Notice of Intent to Sole Source DYSIS View Digital Video Colposcope with diagnostic computer-aided cervical mapping software

Notice of Intent to Sole Source THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE SUPPLY CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division (WMCD), San Diego, intends to award a firm fixed price contract in accordance with Federal Acquisition Regulation (FAR) 13.501(a) Sole Source acquisitions and FAR 13.106-1(b)(1)(i), only one source being available to meet the Government's needs, to: TRYCO INCORPORATED 6736 OLD MCLEAN VILLAGE DR MCLEAN, VIRGINIA 22101-3906 The North American Industry Classification System (NAICS) code for this requirement is 339113 - Surgical Appliance and Supplies Manufacturing; the business size standard is 750 (in number of employees). The Product Service Code (PSC) is 6525 - Imaging Equipment and Supplies: Medical, Dental , Veterinary. The objective of this sole source award is to procure a quantity two (2) digital video colposcopes with relevant accessories for Naval Health Clinic Oak Harbor. The requirement is a contract for procurement of quantity two (2) digital video colposcope, an acetic acid applicator, quantity one (1) small reusable DYSIS speculum, quantity four (4) medium DYSIS speculums, quantity two (2) large wide DYSIS speculums, and quantity two (2) large wide offset DYSIS speculums for Naval Health Clinic (NHC) Oak Harbor. NHC Oak Harbor Women's Health/OBGYN is a primary source for all sponsors and their beneficiaries for all woman healthcare. The required colposcope will further assist in treating and diagnosis. The DYSIS colposcopes and speculums shall have the ability to record and map cervix during procedure. The DYSIS system has proprietary software that will not only identify possible cancerous markings, but it will also capture the data for further investigation for collaboration with a specialist. The system shall quantify acetowhitening and measure speed, intensity, and duration. It shall calculate dynamic curves and assign distinct colors, which assists the clinician in identifying potential areas for concern for further evaluation. Additional Requirements: 1. Supply Delivery. All supplied items shall be certified for use with the Vendor equipment provided. The contractor shall provide delivery to the delivery point identified below: Naval Health Clinic Oak Harbor - Gynecology ATTEN: CMDR Candace Foura 3475 N. Saratoga St. Bldg 993 Oak Harbor, WA 98278 2. Maintenance. The Vendor shall provide trained, experienced, English-speaking personnel, labor, tools, diagnostic equipment, software, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST) and corrective maintenance. The Vendor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator shall be made available to answer technical questions regarding system operations and applications. Equipment listed in this contract will be maintained to meet and retain the original equipment manufacturers (OEM's) specifications / equipment certification. 3. Preventive Maintenance Services. Normal Business Hour Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to 5:00 P.M. local time. Vendor shall provide full service preventive maintenance. Preventive maintenance shall be performed in accordance with OEM recommendations. Vendor shall perform Preventive Maintenance Service checks at the OEM's recommended intervals. All test equipment used in the performance of this contract shall be calibrated, as required by the OEM, and shall be in compliance with Joint Commission (JC) standards as required. 4. Corrective Maintenance. Vendor shall provide on-site corrective maintenance between the hours of 8:00 A.M. and 5:00 P.M. local time, Monday-Friday with unlimited service calls. Telephonic support shall be available 24 hours per day, 7 days per week. A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call, and provide on-site service within twenty-four (24) hours. Equipment shall be operational within 48 hours. Government request for corrective maintenance will be placed by Biomedical Engineering Division (BIOMED) personnel, to the Vendor. Corrective maintenance shall be completed during the hours specified in the contract. Vendor's response to requests for service may include telephone consultation with the equipment user/operator and a Vendor Field Service Engineer (FSE). Telephone consultation 1) shall provide instruction in determining operator error; 2) shall determine the most likely cause of the problem; 3) shall determine if resolution of the problem requires the dispatch of a FSE; and 4) should identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM. Vendor's pricing shall be inclusive of all costs including parts, consumables, labor, travel and shipping. The Vendor shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation/repair of all equipment included in this contract. 5. Replacement Parts/Upgrades. The Vendor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacement parts are required to be shipped, shipping shall be performed in the fastest reasonable means possible at no additional cost to the Government. The Vendor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. Freight, postage, and storage charges associated with shipment and receipt of replacement parts and the return of parts shall be the responsibility of the Vendor. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies are allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The Vendor shall specifically annotate on the Field Service Report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality. The Vendor shall include software revisions and upgrades (field service changes), which are required due to FDA or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Upgrades shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment by the OEM, vendor shall provide installation within 30 days of release regardless of Preventative Maintenance schedules. With approval from the government, the vendor may perform hardware/software upgrades as they become available. 6. Government Furnished Property, Materials, and Services. The Government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the system to function properly as specified by the OEM. The Government will operate the system in accordance with the instruction manual provided by the OEM. The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of Vendor supplies, materials, or for the personal belongings brought onto Government property by Vendor's personnel. 7. Vendor Furnished Property and Material. The Vendor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the Vendor service technicians and as required for the completion of the services in accordance with this contract. 8. Vendor Report Requirements. During normal duty hours, Vendor FSE personnel shall check-in with the Biomedical Engineering Division upon arrival at the Government site and again prior to departure. The Vendor FSEs shall personally notify BIOMED personnel of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment shall be implemented, and the disabled equipment shall be locked out with a letter of intent in compliance with OSHA regulation to prevent any patient hazards. After normal duty hours, Vendor FSEs shall notify the Officer of the Day Desk and the systems operator designated by BIOMED personnel. The Vendor shall provide to BIOMED personnel a full service report within two (2) days after completion of all services performed. Each service report shall at a minimum document the following data legibly and in complete detail: Name of Vendor Contract Number Name of field service technician performing service Vendor log/control number Date, time (beginning and ending), and hours on-site for service call Description of problem reported by user Equipment identification factors to include: manufacturer, make, model, serial number and Facility Equipment Control Number (ECN) Itemized description of service performed to include: labor and travel costs, parts used, parts cost, parts number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action taken or recommended Problem resolution or pending action Total cost (Informational Only) Signatures: Field Service Technician performing services BMET verifying service rendered (Identify Medical Treatment Facility) In the event that agents / sub-vendors are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number) 9. Vendor Responsibility. The Vendor shall be responsible for the repair/replacement of damaged Government owned equipment and property due to the negligence of the Vendor or his representatives. All such replacement or repair shall be at the Vendor's expense and shall be inspected to the satisfaction of the Contracting Officer or appointed representative. 10. Removal of Government Property. No equipment shall be removed without the approval of the Contracting Officer's Representative and Materials Management Department of the Medical Treatment Facility (MTF). Property passes for equipment removal shall be obtained by the Vendor via the Materials Management Department of the MTF. Any failure to obtain such passes which results in detainment or prosecution of service Vendor personnel are the sole responsibility of the service Vendor personnel. The Vendor shall provide a detailed description of removed items in writing on the Vendor's company letterhead. For associated items / accessories, Vendor to provide a detailed written description and quantities of items to be removed. Description to include, as a minimum, manufacturer's serial numbers and equipment control numbers (ECNs) of all equipment / items removed. In the event that items / subassemblies / accessories are repaired via - Repair by Replacement, a detailed description of replaced items is to be included upon return of repaired components. No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a Vendor determined requirement to transport Government owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Vendor. The Vendor shall provide insurance coverage for damage to or loss of equipment while in Vendor or service Vendor's custody. In regards to patient information confidentiality and privacy, all vendors and/or service vendor shall not remove equipment containing patient information from the Government site. The equipment hard drive shall be removed at the MTF prior to removal. Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees. If hard drives are to be replaced, they shall be left at the MTF for disposal. 11. Service beyond the Scope of the Contract. The Vendor shall immediately, but not later than 24 consecutive hours after discovery, notify BIOMED, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment which the Vendor considers they are not responsible for under the terms of this contract. At the same time of the notification, the Vendor shall furnish BIOMED with written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order. Based on market research, TRYCO Incorporated, exclusive distributor of the DYSIS View Digital Colposcope, is the only source that can meet the Government's minimum requirements to provide two digital video colposcopes and speculums for Naval Health Clinic Oak Harbor. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required equipment for Naval Health Clinic Oak Harbor. Capability statements shall not exceed 6 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order. Capability statements are due by 1300 Pacific Time, 20 June 2023. Capability statements shall be submitted by email ONLY as a Microsoft Word or Adobe PDF attachment to the following address: contact@example.gov . The email subject line shall state, - NHCOH - Video Colposcope. NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.