Sol_75N98027Q00012.pdf

75N98027Q00012

1. REQUEST NO.

5a. ISSUED BY

NAME

a. NAME

c. STREET ADDRESS

d. CITY

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON

OR BEFORE CLOSE OF BUSINESS (Date)

2. DATE ISSUED 3. REQUISITION/PURCHASE REQUEST NO. 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG.1

RATING

6. DELIVERY BY (Date)

7. DELIVERY

9. DESTINATION

a. NAME OF CONSIGNEE

b. STREET ADDRESS

PAGE OF PAGES

5b. FOR INFORMATION CALL: (No collect calls)

TELEPHONE NUMBER

AREA CODE NUMBER

8. TO:

b. COMPANY

e. STATE f. ZIP CODE

c. CITY

d. STATE e. ZIP CODE

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5a. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

THIS RFQ

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

IS IS NOT A SMALL BUSINESS SET ASIDEX

10/14/2026

1 8

OD - Office of Logistics and Acquisition Operations 6100 Executive Blvd., Room 6B05

National Institutes of Health

Bethesda, MD 20892-7511

Multiple

+10 000-000000NICHOLAS CAPOBIANCO

10/22/2026 0900 ED

FOB DESTINATION

OTHER

(See Schedule)X

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

The purpose of this NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION is to provide NHLBI with Acquisition of orthopedic procedure for NHLBI protocol patient at medical center. The period of performance is October 22, 2026 - March 31, 2027.

The following FAR clauses and Provisions are applicable to this award.

FAR 52.204-13 System for Award Management Maintenance (Oct 2018);

FAR 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020);

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015).

FAR 52.212-4 Contract Terms and Conditions -In addition to all the applicable commercial Continued ...

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS (%) b. 20 CALENDAR DAYS (%) c. 30 CALENDAR DAYS (%) d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations

13. NAME AND ADDRESS OF QUOTER

b. STREET ADDRESS

c. COUNTY

d. CITY e. STATE f. ZIP CODE

14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

16. SIGNER

a. NAME (Type or print)

c. TITLE (Type or print)

a. NAME OF QUOTER

AREA CODE

NUMBER

15. DATE OF QUOTATION

b. TELEPHONE are are not attached

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition not usable

STANDARD FORM 18 (REV. 6-95)

Prescribed by GSA - FAR (48 CFR) 53.215-1(a)

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 8

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75N98027Q00012

Products and Commercial Services (Nov 2023)

FAR 52.217-8 Option to Extend Services (Nov 1999)

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE

To avoid delay in payment, all invoices must be uploaded into the invoicing processing platform

(IPP) (https://www.ipp.gov). The invoice must match the line item description on the purchase order. It must also state that payment is to be made using a three-way match.

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION

Title: Acquisition of orthopedic procedure for NHLBI protocol patient at medical center

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

(ii) The solicitation number is 75N98027Q00012. This solicitation is issued as a Notice of Intent (NOI) for a non-competitive combined synopsis/solicitation to award a contract or purchase order without providing for full and open competition (including brand-name, if applicable).

This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold. Additional authority includes 41 U.S.C. 1901 and FAR 6.302-3(a)(2)(ii).

The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, intends to negotiate and award a firm-fixed-price purchase order on a non-competitive basis to Suburban Hospital, Inc., 8600 Old Georgetown Road, Bethesda, MD 20814, for an orthopedic hip replacement procedure and associated care for an NHLBI clinical research protocol participant. The participant's orthopedic specialist, Dr. Timothy Bhattacharya, maintains continuity of care with the research participant and is credentialed to perform the required procedure only at facilities at which he holds clinical privileges; accordingly, NHLBI is limited to sourcing vendors at which Dr. Bhattacharya is credentialed.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01, effective 03/13/2026.

(iv) The associated NAICS code is 622110 (General Medical and Surgical Hospitals), and the small business size standard is $47 million. This requirement is not set aside for small business.

(v) Description of Requirement: A research participant in the NHLBI Division of Intramural Research (DIR), who has been enrolled on an NHLBI clinical research protocol for several years and previously underwent a stem cell transplant as part of this protocol, has developed severe orthopedic complications of the transplant, resulting in significant damage to the left hip that now necessitates replacement of the joint. The participant has been under the care of orthopedic surgeon Dr. Timothy Bhattacharya of OrthoBethesda, who consults with the NIH Clinical Center (CC) under an established agreement, for ongoing evaluation and management of this complication. As NIH CC physicians are unable to perform the required hip replacement procedure onsite, Dr. Bhattacharya, the primary orthopedic specialist for the case, has arranged for the surgery to be conducted at an outside outpatient surgical center where he holds privileges. The contractor is responsible for providing all necessary care and medications until the participant can be safely transferred back to the NIH CC for continued medical management, rehabilitation, and ongoing participation in the NHLBI clinical research protocol.

