Source Sought IHS1512223 Ortho Vision Swift Blood Bank Analyzers SAM Announcement.pdf

Sources Sought: Brand Name Only OrthoVision Swift Automated Blook Bank Analyzer & Ortho Workstation IDS-MATS Gel Cards with Equipment Reagents, Controls, Consumables, Service and Support

Sources Sought Notice Number: IHS1512223

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 334516 - Analytical Laboratory Instrument Manufacturing or 325413 – In-Vitro Diagnostic Substance Manufacturing, or - 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, OrthoVision Swift Automated Blook Bank Analyzer & Ortho Workstation IDS-MATS Gel Cards with Equipment Reagents, Controls, Consumables, Service and Support for the IHS Great Plains Area, Office of Health and Promotions Department, Aberdeen, SD.

The Great Plains Area Indian Health Service is seeking a sole-source Contract for a Cost Per Test (CPT) Firm Fixed Price (FFP) Blanket Purchase Agreement (BPA). This agreement will serve the Rosebud Comprehensive IHS Service Unit in Rosebud, SD, Pine Ridge IHS Hospital in Pine Ridge, SD, and Quinten N. Burdick Memorial Healthcare Facility, Belcourt, ND. Under the CPT agreement, pricing will encompass equipment, service, reagents, and consumables for Ortho Vision Swift and Ortho Workstation IDS-MTS Gel Cards.

1.1 OBJECTIVE

The primary objective of this project is to secure the purchase and delivery of a new, brand name only, OrthoVision Swift Automated Blook Bank Analyzer & Ortho Workstation IDS-MATS Gel Cards with Equipment Reagents, Controls, Consumables, Service and Support for the all IHS hospitals and healthcare clinics located in South Dakota and North Dakota; to accommodate the IHS Great Plains Area, Office of Health and Promotions Department.

Using standardized equipment reduces the time required for training, allows contractors to integrate more effectively into laboratory teams, and enhances laboratory quality due to increased familiarity with the equipment. Additionally, standardization enables the area to benefit from volume discount pricing, which helps lower operating costs, especially during periods of budget scrutiny. Smaller hospitals benefit as well, as they can take advantage of the higher testing volumes of larger hospitals rather than facing higher prices for conducting tests at lower volumes. By performing tests on the same model, healthcare providers can compare patient results from another GPA IHS hospital and know that the results are equivalent.

2.0 SCOPE

See attached Specifications and Statement of Work for a brand name only, OrthoVision Swift Automated Blook Bank Analyzer & Ortho Workstation IDS-MATS Gel Cards with Equipment Reagents, Controls, Consumables, Service and 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

Pine Ridge Hospital P.O. Box 1201, East Highway 18, Pine Ridge, South Dakota 57770 Phone 605-867-5131

Rosebud Comprehensive Health Care Hospital P.O. Box 400, 400 Soldier Creek Dr. Rosebud, South Dakota 57570 Phone: 605-747-2231

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.

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 https://obamawhitehouse.archives.gov/sites/default/files/omb/memoranda/2015/m-15-19.pdf https://www.ipp.gov/ mailto:IPPCustomerSupport@fiscal.treasury.gov 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.

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.

http://www.sam.gov/

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 IHS1512223 in the Subject line. The due date for receipt of statements is July 29, 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 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.

mailto:Ursula.Maslonka@ihs.gov mailto:Ursula.Maslonka@ihs.gov

STATEMENT OF WORK (SOW)

Sole Source Request for Ortho Vision Swift Blood Bank Analyzer

A. PROJECT SCOPE: The Great Plains Area Indian Health Service is seeking a sole-source Contract for a Cost Per Test (CPT) Firm Fixed Price (FFP) Blanket Purchase Agreement (BPA). This agreement will serve the Rosebud Comprehensive IHS Service Unit in Rosebud, SD, Pine Ridge IHS Hospital in Pine Ridge, SD, and Quinten N. Burdick Memorial Healthcare Facility, Belcourt, ND. Under the CPT agreement, pricing will encompass equipment, service, reagents, and consumables for Ortho Vision Swift and Ortho Workstation IDS-MTS Gel Cards.

