P03 LSJ_Signed.pdf

VHAPM Part 808.405-6 Limiting Sources Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

LIMITED SOURCES JUSTIFICATION

ORDER >SAT FAR PART 8.405-6

Acquisition Plan Action ID: 36C241-20-AP-0389

1. Contracting Activity: Department of Veterans Affairs, RPOE (Regional Procurement Office East), for the seven (7) VA Medical Centers: Boston-Jamaica Plain/West Roxbury VAHCS, Providence RI VAMC, West Haven CT VAHCS, Togus VAHCS Augusta ME, White River Junction VAMC VT, VAMC Manchester.

2. Description of Action: This acquisition is conducted under the authority of the Multiple-Award

Schedule Program (40 U.S.C. 501). The procurement is for a new Blanket Purchase Agreement contract to replace the current versions of Draeger anesthesia machines, on which the entire VISN 1 has standardized for the last 9 years. VISN 1 is seeking Draeger’s latest technology anesthesia machines that are available, mounting hardware for current patient monitors, hoses and accessories to complete the system. The current 45 Apollos, Fabius GS and Fabius Tiro machines are nearing their full depreciation. The newest Draeger anesthesia machines will be installed in the operating rooms at all VISN 1 sites as replacements for the depreciated machines currently in use.

Order against: FSS Contract Number: FSS Contract Number: 36F79718D0369

(04/15/2018 – 04/14/2023)

Name of Proposed Contractor: Draeger, Inc.

Street Address: 3135 Quarry Road

3. Description of Supplies or Services: The estimated value of the proposed action is $ 2.1 Million BPA (Blanket Purchase Agreement) for up to five years.

Anesthesia machines are essential for anesthetizing VISN 1 Veterans requiring surgery or special procedures.

The veteran population of VISN 1 include a wide range of ages and diagnoses including acute and chronic lung diseases, cardio-thoracic abnormalities, and metabolic disorders resulting in vascular deficiencies as well as morbid obesity that require precise and advanced modes of ventilation. VISN 1 will be replacing approximately the forty-five depreciated Draeger machines (Apollo, Fabius GS, and Fabius Tiro) anesthesia machines with the newest version of Draeger anesthesia machines, mounting hardware for current monitors, hoses and accessories to complete the system. An upgrade to the latest version of Draeger anesthesia machines will enable VISN 1 to reuse their current vaporizers and accessories such as absorber canisters and flow sensors.

4. Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service).

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

4. Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service). (Cont’d from P1.)

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

Anesthesia machines are life critical systems. In order to meet the patient safety requirements of our facilities, these systems must not be reliant upon electrical power for fresh gas flows (O2, Air, N2O, anesthetic agent), and for continued delivery of anesthetic agent. Draeger is the only manufacturer of anesthesia systems possessing this capability.

There is no other machine with the unique features listed below, on the market.

Draeger machines combine the optimal design of an “actively heated breathing system” with the ability to use minimal gas flows. The similar user interface of Draeger anesthesia machines means an easy transition and less training needs for the clinical and biomedical staff.

All Draeger anesthesia machines (exception: Fabius MRI) have “actively heated breathing systems” which help warm the gas delivered to the patient to help maintain body temperature; and help reduce the risk of airway complications.

One of the reasons minimal anesthesia flow is possible, is that Draeger anesthesia machines eliminate systematic leaks by returning the exact gas sampled for analysis back to the breathing system. Other market brands return a mixture of sampled gas and ambient air, effectively diluting the gas in the breathing system.

Heated breathing systems and minimized gas flow maximizes cost savings by reducing expensive anesthetic reagent usage. This significantly decreases the amount of carbon-based greenhouse gases being released into the surrounding atmosphere, which reduces environmental footprint. This feature also helps to prevent condensation in the breathing system, reducing system malfunction.

The Low Flow Wizard SW option monitors the adequacy of fresh gas flow. The feedback loop of the Low Flow Wizard quantifies the most efficient fresh gas flow, providing for real time compliance via simple color and text feedback. The use of the Low Flow Wizard SW option reduces anesthetic agent costs by 50%.

The anesthesia machine must utilize an electronically controlled, electrically driven piston ventilator that is not dependent on drive gas or flow sensor feedback for automatic ventilation. This feature creates higher inspiratory flows producing accurate tidal volumes during periods of extremely low lung compliance and eliminates excessive consumption of oxygen, characteristic of bellows type devices. The Draeger machine decouples fresh gas flows from the ventilated volume thereby providing precise inspiratory volume.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, 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.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: The proposed anesthesia machines, the associated technology, and anesthesia processes/techniques are exclusive to Draeger, Inc.

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.

Draeger’s Innovian anesthesia record keeping system is currently standardized throughout VISN 1. Draeger’s Anesthesia machine and Innovian have been designed to work together as a highly integrated anesthesia workstation. This is beneficial to VISN 1 because integration is managed by a single vendor, Draeger. Software releases for Innovian and the anesthesia machine are harmonized and validated before release and are guaranteed to work together. Furthermore, VISN 1 may use existing device interface licenses and device interface cables, saving the cost of purchasing new of both by VISN 1 which would be required if a different vendor anesthesia machine is selected. This is a savings of $64,275.00 for VISN 1.

Draeger anesthesia machines use the same accessories which will save each site from stocking multiple brands of consumables and accessories.

5. Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: No other brand of anesthesia machines have the unique features (previously described) and benefits offered by the Draeger anesthesia machine. Purchasing Draeger machines will provide consistent operation at all locations (OR, MRI, or ancillary areas) and will allow users to respond intuitively during emergency situations.

This helps reduce VISN 1’s investment in clinician, biomedical staff and technician training.

Draeger’s latest anesthesia machines use the same consumables and accessories saving the sites from stocking multiple brands.

6. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. The following were considered during the market research phase. Results as follows: The NAICS for this procurement is 339112, Anesthesia Apparatus.

Market Research confirms that the Draeger brand machines are the only machines which meet the VA’s needs, due to the unique safety technology, and due to its ability to operate without electrical power. Pursuant to the Veterans First Program, the manufacturer was asked if any SDVOSBs/VOSBs are authorized to sell the required product to the VA. Per the manufacturer, there are two (2) SDVOSBs which are authorized.

HMS Technologies, Inc: One Discovery Place Martinsburg, WV 25403 Office: 304-596-5583 | Fax: 304-596-5589 www.hmstech.com

JANZ Corporation: 6950 F Americana Parkway Reynoldsburg, Ohio 43068 Office: 614-759-7700| Fax: 614-754-5234 www.janzcorp.com

Although both SDVOSB vendors are authorized distributors, they are not authorized to provide training. Beyond satisfaction of socio-economic goals--no value is added. The SDVOSB distributors function as pass-throughs.

Per VAAR 852.219-10(a)(1)(v) and 13 CFR 121.406(b)(1)(iv), the Non-Manufacturing Rule (NMR), neither HMS or Janz qualify for a set-aside. Since no value is added by either SDVOSB, selecting either SDVOSB over the OEM would violate subcontracting limitations per 13 CFR 121.103. Therefore, the OEM is the only source deemed as capable of fulfilling this requirement.

7. Any Other Facts Supporting the Justification: Significant cost savings will be realized via direct procurement from the manufacturer via a 39.6% VA discount offered against the FSS Price List (36F79718D0369), and an additional 5% discount for a BPA. The substantial and appreciable mark-up of SDVOSB conduits offers no value-added to the transactions under this BPA. The added cost would burden the Clinical Engineering budget and poses greater performance risk.

In addition, technicians have been sent out for Draeger Anesthesia Machine PM training, reducing costs when compared to separately procured service contracts. Biomedical technicians would have to be retrained across the VISN for other brands of anesthesia machines, nullifying the cost-savings achieved.

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: The Government will continue to conduct market research to ascertain if there are changes in the marketplace related to the anesthesia machines which have these special features. As innovative technology increases, future orders for anesthesia machines will be reviewed for competition. The LSJ will be posted to Contract Opportunities.

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.)

ASHLEY S.

Digitally signed by ASHLEY

S. O'MARA 233020

O'MARA 233020 Date: 2020.04.24 15:37:22 4/24/2020

SIGNATURE DATE

Ashley OMara Chief Clinical Engineer

NAME TITLE

Clinical Engineering VA New England Healthcare System

SERVICE LINE/SECTION FACILITY

10. APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP:

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

Linda J. Ward 155235 Digitally signed by Linda J. Ward 155235 Date: 2020.04.27 08:25:24 -04'00'

CONTRACTING OFFICER DATE

Linda Ward, Branch Chief NCO1 Manchester, NH 03104

-04'00'

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

Tammy FoxDivision Chief, NCO1 Manchester, NH 03104

HIGHER LEVEL APPROVAL (Required for orders over $700,000):

c. VHA RPO HCA Review and Approval (over $700,000 to $68 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Joseph P. Maletta Executive Director, Regional Procurement Office - East (RPO-E)

Tammy A Fox 706200 Digitally signed by Tammy A Fox 706200 Date: 2020.06.24 09:49:02 -04'00'

JOSEPH MALETTA

1347841

Digitally signed by JOSEPH

MALETTA 1347841

Date: 2020.06.24 15:39:31 -04'00'