Sole Source JA - Anesthesia Machines - Signed.pdf

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 8 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C259-21-AP-1732

RPOW JOFOC Tracking ID: 2021-03-12T11:38:47

1. Contracting Activity: Organizational Activity:

Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office 19 VA Montana Health Care System 6162 S. Willow Dr. Suite 300 3687 Veterans Drive Greenwood Village, CO 80111 Fort Harrison, MT 59636

2237: 436-21-2-029-0027

2. Nature and/or Description of the Action Being Processed:

This justification is intended to result in the award of a single firm fixed price award for Draeger Perseus A500 anesthesia machines.

The VA Montana Health Care System is in need of six (6) brand name Draeger Perseus A500 Anesthesia Machines for delivering anesthesia. The current anesthesia machines are past their lifespan and are experiencing multiple part and sensor failures. The facility does not currently have enough reliably performing machines to manage the needs of scheduled procedures.

Total estimated cost is $536,475.10.

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

Item Description Part Number Qty Unit 0001 Perseus A500 MK06000 6 EA 0002 Main

Configuration:

Basic unit, trolley based

MK08190 6 EA

0003 Electronic Gas Mixer

OPC5763 6 EA

0004 Option: Vapor Communication

OPC5760 6 EA

0005 Quick Reference Guide, En US

9055395 6 EA

0006 Gas Supply for Hanging Gas Cylinder

MK09838 6 EA

0007 Pressure Reducer O2 for Small Cylinder

MK10222 6 EA

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Revision 03 Date: 02/11/2021

0008 Auxiliary Power Outlet

MK09888 6 EA

0009 Mounting Pole Right

MK08523 6 EA

0010 Ventilator and Display

MK08311 6 EA

0011 Pressure Support MK08317 6 EA 0012 Breathing Sound

EM.

MK08316 6 EA

0013 Flexible Breathing Bag Arm

8605088 6 EA

0014 Control Valve NPT 8605566 6 EA 0015 Endotrach Suction

DISS, VAC

MP00686 6 EA

0016 Mounting Kit VAC Suction

MK08653 6 EA

0017 Suction acc. MK10069 6 EA 0018 Mounting Pole

Right

MK08523 6 EA

0019 Pressure Gauge MK09494 6 EA 0020 Drawer Module

Large

MK09854 6 EA

0021 Box with writing tray

MK08487 6 EA

0022 Adapter DISS

M/QC-O2

Ohmeda

4119073 6 EA

0023 Adapter DISS

M/QC-N2O

Ohmeda

4119070 6 EA

0024 Adapter DISS

M/QC-AIR

Ohmeda

4119071 6 EA

0025 Adapter DISS

M/QC-VAC

Ohmeda

4119072 6 EA

0026 Adapter DISS

M/QC-EVAC

Ohmeda

4119074 6 EA

0027 O2 CS hose 10 ft

DISSN/DISSN

4185140 6 EA

0028 N2O CS hose 10 ft

DISSN/DISSN

4185142 6 EA

0029 AIR CS hose 10 ft

DISSN/DISSN

4199605 6 EA

0030 VAC CS hose 10 ft

DISSN/DISSN

4199602 6 EA

0031 EVAC hose DISSN/DISSN 10 ft

4199599 6 EA

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Revision 03 Date: 02/11/2021

0032 Infinity ID Waterlock2

6872020 12 EA

0033 Draeger CLIC Absorber 800+

MX00004 30 EA

0034 Draeger CASTrGARD, small, set of 4

M36049 4 EA

0035 Vapor 3000 Anesthetic Vaporizer

M36500 6 EA

0036 Sevoflurane Filling System

OPC5639 6 EA

0037 D-Vapor 3000, Anesthetic Vaporizer, Desflurane

M36700 6 EA

0038 D-Vapor 3000 Front Cap

OPC5638 6 EA

0039 IACS Monitoring with C500

MS25510 6 EA

0040 Infinity Acute Care System

OP90127 6 EA

0041 Draeger M500 Cable Hook

MS26297 6 EA

0042 Draeger SW 12- Lead

OP90168 6 EA

0043 Draeger SW Arrhythmia II

OP90169 6 EA

0044 Draeger SW Multi

IBP

OP90170 6 EA

0045 Draeger SW M540 Wireless

MS16266 6 EA

0046 IACS Delivery Connectivity

MS34178 6 EA

0047 Device Interface OP90513 6 EA

0048 SW OPT, UPG &

IFU IACS/M540

MS32129 1 EA

0049 IACS S/W Options View Editor

OP90519 1 EA

0050 CK Power Supply for Drawers XL

MK09929 6 EA

0051 Swivel Arm 400x400mm M540

MK08599 6 EA

0052 SPO2 Nellcor Cable

MS20979 6 EA

0053 SPO2 Nellcor Sensor

7262764 6 EA

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Revision 03 Date: 02/11/2021

