75H711-Q-0026 AMENDMENT 01.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES · INDIAN

HEALTH SERVICE

Oklahoma City Area Office — 701 Market Dr., Oklahoma City, OK 73114

COMBINED SYNOPSIS /

SOLICITATION

Commercial products · FAR Part 12 (Revolutionary FAR Overhaul)

Indian Small Business Economic Enterprise (ISBEE) Set-Aside

Issuing office Oklahoma City Area Office

Solicitation No.SF 1449 Block 15A 75H711-Q-0026

Title BIOFIRE SPOTFIRE PCR Laboratory Analyzer – Placement Agreement

Issue dateSF 1449 Block 19 July 17th, 2026

NAICS / size standardSF 1449 Block 23 334516 — Analytical Laboratory Instrument Manufacturing (size standard 1,000 employees)

Product/Service Code 6635

Set-aside authoritySF 1449 Block 24 Indian Small Business Economic Enterprise (ISBEE) Set-Aside (HHSAR 326.603-1(c); 326.604-2)

Place(s) of performanceSF 1449 Block 25 Oklahoma City Area Office, 701 Market Dr., Oklahoma City, OK 73114

Period / delivery 30 ARO - Base plus 4 option years

Quotes dueSF 1449 Block 26 July 31st, 2026 at 7:00 AM CT

Submit toSF 1449 Block 28 Krishna Harriman

1. INTRODUCTION

This is a combined synopsis/solicitation for commercial products prepared in accordance with FAR part 12, using the combined synopsis/solicitation format at FAR 12.202(b), as revised under the Revolutionary FAR Overhaul (Executive Order 14275) and the implementing HHS/IHS class deviation, and the simplified procedures for commercial products and commercial services at FAR 12.201-1. This announcement constitutes the only solicitation; quotations are requested and a separate written solicitation will not be issued. Solicitation number 75H711-Q-0026 is issued as a Request for Quotation (RFQ) for BIOFIRE SPOTFIRE PCR Laboratory Analyzer – Placement Agreement. This acquisition is

BPA Five (5) Year

August 4, 2026

75H711-Q-0026 AMENDMENT 01

kharriman Line kharriman Line kharriman Highlight kharriman Highlight conducted under the Buy Indian Act (25 U.S.C. 47) and HHSAR Subpart 326.6. The associated NAICS code is 334516 — Analytical Laboratory Instrument Manufacturing (size standard 1,000 employees).

RFO note: FAR 52.212-3 and 52.212-5 are removed. Representations and certifications are obtained through the offeror’s active SAM.gov registration; required clauses are drawn from the FAR 12.205 clause tables.

2. SET-ASIDE DETERMINATION

This requirement is a Indian Small Business Economic Enterprise (ISBEE) Set-Aside under HHSAR 326.603-1(c); 326.604-2. The offeror must qualify under the notice provision (352.226-4) below.

3. DESCRIPTION OF REQUIREMENT

The purpose of this project is to provide Oklahoma Area Indian Health Service (IHS) hospital and service unit laboratory locations with BIOFIRE SPOTFIRE FDA-cleared/authorized, CLIA-waived, PCR analyzers to establish and maintain CLIA-waived respiratory

PCR testing capability and support timely patient care.

This requirement is structured as a placement agreement. Under the placement agreement, the Contractor/Vendor shall provide all required CLIA-waived PCR analyzer equipment, delivery, installation, configuration, preventative maintenance, repairs, training, and technical/application support at no cost to the Government for the duration of the contract.

4. DELIVERY, PLACE(S) OF PERFORMANCE, AND PERIOD

Place of performance / delivery: Oklahoma City Area Office, 701 Market Dr., Oklahoma City, OK 73114.

Period of performance / required delivery: 30 ARO - Base plus 4 option years.

F.O.B. point: Destination.

Inspection and acceptance: as provided in the clause at FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services.

5. EVALUATION METHODS

The Government will evaluate quotations and make award using the method below. This language constitutes the tailored fill-in for FAR 52.212-2, Evaluation—Commercial Products and

75H711-Q-0026 AMENDMENT 01

Commercial Services (RFO 12.205(a)(2)), and includes all evaluation factors and criteria for award.

Evaluation. The Government will award a purchase order resulting from this RFQ to the responsible quoter whose quotation conforms to the requirements of this solicitation and offers the lowest price determined to be fair and reasonable. Technical merit will not be evaluated beyond conformance to the specification / statement of work / salient characteristics;

nonconforming quotations may be rejected. The Government intends to make one award on the basis of price and conformance to the requirement and may make award without communications.

Price. The Government will determine price to be fair and reasonable, based whenever possible on adequate price competition. Price will be evaluated inclusive of transportation charges to destination and by adding the prices for all CLINs / option periods to the base requirement.

Prompt payment discounts will not be considered in the price evaluation.

Quotation is not an offer. A quotation is not an offer and cannot be accepted by the Government to form a binding contract. Any resulting purchase order is the Government's offer to the quoter; a binding contract is formed only when the quoter accepts the purchase order, either by written acceptance or by commencing performance. (RFO 12.201-1(b))

Late quotations. The Government will consider all quotations received by the date and time specified above and may, consistent with good business judgment, consider a quotation received after the due date and time. (RFO 12.203(c)(1))

Brief explanation to unsuccessful quoters. Upon request received within 3 days after a quoter receives notification of award, the Government will provide that unsuccessful quoter a brief explanation of the basis for the award decision. (RFO 13.301 / 12.301(b))

6. INSTRUCTIONS TO OFFERORS

Quotations are due no later than July 31st, 2026 at 7:00 AM CT. Email is the only acceptable method of submission. Submit quotations by email to Krishna Harriman.

