follow the same Federal Minimal Acceptable Standards. Surveillance checklists/ Checklists will be used to record surveillance results of contract requirements that will be surveyed on a periodic basis. The Contractor shall be permitted to accompany the GPOC during the receipt of equipment, training, reagents, supplies, or performance of service provided. Defects will be documented by the GPOC to identify the deficiency and the manner in which the deficiency is not in conformity with the contract requirement. The Contractor and Contracting Officer will be provided a copy of such documented reports. Requirements to be inspected under this procedure are listed in Section 5 above. 9.7.2, The Government Point of Contact or Hematology Supervisor will inspect all deliveries, pallets of reagents and supplies, training, and invoices to ensure they have met Minimum Acceptable Standards (MAS). Services and deliveries will be monitored by the GPOC. Results will be recorded on the invoice and receiving report. Installation Specific Security Requirements for PWS/SOW/SOO Installation Physical Security/Access Contractors must check in to the Van Deman Gate upon initial access to perform background check before gaining access to Fort Huachuca. An initial 30 day post pass will be granted at this time. Any additional passes will be requested by the contractor. All personnel employed under this contract will adhere to all Fort Huachuca access control policies which include, weapons registration, transportation of weapons on the installation, access control policies, use of installation passes and ID cards and the operation of motor vehicles. A check of records through the National Crime Information Center (NCIC) Interstate Identification Index (III) is the Army minimum baseline background check for entrance onto Army installations for non-CAC holders to include entrance of visitors. The contractor shall provide employees with company identification (ID) cards prior to their commencement of work. The ID format is subject to approval by the government. IDs shall be laminated and include the company's name, ID number, issue and expiration dates, employee name, job title and color photograph. Employees shall wear ID cards on front exterior clothing, above the waist, when performing under the Performance of Work Statement (PWS)/Statement of Work (SOW) unless otherwise specified herein or approved by the government. Physical Security Plan. The contractor shall address the physical security aspects associated with contract performance in government furnished facilities. The plan shall describe how the Security Plan shall prevent unauthorized access, vandalism, pilferage, larceny, sabotage, and arson directed toward contractor controlled facilities. Information Systems Security Plan. The information systems security plan shall establish security procedures for all computer systems and communications utilized in the performance of this PWS/SOW/SOO. The plan shall conform to AR 25-2, AR 25-1 and AR 380-67. The contractor shall ensure that its employees, performing under this contract who has access to government information systems receive annual Information Technology security training. IRAPT Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) - formerly known as WAWF iRAPT is the authorized method to electronically process vendor request for payment. This application allows DOD vendors to submit and track Invoices and Receipt/Acceptance documents electronically. Contractor shall (i) register to use iRAPT at https://wawf.eb.mil and (ii) ensure an electronic business point of contract (POC) is designated in the System for Award Management at https://www.sam.gov within ten (10) calendar days after award of this contract/order. iRAPT Instructions: Questions concerning payments should be directed to the Defense Finance and Accounting Service (DFAS) location listed in Block 18a of your purchase order/contract. Please have your purchase order/contract number ready when calling about payments. You can easily access payment and receipt information using the DFAS web site at http://www.dfas.mil/money/vendor. Your purchase order/contract number or invoice number will be required to inquire status of your payment. The following codes and information will be required to assure successful flow of iRAPT documents. Foreign Vendors will submit banking information in the Comments Tab of the iRAPT invoice. TYPE OF DOCUMENT [X the appropriate block] Invoice (Contractor Only) Invoice and Receiving Report (COMBO) Invoice as 2-in-1 (Services Only) Receiving Report (Government Only) CAGE CODE: ISSUE BY DODAAC: ADMIN BY DODAAC: INSPECT BY DODAAC: ACCEPT BY DODAAC: SHIP TO DODAAC: PAYMENT OFFICE FISCAL STATION CODE: EMAIL POINTS OF CONTACT LISTING: INSPECTOR Primary: ACCEPTOR Primary: RECEIVING OFFICE POC: CONTRACT ADMINISTRATOR/ SPECIALIST: DSN: Comm: - Fax: CONTRACTING OFFICER: See Block 31b on SF1449 for email address. ADDITIONAL CONTACT: Any modification requests must be in writing and submitted to: ADMIN DODAAC. (End of Clause) CLAUSES INCORPORATED BY REFERENCE 52.212-1 Instructions to Offerors--Commercial Items JAN 2017 52.212-1 ADDENDUM (m) The non-FAR Part 12 discretionary FAR and DFARS provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found. (End of Addendum) CLAUSES INCORPORATED BY FULL TEXT 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016) Definition. As used in this provision-- Commercial and Government Entity (CAGE) code means- An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity; or An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code. The Offeror shall enter its CAGE code in its offer with its name and address or otherwise include it prominently in its proposal. The CAGE code entered must be for that name and address. Enter ``CAGE'' before the number. The