0053 ECG 3-Lead single pin

MP03402 6 EA

0054 ECG 5-Lead single pin

MP03404 3 EA

0055 ECG Extension single pin

MS16256 6 EA

0056 Draeger NBP Extension Hose Adult

MP00953 6 EA

0057 Draeger Infinity MCable Dual Hemo

MS20783 4 EA

0058 Transducer Cable MS22535 8 EA 0059 Temp Probe

Adapter Cable

5198333 6 EA

0060 Infinity R50-N Recorder

5740068 6 EA

0061 Clinical Applicat.Supp Anesthesia

1975970 5 EA

The estimated period of performance includes delivery thirty (30) days after receipt of an order.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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 Draeger Perseus A500 anesthesia machine is the only anesthesia machine manufactured with Airway Pressure Release Ventilation (APRV). APRV is a ventilator mode used in the ICU which has the ability to constantly recruit alveoli, improving oxygenation while minimizing injury from the ventilator. In APRV, the breathing ratios range from 8:1 to 12:1 and even higher which creates an almost constant alveolar recruitment. APRV improves oxygenation by creating better gas exchange, improved lung compliance and decrease work of breathing. It also prevents atelectasis, which is a

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Revision 03 Date: 02/11/2021 common postoperative pulmonary complication and has been shown to prevent acute respiratory distress syndrome (ARDS).

APRV is indicated for patients that have an acute lung injury, ARDS with or without COVID-19, sepsis, obese patients or any patient that is oxygenating poorly because of atelectasis. The Fort Harrison VA hospital is the only VA Medical Center and VA ICU in Montana. The Veterans seen at this facility routinely fall within these high-risk categories. In order to provide the greatest level of consistent safety to these patients, APRV is required for any new anesthesia machines.

Additionally, APRV is required as part of the COVID action plan at the Montana facility. The anesthesia machines are intended for use as long-term ventilators as part of the hospital’s contingency plans. The safety of APRV across multiple categories of high-risk patients provides a safe means of patient support if needed to supplement COVID patient care.

Draeger has stated that their authorized distributors would not be able to provide a quote on the newest version of the patient monitoring software because all the tasks to allow commercial availability through them likely wouldn’t be complete until after 9/30/2021.

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

The required product is manufactured by large business (Draeger, Inc.) and is supplied by at least three (3) authorized Service-Disabled Veteran Owned Small businesses (SDVOSB) distributors:

1. The Janz Corporation

2. Beacon Point LLC

3. Sierra 7, Inc.

The Janz Corporation and Sierra 7, Inc. both have GSA schedules; however, the required product is not listed on their price lists.

A sources sought (36C25921Q0164) was posted to Contracting Opportunities at beta.SAM on 12/22/20 with a close date of 12/31/20. Responses were received from three (3) vendors stating that they could provide the required product (Draeger, Inc., The Janz Corporation, and Sierra 7, Inc.)

and one (1) company that stated they could meet the requirement through other means. (TrillaMed, LLC).

TrillaMed, LLC stated in their sources sought response that “some of the specifications can be met/exceeded through alternate ways, but with the same intended clinical outcome.” Further analysis by the VA’s technical experts indicated that the clinical outcomes were not comparable between GE machines and the Draeger machine for the following reasons:

1. The Time High for Draeger is 10 seconds while it is only 5 seconds for GE.

The Time High is the time of inspiration and is one of the key elements in gaining the recruitment benefits of APRV. The ventilator inspiratory time is the main limiter of GE in achieving similar results to the APRV present on Dreager machines.

2. The Inspiratory:Expiratory Ratio of Draeger is 1:50 to 50:1. For GE, that ratio is 1:8 to 2:1; therefore, it would not be possible to recreate the same clinical outcomes of which Draeger is capable.