Quotations submitted by any other method will not be considered.

Each quotation shall include, at a minimum, the following:

Vendor name Unique Entity Identifier (UEI) Prompt payment terms Delivery time GSA contract number (if applicable) Date the quote expires Warranty Pricing for all line items, and documentation addressing the evaluation factors stated in Section 5

Representations and certifications are made through the offeror’s active SAM.gov registration (FAR 52.212-1; 52.204-7). Failure to provide sufficient technical detail may result in rejection of your quote.

In accordance with HHSAR 352.226-7(b), each offeror shall submit a completed IHS Indian Economic Enterprise Representation form (www.IHS.gov/DAP) with its quotation. Offers from enterprises not qualifying under the Buy Indian (ISBEE) set-aside will be rejected.

Point of contact: [Point of Contact], 580-331-3300.

7. PROVISIONS AND CLAUSES

Provisions and clauses are grouped below — FAR and HHSAR, provisions and clauses separately, in numerical order. Provisions apply to this solicitation only; at award the contract incorporates the clause lists (not the provisions). Items marked “By reference” are incorporated under FAR 52.252-1 (provisions) and 52.252-2 (clauses), with the same force and effect as if printed in full (full text at https://www.acquisition.gov). Items marked “Full text” are printed below; highlighted fill-ins must be completed. Clauses marked “(DEVIATION)” carry the date of the FAR class deviation adopted by your IHS Area.

7.1 FAR Provisions (solicitation only)

Number Title Incorporation

FAR 52.204-

System for Award Management—Registration (DEVIATION) By reference

FAR 52.212-

Instructions to Offerors—Commercial Products and Commercial Services (DEVIATION)

By reference (addenda)

FAR 52.212-

Evaluation—Commercial Products and Commercial Services

(DEVIATION)

Full text — Section 5

FAR 52.222-

Certification Regarding Knowledge of Child Labor for Listed End Products (FEB 2021)

By reference

FAR 52.223-

Recovered Material Certification (MAY 2008) By reference

7.2 FAR Clauses (incorporated into any resulting contract)

Number Title Incorporation

FAR

52.203-6

Restrictions on Subcontractor Sales to the Government (Alternate I) (JUN 2020) By reference

FAR

52.203-17

Contractor Employee Whistleblower Rights (NOV 2023) By reference

FAR Prohibition on Requiring Certain Internal Confidentiality Agreements or By reference

52.203-19 Statements (JAN 2017)

FAR

52.204-13

System for Award Management—Maintenance (DEVIATION) By reference

FAR

52.204-91

Contractor Identification (DEVIATION) By reference

FAR

52.209-6

Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (DEVIATION)

By reference

FAR

52.209-9

Updates of Publicly Available Information Regarding Responsibility Matters

(DEVIATION)

By reference

FAR

52.209-10

Prohibition on Contracting with Inverted Domestic Corporations (DEVIATION) By reference

FAR

52.212-4

Terms and Conditions—Commercial Products and Commercial Services

(DEVIATION)

By reference

FAR

52.217-8

Option to Extend Services (NOV 1999) Full text

FAR

52.217-9

Option to Extend the Term of the Contract (MAR 2000) Full text

FAR

52.219-8

Utilization of Small Business Concerns (DEVIATION) By reference

FAR

52.219-14

Limitations on Subcontracting (DEVIATION) By reference

FAR

52.222-3

Convict Labor (DEVIATION) By reference

FAR

52.222-19

Child Labor—Cooperation with Authorities and Remedies (DEVIATION) By reference

FAR

52.222-35

Equal Opportunity for Veterans (DEVIATION) By reference

FAR

52.222-36

Equal Opportunity for Workers with Disabilities (DEVIATION) By reference

FAR

52.222-37

Employment Reports on Veterans (DEVIATION) By reference

FAR

52.222-40

Notification of Employee Rights Under the National Labor Relations Act

(DEVIATION)

By reference

FAR

52.222-50

Combating Trafficking in Persons (DEVIATION) By reference

FAR

52.222-54

Employment Eligibility Verification (DEVIATION) By reference

FAR

52.222-90

Addressing DEI Discrimination by Federal Contractors (DEVIATION) By reference

FAR

52.223-23

Sustainable Products and Services (DEVIATION) By reference

FAR

52.224-3

Privacy Training (JAN 2017) By reference

FAR

52.226-8

Encouraging Contractor Policies to Ban Text Messaging While Driving (MAY 2024)

By reference

FAR

52.227-14

Rights in Data—General (MAY 2014) By reference

FAR

52.232-33

Payment by Electronic Funds Transfer—System for Award Management (OCT 2018)

By reference

FAR

52.232-40

Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) By reference

FAR

52.233-3

Protest After Award (DEVIATION) By reference

FAR

52.233-4

Applicable Law for Breach of Contract Claim (DEVIATION) By reference

FAR

52.240-91

Security Prohibitions and Exclusions (DEVIATION) By reference

FAR

52.244-6

Subcontracts for Commercial Products and Commercial Services (DEVIATION) By reference

7.3 HHSAR Provisions (solicitation only)

Number Title Incorporation

HHSAR 352.226-

Notice of Indian Small Business Economic Enterprise Set-Aside (JAN 2022)

Full text

HHSAR 352.226-

Indian Economic Enterprise Representation (JAN 2022) Full text

7.4 HHSAR Clauses (incorporated into any resulting contract)

Number Title Incorporation

HHSAR 352.224-

Privacy Act (DEC 2015) By reference

HHSAR 352.226-6 Indian Economic Enterprise Subcontracting Limitations (JAN 2022) Full text

HHSAR 352.239-

Electronic and Information Technology Accessibility (Section 508) (DEC 2015)

By reference

Full-text provisions and clauses (fill-ins highlighted)

FAR 52.217-8 — Option to Extend Services (NOV 1999) FAR 52.217-8 (clause) — full text required (fill-ins)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed [6] months.

