Sources Sought Notice IEE Chemistry Analyzers.pdf

SOURCES SOUGHT NOTICE

THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR QUOTE.

SUBJECT: Bemidji Indian Health Service / White Earth Health Clinic/ Lab Chemistry Analyzers

NAICS CODE: 334516 Analytical Laboratory Instrument Manufacturing/PSC: Q508

POINT OF CONTACT: Mary.simon2@ihs.gov and Winona.kitto@ihs.gov

PLACE OF PERFORMANCE/DELIVERY ADDRESS:

White Earth Health Clinic 40520 County Highway 34 Ogema, MN 56569

Waabinokwe Health Center 2471 310th Ave Mahnomen, MN 56557

RESPONSE DATE/TIME: 02/11/2025

BUY INDIAN ACT

The IHS Contracting Officer will give priority for all purchases, regardless of dollar value, by utilizing ISBEE set-aside to the maximum extent possible. Each acquisition of supplies, services or construction that is subject to commercial items (FAR 12.209) or Simplified Acquisition Procedures (SAP) (FAR 13.106) must be set-aside exclusively for ISBEEs.

Definition(s): INDIAN ECONOMIC ENTERPRISE (IEE) - Any business activity owned by one or more Indians, Federally Recognized Indian Tribes, or Alaska Native Corporations provided that:

The combined Indian, Federally Recognized Indian Tribe or Alaska Native Corporation ownership of the enterprise constitutes not less than 51%;

The Indian, Federal Recognized Indian Tribes, or Alaska Native Corporations must, together, receive at least 51% of the earnings from the contract; and

The management and daily business operations must be controlled by one or more individuals who are Indians.

Definition: INDIAN SMALL BUSINESS ECONOMIC ENTERPRISE (ISBEE) – An IEE that is also a small business concern established in accordance with the criteria and size standards of 13 CFR Part 121.

INTERESTED PARTIES

GENERAL INFORMATION

THIS IS A SOURCES SOUGHT NOTICE ONLY; IT IS NOT A REQUEST FOR QUOTE, RATHER MARKET

RESEARCH TO DETERMINE COMPLAINCE WITH THE BUY INDIAN ACT AND DETERMINATION OF

SETASIDE.

All interested firms who can meet the requirements stated above should respond, in writing, INCLUDING ALL THE

FOLLOWING:

1. Company name.

2. Point of contact (name/title/telephone number/e-mail address).

3. FSS / SEWP Contract number, if applicable.

4. SAM Unique Entity Identifier Number. (Formally DUNS number)

5. Tax ID number.

6. Indication of which business category (IEE or ISBEE) for which the organization qualifies.

7. A capability statement that addresses the organizations qualifications and ability to provide the requirement depictedabove.

8. Documentation from manufacturer (i.e., correspondence from manufacturer) of your firm being an authorizeddistributor for the manufacturer. See Attachment 2: Gray Market Prevention Language.

Additionally, since IHS must conduct sufficient market research in determining if there is reasonable expectation of obtaining offers from two or more Indian Economic Enterprises (IEE), for every commercial contract opportunity, in accordance with HHSAR 326.603-1.

To identify and support responsible IEE/ISBEE(s) and prevent circumvention or abuse of the Buy Indian Act, interested, qualified, vendors must provide the following:

Representation must be made on the designated IHS Indian Economic Enterprise Representation form (attached) through which the offeror will self-certify eligibility; and, Identify the Federally Recognized Indian Tribe or Alaska Native Corporation upon which the offeror relies for its IEE status.

Interested firms are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.1102 required to be registered in the Systems for Award Management (SAM) at the time an offer or quotation is submitted in order to comply with the annual representations and certifications requirements. The Government will use responses to this notice to make an appropriate acquisition decision. This is the only notice: no other copies of this notice will be provided.

Attachment 1: IHS Indian Economic Enterprise Representation form

Lab Chemistry Analyzers

The Contractor shall provide two (2) integrated analyzers, reagents, controls, calibrators, service and any additional supplies at or below GSA contract pricing for the life of the contract.

The Contractor is responsible for all materials during installation and validation of the analyzers at each

Place of Performance. The following specifications and features must also be included.

1. One (1) integrated chemistry analyzer to be used at White Earth Health Center laboratory.

Includes analyzer, computer monitor, keyboard, printer, uninterrupted power supply (UPS)

2. One (1) integrated chemistry analyzer to be used at Waabinokwe Health Center laboratory.

Includes analyzer, computer monitor, keyboard, printer, uninterrupted power supply (UPS)

3. Analyzers need to be the same model, all though the test menu may be different for each laboratory.

Required tests are attached.

4. The spatial requirements for each laboratory are slightly different. Therefore, the Contractor selected will be able to provide an analyzer of the same model to fit the spatial requirements.

1. White Earth spatial requirement: <11'W x 3.5' D x 6'H

2. Waabinokwe spatial requirement: <8'W x 3.5'D x 6'H

5. Analyzers shall meet Turnaround times.

Basic Metabolic Panel (BMP) <10 minutes

Troponin <15 minutes

HCG <20 minutes

The analyzer shall be able to accommodate the following specimen types:

1. Serum

2. Plasma

3. Urine

4. Whole blood

The analyzer shall accommodate the following tubes sizes.

1. 13x75mm

2. 13x100mm

3. 16x100mm

4. Small sample containers

5. Microtainers

Service agreement in place for entirety of contract.

