Justification Pacific Monarch Inc.pdf

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

2. Description of Action:

The proposed action is for a sole-source, blanket purchase agreement (BPA) with Pacific Monarch, Inc. The use of other than full and open competition is to procure Pacific Monarch iMDsoft Metavision software and hardware maintenance, software updates and upgrades, system testing, perpetual unlimited non-exclusive software licenses, technical support services, and training which have been previously procured and installed in two (2) Veteran Integrated Service Networks (VISNs) within six (6) Department of Veterans Affairs Medical Centers (VAMCs). Pacific Monarch iMDSoft Metavision software and hardware is a proprietary system. The details to its proprietary nature will be discussed under section 5 of this document. Pacific Monarch is a small business located at 34855 Doheny PL. Capistrano Beach, CA 92624.

For the VISNs utilizing the Pacific Monarch iMDSoft Metavision software and hardware is the backbone to Veterans Affairs (VA) Anesthesia Record Keepers (ARK) used in critical care.

The BPA will be limited to a five-year ordering period. This will continue to support the existing ARK systems currently used within VISNs.

3. Description of the Supplies or Services:

Background:

On September 24, 2008, the VHA Deputy Under Secretary for Health for Operations and Management (10N) 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 Clinical Information System (CIS) Intensive Care Unit (ICU), 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 the 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 Pacific Monarch iMDSoft Metavision software and hardware to support the implementation of ARK.

Supplies and Services:

Pacific Monarch iMDSoft Metavision software, is a critical care ARK, 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 Pacific Monarch iMDSoft Metavision software and hardware, for electronic documentation in anesthesia care environments. The Pacific Monarch iMDSoft Metavision software supporting ARK is proprietary to Pacific Monarch, Inc. Although the software is commercial in nature, the software is customized and significantly modified to meet clinician needs at each facility.

Pacific Monarch iMDSoft Metavision is software used by clinicians to document anesthesia care. The Pacific Monarch iMDSoft Metavision is a comprehensive clinical documentation system that manages the complex workflow of anesthesia care. Pacific Monarch iMDSoft Metavision provides anesthesia caregivers a complete picture of the patient’s anesthesia record. The Pacific Monarch iMDSoft Metavision enables information sharing and is utilized by anesthetists and certified nurse anesthetists to document and monitor their patients in the preoperative, intraoperative and postoperative stages of surgical care. The system manages large volumes of data and assembles key information to create one contiguous patient record.

Additionally, Pacific Monarch does not authorize a third party to perform software maintenance or service on its software. 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 anesthesia care. In general, the ARK replaced paper records used anesthesia care.

This ARK, provided by Pacific Monarch iMDSoft Metavision software 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 an ARK, clinicians would return to paper charting of anesthesia care;

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 and Veteran Safety.

b) Real Time Interfacing with Medical Devices: This further supports patient safety, as the ARK allows for real time data capture from medical devices such as anesthesia machines, physiological monitors, vital sign monitors and ventilators. Once again, reducing data entry errors and allowing the clinicians to focus on the patient instead of the documentation thereby providing better overall care for the Veteran.

c) Remote Viewing: The system saves Veteran’s lives by promoting the use of remote viewing of patients that are receiving anesthesia care. This is particularly important for smaller hospitals to provide additional clinical support and intervention for anesthesia 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 in the operating room or moderate sedation areas.

d) Medical record standardization. The existing ARK software is modified to meet VA’s data standards, terminology data sets and change control under the VA Pacific Monarch User Group. Standardization supports patient safety as it reduces potential errors with Veteran patient information.

e) Increased patient survivability: The system can provide critical emergency data in seconds to help save Veterans lives.

Requirement:

For ARK, ongoing support is required to maintain functionality and operations.

The proposed action is for a follow-on contract to the existing Pacific Monarch, Inc. contract VA119-16-A-0461. This document covers an ARK that uses Pacific Monarch, Inc. software applications, and hardware. This requirement will continue to maintain the existing ARK 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 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 ARK 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 Pacific Monarch iMDSoft Metavision ARK 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 ARK is uniquely configured, Pacific Monarch, Inc. is currently the only source capable of maintaining the Pacific Monarch iMDSoft Metavision ARK used at various VISNs. The Pacific Monarch iMDSoft Metavision software and hardware is developed and maintained solely by Pacific Monarch, Inc. and is a

Pacific Monarch, Inc. proprietary product. Pacific Monarch, Inc. does not have affiliation or agreements in place with any authorized resellers to resolve technical problems and/or obtain Pacific Monarch, Inc. software updates.

Modified Commercial Software

For all VISNs using Pacific Monarch iMDSoft Metavision, the software is significantly modified to meet the unique needs to each VA facility. As this software interfaces with VISTA, medical devices and analytic systems, configurations to the commercial software are necessary to meet VA’s interoperability and standardized terminology requirement. Today, Pacific

Monarch software is highly configured to meet the VA’s complex ARK workflow in anesthesia care areas.

Time and Duplication of Cost:

The ARK that uses Pacific Monarch iMDSoft Metavision software and hardware has been in place since 2013. To date, VA has funded approximately $2,520,000, which includes ongoing maintenance and getting the system established to the current system the 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. 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 ARK with a different brand-new ARK. This would result in major disruptions in clinical documentation and workflow affecting 6 facilities and 50 anesthesia beds. In addition, extracts to analytics would have to be redeveloped and tested. Approximately 300 personnel would have to be retrained including system administrators, providers, super users, end users, Office of Information Technology (OIT), Biomedical Engineering 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.

Pacific Monarch proprietary software interfaces with VistA. The interface solution is provided by Document Storage Solutions (DSS). DSS supports this

VistA interface. DSS is not easily interchangeable with any other software solution. Therefore, a separate procurement for a new DSS, to support a software other than Pacific Monarch, would be required. A new procurement, based on the existing DSS, is estimated at $450,000. 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 ARK, as a different software 2) Replacement of the existing DSS; as required to interface with the existing VistA and 3) Testing of the new ARK and all new interfaces to ensure functionality.

Duplicative costs are not the only issue; the VA will bear a higher level of risk to its patient’s 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 ARK would take years to accomplish, the existing system would still require maintenance until the new ARK is accepted. The existing ARK, provided by Pacific Monarch iMDSoft Metavision 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 ARK maintenance.

As stated under section 3 of this document, this system is critical to the

VA’s mission and patient care. Therefore, a new contractor would equate

VA not having a functional ARK, which leads to a break in service and the inability to meet the 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 the "Contract Opportunities" under beta.SAM.gov and this justification will be made publicly available.

7. Determination of Fair and Reasonable Price:

Prior to award of the 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 from September 2020 to March 2021. Pacific Monarch, Inc. response indicated that the Pacific Monarch iMDSoft Metavision software is a proprietary system and Pacific Monarch, Inc. is the only organization authorized to provide service and support for the system. Pacific Monarch, Inc. does not utilize resellers in any capacity. The software and hardware used by ARK is not easily replaced by another software/hardware, as the system is modified significantly to meet end user needs. A notice of intent to go sole source was posted April 9, 2021. 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, the VA is researching alternative solutions with ARK such as Cerner.

Also, VA is partnering with the Department of Defense to seek alternatives and lessons learned. Currently, the researched alternative is not able to replace the existing ARK system.

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