JA_GE CARESCAPE Patient Monitoring - Updtd Full and Open_Redacted.pdf

GE Patient Monitoring Gateway Control Number VA-22-00082281

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs (VA)

Office of Procurement, Acquisition, and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, New Jersey 07724

2. Description of Action: The proposed action is for a firm-fixed price 36-month contract to be issued as Full and Open via Contracting Opportunities on SAM.gov for brand name GE CARESCAPE patient monitoring gateway solution inclusive of software, hardware, licenses, upgrades, associated support services, brand name Airstrip One product, project management, training, and implementation services.

3. Description of Supplies or Services: The Department of Veterans Affairs (VA) Electronic Health Record Modernization Integration Office (EHRM IO) provides program management and oversight for the replacement of VA’s legacy electronic health record (EHR), Veterans Health Information System Technology Architecture (VistA), with the Cerner implementation of the new EHR. As part of the new EHR implementation, VA has a requirement for GE CARESCAPE patient monitoring gateways and Airstrip One for all VA facilities to interface and communicate with Cerner’s EHR. This specific action is for the twelve (12) facilities throughout Veterans Integrated Service Networks (VISNs) 17, 19, 21, 22 and 23 that utilize GE CARESCAPE patient monitors. For these 12 facilities requiring brand name GE CARESCAPE Gateway configurations, VA has a requirement for 58 software components (comprised of GE CARESCAPE Gateway (CSG), CSG Test, CSG Backup, GE CARESCAPE Gateway Plus (CSG+), CSG+ Test, CSG+ Backup), 63 virtual machine host hardware, 50 bed licenses, 24 upgrades, and associated support services. GE CARESCAPE patient monitoring gateways offer bi-directional data transfer between a Hospital Information System and/or Clinical Information System and patient monitors located on the CARESCAPE Network using the HL7 protocol standard. In order to upgrade existing GE CARESCAPE patient monitoring gateway configurations to be compatible with Cerner EHR deployment, software of the gateway at each of the 12 facilities will need to be upgraded to the latest version. Backup and test servers will need to be implemented if the site does not currently have them in place. Additional GE CARESCAPE Bed Licenses for Outbound HL7 Vital Signs are needed for facilities whose current amount does not match the amount of beds at a facility. Each of the 12 facilities also require GE CARESCAPE Gateway Plus (CSG+), CSG+ Backup, CSG+ Test software and hardware. Support services are required to install, configure, and test the patient gateways and ensure that HL7 and Admit, Discharge, Transfer feeds function as needed. As part of these support services, a one year warranty covering service and support will be provided.

The government also requires Airstrip’s Airstrip One product, project management, training, and implementation. Airstrip One is a component of the GE CARESCAPE patient monitoring gateway solution and works with GE’s CARESCAPE patient monitoring system to enable live and historical waveform data to be monitored from a secure web viewer. It also sends PDF reports directly to the patient record. Neither GE CARESCAPE nor Airstrip One alone can provide the full capability suite required by the VA for patient care. GE CARESCAPE and Airstrip One have a very close engineering relationship. GE CARESCAPE is deeply embedded in Airstrip One’s product development process, bringing its customer requests and experience to Airstrip One as part of its development roadmap. GE and its authorized reseller, Trillamed, are certified to deploy both GE CARESCAPE products and Airstrip One.

The total estimated value of the proposed action is . A site-by-site schedule for installation at each Veterans Integrated Service Network (VISN) shall commence upon award and be completed within 36-months from award.