B. 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.

C. ORDERS: All products ordered under this BPA are issued by BPA Call 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.

D. BACKGROUND: Pine Ridge IHS and Rosebud IHS installed the Ortho Vision Swift and Ortho Workstation for IDS-MTS Gel Cards in 2024. These were added to contract 75H70621A00009 Mod 7, which will expire on 31 December 2025. The contract modification included the ORTHO VISION Analyzer Gel (Product Code 6904577), the OWS with ID Tipmaster Pipettor (6904630T), a Repair by Replacement OWS (6802661), and the APrem MF 8-5 Vision (6802830), WPrem MF 8-5 Vision (6802836), along with necessary accessories. The service units will keep their current instrumentation since it would eliminate a new installation, verification, and allow them to maintain their processes.

Belcourt ND is using the Ortho Workstation for IDS-MTS Gel Cards. It is Belcourt IHS’s intention to upgrade to the ORTHO VISION Analyzer Gel (Product Code 6904577), the OWS with ID Tipmaster Pipettor (6904630T), a Repair by Replacement OWS (6802661), and the APrem MF 8-5 Vision (6802830), WPrem MF 8-5 Vision (6802836), along with necessary accessories.

E. CONTRACTOR RESPONSIBILITES:

1. The Vendor will be responsible for the following:

a. The analyzers will be LIS (Laboratory Information System) interface able which means that the system used will have the ability to talk to our system and download results into the patient medical record. The vendor will supply LIS specifications and assist with the interface connections.

b. The analyzers will have the capability to program rules and/or rule packages that alert the operator to abnormal, critical or reflex testing parameters allowing automated repeats based on predefined criteria.

c. The Quality Control Software on the analyzers and ancillary computers are windows based or equivalent and offers presentation of data to the operator.

d. The analyzers will have minimal maintenance required.

e. The vendor will be responsible for delivery, installation/setup, and training at the customer’s facility for the instrument or any new testing or procedures. Additionally, the vendor will provide field service support throughout the base period and for four one-year option periods.

SUBJECT: Scope of work – Sole Source Request for Ortho Vision Swift Blood Bank Analyzer

f. The vendor will also supply the customer with all necessary supplies, reagents, and training for conducting predetermined testing based on patient results at each site per month.

F. EQUIPMENT:

The Rosebud and Pine Ridge IHS facilities will retain their Ortho Vision Swift instrumentation which was added to contract 75H70621A00009 Mod 7 when we exercised option year three. A new Ortho Vision Swift automated system will be installed at Belcourt, ND IHS facility.

G. REAGENTS, CONTROLS AND SUPPLIES :

1. The vendor will provide reagents, controls, and Disposables (supplies) for Immunohematology.

2. The vendor will provide a separate table that lists all supplies (reagents, controls, and disposables), including all charges and shipping dates for the quarterly shipping of standing orders.

3. Reagents for the analyzer are marked for easy recognition by the operator.

4. The vendor will supply a list of reagents, controls, and disposables that will be shipped as part of the agreement.

5. Supplies will be shipped on a standing order schedule, as agreed upon by the customer and vendor. The customer may request all or part of a future quarterly standing order up to 10 days ahead of the scheduled ship date of the standing order.

6. Other special orders are subject to shipping charges.

7. The vendor will provide sufficient reagents and supplies for the performance of patient results for the individual sites. Consumables will be provided on demand as needed if the consumable allotments are insufficient to meet the needs of the facility.

8. The customer may purchase additional supplies according to the agreed price schedule. Customers may order additional supplies as required at the prices listed in a table.

9. The vendor will supply all changes in maintenance schedules that affect reagent or cleaning reagent volumes in accordance with the manufacturer's recommendations.

