IHS-SS-26-IHS1520507_release_202609231438.pdf

Solicitation IHS-SS-26-IHS1520507 Page 1 of 7

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 · RFO FAR Part 12 (Revolutionary FAR Overhaul) Full and Open Competition

Issuing office Oklahoma City Area Office

Solicitation No. IHS-26-IHS1520507

Title PCR Laboratory Analyzer

Issue date September 24, 2026

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

Product/Service Code 6640

Set-aside authority Full and Open Competition (RFO FAR part 6 — full and open competition)

Anticipated contract type Blanket Purchase Agreement (BPA) firm-fixed-price calls; individual calls up to $250,000

Place(s) of performance 4 locations (see Section 4)

Period / delivery 1 Year BPA - Dates are TBD

Quotes due October 2, 2026, at 10:00 AM CT

Submit to maryann.yocham@ihs.gov

1. INTRODUCTION

This is a combined synopsis/solicitation for commercial products prepared in accordance with

RFO FAR part 12, using the combined synopsis/solicitation format at RFO FAR 12.202(b), as revised under the Revolutionary FAR Overhaul and the implementing HHS/IHS class deviation, and the simplified procedures for commercial products and commercial services at

RFO FAR 12.201-1. This announcement constitutes the only solicitation; quotations are requested and a separate written solicitation will not be issued. Solicitation number IHS-SS-26-IHS1520507 is issued as a Request for Quotation (RFQ) for PCR Laboratory

Analyzer. The associated NAICS code is 334516 — Analytical Laboratory Instrument

Manufacturing (size standard 1,000 employees).

RFO note: RFO 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

RFO FAR 12.205 clause tables.

Anticipated contract type. The Government anticipates establishing a single blanket purchase agreement (BPA) (RFO FAR 12.201-1(e)(3)(i)(B)) to fill anticipated repetitive needs.

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All calls placed under the resulting agreement will be issued on a firm-fixed-price basis (RFO

FAR 12.104(a)). A BPA is not a contract and obligates no funds; the Government is obligated only to the extent that authorized calls are actually placed (RFO FAR

12.201-1(e)(3)). Quantities stated in this solicitation are estimates for evaluation purposes only and do not represent a guarantee of any volume of business.

2. SET-ASIDE DETERMINATION

This requirement is a Full and Open Competition under RFO FAR part 6 — full and open competition.

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 FDA-cleared/authorized, CLIA-waived respiratory

PCR analyzers to establish and maintain CLIA-waived respiratory PCR testing capability and support timely patient care.

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

Place(s) of performance / delivery:

� Clinton Indian Health Center — 10321 N 2274 Rd, Clinton, OK 73601

� El Reno Indian Health Center — 1801 Parkview Dr., El Reno, OK 73036

� Pawnee Indian Health Center — 1201 Heritage Cir., Pawnee, OK 74058

� Watonga Indian Health Center — 204 W Main St., Watonga, OK 73772

Period of performance / required delivery: 1 Year BPA - Dates are TBD.

F.O.B. point: Destination.

Inspection and acceptance: as provided in the clause at RFO FAR 52.212-4, Contract Terms and

Conditions—Commercial Products and Commercial Services.

Blanket Purchase Agreement Terms The following terms will apply to any BPA established under this solicitation (RFO FAR 12.201-

1(e)(3)(iv)):

� Furnishing of supplies or services. The supplier will furnish the supplies or services described in Section 3, in general terms, if and when requested by an authorized individual during the agreement period of 1 Year BPA - dates TBD, and within a stipulated aggregate amount of $340,000.

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� Extent of obligation. The Government is obligated only to the extent of authorized purchases actually made under the BPA.

� Dollar limitation per call. The dollar limitation for each individual purchase under this BPA is $250,000. This limitation does not exceed the threshold for use of simplified procedures at RFO FAR 12.201-1(a).