The Contracting Officer may exercise the option by written notice to the Contractor within [insert the period, e.g., 30 days before the contract expires].

(End of provision/clause)

FAR 52.217-9 — Option to Extend the Term of the Contract (MAR 2000) FAR 52.217-9 (clause) — full text required (fill-ins)

(a) The Government may extend the term of this contract by written notice to the Contractor within [insert the period, e.g., 30 days]; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least [60] days before the contract expires.

The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed [insert, e.g., 5 years].

(End of provision/clause)

HHSAR 352.226-4 — Notice of Indian Small Business Economic Enterprise Set-Aside

(JAN 2022)

HHSAR 352.226-4 (provision) — HHSAR 326.604-2(e)

Under the Buy Indian Act, 25 U.S.C. 47, offers are solicited only from Indian Economic Enterprises (HHSAR 326.606) that are also small business concerns. Any acquisition resulting from this solicitation will be from such a concern. As required by HHSAR 352.226-7(b), offerors shall include a completed Indian Economic Enterprise Representation form (available at www.IHS.gov/DAP) with the offer. Offers received from enterprises that are not both Indian Economic Enterprises and small business concerns will not be considered and will be rejected.

(End of provision/clause)

HHSAR 352.226-6 — Indian Economic Enterprise Subcontracting Limitations (JAN 2022) HHSAR 352.226-6 (clause) — HHSAR 326.604-2(e)(3) / 326.605-1(b)

(a) Definitions apply as in HHSAR 326.601.

(b) The contractor must comply with FAR 52.219-14, Limitations on Subcontracting, in allocating subcontracted work, and shall not subcontract work exceeding the 52.219-14 limitations to any concern other than a responsible Indian Economic Enterprise.

(c) Work an IEE subcontractor does not perform with its own employees is treated as subcontracted work under 52.219-14.

(d) The contractor must cooperate in any compliance study or survey by the CO or IHS.

(e) The contractor must incorporate the substance of this clause, including this paragraph (e), in all covered subcontracts.

(End of provision/clause)

HHSAR 352.226-7 — Indian Economic Enterprise Representation (JAN 2022) HHSAR 352.226-7 (provision) — HHSAR 326.604-2(e)(4) / 326.606-1

(a) The offeror must represent as part of its offer that it meets the IEE definition in HHSAR

326.601 and intends to meet it throughout performance, and must notify the CO immediately via email of any ownership change affecting this representation.

(b) The representation must be made on the designated IHS Indian Economic Enterprise Representation form (or successor).

(c) False or misleading information is punishable under 18 U.S.C. 1001; false claims are subject to 31 U.S.C. 3729-3731 and 18 U.S.C. 287.

(End of provision/clause)

8. ATTACHMENTS

Attachment 1 — Statement of Work / Specification Attachment 2 — Price Schedule / Quotation form (provides the line-item number(s), items, quantities, and units of measure, including options) Attachment 3 — IHS Indian Economic Enterprise Representation form

Draft — review required before posting. Auto-generated starting point. Verify every provision and clause against the FAR Part 12 class deviation in effect for your IHS Area, the current HHSAR, and IHS policy (IHM Part 5) before posting to SAM.gov. Confirm the IGCE-driven thresholds, NAICS/size standard, the Buy Indian set-aside cascade, and any required deviation/justification approvals. Tailor every italicized fill-in. Not legal advice.

75H711-Q-0026 – AMENDMENT 02

BPA PRICE SCHEDULE

BIOMERIEUX SPOTFIRE® CLIA-WAIVED MOLECULAR TESTING SYSTEM

BPA ORDERING PERIOD: FIVE (5) YEARS FROM DATE OF AWARD

ESTIMATES AND INFORMATION FOR VENDORS:

ESTIMATED VOLUME IS COMBINED OF RSV / COVID / STREP / FLU, BASED ON HISTORICAL UTILIZATION

OF ALL SITES COMBINED = 6,000 PER YEAR (ESTIMATING 30,000 TESTS FOR 5 YEARS)

EXISTING PLACEMENTS:

HASKELL / PAWNEE (OWNED)

ELIGIBLE FOR PLACEMENTS:

CLINTON / EL RENO / WATONGA / LAWTON / ANADARKO / CARNEGIE / WEWOKA.

INSTRUMENT PLACEMENT AND PROFESSIONAL SERVICES

DESCRIPTION UNIT ESTIMATED 5-YEAR QTY

SPOTFIRE MODULE PLACEMENT (REAGENT

RENTAL PROGRAM)

EACH MODULE 16

INSTALLATION AND INITIAL SYSTEM VERIFICATION EACH SITE TBD

INITIAL OPERATOR TRAINING EACH SITE TBD

PREVENTATIVE MAINTENANCE, SOFTWARE

UPDATES, TECHNICAL SUPPORT, AND REPAIR

SERVICES

ANNUAL INCLUDED

CONTRACTOR SHALL FURNISH SPOTFIRE MODULES AT NO ADDITIONAL COST PROVIDED THE

ORDERING ACTIVITY SATISFIES THE MINIMUM REAGENT PURCHASE COMMITMENT ESTABLISHED

UNDER THIS BPA.

