-17649.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 08 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: 36C249-19-AP-1707

1. Contracting Activity: Department of Veterans Affairs, VISN 09, Memphis VA Medical Center, Network Contracting Office (NCO) 9, Purchase Requisition 614-19-3-560-0095.

2. Nature and/or Description of the Action Being Processed: This is a new request for a patient monitoring system upgrade at the VA Memphis Medical Center [Facility] due to obsolescence of the current equipment. The patient monitoring system is fully-integrated and covers bedside and telemetry monitoring capabilities throughout the medical center. This is a sole source action as the patient monitoring system is not only proprietary but utilizes proprietary infrastructure already in place and remaining at the Facility. Firm fixed price contract is planned for this requirement.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for a patient monitoring system upgrade 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 request is for the bedside monitoring portion of the patient monitoring system at the Facility. Components included in the requirements are as follows: patient monitors (Qube), telemetry receivers (Xhibit), and central stations (Xhibit/Xprezzon) for applicable clinical care areas, support infrastructure (cabling, connectors, etc.) as required, project management, installation and training. The primary affected equipment with estimated quantities is listed as follows:

Estimated QTY: Model type Model # Replace with

54 SL2800 91387 Xprezzon

26 SL3800 91387 Xhibit

SL2400 91369-241QU04 Qube

14 SL2600 91370-261QU04 Qube

The primary equipment will have upgrades and replacements to their accessories, associated software packages, and adapters like nasal/oral CO2 cannulas, blood-pressure cuffs, monitoring cables, roll stands, Ultraview SL Command Modules, patient worn telemetry units, and so on.

OFOC SOP Revision 08 Original Date: 03/22/11

The Facility needs to complete the remaining equipment upgrade and facilitate replacement of remaining equipment for its remaining 19 departments still using Spacelabs Healthcare patient monitoring and telemetry equipment that has reached the end of its lifecycle. The upgraded patient monitoring and telemetry system will allow clinicians and staff increased functionality, which will facilitate greater efficiency and proficiency in monitoring patient physiological information in real-time. The upgrade shall include delivery and installation of new Spacelabs Healthcare patient monitoring and telemetry system, training, and maintenance and support services. The period of performance is a 12-month base period for delivery of upgrade equipment, installation, training, maintenance and support. Estimated Cost: $4,042,055.08

4. Statutory Authority Permitting Other than Full and Open Competition: FAR 13.5, Simplified

Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C 1901 and is implemented by for restricting competition on this procurement via FAR 13-106-1(b)(2).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): A patient monitoring system is comprised of multiple, fully integrated components: bedside monitors, central stations, telemetry antennas and transmitters, database and application servers, infrastructure (cabling) and software.

This upgrade of both hardware and infrastructure is for the bedside monitoring, central stations, telemetry receivers, and associated support infrastructure portion of the system. Due to the proprietary nature of complete patient monitoring systems, bedside monitors and central stations purchased from another vendor would not integrate with the database servers and other components that are already in place.

In 2013, the telemetry portion of the system was upgraded (614-A39103) at a cost of $721,849.10.

Additionally, bedside monitors were purchased for the Emergency and PACU Departments in 2015 (614-A59066) at a cost of $362,459.13 and support servers for Spacelabs IntesysClinicalSuite software were upgraded in 2018 (614-A89092) at a cost of $118,998.05. If another vendor was selected, all these system components would have to be replaced unnecessarily increasing the value of this acquisition by an additional $1.2M+. All previously-mentioned acquisition actions for system upgrades and additions were awarded Sole- Source to Spacelabs under their VA NAC, contract - V797D-40190.

Installation of another brand name physiologic patient monitoring and telemetry system would require that the entire telemetry and IT infrastructure and upgraded equipment be replaced. Two unique patient monitoring and telemetry systems would need to be maintained while de-install and install activities take place. This would require nursing staff to perform identical clinical interventions on two non-similar systems, which introduces an unnecessary level of risk for mistakes and subsequently adverse patient outcomes. The Spacelabs Healthcare system upgrades to date and the current patient monitoring and telemetry infrastructure would all be rendered useless. The duplication in costs to replace the entire physiologic patient monitoring and telemetry system would not be recovered through competition.

Spacelabs Healthcare LLC [Spacelabs] retains proprietary rights to software, upgrades, and component equipment to be used with its telemetry and critical care patient monitoring platform. The repair, purchase, installation, and upgrades of these components and parent system can only be completed by Spacelabs to ensure the integrity, safety, and accuracy of systems in accordance with (IAW) original equipment manufacturer (OEM) specifications.

Spacelabs has no authorized distributors capable of providing the needed equipment and

OFOC SOP Revision 08 Original Date: 03/22/11 technical knowledge and skill to fully upgrade the current patient monitoring and telemetry system. The system provides direct patient care and cannot be compromised.