� Authorized callers. Calls may be placed only by Any authorized Contracting Officer for the Oklahoma City Area Office (OCAO). A list of authorized individuals will be incorporated into the resulting agreement.

� Delivery and shipment documentation. Each delivery or shipment must reference the BPA number, the call number, the line item(s), quantities, and the delivery location.

� Invoicing. A summary invoice shall be submitted at least monthly, or upon expiration of this BPA, whichever occurs first, for all deliveries made during the billing period. The summary invoice shall identify the delivery tickets covered, state their total dollar value, and be supported by receipt copies of the delivery tickets, submitted in accordance with

RFO FAR 52.212-4.

� Clauses. The provisions and clauses listed in Section 7 apply to purchases under this BPA (RFO FAR 12.201-1(e)(3)(iv)(G)).

� Annual review. The Government will review this BPA at least annually to confirm that authorized procedures are being followed and that the agreement remains advantageous (RFO FAR 12.201-1(e)(3)(v)).

The requirements at RFO FAR 12.102 and 12.103 apply to each call placed under this agreement.

Calls will be placed directly with the supplier by an authorized individual; the Government does not anticipate competing individual calls under this agreement. This agreement is not exclusive.

The Government may satisfy any requirement within its scope by other means, and nothing in this agreement guarantees any volume of business.

5. EVALUATION METHODS

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

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

Evaluation. The Government will award a purchase order to the responsible quoter whose conforming quotation is most advantageous to the Government, based on a comparative evaluation of quotations against the following factor(s): the Government will evaluate the extent to which the quoted analyzer system and associated CLIA-waived respiratory testing consumables meet the salient characteristics stated in Section 2 of the SOW. The Government will assess the quotation for demonstrated conformance with, at minimum, the following:

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Regulatory status — current FDA clearance/authorization and CLIA-waived categorization for the intended respiratory testing use, for both the analyzer and each proposed respiratory consumable (SOW 2.1.1); Testing method and multiplex capability — self-contained, sample-to-answer, closed-cartridge PCR methodology requiring no separate operator-performed extraction, CLIA-waived for non-laboratorian operation, and capable of running the required multiplex respiratory panel (SOW 2.1.2, 2.2.2); Result time — reportable respiratory panel results within 30 minutes or less per test (SOW 2.1.4); User interface — integrated touchscreen, integrated barcode scanning, and minimum display size/resolution (SOW 2.1.5).;

Environmental and power requirements — operable within the stated temperature, humidity, and standard U.S. power ranges (SOW 2.1.6);; Footprint — conformance with stated maximum dimensions and weight (SOW 2.1.7);; Connectivity and interoperability — wired and wireless connectivity, and demonstrated capability to report results through Data Innovations middleware and integrate into RPMS/EHR workflows (SOW 2.1.8);Software sustainment and hardware/OS refresh — manufacturer-supported software/OS/hardware, with updates maintaining compatibility and functionality at no cost (SOW 2.1.9);, and price. The Government will compare quotations directly against one another under each factor to determine which provides the greatest benefit to the Government; quotations will not be assigned numerical scores or adjectival ratings, and no competitive range will be established. The non-price factors, when combined, are more important than price. The Government may make award without communications, or may communicate with one or more quoters and request revised quotations. Award will represent the best value to the Government, price and other factors considered.

Past Performance. The Government will evaluate the quoter's recent and relevant past performance as an indicator of its ability to perform this requirement. “Recent” means performed within 3 years of the date of this RFQ; “relevant” means similar in size, scope, and complexity. The Government may consider information from any source, including CPARS, references, and the quoter's experience as a subcontractor. A quoter without a record of relevant past performance will not be evaluated favorably or unfavorably on this factor.

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.

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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.

Brief explanation to unsuccessful quoters. Upon request, the Government will provide an unsuccessful quoter a brief explanation of the award decision that explains why that quoter was not selected. If an award notice was not required to be posted to the Governmentwide Point of

Entry, the Government will also provide the information that would have appeared in an award notice.

