Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF APRIL 21, 2023 SAM #7815
SOLICITATION NOTICE

65 -- ThermoChem HT 2000 Lease Instrumentation and Supplies for Perioperative Medicine

Notice Date

4/19/2023 11:27:02 AM
 

Notice Type

Presolicitation
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
 

ZIP Code

20892
 

Solicitation Number

23-005368
 

Response Due

4/25/2023 7:00:00 AM
 

Point of Contact

Malinda Dehner, Phone: 3015946320
 

E-Mail Address

dehnerm@cc.nih.gov
(dehnerm@cc.nih.gov)
 

Description

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The National Institutes of Health (NIH) intends to award a firm-fixed price contract to ThermoSolutions, White Bear Lake, MN 55110 on a sole source basis for a lease instrumentation package, reagentsand supplies.� The period of performance will be for a base year with a one-year option at the government�s discretion.� ThermoSolutions will provide the ThermoChem � HT 2000 System, ThermoChem IPH Procedure Kits, reagents, and consumables on an as-needed basis, installation, training, upgrade and maintenance services that will be used by the Department of Perioperative Medicine located at the NIH Clinical Center (CC). The intended purpose of the equipment is to raise the core temperature of the peritoneum to the desired temperature by continuously lavaging the peritoneum with a circulating warmed physiologically compatible sterile solution.� This process is known as Intraperitoneal hyperthermia.� The ability to administer fluids in a timely manner protects the safety of our surgical research population.� ThermoSolutions is the sole manufacturer and distributor of its proprietary equipment and parts. �ThermoSolutions is the only contractor capable of providing trained and authorized service technicians on their equipment.� Therefore, if an authorized service provider performs services on the ThermoChem� HT 2000, ThermoChem cannot guarantee the integrity of the equipment.� Additionally, if original equipment manufacturer (OEM) parts and supplies are not used with the ThermoChemo HT 2000 system, it will comprise the integrity of the instrument which will cause patient injury or �never events.�� It would negatively impact a patient�s health and cause severe damage to the ThermoChemo HT 2000 System. �Due to the highly technical and carefully engineered nature of this instrument, use of unauthorized parts, maintenance, or repairs, may invalidate the warranty or any existing service agreement. �It is imperative to maintain the continuity of the equipment.� ThermoSolutions is 21 CFR Quality Systems Regulation Part 820 of the Federal Food and Drug Administration (FDA). Certified. This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 � Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available.� Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. Comments to this announcement, referencing this posting number, may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contracting Officer malinda.dehner@mail.nih.gov�by the due date April 25,, 2023 and time marked in this notice.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/88926114d0e8434c8693fcfcef3da562/view)
 

Place of Performance

Address: Bethesda, MD 20814, USA

Zip Code: 20814

Country: USA
 

Record

SN06656167-F 20230421/230419230118 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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