Redacted J and A.pdf

Justification and Approval (J&A) for Federal Acquisition Regulation (FAR) Subpart 6.3 Other Than Full and Open

Competition

Title: RALS software license and maintenance - Naval Medical Center Portsmouth (NMCP) & Langley Air Force Base

(LAFB)

J&A Number: JA-22-0262

1. Identification of the agency and contracting activity: Specify the contracting activity responsible for this action.

Defense Health Agency - Tidewater Contracting Division

2. Nature and/or Description of Action being Approved: State whether approval is being requested for a new contract or bridge action, and whether it is an individual or class justification. (see DHA PG/ 206.3}

New Contract - Individual

3. Description of Supplies/ Services: Describe the supplies and services. Provide the period of performance for the base and all options, and the estimated value by base, option, and the total, including any extension of services, as applicable.

Include type of contract (e.g., Fixed Price or Cost Reimbursement), type of funds to be used, (Department of Defense, Veterans Affairs, Joint Incentive Fund-No Year (DoD/VA JIF-NY), Operations & Maintenance {O&M), Research, Development, Test & Evaluation (RDT&E), Other Procurement {OP}, or Revolving Funds-NY) and, when applicable, the estimated share and ceiling arrangements, and fee and/or profit. If the requirement is for a repair part, address whether or not it has been screened. If the repair part has been screened, provide the Acquisition Method Code {AMC} and

Acquisition Method Suffix Code {AMSC}. Provide the approximate date the technical data package will be available.

This is a non-personal services requirement for a software interface and accompanying maintenance support services that connects point-of-care test results and instruments to the Department of Defense Composite Health Care System

(CHCS)/Genesis health record system. The software and support services should track user certifications, reagents lot numbers, quality control, calibration, expiration dates, and manage patient results, devices, and device configurations.

The requirement includes providing all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items as necessary. Other tasks include managing overall implementation, organizing the necessary resources to provide technical guidance, installation, testing, support for system configuration, training, and annual technology license. The software should interface through VPN connections and all supplied software shall be certified free of malicious codes/damaging properties such as viruses, Trojan horses, worms, spyware etc. Software maintenance releases shall be provided as soon as possible after release but no later than 14 days after release.

The awarded contract will be for a period of 12 months. The software system shall have the ability to interface the below devices:

Abbott i-STAT

Abbott Precision Glucose

Roche ACCU-CHEK® Inform II

Roche CoaguChek® XS Plus/Pro

Nova StatStrip Glucose Module

Quidel Sofia Module

Siemens Healthineers DCA Vantage Module

Siemens Healthineers Clinitek Status Module

IL AVOXimeter l000E Module

I Manual Test Entry

TOTAL Contract Value

POP: From 01/01/2023 to 12/31/2023 Estimated Value:

Type of Contract {Primary):

FAR 16.202 Firm-Fixed Price

Options:

Number of Options: 0

POP {All Options): N/A Estimated Value (all options): N/A

Funding Type: Operations & Maintenance (O&M)

4. Statutory and Regulatory Authority Permitting Other Than Full and Open Competition (see FAR 6.302), or the

Specification of the Statutory and Regulatory Provision Providing Exception to S(a) Program Competitive

Requirements (see FAR 19.805-1):

10 U.S.C. 2304{c){l) 6.302-1- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Rationale Justifying Use of the Statutory Authority Cited: Provide sufficient facts and rationale justifying use of the specific authority cited under Item 4 above {See FAR 6.302, FAR 6.303-2, and FAR 19.805-1).

The current contract for NMCP expired 30 September 2022 and Tidewater contracting was not made aware of the continued need for this requirement, and the need by LAFB, until September 2022. A 3-month bridge contract was issued to end 31 December 2022. NMCP and LAFB initially requested this requirement to have a 12 month base period of performance and four 12 month option periods, and indicated this requirement needed to be sole sourced but upon further investigation it was discovered there are two other Vendors that could potentially meet the needs of the MTF.

