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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 08, 2019 FBO #6314
SOURCES SOUGHT

66 -- Automated Coag Analyzer CPRR

Notice Date

3/6/2019
 

Notice Type

Synopsis
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

00504;Department of Veterans Affairs;Contracting Section;7201 I-40 West Suite 100;Amarillo TX 79106
 

ZIP Code

79106
 

Solicitation Number

36C25719Q0444
 

Response Due

3/18/2019
 

Archive Date

5/17/2019
 

Point of Contact

Robyn.Nussbaum@va.gov
 

Small Business Set-Aside

N/A
 

Description

The South Texas VA Health Care System (STVAHCS) in San Antonio, Texas is seeking Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), or other small business sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. The North American Industry Classification System (NAICS) is 334516. Any SDVOSB, VOSB, or small business firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than NOON PM Central Time, March 18, 2019. Notification shall be e-mailed to Robyn Nussbaum, at robyn.nussbaum@va.gov. Any vendor who responds to this Notice must provide credentials to perform the requirement as outlined in the below scope. DISCLAIMER This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the suppl Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. SCOPE: It is the intent of the Department of Veterans Affairs to establish a contract for Automated Coagulation Instrumentation. The Government will award a CPRR contract to a single Contractor for Automated Coagulation Instrumentation. Additional tests/reagents/instrumentation may be added to the contract as updated technology becomes available on the market and added to the base contract. Contractor will provide service and maintenance as well as reagent kits and supplies as needed to perform Coagulation testing on the Werfen (IL) (2 each at Audie L. Murphy: Instrumentation Laboratory (IL) ACL TOP 750 LAS S/N 17050205 and 17050206 & 1 each at Kerrville: IL ACL TOP 300 CTS S/N13100967) located in the San Antonio and Kerrville Laboratories of Pathology & Laboratory Medicine Service. The Werfen (IL) instruments are a part of a state of the art automation line that allows for various third-party instrument connections. This unique capability that allows for third party connections is needed at the STVHCS to improve turnaround times and assure all specimens are processed in a timely manner. This modifiable test system that is compatible Werfen (IL) ACL Top 750 and 300 CTS reduces the number of work stations and overall labor required to accomplish the required testing in the laboratory. The instruments have random access capability and can simultaneously perform the Hemostasis profile meeting the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Service: The instrumentations are covered under warranty with Werfen (IL) and for this purpose we are not able to utilize any third-party service. Due to the proprietary nature of the software upgrades and hardware updates needed for our Werfen (IL) instruments, only Werfen (IL) Certified Field Service Engineers can perform and resolve defined functionality problems (Proprietary Error Codes). As part of the agreement routine preventive maintenance will be available 7 days per week, 8:00 a.m. to 5:00 p.m. for software, hardware, and technical support, an on-site service technician is to be dispatched within same day if notified prior to 5:00 p.m. (all cost included). Due to the reasons listed above no other vendor would be able to meet the requirements on the Werfen (IL) Instrumentation. Reagents: The Werfen (IL) Test Systems require a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These Werfen (IL) compatible reagents, standards, controls, supplies and disposables shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes or defects in methodology/technology or physical supplies shall be at the expense of the Contractor and replacements will be provided at no cost. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. Special handling for emergency orders of supplies: If the supplies are found to be defective and unsuitable for use with the Contractor s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. Government s Responsibility: The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. Ownership of Equipment: Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer. 1.1.1. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility. 1.1.2. Prior to termination or completion of this contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor during 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 or completion of the contract. 1.1.3. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier. 1.1.4. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are: 1.1.4.1. Contractor must accept the system without the drive; 1.1.4.2. VA s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or 1.1.4.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. 1.1.5. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; 1.1.5.1. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and 1.1.5.2. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract. 1.1.5.3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation. The CPRR program includes the equipment, service and consumables (all reagents, controls and calibrators necessary to operate the Werfen (IL) Systems in place) based on monthly test counts provided by Audie L. Murphy VA Hospital Pathology and Laboratory Medicine service 1.1.6. Cost per Patient Reportable Result (CPRR) - The per patient reportable result price shall include costs covering: (1) 5-year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge. 1.1.7. Cost per Test (CPT) - Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5 year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. 1.2. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes. Location The Service, Maintenance, Reagents and supplies will be used on the Werfen (IL) analyzers and Automation line located in the Pathology and Laboratory Medicine Service s San Antonio Laboratories of the STVHCS. Deliverables/Supplies Cost Per Reportable Reagent Rental Agreement for Werfen (IL) Laboratory Reagents and Supplies for Coagulation Testing. Government Inherent Functions: Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy. General Duties, Requirements, and Expectations: 1. Be professionally competent to handle required duties. 2. Work with staff to ensure safety measures are in place and documented. 3. Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation policies and all applicable Federal, State and Government laws required by the Veteran s Healthcare System. Information Systems Officer, Information Protection: The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. Records Manager/Privacy Officer: 1.1. All information and records provided to Contractor by VA, in whatever medium, as well as all information and documents, including drafts, emails, back-up copies, hand-written notes and copies that contain such information and records gathered or created by Contractor (collectively referred to as VA information ) in the performance of this contract, regardless of storage media, are the exclusive property of VA. Contractor does not retain any property interest in these materials, and will not use them for any purpose other than performance of this contract. 1.2. Upon completion or termination of the contract, Contractor will either provide all copies of all VA information to VA or certify that it has destroyed all copies of all VA information as required by VA in a method specified by VA, at VA s option. Medical records of any kind including notes shall be returned to the VA. The Contractor will not retain any copies of VA information. Where immediate return or destruction of the information is not practicable, Contractor will return or destroy the information within 30 days of completion or termination of the contract. All provisions of this contract concerning the security and protection of VA information that is the subject of this contract will continue to apply to VA information for as long as the Contractor retains it, regardless of whether the contract has been completed or terminated. 1.3. Prior to termination or completion of this contract, Contractor will not destroy VA information received from VA or gathered or created by Contractor in the course of performing this contract without prior written approval by VA. 1.4. Contractor will receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in accordance with the terms of this contract and applicable federal and VA information confidentiality and security laws, regulations and policies. 1.5. The Contractor shall not make copies of VA information except as necessary to perform this agreement or to preserve electronic information stored on Contractor electronic storage media for restoration in case any electronic equipment or data used by the Contractor needs to be restored to an operating state. 1.6. Contractor shall provide access to VA information only to employees, subcontractors, and affiliates only: (1) to the extent necessary to perform the services specified in this Contract, (2) to perform necessary maintenance functions for electronic storage or transmission media necessary for performance of this contract, and (3) only to individuals who first satisfy the same conditions, requirements and restrictions that comparable VA employees must meet in order to have access to the same VA information. These restrictions include the same level of background investigations, where applicable. 1.7. Contractor will store, transport or transmit VA information only in an encrypted form, using an encryption application that meets the requirements of FIPS 140-2, and is approved for use by VA. 1.8. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two other situations: (i) in response to an order of a court of competent jurisdiction, or (ii) with VA s prior written authorization. The contractor will refer all requests for, demands for production of, or inquiries about, VA information to VA for response. 1.9. If VA information subject to the contract includes information protected by 38 USC 7332, or 5705, include the following after the last sentence of the paragraph immediately above: Contractor shall not release information protected by either 38 USC 5705 or 7332 in response to a court order, and shall immediately refer such court orders to VA for response. 1.10. Prior to any disclosure pursuant to a court order, the Contractor shall promptly notify VA of the court order upon its receipt by the Contractor, provide VA with a copy by fax or email, whichever is faster, and notify by telephone the VA individual designated in advance to receive such notices. If the Contractor cannot notify VA before being compelled to produce the information under court order, the Contractor will notify VA of the disclosure as soon as practical and provide a copy of the court order, including a copy of the court order, a description of the records provided pursuant to the court order, and to whom the Contractor provided the records under the court order. The notice will include the following information to the extent that the Contractor knows it, if it does not show on the face of the court order: the records disclosed pursuant to the order, to whom, where, when, and for what purpose, and any other information that the Contractor reasonably believes is relevant to the disclosure. If VA determines that it is appropriate to seek retrieval of information released pursuant to a court order before Contractor notified VA of the court order, Contractor will assist VA in attempting to retrieve the VA information involved. 1.11. The Contractor will inform VA by the most expeditious method available to Contractor of any incident of suspected or actual access to, or disclosure, disposition, alteration or destruction of, VA information not authorized under this Contract ( incident ) within one hour of learning of the incident. An incident includes the transmission, storage or access of VA information by Contractor or subcontractor employees in violation of applicable VA confidentiality and security requirements. To the extent known by the Contractor, the Contractor s notice to VA will identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information was placed at risk or compromised), and any other information that the contractor considers relevant. 1.12. Contractor will simultaneously report the incident to the appropriate law enforcement entity of jurisdiction. The Contractor, its employees, and its subcontractors and their employees will cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The Contractor also will cooperate with VA in any civil litigation to recover VA information, to obtain monetary or other compensation from a third party for damages arising from any incident, or to obtain injunctive relief against any third party arising from, or related to, the incident. 1.13. VA will provide the Contractor with the name, title, telephone number, fax number and email address of the VA official to whom the Contractor will provide all notices required by this Contract. 1.14. VA has the right during normal business hours to inspect the Contractor s facility, information technology systems and storage and transmission equipment, and software utilized to perform the contract to ensure that the Contractor is providing for the security of VA data and computer systems in accordance with the terms of this Contract. 1.15. Contractor will receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with all applicable Federal Information Processing Standards (FIPS) and Special Publications (SPs) issued by the National Institute of Standards and Technology (NIST) concerning VA information that is the subject of this contract. If NIST issues or updates an applicable FIPS or SP after execution of this contract, the parties agree to negotiate in good faith to implement the FIPS or SP in this contract. 1.16. A determination by VA that the Contractor has violated any of the information confidentiality and security provisions of this contract, including a violation of any applicable FIPS or SP, shall be a basis for VA to terminate the contract for cause. 1.17. If anyone performing this contract, including employees of subcontractors, accesses VA computer systems or data in the performance of the contract, VA may monitor and record all such access activity. If VA monitoring reveals any information of suspected or potential criminal law violations, VA will refer the matter to the appropriate law enforcement authorities for investigation. 1.18. Contractor shall inform its employees and other individuals performing any part of this contract that VA may monitor their actions in accessing or attempting to access VA computer systems and the possible consequences to them for improper access, whether successful or not. The Contractor shall ensure that any subcontractors or others acting on behalf of, or for, the Contractor in performing any part of this contract inform their employees, associates or others acting on their behalf that VA may monitor their access activities. Execution of this contract and any subcontract or agreement constitutes consent to VA monitoring. 1.19. The Contractor will ensure that all individuals who will access VA data or systems in performing the contract are appropriately trained in the applicable VA confidentiality and security requirements. Contractor may do this by requiring and documenting that these individuals have completed the VA training for its employees. 1.20. To the extent practicable, Contractor shall mitigate any harmful effect on individuals whose VA information was accessed or disclosed in an incident. 1.21. Contractor shall require subcontractors, agents, affiliates or others to whom Contractor provides access to VA information for the performance of this contract to agree to the same VA information confidentiality and security restrictions and conditions that apply to the Contractor before providing access. 1.22. The contractor shall abide by FAR clauses 52.224-1 and 52.224.2. 1.23. The contractor shall abide by FAR clauses 52.239-1 and 52.224.1-2 for Privacy or Security Safeguards 1.24. In the performance of any part of the work on this contract, the contractor shall utilize only employees, subcontractors or agents who are physically located within a jurisdiction subject to the laws of the United States. Contractor will ensure that it does not use or disclose Patient Health Information (PHI) received from Covered Entity in any way that will remove the PHI from such jurisdiction. Contractor will ensure that its employees, subcontractors and agents do not use or disclose PHI received from Covered Entity in any way that will remove the PHI from such jurisdiction. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (06-MAR-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
 

Web Link

Link To Document
(https://www.fbo.gov/spg/VA/VAAHCS/VAAHCS/36C25719Q0444/listing.html)
 

Place of Performance

Address: Department of Veterans Affairs;P&LMS Section;7400 Merton Minter Blvd;San Antonio, TX

Zip Code: 78229

Country: United States
 

Record

SN05241526-F 20190308/190306230026 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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