SPECIAL NOTICE
65 -- Notice of Intent to Sole Source - Urine Analyzer
- Notice Date
- 6/13/2022 8:05:29 AM
- Notice Type
- Special Notice
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- DEFENSE HEALTH AGENCY FALLS CHURCH VA 22042 USA
- ZIP Code
- 22042
- Response Due
- 6/28/2022 4:30:00 PM
- Point of Contact
- Jonny Nguyen, Phone: 7262030167
- E-Mail Address
-
jonny.k.nguyen.civ@mail.mil
(jonny.k.nguyen.civ@mail.mil)
- Description
- 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. Defense Health Agency intends to award a firm fixed price contract under the authority of 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). 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 reagents, quality control, maintenance, consumables, and two (2) analyzers, laboratory, urine, automated for device code 16-378 for Naval Health Clinic Hawaii. The requirement is a contract for reagents, quality control, maintenance, consumables, and two (2) automated urine laboratory analyzers for Naval Health Clinic Hawaii. 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 Branch Health Clinic Makalapa. TEST 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 Body fluids 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. 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. 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 way� 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 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 electrical requirements are 110VAC, 50 Hz. 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 all necessary user training for four (4) key operators to be used within the first twelve (12) months of the contract, if requested. Corrective system maintenance coverage shall include response times, as specified in the Statement of Work (SOW). Training shall be provided by the vendor, as specified in the SOW. The system shall bi-directionally interface with the Composite Health Care System (CHCS), Military Healthcare System (MHS) Genesis and the laboratory information system (LIS), as specified in the SOW. The vendor shall provide two (2) operational manuals for each analyzer and two (2) service manuals for each analyzer, each in English. Support shall be provided for a period of performance from 1 October 2021 � 31 March 2022, with four (4) subsequent option years. 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. Through a cost per patient reportable result contract, the contractor will provide all analyzer automation, necessary reagents, quality controls, calibrators, spare parts for user level maintenance, and consumables in support of in-house Urinalysis and associated testing at NHC Hawaii. b. Reagents and supplies needed to perform tests will be ordered on an as needed basis via delivery order. c. All supplied items and reagents shall be certified for use with the Vendor equipment provided. d. All supplied items and reagents shall have a minimum shelf life of 6 months upon receipt by the Government. e. All supplied items and reagents that require special handling (e.g. refrigeration, time sensitive, immediate open, 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. f. The contractor shall provide deliveries to the delivery point identified below: Naval Health Clinic Hawaii, Pearl Harbor Makalapa Clinic Bldg 1407 Room 907 Lab Department JBPHH, HI 96860 Naval Health Clinic Hawaii, Kaneohe Bay 3089 D Street Lab Department MCBH Kaneohe Bay, HI 96734 2. Task Personnel Requirements a. US citizenship is required b. All technical staff and service engineers employed by the contractor must have backgrounds in engineering, science, or laboratory technologies. The contractor must provide a rigorous training and credentialing program used to assess competency of and proficiency for those skills necessary to successfully trouble shoot and fix analyzers before being assigned to an account to provide such services. 3. Maintenance. a. The Vendor shall provide OEM-trained, experienced, English-speaking personnel. The Vendor shall provide 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 original equipment manufacturer�s (OEM�s) specifications/equipment certification. d. The Vendor shall provide maintenance services Monday through Friday from 0800-1700 local time, excluding Federal Government holidays as seen at the following site: https://www.opm.gov/policy-data-oversight/payleave/ pay-administration/fact-sheets/holidays-work-schedules-and-pay. This includes annually required preventive maintenance. Customer and technical support should be available by phone 24 hours, 7 days a week. 4. Preventive Maintenance Services. a. Normal Business Hour Maintenance Coverage will be Monday through Friday, from 0800-1700 local time, excluding Federal Government holidays. Vendor shall provide full-service preventive maintenance. b. PM shall be performed in accordance with OEM recommendations. c. The Vendor shall perform PM service checks during the base contract period at the OEM�s recommended intervals. Vendor will also perform PM 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. Vendor shall provide on-site corrective maintenance from 0800-1700 Local Time, Monday-Friday, to include unlimited service calls. Telephonic technical support shall be available 24 hours per day, 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 BIOMED 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 a FSE; 4) 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 quoted annual 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. In the event that 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. 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 dete1mination 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 FDAannounced 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 Contracting Officer, the Vendor may perform hardware/software upgrades as they become available. 7. Training a. The Vendor shall provide operator training for at least four (4) operators, to be used within the first twelve (12) months of the contract. 8. Composite Health Care System (CHCS). a. The system shall be capable of bi-directionally interfacing with the CHCS, Cerner Military Healthcare System (MHS) Genesis, and the laboratory information system (LIS). 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 CHCS 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 and in complete detail: 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 billing cost xi. Signatures: 1. Field Service Technician performing services 2. BMET verifying service rendered xii. In the event that agents/sub-Vendors are used in the performance of repairs, said agents shall be identified on the service report by company name, point of contact, and contact information (i.e. telephone number and email) 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 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 facility equipment control numbers (ECNs) of all equipment/items removed. In the event that items/sub-assemblies/accessories are �repaired 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 Vendor or service Vendor�s custody. d. In regards to 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 for cleaning and decontamination. 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 of or the development of any defects in 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 may 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 a Urine Analyzer at Naval Health Clinic Hawaii. 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 and consumables for Naval Health Clinic Hawaii. 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 1630 Pacific Time, 28 June 2022. Capability statements shall be submitted by email ONLY as a Microsoft Word or Adobe PDF attachment to the following address: jonny.k.nguyen.civ@mail.mil The email subject line shall state, �NHCH � Urine Analyzer� NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/a82e81a6f30246adbf5be5ae146dd728/view)
- Place of Performance
- Address: JBPHH, HI 96860, USA
- Zip Code: 96860
- Country: USA
- Zip Code: 96860
- Record
- SN06355667-F 20220615/220613230101 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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