Statement of Requirements_Rev 12JUN2025.docx

STATEMENT OF REQUIREMENTS

Naval Health Clinic Hawaii has a requirement for a CPRR (cost per reportable result) contract for the lease of two (2) Chemistry analyzers, to include Infinity middleware, QC Module, Navify Lean result validation, Navify Lean result consultation to build rules, reagents, third party quality controls (Bio-Rad), calibrators, consumables, preventive maintenance, maintenance of middleware, Technical Support, and operator training. One (1) clinical chemistry/immunoassay analyzer shall be for Branch Health Clinic (BHC) Makalapa, and one (1) clinical chemistry analyzer shall be for BHC Kaneohe Bay. The contracted analyzer for Makalapa shall be a single platform configuration capable of performing general chemistry, immunoassay, and screening for electrolytes, diabetes, hepatic diseases, thyroid diseases, cardiac diseases, and renal diseases as defined below. The contracted analyzer for BHC Kaneohe Bay shall be capable of performing general chemistry, and screening for electrolytes, hepatic diseases, renal diseases, and cardiac diseases. The contracted analyzers for each clinic shall be capable of performing the tests listed below at the yearly indicated test volume. The contracted analyzers for BHC Makalapa and BHC Kaneohe Bay shall have the same test methodology to ensure accuracy of results between clinics. The contractor shall be capable of 24-hour response time. The contractor shall be available for telephone troubleshooting consultation 24 hours a day, 7 days a week, 365 days per year, except on Federal holidays. The contract shall include offsite Key operator training. The contract shall include water purifiers connected to the analyzers, its’ maintenance service, and all consumables.

BHC Makalapa Requirements:

The contracted analyzer shall be an integrated general chemistry and immunoassay analyzer providing a single footprint. The contracted analyzer shall be capable of completing a minimum of 375 tests per hour. Due to space constraints, the contracted analyzer shall fit within the following dimensions: 70 inches (H) x 98 inches (W) x 32 inches (D). The contracted analyzer shall perform all the analytes at the annual estimated test volume as indicated below.

2025 ANNUAL ESTIMATED TEST VOLUME (REPORTABLE) - BHC MAKALAPA

BHC Kaneohe Bay Requirements:

The contracted general Chemistry analyzer shall be capable of completing a minimum of 375 tests per hour. Due to space constraints, the contracted analyzer shall fit within the following dimensions: 70 inches (H) x 58 inches (W) x 32 inches (D). The contracted analyzer shall perform all the analytes at the annual estimated test volume as indicated below.

2025 ANNUAL ESTIMATED TEST VOLUME (REPORTABLE) - BHC KANEOHE BAY

1. Equipment

a. The analyzers shall utilize liquid, ready-to-use reagents and shall not require the manipulation/reconstitution of reagents for testing

b. The analyzers shall not require major facility changes beyond electrical.

c. The analyzers shall be capable of adding new third-party tests.

d. The analyzers shall be capable of utilizing the following sample types without the need for the following pre-treatments: serum, plasma, and urine.

e. The analyzers shall be capable of automatic quality control (QC) and automatic calibration.

f. The analyzers shall be capable of pre-calibrating and storing at least two (2) lots onboard the unit.

g. The analyzers shall have sufficient onboard storage to accommodate daily workload as outlined above.

h. The analyzers shall complete STAT (urgent) requests in, at most, 60 minutes.

i. The analyzers shall be capable of auto-dilution.

j. The analyzers shall be capable of utilizing sample tube bar codes for accurate sample identification.

k. The analyzers shall be capable of interfacing with the MHS Genesis, laboratory information management system.

l. The analyzers shall include programmable panels to accommodate in-house needs.

m. The analyzers shall be capable of starting up without priming or washes.

n. The analyzers shall be capable of external data storage in compliance with Navy/Department of Defense (DoD) Information Assurance (IA) regulations.

o. The analyzers shall include an uninterruptible power supply (UPS) that is compatible with all system components, is capable of conditioning the power to the system, and allows the system a minimum of 30 minutes run time in case of a power outage.

p. The analyzers shall have the Auto Verification capabilities with the use of middleware to auto-validate samples that do not require manual attention.

q. The analyzers shall have the QC Module to automate and manage quality control (QC) processes.

r. The power requirement is 250 Vac, 50/60 Hz, 30 Amps, single phase AC.

s. The analyzers shall connect to a water purifier system. The contract shall include the water purifiers, its’ maintenance service and all consumables to minimize downtime that can affect productivity.

