J065– DSCSA Compliance ConsortiEX

Notice Type: Combine Solicitation

Posted Date: 27-JUL-21

Office Address: Veterans Affairs, Department of; VETERANS AFFAIRS, DEPARTMENT OF; 257-NETWORK CONTRACT OFFICE 17 (36C257); ARLINGTON, TX 76006

Subject: J065-- DSCSA Compliance ConsortiEX

Classification Code: J - Maintenance, repair & rebuilding of equipment

Solicitation Number: 36C25721Q1211

Contact: Danise Burt

Setaside: N/AN/A

Place of Performance (address): Department of Veteran Affairs North Dallas Healthcare System4500 S Lancaster Road Dallas

Description: Veterans Affairs, Department of

VETERANS AFFAIRS, DEPARTMENT OF

257-NETWORK CONTRACT OFFICE 17 (36C257)

This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only Solicitation; quotes are being requested and a written solicitation will not be issued. Solicitation number 36C25721Q1211 is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular. SET-ASIDE: This requirement is a 100% Total Small Business set aside. In order to be eligible for award an offeror must be small for the applicable NAICS code at the time of the quote submission and at the time of award. Only qualified offerors may submit bids. NAICS Code:541519 and Size Standard is $30 M. Introduction: The Department of Veterans Affairs (VA), North Dallas VA Healthcare System is requesting procurement information for a Software Application for compounding and tracking of pharmaceuticals, The Department of Veteran Affairs is in search of Small Business organizations that are capable of servicing the Department of Veterans Affairs North Dallas VA Healthcare System need to procure the following Software Application for compounding and tracking of pharmaceuticals commercial equipment items. The Government intends to award a firm fixed price contract based on this solicitation.. Description of Services: The Contractor shall design, provide items, deliver items, install, and test all items and equipment for the setup of a new rack storage system for the Dallas VA Medical Center in the Primary and OR Primary. All equipment and installation must meet Original Equipment Manufacturers (OEM) and VA specifications. The Contractor shall furnish all supplies, equipment and services required for delivery, installation and any testing needed of the supplies and equipment.Place of Performance at the NTXVHA:Primary POC for all locations will be Stephanie Carey, 214-857-0556Type of Contract: A Firm Fixed PricePeriod of Performance: TBDEVALUATIONS:Evaluation of quotes will be conducted using Simplified Acquisition Procedures in accordance with FAR 13.106-2 Evaluation of Quotes. Please read each section below carefully for the submittals and information required as part of the evaluation. Failure to provide the requested information below shall be considered non-compliant and your quote could be removed from the evaluation process.Offeror quotes shall be evaluated under FAR 13.106-2(b)(3) Comparative Evaluation. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation but is not required to do so. Each response must meet the minimum requirements of the solicitation.The Government is not obligated to determine a competitive range, conduct discussions with all contractors, solicit final revised quotes, and use other techniques associated with FAR Part 15. The contracting techniques associated with FAR Part 15 are not mandatory.The Government will issue a contract to the responsible offeror whose quotation conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The Government shall award a contract resulting from this solicitation. The following factors shall be used to evaluate offers:----Vendor is a certified small business.Vendor must be registered is SAM with applicable NAICS code by the close of solicitation. Vendor must provide current industry certification to provide call system installations.Vendor must provide past performance for similar service (CPARS)Technical Approach: The Government will evaluate how the offeror s approach meets the requirements in accordance with the solicitation and Performance Work Statement and indicates a thorough approach and understanding of the requirements.Price: Price will be evaluated independently of the non-price factors.QUOTE SUBMISSION DEADLINE: Quotes must be received no later than Thursday, August 6, 2021 at 10:00 am CST. Email your quote to Danised.burt@va.gov. The subject line must specify 36C25721Q1211 Software Application for compounding and tracking of pharmaceuticals Submission. There will be no automated email notification of receipt of quotes. All quotes received without requested documentation will not be considered. