6515--NX EQ Intensive Care Ventilators (VA-24-00028985)

Amendment to Combined Synopsis-Solicitation

36C10G25R0013 0002

The purpose of this amendment is to:

Answer vendor questions received to the solicitation.

The Due Date of the Combined Synopsis-Solicitation remains the same (12/26/2024 at 4:30PM Eastern Time).

>>>>>>>>>>>>>>>>>>>>>>END OF AMENDMENT

Amendment to Combined Synopsis-Solicitation

36C10G25R0013 0001

The purpose of this amendment is to:

update to reflect accurate date on ATTACHMENT G PAST PERFORMANCE QUESTIONAIRE NX EQ INTENSIVE CARE VENILATORS

The Due Date of the Combined Synopsis-Solicitation remains the same (12/26/2024 at 4:30PM Eastern Time).

>>>>>>>>>>>>>>>>>>>>>>END OF AMENDMENT

Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

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Combined Synopsis/Solicitation Notice

36C10G25R0013

*= Required Field

Combined Synopsis/Solicitation Notice

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Solicitation Number:

36C10G25R0013

Notice Type:

Combined Synopsis/Solicitation Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

Solicitation 36C10G25R0013 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Proposal (RFP). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2024-05, dated May 22, 2024.

Requirement Description:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Intensive Care Ventilators product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award.

Intensive Care Ventilators are mechanical devices that can be configured to provide invasive ventilation (e.g., with an endotracheal tube or tracheostomy tube) or noninvasive ventilation (e.g., with a face mask). These ventilators are life support devices that move gas (e.g., air and/or oxygen) to and from a patient's lungs. These devices may provide temporary or permanent respiration for patients who cannot breathe on their own, or who require assistance maintaining adequate ventilation because of illness, trauma, congenital defects, or the effects of drugs (e.g., anesthetics). In most cases, these ventilators are used for a short period of time (a few days to a few weeks) to deliver pressurized medical gases to the patient's lungs to support gas exchange and rest ventilatory muscles until the patient is able to breathe without mechanical assistance.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies. The associated size standard is 1,000 employees. Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (SA).

This acquisition is for a single award Requirements contract, IAW FAR Part 16.5, for Hamilton C6® or Equal Intensive Care Ventilators or equal Units and related equipment and accessories as identified in ATTACHMENT A PRICE COST SCHEDULE - NX EQ Intensive Care Ventilators. All interested companies shall provide a quote for all Contract Line Item Numbers (CLINs) listed in ATTACHMENT A PRICE COST SCHEDULE - NX EQ Intensive Care Ventilators.

The ordering period is for one 12-month base year with four 12-month option years. Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors Commercial Products and Commercial Services, applies to this acquisition including attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Products and Commercial Services, and the specific evaluation criteria as attached addenda also applies to this acquisition.

Proposers are to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Products and Commercial Services, with its offer.

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached.

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached.

All interested proposers must be registered in the System for Award Management (SAM) prior to submitting a quote. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 4:30PM EST on December 19, 2024, to Contract Specialist, at Maurice.Christian@va.gov and Contracting Officer, at Jessica.Edwards6@va.gov. No calls will be accepted.

Proposals are due via email by 4:30 EST on December 26, 2024, to Contract Specialist, , at Maurice.Christian@va.gov, and Contracting Officer, at Jessica.Edwards6@va.gov.

PRODUCT DESCRIPTION

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Intensive Care Ventilators product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award.

Intensive Care Ventilators are mechanical devices that can be configured to provide invasive ventilation (e.g., with an endotracheal tube or tracheostomy tube) or noninvasive ventilation (e.g., with a face mask). These ventilators are life support devices that move gas (e.g., air and/or oxygen) to and from a patient's lungs. These devices may provide temporary or permanent respiration for patients who cannot breathe on their own, or who require assistance maintaining adequate ventilation because of illness, trauma, congenital defects, or the effects of drugs (e.g., anesthetics). In most cases, these ventilators are used for a short period of time (a few days to a few weeks) to deliver pressurized medical gases to the patient's lungs to support gas exchange and rest ventilatory muscles until the patient is able to breathe without mechanical assistance.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Intensive Care Ventilators to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four 12-month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, Brand Name or Equal which requires the proposer indicate that each product being offered as an equal product to the Hamilton C6® or Equal Intensive Care Ventilators. For each equal product, the proposer must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The proposer must also clearly identify the item by brand name (if any) and make/model number. Finally, the proposer must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

Contract Line Items

Manufacture

Part Number

Description

0001

Hamilton

160021

HAMILTON-C6 Ventilator (Includes Trolly)

0002

Hamilton

160971

HAMILTON-C6 O2 Cylinder Holder

0003

Hamilton

160184

HAMILTON-C6 Communication Board (CO2, SpO2, Aerogen w/ Cable)

0004

Hamilton

160969

HAMILTON-C6 Humidifier Holder

0005

Hamilton

160185

HAMILTON-C6 Communication Board (CO2, SpO2)

