6515--NX EQ Humidifiers Airway Heat Moisture Exchange

The purpose of this Amendment is to remove CLINS and revise Attachment A Price Cost Schedule, add a column to Salient characteristics chart for CLIN 0002 for the vendor to indicate where SC is found in technical literature, provide the Government s response to questions received and to extend the closing date from March 4, 2022, at 11:59PM EST to March 11, 2022, at 11:59PM EST.

Please use the charts below when submitting a quote.

CLIN 0001 Apply to the following Salient Characteristics for Humidifiers Airway Heat Moisture Exchange.

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 1

Temperature Settings 31ºC to 37ºC

Literature Review

SC 2

Digital Temperature Display

Literature Review

SC 3

Warm up Time Under 36 Minutes

Literature Review

CLIN 0002 Apply to the following Salient Characteristics for Humidifiers Airway Heat Moisture Exchange.

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 4

Have the Capability to Provide High Flows of Air/Oxygen

Literature Review

SC 5

Can be Used with a Face Mask

Literature Review

SC 6

Flow Rate/Range 2 40 L/Min or Better

Literature Review

Governments Response to Questions Received

Humidifiers Airway Heat Moisture Exchange

Solicitation 36C10G22Q0019

What is the rationale for changing the existing contract (36C10G18Q9098) that is set aside for SDVOSBs to a Full and Open acquisition? The NMR Class Waiver (Federal Register Vol. 83, No 105 dated Thursday, May 2018) used in the previous acquisition is still effective. There are no small businesses that manufacture either the Brand Name devices or any equivalent. The required products required haven t changed significantly. The additional products are sold by SDVOSBs. The requirements of Vets First and Rule of Two mandate has not changed. The multiple SVOSBs in the market for the existing contract are still in the market. The number of competing products has increased, providing the opportunities for additional SDVOSBs to compete. Request this solicitation be amended to again reflect an SDVOSB set-aside.

Response: Market research did not support an SDVOSB set-aside. Market research revealed there are not two or more small business manufacturers for the solicited items. Additionally, there is not a current Non-Manufacturer Class Waiver for Humidifiers as published on the SBA NMR Class Waiver List - https://www.sba.gov/sites/default/files/2021-04/Class%20Waiver%20Database_Remediated-508.pdf

Consider adding a Past Performance Factor and revising the evaluation as follows:

Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Technical Capability factor. Technical Capability will be evaluated for strengths and weaknesses to determine if the items proposed meet or exceed requirements.

Past Performance factor.

Price factor

Factor 1 is more important than Factor 2. When Factors 1 and 2 are combined, they are more important than Factor 3 Price alone.

Response: This acquisition is being conducted in accordance with the procedures of FAR Part 13. The Government will not amend the solicitation to include past performance as part of the evaluation.

We respectfully request you include a Past Performance Evaluation Factor. The VA Source Selection Guide and FAR recommend the use of Past Performance as an evaluation factor. For this high dollar value solicitation, evaluating past performance is especially important:

It will ensure the offeror is able to meet the demands of a VA-wide requirements contract. This national contract requires supplier agreements, distribution agreements, warehouses, shipping, ordering, invoicing, and EDI capabilities that past performance can readily verify. A responsibility determination does not address these areas.

In the current environment of chip shortages, COVID-19, and supply chain problems, a demonstrated ability to perform this critical requirements contracts and Substantial Confidence is even more important. An offeror with limited capabilities could simply claim excusable delay whenever any problem arises. A standard SAC Past Performance Evaluation Factor minimizes this risk.

Response: This acquisition is being conducted in accordance with the procedures of FAR Part 13. The Government will not amend the solicitation to include past performance as part of the evaluation.

To implement VAAR 815.30471(a), recommends the evaluation criteria as follows: Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Factor 1. Socio-economic Factor. Factors in order of precedence:

SDVOSB (Full credit)

VOSB (Partial credit)

Small Business Subcontracting (Some credit)

Factor 2. Technical Capability Factor. Technical Capability will be evaluated for strengths and weaknesses to determine if the items proposed meet or exceed requirements.

Factor 3. Past Performance Factor.

Factor 4. Price Factor

Since this was previously an SDVOSB set-aside, the Socio-economic Factor is more important than the technical factor, which is more important than the Past Performance Factor. When Factors 1, 2, and 3 are combined, they are more important than Factor 4 Price alone.

Response: This acquisition is being conducted in accordance with the procedures of FAR Part 13. The Government will not amend the solicitation to include VAAR clauses 852.215-70 or 852.215-71 as part of the evaluation.