However, this information was not discovered until October 2022 and once discovered did not leave enough time to compete this requirement without a lapse in services. RALS is a laboratory information system {LIS) and the database for all test results that are completed and acts like a laboratory device that transmits completed results to the electronic health record; a sudden change to switch over to a new point of care system would result in interrupted operation of the MTF. Any new instrumentation/device/LIS must have a validation study completed before it can be used in a live environment (the validation study is a comparison between the current in use system and new system/device/LIS being considered as a replacement. The systems run in duplicate for a period to ensure they exactly mirror each other and perform to the manufacturer specifications.) The RALS system is a large portion of the laboratory resulting system, and multiple departments and levels of verification of transmission of patient results would need to be verified to ensure that the laboratory LIS section stay within the MTFs accrediting agency {College of American Pathologists) requirements if the entire system needed to be replaced. This added step of verification, along with re-training of MTF personnel would ultimately result in delay of the implementation of a new software system and would drastically affect the quality and continuity of care due to delay in test results being entered into the electronic medical record. Additionally, if a lapse were to occur at NMCP, the point of care department would be placed in a position of having to shut down testing services in all areas until new policies and procedures are created to allow the entry of completed patient testing results by hand; as this would go against policies of the agency the laboratory accreditation is under. If this were to happen, at NMCP, the result would be weeks' worth of point of care testing not being able to be completed at the patient bedside.

These new procedures would have to be written and approved by the laboratory Quality Assurance department to allow for manual entry. This would entail training staff members how to enter manual results, creating further delay in patient care. All lab results are entered into CHCS are part of the patient's electronic health record and are the only official documents/results that should be used to treat the patient. The current system LAFB has is beyond it's life expectancy, and they are still manually inputting patient results in to records.

Abbott has executive rights to produce, distribute, and maintain the software label and bundle called RALS System. No dealers qualify to work on and/or maintain the product. Furthermore, the product can be interfaced with current Department of Defense health record systems such as CHCS, AHLTA, ESSENTRIS, and GENESIS. The process to interface RALS point-of-care patients results with the Genesis system that will be on line January 2023 has already started. The RALS system has also been authorized to establish communications with the GENESIS HER. While it is noted that MHS GENESIS has the capability to run a point of care system, the decision to purchase the point of care modules/system/internal interfaces that could be included was not purchased for these locations. The RALS system package is the only software used to coordinate and schedule training, certification, and testing of critical medical personnel. Initial installation and setup has already been provided for the RALS via current contract. This requirement is a short-term procurement in order to mitigate a lapse in service to support the mission. Sole source procurement to Abbott Rapid Diagnostics Informatics is recommended. A competitive procurement is being pursued while the sole source procurement is put in place to prevent a lapse in services.

6. Efforts to Obtain Competition: Describe efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required at FAR Subpart 5.2 and, if not, which exception under 5.202 is applicable to the requirement. Justifications citing the authority at FAR 6.302-1 permitting the use of other than full and open competition, shall include the results of the request for information or sources sought notice posted in accordance with DFARS PG/ 206.302-1 (unless the requirement to post has been waived);

and for non-competitive follow-on acquisitions of supplies or services previously awarded on a non-competitive basis, include a copy of the previous justification with the current justification review package to assist the approval authority in determining whether the planned actions to remove any barriers to competition cited on the previous justification were completed.

A special notice was posted on SAM.gov, 1 November 2022 with a 15 day posting period, for interested sources to provide a capabilities statement. No responses were submitted. A notice will be posted on SAM.gov of the Government's intent to sole source these required services for a 12-month period of performance.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable: Describe how the contracting officer determined or will determine that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer has determined the anticipated cost to the Government for the requirement covered by this J&A will be fair and reasonable. The proposed price will be compared to historical prices, prices obtained through market research, and an Independent Government Cost Estimate. A contract will not be awarded unless the prices is determined to be fair and reasonable.

