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 negotiate and 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 supply contract for a two-month base period and four (4) option years for reagents, quality control, maintenance, consumables, and lease of 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 - Ascorbic Acid - 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 - Mucous - Formed Elements - Ova and parasites - Body fluids Additional Requirements: 1. Equipment. a. The units 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 unit shall be capable of performing automated particle classification and sub-particle classification. 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 can run patient samples manually, with or without barcodes, during Laboratory Information System (LIS) downtime. b. The system shall include a computer workstation with the ability to locate patient samples using patient name, accession number, 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 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. c. 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. d. 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 sixty (60) microscopy samples per hour; the system shall also have 60 sample - walk away or pre-loading capability. The system shall be capable of a throughput of at least one hundred (100) chemistry samples per hour. If calibration activities are required, they shall be required at a frequency of no more than monthly. 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 calculations. 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 100 to 240 VAC, 50 to 60 Hz. e. The vendor shall provide installation and validation testing. The vendor shall provide validation of the analyzers, including normal range verification, demonstration of linearity, reportable range, replication studies, recovery studies, and establishment of initial control ranges using control materials. The vendor shall provide preventive maintenance coverage and Corrective system maintenance coverage shall include response times, as specified in this Statement of Work (SOW). Support shall be provided for a two-month base period of performance from 1 August 2023 - 30 September 2023, with four (4) subsequent option years from 1 October 2023 - 30 September 2027. f. 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. The system shall be installed in compliance with OSHA requirements. g. 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. h. 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. 2. Reagent and Supply Delivery. a. The contractor shall provide all analyzer automation, necessary reagents, quality control, calibrators, spare parts for user-level maintenance, and consumables in support of in-house urinalysis and associated testing at NHCH. b. All supplied items and reagents shall be certified for use with the vendor equipment provided. c. All supplied items and reagents shall have a minimum shelf life of six (6) months upon receipt by the Government. d. 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 and two sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified. e. 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 3. Maintenance. a. The vendor shall provide OEM-trained, experienced, English-speaking personnel, and all 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 OEM's specifications/equipment certification. 4. Preventive Maintenance Services. a. Normal business-hour maintenance coverage will be Monday through Friday, from 8:00 A.M. to 5:00 P.M. local time, excluding Federal Government holidays. 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 base contract period at the OEM's recommended intervals. The vendor will also perform preventive maintenance service checks during each option year 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), Food and Drug Administration (FDA), and National Institute of Standards and Technology (NIST) standards. 5. 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 through Friday, with unlimited service calls. Telephonic technical support shall be available twenty-four (24) hours per day, seven (7) days per week. b. A vendor Field Service Engineer (FSE) shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within twenty-four (24) hours after receipt of trouble call. Equipment shall be repaired and deemed operational within forty-eight (48) hours. c. The Government's request for corrective maintenance will be placed by Biomedical Engineering Division (BIOMED) personnel, directly to the vendor or its representatives. 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 FSE. Telephone consultation shall: 1) provide instruction in determining operator error 2) determine the most likely cause of the problem 3) determine if resolution of the problem requires the dispatch of an FSE 4) identify replacement parts likely to be required 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 and provide to its representatives its own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and/or repair of all equipment included in this contract. 6. Replacement Parts/Upgrades. a. The vendor and its representatives shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. If replacement parts require shipment, 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. If 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 provide software revisions, updates, and upgrades (field service changes) required by FDA-announced or manufacturer-announced hazards, alerts, or recalls, including those falling under the 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 during the first scheduled PM inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment, the vendor shall provide installation within 30 days of release regardless of PM schedules. f. With approval from the Government, the vendor may perform hardware/software upgrades as they become available. 7. Training. a. The vendor shall provide an instrument training program that is coordinated with and timely to the equipment installation. b. The vendor shall provide initial operator training at the vendor's training facility for up to two (2) operators per analyzer, to be used within the first twelve (12) months of the contract. c. The factory training program will include transportation, room and board and training/classroom costs for each participant. d. The vendor shall also provide one operator training per analyzer for each completed year of customer contract. e. The vendor shall provide initial on-site operator training to all technicians assigned to the Urinalysis bench prior to the initial use of the equipment. 8. Laboratory Information System (LIS). a. The system shall be capable of bi-directionally interfacing with the Cerner Military Healthcare System (MHS) Genesis, and the laboratory information system (LIS). All equipment, software, and drivers needed to interface the system to the LIS shall be included. b. The system shall have the ability to receive HL7 order messages (ORM) and information from the LIS and provide DICOM Modality Worklist to the modalities. c. If the vendor is not already approved to connect to MHS Genesis bi-directionally, the vendor shall agree to complete any bi-directional interface integration at no additional cost to the Government. Interface integration must be completed prior to final acceptance of the system. 9. 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 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 personnel. 10. 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. 11. 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, in complete detail, and in English: 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 MTF) 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, point of contact, and contact information (i.e., telephone number and email address) 12. Vendor Responsibility. a. The vendor shall be responsible for the repair and/or replacement of damaged Government-owned equipment and property resulting from the negligence of the vendor or its representatives. All such replacement or repair shall be completed at the vendor's expense and shall be inspected to the satisfaction of the Contracting Officer (KO) or his/her appointed representative. 13. Removal of Government Property. a. No equipment shall be removed without the approval of the Contracting Officer's Representative and Materials Management Department (MMD) of the Medical Treatment Facility (MTF). Property passes for equipment removal shall be obtained by the vendor via the MMD of the MTF. Any failure to obtain such passes, which results in detainment or prosecution of service vendor personnel, is the sole responsibility of the service vendor and their personnel. b. The vendor shall provide a detailed description of removed items in writing on the vendor's company letterhead. For associated items/accessories, the vendor shall provide a detailed written description and quantities of items to be removed. Descriptions shall include, at a minimum, the manufacturer's serial numbers, and ECNs of all equipment/items removed. If items/sub-assemblies/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. At the expiration of the contract, vendor will complete equipment decontamination in preparation for its return and removal from MTF at no additional charges. e. Regarding patient information confidentiality and privacy, all vendors and/or service vendors shall not remove equipment containing personally identifiable information or patient health information from the Government site. The equipment hard disk drive (HDD) or solid state drive (SSD) shall be removed by MTF personnel prior to equipment removal from the site. Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees. If HDD or SSD are to be replaced, the HDD or SSD in disrepair shall be left at the MTF for disposal. 14. Service Beyond the Scope of the Contract. a. The vendor shall immediately, but not later than twenty-four (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, for which the vendor considers they are not responsible for repairing under the terms of this contract. b. At the same time of this notification, the vendor shall furnish BIOMED with a 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 and previous acquisition history, it has been determined that 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, 7 July 2023. NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.