JA Automated Lab and Radiology Results Redacted.pdf

VA-24-00009129

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, NJ 07724

2. Description of Action: The proposed sole source action is for a firm-fixed price contract for the renewal of brand name Clinsys Utilization Optimization Subscription Service with Clinsys located at 3300 E Sunrise Dr Tucson, Arizonia, 85718-3208 United States.

3. Description of Supplies or Services: VA, Valley Coastal Bend Health Care System (HCS) Informatics Section has a requirement for the renewal of brand name Clinsys Utilization Optimization Subscription Service for automated lab and radiology results letter functionality software and maintenance. The Contractor shall provide the brand name Clinsys Utilization Optimization (UO) Subscription Service for VA users. Initially, there will be a minimum of 450 users (150 users at each of the three VA sites: VA’s Valley Coastal Bend VA Heathcare System, El Paso VA Heathcare System and Amarillo VA Heathcare System. VA will host the product at a VA data center, maintain the VA hosting environment and upgrade the product in the hosting environment with the updates/upgrades or new releases received from Clinsys. The Contractor shall be aware of changes to any laboratory reference range, reporting units, abnormal value flags, or critical value flag updates and shall update the product to reflect these changes. The Contractor shall provide software updates, upgrades, new releases and shall maintain the integrity of the system and the state-of-the-art technology. These updates, upgrades and new releases shall be provided to VA as they become commercially available. The Contractor shall provide help desk services and 24/7/365 technical support through a toll-free number and a trouble ticket system. Emergency repair and technical support shall be available during business hours, which are 8:00am to 4:30pm local time and after hours, which are 4:30pm to 8:00am and weekends and holidays. Critical trouble tickets shall be resolved within four hours, high priority trouble tickets within 24-48 hours and minor trouble tickets resolved within 72 hours. Trouble tickets shall be documented to include issue, resolution and status (i.e. open or closed).

Issues found by VA will first be vetted through VA Information Technology (IT) team and those which the VA IT team cannot resolve will be directed to the Contractor to resolve.

The Contractor shall provide training (onsite or virtual). Training shall include up to eight hours of end user training per site and up to 16 hours of VA local/site technical support staff training per site. The training shall include and provide example policies and procedures such as standard operating procedure templates. Training shall include and provide initial technical setup and user training, training for go-live support, super user training and follow-up training such as for staff turnover or in case of change in software such as new feature for clinical user or technical staff and the training materials. The Contractor shall provide guidance to the VA technical staff at each of the three VA sites

Brand Name Clinsys Utilization Optimization VA-24-00009129 using the product to help them configure the software to meet each site’s specifications and preferences (e.g. letterhead, initial paragraph, etc.). The Contractor shall provide downloadable PDF versions of operator manuals, service manuals, electronic schematics, troubleshooting guides, diagnostic software and tools to include any upgrades to these documents. These manuals shall include all components and subsystems, including those not manufactured by the Contractor. These manuals and documentation shall be identical to the ones supplied to the manufacturer's service representatives and shall contain the diagnostic codes, commands, and passwords utilized in maintenance, repair and calibration of the equipment/software. Updates to the manuals shall also be provided to VA. The Contractor shall provide the brand name Clinsys UO Subscription Services, Training Materials, Operator Manuals, Service Manuals, Electronic Schematics, Troubleshooting Guides, Diagnostic Software and Tools within 30 days of award. The overall Period of Performance shall be a 12-month Base Period with one (1) 12-month option period to be exercised at the Government’s discretion. The total proposed value of this order is $597,000.00, inclusive of the option period.

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 document, it was determined that Clinsys UO is the only software available that will fulfill VA’s requirements. This software product was originally developed by the Southern Arizona VA Health care system to assist providers in meeting the Veterans Health Administration (VHA) Directive 1088 which stipulates that Veterans will be advised of their diagnostic test results within certain time parameters. In response to this directive the facility Chief of Diagnostics and Radiology developed this application, which would render a note with the diagnostics test results right after all of the results from that accession is available. The letter file then can be sent immediately to the remote Xerox print center to prepare for mailing to Veterans. The Clinsys UO also fomates the letter in such a way that multiple pages could be sent to Veterans. The letter is then rendered to the Computerized Patient Record System (CPRS) as a Text Integrated Utility (TIU) note in real time.

This also permits the provider to edit the letter and review the results all in one workflow process. This successful process was introduced and used at multiple facilities across the enterprise. Due to the limitations of VA resources, the vendor, Clinsys was brought in to manage the product under the current contract that the Veterans Integrated Services Network (VISN) 22 has. Clinsys subscription service and maintenance support provides a unique solution that is compatible and customized to the existing VA clinical workflow. VISN 22 has been using the Clinsys software since 2022. This product has reduced provider burden and eliminate the need for a local facility print shop to manage the printing, folding and mailing of letters.