SECTION A – CLIA-WAIVED TEST PANELS & QUALITY CONTROL MATERIALS

CLIN DESCRIPTION UNIT ESTIMATED

5-YEAR

QTY

UNIT

PRICE

ESTIMATED

PRICE

001 SPOTFIRE RESPIRATORY / SORE THROAT

(R/ST) PANEL MINI

EACH

PANEL

675 $ $

002 SPOTFIRE RESPIRATORY / SORE THROAT

(R/ST) PANEL

EACH

PANEL

325 $ $

003 POSITIVE AND NEGATIVE QUALITY

CONTROL MATERIALS FOR FDA

CLEARED / CLIA WAIVED SPOTFIRE

PANELS

EACH

KIT

45 $ $

**CLIN 003 ESTIMATE IS DETERMINED BY LOT CHANGES.

NOTE: AddiƟonal FDA-cleared / CLIA-waived SpotFire panels introduced during the BPA ordering period shall be negoƟated in accordance with the Contractor’s commercial price list less the awarded BPA discount and added to the BPA by bilateral modificaƟon. shall be within the scope of this BPA and priced in accordance with the Contractor’s awarded pricing schedule.

CONTRACTOR PRICING MATRIX

OFFERORS SHALL COMPLETE THE FOLLOWING PRICING INFORMATION.

ESTIMATED ANNUAL PRICE VOLUME UNIT PRICE PER PANEL

1 - 100 $ 101 - 150 $ 151 - 200 $ 201 - 250 $ 251 - 300 $

PLEASE INCLUDE IF A VOLUME DISCOUNT APPLIES.

INSTRUMENT PLACEMENT INFORMATION

OFFERORS SHALL COMPLETE THE FOLLOWING.

REQUIREMENT CONTRACTOR RESPONSE

MINIMUM ANNUAL REAGENT COMMITMENT PER

SPOTFIRE MODULE

MAXIMUM NUMBER OF MODULES AVAILABLE

UNDER THIS BPA

INSTALLATION INCLUDED YES / NO

INITIAL TRAINING INCLUDED YES / NO

PREVENTATIVE MAINTENANCE INCLUDED YES / NO

SOFTWARE UPGRADES INCLUDED YES / NO

TECHNICAL SUPPORT INCLUDED YES / NO

LOANER / REPLACEMENT MODULE PROVIDED

DURING REPAIR

YES / NO

TYPICAL DELIVERY AFTER RECEIPT OF ORDER _______ DAYS

TYPICAL DELIVERY OF INITIAL SET UP/

INSTALLATION / VALIDATION OF SYSTEM

_______ DAYS

Department of Health and Human Services Oklahoma Area

Indian Health Service

Statement of Work (SOW) BIOFIRE SPOTFIRE PCR Laboratory Analyzer – Placement Agreement

1. PURPOSE OF THE PROJECT

The purpose of this project is to provide Oklahoma Area Indian Health Service (IHS) hospital and service unit laboratory locations with BIOFIRE SPOTFIRE FDA-cleared/authorized, CLIA-waived, PCR analyzers to establish and maintain CLIA-waived respiratory PCR testing capability and support timely patient care.

This requirement is structured as a placement agreement. Under the placement agreement, the Contractor/Vendor shall provide all required CLIA-waived PCR analyzer equipment, delivery, installation, configuration, preventative maintenance, repairs, training, and technical/application support at no cost to the Government for the duration of the contract.

The Government’s cost under this placement agreement will be derived from the purchase of CLIA-waived respiratory testing consumables (test panel consumables and quality control materials), structured as facility-level minimum quantity purchase commitments. This SOW is intended to be scalable across participating Oklahoma Area IHS facilities so each facility may establish its own minimum purchase quantity based on clinical needs and funding availability. The contract shall allow for annual adjustment of each facility’s minimum purchase quantities when exercising option periods or awarding Task Orders, as authorized in writing by the Contracting Officer.

The Oklahoma Area IHS facilities are outpatient federal facilities that provide ambulatory care for eligible Native American patients that are registered for services. The Oklahoma Area IHS facilities include:

ANADARKO INDIAN HEALTH CENTER PHS LAWTON INDIAN HOSPITAL

201 EAST PARKER MCKENZIE DRIVE 1515 NE LAWRIE TATUM ROAD

ANADARKO, OK 73005 LAWTON, OK 73507

CARNEGIE INDIAN HEALTH CENTER PAWNEE INDIAN HEAL TH CENTER

212 E 4TH ST. 1201 HERITAGE CIRCLE

CARNEGIE, OK 73015 PAWNEE, OK 74058

CLINTON INDIAN HEAL TH CENTER WATONGA INDIAN HEALTH CENTER

10321 N 2274 ROAD 1305 S CLARENCE NASH BLVD

CLINTON, OK 73601-7521 WATONGA, OK 73772

El RENO INDIAN HEALTH CENTER WEWOKA INDIAN HEALTH CENTER

1801 PARKVIEW DRIVE 36640 US-270

EL RENO, OK 73036-2103 WEWOKA, OK 74884

HASKELL INDIAN HEALTH CENTER

2415 MASSACHUSETTS ST.

LAWRENCE, KS 66046-4827

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

The Contractor shall provide BIOFIRE SPOTFIRE FDA-cleared/authorized, CLIA-waived PCR analyzer system(s) and CLIA-waived respiratory testing consumables for Oklahoma Area IHS facilities under a placement agreement. At time of award, this SOW only intends to procure CLIA-waived respiratory testing capability using the supplies/capabilities described in Section 2.2.

2.1. CLIA-Waived PCR Analyzer Equipment

2.1.1. System configuration: The Contractor shall provide BIOFIRE SPOTFIRE System(s) comprised of Control Station(s) and stackable testing Module(s). The deployed configuration shall be scalable by facility and may include one (1) to four (4) Modules per Control Station, as required by the Government.

2.1.2. Control Station: The Control Station shall include a touchscreen user interface and barcode scanning capability and shall be provided in the manufacturer’s current standard production configuration for the BIOFIRE SPOTFIRE CLIA-waived PCR platform (or a functionally equivalent configuration). The Control Station configuration shall be sufficient to operate the manufacturer-provided SPOTFIRE software and supported connectivity features for the intended CLIA-waived use described in this SOW and shall not reduce functionality during the period of performance due to hardware/OS refreshes.

At a minimum, the Control Station shall include:

A manufacturer-supported processor/platform sufficient for intended SPOTFIRE system operation.

A minimum of 8 GB RAM.

A minimum of 250 GB solid-state storage.

A manufacturer-supported operating system appropriate for the SPOTFIRE system’s intended CLIA-waived use.

Any manufacturer-initiated hardware or operating system updates during contract performance shall maintain compatibility with the SPOTFIRE system, associated CLIA-waived testing consumables, and supported connectivity features, and shall be provided at no cost to the Government under this placement agreement.

2.1.3. Optical/thermal/PCR control characteristics: The placed system shall include, at a minimum:

Single color optics module and sensor imaging (or manufacturer standard equivalent for the SPOTFIRE platform).

Peltier devices with the following minimum ranges:

o PCR Temperature range: 40°C – 105°C.

o PCR melt rate: 0.1 – 2°C/sec

2.1.4. Environmental and power requirements:

The placed system shall be operable within:

15°C–30°C at 15–80% relative humidity (non-condensing), indoor use.

100–240 VAC, 50–60 Hz frequency.

2.1.5. Control Station connectivity / ports (minimum required interfaces):

Internal IEEE 802.3 compliant 10/100/1000 Ethernet connections (to connect Modules only).

External IEEE 802.3 compliant 10/100/1000 Ethernet connection (RJ-45).

Dual band IEEE 802.11n and IEEE 802.11ac (Wi‑Fi) compliant network connection (2.4 GHz and 5 GHz ISM bands).

USB 2.0 compliant Type A connections.

2.1.6. Display:

8.4 in. diagonal.

1280 x 768 resolution (or greater).

Touch screen interface.

2.1.7. Control Station power entry module:

Current rating: 10A.

Voltage rating: 100 to 240 VAC.

NEMA 5-15R receptacle.

Dual fuse cartridge (or manufacturer standard equivalent).

2.1.8. Module and module connection cable:

IEEE 802.3 compliant 10/100/1000 Ethernet connection.

10 pin RA connector (or manufacturer standard equivalent).

17.17 ±0.39 in. (436 ±10mm) length (or manufacturer standard equivalent).

Power Cable: Only use the Power Cable supplied with the SPOTFIRE System.

Wireless Antenna: Only use antennas supplied with the SPOTFIRE System.

2.1.9. Dimensions and weight:

Control Station Only (W x D x H): 8.52 x 12.77 x 3.82 in (21.64 x 32.43 x 9.70 cm) (or manufacturer standard equivalent).

Modules Only (H): 4.13 in (10.49 cm) each (or manufacturer standard equivalent).

Max Height (4 Modules): 21.0 in (54 cm) (or manufacturer standard equivalent).

Maximum Total Weight: approximately 74 lbs. (33.6 kg) (or manufacturer standard equivalent).

Control Station: approximately 18 lbs. (8.2 kg).

Modules: approximately 14 lbs. (6.4 kg) each.

2.1.10. Compatibility / interoperability requirement: The placed CLIA-waived PCR system shall be compatible with existing Government workflows requiring results reporting through Data Innovations middleware and integration into RPMS/EHR workflows as implemented by the Government. The Contractor shall support connectivity/interface configuration and validation activities when requested by the Government and subject to Government IT/security approvals and site readiness.

2.1.11. Placement services included at no cost: The Contractor shall provide, at no cost to the Government, all services required to place and support the CLIA-waived PCR system(s), to include:

Delivery and installation at Government-designated facilities.

Initial configuration and verification of proper operation.

Onsite and/or remote training (as requested) for laboratory users.

Preventative maintenance, as applicable per manufacturer requirements.

Corrective maintenance/repairs, including labor, parts, and replacement equipment as necessary to maintain operability.

Application support and technical support for the SPOTFIRE platform and the CLIA-waived respiratory testing consumables listed in Section 2.2.

2.2. CLIA-Waived Respiratory Testing Supplies / Capabilities:

At time of award, this SOW supports CLIA-waived respiratory testing capability. Testing supplies available under this placement agreement include the items below. To avoid duplication while accommodating vendor ordering practices, certain items are listed as alternate ordering identifiers for the same consumable type.

2.2.1. External Quality Control Materials: External positive and negative control materials used to support CLIA-waived respiratory testing quality control processes in accordance with facility quality plans and applicable instructions for use.

RSP Pos & Neg Controls (Part# M425)

Indian Health Service

2.2.2. Respiratory Panel Consumable – (multiplex respiratory testing capability): Multiplex CLIA-waived respiratory testing consumable used on the BIOFIRE SPOTFIRE platform to provide broad respiratory detection capability, including respiratory viruses and select atypical bacteria. Respiratory Panel consumable, 30-test pack (30 tests per pack where applicable).

Acceptable ordering identifiers for this Respiratory Panel consumable are:

Respiratory Panel (Part# 424461), OR Respiratory Panel Kit (Part# 423485).