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). PURPOSE - The overall purpose is to deliver and install a complete Software Application for compounding and tracking of pharmaceuticals.SCOPE - The Contractor shall design, provide items, deliver items, install, and test all items and equipment for the setup of a new rack storage system for the Dallas VA Medical Center in the Primary and OR Primary. All equipment and installation must meet Original Equipment Manufacturers (OEM) and VA specifications. The Contractor shall furnish all supplies, equipment and services required for delivery, installation and any testing needed of the supplies and equipment. Schedule0001DSCSA COMPLIANCE AS A SERVICE - ANNUAL SUBSCRIPTIONDSCSA COMPLIANCE AS A SERVICE - ANNUAL SUBSCRIPTION1 each0002IMPLEMENTATION FOR DSCSA COMPLIANCE AS A SERVICEIMPLEMENTATION FOR DSCSA COMPLIANCE AS A SERVICE1 eachEADSCSA Compliance as a Service Solution is uniquely positioned to remove the burden of track and trace Drug Supply Chain Security Act (DSCSA) title II compliance from the hospital community with comprehensive data collection and product traceability services. In addition, these services were developed specifically to integrate with the Department of Veterans Affairs prime vendor, McKesson. Some of the unique services offered to NTVHCS are listed below.The Drug Security Quality Act of 2013, Title II, Section describes the Drug Supply Chain Security Act (DSCSA) requirements for hospitals, including VANTHS. Some of these federal requirements are listed below.Hospitals will store T3 documents for the required minimum of six years and process documents in compliance with the FDCA Sec. 581 (27) (A-G).Hospitals will be able to receive, update, and provide required transaction documents for all shipments/receipt of drug, returns, drop shipments, and exceptions, including product exchange to institutions outside of Hospital and Hospital s definition.Hospitals must have a suspect/illegitimate policy and structure in policy to identify, document and report to their trading partner.Hospitals must only receive DSCSA products with 2D barcoded label and verify the physical product with the DSCSA documentation.Hospitals must produce all required DSCSA documentation, verification records, and policies and procedures upon FDA request within 48 business hours. The DSCSA Compliance as a Service is uniquely positioned to remove the burden of track and trace Drug Supply Chain Security Act (DSCSA) title II compliance from the hospital community with comprehensive data collection and product traceability services. In addition, these services were developed specifically to integrate with the Department of Veterans Affairs prime vendor, McKesson. Some of the unique services offered to VANTHS are listed below.Provides a single source for storing & retrieving all DSCSA documents from the prime vendor and all other trading partners.Provides a service that verifies, validates, and uploads all non-electronic VANTHS DSCSA documents into the single database.Enables Customer to meet the DSCSA requirement for information within the 48-hour timeframe, in response to an FDA request.As a service, (ConsortiEX or Brand Name) monitors and audits T3 documents for missing or unknown NDCs, addresses or description fields as required by law.Provides and maintains a NDC database by which all received product and DSCSA documents are verified against.Provides a barcode scanning application that receives physical product with NDC, lot number, expiration date, and serial number (when available), and auto-verifies the physical product with DSCSA T3 document. Will notify VANTHS of any duplicate serial numbers and short dated products immediately upon scanning, and prior to entering into the hospital supply chain.Will provide VANTHS buyers of over/under shipments.Service provides integration mapping with all McKesson s general accounts, Open Market accounts, and OTC accounts.Will provide recall functionality down to the lot number of any product entering the supply chain and if the product had already entered the supply chain.Guarantees its service compliance for STVHCS with the FDA DQSA title II DSCSA regulation on all received T3 documents.VA North Texas Healthcare System (VANTHS) will achieve and exceed FDA s DSCSA Compliance requirements regulations and improve patient safety and operating efficiencies, With the DSCSA CaaS solutions and tools from ConsortiEX or Brand NameConsortiEX is uniquely provides a single, integrated software and services platform containing the salient elements of DQSA title I (IV compounding workflow) and DQSA title II (DSCSA) compliance.Statement of Work (SOW)GENERALThe contractor shall comply with Federal, State, local laws and regulations applicable to the performance of this contract.SCOPE OF WORK2.1 Contractor will deliver, install the software during normal business hours unless prior authorization is given by the COR, Contracting Officer or designated representative.2.2 The Contractor is responsible for providing all items listed on the quote and fully installing the equipment, calibrating, testing, and evaluating the equipment after installation to include all other agreements pursuant to the quote and training of on-site staff in use of equipment.DESCRIPTION OF WORKThe contractor shall provide all required service for the VA software in accordance with the original equipment manufacturer specifications. Reference below for software type and the required service.Software: Software Application for compounding and tracking of pharmaceuticals Location: Dallas VA Medical