REDACTED J and A.doc

J&A#: 20-00019

CLASS JUSTIFICATION AND APPROVAL (J&A)

FOR USE OF OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity.

Contracting Activity: Naval Medical Logistics Command (NML C), Acquisition and Analytics Di rectorate, Code 05, 693 Neiman Street, Fort Detrick, is acquiring on behalf of Military Treatment Facilities (MTFs) located in the states of California, Florida, Maryland, No11h Carolina, Oregon, Virginia, and Washington as well as MTFs located Outside the Continental United States (OCONUS) in Guam, Cuba, Bahrain, Italy, Japan and Spain.

Description of the Action Being Approved.

The proposed action is to award seven contracts on a sole source basis to provide non-personal services to support the Newborn Screening program for military beneficiaries located at the MTFs that have labor and delivery units.. The authority to act under this class justification expires on 30 April 2021. A single award contract to each state government department is appropriate as there is only one contractor that provides the applicable services within each state. Newborns screened under each state department ' s Newborn Screening program who are positively diagnosed with a screened condition will most likely require long-term care for the diagnosed condition. The notification and coordination of care is managed by each state program and allows the diagnosed patient to receive treatment services provided by the state department. Additionally, the service member of the diagnosed patient may be homesteaded at the MTF location for the required follow-on specialty care. The seven states and state departments as listed below are primary locations where Navy MHS military beneficiaries and applicable MTFs are located. In the case of an OCON US MTF location, the service member would typically be re-located to the state where the newborn screening test took place for follow-on specialty care for the diagnosed patient within that state's department. Based on the beneficiaries' location there is only one source capable of providing the required services as stated in paragraph 3 where Navy MHS military beneficiaries and MTFs are located. Therefore, in order to ensure all beneficiaries receive newborn screening services in all seven primary locations, seven single sole sourced contracts will be awarded.

The government intends on awarding a Single Award Task Order (SATO) Indefinite Delivery Indefinite Quantity (ID IQ), Firm Fixed Priced (FFP) contract to seven state governments in order to ensure all beneficiaries receive newborn screening services for all labor and delivery locations. The only source for each MTF is as follows:

Genetic Disease Screening Program, California Department of Public Health in support of: Naval Medical Center San Diego, CA Naval Hospital Camp Pendleton, CA Naval Hospital Twentynine Pa l ms, CA

Newborn Screening Program, Florida Department of Health in support of: Naval Hospital Jacksonville, FL Naval Hospital Pensacola, FL United States Naval Hospital Guantanamo Bay, Cuba

Newborn Screening Program, North Carolina Department of Health and Human Services in support of: Naval Medical Center Camp Lejeune, NC

Newborn Screening Program, Virginia Department of General Services in support of: Naval Medical Center Portsmouth, VA

Washington Newborn Screening Program, Washington State Department of Health in support of: Naval Hospital Bremerton, WA Naval Health Clinic Oak Harbor, WA

Newborn Screening Laboratory, Maryland Department of Health and Mental Hygiene in support of: United States Naval Hospital Naples, Italy United States Naval Hospital Sigonella, Italy United States Naval Branch Health Cli ni c, Bahrain United States Naval Hospital Rota, Spain

Northwest Regional Newborn Screening Program, Oregon State Public Health Laboratory in support of: United States Naval Hospital Guam United States Naval Hospital Yok osuk a, Japan United States Naval Hospital Oki nawa, Japan

Description of Supplies/Services.

