A.03 SSJA Newborn Screening 12-9-21 fully signed_Redacted.pdf

CUI//SP-SSEL

Control Number: 22-RHCO-A-48

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

(Sep 2021)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office – Atlantic, Fort Bragg, NC.

2. Description of Action: Womack Army Medical Center (WAMC), Department of Pediatrics requests approval for a new Firm-Fixed Price (FFP) contract for non-personal services for Newborn Screening Testing. Operation and Maintenance (O&M) Appropriations funds will be used to fund the resultant contract.

3. Description of Supplies/Services: This requirement is for the procurement of services which are governed by North Carolina State Statue. The program and series of tests that are mandated by State Statue. The proposed contract period of performance will be from 01 April 2022 through 31 March 2023 with three 12 month option periods.

The estimated total contract value is for the base plus three 12 month option periods. This is a service requirement therefore FAR 52.217-8, “Option to Extend Services” will be included in the contract.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: WAMC Department of Pediatrics is currently using North Carolina Department of Health and Human Services (NCDHHS). The only authorized newborn screening laboratory in the State per Statue and rule. An email from the Laboratory Director at NCDHHS received on 17 November 2021 stated they are the only authorized newborn screening laboratory in the state per statute and rule. The Newborn Screening Program in North Carolina is established in accordance with the General Statute, G.S. 130A-125. Per 10A NCAC 42B.0102, all attending physicians shall collect or ensure the collection of specimens for each newborn in North Carolina and submit those specimens to NCDHHS. If WAMC cannot perform the required tests, patients will have to be sent out to other medical facilities. This would be very costly to the government.

6. Efforts to Obtain Competition: A synopsis was posted to SAM.gov on 16 November 2021, one response was received but in accordance with North Carolina State Statue, only NCDHHS is authorized to perform these services. There is no effective competition expected for this requirement. This will be a sole source requirement to NCDHHS due to the Statue governing the program and testing required to fulfill this requirement. A Sole Source Justification was provided by email to the Government. The government will ensure the Contractor submits a subcontracting plan in accordance with DFARS 252.219-7004 to ensure the prime contractor competes its subcontracting opportunities as much as possible.

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

(Sep 2021)

7. Actions to Increase Competition: At this time it is not possible to compete this acquisition. A Performance Work Statement will be included in the solicitation and any proposals received will be evaluated for future requirements. Sole source is necessary to ensure that patients seen at facilities supported by the WAMC laboratory are taken care of properly and required testing materials are available to provide medical care.

8. Market Research: Market research was conducted in accordance with FAR Part 10.

Internet searches show that NCDHHS is the only authorized laboratory in the State that can provide the required services to the Department of Pedatrics at WAMC. A search on Small Businesses Quick Market Search was performed using NAICS code 621511 (Medical Laboratories) and key words “Newborn Screening”. There were no small businesses that met the search criteria. A search on GSA eLibrary was also performed, no additional large or small businesses were found when searching for newborn screening.

9. Interested Sources: To date, only one other source has expressed interest, in writing or otherwise. Unfortunately, due to NC State Statue only NCDHHS can perform these services by law. Notices required by FAR 5.201 shall be published, and any proposals received shall be considered.

10. Other Facts: During market research NCDHHS provided a sole source email stating they are the sole source provider of the laboratory program and testing, as authorized by NC State Statue.

a. Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements.

W91YTZ17C0010 awarded for , with a five year period of performance and a 6 month extension.

(2) The competitive status of these actions. The previous requirement was solicited as competitive unrestricted.

(3) Authority previously cited if less than full and open competition was used. N/A.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. N/A.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. The prior contract was competed however, while

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

(Sep 2021) conducting market research for this requirement it was discovered that the only authorized newborn screening laboratory in the State per Statue and rule is NCDHHS.

An email from the Laboratory Director at NCDHHS received on 17 November 2021 stated they are the only authorized newborn screening laboratory in the state per statute and rule. The Newborn Screening Program in North Carolina is established in accordance with the General Statute, G.S. 130A-125. Per 10A NCAC 42B.0102, all attending physicians shall collect or ensure the collection of specimens for each newborn in North Carolina and submit those specimens to NCDHHS.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. N/A.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. N/A.

b. Other facts. Acquisition data availability. A Performance Work Statement (PWS) will be posted with solicitation. It is anticipated that NCDHHS will be the only company that can perform the required service IAW NC State Statue.

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: ________________________________Date: __________

Typed Name: __James Alarcon_____Title:_____GPM Pediatrics Center______

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: ________________________________Date: __________

Typed Name: __Kimberly Coleman___Title:___Health Systems Specialist___

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. Fair and Reasonable determination is based on the market research and the Independent Government Estimate. Certified cost or pricing data is not required per FAR 15.403-1(b) (3), because the items are commercial in nature.

8 Dec 2021ALARCON.JAMES.RICHARD.10 54928315

Digitally signed by

ALARCON.JAMES.RICHARD.1054928315

Date: 2021.12.08 14:08:05 -05'00'

COLEMAN.KIMBERLY.D

ENISE.1113888691

Digitally signed by

COLEMAN.KIMBERLY.DENISE.1113888691

Date: 2021.12.08 15:21:16 -05'00'

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

(Sep 2021)

Signature: ________________________________Date: __________

Typed Name: _Lonnie Robinson_____Title: __Contracting Officer_______

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: ________________________________Date: __________

Typed Name: _Lonnie Robinson_____Title:__Contracting Officer_______

ROBINSON.LONNI

E.K.1028938116

Digitally signed by

ROBINSON.LONNIE.K.1028938116

Date: 2021.12.08 16:52:22 -05'00'

ROBINSON.LONNIE.

K.1028938116

Digitally signed by

ROBINSON.LONNIE.K.1028938116

Date: 2021.12.08 16:53:07 -05'00'

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

(Sep 2021)

Approval

Based on the foregoing justification, I hereby approve the procurement of services for newborn screening testing for the Department of Pediatrics at a total estimated price of on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, and provided that the services are regulated and mandated by State Statue to North Carolina State Department of Health and Human Services (NCDHHS) herein described have otherwise been authorized for acquisition.

Signature: _______________________ Date: ____________________________

Typed Name: _____________________ Title:_____________________________

ALVARENGA.KERRY.AN

N-MARIE.1185865882

Digitally signed by ALVARENGA.KERRY.ANN-MARIE.1185865882 Date: 2021.12.09 07:46:49 -06'00'