Center, Dallas, TXSoftware applications and related products and services to facilitate the compounding of pharmaceuticals and the tracking and management of the same. Software will store T3 documents for the required minimum of six (6) years and process documents in compliance with the FDCA Sec. 581 (27) (A-G). Through software, Customer will be able to receive, update, and provide required transaction documents for all shipments/receipt of drug, returns, drop shipments, and exceptions, including product exchange to institutions outside of Customer and Customer s definition. Software will be the single source for storing & retrieving DSCSA documents. Software will enable Customer to meet the DSCSA requirement for information within the 2-day timeframe, in response to an FDA request. Software will monitor and audit T3 documents for missing or unknown NDCs, addresses or description fields as required. Software will provide timely system updates in response to changes in DSCSA regulations3.1 SECURITY STATEMENT: The Vendor will not transfer any VA information to a location outside the VA and only to VA locations determined by the VA System Administrator.---- The information in these systems may be covered by the Privacy Act 1974 which contains criminal penalties of abuse of information.3.2 For Remote access the vendor will not be issued a userID/Password to the systems covered under this contract.---- A VA IT system administrator will initiate a collaborative software utility (for example Net Meetings) and invite the vendor to join.---- The VA system administrator will log into the systems using their credentials and allow vendor to watch the results as the system administrator follows the directions of the vendor.---- In some situations, the system administrator may give control of the system administrator s desktop to the vendor. ----The system administrator will supervise and BE RESPONSIBLE for the actions of the vendor.-------- 3.3 The COTR is responsible for the actions of the system administrator.---- The Vendor and all VA employees are required to immediately report any security violations to the Information Security Officer. ----No other security statements are required.3.4 During onsite service, the Vendor shall be chaperoned by a VA System Administrator.---- The vendor shall not be issued a UserID/Password.---- The chaperon shall log the vendor onto the system and be accountable for the actions of the vendor.---- The Vendor shall not enter or will immediately leave the computer room if the chaperon is not in the computer room.3.5 Non-volatile memory devices, working or non-working, shall NOT be removed from the VA. For magnetic devices and media, the data destruction will be by degaussing.---- Other forms of cleansing will be used for non-magnetic media.Information Technology Security requirements sectionAs prescribed in 839.201, insert the following clause:The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information andinformation system security as delineated in this contract.1. GENERALContractors, contractor personnel, subcontractors, and subcontractor personnel shall besubject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMSa. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates onlyto the extent necessary to perform the services specified in the contract, agreement, or taskorder.b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning andNational Security Service within the Office of Operations, Security, and Preparedness.d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/ subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.3. VA INFORMATION CUSTODIAL LANGUAGEa. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request.j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor /subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.GENERAL RULES OF BEHAVIORa. Rules of Behavior are part of a comprehensive program to provide completeinformation security. These rules establish standards of behavior in recognition of the fact that knowledgeable users are the foundation of a successful security program. Users must understand that taking personal responsibility for the security of their computer and the information it contains is an essential part of their job.b. The following rules apply to all VA contractors. I agree to:(1) Follow established procedures for requesting, accessing, and closing user accountsand access. I will not request or obtain access beyond what is normally granted to users or by what is outlined in the contract.(2) Use only systems, software, databases, and data which I am authorized to use,including any copyright restrictions.(3) I will not use other equipment (OE) (non-contractor owned) for the storage, transfer,or processing of VA sensitive information without a VA CIO approved waiver, unless it has been reviewed and approved by local management and is included in the language of the contract. If authorized to use OE IT equipment, I must ensure that the system meets all applicable 6500 Handbook requirements for OE.(4) Not use my position of trust and access rights to exploit system controls or accessinformation for any reason other than in the performance of the contract.