Only one source is acceptable due to patient safety risk that would occur from departmental differences. The entire facility must be trained and familiar with the same type of patient monitoring equipment to ensure no adverse events occur. Facility healthcare provides work between departments and need to have standardization to provide the same level of patient care. Sole Sourcing to Spacelabs for this requirement will meet the standards of a high reliability organization.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought Notice 36C24919Q0317 was posted from June 5, 2019 through June 11, 2019 on Federal Business Opportunity (FBO). Two responses were received. One company was a large business and one was a Service-Disabled Veteran-Owned Small Business (SDVOSB). The profiles of both companies were reviewed by both the Contracting Office and the subject-matter experts (SME) at the Facility. The large business offered a product that was not Spacelabs. And, the SDVOSB was confirmed with Spacelabs representatives to be a pass-through entity with no actual Spacelabs product regularly on-hand and no training or authorization in the repair, installation, modification, maintenance, or training of any Spacelabs products.

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

Price Analysis will be conducted, and subsequent negotiations held as necessary. IAW FAR 13.003(g) (2), the Contracting Officer (CO) intends to use an applicable procedure in FAR 15.404-1(b)(2)(ii), to ensure that the quoted pricing will be determined fair and reasonable based upon comparison of proposed prices to historical prices paid for similar services, the IGCE, and Spacelabs current NAC contract prices. Additional price discounts will be sought.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: As described in Section 6 above, market research, IAW FAR

Part 10, was conducted by synopsizing the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

The Vetbiz registry [VIP] with NAICS 334510 and keyword “Spacelabs” gave zero (0) results.

Market research was conducted on GSA eLibrary reviewing Schedule 65-IIA, Medical Equipment and

Supplies SIN A-50A, Vital Signs Monitors under North American Industry Classification System

(NAICS) 334510 Patient Monitoring Equipment Manufacturing. The market research findings revealed there were 40 vendors, including Spacelabs, that offer patient monitoring systems;

however, none are technically compatible with the current infrastructure, except for Spacelabs. All network requirements, installation site services, additional server installation, clinical configuration, software upgrades, and additional hardware installation shall operate and be compatible with the existing Spacelabs patient monitoring system architecture.

An FPDS search of keyword “Spacelabs” and Treasury Account Symbol 360160 revealed 422 contract actions where only six actions were given to three vendors: ENBIO Corporation (Small business), AvKare (SDVOSB), and Cardinal Health 200, Inc. (Large Business) for dollar amounts less than $100,000.00.

OFOC SOP Revision 08 Original Date: 03/22/11

Although market research results did show that other companies irregularly provided Spacelabs products, none of the market research found any of these other companies providing products and services at the current quantity, cost, or level of project complexity required of this procurement.

Spacelabs’ current NAC contract expires June 30, 2019 and will not be renewed. There is not enough time to award or procure using a Limited Source Justification IAW FAR part 8. Considering the scope of this requirement, the level of reviews required, the finalization of contract documents, and the NAC contract expiring without renewal in two weeks, the only feasible option to ensure proper mitigation of involved risks to stakeholders is to utilize FAR 13.5 procedures.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: As previously indicated, the proprietary nature of integrated patient monitoring systems necessitates all components be from the same vendor for storage and accessibility of patient data. This requirement is to upgrade only a portion of the patient monitoring system as other portions have previously been upgraded. Procuring only a portion of the system (bedside monitors and central stations) from another vendor is not an option as those components would not function in the already established system environment.

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

Janz Corporation – SDVOSB – DUNS: 103534595 [Open Market] Nihon Kohden – Large Business – DUNS: 021063219 [V797P-4439B, expires 10/31/2019]

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:

Competitive procedures to replace patient monitoring systems may be available in the future dependent upon the Facility's need to do a complete overhaul or replacement of the whole systems, or the current method becomes too cost prohibitive to operate/update, not only in terms of dollars, but in delivery of excellent Veteran patient care, diagnosis, and treatment.

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.

CHRISTOPHER S

POINDEXTER 146042

Digitally signed by CHRISTOPHER S

POINDEXTER 146042

Date: 2019.06.13 10:40:45 -05'00'

Christopher S. Poindexter Date Asst. Chief, Logistics Memphis VAMC

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.

OFOC SOP Revision 08 Original Date: 03/22/11

Digitally signed by Robert M Kellner 184085 Date: 2019.06.13 10:49:44 -05'00'

Robert M. Kellner Division Chief – Supplies, Services, & Prosthetics

NCO-9

Date

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.

Digitally signed by Linda S. Greaves

Linda S. Greaves 404790 404790 Date: 2019.06.18 11:38:55 -05'00'

Linda S. Greaves Date Director of Contracting

NCO-9

c. VHA SAO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

Mr. Randy L. Hays Acting Executive Director VHA Regional Procurement Office

Date

Robert M Kellner 184085