Source Sought IHS1512977 DxM1040 MicroScan WalkAway SAM Announcement.pdf

Sources Sought: Brand Name Only Beckman Coulter DxM 1040 MicroScan WalkAway Instrument (Part Number B1018-340) Analyzer. This will be a Cost Per Test Agreement. This agreement covers Equipment, Service, Reagents, Calibrators, Controls, Supplies, Consumable/Disposable items, Parts, Accessories, Warranty, Other Pertinent Items for the Operation of Equipment including and 24/7 Technical Support.

Sources Sought Notice Number: IHS1512977

This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation, an obligation or commitment by the Indian Health Service.

This notice is intended strictly for market research to determine the availability of Indian Small Businesses Economic Enterprise (ISBEE) and/or Indian Economic Enterprises (IEE)

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The anticipated applicable NAICS code for this acquisition is 334412 - Medical Electronic Equipment Manufacturing and/or 334516, Analytical Laboratory Instrument Manufacturing - other relevant NAICS codes will be considered based on responses received.

1.0 BACKGROUND

The Indian Health Service (IHS), Great Plains Area (GPA) location, located in Aberdeen, SD plans to identify potential sources that can provide brand name only medical equipment, supplies and services.

The purpose of this request is to identify potential ISBEE and/or IEE vendors or contractors to purchase and deliver of a new brand name only, Beckman Coulter DxM 1040 MicroScan WalkAway Instrument (Part Number B1018-340) Analyzer. This will be a Cost Per Test Agreement. This agreement covers Equipment, Service, Reagents, Calibrators, Controls, Supplies, Consumable/Disposable items, Parts, Accessories, Warranty, Other Pertinent Items for the Operation of Equipment including and 24/7 Technical Support for the IHS Quentin N. Burdick Memorial Healthcare Facility, Belcourt, ND.

IHS Quentin N. Burdick Memorial Healthcare Facility plans on maintaining laboratory operations and relies on support services for this contract agreement that includes Equipment, Service, Reagents, Calibrators, Controls, Supplies, Consumable/Disposable items, Parts, Accessories, Warranty, Other Pertinent Items for the Operation of Equipment including and 24/7 Technical Support.

1.1 OBJECTIVE

The primary objective of this project is to secure the purchase and delivery of a new, brand name only, Beckman Coulter DxM 1040 MicroScan WalkAway Instrument (Part Number B1018-340) Analyzer.

This will be a Cost Per Test Agreement. This agreement covers Equipment, Service, Reagents, Calibrators, Controls, Supplies, Consumable/Disposable items, Parts, Accessories, Warranty, Other Pertinent Items for the Operation of Equipment including and 24/7 Technical Support for the IHS Quentin N. Burdick Memorial Healthcare Facility, Belcourt, ND.

2.0 SCOPE

See attached Specifications and Statement of Work for a brand name only, Beckman Coulter DxM 1040 MicroScan WalkAway Instrument (Part Number B1018-340) Analyzer. This will be a Cost Per Test Agreement. This agreement covers Equipment, Service, Reagents, Calibrators, Controls, Supplies, Consumable/Disposable items, Parts, Accessories, Warranty, Other Pertinent Items for the Operation of Equipment including and 24/7 Technical Support. See attached Statement of Work/Specifications on requirements.

3.0 CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS

See attached Statement of Work/Specifications on requirements.

4.0 TYPE OF ORDER

This is a firm fixed-price, commercial item, purchase order medical equipment and supplies. The unit price is an all-inclusive cost. All "inclusive cost" is defined to include travel, lodging, per diem, fringe benefits, i.e., life insurance, social security, federal, state, and local taxes, plus all other costs pertinent to the performance of this purchase.

5.0 ANTICIPATED PERIOD OF PERFORMANCE

Period of Performance: Award of contract with four (4), one (1) year option periods.

6.0 PLACE OF PERFORMANCE

Turtle Mountain Service Unit Quentin N. Burdick Memorial Health Care Facility Moonlight Drive Highway 5, Belcourt, North Dakota 58316 Phone (701) 477-6111

7.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

Delivery shall be made 30 days after award is distributed.

8.0 PAYMENT

INVOICE SUBMISSION AND PAYMENT

Invoice Processing Platform (IPP)

The Indian Health Service (IHS) is in the process of implementing an electronic invoicing system.

