LSJ.pdf

Chapter VI: Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Limited Sources Justification Format >$150K

OFOC SOP Revision 05 Page 1 of 5 Original Date: 03/22/11 Revision 05 Date: 05/02/2016

LIMITED SOURCES JUSTIFICATION

ORDER >$150,000

FAR PART 8.405 6

Acquisition Plan Action ID: ______VA241 18 AP 3991______

This acquisition is conducted under the authority of the Multiple Award Schedule Program. The material or service listed in par. 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 – Federal Supply Schedules, is precluded for the reasons indicated below.

Restricted to the following source: Provide original manufacturer’s name for material or contractor’s name for service. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.)

Manufacturer/Contractor: Draeger, Inc Manufacturer/Contractor POC & phone number: Stephen Moore, 978 380 8587 Mfgr/Contractor Address: 3135 Quarry Road; Telford, PA 18969 Dealer/Rep address/phone number: N/A

The requested material or service represents the minimum requirements of the Government.

(1) AGENCY AND CONTRACTING ACTIVITY: Department of Veterans Affairs VA Boston Healthcare System________ 1400 VFW Parkway________________ West Roxbury, MA 02132

VISN: 1

(2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED:

Limited acquisition procurement of twenty (20) Draeger Evita Infinity V500 (with nebulizer) ventilators and accessories for Respiratory at West Roxbury and the trade in of V500 (Puritan Bennett 840).

(3) (a) A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY’S NEED:

Twenty (20) Draeger Evita Infinity V500 (with nebulizer) ventilators to be used immediately following surgery, during treatments for lung disease or other conditions affecting lung condition, and for conditions affecting normal breathing including trauma, illness, infections, injury or disease. Ventilators also help with lung assessment and recruitment, patient weaning, patient monitoring and patient ventilator synchrony. Needs to be able to send alarms to the Curbell Medical nurse call system and the Philips Intellivue patient monitors via a Vuelink module. Needs to be able to send numerical, patient, physiologic data to the Philips Intellivue patient monitors via the Vuelink module and to the Clinicomp Essentris info system via the Clinicomp UDAS.

(b) ESTIMATED DOLLAR VALUE: $529,258.97

OFOC SOP Revision 05 Page 2 of 5 Original Date: 03/22/11 Revision 05 Date: 05/02/2016

(c) REQUIRED DELIVERY DATE: 9/30/2018

(4) IDENTIFICATION OF THE JUSTIFICATION RATIONALE (SEE FAR 8.405 6), AND IF APPLICABLE, A

DEMONSTRATION OF THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS TO PROVIDE THE

REQUIRED SUPPLY OR SERVICE. (CHECK ALL THAT APPLY AND COMPLETE)

Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources.

The Draeger Evita Infinity V500 (with nebulizer) is unique in the following product specifications: it has an internal and external battery, built in USB port for aerogen nebulizer option, does not require extra cables other than the USB device which is consistent with our current device, ETCO2 monitoring helps patient evaluation and weaning, disposable filters, and unique modes and capabilities that are not offered in competitive models.

A patent, copyright or proprietary data limits competition. The proprietary data is:

(If FAR 8.405 6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

The ventilator needs to be able to send alarms to the Curbell Medical nurse call system and the Philips Intellivue patient monitors via a Vuelink module. Needs to be able to send numerical patient physiologic data to the Philips Intellivue patient monitors via the Vuelink module and to the Clinicomp Essentris info system via the Clinicomp UDAS.

The new work is a logical follow on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

OFOC SOP Revision 05 Page 3 of 5 Original Date: 03/22/11 Revision 05 Date: 05/02/2016

An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.4

TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION:

This order represents the best value because Draeger’s V500 includes unique, specialized ventilation modes, lung recruitment tools, and advanced graphics. It also clearly presents patient status, ventilation settings, and alarms in a format that allows users to quickly assess the current clinical situation. It also includes SmartCare/PS for automated patient weaning, AutoFlow, Airway Pressure Release Ventilation (APRV) with AutoRelease, Smart Pulmonary View graphic lung display, Variable Pressure Support, Low Flow PV Loop for lung recruitment, and comprehensive graphics and trending capabilities. The anticipated cost to the government is fair and reasonable.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS

OR A STATEMENT OF THE REASONMARKET RESEARCHWAS NOT CONDUCTED:

The following manufacturer/models were researched: Medtronic Puritan Bennett 980, Maquet Servo U, Carefusion Avea, Hamilton G5, and GE Carescape R860. In addition to obtaining information from the professional organizations, ECRI and MD Buyline, onsite vendors provided demonstrations to clinical users and Clinical Engineering staff. The results are as follows:

Medtronic Puritan Bennett 980 – Hazards reported on inoperative flow sensor, battery failures, and display screen failures; high cost; aerogen nebulizer is an extra cost; ETCO2 monitoring is not available until October 2018 Maquet Servo U – Expiratory manifold is not disposable (adding additional cleaning between uses);

aerogen nebulizer is not available; external modules are extra costs; poor battery life Carefusion Avea – Utilizes a small volume nebulizer, which is not used anymore; no ETCO2 monitoring;

design is not durable; design has a large footprint; high cost Hamilton G5 – Hazards reported on software and display GE Carescape R860 – Device has not been in the market long; features/specs provide more than what is needed at VA Boston HCS (adding complexity for clinical users)

OFOC SOP Revision 05 Page 4 of 5 Original Date: 03/22/11 Revision 05 Date: 05/02/2016

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION:

(8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION

FOR THE SUPPLIES OR SERVICES IS MADE:

(9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

X

Signed by: people 5/11/18

SIGNATURE DATE

Lisa Bradley Supervisory Clinical Engineer Clinical Enginering

NAME TITLE SERVICE LINE/SECTION

VA Boston Healthcare Syste

FACILITY

(10) APPROVALS IN ACCORDANCE WITH THE VHAPM, Volume 6, Chapter VI: OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

a. CONTRACTING OFFICER’S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

Mary K. Bosch 948409 Digitally signed by Mary K. Bosch 948409 Date: 2018.05.14 07:24:04 -04'00'

William A. Prenzler 145645 Digitally signed by William A. Prenzler 145645 Date: 2018.05.14 08:06:01 -04'00'

P03 Signed Limited Source Justification-ICU Vents-signed MKB_WP