6550--Cytology Reagents, Supplies & Service

THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). 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. IAW 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. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources sought/RFI only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 325413 (size standard of 1250 employees). Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking sources that can provide a Cytology Reagents, Supplies & Service that at a minimum meets the requirements in Attachment A and the following Statement of Work for the VISN 22 wide Healthcare System, to be ordered on an as needed basis. Estimated Period of Performance: One year period of performance from time of award plus four option years. Statement of Work- VISN 22 PLMS 1. Introduction The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the successful offeror in relation to the VISN 22 Pathology and Laboratory Medicine Service for GYN and NonGYN ThinPrep testing. 2. Background The Desert Pacific Healthcare Network (VISN 22) is one of the most diversified tertiary health care providers in the VA. It consists of teaching hospitals, providing a full range of patient services, with state-of-the art technology as well as education and research. It also boosts one of the largest and most diverse patient populations in the VA system. When collecting the pap smear, the provider collects cervical or vaginal cells from the patient using the Hologic cytobrush/plastic spatula collection device, places the specimen into the Hologic collection vial containing the CytoLyt preservative, and submits to the Pathology Laboratory. The Thin Prep pap test by Hologic uses filtration technology to remove interfering substances and non-diagnostic material from the pap sample in the liquid preservative. This filtration technology also is responsible for collecting a sufficient amount of diagnostic material from the sample and transferring it onto a glass microscope slide, creating a representative monolayer of cells on the microscope slide labeled with the patient s identifying information. The monolayer of material on the slide, which ensures that all cells are readily visible, is microscopically viewed by the cytotechnologist and the pathologist to detect diseased cells and diagnosis any pathological condition and allowing the patient to be treated. 3. Scope Supplies: The vendor shall supply kits that are equal to or equivalent to the Hologic reagents and consumables listed below. Item # Description ASY-14756 PreservCyt Solution Vials, 100 per Box 70205-001 Non-Gyn Filters, 100 per Box ASY-15207 CytoLyt Solution Collection Cups, 50 Collection Cups, Pre-filled with 30 ml 70372-001 ThinPrep Microscope Slides, 100 per Box 236004 CytoLyt® Solution 32 oz Bottles, 4 per Box 70096-003 ThinPrep Pap Test Kit, 500 Test and 500 Cytobrush/Plastic Spatula Collection Devices per Kit 70137-001 Laboratory Kit, 500 Filters and 500 Slides per Kit 71305-001 Cellient Filter Cassette Kit, 50 per Box 234004 PreservCyt Solution 32 oz Bottles, 4 per Box 51973-001 Charcoal Filter 71103-001 Filter Cap Assembly 05503-001 Embedding Molds 70825-001 Slide Kit, ThinPrep Imaging, SMS, 500 Imaged Slides 70280-001 Base Liners, 4 per pack ASY-14760 ThinPrep UroCyte PreservCyt Vial, 100 Vials, Pre-filled with 20 ml 70472-001 ThinPrep UroCyte Filters, 100 per Box 70471-001 ThinPrep UroCyte Microscope slides, 100 per Box ASY-15208 CytoLyt Solution Centrifuge Tubes, 80 Centrifuge Tubes per box, Pre-filled with 30 ml 70303-001 ThinPrep Microscope Slides, 500 per Box 70124-001 Cytobrush/Plastic Spatula Collection Devices, 500 per Box 70101-001 Broom-like Collection Devices, 500 per Box 70096-007 ThinPrep Pap Test Kit, 500 Test and 500 Rovers Combi Brush Collection Devices per Kit 70136-002 Physician s Kit, 500 Vials and 500 Cytobrush/Plastic Spatula Collection Devices per Kit See Attachment A for quantities Salient Characteristics Hologic T2000 or T5000 ThinPrep reagents and consumables listed in 2. Scope of SOW must be 100% compatible with all features, must physically fit without alteration, and not void the preventive maintenance and service or warranty of the current VA-owned Hologic T2000 or T5000 ThinPrep instrument/system. The T2000 or T5000 ThinPrep automated instrument by Hologic uses filtration technology to remove interfering substances and non-diagnostic material from the pap sample in the liquid preservative. This filtration technology also is responsible for collecting a sufficient amount of diagnostic material from the sample and transferring it onto a glass microscope slide, creating a representative monolayer of cells on the microscope slide labeled with the patient s identifying information. The monolayer of material on the slide, which ensures that all cells are readily visible, is microscopically viewed by the cytotechnologist and the pathologist to detect diseased cells and diagnosis any pathological condition and allowing the patient to be treated. Hologic T2000 or T5000 ThinPrep compatible reagents and consumables must be FDA approved. Hologic T2000 or T5000 ThinPrep compatible reagents and consumables must not negatively impact system performance, assay results, safety, and equipment life cycle of the current VA-owned Hologic T2000 or T5000 ThinPrep instrument/system. Pricing must include all handling, HAZMAT and shipping fees when applicable. Service and preventive maintenance contract for all VISN22 Hologic equipment. - Instrument #1 Model Instrument #1 Serial # Instrument #2 Model Instrument #2 Serial # Albuquerque T2000 06475K18D0 - Greater LA T2000 05850J13D0 T2000 05849J13D0 Loma Linda T2000 N0195I18D0 T2000 N0202J18D0 Long Beach T5000 91820A19DO T2000 UL61010-1 Phoenix - T2000 N0209K18D0* - T2000 05344 San Diego T5000 91754K18D0 T2000 05471C12D0 Tucson T5000 91827A19D0 T2000 053976110 * The ThinPrep 2000 Instrument (Serial No. N0209K18D0) is Hologic-owned and Service should be included in the price of the consumables for this Instrument. Unlimited service visits Monday through Friday from 8:00 a.m. to 5:00 p.m. (local time). Customer Support Center Specialists are available by phone 24 hours a day, 365 days a year to assist in troubleshooting. All necessary warranted repair parts and the travel and labor to install parts. Labor and preventive maintenance kits for preventative maintenance visit(s). Response for emergency repairs within 24 hours of request Monday through Friday local time. Remote access connectivity for problem identification, training, and monitoring. A maximum labor charge for each service visit outside of contract coverage hours. System repaired at customer site. Preventative maintenance visits. Factory authorized updated/modifications. 4. Technical Requirements Staff must be Hologic trained and certified to work on Hologic instrumentation. Staff must be Hologic certified to work on the Hologic T2000 and T5000 models. 5. Period of Performance One year period of performance from time of award plus four option years. 6. Hours of Operation Normal tour-of-duty hours are 7:30 am to 5:00 pm, Monday through Friday, excluding Federal holidays. However, the service is operating 24/7 and as such there may be instances in which the vendor s workday may be outside of this period. The vendor is required to coordinate these times with the designated Program Manager. In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as Legal Federal official holidays New Year s Day January 1st Martin Luther King s Birthday Third Monday in January President s Day Last Monday in January Memorial Day Last Monday in January Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veteran s Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies. Security 7.1 Information Security The vendor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The vendor s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA Project Manager and the VBA Headquarters Information Security Officer as soon as possible. The vendor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation. The contractor shall follow The Veterans Affair Acquisition Regulation (VAAR) security clause VAAR- 852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES sited in section C. Contract Clauses (a) The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce's National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST's Web site at: http://checklists.nist.gov (b) To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in "VA Information and Information System Security/Privacy Requirements for IT Contracts" located at the following Web site: http://www.iprm.oit.va.gov 7.2 Contract Personnel Security All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004 and is available at: http://www.va.gov/pubs/asp/edsdirec.asp (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award, and are to be completed and returned to the VA Security and Investigations Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for resources necessary to remedy the incident. The information identified above and in Attachment A is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested and are capable of providing the sought-out supplies/services, please provide the requested information in Attachment A as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.) (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer or distributor of the items being referenced above (or equivalent product/solution)? What is the manufacturing country of origin of these items? (4) If you re a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (5) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract type and number. (6) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (7) Please provide general pricing for your products/solutions for market research purposes. (8) Please state your company s UEI number. (9) Please submit your capabilities in regard to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? *** Submissions addressing Section (9) should show clear, compelling and convincing*** evidence that all equal to items" meet all required salient characteristics. Responses to this notice shall be submitted via email to contact@example.gov. Telephone responses shall not be accepted. Responses must be received no later than Tuesday, January 31st, 2023, at 1:00 p.m. PST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.