0006

Hamilton

281718

CAPNOSTAT-5 CO2 SENSOR

0007

Hamilton

160154

HAMILTON-C6/C3 Quick Lock

0008

Hamilton

160162

HAMILTON-C6/C3 Water Bag Pole

0009

Hamilton

MSP369130

HAMILTON-C6 Li-Ion Battery

0010

Hamilton

369136

HAMILTON-C6 Battery Calibrator

0011

Hamilton

160760

HAMILTON-C6 P/V Tool Pro Application

0012

Hamilton

160762

HAMILTON-C6 High Flow O2 Therapy Application

0013

Hamilton

160763

HAMILTON-C6 IntelliSync+ Application

0014

Hamilton

160752

HAMILTON-C6 nCPAP-PS Application

0015

Hamilton

160751

HAMILTON-C6 Neonatal Application

The Department of Veterans Affairs (VA) is seeking vendors who can provide Hamilton C6® or Equal Intensive Care Ventilators or equal as listed above which meet all the following salient characteristics. Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor s pricing volume with a quantity of zero. The columns highlighted below SHALL BE completed.

CLINS 0001 apply to the following SCs:

SC #

Salient Characteristics

Method of Evaluation

MUST BE COMPLETED

APPLICABLE CLINS

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 1

Must have an Adult Inspiratory Flow capable of 120L/min or higher

Literature Review

SC 2

Must have CMV, SIMV, Pressure controlled-CMV, Spontaneous, and CPAP Ventilation modes

Literature Review

SC 3

Must have a Respiratory Rate (or b/min Rate) range of 1 to at least 80 or better

Literature Review

SC 4

Must have an FiO2 (Oxygen) Range of at least 21 to no less than 100

Literature Review

SC 5

Must be able to connect to Electronic Medical Records (EMR)/Electronic Health Records (EHR)/CERNER/Patient Data Management.

Literature Review

SC 6

Must have a Battery Back-up that is hot swappable or can be automatically switched from internal to external

Literature Review

SC 7

Must have at a minimum of 1-hour external battery backup run time

Literature Review

SC 8

Must have alarms for:

-Apnea

-High/Low Pressure/Airway Pressure

-Loss of Power or Internal Battery/ Battery Failure

-Low Minute Volume/Volume Monitoring (VT)

-Low Tidal Volume or Expiratory Minimum Volume/Low Airway Pressure

-Low Oxygen/O2 concentration (FiO2)

-Circuit Disconnect/Disconnection

Literature Review

SOFTWARE INSTALLATION AND UPDATES

The Contractor grants to VA non-exclusive, non-transferrable licenses to use the Intensive Care Ventilators and all associated accessories and software, including any documentation, for the systems intended purposes. At no additional cost, Customer will be entitled to Software updates when such updates are made generally available without cost to other licensees of the software. The Contractor shall coordinate the installation of any software upgrades with designated facility POC and Biomedical engineer.

MAINTENANCE, REPAIRS AND REPLACEMENT

Preventative Maintenance will be performed as prescribed by the manufacturer s specifications. Maintenance, repairs and replacement will be performed by authorized technicians and will be coordinated through the designated facility POC and Biomedical Engineer.

PRODUCT REFRESH

Product refresh is when a current CLIN is no longer being manufactured due to

obsolescence and the product item is being replaced with a newer, and more often, a

superior version of the same item. The current CLIN product will be revised to reflect the

refreshed product information, manufacturer s part number, IDIQ price (inclusive of

Service Level Agreement (SLA) fee), etc.

The Government reserves the right to not accept the products offered under

product refresh. The contractor will be notified in writing if a product refresh is not

accepted. All products offered shall be provided with the warranty that is agreed upon

for this contract.

The contractor agrees to ensure that all upgraded improved/replaced products

meet American with Disabilities Act (ADA) and Health Information Portability and

Accountability Act (HIPAA) Federal requirements.

The contractor shall provide the COR and CO the following information for product

refresh:

(1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule (to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA fee)).

(2) Product literature for the item(s) refreshed.

(3) A detailed description of the differences or benefits of refreshed as compared to the item(s) being discontinued or added.

(4) Proper identification of any product requirements and/or procedures related to those product(s) proposed to be refreshed or upgraded.

(5) FDA approval, if applicable

(6) Provide historical sales to VA by item(s), if applicable

(7) Copy of Commercial Warranty.

The request shall be submitted to the COR, copy to the Contract Specialist and Contracting Officer, for review and recommendation of approval to be submitted to the CO. The CO shall prepare a bilateral modification for execution.

PRODUCT REMOVAL OR RECALL

For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer agrees to take following steps immediately:

Notify the Contracting Officer (CO) at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

Provide copies of the notification to CO, Contracting Specialist, Contracting Officer

Representative, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from

customers and the contract number assigned as a result of an issuance on

the solicitation;

(2) Reasons for modifications, removal or recall; and

(3) Necessary instructions for return for credit, replacement or corrective

action.

A copy of the notification will be provided to:

Manager, Product Recall Office

National Center for Patient Safety

Veterans Health Administration

24 Frank Lloyd Wright Drive, Lobby M

Ann Arbor, MI 48106