10. Disposables, printer paper, printer cartridges, and service items, such as pick-up tubes, were excluded.

11. Excluded are control materials and calibrators not provided/ manufactured by the vendor.

H. SERVICES:

1. The contractor shall provide telephone number(s) and contact person to be used by the IHS for technical issues.

a. Warranty and Post Warranty Service of all instrumentation.

b. Vendor will provide Field Service Support for the term of the agreement

c. Vendor provides service 24 hours/7 days via toll free hot line.

d. Vendor supplies all replacement parts (excluding accessories and disposables) after warranty 1 year period.

e. Vendor will supply service agreements which will be identified at the task order, these service agreements are available for life of agreement, Ortho Vision Basic Monday- Friday.

f. Preventive maintenance will be scheduled according to manufacturer's recommendations for each instrument no less than every 6 months. All repairs will be invoiced to the customer on the agreed to price list.

g. Parts and supplies shall be available from 7 years after the discontinuance of the manufacturer of the instrument.

h. Includes Software upgrades and all accessories including printers.

i. Service technicians must be certified by Ortho to perform repairs and maintenance on the analyzer.

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

I. UPTIME GUARANTEE/PERFORMANCE PENALTY:

1. Vendor agrees that all equipment provided shall be operable no less than 98% of operational time. Each instrument at each site shall be computed separately.

a. Operational time is 24 hrs. a day 7 days a week.

b. Downtime is defined as when a customer is not able to produce clinically acceptable results on the system monitor and will be computed from the time the customer notified the hotline during normal working hours until the Field Service Engineer returns the instrument to the customer and the customer can produce acceptable clinical results. Scheduled maintenance is excluded from downtime.

c. Vendor will provide a Downtime Summary report of instrumentation prior to the contract.

J. OTHER SERVICES:

1. Once the instrument has been installed according to the Vendor specifications at the customer location the vendor will supply a technical representative to assist with method validation studies.

2. Method validations will be completed and the necessary studies required for Clinical Laboratory Information Act (CLIA) and The Joint Commission (TJC) regulatory agencies. Validation studies will be presented in binders and include the necessary Laboratory staff approval and dates. The IHS will not accept equipment until it passes initial validation testing.

3. The IHS will provide all the samples necessary for the validation studies.

K. TRAINING:

1. The Contractor shall provide, at no cost to the government, two (2) technical operator training slots for each instrument per facility within the first year with one provider prior to instrument installation. The training will include all travel (to and from training center), hotel, per-diem, tuition and books.

2. Contractor will provide one (1) additional off-site training each consecutive year after initial training per instrument to include tuition, training materials, airfare, lodging, meals, and transportation to and from the training facility. Additional on-site training shall be provided as needed, at no additional cost, as needed by the Government.

3. The contractor will have an on-going training program for IHS employees by the technical service representatives on any new products or updates. All materials for training will be provided at no additional cost to the Government.

4. The vendor will provide competency assessments protocols for use at each site consistent with Federal (CLIA) and accreditation training requirements.

L. VALUE ADDED ITEMS:

1. Uninterruptible power Supplies (UPS).

2. Operating Manual for analyzer at the time of installation.

3. Printer and maintenance for printer; (printer shall be replaced if inoperable).

M. Standing Orders: Standing orders will meet the needs of the service unit. A proposed Standing order is listed in Attachment B based on the current testing needs of the individual service units.

