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 access to DI’s proprietary source code is required in order to ensure the services provided to the hardware and software components of the systems are properly configured. Failure to upgrade VA’s existing DI’s software will leave VHA without an integrated laboratory management system resulting in the need to transmit lab results/orders in a manual fashion to the new Cerner EHR. Any such manual intervention would significantly impact VA patient care as VA clinical staff are dependent on the existing DI system to analyze laboratory results for accurate diagnosis/trend tracking. Furthermore, replacing the existing system or implementing a new and separate laboratory management system for these VISNs to integrate with the new Cerner EHR would require an extensive implementation effort, including the replacement of all existing driver specific Endpoint Devices which are not compatible or interoperable with any other laboratory management software. Any such replacement or new implementation effort is estimated to cost and take at least to complete. This estimate is based on previous implementation efforts of similar size and scope. Aside from this duplicative cost that would not be recovered through competition, and which would delay the Cerner transition for these VISNs, requiring VA lab technicians and managers to learn, operate and manage a new system and workflows as part of the Cerner integration would add unnecessary complexity and duplicative activities thereby compromising patient care.

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 could meet the Government’s requirements. However, the undersigned VA technical representative determined that limited competition is available. In accordance with FAR 6.302-1(c)(1)(ii)(c) and 5.102(a)(6) this justification shall be posted with the solicitation. Furthermore, the proposed action will be synopsized on the Contracting Opportunities Page in accordance with FAR 5.201. Any proposals submitted in accordance with Section E.9 of the Solicitation shall be evaluated.

7. Actions to Increase Competition: In order to remove or overcome barriers to competition in future acquisitions for this requirement, the Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed. Specifically, the Government will continue to monitor the marketplace to determine whether other manufacturers can be upgraded into the existing DI databases at VAMCs.

8. Market Research: Technical experts reviewed alternate laboratory management systems, which consisted Each vendor is able to meet the VA’s ability to capture laboratory management information; however, these vendors are unable to integrate with the existing management platform due to the proprietary software to analyze laboratory results for diagnosis/trend tracking that clinical staff are dependent on for accurate diagnosis. Furthermore, as outlined in Section 5 of this Justification, only DI or an authorized reseller has access to the proprietary cutover and access to upgrade software that the DI database uses at VAMCs currently in place across the VA. In addition, VA technical experts regularly review industry trade publications and conduct internet research to ascertain if any other brand name equipment is available. Market research revealed that DI’s add-on software is the only brand software that can be added to the VA’s current Laboratory Management System & DI database without disrupting the existing clinical workflow.

The Contract Specialist conducted additional market research, in May 2023, by utilizing the NASA SEWP V Providers Lookup Tool and posted a Request for Information (RFI).

The Provider Lookup Tool identified five contract holders that are resellers of the brand name DI laboratory management system, which includes hardware, software, associated support and maintenance and training/consulting. Of these five resellers, three (3) are verified SDVOSBs, one (1) Woman-Owned Small Business and one (1) Large Business.

Furthermore, a Request for Information (RFI) #271893 was posted to all 129 Contract Holders on NASA SEWP Groups B, C and D on May 19, 2023 with a closing date of May 25, 2023 to verify the capability of the Vendors. The results for RFI 271893 are shown below in the table.

Vendor/POC/GSA Contract Number

Date Responded

Size Standard

Quote Status

05/19/2023 No Bid, Unable to quote at this time.

05/25/2023 Interested and Capable

05/25/2023

No Bid, Not Authorized

05/25/2023 No Bid;

Unable to bid on this opportunity

05/19/2023 No Bid;

submitting a no bid at this

05/23/2023 No Bid; No bidding at this

05/23/2023 No bid;

unable to source all products.

Of the seven (7) responses, six (6) responded with a no bid for various reasons for this requirement and one (1) stated they could provide a quote should a Request for Quote (RFQ) be posted later. was one of the five Vendors listed as having the brand name products under the Provider Lookup Tool. The Contract Specialist followed up with the other four Vendors found on the Provider Lookup tool as having these brand name products and services to determine why they didn’t respond. Two of the four Vendors responded, one of which was a and the other was a stating they would be interested in providing a quote for a future RFQ. As two SDVOSB vendors were deemed capable and interested , this was initially a SDVOSB set-aside. However, , one of the two interested SDVOSB vendors, subsequently informed the Contract Specialist, that they are no longer able to provide further NASA SEWP bids and therefore would not be able to respond to this requirement. This email is retained and filed.

Due to this new information, the Contract Specialist contacted the Original Equipment Manufacturer (OEM) to verify if there are any more SDVOSB authorized resellers of their products that are not included on NASA SEWP V GWAC. The OEM provided a letter informing the Contract Specialist there has been an established Small Business reseller partnership with as the only authorized reseller across all socio-economic business size standards of the products needed by the Department of Veterans Affairs. The OEM letter also stated they would be interested in providing a quote for this requirement should a Request for Quote be posted in the future.

Considering this new information, the Contract Specialist reviewed General Services Administration (GSA) Multiple Award Schedule (MAS) contracts for the

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.

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.

Uriel Gomez Date: 8/18/2023

OEHRM Biomedical Engineer 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 anticipation of competition and discounts among authorized resellers of the required brand name Data Innovations software maintenance support services. Additionally, a price analysis shall be conducted by comparing the successful quote with the Independent Government Cost Estimate as well as historical pricing of same items.

Patrick J. Hamilton 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.

Patrick J. Hamilton Date: _____________________

Procuring Contracting Officer Signature: __________________

Patrick J. Hamilton 3629894

Digitally signed by Patrick J.

Hamilton 3629894 Date: 2023.08.21 10:17:00 -04'00'

Patrick J.

Hamilton 3629894

Digitally signed by Patrick J.

Hamilton 3629894 Date: 2023.08.21 10:17:35 -04'00'