36C10G21A0002_2.docx

Control Number: 13-018

GENERAL INFORMATION

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SET-ASIDE

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contracting Officer Brian Love Brian.Love@va.gov 202-891-9187

AWARD INFORMATION

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AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

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DESCRIPTION

The Department of Veterans Affairs Strategic Acquisition Center (SAC) has awarded the following sole source Blanket Purchase Agreement (BPA) to Clinicomp International, Inc. for Clinical Information Systems (CIS) Software and Hardware Support. The Maximum aggregate value for all orders awarded under this BPA shall not exceed $62,965,128. This is for informational purposes only and not a request for competitive proposals.

Award Notice Award Notice

*= Required Field Award Notice Award Notice

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Pursuant to FAR Subpart 13.501

1. Contracting Activity:

Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Avenue Suite 400 Fredericksburg, VA 22408

This requirement is for the Office of Procurement and Logistics.

2. Description of Action:

The proposed action is for a sole-source, blanket purchase agreement (BPA) with CliniComp International Inc. The use of other than full and open competition to procure CliniComp Electronic Heath Record (EHR) for software and hardware maintenance, software updates and upgrades, system testing, perpetual unlimited non-exclusive software licenses, technical support services, and training. CliniComp EHR software is a proprietary system. The details to its proprietary nature will be discussed under paragraph 5 of this document. CliniComp’s International Inc. will be hereinafter referred to as CliniComp. CliniComp is a Large Business located at 9655 Town Center Dr. San Diego, CA 91121.

For the Veterans Integrated Service Networks (VISNs) utilizing CliniComp’s EHR, this software and hardware is the backbone to Veterans Affairs (VA) Clinical Information System (CIS) used in critical care.

The BPA will be limited to a five-year ordering period. This will continue to support the existing CIS systems currently used within Veterans Health Administration (VHA) VISN.

3. Description of the Supplies or Services:

Estimated Value:

The BPA has an estimated value of $62,965,128.

Background:

On September 24, 2008, VHA Deputy Under Secretary for Health for Operations and Management issued memorandum titled “VISN-Wide Acquisition and Implementation Process for Intensive Care Unit and Anesthesia Record Keeping Clinical Information Systems and the Analytics System”. This memorandum mandated the requirements and process for the acquisition, implementation, sustainment and standardization of the CIS Intensive Care Unit (ICU), Anesthesia Record Keepers (ARK), and the Analytics System. This mandate was further iterated with memo dated December 13, 2010 and titled “National Standards in Implementation and Use of Intensive Care Unit and Anesthesia Record Keeping Clinical Information and the Analytics System”, also signed by VA Deputy Under Secretary for Health for Operations Management.

The earlier direction stated in these memos, paved a path to a robust medical system that is efficient, fully operational and utilized within the complex VA’s medical system today. VHA depends on CIS and ARK to meet mission goals as these systems provide real time data and information, regarding patients needing critical, surgical, and anesthesia health care.

As a result of the stated memo, in September 2009, several VISNs purchased and installed CliniComp’s EHR software and hardware to support the implementation of CIS.

Supplies and Services:

CliniComp’s EHR software is a critical care CIS that interfaces with Veterans Health Information Systems and Technology Architecture (VISTA). This enables real time bi-directional exchanges of data in VISTA, both in batch and real time. VHA uses CliniComp’s EHR software and hardware, for electronic documentation in critical care environments. The EHR software supporting CIS is proprietary to CliniComp. The proprietary nature to such software is addressed under paragraph 5. Additionally, CliniComp does not authorize any third party to perform software maintenance or services on its software. Although the software is commercial in nature, the software is customized and significantly modified to meet clinician needs at each facility. The software provides users important data, such as patient demographics, text integration, patient allergies, orders, problem lists, care status and delivery, lab results, medication administration, and information regarding care. In general, the CIS replaced paper records used in critical care.

This CIS, provided by CliniComp’s EHR software and hardware, is critical to VA’s mission for patient safety and quality care due to the following reasons:

a) Accurate Charting: It allows clinicians to focus solely on patient’s needs. Without a CIS, clinicians would return to paper charting; which makes the documentation process time consuming and leaves room for human error. As less time is needed for paperwork flows, clinicians can spend more time on patient care which results in better medical quality.

b) Real Time Interfacing with Medical Devices: This further supports patient safety, as the CIS allows for real time data capture from medical devices such as physiological monitors, vital sign monitors, telemetry systems, ventilators, intra-aortic balloon pumps, hemodialysis machines, cardiac output machines, infusion pumps and anesthesia machines. Once again, reducing data entry errors and allowing the clinicians to focus on the patient instead of the documentation.

c) Tele-Critical Care and Remote Viewing: The system promotes use of tele-critical care and remote viewing of patients that are receiving critical care. This is particularly important for smaller hospitals to provide additional clinical support and intervention for critical care demand. For example with COVID-19, demand could increase unexpectantly. If this were the case, the remote viewing would leverage additional clinical expertise that would not be physically located at the facility.

d) Medical record standardization. Standardization supports patient safety as it reduces potential errors with patient information.

e) Increased patient survivability: The system can provide critical emergency data in seconds.

Requirement:

For CIS, ongoing support is required to maintain functionality and operations. The proposed action is for a follow-on BPA to the existing CliniComp BPA VA119-16-A-0157. This document covers a CIS that uses CliniComp’s software, software applications, and hardware. This requirement will continue to maintain the existing CIS maintenance services including software updates, upgrades, scheduled maintenance, unscheduled maintenance, technical support, data base administration support and training.

4. Statutory Authority:

The statutory authority permitting other than full and open competition, under FAR subpart 13.501 is 41 U.S.C.1901.

