Spotfire Spec Sheet_V2.pdf

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SOLE SOURCE TO BIOMERIEUX, INC FOR THE SPOTFIRE ANALYZER SYSTEM AND TEST KITS
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IHS1498418
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This document is a government specification sheet for a Spotfire 4 PCR Laboratory Analyzer system required by the Pawnee Indian Health Center, Indian Health Services (IHS). The Pawnee Indian Health Center has a need for a FDA-approved, CLIA-waived PCR analyzer that can perform COVID-19, Flu A, Flu B, RSV, and Rhinovirus testing on a single sample with a turnaround time of less than 20 minutes.

The specification sheet details the technical requirements for the Spotfire 4 module system, including the control station, optics module, temperature ranges, power requirements, and software. It also specifies the required quantities of related test kits and controls. The contractor must provide a one-year warranty, software support, telephone support, and repair services. The contract has a 30-day period of performance from the date of award. The government will not provide any property, facilities, or services - the contractor must furnish all required personnel, materials, supplies, and equipment.

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Department of Health and Human Services Indian Health Service Oklahoma City Area

Specifications Spotfire 4 PCR Laboratory Analyzer

1. PURPOSE OF THE PROJECT

The Pawnee Indian Health Center (PIHC), Indian Health Services (IHS) has a need for a FDA approved PCR (Polymerase Chain Reaction) CLIA Waived analyzer that performs COVID-19, FluA, FluB, RSV, and Rhinovius on one collection sample. The analyzer should be capable of a turn-around-time of less than 20 minutes. This will allow the Medical clinic to continue to provide comprehensive daily lab respiratory testing services for Native American and Alaskan Natives of the PHIC.

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

The contractor shall provide the following for the Pawnee Indian Health Center Laboratory Department:

QTY (1) Spotfire 4 Module System (Part# 4707799). CLIA-Waived 4 module system Control station with touch screen and barcode scanner Single color optics module and sensor imaging Peltier Devices with following ranges:

o PCR Temperature range 40° C - 105°C o PCR melt rate from 0.1 - 2°C/sec

100-240 VAC Voltage 50-60 Hz Frequency Inel Atom x7-E3950 CPU 250 GB or greater solid-state hard drive

8 GB RAM

Microsoft Windows OS

QTY (1) RSP Pos & Neg Controls (Part# M425) QTY (2) Respiratory Panel Mini, 30 test (Part# 424589) QTY (1) Respiratory Panel, 30 test (Part#424461)

PERIOD OF PERFORMANCE

30 days from date of award

3. LEVEL OF EFFORT

3.1. The contractor shall provide 1 year warranty under normal use and appropriate maintenance.

3.2. Contractor shall provide software support and new releases, versions and upgrades as necessary.

3.3. Contractor shall provide telephone support during all business hours of the PIHC.

3.4. Contractor shall furnish labor, parts and/or replacement equipment necessary to repair operational or mechanical breakdowns.

Oklahoma City Area

3.5. Contractor shall provide equipment as listed in Technical Requirements, no substitutions will be accepted.

4. SPECIAL REQUIREMENTS

4.2. In accordance with HHSAR 304.1300(b) non-routine contractor employees shall comply with OPDIV DHHS/SE Region – Human Resources, Security Clearance Guidance – Visitors (3/29/12) policy for contract performance period. Contractor employees will be required to obtain a visitor’s pass upon arrival for services from Facilities Management.

4.3. The USPHS Pawnee Indian Health Center is a tobacco/smoke free environment (buildings and grounds).

No tobacco/smoking use will be tolerated during service.

4.4. Security Requirements: Contractor personnel will be required to contact the government designated point of contact upon arrival when reporting for service calls or delivery supplies. The contractor shall be responsible for the security of all organizational information. Current rules and regulations applicable to the premises, where the work shall be performed shall apply to the contractor and its employees while working on the premises. These regulations include but are not limited to, escort by Pawnee Indian Health Center official, presenting valid identification, smoking restriction and any safety procedures.

4.5. The contractor shall not disclose or cause to disseminate any information concerning operations of Pawnee Indian Health Center. Such action(s) could result in violation of the contract and possible legal actions.

4.5.1. All inquiries, comments, or complaints arising from any matter observed, experienced or learned of as a result of or in connection with the performance of the contract, the resolution of which may require the dissemination of official information, shall be directed to the government’s designated representative.

4.6. Termination Amortization Schedule: A termination amortization schedule shall be included as an attachment of the awarded contract. If the Government does not exercise any of the options listed in the price / cost schedule, the Government’s not exercising the options will have the same effect as if the Government terminated for convenience. All remedies afforded to contractor in regards to a termination for convenience shall be available to the contractor.

5. DELIVERABLES AND REPORTING REQUIREMENTS

5.2. Delivery: The contractor will coordinate the delivery with the designated government employee. The government will provide the contractor with dock access and building access for this sole purpose. The designated government employee will work with the pertinent government agency to secure the needed dock access. No deliveries can be made after 4:15pm. Driver needs a valid ID.

5.3. Contractor Point of Contact: The contractor shall furnish one designated point of contact (POC) to the government’s designated representative for coordination of supplies, delivery, and/or maintenance. The

Oklahoma City Area

POC will be empowered to make daily decisions to ensure that the contract implementation and day-to-day maintenance meets the terms and conditions of this contract.

5.4. Contractor’s Phone Numbers: The contractor shall provide a toll-free telephone number for service calls, which must be answered during at least eight working hours, between 8:00 am and 4:30 pm, Monday through Friday.

6. GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES

6.2. The Government shall make no supply of property, facilities, and services.

7. CONTRACTOR FURNISHED PROPERTY, FACILITIES AND SERVICES

7.2. Required personnel, materials, supplies and equipment: The contractor shall furnish all personnel, materials, supplies and equipment required to perform work under the contract, to include but not limited to: equipment, consumable supplies and personnel for installation.

8. CHANGES TO THE SPECIFICATIONS

Any changes to these specifications shall be authorized and approved only through written correspondence from the Contracting Officer. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

John A. Brown -S

Digitally signed by John A.

Brown -S Date: 2024.06.28 10:23:19 -05'00'

Terry L. Burris -S

Digitally signed by Terry L.

Burris -S Date: 2024.06.28 11:45:47 -05'00'

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