CAGE code is required prior to award. CAGE codes may be obtained via-- Registration in the System for Award Management (SAM) at www.sam.gov. If the Offeror is located in the United States or its outlying areas and does not already have a CAGE code assigned, the DLA Commercial and Government Entity (CAGE) Branch will assign a CAGE code as a part of the SAM registration process. SAM registrants located outside the United States and its outlying areas shall obtain a NCAGE code prior to registration in SAM (see paragraph (c)(3) of this provision). The DLA Commercial and Government Entity (CAGE) Branch. If registration in SAM is not required for the subject procurement, and the offeror does not otherwise register in SAM, an offeror located in the United States or its outlying areas may request that a CAGE code be assigned by submitting a request at https://cage.dla.mil. The appropriate country codification bureau. Entities located outside the United States and its outlying areas may obtain an NCAGE code by contacting the Codification Bureau in the foreign entity's country if that country is a member of NATO or a sponsored nation. NCAGE codes may be obtained from the NSPA at https://eportal.nspa.nato.int/AC135Public/scage/CageList.aspx if the foreign entity's country is not a member of NATO or a sponsored nation. Points of contact for codification bureaus, as well as additional information on obtaining NCAGE codes, are available at http://www.nato.int/structur/AC/135/main/links/contacts.htm. Additional guidance for establishing and maintaining CAGE codes is available at https://cage.dla.mil. When a CAGE Code is required for the immediate owner and/or the highest-level owner by 52.204-17 or 52.212-3(p), the Offeror shall obtain the respective CAGE Code from that entity to supply the CAGE Code to the Government. Do not delay submission of the offer pending receipt of a CAGE code. (End of Provision) CLAUSES INCORPORATED BY REFERENCE 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 Certifications. OCT 2015 CLAUSES INCORPORATED BY FULL TEXT 52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS-- REPRESENTATION (NOV 2015) Definitions. Inverted domestic corporation and subsidiary have the meaning given in the clause of this contract entitled Prohibition on Contracting with Inverted Domestic Corporations (52.209-10). Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4. Representation. The Offeror represents that-- It [ ] is, [ ] is not an inverted domestic corporation; and It [ ] is, [ ] is not a subsidiary of an inverted domestic corporation. (End of provision) 52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that-- Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government. The Offeror represents that-- It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months. (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): HTTPS://FARSITE.HILL.AF.MIL (End of provision) 52.252-5 AUTHORIZED DEVIATIONS IN PROVISIONS (APR 1984) The use in this solicitation of any Federal Acquisition Regulation (48 CFR Chapter 1) provision with an authorized deviation is indicated by the addition of"(DEVIATION)" after the date of the provision. The use in this solicitation of any DoD FAR Supplement (48 CFR Chapter 2) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation. (End of provision) 252.203-7005 REPRESENTATION RELATING TO COMPENSATION OF FORMER DOD OFFICIALS (NOV 2011) Definition. Covered DoD official is defined in the clause at 252.203-7000, Requirements Relating to Compensation of Former DoD Officials. By submission of this offer, the offeror represents, to the best of its knowledge and belief, that all covered DoD officials employed by or otherwise receiving compensation from the offeror, and who are expected to undertake activities on behalf of the offeror for any resulting contract, are presently in compliance with all post-employment restrictions covered by 18 U.S.C. 207, 41 U.S.C. 2101-2107, and 5 CFR parts 2637 and 2641, including Federal Acquisition Regulation 3.104-2. (End of provision) 252.204-7008 COMPLIANCE WITH SAFEGUARDING COVERED DEFENSE INFORMATION CONTROLS (OCT 2016) Definitions. As used in this provision-- Controlled technical information, covered contractor information system, covered defense information, cyber incident, information system, and technical information are defined in clause 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting. The security requirements required by contract clause 252.204-7012 shall be implemented for all covered defense information on all covered contractor information systems that support the performance of this contract. For covered contractor information systems that are not part of an information technology service or system operated on behalf of the Government (see 252.204-7012(b)(2))-- By submission of this offer, the Offeror represents that it will implement the security requirements specified by National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171, ``Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations'' (see http://dx.doi.org/10.6028/NIST.SP.800-171) that are in effect at the time the solicitation is issued or as authorized by the contracting officer not later than December 31, 2017. (2)(i) If the Offeror proposes to vary from any of the security requirements specified by NIST SP 800-171 that are in effect at the time the solicitation is issued or as authorized by the Contracting Officer, the Offeror shall submit to the Contracting Officer, for consideration by the DoD Chief Information Officer (CIO), a written explanation of- Why a particular security requirement is not applicable; or How an alternative but equally effective, security measure is used to compensate for the inability to satisfy a particular requirement and achieve equivalent protection. (ii) An authorized representative of the DoD CIO will adjudicate offeror requests to vary from NIST SP 800-171 requirements in writing prior to contract award. Any accepted variance from NIST SP 800-171 shall be incorporated into the resulting contract. (End of provision) 52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014) a. See Addendum 52.212.2 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. (End of provision) 52.212-2 ADDENDUM Award will be made using the lowest price technically acceptable (LPTA) source selection process. Award will be made to the responsibleofferor on the basis of the lowest evaluated price of proposals meeting or exceeding the acceptability standards for non-cost factors. Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary. Paragraph (a) is hereby replaced with the following: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation is Lowest Price, Technically Acceptable (LPTA). Award will be made on all or nothing basis. The following evaluation factors shall be used to evaluate offers: Technically Acceptability and Price Technical Capability. The following adjectival ratings will be used in evaluating the offeror's technicalquote: Acceptable - To receive this rating, the offerors product shall meet each of the performance objectives set forth in the solicitation. Unacceptable - An unacceptable rating will be assessed on any offeror that presents items that demonstrate any of the following: Failure to meet each of the performance objectives set forth in the solicitation. Failure to qualify the "yes" or "no" response of each salient characteristic in sufficient detail for the Government to determine whether the item satisfactorily meets the requirements of this solicitation. Failure to provide brochures and/or product information Technical acceptability: If providing an "equal" item(s), comply with FAR Provision 52.211-6, Brand Name or Equal. Explain how your company will meet the salient characteristics of the items as listed in the solicitation. Offeror will be found technically acceptable if the offer meets the salient characteristics listed below. Stago Satellite #58104, Cost Per Reportable Results: Must be provide fully automated coagulation analyzer Must provide reagents Must perform Prothrombin Time (PT) and calculation International Normalized Ratio (INR) Must perform Partial Tromboplastin Time (PTT) Must perform calculation International Normalized Ratio (INR) Must include Preventive and Emergency Maintenance Must include delivery, installation Must be FDA approved Price Contractor must submit their proposals to the following address: Regional Health Contracting Office - Central MCAA-S Attn: MaryAnn Teniente 3551 Roger Brooke Drive, Room L31-9V Fort Sam Houston, TX 78234-6200 Proposals must be submitted on time to the mailing address above, or by e-mail to maryann.i.teniente.civ@mail.mil. Evaluation Process: All quotes will be evaluated on their prices and technical acceptability. The award decision will be based on the lowest priced technically acceptable quote. Potential contractor must be registered in the System for Award Management (SAM) to be eligible for award. The SAM website is https://www.sam.gov. (End of Provision) CLAUSES INCORPORATED BY FULL TEXT 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (NOV 2017) ALTERNATE I (OCT 2014) The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site located at https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) of this provision. Definitions. As used in this provision-- "Economically disadvantaged women-owned small business (EDWOSB) concern" means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program. "Forced or indentured child labor" means all work or service- Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties. "Highest-level owner" means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner. "Immediate owner" means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees. "Inverted domestic corporation," means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c). "Manufactured end product" means any end product in product and service codes (PSCs) 1000-9999, except- PSC 5510, Lumber and Related Basic Wood Materials; Product or Service Group (PSG) 87, Agricultural Supplies; PSG 88, Live Animals; PSG 89, Subsistence; PSC 9410, Crude Grades of Plant Materials; PSC 9430, Miscellaneous Crude Animal Products, Inedible; PSC 9440, Miscellaneous Crude Agricultural and Forestry Products; PSC 9610, Ores; PSC 9620, Minerals, Natural and Synthetic; and 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. "Restricted business operations" means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate- Are conducted under contract directly and exclusively with the regional government of southern Sudan; Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization; Consist of providing goods or services to marginalized populations of Sudan; Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization; Consist of providing goods or services that are used only to promote health or education; or Have been voluntarily suspended. "Sensitive technology"- Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically- To restrict the free flow of unbiased information in Iran; or To disrupt, monitor, or otherwise restrict speech of the people of Iran; and Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)). "Service-disabled veteran-owned small business concern"- Means a small business concern- Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran. Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service- connected, as defined in 38 U.S.C. 101(16). "Small business concern" means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation. "Small disadvantaged business concern, consistent with 13 CFR 124.1002," means a small business concern under the size standard applicable to the acquisition, that-- Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by-- One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition. "Subsidiary" means an entity in which more than 50 percent of the entity is owned- Directly by a parent corporation; or Through another subsidiary of a parent corporation. "Veteran-owned small business concern" means a small business concern- Not less than 51 percent of which is owned by one or more veterans(as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and The management and daily business operations of which are controlled by one or more veterans. "Women-owned business concern" means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of the its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women. "Women-owned small business concern" means a small business concern -- That is at least 51 percent owned by one or more women or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and Whose management and daily business operations are controlled by one or more women. "Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127)," means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States. Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the SAMwebsite. The offeror has completed the annual representations and certifications electronically via the SAM website accessed through https://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representation and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs. [Offeror to identify the applicable paragraphs at (c) through (u) of this provision that the offeror has completed for the purposes of this solicitation only, if any. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.] Offerors must complete the following representations when the resulting contract is to be performed in the United States or its outlying areas. Check all that apply. Small business concern. The offeror represents as part of its offer that it [ business concern. ] is, [ ] is not a small Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [ is not a veteran-owned small business concern. ] is, [ ] Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a service-disabled veteran-owned small business concern. Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.]The offeror represents that it [ disadvantaged business concern as defined in 13 CFR 124.1002. ] is, [ ] is not, a small Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.]The offeror represents that it [ owned small business concern. ] is, [ ] is not a women- Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold. WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women- owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that- It [ ] is, [ ] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture:.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation. Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that- It [ ] is, [ ] is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture:.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation. Women-owned business concern (other than small business concern). [Complete only if the offeror is a women- owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ] is, a women-owned business concern. Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price: HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that-- It [ ] is, [ ] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR part 126; and It [ ] is, [ ] is not a HUBZone joint venture that complies with the requirements of 13 CFR part 126, and the representation in paragraph (c)(10)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture:.] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation. (Complete if the offeror has represented itself as disadvantaged in paragraph (c)(4) of this provision.) [The offeror shall check the category in which its ownership falls]: Black American. Hispanic American. Native American (American Indians, Eskimos, Aleuts, or Native Hawaiians). Asian-Pacific American (persons with origins from Burma, Thailand, Malaysia, Indonesia, Singapore, Brunei, Japan, China, Taiwan, Laos, Cambodia (Kampuchea), Vietnam, Korea, The Philippines, Republic of Palau, Republic of the Marshall Islands, Federated States of Micronesia, the Commonwealth of the Northern Mariana Islands, Guam, Samoa, Macao, Hong Kong, Fiji, Tonga, Kiribati, Tuvalu, or Nauru). Subcontinent Asian (Asian-Indian) American (persons with origins from India, Pakistan, Bangladesh, Sri Lanka, Bhutan, the Maldives Islands, or Nepal). Individual/concern, other than one of the preceding. Representations required to implement provisions of Executive Order 11246 -- Previous contracts and compliance. The offeror represents that -- It [ ] has, [ ] has not, participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and It [ ] has, [ ] has not, filed all required compliance reports. Affirmative Action Compliance. The offeror represents that -- It [ ] has developed and has on file, [ ] has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 CFR parts 60-1 and 60-2), or It [ ] has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor. Certification Regarding Payments to Influence Federal Transactions (31 U.S.C. 1352). (Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payments of reasonable compensation were made. Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225-1, Buy American - Supplies, is included in this solicitation.) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of "domestic end product." The terms "commercially available off-the-shelf (COTS) item," "component," "domestic end product," "end product," "foreign end product," and "United States" are defined in the clause of this solicitation entitled "Buy American-Supplies." Foreign End Products: LINE ITEM NO. COUNTRY OF ORIGIN [List as necessary] The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. (g) Buy American -- Free Trade Agreements -- Israeli Trade Act Certificate. (Applies only if the clause at FAR 52.225-3, Buy American -- Free Trade Agreements -- Israeli Trade Act, is included in this solicitation.) The offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The terms "Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product," "commercially available off-the-shelf (COTS) item," "component," "domestic end product," "end product," "foreign end product," "Free Trade Agreement country," "Free Trade Agreement country end product," "Israeli end product," and "United States" are defined in the clause of this solicitation entitled "Buy American--Free Trade Agreements--Israeli Trade Act." The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act": Free Trade Agreement Country End Products (Other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products: LINE ITEM NO. COUNTRY OF ORIGIN [List as necessary] The offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) or this provision) as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements- Israeli Trade Act." The offeror shall list as other foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of "domestic end product." Other Foreign End Products: LINE ITEM NO. COUNTRY OF ORIGIN [List as necessary] The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate I. If Alternate I to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g)(1)(ii) The offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act": Canadian End Products: Line Item No.: [List as necessary] Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate II. If Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g)(1)(ii) The offeror certifies that the following supplies are Canadian end products or Israeli end products as defined in the clause of this solicitation entitled "Buy American--Free Trade Agreements--Israeli Trade Act'': Canadian or Israeli End Products: Line Item No.: Country of Origin: [List as necessary] Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate III. If Alternate III to the clause at 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act": Free Trade Agreement Country End Products (Other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products: Line Item No.: Country of Origin: [List as necessary] Trade Agreements Certificate. (Applies only if the clause at FAR 52.225-5, Trade Agreements, is included in this solicitation.) The offeror certifies that each end product, except those listed in paragraph (g)(5)(ii) of this provision, is a U.S.- made or designated country end product as defined in the clause of this solicitation entitled "Trade Agreements." The offeror shall list as other end products those end products that are not U.S.-made or designated country end products. Other End Products Line Item No.: Country of Origin: [List as necessary] The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for such products are insufficient to fulfill the requirements of the solicitation. Certification Regarding Responsibility Matters (Executive Order 12689). (Applies only if the contract value is expected to exceed the simplified acquisition threshold.) The offeror certifies, to the best of its knowledge and belief, that the offeror and/or any of its principals-- (1) [ ] Are, [ ] are not presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency; (2) [ ] Have, [ ] have not, within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a Federal, state or local government contract or subcontract; violation of Federal or state antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property; and (3) [ ] Are, [ ] are not presently indicted for, or otherwise criminally or civilly charged by a Government entity with, commission of any of these offenses enumerated in paragraph (h)(2) of this clause; and (4) [ ] Have, [ ] have not, within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds $3,500 for which the liability remains unsatisfied. Taxes are considered delinquent if both of the following criteria apply: The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted. The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded. Examples. The taxpayer has received a statutory notice of deficiency, under I.R.C. §6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appear rights. The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. §6320 entitling the taxpayer to request a hearing with the IRS Office of Appeals Contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights. The taxpayer has entered into an installment agreement pursuant to I.R.C. §6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment. The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. §362 (the Bankruptcy Code). Certification Regarding Knowledge of Child Labor for Listed End Products (Executive Order 13126). [The Contracting Officer must list in paragraph (i)(1) any end products being acquired under this solicitation that are included in the List of Products Requiring Contractor Certification as to Forced or Indentured Child Labor, unless excluded at 22.1503(b).] Listed End Product Listed End Product: Listed Countries of Origin: Certification. [If the Contracting Officer has identified end products and countries of origin in paragraph (i)(1) of this provision, then the offeror must certify to either (i)(2)(i) or (i)(2)(ii) by checking the appropriate block.] [ ] (i) The offeror will not supply any end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. [ ] (ii) The offeror may supply an end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. The offeror certifies that is has made a good faith effort to determine whether forced or indentured child labor was used to mine, produce, or manufacture any such end product furnished under this contract. On the basis of those efforts, the offeror certifies that it is not aware of any such use of child labor. Place of manufacture. (Does not apply unless the solicitation is predominantly for the acquisition of manufactured end products.) 