Only one of the above ordering identifiers is expected to be used for a given purchase, based on the awarded price schedule and the vendor’s ordering method.

Intended respiratory capability includes detection of:

Viruses: Adenovirus; Seasonal Coronavirus; SARS‑CoV‑2; Human Metapneumovirus; Human

Rhinovirus/Enterovirus; Influenza A (including A/H1‑2009 and A/H3); Influenza B; Parainfluenza virus;

Respiratory Syncytial Virus (RSV).

Bacteria: Bordetella parapertussis; Bordetella pertussis; Chlamydia pneumoniae; Mycoplasma pneumoniae.

2.2.3. Respiratory Panel Mini Consumable – (focused respiratory viral testing capability): Focused CLIA-waived respiratory viral testing consumable used on the BIOFIRE SPOTFIRE platform to provide detection for high-demand respiratory viral targets. Respiratory Panel Mini consumable, 30-test pack (30 tests per pack where applicable).

Acceptable ordering identifiers for this Respiratory Panel Mini consumable are:

Respiratory Panel Mini (Part# 424589), OR Respiratory Panel Mini Kit (Part# 424537).

Only one of the above ordering identifiers is expected to be used for a given purchase, based on the awarded price schedule and the vendor’s ordering method.

Intended respiratory capability (Respiratory menu) includes detection of:

SARS‑CoV‑2; Human Rhinovirus; Influenza A; Influenza B; RSV

2.2.4. Test quantity definition (kits/packs and tests): For the panel/kit items listed above, where the item is packaged/labeled as a 30-test/30-pack, one (1) pack/kit contains thirty (30) tests (30 reportable tests per 30-test pack). If any CLIA-waived respiratory-capable consumable is offered/ordered in a different pack size, the tests-per-pack quantity shall be the quantity stated on the manufacturer labeling and the awarded price schedule for that item.

2.2.5. Scope limitation: This SOW supports CLIA-waived respiratory testing capability only at time of award. Any expansion beyond CLIA-waived respiratory testing (or addition of other SPOTFIRE panels/controls not respiratory-related) may be added only by written modification executed by the Contracting Officer.

2.3. CLIA-Waived Consumable Minimum Quantity Purchase Structure: Minimum quantity purchases for CLIA-waived respiratory testing consumables shall be established per facility in the awarded price/cost structure.

Minimum purchase quantities shall be stated in:

Minimum number of kits/packs purchased per facility per contract year; and The corresponding minimum number of tests represented by those kits/packs, based on manufacturer-labeled tests-per-pack (e.g., 30 tests per 30-test pack, where applicable).

Each facility’s minimum purchase quantity may be adjusted annually when exercising option periods, as authorized in writing by the Contracting Officer.

R/ST Panel (Part #423485)

R/ST Panel Mini (Part 424537) kharriman Line kharriman Line kharriman Line kharriman Line kharriman Highlight kharriman Highlight

3. PERIOD OF PERFORMANCE

12 months from date of award

Base plus an additional four (4) option years

4. LEVEL OF EFFORT

4.1. Deployment / placement implementation: The Contractor shall facilitate the delivery of BIOFIRE SPOTFIRE FDA-cleared/authorized, CLIA-waived PCR system(s) (Control Station and Module(s)) including required manufacturer software/accessories, and shall provide installation, configuration, verification of proper operation, and initial training at Government-designated Oklahoma Area IHS facilities. Delivery, installation, configuration, verification, and training shall be coordinated with Government on-site Laboratory personnel and the Government-designated Point(s) of Contact (POC).

4.2. Implementation timeline: The Contractor shall complete delivery, installation, configuration, verification of proper operation, and initial training within sixty (60) calendar days from date of award, or within sixty (60) calendar days of the Government’s written request to deploy to a specific facility (for staged deployments), unless otherwise coordinated and documented by the Government.

4.3. No-cost placement services: The Contractor shall provide placement-included services at no cost to the Government for the duration of the contract, to include preventive maintenance (as applicable per manufacturer requirements), corrective maintenance/repairs, labor, parts, and replacement equipment as necessary to maintain operability of the placed CLIA-waived PCR system(s).

4.4. Technical and application support: The Contractor shall provide technical and application support for the placed CLIA-waived PCR system(s) and the CLIA-waived respiratory testing consumables listed in this SOW. Support shall include troubleshooting assistance and escalation to qualified service personnel as required.

4.5. Service access / support hours: The Contractor shall provide a direct service telephone number (toll-free or equivalent) to contact qualified personnel for emergency or other issues (technical, application, information) with a BIOFIRE SPOTFIRE system. The Contractor shall provide direct telephone support during IHS facility business hours (8:00 am to 4:30 pm local time, Monday through Friday, excluding Federal holidays).

4.6. Software support and updates: The Contractor shall provide software support and manufacturer-supported new releases, versions, and upgrades as necessary for continued operation of the placed system(s), at no cost to the Government, subject to Government IT/security requirements and change control.

4.7. Repairs, parts, and replacement equipment: The Contractor shall furnish labor, parts, and/or replacement equipment necessary to repair operational or mechanical breakdowns and restore system functionality in a timely manner compatible with patient testing needs and facility schedules.

4.8. No substitutions: The Contractor shall provide equipment as listed in Section 2 (Technical Requirements). No substitutions will be accepted unless authorized in writing by the Contracting Officer.

4.9. Minimum quantity purchase structure: The Contractor shall support facility-level minimum quantity purchase commitments for CLIA-waived respiratory testing consumables (kits/packs and associated tests) and shall allow for annual adjustment of minimum purchase quantities per facility when exercising option periods, as authorized in writing by the Contracting Officer.