4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

5. Rationale Supporting Use of Authority Cited Above: Based on market research as described in Section 8 of this Justification, it was determined that limited competition is viable among only two possible sources, GE and Trillamed, who are authorized to provide both GE CARESCAPE and Airstrip One products and services jointly, as required. VISNs 17, 19, 21, 22, and 23 utilize GE physiological monitor solutions to continuously monitor physiological data (including waveforms) for patients. As the manufacturer, only GE, and its authorized reseller, Trillamed, are authorized to provide software, software licenses, hardware, upgrades, and technical support required to configure physiological monitors and gateways to integrate with Cerner EHR. Failure to utilize GE CARESCAPE gateway would cause patient data obtained from the monitors to not be integrated into the patient’s record. This would lead to delays in patient care and lead to errors associated with manually entering physiological data into the patient’s electronic health record. A worst case scenario involves information that could be entered into the wrong patient’s record and as a result, misdiagnosis could be given to both patients involved. Additionally, the use of any other vendor solution would require VA to reprocure bedside physiologic monitoring devices and construction to install the cabling unique to the alternative vendor. Currently, VA owns in excess of $60M worth of non-expendable GE physiologic monitoring devices in VISN 17, 19, 21, 22 and 23 that are part of the Medical Local Area Network (LAN) and would need to be duplicated with any other brand name equipment or alternative solution. It is estimated that a procurement to replace all of the equipment that communicates on the VISN’s Medical LAN would exceed the $60M identified above due to price increases, installation services, and training requirements. To switch from one patient monitoring vendor to another also requires significant infrastructure replacement for switches, wireless access points and network cabling in all nursing areas that currently use patient monitors, which include but are not limited to, inpatient, Intensive Care Unit (ICU), Gastrointestinal (GI), Emergency Department (ED), and Post-Anesthesia Care Unit (PACU) units. Based on previous acquisition history, the cost to perform this work is approximately $500k for VA’s lowest complexity facilities that utilize this equipment. The cost to do this work would increase according to facility and complexity. Furthermore, VA would be replacing items that are not beyond their end of useful life. Given all the factors related to replacing all GE CARESCAPE infrastructures with a new vendor, it was determined that only the purchase of brand name software and services can meet VA’s requirements.

In addition to cost impacts, replacing existing patient monitoring systems would also have impacts on time and patient safety. To purchase and deploy a brand-new patient monitoring system for a single facility could take over a year, and even longer depending on the number of clinical departments (such as ICU, ED, PACU) in each hospital. In this proposed action, there are 12 facilities and some of these facilities are expected to go live in FY23. Replacing the entire system would delay the Cerner Go- Live. Additionally, introducing a new patient monitoring system in this delayed timeline on top of clinical staff learning how to use a new medical record system would add an unnecessary burden to clinical staff and take away from time spent providing patient care.

VA requires both the GE CARESCAPE and Airstrip One products to be integrated in the total capability suite solution. GE CARESCAPE alone is unable to provide the total capability suite needed for patient care. Airstrip One is needed to make up the remainder of the total capability suite. Without Airstrip One, the VA would only be able to send discrete vitals into the patient record, which would not meet VA’s requirements.

This is because GE CARESCAPE patient monitoring gateway solution does not inherently possess the capability that allows remote viewing of vitals, as well as the ability to export PDF wave strips into the patient record, which are both crucial requirements. Airstrip One closes the gap and allows the solution to meet VA’s requirements. On the other hand, the Airstrip One product alone is unable to integrate directly with end point patient monitors and would not be able to capture and send discrete vitals into the patient record. Therefore, the integration, which is only available between GE CARESCAPE and Airstrip One, provides the required collective enhanced capabilities for patient care that are not available through other GE and vendor partnerships. GE is authorized to provide the Airstrip products. Conversely, Airstrip is not authorized to provide GE products. Furthermore, only GE and its reseller, Trillamed are certified for deployment of GE CARESCAPE products and Airstrip One solutions, allowing VA to meet its requirement for a single vendor to provide deployment and integration support rather than working with multiple vendors. Trillamed is the only reseller which can provide both the GE CARESCAPE and Airstrip One products, which has been confirmed with by GE and Airstrip. In addition, VA requires a single integrator to install and configure both GE CARESCAPE and Airstrip One products simultaneously to ensure that the devices are properly configured to work in tandem. This will also allow for support of the solution, such as software patching to remediate cybersecurity vulnerabilities, to be provided by a single vendor. Based on previous similar efforts, when support was provided by two separate vendors, there were significant issues with applying patching that impacted the ability of the clinical application on the server to function properly. Getting the separate vendors to agree on where the issue resided presented a patient safety risk by delaying patient care. With support provided by one vendor, the sole vendor assumes responsibility of remediating support issues and can alleviate these significant risks which could compromise patient safety.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in Section 8 of this Justification. This effort did not yield any additional sources that can meet the government’s requirements. However, the undersigned VA technical representative determined that limited competition is available. In accordance with FAR 6.302-1(c)(1)(ii)(c) and 5.102(a)(6) this justification shall be posted with the solicitation.

