AIMS J-and-A-Other-Than-Full-and-Open (CO Signed).pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Acquisition Title: IHS Implementation of CARES Act Section 18115 Electronic Lab Reporting Requirements

Agency: IHS

Acquisition Year: 2020

Author: Charles Cross

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s): Association of Public Health Laboratories (APHL) DUNS=617077243

Street Address: 8515 Georgia Avenue, Suite 700

City, State, Zip: Silver Spring, MD 20910

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is $ 167,000.00

This acquisition is to participate in national laboratory reporting by obtaining a connection to the Association of Public Health Laboratories' (APHL) electronic lab reporting tool, Informatics Messaging Services (AIMS) Platform. The service provides a mechanism whereby IHS facilities can report COVID-19 testing activities to State and Federal agencies as mandated by the HHS memo "COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115" dated June 4, 2020. The memo requires all laboratories conducting COVID-19 testing to report their activities via one of three methods. Of the three methods described, only the AIMS platform provides a way that allows the possibility of meeting the August 1, 2020 deadline and begin submission for IHS as a whole (all states) utilizing an automated process. This single connection is the most cost effective for the government in that a single interface to this repository provides information to all states as opposed to 28+ individual interfaces to each state.

The estimated cost of this service includes a $95,000 initiation fee and an on-going per message fee of $0.40 each. Based on current reports of testing activity, this per message fee is estimated to be approximately $18,000/year.

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C. 3304(a) (1). See justification below.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

The Association of Public Health Laboratories (APHL) is the single centralized integrated source identified by DHHS and the Cares Act Section 18115. As provided in the June 4, 2020 guide the following options to report COVID 19 data are provided;

1. Submission of laboratory testing data directly to state or local public health departments, as required by state and/or local law or policy. These entities will then submit de-identified data to the CDC on a daily basis using either Health Level 7 (HL7) messaging or the CDC-provided CSV format.

2. Submission of laboratory testing data to state and local public health departments through a centralized platform (such as the Association of Public Health Laboratories’ AIMS platform) where such data will then be routed to the appropriate state and local authorities and routed to CDC after removal of elements to achieve de-identification according to applicable rules and regulations.

3. Submission of laboratory testing data through a state or regional Health Information Exchange (HIE) to the appropriate state or local public health department and to the CDC as directed by the state.1. Submission of laboratory testing data directly to state or local public health departments, as required by state and/or local law or policy. These entities will then submit de-identified data to the CDC on a daily basis using either Health Level 7 (HL7) messaging or the CDC-provided CSV format.

Because IHS has facilities located in more than 30 states, option two, AIMS platform is the most cost and deployment efficient approach for the government.

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2)

On March 13, 2020 the COVID-19 pandemic was declared an emergency by the President of the United States. Subsequent to this declaration, HHS issued a memo entitled "COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115" dated June 4, 2020 that sets a deadline of August 1, 2020 for all laboratories conducting SARS-CoV-2 to report testing activity to State or local public health departments within 24 hours of the results being known. Given the testing effort underway in the IHS there is a compelling urgency to obtain a service that automates COVID-19 laboratory testing activity reporting to the public health agencies.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5)

CARES Act - Section 18115.

Other (See FAR Subpart 6.3 for additional authority):

5. Bridge Contracts:

N/A

6. Actions to Increase Competition:

A notice was not publicized because an unusual and compelling urgency precludes competition to the maximum extent practicable due to the requirements published in HHS memo entitled "COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115" dated June 4, 2020.

7. Market Research:

Based on the the CARES Act citation, the AIMS platform has been the only service identified by DHHS that provides an acceptable option for single intake point to reach all the State jurisdictions in which IHS operates. AIMS has existing connections to all 50 state public health departments, the CDC, and several local public health organizations. Having a single point of intake reduces the administration, configuration, and maintenance level of effort required to automate the required COVID-19 test reporting. The reduced level of effort will facilitate the effort to achieve the reporting guidance contained in the HHS memo.

8. Procurement History:

Purchase order or contract number: N/A. New requirement.

Was action competed? Yes No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

FAR 6.302-1: Only one responsible source and no other supplies or services with satisfy agency requirements, 41 U.S.C. 3304(a)(1) - Only one (1) source identified by the HHS directive. This procurement is to allow compliance with COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115 reporting requirements and is related to the public health emergency proclamation issued on March 13, 2020 concerning the Novel Coronavirus Disease (COVID-19) Outbreak. Once the emergency has been rescinded, a determination will be made as to whether the service is still required and if so, a full competition can be conducted. 9. Additional Information to support the justification

Identification by HHS of only one (1) suitable solution/vendor for this requirement and Federally mandated reporting requirements present sourcing and time constraints, and preclude the completion of a technical package to facilitate competition.

10. Technical / Requirements Certification: By my signature below, I certify that the supporting data under my review which is included in this J&A is accurate and complete.

Program Manager

Name: Charles P. Cross

Position Title: Supervisory IT Specialist, RPMS Development (Acting)

Email address: charles.cross@ihs.gov

Phone: 405 323 4776

Program Manager Supervisor (or one level above Program Manager)

Name: Jeanette Kompkoff

Position Title: Director, Division of Information Technology

Email address: jeanette.kompkoff@ihs.gov

Signature

Date:

11. Fair and Reasonable Price Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

12. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date:

13. Legal Review:

Jeanette Kompkoff -S Digitally signed by Jeanette Kompkoff -S Date: 2020.07.10 15:20:37 -07'00'

Brendon Moran (301) 348-3458

07/17/2020Signed by Brendon Moran

14. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million value calculated including all options):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Phone:

Signature: Date:

15. Office of Small and Disadvantaged Business Utilization I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Phone:

Signature: Date:

16. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million value calculated including all options):

Name: Phone:

Signature: Date:

HHS Senior Procurement Executive (SPE) Approval Based on the foregoing justification, I hereby approve the procurement of (state supplies/services being procured) on an other than full and open competition basis pursuant to the authority of (state the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304), as implemented by FAR 6.301), subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date: