SOLICITATION NOTICE
J -- DSCSA Compliance ConsortiEX
- Notice Date
- 7/27/2021 4:09:26 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
- ZIP Code
- 76006
- Solicitation Number
- 36C25721Q1211
- Response Due
- 8/2/2021 8:00:00 AM
- Archive Date
- 10/01/2021
- Point of Contact
- Danise Burt, Contract Specialist, Phone: 972-708-0842
- E-Mail Address
-
danised.burt@va.gov
(danised.burt@va.gov)
- Awardee
- null
- Description
- 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, 214-857-0556 Type of Contract: A Firm Fixed Price Period of Performance: TBD EVALUATIONS: 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. Schedule 0001 DSCSA COMPLIANCE AS A SERVICE - ANNUAL SUBSCRIPTION DSCSA COMPLIANCE AS A SERVICE - ANNUAL SUBSCRIPTION 1 each 0002 IMPLEMENTATION FOR DSCSA COMPLIANCE AS A SERVICE IMPLEMENTATION FOR DSCSA COMPLIANCE AS A SERVICE 1 each EA DSCSA 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 Name ConsortiEX 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) GENERAL The contractor shall comply with Federal, State, local laws and regulations applicable to the performance of this contract. SCOPE OF WORK 2.1 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 WORK The 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, TX Software 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 regulations 3.1 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 section As 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 and information system security as delineated in this contract. 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject 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 SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. 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 and National 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 LANGUAGE a. 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 BEHAVIOR a. Rules of Behavior are part of a comprehensive program to provide complete information 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 accounts and 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 access information for any reason other than in the performance of the contract. (5) Not attempt to override or disable security, technical, or management controls unless 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 terms of the contract. I understand no personal use is authorized. I will only use other Federal government 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 to know. (8) Protect passwords from access by other individuals. (9) Create and change passwords in accordance with VA Handbook 6500 on systems and any devices protecting VA information as well as the rules of behavior and security settings for the particular system in question. (10) Protect information and systems from unauthorized disclosure, use, modification, or destruction. 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 VA information. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders. (12) Ensure that the COTR has previously approved VA information for public dissemination, 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 and use of any information assets or resources associated with my performance of services under the contract terms with the VA unless explicitly authorized under the contract or in writing by the COTR. (14) Protect government property from theft, destruction, or misuse. I will follow VA directives 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 software authorized 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/or firewall/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 of the system. (18) Complete required information security and privacy training, and complete required training 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 defectsin 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 STATEMENT a. 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 la...
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- Place of Performance
- Address: Department of Veteran Affairs North Dallas Healthcare System 4500 S Lancaster Road, Dallas 75216
- Zip Code: 75216
- Zip Code: 75216
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- SN06074547-F 20210729/210728203728 (samdaily.us)
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