(5) Not attempt to override or disable security, technical, or management controlsunless expressly permitted to do so as an explicit requirement under the contract or at the direction of the COTR or ISO. If I am allowed or required to have a local administrator account on a government-owned computer, that local administrative account does not confer me unrestricted access or use, nor the authority to bypass security or other controls except as expressly permitted by the VA CIO or CIO's designee.(6) Contractors use of systems, information, or sites is strictly limited to fulfill the termsof the contract. I understand no personal use is authorized. I will only use other Federalgovernment information systems as expressly authorized by the terms of those systems. I accept that the restrictions under ethics regulations and criminal law still apply.(7) Grant access to systems and information only to those who have an official need toknow.(8) Protect passwords from access by other individuals.(9) Create and change passwords in accordance with VA Handbook 6500 on systemsand any devices protecting VA information as well as the rules of behavior andsecurity settings for the particular system in question.(10) Protect information and systems from unauthorized disclosure, use, modification, ordestruction. I will only use encryption that is FIPS 140-2 validated to safeguard VA sensitive information, both safeguarding VA sensitive information in storage and in transit regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA.(11) Follow VA Handbook 6500.1, Electronic Media Sanitization to protect VAinformation. I will contact the COTR for policies and guidance on complying with thisrequirement and will follow the COTR's orders.(12) Ensure that the COTR has previously approved VA information for publicdissemination, including e-mail communications outside of the VA as appropriate. I will not make any unauthorized disclosure of any VA sensitive information through the use of any means of communication including but not limited to e-mail, instant messaging, online chat, and web bulletin boards or logs.(13) Not host, set up, administer, or run an Internet server related to my access to anduse of any information assets or resources associated with my performance of servicesunder the contract terms with the VA unless explicitly authorized under the contract or inwriting by the COTR.(14) Protect government property from theft, destruction, or misuse. I will follow VAdirectives and handbooks on handling Federal government IT equipment, information, and systems. I will not take VA sensitive information from the workplace without authorization from the COTR.(15) Only use anti-virus software, antispyware, and firewall/intrusion detection softwareauthorized by VA. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with VA.(16) Not disable or degrade the standard anti-virus software, antispyware, and/orfirewall/intrusion detection software on the computer I use to access and use information assets or resources associated with my performance of services under the contract terms with VA. I will report anti-virus, antispyware, firewall or intrusion detection software errors, or significant alert messages to the COTR.(17) Understand that restoration of service of any VA system is a concern of all users ofthe system.(18) Complete required information security and privacy training, and complete requiredtraining for the particular systems to which I require access.PERSONNEL Program Manager. The contractor shall provide in writing the name and phone number of a Program Manager within (10) ten calendar days of the award of the contract. The Program Manager shall be a qualified and experienced manager to oversee the personnel assigned to perform the installation and maintenance services. The contractor s Program Manager shall correspond with the COR on a regular basis to discuss any problems that the contractor or contractor s personnel may be experiencing during the performance of this contract. Unresolved problems shall be referred to the Contracting Officer for resolution. Contractor Service Personnel (CSP). All subcontractors performing work for primary contractor shall meet all specifications and standards that apply to CSP under this agreement. CSP shall maintain clean and neat appearance and shall wear an identification badge at all times when performing services at the Government site. Identification badges shall be worn in a clearly visible area of the outer garment. The COR shall furnish this badge. Due to conflict of interest, the contractor shall not employ a current DOD employee, military or civilian to provide services under this contract. Government point of contact (POC). The COR will be the Government s POC. If required, the COR will be designated in writing to the Contractor and the scope of authority will be set forth therein. Contractor shall respond only to calls from COR or a designated representative from the Medical Center.ACRONYMS AND DEFINITIONS Contracting Officer (CO). A person duly appointed