8. Market Research: Describe the extent of the market research conducted and when conducted, method utilized, and results, or, if market research was not conducted, provide the rationale (see FAR Part 10 Techniques for Conducting

Market Research). The market research conducted or rationale provided in this section should help support the rationale justifying the use of the Statutory and Regulatory Authority in Section 5 above.

I Yes ..:J Market Research Conducted?

When was it conducted? July 2022 Description:

The Technical/Functional Representative for this requirement noted that in addition to Abbott Informatics, two other companies interface point-of-care results with an electronic records system. The first company, Telcor has just recently completed the process to be authorized on a DHA network. Siemens Healthineers is the other system on the market available and provided quote information to in July 2022. Additionally, while other systems exist, they will not work with the system in-use that is at NMCP in the timeframe required for this procurement. The COR applied personal knowledge and reviewed results of recent market research of the previous contract, N0018319P0789; and contacted POC regarding market capabilities to meet the requirements. The Ability One site was searched 4 October 2022 for the RALS-Web 3 System with no results returned. The site for

Federal Prison Industries, Inc. was searched 4 October 2022 with a keyword of "software" and no results were returned.

A SBA Quick Market Search was performed on 7 October 2022 for NAICS Code 513210 and no results were returned. The

COR had meetings/discussions with the . The Federal Supply Schedule was also reviewed and produced no results for the software and services required. It is noted MHS

Genesis does have the capability for point of care test result these relevant modules were not purchased by the

Enterprise for the MTFs. Due to time constraints from the time Tidewater contracting became aware of this requirement and the continued need for this requirement; a 12-month sole-source is being put in place to mitigate a lapse in service while the competitive requirement is being worked.

9. Other Facts: list any other facts supporting the use of other than full and open competition, such as an explanation as to why technical data packages, specifications, engineering descriptions, statements of work, or purchase descriptions suitable for full and open competition have not been developed or are not available.

The validation processes in implementing a new system to connect point-of-care test results with patient records must be strictly adhered to in order to maintain accreditation with the College of American Pathologists. These validation tests include, but are not limited to, accuracy, precision, reportable range, and system verification studies for a certain amount of patient samples (usually around 30-40 samples for each testing methodology that will be connected) to ensure everything (results, ref. ranges, critical results/other flags, units of measure) is crossing over appropriately. These studies take at least 3-6 months to complete, but can often take longer. With the implementation of the enterprise electronic medical record system (MHS GENESIS) in January 2023, RALS is the system of choice to provide continuity of care and patient care for NMCP Portsmouth and Langley AFB. RALS is a verified system that communicates effectively with MHS GENESIS and is currently in use. Given a standard DHA PALT of 145 calendar days for full and open competition of an acquisition this size, plus the length of time required to validate a new system, a 1-year sole source for

RALS is in the best interest of the government and the patients it supports at NMCP Portsmouth and Langley AFB.

10. Interested Sources: Include a listing of the sources, if any, which have expressed, in writing, an interest in the acquisition.

Abbott Rapid Diagnostics Informatics, Inc.

11. Actions to overcome barriers: Describe the actions, if any, the agency may take, or is taking, to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

The long-term plans for this acquisition is to compete. This action is planned to be a short-term contract in order to mitigate a lapse in service. The government is currently working on a procurement package for the follow-on acquisition to be competed.

14. Fair and Reasonable Cost Determination: Provide the basis for this determination (e.g., describe techniques utilized, or to be utilized, to determine cost/price fair and reasonableness, such as cost analysis, price analysis, audit, should cost, independent Government estimate). As part of this basis, indicate whether certified cost or pricing data will be required or if one of the exceptions in FAR Part 15.403 will apply. Contracting Officer to include the following determination:

The Contracting Officer will determine the anticipated cost to the Government of the supplies covered by this justification to be fair and reasonable by conducting additional pricing analysis before an award is made. This acquisition will utilize the proposal analysis techniques outlined in FAR 15.404-l(b)(2) - Price Analysis. Certified Cost or