Philips CIS ARK Support Justification for Sole Source Award.pdf

Justification for a Sole Source Award

1. Contracting Activity:

U.S. Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Avenue, Suite 400 Fredericksburg, Virginia 22408

2. Description of Action:

The proposed action is for a sole-source, blanket purchase agreement (BPA) with Philips North America, LLC. The use of other than full and open competition to procure Philips North America, LLC. IntelliSpace Critical Care and Anesthesia (ICCA) Clinical Information System (CIS) and CompuRecord Anesthesia Record Keeping System (ARK) software and interface device support. ICCA CIS and CompuRecord ARK have been previously procured and installed in five (5) Veteran Integrated Service Networks (VISNs) and twenty eight (28) Department of Veterans Affairs Medical Centers (VAMCs). The following is a list of facilities using Philips CIS/ARK.

VISN

Facility

Software

5 Clarksburg ICCA

5 Baltimore ICCA

5 Beckley ICCA

5 Huntington ICCA

5 Martinsburg ICCA

5 Washington ICCA

15 Columbia ICCA

15 Kansas City ICCA 15 Leavenworth ICCA

15 Marion ICCA

15 St. Louis ICCA

15 Topeka ICCA

15 Wichita ICCA

20 Boise ICCA

20 Portland ICCA 20 Seattle ICCA

22 Loma Linda ICCA /CompuRecord

22 Long Beach ICCA /CompuRecord

22 Los Angeles ICCA

22 San Diego ICCA /CompuRecord

23 Des Moines ICCA /CompuRecord

23 Fargo ICCA

23 Fort Meade ICCA /CompuRecord

23 Iowa City ICCA /CompuRecord

23 Minneapolis ICCA /CompuRecord

23 Omaha ICCA /CompuRecord

23 Sioux Falls ICCA

23 St. Cloud CompuRecord

Philips North America, LLC. ICCA CIS and CompuRecord ARK software and interface devices is a proprietary system. The details to its proprietary nature will be discussed under paragraph 5 of this document. Philips North America, LLC. is located at 3000 Minuteman Road, Andover, MA 01810.

The BPA will be limited to a five-year ordering period. This will continue to support the existing Philips North America, LLC. ICCA CIS and CompuRecord ARK systems currently used within Veterans Health Administration (VHA) 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 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 direction stated in these memos paved a path to a robust medical system that is efficient, fully operational and utilized within the complex Veteran Affair’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 Philips North America, LLC. ICCA CIS and CompuRecord ARK software and interface devices to support the implementation of CIS and ARK.

Supplies and Services:

Philips North America, LLC. ICCA CIS and CompuRecord ARK software, is a critical care CIS/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 Philips North America, LLC.

ICCA CIS and CompuRecord ARK software and interface devices, for electronic documentation in general ward mid-acuity, critical care high-acuity and anesthesia care areas. Philips North America, LLC. ICCA CIS and CompuRecord ARK is software used by clinicians to document critical care and anesthesia care.

The Philips North America, LLC. ICCA CIS and CompuRecord ARK is a comprehensive clinical documentation system that manages the complex workflow of critical care and anesthesia care. Philips North America, LLC. ICCA CIS and CompuRecord ARK provides caregivers a complete picture of the patient’s critical care and anesthesia record. The Philips North America, LLC. ICCA CIS and CompuRecord ARK enables information sharing and is utilized by anesthetists and certified nurse anesthetists to document and monitor their patients in the general ward mid-acuity, critical care high-acuity and anesthesia care areas (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.

The Philips North America, LLC. ICCA CIS and CompuRecord ARK software supporting CIS/ARK is proprietary to Philips North America, LLC. The proprietary nature to such software is addressed under paragraph 5. Additionally, Philips North America, LLC.

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 critical care and anesthesia care. In general, the CIS/ARK replaced paper records used in critical care and anesthesia care.