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Revision 03 Date: 02/11/2021

An individual waiver of the nonmanufacturer rule was granted by the SBA on 7/9/2021. After issuing the solicitation on Contract Opportunities (www.SAM.gov), an employee of Draeger called and emailed stating that a new software release for patient monitoring is in the final stages of US marketability but that the SDVOSB suppliers would not be able to provide a quote until it got approved. He also stated that Draeger could sell these machines directly to the Department of Veterans Affairs with the existing software and provide an upgrade to the new version, when available. That option was not available for the SDVOSBs due to it not being commercially available yet.

Draeger believed that the software would get approved before 9/22/2021 so an amendment was issued to extend the solicitation. On 9/16/2021 Draeger provided an update stating they did not believe the software would get approved by 9/22/2021 and that they could not promise it by 9/30/2021.

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

Anticipated cost to the Government will be fair and reasonable based on comparison of proposed prices from similar requirements for anesthesia machines.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research conducted and the results include the following.

- A search of www.Vip.vetbiz.va.gov with NAICS 339112 and keyword “anesthesia” found 2

SD/VOSB.

- A search of www.fpds.gov found that the VA has purchased anesthesia machines from SDVSOBs and the VA has purchased anesthesia machines from large businesses, Draeger Medical and GE Medical.

- Through postings on Contract Opportunities via beta.SAM.gov, it was identified that there are at least three (3) companies capable of providing the requirement.

- An SBA Dynamic Search with NAICS 339112 and keyword “anesthesia” found 38 small businesses.

The technical experts reviewed the websites of GE, Draeger, Mindray and Avante (via the information in the following websites) and found the Draeger Perseus A500 is the only anesthesia machine manufactured with an APRV.

https://www.gehealthcare.com/products/anesthesia-delivery/avance-cs2 http://www3.gehealthcareturkiye.com/~/media/documents/turkey/products/anesthesia%20del ivery/product%20specification%20sheets/aisys%20cs2/aisys%20cs2%20spec%20sheet.pdf?Pare nt=%7B4EAD3924-0CD3-4A07-B9EF-FC1F9B92A68A%7D https://www.draeger.com/Products/Content/perseus-mechanical-pi-9069004-en-1506-2.pdf https://www.mindraynorthamerica.com/cmsAdmin/uploads/a7-us-brochure_tri-fold_1487-revb.pdf https://storage.googleapis.com/avante/documents/Avante_Integra_SL.pdf

Based on the market research conducted, although there are two or more VIP verified and capable SDVOSBs identified that appeared capable of performing the requirement, the nonmanufacturer

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Revision 03 Date: 02/11/2021 rule as set forth in 13 CFR 121.406(b)(1)(iv) cannot be satisfied and precludes the use of a set aside for this requirement. An individual class waiver of the nonmanufacturer rule was granted but after issuing the solicitation as an SDVOSB set-aside, it was determined that only the manufacturer, Draeger, would be able to provide a quote for the required patient monitoring software. Therefore, it is anticipated that a sole source award will be made to Draeger.

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

The anesthesia machines currently at the facility are beyond end of life. Operational failures prevent reliability of the machines for scheduled patient procedures.

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

1. The Janz Corporation, SDVOSB, cannot meet requirements for newest patient monitoring software

2. Sierra 7, Inc., SDVOSB, cannot meet requirements for newest patient monitoring software

3. Draeger, Inc., Large Business, stated that they can meet all requirements

4. TrillaMed, LLC., SDVOSB, stated that they would offer GE which does not meet the APRV requirement

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:

The station will continue to search for other equal anesthesia machines for future requirements.

The technology behind APRV is becoming more widely accepted and it is anticipated that the number of machines offering this feature will increase for subsequent acquisitions.

12. 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 and belief.

Patrick J. Davidson, CRNA Anesthesia Dept Montana VA Health Care System

Patrick J. Davidson 1794332

Digitally signed by Patrick J. Davidson 1794332 Date: 2021.09.21 10:27:16 -06'00'

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Revision 03 Date: 02/11/2021

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Maurice Walker Contracting Officer, Supply 2 VHA Regional Procurement Office West Network Contracting Office (NCO) 19

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Jason Thomas Division Chief VHA Regional Procurement Office West Network Contracting Office (NCO) 19

MAURICE J.

WALKER 170775

Digitally signed by MAURICE

J. WALKER 170775

Date: 2021.09.21 11:40:18 -06'00'