6. INSTRUCTIONS TO OFFERORS

Quotations are due no later than October 2, 2026, at 10:00 AM CT. Email is the only acceptable method of submission. Submit quotations by email to maryann.yocham@ihs.gov. Quotations submitted by any other method will not be considered.

Questions concerning this solicitation must be submitted by email to maryann.yocham@ihs.gov no later than September 28, 2026. Questions received after that date may not be answered.

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

(RFO FAR 52.212-1; 52.204-7). Failure to provide sufficient technical detail may result in rejection of your quote.

Point of contact: Mary Ann Yocham, 405-951-6043.

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

Solicitation IHS-SS-26-IHS1520507 Page 6 of 7 under RFO FAR 52.252-1 (provisions) and 52.252-2 (clauses), with the same force and effect as if printed in full. RFO FAR deviation text: https://www.acquisition.gov/far-overhaul/far-part-deviation-guide. Official HHSAR text: https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar-overhaul/index.html. Items marked

“Full text” are printed below; highlighted fill-ins must be completed. Clauses marked

“DEVIATION” are issued under the FAR/HHSAR class deviation adopted by this IHS Area; the deviation date shown with them is that class deviation’s date.

7.1 FAR Provisions (solicitation only)

Number Title Incorporation

RFO FAR 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions

By reference

RFO FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements— Representation

By reference

RFO FAR 52.204-7 System for Award Management—Registration (DEVIATION) By reference

RFO FAR 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (DEVIATION)

By reference (addenda)

RFO FAR 52.212-2 Evaluation—Commercial Products and Commercial Services

(DEVIATION)

Full text — Section 5

RFO FAR 52.217-5 Evaluation of Options By reference

RFO FAR 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns

By reference

RFO FAR 52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products (FEB 2021)

By reference

7.2 FAR Clauses (incorporated into any resulting contract)

Number Title Incorporation

RFO FAR 52.203-17 Contractor Employee Whistleblower Rights (NOV 2023) By reference

RFO FAR 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)

By reference

RFO FAR 52.204-13 System for Award Management—Maintenance (DEVIATION) By reference

RFO FAR 52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (DEVIATION)

By reference

RFO FAR 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations

(DEVIATION)

By reference

RFO FAR 52.212-4 Terms and Conditions—Commercial Products and Commercial Services (DEVIATION)

By reference

RFO FAR 52.222-3 Convict Labor (DEVIATION) By reference

RFO FAR 52.222-19 Child Labor—Cooperation with Authorities and Remedies By reference

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(DEVIATION)

RFO FAR 52.222-35 Equal Opportunity for Veterans (DEVIATION) By reference

RFO FAR 52.222-36 Equal Opportunity for Workers with Disabilities (DEVIATION) By reference

RFO FAR 52.222-37 Employment Reports on Veterans (DEVIATION) By reference

RFO FAR 52.222-50 Combating Trafficking in Persons (DEVIATION) By reference

RFO FAR 52.222-54 Employment Eligibility Verification (DEVIATION) By reference

RFO FAR 52.222-90 Addressing DEI Discrimination by Federal Contractors

(DEVIATION)

By reference

RFO FAR 52.223-23 Sustainable Products and Services (DEVIATION) By reference

RFO FAR 52.224-1 Privacy Act Notification By reference

RFO FAR 52.224-2 Privacy Act By reference

RFO FAR 52.224-3 Privacy Training (JAN 2017) By reference

RFO FAR 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving (MAY 2024)

By reference

RFO FAR 52.232-33 Payment by Electronic Funds Transfer—System for Award Management (OCT 2018)

By reference

RFO FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023)

By reference

RFO FAR 52.233-3 Protest After Award (DEVIATION) By reference

RFO FAR 52.233-4 Applicable Law for Breach of Contract Claim (DEVIATION) By reference

RFO FAR 52.240-91 Security Prohibitions and Exclusions (DEVIATION) By reference

RFO FAR 52.244-6 Subcontracts for Commercial Products and Commercial Services (DEVIATION)