As required by VAAR 815.304-71(a), recommend including an additional Evaluation Factor described in VAAR 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors. (OCT 2019)

Response: This acquisition is being conducted in accordance with the procedures of FAR Part 13. The Government will not amend the solicitation to include VAAR clauses 852.215-70 or 852.215-71 as part of the evaluation.

To avoid Grey-market sales, recommend the Technical Factor include a requirement to provide a specific Letter of Supply and a Letter of Authorization to fulfill the requirements of this contract and distribute to the VA, if the offeror is not the manufacturer.

Response: Authorized Distributor letters certified by OEM are required with all quotes (see Attachment D Solicitation Provisions.

Section C CONTRACT CLAUSES, includes 52.216-21 REQUIREMENTS (OCT 1995), which provides at 52.216-21(c): Except as this contract otherwise provides, the Government shall order from the Contractor all the supplies or services specified in the Schedule that are required to be purchased by the Government activity or activities specified in the Schedule. Similarly, Clause B.2.d. notes the subject products are intended to be part of a VA-wide (otherwise referred to as national ) single award Requirement s contract.

Is the Requirement for this purpose the VAs requirement for the Brand selected?

What process will be used to implement 52.216-21 (c)?

Is there a VAAR or VAAM reference or policy letter that serves to ensure compliance with this clause?

Response: Yes, the requirement as it relates to 52.216-21 is the Brand awarded. There is a VHA policy letter that makes all Non-Expendable Equipment Contracts mandatory sources throughout VHA.

This is a five-year FFP contract. Given the current high and uncertain level of inflation, the current RFP places significant risk on the contractor.

Request a standard Economic Price Adjustment (EPA) clause be included in this contract. Inflation is not only impacting the price of produced medical goods, but also labor, shipping, energy, and other costs. Recommend the use of the CPI index. This approach not only equitably shares the risk between the Government and contractor, but provides for best pricing, and avoids unbalanced pricing.

Response: The solicitation allows for quoters to quote separate prices for the base year and each of the 4 option years, see Solicitation Attachments A and D. The Government will not amend the solicitation to include an Economic Price Adjustment. However, the Government is always for looking at ways to improve the NX Program. Please provide the Contracting Officer, David Barber at david.barber@va.gov, any recommendations you may have regarding the uncertain supply chain environment. Specifically, what index or combination of indexes is appropriate, with data that supports there is serious doubt concerning the stability of the market, etc.

Please clarify the Requirements in the Combined Synopsis. Paragraph 1 states: The Humidifiers Airway Heat Moisture Exchange products required for this program have been identified as most advantageous to the Government to be incorporated into a national Requirements contract. The salient characteristics (SC) for these commercial items are identified in the Humidifiers Airway Heat Moisture Exchange Product Description.

No product descriptions were included. Are the product descriptions that the Government will use for determining or equal found on-line at the links below? If not, could you provide the relevant product descriptions? MR850 - https://www.fphcare.com/us/hospital/adult-respiratory/invasive-ventilation/850- system-invasive-ventilation/ AIRVO2 - https://www.fphcare.com/us/hospital/adult-respiratory/optiflow/airvo-2-system/

Response: The Product description is part of the Combined Synopsis RFQ and is on pages 5 thru 7. It lists a description of the Humidifiers Airway Heat Moisture Exchange, the Contract Line Items (CLINS) and Salient Characteristics (SCs) that need to be addressed for this requirement.

What is the contract ceiling?

Response: The contract resulting from this solicitation will be a Requirements contract in accordance with FAR 16.503. As such, the Government has provided realistic estimates in the total quantities anticipated to be ordered. The Government has not identified a contract ceiling, as is not required by FAR 16.503. However, order limitations are defined C.5, 52.216-9, contained in Attachment D of the solicitation.

How will the Small Business Subcontracting Plans be evaluated?

Response: If required, Subcontracting Plans will be evaluated in accordance with D.7, Addendum to FAR 52.212-2 Evaluation Commercial Items (Nov 2021), contained in Attachment D of the solicitation.

What specific SDVOSB and other small business subcontracting goals are required to be addressed if an offerors Small Business Subcontracting Plan (SBSP) to be found acceptable?

Response: If a Subcontracting Plan is required, the requirements of VAAR 819.704 will apply.

Will the VA OSDBU evaluate any SBSP?

Response: If a Subcontracting Plan is required, the requirements of VAAR 819.704 will apply.