Only one responsible source and no other supplies or services will satisfy agency requirements as the services, software, and configuration of the CIS is highly specialized for this follow-on requirement.

5. Unique Qualifications and Rationale Supporting Use of Authority Cited Above:

Time, money and effort has been utilized to obtain the CliniComp’s EHR CIS as it stands today. Per the above, a significant duplication of cost, time and effort would result, if a competition occurred. This is explained in detail below.

Maintenance of Proprietary Software:

As this CIS is uniquely configured, CliniComp is currently the only source capable of maintaining the CliniComp’s EHR CIS used at various VISNs. The EHR software and hardware is developed and maintained solely by CliniComp and is a CliniComp’s. proprietary product. CliniComp. does not have affiliation or agreements in place with any authorized resellers to resolve technical problems and/or obtain CliniComp software updates.

Modified Commercial Software For all VISNs using CliniComp’s EHR, the software is significantly modified to meet the unique needs to each VA facility using CliniComp systems. As this software interfaces with VISTA, medical devices, tele-critical care, and analytic systems, configurations to the commercial software are necessary to meet VA’s interoperability and standardized terminology requirement. Today, CliniComp’s software is highly configured to meet VA’s complex CIS workflow in intensive care, progressive care (step down units), COVID-19 beds, and other care areas.

Time and Duplication of Cost:

The CIS that uses CliniComp’s software and hardware has been in place since 2008. To date, VA has funded approximately $47,971,027, which includes ongoing maintenance and getting the system established to the current system VA has today.

Retention and cost for a follow on to this requirement would be more cost effective than purchasing a new system to include the maintenance and services. For another company to support this effort, it would require changing CIS. The estimated cost associated with procurement of a replacement solution would include software, hardware, services including project management, implementation, testing training, and VISTA interface reconfiguration. The replacement solution would require a complete swap out of the existing like-new CIS with a different brand-new CIS. This would result in major disruptions in clinical documentation and workflow affecting 44 facilities and 2,063 critical care beds. In addition, extracts to analytics would have to be redeveloped and tested. Approximately 38,000 personnel would have to be retrained including system administrators, providers, super users, end users, Office of Information Technology (OIT), Biomedical Engineering, Pharmacy, Respiratory, Dieticians and other staff. The network infrastructure and reconfiguration would result in severe disruptions as the entire Medical Device Isolation architecture including controlled access lists, communication ports and internet protocol addresses would have to be reestablished beginning with requests through OIT.

As VISTA interfaces with CliniComp’s proprietary software, it requires Document Storage Solutions (DSS) which supports this VISTA interface. DSS is not interchangeable with any other software solution. Therefore, a separate procurement for a new DSS, to support a software other than CliniComp, would be required. A new procurement, based on the existing DSS, is estimated at $3,330,000. Additionally, the VISTA interface with a new system would also have to be reconfigured including logical links, menus, and keys.

In summary, for a competition the Government would need: 1) A new CIS, as a different software would be required, 2) Replacement of the existing DSS; as required to interface with the existing VISTA and 3) The new CIS and all new interfaces would have to be tested to ensure functionality.

Based on all the points above, the total cost for VA to select a new contractor in the spirit of competition would be $86,684,843, based on the below breakout:

Follow-on Support (Required Until New CIS Goes Live)

$26,812,046.00

Duplicative costs are not the only issue; VA will bear a higher level of risk to its patients as the time it would take to get a new system in place would require a phased approach taking an estimated 10 years.

Because a swap of CIS would take years to accomplish, the existing system would still require maintenance until the new CIS is accepted. The existing CIS, provided by CliniComp’s EHR software and hardware, would not be supported during the new acquisition process due to warranty expirations. As such, VA would continue to pay for the CIS maintenance.

As stated under paragraph 3 of this document, this system is critical to VA’s mission and patient care. Therefore, a new contractor would equate VA not having a functional CIS, which leads to a break in service and inability to meet VA’s mission. Overall, it is not acceptable for VA to bear these duplicative costs nor for individual Veteran care to bear higher levels of avoidable risk merely to enable competition. These circumstances justify the proposed sole source action.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable:

Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government's requirements. There is no competition anticipated for this acquisition. In accordance with FAR 5.301, this action will be synopsized at award on "Contract Opportunities" under beta.SAM.gov and this justification will be made publicly available.

7. Determination of Fair and Reasonable Price:

Prior to any BPA, the Contracting Officer shall determine the price to be fair and reasonable. In accordance with FAR 13.106-3(a) “Basis for award: “Before making award, the contracting officer must determine that the proposed price is fair and reasonable”. Therefore, a fair and reasonable determination will be made using commercial price lists and existing Government contracts. In such circumstances where commercial price list and Government contracts are not available, then the Contracting Officer shall use any other reasonable basis to support a price fair and reasonableness.

8. Market Research:

Market research was conducted in October 2020. CliniComp’s response indicated that the EHR software is a proprietary and. CliniComp is the only organization authorized to provide service and support for the EHR software that supports the CIS. CliniComp does not utilize resellers in any capacity. The software and hardware used by CIS is not easily replaced by another software/hardware, as the system is modified significantly to meet end user needs. A notice of intent to sole source was posted on November 30, 2020. No responses were received.

9. Other Facts:

None.

10. A Listing of the Sources, if any, that Expressed an Interest in the Acquisition:

None.

11. Statement of Actions the Agency May Take to Overcome Barriers to Competition in the Future:

Currently, VA is researching alternative solutions with CIS/ARK such as Cerner. Also, the VA is partnering with the Department of Defense to seek alternatives and lessons learned. Currently, the researched alternative is not currently able to replace the existing CIS/ARK system.

In general, the Government will continue to perform additional market research to determine if alternate providers become available.

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