In compliance with the Office of Management and Budget (OMB) M-15-19 memorandum, Improving Government Efficiency and Saving Taxpayer Dollars Through Electronic Invoicing, directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors. Invoices submitted under any award resulting from this solicitation will be required to utilize the Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests.

https://obamawhitehouse.archives.gov/sites/default/files/omb/memoranda/2015/m-15-19.pdf

IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury’s Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register- however, we encourage you make sure your organization and designated IPP user accounts are valid and up to date.

The IPP website address is: https://www.ipp.gov

If you require assistance registering or IPP account access, please contact the IPP Helpdesk at (866) 973-3131 (M-F 8AM to 6PM ET), or IPPCustomerSupport@fiscal.treasury.gov

Should the contractor feel that use of the IPP would be unduly burdensome, their response to this solicitation should include an explanation of this position for a determination by the contracting officer.

Additional Information:

A. Anticipated Period of Performance:

Period of Performance shall be applicable, but a delivery timeframe will be issued.

B. Capability Statement/Information:

B1. The Contractor must provide only new equipment and new parts for the required products described herein; no used, refurbished, or remanufactured equipment or parts shall be provided under any circumstances. Absolutely no Gray Market Goods or Counterfeit Electronic Parts shall be provided. Gray Market Goods are defined as genuine branded goods intentionally or unintentionally sold outside of an authorized sales-territory or by non-authorized dealers in an authorized territory. All equipment shall be accompanied by the Original Equipment Manufacturers (OEMs) warranty. Counterfeit Electronic Parts are defined as unlawful or unauthorized reproduction, substitution, or alteration that has been knowingly mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified electronic part from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitution includes used electronic parts represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

B2. Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm’s own risk. The following information shall be included in the capability statement:

1. Company Name and Company SAM Unique Entity identifier (UEI) number.

2. System for Award Management (SAM) registration status. All respondents must register on the SAM located at http://www.sam.gov .

3. Name, Telephone number and E-mail address of a company point of contact who has the authority and knowledge to clarify responses with government representatives.

https://www.ipp.gov/ mailto:IPPCustomerSupport@fiscal.treasury.gov http://www.sam.gov/

4. Date Submitted

5. Applicable company GSA Schedule number or other available procurement vehicle.

6. Business Size Standard of Company (i.e. small business, 8(a), Woman owned, veteran owned, etc.).

7. Capability Statement: Detailed capability statement addressing the company’s qualifications and ability to provide the requirements listed herein, with appropriate and specific documentation supporting claims of recent organizational and staff capability to support this requirement. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.

8. Geographic Coverage: Please identify the areas of the United States where your organization provides this supplies/equipment.

9. References: Provide a list of all private industry or government contracts for similar items that you have delivered within the last 3 years. Please include the customers’ contact names, addresses, telephone number, dollar value of contract, and brief description of the supplies provided on the contract.

10. Specifications: Provide evidence that you can meet the attached Specifications.

11. Delivery/Logistics: Provide evidence that the item is readily available and can meet the Delivery timeframe.

12. Warranty: Provide evidence that the item has warranty options.

13. If American Indian/Native American owned small business, then complete attached IEE Representation Form.

C Closing Statement

C1. Point of Contact: Ursula Maslonka, Contract Specialist, at Ursula.Maslonka@ihs.gov

C2. Submission Instructions:

Interested parties shall submit capability via email to Ursula Maslonka, Contract Specialist, at Ursula.Maslonka@ihs.gov; the following information:

Sources Sought Number IHS1512977 in the Subject line. The due date for receipt of statements is July 28, 2025, 9:00 am Central Time.

All responses must be received by the specified due date and time in order to be considered.

This notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of IHS.

IHS does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this notice, IHS may issue a Request for Quote (RFQ).

THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against IHS shall arise as a result of a response to this notice or IHS’s use mailto:Ursula.Maslonka@ihs.gov mailto:Ursula.Maslonka@ihs.gov of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.

Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in SAM.gov.

However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response.

STATEMENT OF WORK

Automated Microbiology ID/AST

Great Plains Area Indian Health Service

PROJECT SCOPE: The Great Plains Area Indian Health Service (GPA IHS) requires the Cost Per Test (CPT) Sole Source