with the authority to enter into and administer contracts on behalf of the U.S. Government. Contracting Officer s Representative (COR). An individual designated in writing by the Contracting Officer to act as an authorized representative of the Contracting Officer to perform specific contract administrative functions within the scope and limitations as defined by the Contracting Officer.EQUIPMENT OWNERSHIP. Title to equipment shall remain with the contractor until installed and established. After completion, a satisfactory inventory and inspection is completed by Contractor, COR and Maintenance personnel. Upon approved inspection, title, equipment, accessories and ownership will be released to VA North Texas Healthcare system (VANTHCS).LIMITED WARRANTY. All equipment listed on Schedule B and pursuant to the attached quote, shall be fit and sufficient for the purpose intended as set forth in the user manuals; and merchantable, of good quality and free from defects in materials or workmanship; for a period of one (1) year from the date of the first invoice under this agreement.6.2. Maintenance and/or repairs that are not covered under the warranty will be paid by the Government.6.3 All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTXHCS) and must be returned to VANTXHCS at the end of the contract or destroyed in accordance to the VHA Record Control Schedule (RCS)10-1.PRIVACY STATEMENTa. Contractors and any subcontractors must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act(HIPAA) of 1996. This includes both the Privacy and Security Rules published by the Department of Health and Human Services (HHS). b. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA). In accordance with HIPAA, the contractor may be required to enter into a Business Associate Agreement (BAA) with VHA. c. Business associates must follow VHA privacy policies and practices when applicable. All contractors and business associates must receive privacy training annually. d. For contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually Identifiable Health Information as determined by VHA. e. For contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required upon request.NARA Records Management Language for Contracts (May 2017)1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.----2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.----3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.----4. [FACILITY] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [FACILITY] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [FACILITY]. The agency must report promptly to NARA in accordance with 36 CFR 1230.5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [FACILITY] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [FACILITY] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [FACILITY] policy.----8. The Contractor shall not create or maintain any records containing any non-public [FACILITY] information that are not specifically tied to or authorized by the contract.----9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.----10. The [FACILITY] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [FACILITY] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.11. Training. ----All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.----TERMINATIONThe Agreement is terminated at the completion of the inspection and satisfactory evaluation.Capability Statement Requirements:RESPONSES MUST INCLUDE THE FOLLOWING INFORMATION:Company Name, Address, Size Standard, DUNS #, Cage Code Point of contact name, phone number, and email addressNAICS Code 531130 and Small Business Size Standard 500 employee MUST be assigned to company Commercial Medical Concepts Shelving and Carts Equipment Price List (your price list or the price list you intend to use)Capability Statement Specify the specific line items in which you intend to provide/install.If you will NOT be manufacturing the equipment, you MUST provide information on the manufacturer you intend to use, i.e. authorized distributor letter, etc. If you will NOT be performing the installation, you must provide a Letter of Intent from the business you intend to use (explaining their agreement with you to perform the installations according to the solicitation), along with references of their past Medical Concepts Shelving and Carts equipment installations.*NOTE Acquisitions will only be set aside for SDVOSBs/VOSBs if two or more responses are received with the required information listed above, by the due date specified below. The following clauses and provisions apply to this solicitation: 52.209-5, Certification Regarding Responsibility Matters52.212-3, Offeror Representations and Certifications-Commercial Items52.212-4, Contract Terms and Conditions-Commercial Items52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items52.217-8, Option to Extend ServicesThe 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)Except when it is determined in accordance with FAR 17.206(b) not to be in the Government s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. This includes options under FAR 52.217-8, Option to Extend Services, which applies to this solicitation.---- Evaluation of options under FAR 52.217-8 will be accomplished by using the prices offered for the last option period to determine the price for a 6-month option period, which will be added to the base and other option years to arrive at the total price.---- Evaluation of options will not obligate the Government to exercise the option(s).(End of Addendum)52.203-17 Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Right52.203-99 Prohibition of Contracting with Entities That Require Certain Internal Confidentiality Agreements 52.219-8, Utilization of Small Business Concerns (OCT 2014) (15 U.S.C. 637(d)(2) and (3).52.222-3, Convict Labor52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67)52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67)52.222-43, Fair Labor Standards Act and Service Contract Labor Standards Price Adjustment (Multiple Year and Option Contracts) (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67)52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015)52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving52.228-5 Insurance-Work on a Government Installation (JAN 1997)52.232-33, Payment by Electronic Funds Transfer-System for Award Management52.237-3 Continuity of Services (JAN 1991)52.232-39, Unenforceability of Unauthorized Obligations (In the FAR https://www.acquisition.gov/far/html/52_232.html#wp1160005)52.233-3, Protest after Award (In the FAR https://www.acquisition.gov/far/html/52_233_240.html)852.203-70, Commercial Advertising (JAN 2008)852.232-72, Electronic Submission of Payment Requests852.237-70, Contractor Responsibilities852.273-70, Late Offers (Jan 2003)52.252-1, Solicitation Provisions Incorporated by Reference:This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es).52.252-2, Clauses Incorporated by Reference: This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address (es). Full text can be obtained at http://www.acquisition.gov/far/index.html52.219-6 NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE (MAR 2020) ALTERNATE I (MAR 2020)(a) Definition. "Small business concern," as used in this clause, 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 size standards in this solicitation.(b) Applicability. This clause applies only to (1) Contracts that have been totally set aside for small business concerns; and(2) Orders set aside for small business concerns under multiple-award contracts as described in 8.405-5 and 16.505(b)(2)(i)(F).(c) General.(1) Offers are solicited only from small business concerns and Federal Prison Industries, Inc. (FPI). Offers received from concerns that are not small business concerns or FPI shall be considered nonresponsive and will be rejected.(2) Any award resulting from this solicitation will be made to either a small business concern or FPI.(End of Clause)VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE (JUL 2018) (a) This solicitation includes FAR 52.219-6, Notice of Total Small Business Set-Aside and FAR 52.219-14 Limitations on Subcontracting (MAR 2020). (b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6, or the limitations on subcontracting requirements in the FAR clause, as applicable. The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) retained by VA to assist in assessing the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to Contractor's offices where the Contractor's business records, or other proprietary data are retained and to review such business records regarding the Contractor's compliance with this requirement. (c) All support contractors conducting this review on behalf of VA will be required to sign an Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. (d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirement. (End of Clause)52.233-2 SERVICE OF PROTEST (SEP 2006)Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from: Hand-Carried Address: Department of Veterans Affairs Network Contracting Office (NCO 17) NCO 17 RPO West 124 E. Hwy 67 Duncanville, Texas 75137 Mailing Address: Department of Veterans Affairs Network Contracting Office (NCO 17) NCO 17 RPO West 124 E. Hwy 67 Duncanville, Texas 75137 (b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.(End of Provision)VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018) (a) Any protest filed by an interested party shall (1) Include the name, address, fax number, email and telephone number of the protester; (2) Identify the solicitation and/or contract number; (3) Include an original signed by the protester or the protester s representative and at least one copy; (4) Set forth a detailed statement of the legal and factual grounds of the protest, including a description of resulting prejudice to the protester, and provide copies of relevant documents; (5) Specifically request a ruling of the individual upon whom the protest is served; (6) State the form of relief requested; and (7) Provide all information establishing the timeliness of the protest. (b) Failure to comply with the above may result in dismissal of the protest without further consideration. (c) Bidders/offerors and Contracting Officers are encouraged to use alternative dispute resolution (ADR) procedures to resolve protests at any stage in the protest process. If ADR is used, the Department of Veterans Affairs will not furnish any documentation in an ADR proceeding beyond what is allowed by the Federal Acquisition Regulation.