7.4 HHSAR Clauses (incorporated into any resulting contract)

RFO HHSAR

352.224-70

Privacy Act (DEC 2015) By reference

RFO HHSAR

352.224-71

Confidential Information By reference

RFO HHSAR

352.239-73

Electronic and Information Technology Accessibility (Section

508) (DEC 2015)

8. ATTACHMENTS

� Attachment 1 — Specifications

� Attachment 2 — Price Schedule

Department of Health and Human Services Oklahoma Area

Indian Health Service

Statement of Work (SOW) PCR Laboratory Analyzer

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 FDA-cleared/authorized, CLIA-waived respiratory 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 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:

Facility Address Clinton Indian Health Center 10321 N. 2274 Road, Clinton, OK 73601-7521 El Reno Indian Health Center 1801 Parkview Drive, El Reno, OK 73036-2103 Pawnee Indian Health Center*** 1201 Heritage Circle, Pawnee, OK 74058 Watonga Indian Health Center 1305 S. Clarence Nash Blvd, Watonga, OK 73772 ***VC-Spotfire 4 is owned by Pawnee and is supported under its own separate arrangement. Only consumables will be required for Pawnee

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

The Contractor shall provide a CLIA-waived, FDA-cleared/authorized, multiplex respiratory PCR analyzer system and associated 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.

The BioFire SPOTFIRE system is cited as the brand-name reference product for this requirement.

This is a "brand name or equal" requirement. The provision at FAR 52.211-6, Brand Name or Equal, applies (see Section 2.0.1 below). An offeror may propose an "equal" product that meets the salient characteristics identified in this Section 2. Any product offered as "equal" will be evaluated for conformance with the salient physical, functional, and performance characteristics stated herein.

2.0.1. FAR 52.211-6, Brand Name or Equal (incorporated)

The provision at FAR 52.211-6, Brand Name or Equal, is incorporated into this solicitation by reference. In accordance with that provision:

(a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that an "equal" product must meet are specified in Section 2 (see the salient characteristics identified in Sections 2.1 and 2.2, expressly marked "(Salient characteristic)").

(b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must:

(1) Meet the salient physical, functional, or performance characteristic(s) specified in this solicitation;

(2) Clearly identify the item by brand name, if any, and make or model number; and

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive literature or specifications sufficient for the Government to determine whether the product offered meets the salient characteristics of this solicitation.

(c) The Government will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Government. The Government is not responsible for locating or obtaining any information not identified in the offer.

(d) If an offeror is unable to furnish descriptive literature by the time specified for receipt of offers, the offeror shall so notify the Contracting Officer, who may specify a later date.

(e) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

2.1. CLIA-Waived PCR Analyzer Equipment

Brand name reference: BioFire SPOTFIRE System (Control Station and stackable testing Module(s)).

The Contractor shall provide a CLIA-waived, FDA-cleared/authorized, multiplex respiratory PCR analyzer system that meets the following salient characteristics. Physical dimensions and hardware component details of the reference product are provided for informational context only and are not salient characteristics except where expressly marked below.

2.1.1. Regulatory status (Salient characteristic)

The system, and each respiratory testing consumable proposed for use on it, shall hold current FDA clearance/authorization and CLIA-waived categorization for the intended respiratory testing use described in Section 2.2. Any product offered as "equal" must be CLIA-waived; systems that are moderate- or high-complexity under CLIA do not meet this requirement, as CLIA-waived status is essential to the intended use at these facilities.

2.1.2. Testing method and multiplex capability (Salient characteristic) The system shall use nucleic acid amplification (PCR-based) methodology in a self-contained, sample-to-answer, closed-cartridge/consumable format that requires no separate operator-performed nucleic acid extraction step and that is CLIA-waived for operation by trained non-laboratorian staff. The system shall be capable of running a multiplex respiratory panel detecting, at minimum, the respiratory target menu specified in Section 2.2.2.