Water system provided and installed, if required for each site.

o Additional water storage unit if required

Reagents, calibrators and other supplies must have 90% of shelf life left when received at the laboratory.

Capability to communicate with the LIS via Data Innovations middleware; code 39 barcode reading capability

Automated dilution capabilities

Automated reflex testing capabilities

Automated sample repeat capabilities

Low sample volume capabilities

Automated sample integrity checks

1. Hemolysis

2. Lipemia

3. Icterus

4. Clot detection

5. Short sample detection

Minimal daily, weekly, and monthly user maintenance

Analyzer maintenance and reagent monitoring system

1. Will not allow patient testing if expired reagents are on board, non-calibrated reagents exist, or out of range quality control.

2. Will not allow for operation of analyzer if maintenance is overdue.

On board Quality Control Levey Jennings display with print capabilities.

o Downloadable quality control data for input of quality control to QC data management program.

Operating ambient temperature 18-30ᵒC.

Operating ambient humidity (non-condensing) 20-80%.

Installation and validation of analyzer at each laboratory.

Service availability

1. Via telephone within 30 minutes

2. Technician availability within 24 hours of initial call

3. Preventative maintenance visits performed on schedule per manufacturer recommendations

Must supply all hardware required for each analyzer to operation

1. Computer

2. Monitor

3. Keyboard

4. Uninterrupted Power Supply (UPS)

5. Printer

Vendor will supply 6 toner cartridges at time of contract award for each site.

Pre-award demonstration of analyzer provided by Contractor, if requested.

Analyzer Test Capabilities

Anemia, bone metabolism, cardiac, diabetes, drugs of abuse, general chemistry, immunosuppressed drugs, oncology, reproductive, sepsis, specific proteins, therapeutic drug monitoring, and thyroid testing.

Analyzers must be FDA approved with moderate complexity test categorization through CLIA.

Service

Service fee will be included in Cost Per Reportable Result contract terms.

Service agreement will be in place for entirety of contract.

The Contractor shall provide 24 hours a day, 7 days a week phone technical support and return customer call within one (1) hour of initial call in.

The Contractor shall provide a 24-business hour, or less, response by field service representative.

Preventative maintenance (PM) performed on schedule by Contractor per manufacturer recommendations.

o Each analyzer under contract will receive a thorough inspection developed to prevent unplanned service events.

o Each PM includes all non-consumable parts, field engineer labor, and travel at no charge.

Service reports emailed to customer within 24 business hours of on-site visit.

The Contractor shall provide service manuals.

Training

The Contractor shall provide at the minimum, per analyzer per Place of Performance:

o Two (2) advanced user training slots.

Training shall include, but not limited to:

o Education o Travel o Housing

On-site staff training upon implementation of analyzer.

Workload

The analyzers placed at White Earth Health Center and Waabinokwe Health Center laboratories will have the capability to perform an estimated 500 tests per hour (chemistry and immunoassay combined)

All analyzers shall be able to accommodate quality controls to be run 3 times a day every 8 hours.

Reagents, Calibrators, Quality Control Material

Costs will be included in Cost Per Reportable Result contract terms.

All reagent, calibrator and quality control materials shall be able to be stored between 2-35oC or cooler than -20 oC.

Reagent monitoring system.

o Barcode capability to input new reagents for use onboard.

o Will flag expired reagents on analyzer.

All shipping costs will be paid by Contractor.

Reagents, calibrators and QC material may be ordered as needed during the contract, and billed accordingly to the government.

Extended expiration on calibrations

Analyzer must be able to maintain a minimum of four lot sets per type of quality control (QC) data in the software files onboard.

Analyzer will flag out of range quality controls while allowing for user intervention documentation.

Analyzer must be capable of printing Levey-Jennings graphs with associated results and statistics.

The Contractor shall provide the capability of downloading QC data for submission to obtain peer group statistical analysis.

The Contractor must be able to fulfill urgent delivery requirements for overnight delivery of reagents, calibrators and QC material, if necessary.

Reagents, calibrators and QC material will be delivered within five (5) business days of order to Place of

Performance.

o Deliveries shall be between the hours of 0800-1600 Monday-Friday, excluding Federal holidays.

The Contractor must allow a return, replacement, or provide a full credit for damaged reagents, calibrators, or QC material with expiration dates not allowing for reasonable shelf life.

o Any product received frozen will be rejected by the customer with the Contractor completing a full replacement at no additional charge.

o Return shipping is the responsibility of the Contractor.

Additional Requirements

Additional consumable parts to successfully operate analyzer will be included in CPRR billing terms.

The Contractor shall provide all codes necessary to interface communication between the analyzers and the Data Innovations middleware (interface instrument manager).

The Contractor shall provide a designated customer service person to handle all problems that arise with the contract, ordering of reagents and consumables throughout the term of the contract.

o Any change in staffing must be communicated by the Contractor to the government within 30 days.

The Contractor must provide notification to the COR for any consumables (reagents, controls, calibrators) that are placed on backorder.

During installation at each Place of Performance the Contractor shall make all efforts to avoid disrupting patient testing.

The Contractor will designate an installation specialist to install each analyzer.

o The Contractor’s installation specialist will aid in the establishment of flagging rules, reference ranges, and critical values.

The Contractor will provide analyzer methodology information to desired medical staff to aid in the transition to new analyzers.

The analyzer and consumables selected will be from one Contractor.

Routine operational software and hardware system upgrades will be installed at no additional charge to the government.

Equipment and supplies must comply with green purchasing procurement requirements when possible.