36C24218Q0327-003.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >$150K

OFOC SOP Revision 06 Page 1 of 5 Original Date: 03/22/11 Revision 06 Date: 08/30/2017

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>$150K)

Acquisition Plan Action ID: VA242-18-AP-4263

1. Contracting Activity and Agency:

Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office 2 VA Western New York Healthcare System 76 Veterans Avenue 3495 Bailey Avenue Bath, NY 14810 Buffalo, NY 14215

VISN 2

2. Nature and/or Description of the Action Being Processed: The Department of Veterans Affairs, Network Contracting Office 2 and the VA Western New York Healthcare System in Buffalo, NY anticipate a new, single source (brand name) firm fixed price procurement action for ICU ventilators and associated items.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

20 each Infinity Evita V500 Elite Critical Care workstations with C500 cockpit for ventilation of adult and pediatric patients. System cables.

o Elite provides 3 year warranty o Preventive Maintenance kits for 5 years

Volume and pressure controlled ventilation modes with Automatic Tube Compensation, Autoflow and Volume Guarantee, Spontaneous breathing modes, Weaning parameters (P0.1, RSBI, NIF)

Non-invasive ventilation

Automatic leakage compensation

Oxygen Therapy

Single patient use Infinity ID Flow Sensor and expiratory valve system Disp. Xvalve V500

Single patient use CO2 cuvettes

6 configurable screens

Turbine style compressor GS500

4 Hour External battery capable of supplying power to the ventilator and the 2 hours to the compressor GS500

30 minute Internal Battery

Data export via USB flash drive

Integrated pneumatic nebulizer connection

Smart Pulmonary View for displaying dynamic recognition of compliance and resistance changes as well as patient vs ventilator trigger activity

Graphical representation of compliance (Cdyn) and Resistance

PC-PSV Pressure control mode & Volume control mode with guaranteed minimum respiratory rate (backup respiratory rate)

OFOC SOP Revision 06 Page 2 of 5

Revision 06 Date: 08/30/2017

Volumetric CO2 monitoring

Trolley, O2, Air 10 ft. hoses DISS Hand tight with Chemtron wall adapters

Test Lung, quick stop hinged arm, water bag pole, universal holder with standard rail, mounting kit for humidifier, and basket

One (1) Biomedical training seminar for Evita V500 Vent

Rail mounting kit for humidifier

Free ICON Support – To provide 24x7 clinical support and monthly CEU webinars Lifetime

Clinical Application Support

Trade in of 15 Evita XL ventilators $750.00 ea.

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1. The specific paragraph must be cited. Most likely, only the -1 or -2 authorities will be cited. Please be aware that failure to adequately plan for future requirements does not constitute appropriate use of the unusual and compelling urgency statutory authority.

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The V500 is the only critical care ventilator that has a fully disposable flow sensor and exhalation system. This is required due to the limited cleaning capabilities within the respiratory care department and it is the most effective way to reduce infection from cross contamination.

Furthermore, single patient use components decrease down time of equipment due to not having reprocessing requirements thus making the equipment more available for patient use.

The Evita V500 is the only ventilator with a 2 hour integrated battery that supplies power to both the ventilator and the compressor GS500. This is required to ensure that the same standard of care that is delivered while the patient is in the ICU is able to be delivered while the patient is on transport. Additionally, by supplying power to the compressor, the hospital will not have to have a supply of air tanks to provide the prescribed FIO2 necessary to support the patients FIO2 needs.

Finally, having a 2 hour integrated battery ensures that in the event of a catastrophic power failure, the ventilator will be capable of supporting the patient for 2 hours with the GS500 and 4 hours without the GS500 allowing for the hospital staff to develop means for alternative support.

Volumetric CO2 is required so that proper tube placement may be verified at the bedside immediately post intubation. Furthermore, volumetric CO2 measurements ensure patient safety through breath by breath monitoring of gas exchange. Finally, volumetric CO2 may be utilized to optimize lung recruitment and reduce the risk of lung injury.

OFOC SOP Revision 06 Page 3 of 5

Revision 06 Date: 08/30/2017

The Evita V500 is currently the only ventilator that offers ICON support. The purchase of Dräger ventilators includes invaluable clinical support from ICON (Intensive Care Online Network) a Dräger exclusive at no charge. ICON services include:

Fully staffed resource center available for telephone and web based consultation 24/7 for Dräger customers and Dräger staff

Physician resource accessible to Dräger customers and Dräger staff for clinical consultation 24/7

Access to ICON’s quick reference software database of Dräger ventilators and current ventilation knowledge base, application and research.

Access to ICON’s electronic medical library of up to date journal articles regarding mechanical ventilation and patient management

Training facility on-site at ICON.

Physician based education for Dräger customers and Dräger staff

Interactive web site with educational tools and opportunity for on-line CEU’s for Dräger customers.

Development of customer tailored ventilator protocols.

Respiratory data management services.

Web cast educational seminars.

The Evita V500 is the only critical care ventilator with an integrated pneumatic nebulizer. This eliminates the need for expensive auxiliary electronic nebulizers. Additionally, only the V500 provides automatic compensation for the delivered tidal volume and FIO2. This ensures proper ventilator support and patient safety during the course of medication delivery.

The Buffalo VAMC has old end-of-life Draeger Evita XL ventilators which must be upgraded/replaced. The clinical advantages of the new Draeger Infinity V500 will greatly enhance the ICU department’s ability to wean patients in a timely manner, and provides modes of ventilation needed to decrease days on the ventilator and conintue with their decision to use totally disposable flow sensors and exhalation valves.

The nomenclature used in the V500 is similar to the Evita XL and the process of exchanging flow sensors and exhalation vlaves and set up is very similar thus requiring minimal staff training on the V500. Training can focus on the new therapeutic intervention features of the V500

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A Notice of Intent to Sole Source will be posted to FBO advising vendors in Classification Code 65 (Medical equipment) of the intent to purchase the required items on a brand name only basis.

The Contracting Officer contacted the Field Director for Government Accounts for Draeger Medical, Inc., Mr. Thomas Caltabiano, and inquired as to the availability of authorized Veteran Owned Small Businesses (VOSB) and/or Service Disabled Veteran Owned Small Businesses (SDVOSB). He responded stating that Draeger Medical Inc., does in fact have one (1) SDVOSB authorized vendor who will be able to provide the required items.

OFOC SOP Revision 06 Page 4 of 5

Revision 06 Date: 08/30/2017

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

If more than one offer is received, the proposals will be compared against one another as well as the Independent Government Cost Estimate (IGCE) and a fair and reasonable pricing determination will be made. If only one offer is received, the contracting officer will request pricing data from the vendor pertaining to previous awards to VA facilities and a price analysis will be conducted to determine fair and reasonable in accordance with FAR 6.303-2(b)(7).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

As described in Section 6 above, market research, in accordance with FAR Part 10, will be conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

A comprehensive search was conducted on the Veterans Information Pages (VIP) resulted in the following “hits”:

Drager – 0 Draeger – 0 Ventilator – 13

Additionally, a search on FPDS-NG for Drager, Draeger and Evita resulted in many “hits”, all for Draeger Medical, Inc.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Statement of Work attached

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Draeger Medical, Inc.

HMS Technologies, Inc.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required:

In this instance, CO determines that a brand name requirement is valid and appropriately justified.

Small business authorized distributors have been requested as required.

https://www.acquisition.gov/?q=/browse/far/6