2. Training and Support

a. System, Infinity middleware, QC module and Auto verification module installation, validation, correlation, consultation to build rules, and onsite and offsite training are required.

b. Yearly off-site training for key operator staff shall be provided for each analyzer.

c. On-site assistance during system validation shall be provided.

3. Reagent and Supply Delivery

a. All supplied items and reagents shall be certified for use with the equipment provided by the selected vendor.

b. All supplied items and reagents that require special handling (e.g., refrigeration, time sensitivity, immediate open, etc.) will be marked in an explicit manner with a label that is easily read, understandable, and a minimum of 3 inches x 3 inches (9 sq. inches). The label will be placed in three (3) or more locations on the container (top & two sides). Supplies or items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

c. Vendor will provide third party Quality Control materials from Bio-Rad for each assay that is performed on the analytical instruments at no additional cost to the government.

d. The contractor shall provide deliveries to the delivery point 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

4. Maintenance

a. The Vendor Field Service Engineers shall be original equipment manufacturer (OEM) trained, experienced, and 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 (CM).

b. The Vendor shall provide telephonic communications to discuss technical matters relating to the performance of this contract. An English-speaking 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 and/or equipment certification.

5. 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. Vendor shall provide full-service preventive maintenance.

b. Preventive maintenance shall be performed in accordance with OEM recommendations.

c. Vendor shall perform preventive maintenance service checks during the base contract period at the OEM’s recommended intervals. 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 the Joint Commission (JC), OEM, the College of American Pathologist’s (CAP), and Food and Drug Administration (FDA), and National Institute for Standards and Technology (NIST) standards.

6. Corrective Maintenance

a. Vendor shall provide on-site corrective maintenance between the hours of 8:00 A.M. and 5:00 P.M. local time, Monday-Friday, to include unlimited service calls. Telephonic support shall be available 24 hours per day, 7 days per week, 365 days a year, excluding Federal Government holidays:

Independence Day

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 forty-eight (48) hours of the initial trouble call.

c. Government request for corrective maintenance will be placed by NHC Hawaii Lab personnel or 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 a Field Service Engineer (FSE)

4. should 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 FSE shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and repair of all equipment included in this contract.

7. 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. If 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-out 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, non-refurbished, and certified as OEM replacement parts.

e. The vendor shall install software revisions, updates, and upgrades (field service changes) that are required by FDA- or manufacturer-announced safety hazards, alerts, or recalls, including the FDA Year 2000 (Y2K) Compliance Directive, as part of the contract at no additional cost to the Government. Updates, revisions, and upgrades shall be performed as soon as possible after release.

f. With approval from the Government, the vendor may perform hardware/software upgrades as they become available.

8. 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 Vendor’s supplies, materials, or the personal belongings (brought onto Government property by Vendor’s personnel) that have been damaged or lost due to fire, theft, accident, or other disasters.

9. 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 FSE as required for the completion of the services in accordance with this contract.

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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 Duty BIOMED personnel.

b. The vendor shall provide a full-service report to BIOMED within two (2) days of completion of all services performed. Each service report shall, at a minimum, document the following data in legible writing, 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 (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)

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13. 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 its representatives. All such replacement or repair shall be at the vendor's expense and shall be inspected to the satisfaction of the Contracting Officer (KO) or appointed BIOMED representative.

12. 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 vendor FSE 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, the vendor will provide a detailed written description and quantities of items to be removed. This description will include, as a minimum, the manufacturer’s serial numbers and facility equipment control numbers (ECNs) of all equipment and/or items removed. If 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 custody.

d. At the expiration of the contract, vendor will complete equipment decontamination in preparation for its return and remove from MTF at no additional charges.

a. In regard to patient information confidentiality and privacy, all vendors shall not remove equipment containing patient information from the Government site. The equipment hard drive(s) and/or solid state drive(s) shall be removed at the MTF prior to removal. If hard drives are to be replaced, they shall be left at the MTF for disposal.

13. Service Beyond the Scope of the Contract

a. The vendor shall immediately, but no later than 24 consecutive hours after discovery, notify BIOMED in writing of the existence of or of the development of any defects in, or repair required to, the contracted equipment, for which the vendor considers they are not responsible under the terms of this contract.

b. At the same time of this written notification, the vendor shall furnish BIOMED with a written cost estimate 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.

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