2.1.3. Scalable/modular throughput (Salient characteristic)

The system shall support scalable per-facility throughput through a control unit paired with one (1) to four (4) independently operable testing modules/positions per control unit, allowing simultaneous or staggered processing of multiple samples. The deployed configuration shall be scalable by facility as required by the Government.

2.1.4. Result time (Salient characteristic)

The system shall provide reportable respiratory panel results within 30 minutes or less per test from sample loading.

2.1.5. User interface (Salient characteristic)

The system shall provide an integrated touchscreen user interface and integrated barcode scanning capability for specimen/consumable identification. The system shall include an integrated visual display that supports on-screen entry of test/specimen information and on-screen review of test results, with a minimum diagonal display size of 7 inches and a minimum resolution of 1024 x 600.

2.1.6. Environmental and power requirements (Salient characteristic) The system shall be operable within the following ranges using standard U.S. facility power:

• Operating temperature: capable of operation within a 15°C–30°C range, indoor use.

• Relative humidity: capable of operation within a 15–80% relative humidity range (non-condensing).

• Electrical: operable on 100–240 VAC, 50–60 Hz, using a standard NEMA 5-15 grounded receptacle.

2.1.7. Footprint (maximums) (Salient characteristic)

The placed system shall fit within Government-provided bench space. The following are maximum dimensions and weights; smaller/lighter equivalents are acceptable:

• Control unit footprint: shall not exceed 9 in (W) x 13 in (D).

• Fully configured stack height (control unit plus up to 4 modules): shall not exceed 22 in (H).

• Total configured system weight (control unit plus up to 4 modules): shall not exceed 75 lbs.

2.1.8. Connectivity and interoperability (Salient characteristic) The system shall provide the network connectivity necessary to support results reporting and integration into existing Government laboratory workflows, at minimum:

• Wired Ethernet connectivity (IEEE 802.3-compliant, RJ-45), and

• Wireless network connectivity (IEEE 802.11-compliant, supporting standard 2.4 GHz and 5 GHz enterprise Wi-Fi).

The placed system shall be capable of 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. Compatibility with the Government's existing Data Innovations middleware and RPMS/EHR environment is essential; an "equal" product must be able to demonstrate this interoperability.

2.1.9. Software sustainment and hardware/OS refresh (Salient characteristic) The control unit shall run manufacturer-supported software on a manufacturer-supported operating system and hardware platform appropriate for the system's intended CLIA-waived use. Any manufacturer-initiated hardware or operating system updates during contract performance shall maintain compatibility with the system, its CLIA-waived respiratory testing consumables, and supported connectivity features, shall not reduce functionality during the period of performance, and shall be provided at no cost to the Government under this placement agreement.

2.1.10. Reference product specifications (informational only — NOT salient) The following characteristics of the brand-name reference product (BioFire SPOTFIRE) are provided for informational context only and shall not be used to reject an otherwise conforming "equal" product:

single-color optics module and sensor imaging; PCR temperature range 40°C–105°C; PCR melt rate 0.1–2°C/sec; 8.4 in diagonal display at 1280 x 768 resolution; specific module connection cable type/length; specific control-station RAM/storage figures; and specific individual component weights and dimensions. Offerors proposing an "equal" product need not match these reference-product details provided the salient characteristics in Sections 2.1.1 through 2.1.9 are met.

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 awarded 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. Consumables shall be compatible with, and validated by the manufacturer for use on, the awarded analyzer platform.

The BioFire SPOTFIRE respiratory consumables identified below are cited as brand-name references.

Offerors proposing an "equal" analyzer shall propose the corresponding manufacturer-validated consumables for that platform that meet the salient testing-capability characteristics stated below. Part numbers are provided to identify the reference products and are not, in themselves, salient characteristics; the salient characteristic is the testing capability (target menu and CLIA-waived status).