BPA purchase of the Beckman Coulter Walk Away Microscan 1040 (Part Number B1018-340) as listed in the FSS contract V797D-70260. This analyzer must be able to identify bacteria, do antibiotic susceptibility testing (AST), minimum inhibitory concentrations (MIC), run epidemiology reports, print patient reports, and transmit patient reports through our current Data Innovations Instrument Manager software to the laboratory information system. The contracted analyzer must allow for manual reading, must allow for “Combo” Panels (allowing bacterial identifications and susceptibilities to be performed at the same time), and must provide a “true” MIC as opposed to the estimated MIC amongst other requirements. The analyzer is needed at the Quentin N. Burdick Memorial Healthcare Facility (QNB), Belcourt, ND. The contracted price will be an inclusive price that will include WA-40 Plus System with computer, LabPro software, report printer, bar code printer, UPS, (1) RENOK, (1) turbidity meter, (1) Year Warranty.

a. The minimum guarantee in the amount of $1,000.00 is to be awarded as the first BPA Call concurrent with contract award. Upon issuance of a BPA Call, the minimum guarantee of $1,000 will be de-obligated and cannot be invoiced as the minimum guarantee was met with award of a BPA Call. In the event a BPA Call is not awarded on this contract, the contractor is entitled to invoice for the minimum guarantee of $1,000.

b. ORDERS: All products ordered under this BPA are issued by BPA Calls placed by the individual service unit. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA Calls issued by authorized individuals.

i. Minimum ordering volumes requirements will be negotiated at the ordering facility level. This includes (based on current and forecasted use) re-estimating the minimum and maximum volume requirement for the instrument maintained by the ordering facility. Any and all adjustments to the volume and associated costs shall be negotiated at the ordering facility.

ii. Specifications: Brand Name supplies only

Part # Consumable Description Pack Per Year DxM 1040 MicroScan WalkAway S/N 4401007 Installed

B1017-219 PNL POS COMBO 45 37

B1017-423 PNL Neg Urine Combo 73 50

C48640 PNL NEG URINE COMBO 90 1

B1013-40 INOCULATORS-D USA 240/PK 8

B1026-10D PROMPT INOCULATION SYSTEM-D (60) 30

B1010-41A RGNT KOVAC'S 30ML 1

B1010-42A RGNT ALPHA NAPTHOL US 1.5GM 1

B1010-43A POTASSIUM HYDROXIDE 40% 30ML 1

B1010-44A RGNT SULFANILIC ACID 30ML 0.8% 1

B1010-45A DIMETHYLALPHANA PHTHYLAM 0.5%NN 1

B1010-48A RGNT FERRIC CHLORIDE 10% 30ML 1

B1018-18 TRAY LID – W/A (240/PK) 1

B1018-198 WALKAWAY WASTE CONTAINER (4) 1

B1012-30B RGNT PEPTIDASE REAGENT 30 ML 1

c. PRICES AND TERMS: GPA IHS will provide an estimated volume by test as reflected in Attachment A.

Pricing is based on the AVERAGE daily test volume. The Government estimates the volumes as listed in

Attachment A, but does not guarantee volumes as listed; they are estimates ONLY. For volume growth, estimate 20% increase per year over the length of the contract.

d. TERM OF AGREEMENT: This will be a Sole Source award, CPT BPA with one base year and four, one-year options and shall be effective for the term of the contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the

CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO.

This BPA shall be reviewed annually. GPA IHS intends to establish the base year of the agreement for the period of 1/1/2026 through 12/31/2030.

e. IDENTIFICATION: BPA Calls issued shall be identified by their applicable BPA Contract

Number.

f. ORDERING METHOD: The participating facilities may order products via Electronic Data

Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

a. SCOPE OF PROCUREMENT:

i. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work.

ii. Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory.

iii. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity, and tested to assure precision and accuracy. The expiration date must be clearly marked on reagent, standards, and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment, as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award.

iv. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal

Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

b. Test Menu: Refer to Attachment A for desired test Panel and estimated annual volumes by laboratory.

3. GENERAL REQUIREMENTS:

a. Analyzer – A Beckman Coulter DxM 1040 MicroScan WalkAway Instrument will be installed at the

Quintin Quentin N. Burdick Memorial Healthcare Facility, Belcourt, ND.

b. Operational and Technical Features‐ The instrumentation offered shall be approved by the Food and Drug Administration (FDA) and Contractor’s FSS Contract at the time of proposal submission and have the following:

i. Sufficient capacity and throughput to meet the volume and service demands as defined in

Attachment A.

ii. Must have onboard reagent storage

iii. Must have LabPro alert system

iv. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

v. The system must contain computer interface compatible with the current IHS laboratory information system (RPMS) and existing universal interface (Data Innovations). The fully operational interface (both hardware and software) shall be immediately available for implementation to the IHS computerized hospital information system.

vi. Must have onboard oil storage

vii. Must have onboard waste storage

viii. Must have onboard water storage

ix. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric concurrently.

x. Service:

1. On-site service shall be provided Monday – Friday 8 am – 5 pm with phone hotline service provided 24/7.

2. The vendor shall provide a list of authorized field service persons who may/will service the device on site that includes their first, middle initial, last name and title.

