6515--Noninvasive Ventilators (VA-23-00019311)

Solicitation Number: - 36C10G24Q0073 - Notice Type: - Combined Synopsis/Solicitation - Synopsis: - COMBINED SYNOPSIS/SOLICITATION - This is a combined synopsis/solicitation for brand name or equal 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; quotes are being requested and a written solicitation will not be issued. - Solicitation number 36C10G24Q0073 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2024-02, dated 22 January 2024. Requirement Description: VA has a requirement to purchase Noninvasive Ventilators to deliver patient care at its VA Medical Centers around the country. Noninvasive Ventilators: which are also called positive pressure ventilators, are machines that act as bellows to move air in and out of the lungs using a face mask, nasal mask, or a helmet instead of tubes that extend down into the neck. Its primary function is to facilitate breathing by controlling how often it pushes air into the patient s lungs and how much air they will receive. Noninvasive Ventilators are mainly used in hospitals and in transport systems such as ambulances and MEDEVAC air transport. They can also be used for home respiratory therapy. Noninvasive ventilation machines can treat a patient with a single device throughout their hospital stay, regardless of changing conditions. They are designed to improve patient care because the machine moves with the connected patient between hospital departments. A single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name or Equal in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes shall contain the terms for cost/price and technical capabilities of the brand name or equal equipment. The Government reserves the right to award without discussions. - The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 850 employees. This procurement action is issued as full and open competition on an unrestricted basis. This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Hamilton C1 brand name or equal Noninvasive Ventilators as identified in ATTACHMENT A PRICE COST SCHEDULE - NX EQ NONINVASIVE VENTILATORS. All interested companies shall provide a quote for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A PRICE COST SCHEDULE - NX EQ NONINVASIVE 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, applies to this acquisition including attached addenda to the provision. The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition. The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer. Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, 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 Items, 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 quoters 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 03:00PM EST on February 22, 2024, to Contract Specialist, Jalima Jones at contact@example.gov and Contracting Officer, Sara Vickroy at contact@example.gov No calls will be accepted. Quotes are due via email by 03:00PM EST on March 01, 2024, to Contract Specialist, Jalima Jones at contact@example.gov and Contracting Officer, Sara Vickroy at contact@example.gov SCOPE OF WORK - The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Noninvasive Ventilators product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. - Noninvasive Ventilators which are also called positive pressure ventilators, are machines that act as bellows to move air in and out of the lungs using a face mask, nasal mask, or a helmet instead of tubes that extend down into the neck. Its primary function is to facilitate breathing by controlling how often it pushes air into the patient s lungs and how much air they will receive. Noninvasive Ventilators are mainly used in hospitals and in transport systems such as ambulances and MEDEVAC air transport. They can also be used for home respiratory therapy. Noninvasive ventilation machines can treat a patient with a single device throughout their hospital stay, regardless of changing conditions. They are designed to improve patient care because the machine moves with the connected patient between hospital departments. The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Noninvasive Ventilators to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for one 12-month base period 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 offeror indicate that each product being offered as an equal product to the Hamilton C1, Noninvasive Ventilators. For each equal product, the offeror 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 offeror must also clearly identify the item by brand name (if any) and make/model number. Finally, the offeror 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 Item# Brand Part Number Description 0001 Hamilton 1610010 C1 Ventilator 0002 Hamilton 161150 Trolley 0003 Hamilton 281671 Circuit Support Arm 0004 Hamilton 161520 Communication Board with CO2, Nurse Call, and COM 1 0005 Hamilton 161058 C1 Trends / Loop Application 0006 Hamilton 161059 C1 NIV, NIV S/T Application 0007 Hamilton MSP369108 Li-Ion Battery-Rechargeable 0008 Hamilton 161087 High Flow O2 Therapy Application The Department of Veterans Affairs (VA) is seeking vendors who can provide Hamilton C1® Noninvasive Ventilators or equal as listed above which meet all the following salient characteristics. The Government intends for offerors to include all ancillary items, to ensure the equipment can function as designed by the OEM and as clinically required. Products quoted in the technical volume must be captured on the Vendor s pricing volume (Attachment A - Price Cost Schedule) of the solicitation. Additionally, responses can include any additional product and other product-related services necessary to obtain the supplies as required that may be beneficial and essential to the functionality of the proposed solution. These items must be clearly identified by brand name and part number. When offerors include their additional proposed product items/services, these items may be considered for evaluation, and must be captured in the vendor s pricing volume with an estimated quantity of zero. SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION APPLICABLE CLINS PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE SC 1 Device shall have ventilation modes of a. A/C-Pressure Control (PC). b. A/C-Volume Control (VC). c. Continuous Positive Airway Pressure (CPAP). d. Pressure Support Ventilation (PSV). e. Spontaneous/Timed Ventilation (S/T). f. Synchronized Intermittent Mandatory Ventilation (SIMV); and g. SIMV-VC Literature Review 0001 - SC 2 Device shall have High and Low Alarms that cover. a. Pressure, b. Tidal Volume, c. Minute Ventilation, d. Disconnection, and e. Apnea Interval f. Respiratory Rate Literature Review 0001 - SC 3 Device shall accommodate adults (adult/pediatric use is acceptable) Literature Review 0001 - SC 4 Device shall have a Tidal Volume Range of 200mL or less to 2000mL or greater Literature Review 0001 - SC 5 Device shall offer the clinician the option to use single or dual limb circuits Literature Review 0001 SC 6 Device shall have Oxygen High Pressure rate of 280 to 600 kPa (41 to 87 psi) Literature Review 0001 SC 7 Device shall have a Respiratory Rate (RR or Rate ) of 1 or less to 80 Breathes Per Minute (BPM) or more. Literature Review 0001 SC 8 Device shall have Peak Inspiratory Flow (PIF) from 0 to 200 I/min or greater. Literature Review 0001 SC 9 Device shall have Peak Inspiratory Pressure (PIP)(Working Pressure) rate between 0 and 90 cmH2O Literature Review 0001 SC 10 The device shall have Mean Airway Pressure monitor range between 0 and 90 cmH2O. Literature Review 0001 SC 11 Device shall have (inspiratory) pressure support/control of 0 - 60 cmH2O Literature Review 0001 SC 12 Device shall have Flow Trigger Sensitivity Controls of (Low End) 0.5 and (High End) 20 I/min Literature Review 0001 SC 13 Device must meet IEC 60601-1 Medical Electrical Equipment standards for Safety Literature Review 0001 SC 14 Device must have battery backup Power Literature Review 0001 SC 15 Device must be able to connect to Electronic Medical/Health Records (EMR/EHR) Literature Review 0001 SC 16 Device must have Fi02/Oxygen of 21%-100% Literature Review 0001 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 following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this combined synopsis/solicitation. See attached document: ATTACHMENT A - PRICE COST SCHEDULE - NX EQ NONINVASIVE VENTILATORS. See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ NONINVASIVE VENTILATORS. See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX EQ NONINVASIVE VENTILATORS. See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ NONINVASIVE VENTILATORS. See attached document: ATTACHMENT E - REPORTING TOOL - NX EQ NONINVASIVE VENTILATORS.