36C26219C0124-001.pdf

OFOC SOP Revision 08 Page 1 of 5 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C262-19-AP-4403

1. Contracting Activity:

Department of Veterans Affairs, VISN 22, VA Loma Linda Healthcare System has a requirement for Preventive Maintenance and Inspection (PMI) on Government-Owned General Electric (GE) MacLab and ComboLab systems service contract, which will require justification for other than full and open competition. The funding request number and Acquisition Plan Action ID are identified below:

Table 1 – Acquisition Plan ID

Funding Request Number Acquisition Plan Action ID

605-19-3-027-0183 36C262-19-AP-4403

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

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for a Sole Source contract for Preventive Maintenance and Inspection (PMI) on Government-Owned GE MacLab and ComboLab systems at VA Loma Linda Healthcare System (VALLHS) in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

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

This is an all-inclusive service contract that will cover parts, labor, service, software and technical support on the MACLABs & COMBOLAB.

1. GE MACLAB System integrated with GE IGS 740 System. AssurePoint Standard 8-9 INV, service.

2. GE MACLAB System integrated with Siemens Bi-plane System. AssurePoint Standard 8-9 INV, service.

3. GE COMBOLAB System integrated with GE Innova System. AssurePoint Standard 8-9 INV, service.

The PMI service contract will cover repair, exchange, labor, and maintenance on each unit, plus needed repairs during the term of the contract. Replacement parts will be furnished on an exchange basis at GE Healthcare’s expense and will be a new part or reconditioned part equivalent to new. All preventive maintenance are to be completed in accordance with OEM specifications and any maintenance completed during the terms of the contract will result in a complete service report provided to the VALLHS.

The following are included features of AssurePoint Standard:

• Field Engineer (FE) Onsite Coverage Hours: Mon - Fri, 8am-9pm

• FE Onsite Response Time: Within 24 Hours

• Insite Remote Diagnostics: Included for Applicable Products

• Parts Delivery: Priority

OFOC SOP Revision 08 Page 2 of 5

Revision 08 Date: 04/18/2018

• Phone Clinical Apps Support: Mon-Fri, 8am-5pm

• Phone Tech Support Coverage Hours: 24x7

• Phone Tech Support Response: 1 Hour

• Preventive Maintenance Coverage Hours: Same as FE Onsite Coverage Hours

• Uptime Commitment: 99%

The estimated total dollar value of the contract, including options, is $350,685.00. The Period of Performance are as follows:

Table 2 – Period of Performance

Base Year 07/01/2019 – 06/30/2020 Option Year 1 07/01/2020 – 06/30/2021 Option Year 2 07/01/2021 – 06/30/2022 Option Year 3 07/01/2022 – 06/30/2023 Option Year 4 07/01/2023 – 06/30/2024

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1(b)(2);

( ) (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):

GE Healthcare is the original equipment manufacturer (OEM) of the MacLab and ComboLab equipment and maintains hardware/software components. GE Healthcare Field Service Engineers (FSE) are trained and certified by GE Healthcare and are authorized to perform scheduled/unscheduled repairs to the MacLab and ComboLab systems. In accordance with the MacLab/ComboLab service manual regarding troubleshooting and repair, “Diagnosing and correcting problems with the MacLab/CardioLab system must be done by a trained GE Healthcare Field Service Engineer.” Currently, GE Healthcare has not authorized, nor does it endorse, any third parties to service the MacLab and ComboLab systems.

GE Healthcare’s ComboLab and MacLab systems are highly specialized tools requiring unique skills and test equipment to keep these systems within OEM. The MacLab and ComboLab systems are classified as Level II Medical Devices meaning thay have a moderate to high risk to the patient and/or user. Maintaining these systems incorrectly can cause improper function of the unit, impairment of diagnostic procedures, and can potentially injure staff and patients.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An Intent to Sole Source notification (36C26219R0103) was posted on Federal Business Opportunities (FBO) from May 21, 2019 – May 31, 2019 for all vendors to respond.

The posting yielded zero (0) response.

OFOC SOP Revision 08 Page 3 of 5

Revision 08 Date: 04/18/2018

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

Determination of cost fair and reasonableness will be accomplished by comparing the estimated contracts total value with other similar contracts that were previously awarded by NCO22. No cost escalation was included in the quote submitted by GE Healthcare.

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

Table 3 – Market Research Summary

Resource Technique Result vip.vetbiz.va.gov

Keyword: MacLab NAICS: 811219 Zero (0) potential vendors

Keyword: ComboLab NAICS: 811219 Zero (0) potential vendors

NAICS: 811219

State: California 142 potential vendors fbo.gov

Intent to Sole Source Special Notice Posting Zero (0) Responses

Keyword: MacLab

8 Postings by agencies other than NCO22.

Three (3) of the eight (8) were Intent to Sole Source Notice; One (1) was a J&A Notice; three (3) were Sources Sought

Notice; and One (1) was for a Combined Synopsis.

fpds.gov

Keyword: MacLab

NAICS: 811219

Thirty-five (35) Contract Actions Reported. Four (4) vendors were awarded contracts. All vendors are Large Businesses. Three (3) of the four (4) vendors is GE or a subsidiary of GE. One

(1) contract awarded to Spectranetics

Corporation.

Keyword: ComboLab

NAICS: 811219

Three (3) Contract Actions Reported.

Only one (1) vendor received award – GE

Keyword: MacLab, ComboLab

NAICS: 811219

Zero (0) Contract Actions Reported.

dsbs.sba.gov

Keyword: MacLab NAICS: 811219 Zero (0) vendors.

Keyword: ComboLab NAICS: 811219 Zero (0) vendors.

OFOC SOP Revision 08 Page 4 of 5

Revision 08 Date: 04/18/2018

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

NCO22 has awarded 2 contracts in the past for the same or similar requirement. Details of the previous contracts are as follows:

Table 4 – Acquisition History

Contract Number Station Competition Requirement

# of Offers Received

Awardee

VA26214C0175 San Diego Competed Under SAP – No Set Aside 1 General Electric

VA26217P0136 Loma Linda Not Competed - Only One Source 1 General Electric

An approved justification and approval was obtained for contract number: VA262-17-P-0136.

Contract number VA262-14-C-0175 was competed full and open, however, only 1 quote was received and that was from the OEM – General Electric.

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

GE Healthcare 3000 N Grandview Blvd W443 Waukesha, WI 53188

Size Standard: $20.5M

DUNS: 073838534

Large Business

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:

Currently GE Healthcare is the sole authorized vendor who can perform the services required for the MacLab and ComboLab systems. At the exercise of each option year, market research will be conducted to verify if GE Healthcare is still the sole provider of services and hardware and whether the contract still satisfy VALLHS requirement.

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.

ROLANDO JARA Date Supervisor, Biomedical Equipment Support Specialist VA Loma Linda Healthcare System

VHALOMMorfoS Cross-Out

VHALOMMorfoS Cross-Out

VHALOMMorfoS Typewritten Text Sarah Morford Chief, Biomedical Engineering

VHALOMMorfoS Typewritten Text 6/10/2019

OFOC SOP Revision 08 Page 5 of 5

Revision 08 Date: 04/18/2018

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.

TIEN NGUYEN-TU Date Contracting Officer

NCO22

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

SANDRA L. FUSCO Date Branch Chief, Services I&II

NCO22

http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx