36F79720D0041-014.pdf

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 402-20-2-100-0033

Contracting Activity: Department of Veterans Affairs, VISN 01, VAMC Togus ME.

Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). This purchase request is for the purchase of new GE MAC VU360 ECG equipment to replace current fleet which is beyond useful life and is being replaced to maintain the same standard of care that is available at other facilities.

Order against: FSS Contract Number: V797P-4269B Name of Proposed Contractor: TrillaMed, LLC Street Address: 30100 Telegraph Rd. Suite 366 City, State, Zip: Bingham Farms MI 48025

1. Description of Supplies or Services:

The estimated value of the proposed action is $278,350.96

This procurement is for the purchase of eighteen new GE (General Electric) MAC VU360 ECG systems to replace the current fleet, which is beyond useful life, and is being replaced to maintain the same standard of care that is available at other facilities.

The GE MAC VU360 ECG System includes the ECG Machine and interconnecting components including: The GE Healthcare Echocardiogram (ECG)/Electrocardiogram (EKG) Acquisition and Analysis Cardiac Diagnostic System Model MAC VU360 with 12SL, High-Definition Pacemaker, and GE Modular MAC Trolley with Wi-Fi configuration, mounting arm, front and rear bins.

This procurement will allow VAMC Togus to upgrade current equipment to the latest technology, allowing the medical center to standardize to the level of care currently offered at other VA Medical Centers throughout VISN1, and to maintain commitment to and alignment with, the high quality of care supporting the VA mission.

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and (C) or 8.405-6(b)), 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)

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

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; GE 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; (FAR 8.405-6(a)(1)(i)(B)). The products of brand names specified above must be provided to maintain standardization between products currently used at the Boston VA medical center and outpatient clinics. Standardization allows for consistent and reduction of variability in stocking of parts and supplies and training of equipment users and maintainers.

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(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and

(C) or 8.405-6(b)), 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) (cont’d)

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.

Items peculiar to one manufacturer:

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.

(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:

These ECG machines are critical for patient care. The MAC VU360 system offers a comprehensive suite of ECG interpretation and clinically validated analysis programs. This equipment allows physicians to address a wider range of disease management needs and to make more expedient and accurate treatment decisions. Due to the complexity and the high profiles use of this equipment throughout VA Maine, the OEM, GE, is the only brand that can provide the services we need.

This GE MAC VU360 Smart Acquisition Technology offers: high-quality biofeedback, rapid ECG data readouts, seamless integration of ECG data from one workstation, and inherent EGC-system security.

The advantage of this technology compared to market equivalents, is that this ECG system enhances capabilities by reducing repeats, by providing immediate capture and display of first clean, high-quality ECG waveforms. The new Smart Lead Technology automatically detects a newly connected patient, isolating that data to avoid patient data mix-ups. The streamlined analytics enhances diagnosis by reducing waveform variability; the smart-system technology guides new and experienced users to clean, high-quality waveforms.

The GE MAC VU 360 affords efficiency and enhanced healthcare by increasing the accuracy and quality of diagnostics with Zero Phase Distortion technology. Specifically, this technology includes high-definition pacemaker detection not visible in the EGC waveform. It allows physicians to view and segregate artificial paced beats or conduction abnormalities.

This ECG system also improves patient comfort and facility of care. The height-adjustable Easy Clean trolley improves patient comfort and reduces workplace injury. The Easy-Clean surface and enclosed storage reduces risk of cross-contamination. The trolley also facilitates treatment due to its increased maneuverability and its ease of storage; this trolley is 12% smaller and lighter than other premium ECG Systems.

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The GE MAC VU360 also facilitates workflow via the improved Integration w/ MUSE and CV web Systems. This feature affords enhanced system connectivity and interface with MUSE System, allowing for ECG comparisons with multiple sets of data and with prior clinical studies. This serves to afford a higher-level of quality healthcare by providing healthcare professionals with quick access to informed cardiac-care decisions. The MAC VU360 supports DICOME ECG workflows, allowing user flexibility to select from a wide variety of third-party CVIS, EMR/HER and ECG management systems.

In summary, the Mac VU360 affords the best value to the government, for several reasons:

1. The GE MAV VU 360 ECG is built with wireless communication technology which is compatible with VA infrastructure. 2.

2. This system can send EKG’s to our Cardiology PACS system: MUSE, seamlessly and without modification or black box translation.

3. This GE ECG product looks and operates similar to our existing fleet, minimizing the education curve for clinicians and lowering risks of medical errors.

4. VAMC Togus, ME has historical knowledge of repair history of the GE MAC VU 360 ECG and EKG systems. We are confident that this new system will afford minimal downtime, as well as real-time availability of repair technicians.

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

RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

Market research was conducted In Accordance With (IAW) FAR 10.001. Exclusion of mandatory sources was determined (IAW) FAR 8.002: a) Excess from VA Inventories, b) Excess from Other Agencies (FAR 8.002); c) Federal Prison industries (NA); d) Industries for the Blind (NA). (Cont'd Page 3). None of the mandatory sources were capable of satisfying acquisition needs.

In accordance with VAAR 819.7005 and 819.7006, market research was expanded, geared towards identifying SD/VOSB (Service-Disabled/Veteran-Owned Small Business vendors, offering contracting opportunities to at least two responsible VIP (Veteran Information Pages)-vendors, IAW VFCP (Veteran’s First Contracting Program), IAW VAAR 810.001-70, who were capable, and likely to offer “fair and reasonable” pricing (VAAR 813-003-70(c)), complying with 38 USC 8127(d), “The Rule of 2.” Extensive market research was conducted. A VetBiz screening for NAICS Code 334510, using the Keywords: “GE MAC VU 360. This screening identified twenty-nine SDVOSB. Of the twenty-nine SDVOSB vendors, only one vendor, TrillaMed, LLC, is an authorized SDVOSB distributor for GE Healthcare.

Market research revealed that there is moderate availability for procurement on the open market.

Following the precedence established per FAR 8.004 (a)(1) and VAAR 808.004-70, market research was redirected to non-mandatory sources, with hopes of locating responsible small business vendors, who were capable of fulfilling requirements, and who would also be likely to offer “fair and reasonable” pricing.

A search of the GSA Library, FSS (Federal Supply Schedule) contracts, yielded forty-two potential vendors under Schedule 65 II A Medical Equipment and Supplies, SIN A-53: ECG/EKG Apparatus. Of the forty-two vendors, there were: 8 SDVOSBs, 4 VOSBs, 20 Small Businesses, and 10 Large Business vendors identified as potential acquisition sources.

IAW FAR 19.202-2, a RFQ was/was not dispatched, due to the unique capabilities required and the limited distribution channels available required with regard to the GE MAC VU 360 ECG System. The VISN1 VA Healthcare System is seeking to standardize upon the GE MAC VU 360 ECG and EKG technology, due to the advances in patient care technology offered by the GE MAC 360 technology, and due to the value in economy afforded by a sole source procurement.

Market research indicates that best value would be best achieved with the GSA FSS Schedules offered via Schedule 65 II A, SIN A-53: ECG and EKG Apparatus. Additionally, the Government will achieve a best value outcome due to efficiency afforded by ease of access for technical services and training, and, due to the ease of re-supply and upgrade

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The total value of the proposed procurement for VAMC Togus, ME is $278,350.96. According to market research, this is the “best-value” price on the market. This price offered by the FSS Contract V797P- 4269B. This contract is held by TrillaMed, LLC, a SDVOSB.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION:

The GE MAC VU 360 ECG offers excellent cybersecurity. The DEPS (Design Engineering for Privacy and Security) technology is designed to provide ongoing security vigilance and while facilitating customer communication. This system easily integrates with GE record-keeping equipment.

(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.

SIGNATURE DATE

NAME TITLE 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 and belief.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

NAME AND TITLE FACILITY

3/12/2020

Stacey Morissette Supervisory HSS/AO Medical Service

VA Maine Healthcare System, Togus

SISSSSSSSSS GNATURURURURURURURUURURU EEEEEEEEEE

Stacey Morisrisrisrisrisrisisrisisssetsesseseseseseseses te

VHAPM Part 808.405-6 Limiting Sources Page 5 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

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

NAME

NCO/PCO XX Duty Title

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

c. VHA SAO 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.

NAME DATE

VHA Head of Contracting Activity (HCA)

d. VHA Senior Procurement Executive Approval (over $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 other than full and open competition.

JAN R. FRYE DATE

Deputy Assistant Secretary Office of Acquisition and Logistics Senior Procurement Executive (SPE)