3. The vendor shall provide a statement of competency and/or a model specific certificate of training for each field service person who may/will service the device.

4. The vendor shall provide a detailed preventive maintenance/scheduled service checklist when performing scheduled PM services.

5. The vendor is responsible for performing timely patching and software updates for

LabPro Computer system when needed and provide a service report at completion.

6. The vendor will replace the LabPro computer if the operating system becomes unsupported.

7. The vendor will not remove any part of the system without prior clearance from the

QNB Clinical Engineering Department due to ePHI concerns.

8. The vendor will provide the QNB Clinical Engineering Department a report upon completion of preventive maintenance, scheduled serviced, and repairs.

b. Method Performance/Validation Requirements

1. Method performance/comparison shall be at the expense of the Contractor and be consistent with current CLSI guidelines and related documents, The Joint Commission (TJC) standards, and all Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory.

c. Support Features‐

i. Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

ii. Start‐Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this BPA contract. The Contractor shall perform/assist, to the satisfaction of the Government, all verification studies. The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and provide electronic and hard‐copy data in an organized, clearly comprehensible format.

iii. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal

Supply Schedule FSC Group 66, Part III, Cost‐Per‐Test/Cost Per Reportable Result Clinical

Laboratory Analyzers contract. Advanced off-site training for Two (2) employees per instrument to include airfare, and room & board.

1. In addition, basic operator training shall be provided by Contractor on‐site for all operators on all shifts, as applicable.

iv. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all instrumentation, and any incremental support/ancillary equipment, e.g., water system, offered according to the following terms:

1. Service Requirements

1. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour.

2. Equipment repair service shall be provided 24/7 for medical center-based laboratories.

3. Service technicians must be certified by Beckman Coulter to perform repairs and maintenance on the instrument.

4. Certifications must be presented by the vendor showing that service technicians are qualified and certified by Beckman Coulter to repair and maintain the instrument.

2. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and IHS laboratory personnel. Equipment repair response time shall be no more than 8 hours.

1. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

2. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

i. date and time notified

ii. date and time of arrival

iii. serial number, type and model number of equipment

iv. time spent for repair

3. Each notification for an emergency repair service call shall be treated as a separate and new service call.

v. Upgrades ‐ The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state‐of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability.

vi. Ancillary support equipment ‐ The Contractor shall provide, install and maintain through the life of the BPA , as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g., UPSs with line conditioner, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, preventative maintenance and repair, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc.

vii. Interface Requirements

1. TCP/IP is the preferred connection with Data Innovations middleware. If a serial connection is required the contractor is responsible for purchasing Lantronix boxes and appropriate cable from Data Innovations.

2. The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. The contractor will assist in the set-up of the interface to the Data Innovations middleware.

3. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the Data Innovations middleware.

viii. Commercial offerings ‐ The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g., Computer disc containing their procedure manual in CLSI format or an on‐line procedure manual in the instrument software.

ix. Implementation/transition timeframe ‐ The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the BPA contract. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

1. Upon award of an BPA, the transition period for the awarded contract to have all equipment and peripherals installed and operational shall be from date of award through

90 days. During this same period all initial training of IHS personnel in the operation and maintenance of said award shall also be completed.

2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA.

1. At the end of 90 days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA.

x. Standard and Quality of Performance‐ This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the BPA is accepted by the

Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any BPA at an effectiveness level of 90% or more.

1. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day‐by‐day basis until the standard of performance is met for a total of 30 consecutive days.

2. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212‐4 entitled “Termination for cause.”

(The Contractor shall receive revenue for tests reported during the 90‐day acceptance period.)

3. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure.

Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

4. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

5. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

6. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. The same terms and conditions apply to ancillary/support equipment provided under this BPA, i.e., water system UPS, etc.

xi. Government’s Responsibility‐ The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

xii. Ownership of Equipment‐ Title to the equipment shall remain with the Contractor. All accessories

(unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer

(gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

xiii. The Contractor will identify if removable media is required to perform their duties. The Clinical

Engineering Department will ensure the removable media is scanned with anti‐virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

xiv. Prior to the termination of this BPA, the Contractor/subcontractor shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/IHS policies and shall not dispose of any records unless authorized by HHS/IHS.

xv. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation to the

CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

xvi. Bio‐Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with IHS sensitive information must not be returned to the Contractor at the end of lease, for trade‐in, or other purposes. The options are:

1. Contractor must accept the system without the drive;

2. IHS’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn‐in; or

3. IHS must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

xvii. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the IHS to retain the hard drive, then;

1. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

2. Any fixed hard drive on the device must be non‐destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using IHS approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre‐ approved and described in the purchase order or BPA.