4.10. Training: Comprehensive training for the BIOFIRE SPOTFIRE CLIA-waived PCR system(s) and related software shall be provided at no additional cost by qualified contractor personnel on-site, in-person when requested, and as needed for all participating Oklahoma Area IHS facility Laboratory staff. Training shall be coordinated with the Government POC.

5. SPECIAL REQUIREMENTS

5.1. The supervising official will determine if the contractor will be subject to PIV credentialing requirements for physical and logical access, in line with the below requirements.

5.1.1. Long-term contractors are defined as working in excess of four months (or 120 days, consecutively) for the purpose of background investigations. All long-term contractors must have, at minimum, a favorably adjudicated Tier 1 background investigation. Some positions may require a higher-tiered investigation, in accordance with the OMB M- 05-24 Sections, 7.F “Applying guidance to temporary employees and contractors.”

5.1.2. Short-term contractors are defined as working for less than six months or 1040 hours in a one-year period of service for the purpose of HSPD-12, in accordance with 5 CFR Part 316. Short-term contractors are not issued a PIV card, except when required for routine facility or network access. Short-term contractors are subject to an investigation conducted in accordance with the risk/sensitivity of the position.

5.1.3. Temporary hires and volunteers are defined as working for 120 days or less. The supervising official will determine whether a temporary hire working 121 days or more will be subject to PIV credentialing requirements based on the need for network and facility access. Temporary hires are subject to all personnel security requirements.

5.1.4. If onsite service employee does not require 5.1.1 through 5.1.3, then a visitor’s pass must be requested upon arrival with either the front desk or facilities and worn at all times while on the premises.

5.2. The USPHS Oklahoma Area Indian Health Service facilities are a tobacco/smoke free environment (buildings and grounds). No tobacco/smoking use will be tolerated during service.

5.3. 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 IHS official, presenting valid identification, smoking restriction and any safety procedures.

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

5.4.1. 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.

6. PERSONNEL QUALIFICATIONS, CREDENTIAL VERIFICATION, AND INSURANCE

6.1. Applicability. This section applies to all Contractor and subcontractor personnel performing work under this contract.

6.2. Personnel Qualifications.

6.2.1. Education/Training: Contractor personnel performing delivery, installation, configuration, training, maintenance/service, application support, technical support, and/or connectivity/interface support for the BIOFIRE SPOTFIRE CLIA-waived PCR system(s) shall be manufacturer-trained and qualified for the BIOFIRE SPOTFIRE platform, as evidenced by documentation available upon request.

6.2.2. Licensure/Certification: Contractor personnel shall hold any licensure/certification required by applicable law, regulation, or policy to perform their assigned duties. Any manufacturer-required service or application certifications (if applicable) shall be current and in good standing.

6.2.3. Additional Requirements: Personnel shall meet any other qualifications required by applicable law, regulation, or policy, including agency security, training, and health/safety requirements.

6.3. Non-Personal Services. It is expressly agreed and understood that this is a non-personal services contract as described in the Federal Acquisition Regulation. The Government may evaluate the quality of professional and administrative services provided, but does not supervise or control the Contractor’s professional methods, judgment, diagnosis, or treatment decisions. The Contractor is solely responsible for the professional aspects of performance and for the acts or omissions of its employees and agents. The Contractor shall indemnify the Government for liability-producing acts or omissions of the Contractor, its employees, or agents.

6.4. Contractor Responsibility for Credential Verification:

6.4.1. Primary Source Verification: The Contractor is responsible for verification of the current status and validity of each individual’s education/training, certification(s) (if applicable), and any required registration or credentialing prior to the commencement of services and throughout performance.

6.4.2. Cooperation: The Contractor shall fully cooperate and provide information or documentation reasonably requested by the Government to facilitate confirmation of qualification, certification, or credentialing status.

6.4.3. Recordkeeping: The Contractor shall maintain a credential/training file for each individual, including copies of required credentials and dated proof of verification. Upon request, the Contractor shall provide the requested documentation to the Government within two (2) business days.

6.5. Removal and Replacement of Unqualified Personnel: If any individual lacks the required qualifications or if any required credential becomes expired, suspended, restricted, or otherwise invalid, the Government may direct the Contractor to remove that individual from the assignment immediately. The Contractor shall promptly provide a qualified replacement who meets all requirements of this section at no additional cost to the Government.

6.6. Government Review: The Government may review rosters, sample files, and verification evidence at any time, on reasonable notice. Government review, acceptance, or failure to object does not waive or diminish the Contractor’s responsibilities under this section.

7. DELIVERABLES AND REPORTING REQUIREMENTS

7.1. Delivery: The Contractor shall coordinate delivery, installation, configuration, verification of proper operation, and training date(s) with the Government-designated point(s) of contact (POC) for each participating facility. The Government will provide building access for the sole purpose of delivery, installation, and training. No deliveries can be made after 4:15 pm local facility time unless approved in advance by the Government POC. Driver must present a valid ID.