Reconsider the estimated quantities for two of line items. The RFP calls for 150 units per year for each of 19-line items. This may not be a realistic quantity for the following line items:

900PT601Â Â Â Disinfection Filter (Airvo). This filter, used in disinfection of the unit, must be changed after every patient. If a typical VA unit is used 4 times a month, it creates a new filter requirement for approximately 50 of these line items per unit per year. For the 150 units acquired in the first year, that creates a realistic estimated requirement for 150x50=7,500. In the second contract year, these filters are required for both the first 150 units and the second-year 150 units. That creates a requirement for 300x50=15,000 units in year two. Similarly, the requirement for year 3 becomes 22,500; year 4 becomes 30,000; and year 5 becomes 37,500.

900PT603 Clean Storage Cover (Airvo) - Similarly, for each new patient, a new clean storage cover is required. Therefore, this line item also should reflect the same estimated quantities as above. (These may come in case quantities).

Response: These CLINs will be removed from the solicitation. These items are available on the MSPV Product List and can be ordered from each VHA facility s perspective Prime Vendor.

Reconsider adding the following essential items not in the current RFP. Note these items also must be changed between patients:

900PT561Â Â Â Â Â Â Â Â Â Â Â Â Circuit and water chamber (AIRVO) 10 pack

900PT913Â Â Â Â Â Â Â Â Â Â Â Â Air Filter (AIRVO) 2 Pack

Interface- one per patient turn

OPT942 or OPT944 or OPT946 Optiflow & Nasal Cannula (s, m, l) 20 pack

OPT970 Trach adapter (20 pack)

OPT980 Mask adapter interface (20 Pack)

Response: These CLINs will not be added to the solicitation. These items are available on the MSPV Product List and can be ordered from each VHA facility s perspective Prime Vendor.

Recommend adding the above essential items to the solicitation at the same quantities as required for new patient items. (i.e., 7,500 year 1, 15,000 year 2, 22,500 year 2, 30,000 year 3, 37,500 year 4. Adding these items and the correct quantities has multiple benefits:

It will enable the SAC ELCM program to evaluate the Life Cycle Cost of the products and provide a solid foundation to compare BNOE candidates. Some systems have low-cost prices for the basic system, but very high prices for the per patient requirements. Having all necessary items and realistic estimated quantities will facilitate a Total Price Evaluation that reflects the true VA Life Cycle Cost.

Adding the other required items will allow VA ordering officers to obtain all needed supplies from this single national contract. Since the previous NX contract did not have any per patient line items, there was very limited use of the contract.

Adding the per patient line items will reduce logistics/contracting workload by allowing facilities to take a single contract action rather than multiple contract actions.

Correcting the quantities to a realistic estimated quantity is required by FAR for requirements contracts.

Enables an offeror to provide their best price.

Ensures an offeror plans to warehouse sufficient products to meet VA requirements.

Response: These CLINs will not be added to the solicitation. These items are available on the MSPV Product List and can be ordered from each VHA facility s perspective Prime Vendor.

Salient Characteristics Flow Rate Consider revising the Flow Rate Requirements. The current Salient Characteristics only require a flow rate of 40 liter per minute (lpm) or better. The current NX units fielded across the VA provide a 60 pm flow rate. The attached Flow Matters paper shows that a flow rate greater than 45 Lpm has been required by clinicians in 82% or more of documented studies of patients requiring High Flow Humidification Therapy. The studies and clinical evidence show that the positive outcomes occur at flow rates of up to 60 lpm. We know of no VA clinical data that contradicts the studies referenced in the attached papers or supports limiting flow rates to 40 lpm. Multiple current industry Nasal High Flow (NHF) systems can support up to 60 lpm.

Recommend that the RFP Salient Characteristic be changed to require a flow rate up to 60 lpm. For your reference see attachments 1, 2, 3 and 4.

Response: The SC will not be changed.

The RFP identifies very general salient characteristics. Will the evaluation determine include product strengths and weaknesses?

Response: All quotes will be evaluated in accordance with Section D.7 of Attachment D. Take note that comparative evaluations will be conducted.

CLIN 0001 SC 1 Heated Humidifier Temperature Settings - In light of these concerns, would it make sense to for the salient characteristics to specify temperature settings to read 31°C and 37°C fixed setting?

Response: The SC will not be changed.

CLIN 0002 SC 6 Flow Rate/Range 2 40 L/Min or Better - In light of the clinical evidence emphasizing the use of flow rates up to 60L/min that provides the clinical rational for the recent international and national Nasal High Flow Therapy Clinical Practice Guidelines shouldn t the required flow range be stated as up to 60L/min?

Response: The SC will not be changed.