The contractor will be required to provide agreed-upon necessary medical supplies, including, but not limited to, the implantable surgical device for the joint replacement procedure, surgical instruments, operating room, and all associated facility supplies for medical and emergency management as required by federal and state law; follow all regulations associated with privacy and health information under HIPAA of 1996; comply with all federal and state regulations applicable to Ambulatory Surgical Centers (ASCs) and medical centers, including CMS "Conditions for Coverage" (42 CFR Part 416) for Medicare, Maryland state licensure requirements, and local fire/safety codes, and maintain accreditation (e.g., Joint Commission, AAAHC); provide all outpatient clinic charges via invoicing to NHLBI; and report clinical results to the NHLBI clinical teams during the procedure at time of handoff. The period of performance is October 22, 2026 – March 31, 2027. Invoices shall be billed at Medicare rates for 2026.

(vi) Delivery Location: Services are to be provided on-site at the Contractor's ambulatory surgical center / medical center. Invoices shall be submitted via the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov

(vii) [Reserved]

(viii) FAR 52.204-7, System for Award Management, applies to this acquisition.

(ix) The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition.

(x) The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

(a) A written notice of award or acceptance of an offer, issued to the successful offeror within the time specified in the offer, shall result in a binding contract without further action by either party. The Government reserves the right to accept any offer (or part of an offer) before the expiration date, whether or not discussions are conducted, unless a written notice of withdrawal is received prior to award.

(xi) FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

(xii) Additional contract requirements or terms and conditions, as determined necessary by the Contracting Officer and consistent with customary commercial practices: None.

(xiii) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(xiv) Submission Requirements: Responses must include sufficient information to demonstrate the respondent's capability to provide the required product or service. Price quotations shall include, at a minimum: unit price, list price, shipping and handling costs, delivery timeframe after award, delivery terms, prompt payment discount terms, F.O.B.

point (destination or origin), product or catalog numbers, product descriptions, and any other relevant information.

Evaluation factors may include, but are not limited to: past performance, technical capability, special features, trade-in considerations, expected lifecycle, warranty, maintenance availability, and environmental or energy efficiency considerations.

Respondents claiming to be manufacturers or authorized resellers of a specified brand-name product must provide: (a) Product, catalog, model, and/or part number(s); (b) Product description; (c) Documentation demonstrating that the offered item meets all required salient characteristics; (d) Quantity; (e) Estimated price or cost; (f) Shipping, handling, and/or installation charges; and (g) Delivery timeframe after receipt of order.

Responses must also include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received by October 22, 2026, at 9:00 AM EDT and must reference solicitation number 75N98027Q00012. Responses may be submitted electronically to nicholas.capobianco@nih.gov.

(xv) Point of Contact: Nicholas Capobianco, Contracting Specialist, National Institutes of Health, Email: nicholas.capobianco@nih.gov mailto:nicholas.capobianco@nih.gov mailto:nicholas.capobianco@nih.gov

Statement of Work (SOW)

1. Project Title AcquisiƟon of orthopedic procedure for NHLBI protocol paƟent at medical center

2. Introduc on and Background

The NHLBI Division of Intramural Research (DIR) includes several teams conducƟng Food and Drug AdministraƟon (FDA) InvesƟgaƟonal New Drug (IND) clinical research trials uƟlizing stem cell transplantaƟon methodology as the intervenƟon for those trials; such transplantaƟon methods are oŌen used to treat hematologic diseases such as mulƟple types of leukemia, lymphoma, and mulƟple myeloma, as well as aplasƟc anemia, immune system deficiencies, myelodysplasƟc syndromes, Sickle Cell Disease, and Beta-Thalassemia.

The use of stem cell transplantaƟon is associated with myriad complicaƟons, someƟmes serious, and can vary tremendously by paƟent as well as disease process. One such complicaƟon is orthopedic in nature, leading to deterioraƟon of the joints, especially hip and knee joints. NHLBI requires the ability to access outside medical services in order to treat complicaƟons that require specialty care beyond which can be provided at the NIH Clinical Center.

3. Statement of Need and Objec ves

An NHLBI Division of Intramural Research (DIR) research parƟcipant, who has been enrolled on an NHLBI clinical research protocol for several years and has undergone stem cell transplant as part of this protocol, has experienced orthopedic complicaƟons of stem cell transplant. Medical complicaƟons of the transplant process have damaged the paƟent's leŌ hip to the point that it requires replacement of the joint. The research parƟcipant is already being followed by orthopedic surgeon Dr. Timothy BhaƩacharya of OrthoBethesda (who regularly consults via agreement with the NIH Clinical Center) for evaluaƟon and management of this complicaƟon since symptoms declared themselves. NIH Clinical Center (CC) physicians are unable to complete the required procedure at the NIH CC. Following iniƟal evaluaƟon in March 2026, Dr. BhaƩacharya indicated that the joint will require addiƟonal specialty care given increased mobility changes and necrosis experienced by the paƟent. Dr. BhaƩacharya, as the physician of record for this specialty care for this research parƟcipant, has a pre-exisƟng agreement with an outside outpaƟent surgical center at which the procedure to replace the joint may be performed.

Following this, the plan is to transfer the paƟent back to the NIH CC for medical management and rehabilitaƟon.

The medical center is required to provide any necessary care and medicaƟon(s) for the paƟent’s medical situaƟon and required management unƟl the paƟent may be transferred back to the NIH CC to recover, and to conƟnue their involvement in the planned NHLBI clinical research protocol.

4. Product Specifica ons/Features/Salient Characteris cs

The contractor will be required to:

Provide agreed-upon necessary medical supplies, including, but not limited to:

implantable surgical device for the joint replacement procedure; surgical instruments;

operaƟng room and all associated facility supplies for medical and emergency management, as required by federal and state law.

Follow all regulaƟons associated with privacy and health informaƟon, according to the Health Insurance Portability and Accountability Act (HIPAA) of 1996;

Follow all regulaƟons associated with Ambulatory Surgical Centers (ASCs) at both federal and state levels to ensure safety and quality. The ASC must meet CMS "CondiƟons for Coverage" (42 CFR Part 416) for Medicare, Maryland state licensure requirements, local fire/safety codes, and maintain AccreditaƟon (e.g., Joint Commission, AAAHC).

Provide all outpaƟent clinic charges via invoicing to NHLBI; and

Report clinical results to the NHLBI clinical teams during procedure at Ɵme of handoff.

5. General Contractor Responsibili es

Independently, and not as an agent of the Government, Contractor shall furnish all necessary labor, materials, supplies, equipment, and services not otherwise provided by the Government to accomplish the required paƟent care to complete the procedure and support associated physicians in that mission.

6. Delivery or Performance Loca on

Services will be provided by the Contractor at an off-site locaƟon, following all regulaƟons associated with Ambulatory Surgical Centers (ASCs) and medical centers at both federal and state levels to ensure safety and quality. The ASC or medical center must meet CMS "CondiƟons for Coverage" (42 CFR Part

416) for Medicare, Maryland state licensure requirements, local fire/safety codes, and maintain AccreditaƟon (e.g., Joint Commission, AAAHC).

7. Delivery Date

The period of performance of this contract will be October 22nd, 2026 – March 31st, 2027.

8. Inspec on and Acceptance

NHLBI clinical staff shall be responsible for raising any issues with and assessing the quality of the services rendered by the Contractor. Any issues with the Contractor’s work will be addressed by email and virtual meeƟng between the Contractor and NHLBI. Contractor must be able to furnish details of invoices on line-item basis by request for audit by the Project Officer, on an as-needed basis.

9. Point of Contact

Mari Steele mari.steele@nih.gov Building 10/Room 7N311

10 Center Drive Bethesda, MD 20892 301-402-2712

10. Security

Contractor will abide by confidenƟality principles when dealing with government furnished informaƟon, including but not limited to intellectual property informaƟon belonging to NHLBI physician scienƟsts.

11. Government Furnished Property (GFP) and Government Furnished Informa on (GFI)

NHLBI staff shall be responsible for issuing all required medical records associated with the research parƟcipant to the Contractor at the Ɵme of the required procedure, and transporƟng the paƟent as necessary between the NIH Clinical Center and Contractor ambulatory surgical center. No GFP will be provided to the Contractor other than that necessary to properly transport the research parƟcipant for care.

12. Invoices

Two-Way Invoices: The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing Plaƞorm (IPP) at:

1. hƩps://www.ipp.gov and

2. NHLBIContractsBranchB@mail.nih.gov

Invoices shall be billed at Medicare rates for 2026.