(End of Provision)VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018) (a) As an alternative to filing a protest with the Contracting Officer, an interested party may file a protest by mail or electronically with: Executive Director, Office of Acquisition and Logistics, Risk Management and Compliance Service (003A2C), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420 or Email: EDProtests@va.gov. (b) The protest will not be considered if the interested party has a protest on the same or similar issue(s) pending with the Contracting Officer.(End of Provision) PLEASE NOTE: The correct mailing information for filing alternate protests is as follows: Deputy Assistant Secretary for Acquisition and Logistics, Risk Management Team, Department of Veterans Affairs 810 Vermont Avenue, N.W. Washington, DC 20420 Or for solicitations issued by the Office of Construction and Facilities Management: Director, Office of Construction and Facilities Management 811 Vermont Avenue, N.W. Washington, DC 20420REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE SYSTEM (CPARS):As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed $100,000 and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, the Contractor Performance System (CPARS). Each contractor whose contract award is estimated to exceed $100,000.00 is required to register. at the following web address: http://www.cpars.gov/For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPS to the contractor s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer.The Duncan Hunter National Defense Authorization Act of 2009 (Public Law 110-417) was enacted on October 14, 2008. Section 872 of this Act required the development and maintenance of an information system that contains specific information on the integrity and performance of covered Federal agency contractors and grantees. The Federal Awardees Performance and Integrity Information System (FAPIIS) were developed to address these requirements. FAPIIS is a distinct application that is accessed through the Past Performance Information System (PPIRS) and is available to federal acquisition professionals for their use in award and responsibility determinations. FAPIIS provides users access to integrity and performance information from the FAPIIS reporting module in the Contractor Performance Assessment Reporting System (CPARS), proceedings information from the Central Contractor Registration (CCR) database, and suspension/disbarment information from the Excluded Parties List system (EPLS).SUBMISSION OF QUOTE (FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS): The Offeror shall submit their quote on company letterhead and shall include unit price, overall total price, name, address, and telephone number of the offeror, firm's DUNS# and ORCA document in SAM at www.sam.gov. Complete copy of 52.212-3 Offerors Representations and Certifications- Commercial Items, and ORCA document. The Offeror shall provide sufficient evidence that they possess adequate resources, capability, experience, responsibility and integrity to meet the technical capabilities to comply with the requirements of the resulting contract.The Offeror shall be registered in SAM.gov prior to contract award.To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."OR"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"The offeror shall meet the limitation in subcontracting clause. The subcontract vendor must be similarly situated in the same.The offeror shall outline how they will be in agreeance/compliance with the limitations on subcontracting requirements in 13 CFR ----125.6. Any quotes using subcontractors or teaming partners to perform any part of the work must show the subcontractor or teaming partner to be similarly situated as the prime. A similarly situated subcontractors or teaming partners is a company who has the same size standard and NAICS code as the prime offeror/vendor. Similarly situated entity is a subcontractor that has the same small business program status as the prime contractor. This means that: For a HUBZone requirement, a subcontractor that is a qualified HUBZone small business concern; for a small business set-aside, partial set-aside, or reserve a subcontractor that is a small business concern; for a SDVO small business requirement, a subcontractor that is a self-certified SDVO SBC; for an 8(a) requirement, a subcontractor that is an 8(a) certified Program Participant; for a WOSB or EDWOSB contract, a subcontractor that has complied with the requirements of part 127. In addition to sharing the same small business program status as the prime contractor, a similarly situated entity must also be small for the NAICS code that the prime contractor assigned to the subcontract the subcontractor will perform.

Link/URL: https://beta.sam.gov/opp/cc12ad32a7834477b27f4b0272889965/view