36C10G24Q0083 0001_1.docx

Amendment to a Previous Combined Solicitation

Amendment to a Previous Combined Solicitation

GENERAL INFORMATION

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contract Specialist Jalima J. Jones Jalima.Jones@va.gov

(202) 570-8856

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

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:

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.

1. 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.

1. 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.

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Amendment to a Previous Combined Solicitation