Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF AUGUST 21, 2022 SAM #7569
SOURCES SOUGHT

65 -- Fisher Ion Reagent

Notice Date

8/19/2022 10:54:09 AM
 

Notice Type

Sources Sought
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

256-NETWORK CONTRACT OFFICE 16 (36C256) RIDGELAND MS 39157 USA
 

ZIP Code

39157
 

Solicitation Number

36C25622Q1455
 

Response Due

8/23/2022 5:00:00 AM
 

Archive Date

08/26/2022
 

Point of Contact

William Shaver, Contract Specialist, Phone: 601-206-6953
 

E-Mail Address

William.Shaver@va.gov
(William.Shaver@va.gov)
 

Awardee

null
 

Description

DEPARTMENT OF VETERANS AFFAIRS VETERANS INTEGRATED SERVICE NETWORK (VISN) 16 REQUEST FOR INFORMATION 36C25622Q1455 REQUESTED RESPONSES: The intent of this Request for Information is to establish sources in order to define the procurement strategy. Interested contractors are requested to respond in accordance with the following POTENTIAL SOURCES SHALL PROVIDE ALL THE FOLLOWING INFORMATION IN THEIR RESPONSE: 1) Please respond to this RFI if you are capable of providing the brand name products listed in the Performance Work Statement found in the background section below. In the response, please cite business size status. 2) Company name, address, phone number, primary contact(s), e-mail address, NAICS code(s), business size (i.e., small/large), proof that supplies are domestically made, proof that supplies are from a domestic small business if offeror is not the manufacturer, and unique entity identifier used in SAM.gov. 2) Provide a Statement of Capability that demonstrates the offeror's past performance in providing these types of supplies. Please include the following: (a) Proof of OEM or OEM distributor of brand name supplies. (b) examples of prior completed Government contracts, references, and other related information. Please include contract number of previous contract(s). CONTACT INFORMATION AND RESPONSE DUE DATE: Please email all responses to William.Shaver@va.gov. Please respond to this RFI no later than 07:00 Central Standard Time on Tuesday, August 23, 2022. DISCLAIMER: This RFI is issued solely for informational and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and cannot be accepted by the Department of Veterans Affairs to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this RFI. BACKGROUND: STATEMENT OF WORK Reagents for the Thermo Fisher Ion Torrent Genexus Integrated Sequencing Systems and Genexus Purification System (Limited Source) PURPOSE The overall purpose is to provide next generation sequencing reagents and supplies for the Central Arkansas Veterans Healthcare System (CAVHS), Pathology and Laboratory Medicine Service, Little Rock, AR 72205. The reagents/supplies are required to perform specialized diagnostic and/or genetic testing on veterans FFPE, tissue, blood, and bone marrow samples, and must meet stringent quality control and compliance standards. These reagents are very sensitive to temperature, and therefore many must ship on dry ice or ice packs directly to the laboratory. SCOPE The Contractor shall be able to provide all listed reagents. Ordering of reagents will be done on an as need basis with shipments delivered within at least 5 business days. All products must meet all salient characteristics defined in this section. All reagents must meet manufacturers and VA specifications. The Contractor shall perform to the standards in this contract. SALIENT CHARACTERISTICS Molecular Diagnostics reagents: The contractor shall provide the Molecular Diagnostics laboratory the reagents and supplies needed for the operation of the Ion Torrent Genexus Integrated Sequencing Systems and Genexus Purification System that are already onsite. These reagents and supplies will be delivered to Central Arkansas Veterans Healthcare System (CAVHS), Pathology and Laboratory Medicine Service, Little Rock, AR 72205. Ordering of reagents will be done on an as needed basis. (no min or max threshold will be in place) Reagents will be ordered on an as needed quantity and delivery basis for the duration of the contract as funding allows. All reagents, consumables, and ancillary items needed for the operation of the Genexus Integrated Sequencers and the Genexus Purification System shall be included in this contract. All reagents, consumables, and ancillary items needed to perform myeloid and solid tumor testing on the Genexus systems shall be included on this contract. All the reagents shall be prepackaged and ready for use. These items shall be of the highest quality, sensitivity and tested to assure precision and accuracy. Expiration dates must be clearly marked on all reagent containers. Unexpected changes in methodology/technology