2.2.1. External Quality Control Materials (Salient characteristic: CLIA-waived respiratory QC capability) External positive and negative control materials sufficient to support CLIA-waived respiratory testing quality control processes in accordance with facility quality plans and applicable instructions for use, validated for use on the awarded platform.

• Brand-name reference: RSP Pos & Neg Controls (Part# M425).

2.2.2. Respiratory Panel Consumable — multiplex respiratory testing capability (Salient characteristic: target menu below) A multiplex CLIA-waived respiratory testing consumable, validated for use on the awarded platform, providing broad respiratory detection capability. Packaged as a multi-test pack (reference pack size:

30 tests per pack). At minimum, the panel shall detect the following targets:

• 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.

Brand-name reference ordering identifiers (either acceptable for the reference product):

• Respiratory Panel (Part# 424461), OR

• Respiratory Panel Kit (Part# 423485).

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

2.2.3. Respiratory Panel Mini Consumable — focused respiratory viral testing capability (Salient characteristic: target menu below) A focused CLIA-waived respiratory viral testing consumable, validated for use on the awarded platform, providing detection for high-demand respiratory viral targets. Packaged as a multi-test pack (reference pack size: 30 tests per pack). At minimum, the panel shall detect the following targets:

• SARS-CoV-2; Human Rhinovirus; Influenza A; Influenza B; RSV.

Brand-name reference ordering identifiers (either acceptable for the reference product):

• Respiratory Panel Mini (Part# 424589), OR

• Respiratory Panel Mini Kit (Part# 424537).

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

2.2.4. Test quantity definition (kits/packs and tests)

For the panel/kit items above, where the item is packaged/labeled as a 30-test pack, one (1) pack/kit contains thirty (30) reportable tests. 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 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).

3. PERIOD OF PERFORMANCE

1 YEAR BLANKET PURCHASE AGREEMENT

4. LEVEL OF EFFORT

4.1. Deployment / placement implementation: The Contractor shall facilitate the delivery of the awarded FDA-cleared/authorized, CLIA-waived PCR system(s) (Control Station/control unit 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 at the intervals specified in the manufacturer's published maintenance schedule, corrective maintenance/repairs, labor, parts, and replacement equipment as necessary to maintain operability of the placed CLIA-waived PCR system(s).

4.4. Warranty: The Contractor shall provide, at minimum, a one (1) year manufacturer warranty on all placed equipment and components under normal use and appropriate preventative maintenance. This warranty runs concurrently with, and does not limit, the Contractor's obligation under Section 4.3 to maintain operability of the placed system(s) at no cost to the Government for the full duration of the contract.

4.5. 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, where an issue cannot be resolved on the initial contact, escalation to qualified service personnel within one (1) business day of the initial contact.

4.6. 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 the awarded 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). The Contractor shall answer service calls placed during those hours by a live representative or return the call no later than four (4) business hours after the call is placed.

4.7. 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.

4.8. 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, with restoration of a functioning system (by repair or replacement) completed no later than two (2) business days after the Contractor's receipt of the Government's report of the breakdown.

4.9. Brand name or equal; substitutions: This is a "brand name or equal" requirement. The equipment and consumables identified in Section 2 by brand name (BioFire SPOTFIRE) are cited as reference products. In accordance with FAR 52.211-6, Brand Name or Equal, an offeror may propose an "equal" product that meets the salient physical, functional, and performance characteristics identified in Section 2 (those expressly marked "Salient characteristic"). Products offered as "equal" will be evaluated for conformance with those salient characteristics as provided in Section 2 and FAR 52.211- 6.

After award, the Contractor shall provide the awarded product (whether the brand-name reference product or an approved "equal") and shall not substitute a different make, model, or consumable for the awarded product without prior written authorization from the Contracting Officer. Any post-award substitution request shall be submitted in writing and shall demonstrate that the proposed substitute meets or exceeds all salient characteristics identified in Section 2. Substitutions are effective only upon written approval by the Contracting Officer.

4.10. 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).

