Notice of Intent to Sole Source - Urine Analyzer

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 for reagents, quality control, maintenance, consumables, and two (2) automated urine laboratory analyzers for use at Naval Health Clinic Hawaii (NHCH) 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: BECKMAN COULTER, INC. 250 S KRAEMER BLVD BREA, CA 92821-6232 The North American Industry Classification System (NAICS) code for this requirement is 325413 - Analytical Laboratory Instrument Manufacturing; the business size standard is 1,250 (in number of employees). The Product Service Code (PSC) is 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets. The objective of this sole source award is to procure a six-month term supply contract with two (2) six-month options for reagents, quality control, maintenance, consumables, and two (2) automated urine laboratory analyzers for use at NHCH Makalapa and Branch Health Clinic Kaneohe Bay. Together, the units shall be capable of performing at least the tests listed below for an estimated annual workload of at least 7,200 microscopic samples and 7,200 chemistries for Branch Health Clinic Kaneohe Bay, and at least 10,800 microscopic samples and 10,800 chemistries for NHCH Makalapa. TESTS: - Color - Clarity - pH - Protein - Glucose - Ketone - Bilirubin - Blood - Nitrite - Urobilinogen - Leukocytes - Specific gravity - Formed Elements - Red Blood Cells - Formed Elements - Squamous Epithelial Cells - Formed Elements - Yeast - Formed Elements - Crystals - Formed Elements - Sperm - Formed Elements - White Blood Cells - Formed Elements - Bacteria - Formed Elements - Casts - Formed Elements - Non-squamous Epithelial Cells - Formed Elements - Ova and parasites - Body fluids The system shall be fully automated and capable of performing both macroscopic and microscopic testing. The system shall be capable of performing high detection of urine sediments. The system shall be capable of auto correcting for abnormal urine colors. The system shall be capable of interfacing with the MHS Genesis and the laboratory information system. The system shall provide reagent barcode reading capability and inventory control including archiving and active reagent volume monitoring and warning. The system shall be capable of reading bar coded patient samples using the VistA Universal Identification system, and have the ability to run patient samples manually, with or without barcodes, during Hospital Information System (HIS)/Laboratory Information System (LIS) downtime. The system shall include a computer workstation with the ability to locate patient samples using patient name, SSN, or unique ID, and determine when results will be available. The workstation shall be capable of generating and printing patient reports in a chartable medical record format that may be sent to providers during HIS/LIS downtime. The workstation shall be capable of retransmitting results after LIS or instrument downtime. The workstation shall be capable of easily adding or updating quality control and calibrator materials, values, and track changes. The workstation shall be capable of running new and old lot numbers of QC concurrently for parallel testing. The workstation shall be capable of using only one printer to print QC data, review screens, or print files while running patient samples. The system shall include an interactive on-board QC package with modified Westgaard rules and Levy-Jennings plots. QC results shall be printable and include standard deviation index. The QC package shall include electronic archiving and corrective action documentation. The system shall allow evaluation and printing of QC results while the instrument is analyzing patient samples. The system shall allow monitoring of calibrations for slope, intercept, and blank. The system shall allow export of values to a commercial quality control program. The system shall include bidirectional LIS host query with a Data Innovations interface. All equipment, software, and drivers needed to interface the system to the LIS shall be included. The system shall allow for reviewing abnormal results on the instrument. The system shall be capable of providing true STAT interrupt. The system shall be capable of a throughput of at least forty (40) tests per hour. The system shall have a detector system for bubbles, clots, and incomplete sample aspirations. The system shall have a cleansing mechanism for small clots. The system shall not require external water, pressure, or vacuum. The system shall be calibrated on assayed material compatible with College of American Pathologist's (CAP) guidelines. The analyzer shall compile all calculation. Calculation factors shall be stored internally and activated internally at the operator's discretion. The system shall be capable of providing microscopic images on the instrument screen. The vendor shall provide information on reagent calibration stability and carryover specifications. The electrical requirements are 110VAC, 60 Hz. System installation, validation, correlation, onsite and offsite training, and preventive maintenance coverage shall be included. Corrective system maintenance coverage shall include response times as specified in the Statement of Work. Support shall be provided for the six-month base term from 29 March 2023 - 30 September 2023, with two (2) options for an additional six (6) months each. The units shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements. Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. Additional Requirements: 1. Reagent and Supply Delivery. a. All supplied items and reagents shall be certified for use with the vendor equipment provided. b. All supplied items and reagents that require special handling, e.g. refrigeration, time sensitive, open immediately, etc., will be marked in a clear manner with a label that is easily read, understandable and a minimum of 3 x 3 (9 sq. inches). The label will be placed in three (3) or more locations on the container (top & sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified. c. The contractor shall provide deliveries to the delivery points identified below: Naval Health Clinic Hawaii Makalapa Laboratory 1253 Makalapa Rd., Bldg. 1407 JBPHH, HI 96860 Naval Health Clinic Hawaii MCBH Kaneohe Bay Laboratory Harris Avenue, Bldg. 6905 Kaneohe, HI 96863 2. Maintenance. a. 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. b. 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. c. Equipment listed in this contract will be maintained to meet and retain the original equipment manufacturer's (OEM's) specifications / equipment certification. 3. Preventive Maintenance Services. a. Normal Business Hour Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to 5:00 P.M. local time. The vendor shall provide full-service preventive maintenance. b. Preventive maintenance shall be performed in accordance with OEM recommendations. c. The vendor shall perform Preventive Maintenance Service checks during the six-month base period at the OEM's recommended intervals. The vendor will also perform Preventive Maintenance Service checks during each option period at a date and time mutually agreed upon by the vendor and the Government. d. 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), OEM, the College of American Pathologist's (CAP), and Food and Drug Administration (FDA) standards as required. 4. Corrective Maintenance. a. The 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. b. 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. c. 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. d. The 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 an 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. e. The vendor's pricing shall be inclusive of all costs including parts, consumables, labor, travel, and shipping. f. 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. a. 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. b. The vendor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. c. 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. d. 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. e. 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, the vendor shall provide installation within 30 days of release regardless of Preventative Maintenance schedules. f. With approval from the Government, the vendor may perform hardware/software upgrades as they become available. 6. Government Furnished Property, Materials, and Services. a. 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. b. The Government will operate the system in accordance with the instruction manual provided by the OEM. c. 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. a. 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. a. 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. b. 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: i. Name of Vendor ii. Contract Number iii. Name of field service technician performing service iv. Vendor log/control number v. Date, time (beginning and ending), and hours on-site for service call vi. Description of problem reported by user vii. Equipment identification factors to include: manufacturer, make, model, serial number and Facility Equipment Control Number (ECN) viii. 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 ix. Problem resolution or pending action x. Total cost (Informational Only) xi. Signatures: 1. Field Service Technician performing services 2. BMET verifying service rendered (Identify Medical Treatment Facility) xii. 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. a. 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. a. 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. b. 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. c. 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 the vendor or service vendor's custody. d. 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. a. 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. b. 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, BECKMAN COULTER, INC. is the only source that can meet the Government's minimum requirements to provide all analyzers, reagents, controls, and training for the urine analyzers at Naval Health Clinic Hawaii. This notice of intent is not a request for competitive proposals, and no solicitation document exists for this 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 and consumables for Naval Health Clinic Hawaii. Capability statements shall not exceed six (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. If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or Adobe PDF attachment to Michelle Sanders at contact@example.gov. The closing date for challenges is no later than 1600 Pacific Time, 10 March 2023. NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.