7.1.1. Location information is as follows:

7.1.1..1. Anadarko Indian Health Center: 201 East Parker McKenzie Drive, Anadarko, OK 73005 7.1.1..2. Carnegie Indian Health Center: 212 E 4th St., Carnegie, OK 73015 7.1.1..3. Clinton Indian Health Center: 10321 N. 2274 Road, Clinton, OK 73601 7.1.1..4. El Reno Indian Health Center: 1801 Parkview Drive, El Reno, OK 73036 7.1.1..5. Haskell Indian Health Center: 2415 Massachusetts St., Lawrence, KS 66046 7.1.1..6. Pawnee Indian Health Center: 1201 Heritage Circle, Pawnee, OK 74058 7.1.1..7. PHS Lawton Indian Hospital: 1515 NE Lawrie Tatum Road, Lawton, OK 73507 7.1.1..8. Watonga Indian Health Center: 1305 S. Clarence Nash Blvd, Watonga, OK 73772 7.1.1..9. Wewoka Indian Health Center: 36640 US-270, Wewoka, OK 74884

7.2. Contractor Point of Contact: The Contractor shall furnish one designated point of contact (POC) to the Government’s designated representative for coordination of equipment placement, consumables ordering support (as applicable), delivery, installation, training, and/or maintenance. The Contractor POC shall be empowered to make daily decisions to ensure that contract implementation and day-to-day support meet the terms and conditions of this placement agreement.

7.3. Contractor’s Phone Numbers: The Contractor shall provide a toll-free telephone number (or other Government-approved 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, excluding Federal holidays.

7.4. Personnel Qualifications: Contractor personnel performing delivery, installation, training, maintenance/service, and/or connectivity/interface support shall meet the requirements of Section 6.

8. GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES

8.1. The Government shall provide, as applicable, the following to support placement and operation of the BIOFIRE SPOTFIRE FDA-cleared/authorized, CLIA-waived PCR system(s):

8.1.1. Suitable space and environmental conditions consistent with Section 2 technical requirements (temperature/humidity/indoor use).

8.1.2. Electrical power meeting the requirements stated in Section 2 (100–240 VAC, 50–60 Hz).

8.1.3. Government-designated point(s) of contact (POC) at each facility for scheduling, access coordination, and operational readiness.

8.1.4. Building access for Contractor personnel for delivery, installation, training, and maintenance/service visits, in accordance with facility security requirements.

8.1.5. If network connectivity and/or interfacing is requested by the Government, the Government shall provide approvals, access, and coordination consistent with Government IT/security requirements and facility readiness (including coordination as applicable for Data Innovations middleware and RPMS/EHR workflow integration).

9. CONTRACTOR FURNISHED PROPERTY, FACILITIES AND SERVICES

9.1. Required personnel, materials, supplies and equipment: The Contractor shall furnish all personnel, materials, supplies and equipment required to perform work under the placement agreement, to include:

9.1.1. BIOFIRE SPOTFIRE FDA-cleared/authorized, CLIA-waived PCR system(s) as described in Section 2 (Control Station(s) and Module(s)), including manufacturer standard accessories, cables, and components required for intended use and operation.

9.1.2. Placement services provided at no cost to the Government, including delivery, installation, configuration, verification of proper operation, and training, as described in Sections 2 and 4.

9.1.3. Preventative maintenance (as applicable per manufacturer requirements), corrective maintenance/repairs, labor, parts, and replacement equipment necessary to maintain operability of the placed system(s) at no cost to the Government for the duration of the contract.

9.1.4. Technical support and application support for the SPOTFIRE platform and the CLIA-waived respiratory testing consumables listed in Section 2.2, including telephone support as described in Section 4.

9.1.5. CLIA-waived respiratory testing consumables and quality control materials listed in Section 2.2 (menu items), available for purchase by the Government in accordance with the contract pricing structure, including facility-specific minimum quantity purchase commitments.

9.1.6. Qualified personnel to perform installation, training, maintenance/service, and connectivity/interface support (when requested by the Government), in accordance with Section 6.

10. CHANGES TO THE STATEMENT OF WORK (SOW)

Any changes to this SOW 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.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Office of Management Services Division of Acquisition Policy (DAP)

5600 Fishers Lane Rockville, MD 20857

INDIAN HEALTH SERVICE

BUY INDIAN ACT

INDIAN ECONOMIC ENTERPRISE

REPRESENTATION FORM

SOLICITATION/SOURCES SOUGHT/RFI #: _________________________________________________

PROJECT TITLE: ________________________________________________________

DATE: ___________________________________________________________________

In accordance with 25 U.S.C. 47 the Buy Indian Act, the signature below constitutes self-certification that the Offeror meets the definition of an “Indian Economic Enterprise” (HHSAR 326.601) in response to this Sources Sought Notice, Request for Information (RFI) or Solicitation and resultant contract.

The enterprise must meet the definition of “Indian Economic Enterprise” throughout the following time periods:

(1) At the time an offer is made in response to this solicitation;

(2) At the time of contract award; and

(3) During the full term of the contract performance period. At any point during these periods, if the Contractor no longer meets the eligibility requirements, the contractor must provide immediate written notification to the Contracting Officer.

Individual Contracting Officers may require documentation of eligibility before awarding a set-aside or sole source contracts under the Buy Indian Act and awards may be subject to protest if the eligibility of the successful Offeror is in question. In addition to the self-certification requirements, successful Offerors must also be registered with the System of Award Management (SAM).

Any false or misleading information submitted by an enterprise when submitting an offer in consideration of an award set-aside under the authority of the Buy Indian Act is a violation of the law and punishable under 18 U.S.C. 1001.

False claims submitted as part of contract performance are subject to the penalties enumerated in 31 U.S.C. 3729 to 3731 and 18 U.S.C. 287.

REPRESENTATION

The Offeror represents as part of its offer that it does _____, does not _____ meet the definition of an “Indian Economic Enterprise” with “Indian Ownership” under the authority of the Buy Indian Act.

Name of the 51% owner of IEE Firm

Certifying Signature

Print Name

Name of Federally Recognized Tribal Entity

Business Name

UEI Number