4.11. Consumables shipping: Quality control materials and testing panels shall be shipped within ten

(10) business days of order placement.

4.12. Training: Comprehensive training for the awarded CLIA-waived PCR system(s) and related software shall be provided at no additional cost by qualified contractor personnel on-site and in-person when requested by the Government, for all participating Oklahoma Area IHS facility Laboratory staff designated by the Government. Initial training shall be completed within the deployment timeline stated in Section 4.2. Upon written request by the Government POC, the Contractor shall provide follow-on or refresher training within thirty (30) calendar days of the request. 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 OMB M-05-24, Section 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 an 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 of 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 AND CREDENTIAL VERIFICATION

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 awarded CLIA-waived PCR system(s) shall be manufacturer-trained and qualified for the awarded 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 provide a qualified replacement who meets all requirements of this section, at no additional cost to the Government, no later than ten (10) business days after the Government's direction to remove the individual, unless a longer period is authorized in writing by the Contracting Officer.

6.6. Government Review: The Government may review rosters, sample files, and verification evidence at any time, upon at least two (2) business days' advance notice to the Contractor. Government review, acceptance, or failure to object does not waive or diminish the Contractor's responsibilities under this section.

7. REGULATORY COMPLIANCE

7.1. The Contractor shall comply with the following regulations:

• Privacy Act, 5 U.S.C. 552a

• Health Insurance Portability and Accountability Act (HIPAA) — 45 CFR Part 164 (Security and

Privacy)

• 42 CFR Part 2 — Confidentiality of Substance Use Disorder Patient Records

7.2. Section 508 / Accessibility: All Information and Communication Technology (ICT) deliverables under this contract (e.g., websites, applications, electronic documents, and multimedia) must comply with the Revised Section 508 Standards (36 CFR Part 1194) and the Web Content Accessibility Guidelines (WCAG) 2.1 Level AA standards. The Contractor shall ensure accessibility of all ICT deliverables and provide conformance documentation in the form of a Voluntary Product Accessibility Template (VPAT®) / Accessibility Conformance Report (ACR), or by completing the HHS Section 508 Accessibility Checklists. The Contractor shall remediate any identified accessibility issues at no additional cost.

8. DELIVERABLES AND REPORTING REQUIREMENTS

8.1. 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.

8.1.1. Location information is as provided in the facility table in Section 1.

8.2. 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.

8.3. 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.

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

9. GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES

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

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

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

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

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

9.1.5. 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).

10. CONTRACTOR FURNISHED PROPERTY, FACILITIES AND SERVICES

10.1. 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:

10.1.1. The awarded FDA-cleared/authorized, CLIA-waived PCR system(s) as described in Section 2 (control unit(s) and Module(s)), including manufacturer standard accessories, cables, and components required for intended use and operation.

10.1.2. 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.

10.1.3. 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.

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

10.1.5. 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.

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

11. 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.

12. DELIVERABLES/PERFORMANCE MATRIX

Measurable to be evaluated at the conclusion of awarded contract Result Deployment timeliness (60-calendar-day completion) — AQL ≥95% ☐YES ☐NO ☐N/A Deployment completeness: All delivery, installation, configuration, verification, and initial training completed — AQL ≥95% ☐YES ☐NO ☐N/A

Support line availability (8:00–4:30, Mon–Fri, excluding holidays): contact attempts during required hours were successful — AQL ≥95% ☐YES ☐NO ☐N/A

Consumables order accuracy: correct part number + quantity received —

AQL ≥95% ☐YES ☐NO ☐N/A

Consumables shipping timeliness: QC and testing panels shipped within 10 business days of order — AQL ≥95% ☐YES ☐NO ☐N/A

Repair downtime: labor, parts, and/or replacement equipment provided with downtime no greater than 2 business days ☐YES ☐NO ☐N/A

Standards & Guidelines of accrediting organizations and applicable regulating agencies upheld ☐YES ☐NO ☐N/A

Software/Quality Improvement update information provided when required…