This CIS/ARK, provided by Philips North America, LLC. ICCA CIS and CompuRecord ARK 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

CIS/ARK, clinicians would return to paper charting of mid-acuity, high-acuity and 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 CIS/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 critical care and anesthesia care. This is particularly important for smaller hospitals to provide additional clinical support and intervention for critical care and 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 CIS/ARK software is modified to meet VA’s data standards, terminology data sets and change control under the VA Philips North America, LLC. ICCA CIS and CompuRecord ARK 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 CIS/ARK, ongoing support is required to maintain functionality and operations. The proposed action is for a follow-on contract to the existing Philips North America, LLC.

ICCA CIS and CompuRecord ARK contract VA119-17-A-0192. This document covers CIS/ARK that uses Philips North America, LLC. software applications, and interface devices. This requirement will continue to maintain the existing CIS/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. (e)(2). Only one responsible source and no other supplies or services will satisfy agency requirements as the services, software, and configuration of the CIS/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 Philips North America, LLC.

ICCA CIS and CompuRecord 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 CIS/ARK is uniquely configured, Philips North America, LLC. is currently the only source capable of maintaining the Philips North America, LLC. ICCA CIS and

CompuRecord ARK used at various VISNs. Philips North America, LLC. ICCA CIS and CompuRecord ARK software and interface devices is developed and maintained solely by Philips North America, LLC. and is a Philips North America, LLC.

proprietary product. Philips North America, LLC. does not have affiliation or agreements in place with any authorized resellers to resolve technical problems and/or obtain Philips North America, LLC. software updates.

Modified Commercial Software

For all VISNs using Philips North America, LLC. ICCA CIS and CompuRecord ARK, 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, Philips North

America, LLC. software is highly configured to meet the VA’s complex CIS/ARK workflow in critical care and anesthesia care areas.

Time and Duplication of Cost:

The CIS/ARK that uses Philips North America, LLC. ICCA CIS and CompuRecord

ARK software and interface devices has been in place since 2013, 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. For another company to support this effort, it would require changing CIS/ARK. The estimated cost associated with procurement of a replacement solution would include software, hardware, interface devices, 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/ARK with a different brand-new CIS/ARK. This would result in major disruptions in clinical documentation and workflow affecting 28 facilities. In addition, extracts to analytics would have to be redeveloped and tested. Approximately 1,000 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.

Philips North America, LLC. 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

Philips North America, LLC., would be required. 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/ARK, as a different software is required. 2) Replacement of the existing DSS; as required to interface with the existing VistA and 3) The new CIS/ARK and all new interfaces would have to be tested 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 CIS/ARK would take years to accomplish, the existing system would still require maintenance until the new CIS/ARK is accepted. The existing

CIS/ARK, provided by Philips North America, LLC. ICCA CIS and CompuRecord

ARK software and hardware, would not be supported during the new acquisition process because Philips North America, LLC. ICCA CIS and CompuRecord ARK software is not under warranty. As such, the VA will continue to pay for the

CIS/ARK maintenance.

VA is migrating to Cerner. It would also be duplicative cost and effort to fully fund and replace Philips North America, LLC. with another CIS/ARK, while training and bringing online another competitor, simply to have that solution abandoned by 2027. This would result in needless risk, complexity, and waste.

As stated under paragraph 3 of this document, this system is critical to the VA’s mission and patient care. Therefore, a new contractor would equate the VA not having a functional CIS/ARK, which leads to a break service and inability to meet the VA’s mission. Overall, it is not acceptable for the VA to bear these duplicative costs nor for individual Veteran Care 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 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 from September 2020 to March 2021 by Veterans Health Administration technical experts and contracting staff in a collaborated effort in accordance with FAR 10.002. Philips North America, LLC. ICCA CIS and CompuRecord ARK response indicated that the Philips North America, LLC. ICCA CIS and CompuRecord CIS/ARK software is a proprietary and Picis Clinical Solutions, Inc.

is the only organization authorized to provide service and support for the system.

Philips North America, LLC. does not utilize resellers in any capacity. The software and hardware used by CIS/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 on Wednesday, June 16, 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 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.