Furthermore, the proposed action will be synopsized on the Contracting Opportunities Page in accordance with FAR 5.201. Any proposals submitted in accordance with Section E.9 of the Solicitation shall be evaluated.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed. Specifically, the Government will continue to monitor the marketplace to determine whether other manufacturers are authorized to make the changes to allow the existing system to function with Cerner’s EHR.

8. Market Research: Market research has been continuously conducted as recently as September 2022, by technical experts to choose a physiological monitoring solution at each of the 12 respective sites. Specifically, technical experts reviewed similar solutions from alternative manufacturers including those from Philips, Spacelabs, and Draeger.

Though devices from each of the aforementioned manufacturers clinically function similarly to the GE CARESCAPE Gateway and Airstrip One system, no alternative solutions were determined to function in the current information technology infrastructure of the 12 facilities identified above in VISNs 17, 19, 21, 22, and 23 due to the proprietary nature of each of the alternative vendor’s systems. Thus, the only way to support the 12 facilities other than through this limited competition, would be to do full scale replacement of all the GE CARESCAPE bedside physiologic monitoring devices on Medical LAN with alternate devices, which would result in the consequences described in Section 5, including estimated equipment replacement costs in excess of the current equipment value, delays in patient care, and errors associated with manual entering. Nothing has changed in the marketplace that would allow these other vendors’ systems to work with existing GE patient monitors to connect with Cerner’s EHR. To clearly demonstrate the relevant and crucial authorizations and partnerships, GE is the original equipment manufacturer and an authorized seller of GE CARESCAPE. Through GE’s partnership with Airstrip, GE is also authorized to deploy Airstrip One. Through Trillamed’s partnership with GE, Trillamed is an authorized reseller of GE products, including GE CARESCAPE and Airstrip One. GE confirmed in writing on February 8, 2022, that Trillamed is its only authorized reseller of required GE CARESCAPE and Airstrip One products. Trillamed does not have a direct partnership with Airstrip in order to solely resell Airstrip One; however, due to Trillamed’ s partnership with GE, Airstrip has authorized Trillamed to resell Airstrip products. Airstrip confirmed in writing on October 20, 2022, that due to Trillamed’s partnership with GE, Trillamed is authorized to resell Airstrip products. In conclusion, no alternative vendors other than GE or Trillamed can perform the required services because the proposed action is a modification to the existing system, the existing system is built off proprietary source code, and the manufacturer is the only authorized vendor by the Original Equipment Manufacturer to perform the duties.

The intent was to solicit via General Service Administration (GSA) Multiple Award Schedule (MAS) 65 II A under the authority of the MAS Program. Both GE and Trillamed are GSA contract holders, however it was found that both GE and Trillamed were not members of the specific category GSA MAS Schedule contract that would allow competition between the forementioned contract holders. In order to promote competition among the two capable vendors this solicitation will now need to be solicited as Full and Open for the brand name requirement.

9. Other Facts: None

10. Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

11. Determination of Best Value: I hereby determine that the proposed contract action will represent the best value to the Government consistent with FAR 6.302-1(c). Price analysis, to include an analysis of proposed level of effort and mix of labor, will be conducted and subsequent negotiations held as necessary. Additionally, price discounts will be sought.

12. Procuring Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Approval

In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the acquisition of brand name GE CARESCAPE patient monitoring gateway solution inclusive of software, hardware, licenses, upgrades, associated support services, brand name Airstrip One product, project management, training, and implementation services, on an other than full and open basis pursuant to the authority cited in Section 4 above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition.