36C10B-23-Q-0126 Data Innovations_Justification and Approval_21AUG2023_Redacted.pdf

Data Innovations Control Number: VA-22-00095838

JUSTIFICATION

FOR AN EXCEPTION TO FAIR OPPORTUNITY

1. Contracting Activity: Department of Veterans Affairs Office of Procurement, Acquisition, and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed action is for a firm-fixed-price contract to be issued as Full and Open via Contracting Opportunities on SAM.gov for brand name Data Innovations (DI) Instrument Managers (IM) laboratory management system, which includes hardware, software, associated support and maintenance, and training.

3. Description of the Supplies or Services: The Department of Veterans Affairs (VA), Office of Electronic Health Record Modernization (OEHRM), has a requirement for brand name DI laboratory management system, which includes hardware, software, associated support and maintenance, and training. To add the function of Lab Intelligence to Manila Outpatient Clinics Laboratory and existing Data Innovations Instrument Manager. The capability to demonstrate and document overall workflow efficiencies by displaying dashboards to users in a visual display of information which is consolidated and arranged on a single screen so the information can be monitored immediately. Examples of these are turn-around time, auto-verification, test/specimen volumes per day, quality indicators and quality check violations.

VISN 21 recognizes that other Veterans Health Administration (VHA) facilities may encounter the same challenges and need for software licenses and migration services for Data Innovations Instrument Managers for their Cerner implementations. Therefore, the Data Innovations Cerner migration and software solutions procured by VISN 21 may be implemented as an option at other VHA facilities.

Clinical laboratories use a variety of automated instruments from several different vendors in order to run their ever-growing complement of lab tests. DI IM integrates and coordinates the management of all these instruments using their driver libraries in an unrestricted, vendor-neutral manner. This procurement adds software (DMS licenses) to existing Data Innovations Instrument Managers allowing then to communicate with devices that are connected through another laboratory middleware or data management systems.

The period of performance shall be a base period of 12 months. The total estimated value of the proposed action is .

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 limited competition is available for this procurement among DI resellers. VA currently utilizes DI laboratory

Data Innovations Upgrade Control Number: VA-22-00095838 management systems throughout the VA enterprise to help labs keep track of their equipment, samples, and test results, manage their workflows/protocols, create compliance reports, and analyze findings. Only DI or an authorized reseller can provide the required integration services because of the proprietary source codes. Without access to this code, the software could not be properly configured which would render the DI laboratory management system as inoperable. In addition, DI laboratory management systems is the only laboratory management system on the Cerner approved interface list with bi-directional Cerner Connectivity Engine Terminal Servers connection to the federal enclave and is the only laboratory management system hardware and software that will interoperate with the existing VA-owned DI laboratory management system equipment. In addition, DI offers unique features that other laboratory management systems do not offer such as the most Auto-verification Rulesets across 5 Laboratory disciplines. This is required for autoverification to automate time-consuming work of validating test results and extended laboratory disciplines is needed for optimal workflow also a patient safety element human error can be removed from equation. Furthermore, only DI brand name laboratory management system that has over 1500 unique drivers for laboratory end-point devices. This feature is required to have a single Laboratory Instrument manager interface to configure/track as many laboratory end-point devices as possible to avoid confusion and reduce operational complexity, which reduces patient safety risk.

Failure to acquire DI laboratory management system would leave the VHA without an integration solution for hundreds of laboratory end-point devices for EHRM operations.

A new vendor’s platform would need to be implemented along side the the current laboraty management platform. This would result in updates and changes to existing end-point devices connected to support connections from the unfamiliar vendor.

Additionally, VA staff would have to implement and manage a separate laboratory management platform and integrate it to a the Cerner EMR, which would be duplicative with new workflows that would impact clinical operations. For these reasons a second vendor is not compatible with the DI laboratory management system for this VA requirement.

Further, the procurement of alternate brands would result in substantial duplication of costs that would not be recovered through a new competitive acquisition. Currently, the VA has DI laboratory management system hardware/software across 100+ plus locations (comprised of VAMCs, Regional Data Centers) and has invested ten (10) years of project and implementation time to support logistics, VA travel, VA site outage maintenance windows and other local ad-hoc coordination needs. The VA has conducted regional wide training sessions in a multi-year time span that introduced proprietary DI laboratory management system knowledge to implement, management and conduct break/fix support across the existing VA production DI laboratory management system infrastructure. Only DI add-on software and associated integration and cut-over services are capable of meeting VA’s requirements for this effort. No other brand software can be used to upgrade the existing DI laboratory management system due to the proprietary nature of the system. Further, no other source is capable of providing the required configuration, cut-over, and interface development services as

Data Innovations Upgrade Control Number: VA-22-00095838

Data Innovation products, services and support for this requirement. It was determined neither were members of the specific category GSA MAS contract that would allow competition between the forementioned contract holders. In order to promote competition among the only potential capable vendors, this solicitation will now need to be solicited as Full and Open for the brand name requirement. Results of this market research has been included in the contract file.

9. Other Facts: None.