6515--NX EQ Noninvasive Ventilators
Closed Solicitation Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- 36C10G24Q0083
- Agency
- Headquarters Department of Veterans Affairs
- Responses due
- Set-aside
- Service-Disabled Veteran-Owned Small Business
Opportunity facts
- NAICS code
- 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing
- Place of performance
- Nationwide
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs is seeking quotes for a single award requirements contract to provide noninvasive ventilators and related accessories to VA medical centers nationwide. The solicitation requires Hamilton C1 ventilators or equal that meet 16 salient characteristics for ventilation modes, alarms, pressures, flows and regulatory compliance. Quotes are due by March 8, 2024 and will be evaluated based on the ability of the equipment to meet the technical requirements and pricing for the base year and four option years.
This procurement is set aside only for Service-Disabled Veteran-Owned Small Businesses. The associated NAICS codes are 334510 and 6515 for electromedical equipment and medical instruments respectively. The place of performance will be VA medical facilities across the United States. Quotes must include pricing for the base year plus four one-year options for the ventilators and eight accessories with an estimated total value between $5-10 million over the five-year period.
Notice text
2 versions
Update #2 · Latest ·
The purpose of this amendment is to provide answers to questions received in reference to solicitation #36C10G24Q0083. Please see page 4.
No additional questions will be accepted.
Question 1
The RFQ lists 16 salient characteristics and requires any or equal product to meet all 16. Many of these 16 salient characteristics are so extremely specific as to overly restrict competition. Many specify not only the required function, but also specify a very exact range of performance that are peculiar to one manufacturer and thereby preclude your consideration of product(s) manufactured by one or more other companies. Is there a required justification and approval that supports these 16 restrictive salient requirements as essential to the Government s requirements? If not, we suggest the salient characteristics be revised to be more general in their description of the physical, functional, or performance characteristics - or ideally replaced with a set of minimum technical requirements (MTRs). This approach would then comply with FAR 11.1. We respectfully suggest that the use of more general salient characteristics would better support your planned comparative technical evaluation.
Answer:
The Salient Characteristics are developed and approved by our Respiratory Medical Team of Doctors to meet the unique needs of the Veterans Affairs Hospitals. The Salient Characteristics cannot be altered.
Question 2
We have a ventilator product (Breas Vivo 45LS at breas.us/en-US/products/life-support/vivo-45ls) to offer that readily meets or exceeds 13 of the 16 currently specified RFQ Brand Name Salient Characteristics, and in many ways exceeds the performance of the Brand Name item you have specified. We are confident that in your planned comparative technical evaluation, your VA clinicians will find our product meets or exceeds all essential VA ventilator requirements, and in many ways provides a much safer product for our veterans. However, the RFQ s currently listed overly specific Salient Characteristics that must be met would preclude your clinicians from making this fair clinical evaluation of the Brand Name product versus the Breas Vivo 45LS. We therefore request you revise just three of the sixteen RFQ salient characteristics so that our product can be fairly and comparatively evaluated. The three SC changes requested are as follows:
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A. SC 9: Device shall have Peak Inspiratory Pressure (PIP)(Working Pressure) rate between 0 and 90 cmH2O. Our Vivo 45LS has a PIP range between 4 50 cmH2O. Our partner s respiratory therapists have found no need for a peak pressure greater than 30 cmH2O to safely ventilate a patient. If a patient did require a pressure higher than 30 cmH2O for extended periods of time, conventional ventilation was not recommended. We request this SC requirement be changed to 4-50 cmH2O. This change will enable competition and improve patient safety.
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SC 11: Device shall have (inspiratory) pressure support/control of 0 - 60 cmH2O. The Vivo 45LS has a Pressure Support range between 2 50 cmH2O. For the same reason as above, the need for high pressures to conventionally ventilate a patient should be avoided. A pressure support range that provides a maximum setting of 50 cmH2O should be considered acceptable for the safety of the patient. We request this range requirement be changed to 2 50 cmH2O. This change will enable competition and improve patient safety.
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SC 5: Device shall offer the clinician the option to use single or dual limb circuits. The main benefit of a ventilator incorporating dual limb circuits is that it will provide the user with inspiratory and expiratory volume measurements. The Vivo 45LS will only incorporate single limb circuits. Single limb active exhalation valve circuits will provide the user with measured inspiratory volumes and the single limb passive circuits will provide a calculated expiratory volume. In our experience in the hospital setting, the desire for a dual-limb circuit is usually associated with the care of critical care patients. The use of a single limb circuit is certainly appropriate for all care areas. Request this SC requirement be limited to single limb circuits which is appropriate for all care areas. This change will enable competition.
Answer:
The Salient Characteristics are developed and approved by our Respiratory Medical Team of Doctors to meet the unique needs of the Veterans Affairs Hospitals. The Salient Characteristics cannot be altered.
Question 3
Request you delay the date that quotes are required until two weeks after all offeror questions are answered and published.
Answer:
The Government has taken this question into consideration and has determined no extension is necessary for this requirement.