Attachment A: Test Volume

Test Volume Rosebud Pine Ridge Belcourt, ND

ABO/Rh 479 638 204 Antibody Screen 448 469 180

Crossmatch 314 695 117 DAT IgG 2 3 2

Attachment B – Proposed Standing Order

Pine Ridge:

MATERIAL DESCRIPTION Total

6902316 0.8% SURG 3X10ML

GTIN-10758750007660 7 7 7 7 7 7 7 7 7 7 7 7 7 91

MTS9230 MTS ROUND DIL2 100ML/5BTLS

GTIN-10758750006038

1 1 1 1 1 1 6

MTS9330 MTS ROUND DIL2+ 100ML/ 5BTLS

GTIN-10758750006045 1 1 1 1 1 1 1 1 1 1 1 1 1 13

6844285 ORTHO 7% BSA

GTIN-10758750030743

5 5 5 5 5 5 30

MTS080515 MTS A/B/D MONO & REV GRP 5x20

GTIN-10758750005932 1 2 1 2 1 2 1 2 1 2 1 2 1 19

MTS081115 MTS A/B/D/A/B/D MONO GRP 5x20

GTIN-10758750005963

1 2 1 2 1 2 9

MTS084024 MTS ANTI-IGG CARD 5X20

GTIN-10758750005994

1 1 3 1 1 3 1 1 3 1 1 3 20

6843005 OV SingleUseEvaporationCaps250

GTIN-10758750030262

1 1 2

719201 0.8% AFFIRMAGEN 2X10ML

GTIN-10758750003877 7 7 7 7 7 7 7 7 7 7 7 7 7 91

6904591 OV Single Use Dilution Tray

GTIN-10758750030279

1 1 2

MTS9633 MTS PIPET TIPS RACKD 12X96

GTIN-10758750006083

1 1 1 1 4

6904553 Anti-D (Weak D) 1x5ml GEL

GTIN-10758750013067

1 1 1 1 4

6708858 ORTHO Daily WB QC Kit

GTIN-4065266566086 4 4 4 4 4 4 4 4 4 4 4 4 4 52

6902096 ORTHO CONFIDENCE SYSTEM

GTIN-10758750007554 1 1

Rosebud:

MATERIAL DESCRIPTION Total

6902316 0.8% SURG 3X10ML

GTIN-10758750007660 7 7 7 7 7 7 7 7 7 7 7 7 7 91

MTS9230 MTS ROUND DIL2 100ML/5BTLS

GTIN-10758750006038

1 1 1 1 1 1 6

MTS9330 MTS ROUND DIL2+ 100ML/ 5BTLS

GTIN-10758750006045 1 1 1 1 1 1 1 1 1 1 1 1 1 13

6844285 ORTHO 7% BSA

GTIN-10758750030743

5 5 5 5 5 5 30

MTS080515 MTS A/B/D MONO & REV GRP 5x20

GTIN-10758750005932 1 2 1 2 1 2 1 2 1 2 1 2 1 19

MTS081115 MTS A/B/D/A/B/D MONO GRP 5x20

GTIN-10758750005963

1 2 1 2 1 2 9

MTS084024 MTS ANTI-IGG CARD 5X20

GTIN-10758750005994

1 1 3 1 1 3 1 1 3 1 1 3 20

6843005 OV SingleUseEvaporationCaps250

GTIN-10758750030262

1 1 2

719201 0.8% AFFIRMAGEN 2X10ML

GTIN-10758750003877 7 7 7 7 7 7 7 7 7 7 7 7 7 91

6904591 OV Single Use Dilution Tray

GTIN-10758750030279

1 1 2

MTS9633 MTS PIPET TIPS RACKD 12X96

GTIN-10758750006083

1 1 1 1 4

6904553 Anti-D (Weak D) 1x5ml GEL

GTIN-10758750013067

1 1 1 1 4

6708858 ORTHO Daily WB QC Kit

GTIN-4065266566086 4 4 4 4 4 4 4 4 4 4 4 4 4 52

Belcourt, ND (Quentin N. Burdick Memorial Healthcare Facility)

MATERIAL DESCRIPTION Total

6902316 0.8% SURG 3X10ML

GTIN-10758750007660 7 7 7 7 7 7 7 7 7 7 7 7 7 91

MTS9230 MTS ROUND DIL2 100ML/5BTLS

GTIN-10758750006038

1 1 1 1 1 1 6

MTS9330 MTS ROUND DIL2+ 100ML/ 5BTLS

GTIN-10758750006045 1 1 1 1 1 1 1 1 1 1 1 1 1 13

6844285 ORTHO 7% BSA

GTIN-10758750030743

5 5 5 5 5 5 30

MTS080515 MTS A/B/D MONO & REV GRP 5x20

GTIN-10758750005932 1 2 1 2 1 2 1 2 1 2 1 2 1 19

MTS081115 MTS A/B/D/A/B/D MONO GRP 5x20

GTIN-10758750005963

1 2 1 2 1 2 9

MTS084024 MTS ANTI-IGG CARD 5X20

GTIN-10758750005994

1 1 3 1 1 3 1 1 3 1 1 3 20

6843005 OV SingleUseEvaporationCaps250

GTIN-10758750030262

1 1 2

719201 0.8% AFFIRMAGEN 2X10ML

GTIN-10758750003877 7 7 7 7 7 7 7 7 7 7 7 7 7 91

6904591 OV Single Use Dilution Tray

GTIN-10758750030279

1 1 2

MTS9633 MTS PIPET TIPS RACKD 12X96

GTIN-10758750006083

1 1 1 1 4

6904553 Anti-D (Weak D) 1x5ml GEL

GTIN-10758750013067

1 1 1 1 4

6708858 ORTHO Daily WB QC Kit

GTIN-4065266566086 4 4 4 4 4 4 4 4 4 4 4 4 4 52

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: Office of Health Programs Requisition: IHS1512223

1. Nature and/or Description of action being approved: Ortho Vision Swift Automated Blood Bank Analyzers.

The purpose of this contract is to provide Pine Ridge, Rosebud, and Belcourt IHS facilities with automated blood bank analyzers manufactured by Ortho Inc.

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

Quidel-Ortho Ortho Vision Swift Automated Blood Bank Analyzer instrument, reagents, controls, consumables, and service and support.

3. Estimated Value of Procurement (to include options): $1,004,925.35

4. Recommended Source:

a. Contractor Name: Quidel Ortho

b. UEI Number: JG5JF2JQJ121

c. Address: 1001 US Highway 202, Raritan, NJ 08869

d. POC: Sindy Woodhams, sincy.woodhams@quidelortho.com, 585-453-4265

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:

Pine Ridge, Rosebud IHS facilities installed their Ortho Vision Swifts in 2024. It would be wasteful to switch to a new vendor in such a short time. Switching to will cause undue burden on the laboratory having to complete new verification studies and potentially learn a new system. By staying with Ortho there will not be any disruption to established processes.

Belcourt IHS uses the Ortho manual gel workstation which uses the same technology as the Ortho Vision Swift. Belcourt IHS had a near sentinel event when a contractor mis-read a gel card. By moving to an automated system, it will eliminate such errors. Belcourt IHS has multiple contractors rotate through their facility yearly due to staffing shortages. It is also beneficial to mailto:sincy.woodhams@quidelortho.com remain with a technology that the staff is familiar and comfortable with. By placing an automated system at Belcourt it will standardize instrumentation throughout the GPA IHS footprint.

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

A burden would be placed on the facilities since they would have to complete new verification studies and change processes. Since two of the facilities have brand new instruments it would be wasteful changing them out in such a short time.

With all three GPA IHS facilities, that perform blood bank, having the same instrumentation reagent sharing is allowed. Training time is reduced for contractors rotating through the facilities and the automated platforms mitigate potential sources of error.

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 ☐

9. A determination the anticipated cost to the Government will be fair and reasonable: Yes, the pricing is comparable to the previous price quotes from the original contract.

Program/Project Manager:

6/4/2025

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

Donald Johnston/ GPA IHS Deputy Laboratory Consultant Date

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.

https://www.acquisition.gov/far/part-6#FAR_6_302_1 https://www.acquisition.gov/far/part-5#FAR_5_102

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.