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- [ ] 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 [ ] Outside the United States. Certificates regarding exemptions from the application of the Service Contract Labor Standards. (Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services.) [The contracting officer is to check a box to indicate if paragraph (k)(1) or (k)(2) applies.] (1) [ ] Maintenance, calibration, or repair of certain equipment as described in FAR 22.1003-4(c)(1). The offeror [ ] does [ ] does not certify that- The items of equipment to be serviced under this contract are used regularly for other than Governmental purposes and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontract) in substantial quantities to the general public in the course of normal business operations; The services will be furnished at prices which are, or are based on, established catalog or market prices (see FAR 22.1003-4(c)(2)(ii)) for the maintenance, calibration, or repair of such equipment; and The compensation (wage and fringe benefits) plan for all service employees performing work under the contract will be the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers. (2) [ ] Certain services as described in FAR 22.1003-4(d)(1). The offeror [ ] does [ ] does not certify that- The services under the contract are offered and sold regularly to non-Governmental customers, and are provided by the offeror (or subcontractor in the case of an exempt subcontract) to the general public in substantial quantities in the course of normal business operations; The contract services will be furnished at prices that are, or are based on, established catalog or market prices (see FAR 22.1003-4(d)(2)(iii)); Each service employee who will perform the services under the contract will spend only a small portion of his or her time (a monthly average of less than 20 percent of the available hours on an annualized basis, or less than 20 percent of available hours during the contract period if the contract period is less than a month) servicing the Government contract; and The compensation (wage and fringe benefits) plan for all service employees performing work under the contract is the same as that used for these employees and equivalent employees servicing commercial customers. If paragraph (k)(1) or (k)(2) of this clause applies- If the offeror does not certify to the conditions in paragraph (k)(1) or (k)(2) and the Contracting Officer did not attach a Service Contract Labor Standards wage determination to the solicitation, the offeror shall notify the Contracting Officer as soon as possible; and The Contracting Officer may not make an award to the offeror if the offeror fails to execute the certification in paragraph (k)(1) or (k)(2) of this clause or to contact the Contracting Officer as required in paragraph (k)(3)(i) of this clause. Taxpayer identification number (TIN) (26 U.S.C. 6109, 31 U.S.C. 7701). (Not applicable if the offeror is required to provide this information to the SAM database to be eligible for award.) All offerors must submit the information required in paragraphs (l)(3) through (l)(5) of this provision to comply with debt collection requirements of 31 U.S.C. 7701(c) and 3325(d), reporting requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations issued by the Internal Revenue Service (IRS). The TIN may be used by the government to collect and report on any delinquent amounts arising out of the offeror's relationship with the Government (31 U.S.C. 7701(c)(3)). If the resulting contract is subject to the payment reporting requirements described in FAR 4.904, the TIN provided hereunder may be matched with IRS records to verify the accuracy of the offeror's TIN. Taxpayer Identification Number (TIN). [ ] TIN:. [ ] TIN has been applied for. [ ] TIN is not required because: [ ] Offeror is a nonresident alien, foreign corporation, or foreign partnership that does not have income effectively connected with the conduct of a trade or business in the United States and does not have an office or place of business or a fiscal paying agent in the United States; [ ] Offeror is an agency or instrumentality of a foreign government; [ ] Offeror is an agency or instrumentality of the Federal Government; Type of organization. [ ] Sole proprietorship; [ ] Partnership; [ ] Corporate entity (not tax-exempt); [ ] Corporate entity (tax-exempt); [ ] Government entity (Federal, State, or local); [ ] Foreign government; [ ] International organization per 26 CFR 1.6049-4; [ ] Other. Common parent. [ ] Offeror is not owned or controlled by a common parent: [ ] Name and TIN of common parent: Name TIN Restricted business operations in Sudan. By submission of its offer, the offeror certifies that the offeror does not conduct any restricted business operations in Sudan. Prohibition on Contracting with Inverted Domestic Corporations- Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4. Representation. The Offeror represents that-- It [ ] is, [ ] is not an inverted domestic corporation; and It [ ] is, [ ] is not a subsidiary of an inverted domestic corporation. Prohibition on contracting with entities engaging in certain activities or transactions relating to Iran. The offeror shall email questions concerning sensitive technology to the Department of State at CISADA106@state.gov. Representation and Certification. Unless a waiver is granted or an exception applies as provided in paragraph (o)(3) of this provision, by submission of its offer, the offeror- Represents, to the best of its knowledge and belief, that