Question 4
The SAC has previously asked industry for any recommendations regarding the supply chain environment. As we witnessed during COVID-19, ventilators were in critically short supply. VISNs had to issue orders outside the SAC national requirements contract to obtain ventilators. In addition, multiple FDA recalls of various OEM ventilators also threaten any VA single source of ventilator supply. To minimize this supply chain risk, we recommend that you consider making awards for two or more different OEM products. This will allow the VISNs to select the model/price that best meets their needs, and greatly reduce the high supply chain risk that has proven to exist with these items.
Answer:
The Government has taken this statement into consideration and has determined the requirements to remain the same with no additional products or salient characteristics of ventilators added to this requirement.
Update #1 ·
Solicitation Number:Â Â
36C10G24Q0083Â
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Notice Type:Â Â
Combined Synopsis/Solicitation Â
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Synopsis:Â Â
COMBINED SYNOPSIS/SOLICITATIONÂ
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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.Â
Solicitation number 36C10G24Q0083 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.Â
Requirement Description:Â
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. Â
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 a 100% Service-Disabled Veteran Owned Small Businesses (SDVOSB) set aside.Â
This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Hamilton C-1® 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. Â
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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. Â
The FAR provision at 52.212-1, Instructions to Offerors Commercial, applies to this acquisition including attached addenda to the provision.Â
The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition.Â
The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer.Â
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.Â
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.Â
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/.Â
Quotes are due via email by 04:30PM EST on March 08, 2024, to Contract Specialist, Jalima Jones at Jalima.Jones@va.gov and Contracting Officer, William Milline at William.Milline@va.gov No calls will be accepted.
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SCOPE OF WORKÂ Â Â
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. Â
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.Â
2.  REQUIREMENTÂ
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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 C-1® or equal, 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.Â
The following line items comprise the Noninvasive Ventilators product line:
Contract Line Item#Â
BrandÂ
Part NumberÂ
DescriptionÂ
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 SDVOSB 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 #Â
SALIENT CHARACTERISTICSÂ
METHOD OF EVALUATIONÂ
APPLICABLE CLINSÂ
PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATUREÂ
SC 1Â
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 ReviewÂ
0001
Â
SC 2Â
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 ReviewÂ
0001
Â
SC 3Â
Device shall accommodate adults (adult/pediatric use is acceptable)
Literature ReviewÂ
0001
Â
SC 4Â
Device shall have a Tidal Volume Range of 200mL or less to 2000mL or greater
Literature ReviewÂ
0001Â
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SC 5
Device shall offer the clinician the option to use single or dual limb circuits
Literature ReviewÂ
0001
SC 6
Device shall have Oxygen High Pressure rate of 280 to 600 kPa or greater (41 or less to 87 psi or greater)
Literature ReviewÂ
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 ReviewÂ
0001
SC 8
Device shall have Peak Inspiratory Flow (PIF) from 0 to 200 I/min or greater.
Literature ReviewÂ
0001
SC 9
Device shall have Peak Inspiratory Pressure (PIP) (Working Pressure) rate of 0 to 90 cmH2O or greater
Literature ReviewÂ
0001
SC 10
The device shall have Mean Airway Pressure monitor range of 0 to 90 cmH2O, or greater.
Literature ReviewÂ
0001
SC 11
Device shall have (inspiratory) pressure support/control of 0 to 60 cmH2O or greater.
Literature ReviewÂ
0001
SC 12
Device shall have Flow Trigger Sensitivity Controls of 0.5 I/min or less on the Low End to 20 I/min or greater on the High End.
Literature ReviewÂ
0001
SC 13
Device must meet IEC 60601-1 Medical Electrical Equipment standards for Safety
Literature ReviewÂ
0001
SC 14
Device must have battery backup Power
Literature ReviewÂ
0001
SC 15
Device must be able to connect to Electronic Medical Records/ Electronic Health Records (EMR/EHR)
Literature ReviewÂ
0001
SC 16
Device must have Fi02/Oxygen of 21% or less to no less than 100%
Literature ReviewÂ
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.Â
The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this combined synopsis/solicitation.Â
Attachments
| File | Type | Posted |
|---|---|---|
| 36C10G24Q0083 0001_1.docx | DOCX document | |
| ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ NONINVASIVE VENTILATORS -.docx | DOCX document | |
| ATTACHMENT A - PRICE COST SCHEDULE - NX EQ NONINVASIVE VENTILATORS -.xlsx | XLSX spreadsheet | |
| ATTACHMENT E - REPORTING TOOL - NX EQ NONINVASIVE VENTILATORS.xlsx | XLSX spreadsheet | |
| ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ NONINVASIVE VENTILATORS -.docx | DOCX document | |
| ATTACHMENT C - CONTRACT CLAUSES - NX EQ NONINVASIVE VENTILATORS -.docx | DOCX document | |
| 36C10G24Q0083.docx | DOCX document |
Notice history
| Notice | Type | Posted |
|---|---|---|
| 6515--NX EQ Noninvasive Ventilators | Award Notice | |
| 6515--NX EQ Noninvasive Ventilators | Solicitation |
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