In the course of looking for other lab and diagnostic letter options none could be found that supported VA’s workflow functunalites. VA’s functionalities include the ablitity to review all labs in real time, compose and edit letters for Veterans and send multiple pages to remote printing to the same extent as the Clinsys UO software product. Additional functunatlities that the Clinsys UO software has is ablitily to have a TIU note alert notification, Health Level 7 mediated interface to render a completed TIU note upon lab and radiology test completion. No other vendor is able to provide these features needed by VA. This software is proprietary to Clinsys. There is no other brand or company besides Clinsys that can provide the required software and updates due to exclusive rights owned by them.

6. Efforts to Obtain Competition: 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. Additionally, the proposed action will be synopsized on the System for Award Management’s Contracting Opportunities page in accordance with FAR 5.201. Any proposals that are received shall be evaluated.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the market place that would enable future actions to be competed. Specifically, the Government will continue to monitor the marketplace to determine whether another company has a product that would integrate into VA’s existing suite of Clinsys UO application.

8. Market Research: Market research activities occurred from August to December 2023 first through online searches by the requiring activity. The requiring activity concluded that the only two solutions in the marketplace able to offer what VA is requesting are the Clinsys UO and Brillians Letter application. VA technical experts performed testing with the Brillians letter product and it did not produce an alert nofication to the ordering provider when the letter was available for signature. Letters had to be queued either individually or as a batch to print at intervals. Providers were not able to review results prior to the letter being sent for mailing. Letters of multiple pages could not be printed through the remote Government print center. In discussion with the Brillians developer, he advised facilities that use the Brillians letter solution to employ a local facility print center instead of a remote Government print center. Neither Valley Coastal Bend HCS, Amarillo HCS nor El Paso HCS have local print centers which could manage the letter volumes needed to support the excess of 2000 letters per week. The Clinsys UO product provides the best fit to the existing clinician provider workflow specifically, creation of an alert notification that permits the user to review results prior to mailing, creation of a TIU note that can be edited once results are completed and available as well as the results notes being broken into multiple letters if lengthy to permit remote printing. Failure to acquire this application would result in additional undue administrative burden upon clinicians contributing to burnout and potentially adversely impacting access. This would require a higher level of burden placed on providers in order to meet VHA Directive

1088 and will have a negative downstream impact on access and provider retention, ultimately negatively effecting Veterans.

A search of the Wholesale Supply Sources under the General Services Administration did not return any suitable products. Market research activities also included collaboration with other Informatics colleagues across the enterprise. Dr. Kendle conferred with Dr. Greg Orshansky, Dr. Jay Mavi and Dr. Adam Bock. Together they reviewed the existing automated letter options, Brillians and Clincsys. In addition, a search was conducted using VetBiz. No similar products were identified. VetBiz permitted a search of VA Office of Small and Disadvantaged Businesses. When searching VetBiz NAICS code 541511 yielded over 2K search results. Subsequent filtering using the keyword search term ‘automated print’ yielded 64 results. None of these supported the requirements of TIU note and alert creation with laboratory and radiology results. The NAICS code 513210 was searched using keyword “Automated Lab Results” yielding zero results.

Also, on November 8, 2023 Mr. Dan Nelson from Clinsys submitted to the Contracting Officer via email it’s sole source letter, which has been uploaded to the contract file. The sole source letter stated that they are the sole supplier and intellectual property onswer of this application. It also stated that the software, services and training relating to the UO solution are not available from any other supplier source.

Clinsys does not have any current resellers or service providers for its subscription.

A Request for Information (RFI) was released on November 30, 2023 on Sam.gov Contract Opportunities and closed on December 5, 2023. The only response was from Clinisys on December 5, 2023. The response re-affirmed that Clinisys is the sole provider of the Clinisys UO and the ancillary services. As the manufacturer of the OU solution, Clinisys meets VA’s requirements as the only available source at this time to provide Clinisys Utilization Optimization subscription service for generating a letter document within the VA’s CPRS, which can then be printed either remotely or locally and mailed to the Veteran.

Based on the above, it has been determined that the subscription service can only be provided by Clinsys due to the required VA functionalities and the proprietary nature.

9. Other Facts: N/A

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.

Name Kathleen Kendle, MD Date: ________________________________

Title Chief, Health Informatics Signature: ____________________________

11. Fair and Reasonable Cost Determination: I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable based on comparing the quote to the Independent Government Cost Estimate and additional price analysis.

Kendra M. Casebolt Date: ________________________________

Procuring Contracting Officer Signature: ____________________________

12. Procuring Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief. As this contract action does not exceed $750,000, the certification below required by FAR 6.304(a)(1) serves as approval.

Kendra M. Casebolt Date: ________________________________

Procuring Contracting Officer Signature: ____________________________