shall be at the expense of the contractor. The contractor shall state the open date stability for the reagents for both room temperature and refrigeration. The contractor shall package reagents in such a manner as to ensure the integrity of the reagents during transport. The contractor shall explain their policy on replacement of unsuitable or damaged products or products shipped in error. The contractor shall supply all Safety Data Sheets for their proposed reagents. The contractor shall inform the Molecular Diagnostics Supervisor of any reagent recalls or bulletins due to product unavailability due to manufacturing issues. Alert/Notifications of any delays in shipment as well as any or all technical advisory/recall/alerts, prior to or simultaneously with filed alerts should be forwarded to the Molecular Diagnostics Supervisor. The contractor shall provide their plan for product availability if supplies/products become scarce or unavailable. DELIVERY Delivery of reagents will be on an as needed basis. Molecular Diagnostics Supervisor will place an order for required reagents and supplies based on need - Process for this order placement will be determined after award of contract. Shipments should arrive within 5 business days of placement of order. Contractor shall deliver all reagents acceptably packaged to the Central Arkansas Veterans Healthcare System (CAVHS), Pathology and Laboratory Medicine Service, Little Rock, AR 72205. SITE CONDITIONS There shall be no smoking, eating, or drinking inside the hospital at any time. INSPECTION AND ACCEPTANCE: The COR shall ensure all items are satisfactory prior to acceptance. Disputes shall be resolved by the Contracting Officer. DELIVERY/STORAGE REQUIREMENTS Deliver reagent materials to job in manufacturer's original sealed containers with brand name marked thereon. Package to prevent damage or deterioration during shipment, handling, and storage. Deliver specified items only when the site is ready to proceed. Store products in dry condition inside enclosed facilities. Delivery dates will be communicated when products orders are placed. Delivery will be coordinated through the Molecular Diagnostics Supervisor. Installation is not required INSPECTION AND ACCEPTANCE: The Molecular Diagnostics Supervisor shall ensure all items are satisfactory prior to acceptance. Disputes shall be resolved by the Contracting Officer. DELIVERABLES Items as required for the operation of the Ion Torrent Genexus Integrated Sequencing Systems and Genexus Purification System. SECURITY REQUIREMENTS 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. SECURITY CLAUSE: ""A&A requirements do not apply--Security Accreditation Package is not required"". 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 onsite 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. 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 vendor at the end of lease, for trade-in, or other purposes. The options are: (1) Vendor must accept the system without the drive; (2) VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase occur that may (4) 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; (a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; (b) 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 preapproved and described in the purchase order or contract. (c) 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 ISO needs to maintain the documentation. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: a. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by the VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. b. The CO will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the CO for response. c. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. 7. REFERENCE (S): 1. VA Affairs Handbook 6500, Risk Management Framework for VA Information Systems Tier 3: VA Information Security Program, 10 Mar 2015. 2. Veterans Health Administration Procurement Manual (VHA PM) 11/3/2014. 3. VA Handbook 1901.01, Health Information Management and Health Records 19 Mar 15. 4. VHA Handbook 1605.5, Business Associate Agreements 22 July 2014 5. Privacy Act of 1974 (5 U.S.C. 552a). DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), 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 RFI. End of Document
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/113e182b93824a5c96c26314ff73210b/view)
 

Place of Performance

Address: Department of Veterans Affairs Central Arkansas Veterans Healthcare System 4300 W. 7th St., Little Rock 72205, USA

Zip Code: 72205

Country: USA
 

Record

SN06434878-F 20220821/220819230117 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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