the offeror does not export any sensitive technology to the government of Iran or any entities or individuals owned or controlled by, or acting on behalf or at the direction of, the government of Iran; Certifies that the offeror, or any person owned or controlled by the offeror, does not engage in any activities for which sanctions may be imposed under section 5 of the Iran Sanctions Act; and Certifies that the offeror, and any person owned or controlled by the offeror, does not knowingly engage in any transaction that exceeds $3,500 with Iran's Revolutionary Guard Corps or any of its officials, agents, or affiliates, the property and interests in property of which are blocked pursuant to the International Emergency Economic Powers Act (50(U.S.C. 1701 et seq.) (see OFAC's Specially Designated Nationals and Blocked Persons List at http://www.treasury.gov/ofac/downloads/t11sdn.pdf). The representation and certification requirements of paragraph (o)(2) of this provision do not apply if- This solicitation includes a trade agreements certification (e.g., 52.212-3(g) or a comparable agency provision); and The offeror has certified that all the offered products to be supplied are designated country end products. Ownership or Control of Offeror. (Applies in all solicitations when there is a requirement to be registered in SAM or a requirement to have a unique entity identifier in the solicitation. The Offeror represents that it [ ] has or [ ] does not have an immediate owner. If the Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall respond to paragraph (2) and if applicable, paragraph (3) of this provision for each participant in the joint venture. If the Offeror indicates "has" in paragraph (p)(1) of this provision, enter the following information: Immediate owner CAGE code:. Immediate owner legal name:. (Do not use a "doing business as" name) Is the immediate owner owned or controlled by another entity: □ Yes or □ No. If the Offeror indicates "yes" in paragraph (p)(2) of this provision, indicating that the immediate owner is owned or controlled by another entity, then enter the following information: Highest-level owner CAGE code:. Highest-level owner legal name:. (Do not use a "doing business as" name) Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, The Government will not enter into a contract with any corporation that- Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government. The Offeror represents that- It is □ is not □ a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and It is □ is not □ a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months. Predecessor of Offeror. (Applies in all solicitations that include the provision at 52.204-16, Commercial and Government Entity Code Reporting.) The Offeror represents that it [ or grant within the last three years. ] is or [ ] is not a successor to a predecessor that held a Federal contract If the Offeror has indicated ``is'' in paragraph (r)(1) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last three years (if more than one predecessor, list in reverse chronological order): Predecessor CAGE code: (or mark ``Unknown''). Predecessor legal name:. (Do not use a ``doing business as'' name). Public Disclosure of Greenhouse Gas Emissions and Reduction Goals. Applies in all solicitations that require offerors to register in SAM (52.212-1(k)). This representation shall be completed if the Offeror received $7.5 million or more in contract awards in the prior Federal fiscal year. The representation is optional if the Offeror received less than $7.5 million in Federal contract awards in the prior Federal fiscal year. Representation. [Offeror to check applicable block(s) in paragraph (t)(2)(i) and (ii)]. (i) The Offeror (itself or through its immediate owner or highest-level owner) [ ] does, [ ] does not publicly disclose greenhouse gas emissions, i.e., makes available on a publicly accessible Web site the results of a greenhouse gas inventory, performed in accordance with an accounting standard with publicly available and consistently applied criteria, such as the Greenhouse Gas Protocol Corporate Standard. The Offeror (itself or through its immediate owner or highest-level owner) [ publicly disclose a ] does, [ ] does not quantitative greenhouse gas emissions reduction goal, i.e., make available on a publicly accessible Web site a target to reduce absolute emissions or emissions intensity by a specific quantity or percentage. A publicly accessible Web site includes the Offeror's own Web site or a recognized, third-party greenhouse gas emissions reporting program. If the Offeror checked ``does'' in paragraphs (t)(2)(i) or (t)(2)(ii) of this provision, respectively, the Offeror shall provide the publicly accessible Web site(s) where greenhouse gas emissions and/or reduction goals are reported:. (u)(1) In accordance with 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), Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with an entity that requires employees or subcontractors of such entity seeking to report waste, fraud, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information. The prohibition in paragraph (u)(1) of this provision does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information. Representation. By submission of its offer, the Offeror represents that it will not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General). (End of provision)
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(https://www.fbo.gov/spg/USA/MEDCOM/DADA09/W81K0018Q0079/listing.html)
Place of Performance: Address: Raymond W Bliss Army Health Center, 2240 E Winrowave, Fort Huachuca, Arizona, 85613, United States; Zip Code: 85613
Record: SN04955311-W 20180616/180614230735-5b87975bcc27d949e75a56ffa3b41aed (fbodaily.com)
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