3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed.

The Information Security Officer (ISO) needs to maintain the documentation.

2. Salient Characteristics:

a. Fully automated walkaway design

b. Able to utilize “Combo” panels (allowing bacterial identifications and susceptibilities to be performed at the same time.

c. Able to perform rapid panels.

d. Provide a true Minimum Inhibitory Concentration (MIC) not extrapolated MIC.

e. Perform MIC testing on fastidious organisms

f. Able to perform manual reading (when needed)

g. Flag unusual results

h. Capable of producing antibiograms.

i. Able to produce epidemiology reports.

j. Support multiple barcode formats (Code 39, Code 128)

k. Incubation temperature stability: ±1°C

l. Reagent type capacity: 10 reagents total

m. Reagent dispense volume (μl): 15 to 90, depending on reagent dispensed

n. Pipettes all reagents and oil; oil dispenses at a volume (μl): 60 to 150

ATTACHMENT A: Test Volume

Quentin N. Burdick Memorial Healthcare Facility, Belcourt, ND Panel Volume B1017-423 Neg Urine Combo 73 1100 tests (55 boxes) B1017-219 Pos Combo 45 600 tests (30 boxes)

ATTACHMENT B: Core Business Hours Quentin N. Burdick Memorial Healthcare Facility

Laboratory

Facility Hours of Operation Turtle Mountain Service Unit Quentin N. Burdick Memorial Health Care Facility Moonlight Drive Highway 5, Belcourt, North Dakota 58316 Phone (701) 477-6111

24/7

Delivery Hours: M – F 8:00 am – 4:30 pm

DEPARTMENT OF HEALTH & HUMAN SERVICES

Indian Health Service

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

DUNS Number

Justification for Other than Full and Open Competition

Brand Name Justification

Program Office/Service Unit: Automated Microbiology ID/AST Requisition: IHS1512977

1. Nature and/or Description of action being approved:

The purpose of this contract is to provide the Quentin N. Burdick Memorial Healthcare Facility at Belcourt, ND with a reagent and service agreement in support of their current Beckman Coulter DxM 1040 Walkaway Microscan.

2. Description of Product, Supplies or Services required to meet the agency’s need :

Beckman Coulter DxM 1040 Walkaway Microscan reagents, controls, consumables, and service and support

3. Estimated Value of Procurement (to include options): $167,656.00

4. Recommended Source:

a. Contractor Name: Beckman Coulter

b. UEI Number: PU6HHX2R11C7

c. Address: 250 S. Kraemer Blvd, Brea, CA 92821

d. POC: Sherry Hope; shope@beckman.com; 800-526-3821

5. Reason for Sole Source/Limited Sources/Expedited Processing: Check one

☐ Brand Name essential to the Government’s needs. FAR 11.104 (b) Brand name or equal purchase descriptions must include, in addition to the brand name, a general description of those salient physical, functional, or performance characteristics of the brand name item that an "equal" item must meet to be acceptable for award. Use brand name or equal descriptions when the salient characteristics are firm requirements.

☒ Items peculiar to one manufacture. FAR 11.105 (a) The particular brand name, product, or feature is essential to the Government’s requirements, and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency’s needs

6. Justification Narrative:

The contracted analyzer must allow for manual reading, must allow for “Combo” Panels (allowing bacterial identifications and susceptibilities to be performed at the same time), and must provide a “true” MIC as opposed to the estimated MIC amongst other requirements.

7. Impact to the Government if not awarded in accordance with above:

Not awarding the contract would limit QNB laboratory. Having microbiology capabilities in-house allows the facility to receive identification and antibiotic sensitivities of microorganisms faster than sending the specimens out for identification and antibiotic sensitivity. The ability to read the culture plates manually allows the laboratory staff to continue generating ID and sensitivities should the network malfunction.

8. Synopses of proposed contract action (SAM.gov): Yes ☒ No ☐ In the case of a brand name justification under 6.302-1(c), the justification shall be posted with the solicitation (see 5.102(a)(6)). Yes ☒ No ☐ mailto:shope@beckman.com https://www.acquisition.gov/far/part-6#FAR_6_302_1 https://www.acquisition.gov/far/part-5#FAR_5_102

9. A determination the anticipated cost to the Government will be fair and reasonable: Yes, the reagent prices are all listed on the Federal Supply Schedule.

Program/Project Manager:

7/14/2025

X Donald Johnston Donald Johnston GPA Deputy Laboratory Consultant Signed by: Donald C. Johnston -S

Acquisition: Prepared by

Name, Contract Specialist/Purchasing Agent Date

Contracting Officer Certification: This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Name, Contracting Officer Date

Competition Advocate Approval: Competition Advocate Approval: over $750,000 but not exceeding $15 million This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete. IAW FAR 13.501(a) (2)(ii)

Name, Competition Advocate Date

*See Attached Applicable FAR References 11.104, 11.105, 6.302-1, 6.303-1 & 6.303-2

*6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

(a) Authority.

(1) Citations: 10 U.S.C. 2304(c) (1) or 41 U.S.C. 253(c) (1).

(2) When the supplies or services required by the agency are available from only one responsible source, or, for DOD, NASA, and the Coast Guard, from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

(i) Supplies or services may be considered to be available from only one source if the source has submitted an unsolicited research proposal that-

(A) Demonstrates a unique and innovative concept (see definition at 2.101), or, demonstrates a unique capability of the source to provide the particular research services proposed;

(B) Offers a concept or services not otherwise available to the Government; and

(C) Does not resemble the substance of a pending competitive acquisition. (See 10 U.S.C.

2304(d)(1)(A) and 41 U.S.C. 253(d)(1)(A).)

(ii) Supplies may be deemed to be available only from the original source in the case of a follow-on contract for the continued development or production of a major system or highly specialized equipment, including major components thereof, when it is likely that award to any other source would result in-

(A) Substantial duplication of cost to the Government that is not expected to be recovered through competition; or

(B) Unacceptable delays in fulfilling the agency's requirements. (See 10 U.S.C.

2304(d)(1)(B) or 41 U.S.C. 253 (d)(1)(B).)

(iii) For DOD, NASA, and the Coast Guard, services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in-

(A) Substantial duplication of cost to the Government that is not expected to be recovered through competition; or

(B) Unacceptable delays in fulfilling the agency's requirements. (See 10 U.S.C. 2304(d)(1)(B).)

(b) Application. This authority shall be used, if appropriate, in preference to the authority in 6.302-7; it shall not be used when any of the other circumstances is applicable. Use of this authority may be appropriate in situations such as the following (these examples are not intended to be all inclusive and do not constitute authority in and of themselves):

(1) When there is a reasonable basis to conclude that the agency's minimum needs can only be satisfied by-

(i) Unique supplies or services available from only one source or only one supplier with unique capabilities; or

(ii) For DOD, NASA, and the Coast Guard, unique supplies or services available from only one or a limited number of sources or from only one or a limited number of suppliers with unique capabilities.

(2) The existence of limited rights in data, patent rights, copyrights, or secret processes; the control of basic raw material; or similar circumstances, make the supplies and services available from only one source (however, the mere existence of such rights or circumstances does not in and of itself justify the use of these authorities) (see Part 27).

(3) When acquiring utility services (see 41.101), circumstances may dictate that only one supplier can furnish the service (see 41.202); or when the contemplated contract is for construction of a part of a utility system and the utility company itself is the only source available to work on the system.

(4) When the agency head has determined in accordance with the agency's standardization program that only specified makes and models of technical equipment and parts will satisfy the agency's needs for additional units or replacement items, and only one source is available.

(c) Application for brand name descriptions. An acquisition that uses a brand name description or other purchase description to specify a particular brand name, product, or feature of a product, peculiar to one manufacturer does not provide for full and open competition regardless of the number of sources solicited. It shall be justified and approved in accordance with FAR 6.303 and 6.304. The justification should indicate that the use of such descriptions in the acquisition is essential to the Government's requirements, thereby precluding consideration of a product manufactured by another company. (Brand-name or equal descriptions, and other purchase descriptions that permit prospective contractors to offer products other than those specifically referenced by brand name, provide for full and open competition and do not require justifications and approvals to support their use.)

(d) Limitations.

(1) Contracts awarded using this authority shall be supported by the written justifications and approvals described in 6.303 and 6.304.

(2) For contracts awarded using this authority, the notices required by 5.201 shall have been published and any bids and proposals must have been considered.