Newborn Screening is recognized nationally as an essential preventive public health measure established under Public Health Service Act, Title X I, § 1109 (42 U.S.C.300b- l 0), as amended by the Newborn Screening Saves Li ves Reauthorization Act of2019 (H.R. 2507) was originally put into place in 2008, was amended in 2014 and was recently amended and passed by the House of Representatives of the United States of America Congress on 24 July 2019. Newborn screening is a well-established and proven health program that identifies newborns with certain genetic, metabolic, hormonal and functional conditions. With the early detection afforded by Newborn Screening, affected infants receive prompt treatment, which can prevent permanent disability, developmental delay and even death. A vital part of a successful screening program is appropriate medical intervention for positively tested babies. For some of the disorders screened, this intervention may require urgent or even emergent medical care for the identified baby. It is therefore critical to coordinate notification of abnormal results to healthcare providers to ensure appropriate intervention is initiated. Newborn Screening testing is not just an endpoint, it is the gateway to state services for newborns.

Considering the above, the three requirements of the Navy' s Newborn Screening program are:

1. Newborn screen blood spot testing, to include at a minimum, the disorders in the Recommended Universal Screening Panel (RUSP). The most up-to-date RUSP can be found here:

http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/recommendedpanel/

Estimated Dollar Value

An Independent Government Cost Estimated (IGCE) was established using the anticipated amount of tests the individual MTFs have historically required with a 10% quantity increase added per fiscal year to account for the potential increase in newborn births and a 10% value increase for any potential increases associated with screening test fees or advances in technology.

The total estimated value for the seven contracts is estimated at $17,330,297.48 for a period of five years.

The Newborn Screening service contracts will not be funded at the contract level and initial task orders will not be issued without sufficient O&M DHP funding for the base period of performance from 0 I May 2021 through 30 April 2022.

Statutory Authority Permitting Other Than Full and Open Competition.

The statutory exception permitting other than full and open competition for this acquisition is IO U.S.C. 2304(c)( I) and FAR 6.302-1 only one source.

Rationale Justifying Use of Cited Statutory Authority.

Newborn Screening is recognized nationally as an essential preventive public health measure. All states in the nation and the District of Columbia have established Newborn Screening programs to comply with recommendations of the Health and Human Services Secretary. These recommendations which continue to expand are established by the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), which was established under the Public Health Service Act, Title XI, § I I 09 (42 U.S.C. 300b- I 0), as amended by the Newborn Screening Saves Lives Reauthorization Act of2019 (H.R. 2507). State programs now screen for up to 63 conditions, which began as early as 1966 with the testing for phenylketonuria (PKU).

The role of the states in the broader Newborn Screening community is: develop and test innovative treatments and strategies to improve outcomes, educate providers about Newborn Screening, create and implement communication systems for Newborn Screen i ng, and sponsor research and research training programs on topics related to the health of ch il dren, adu l ts, fam ilies, and populations and to develop systematic methods for identifying additional conditions for Newborn Screening. For example, some of the disorders screened lead to liver failure if not managed appropriately in the first weeks of life. The lifetime medical costs for that child’s liver transplant would range from 3 to 10 million dollars. This does not even take in to account the cost of pain and suffering for the child and the family.

States certify their own laboratories and allow patients entry into their state-funded treatment services based on the results of those tests performed at those labs. Military Healthcare System (MHS) MTF beneficiaries screened by the state's Newborn Screening program who are diagnosed with a screened condition will most likely require long-term care for the diagnosed condition. The notification and coordination of care is also managed by the state program.

Program case managers for the state facilitate necessary medical consultation for providers with specialists in the fields of metabolic genetics, hematology, endocrinology or immunology, as appropriate to provide for timely follow up to begin the appropriate intervention.

When a baby is tested out of state, there is no requirement that a state being asked to provide treatment accept patients into their programs. While retesting can occur to allow the patient program entry in the state where treatment will occur, this entails further financial outlay for the government, can lead to delay in critical medical treatment and forces the patient and family to wait addition al time to enter into state programs. The opportunity to enter into a sole source agreement with local states will allow patients to receive the same standard of care that civilian children receive.

Military beneficiaries are a mobile population; however, babies identified with a disorder will in most instances be enrolled into the Exceptional Family Member Program (EFMP) and the service member homesteaded for the required follow-on specialty care. In many cases, the physicians providing that care are the ones consulting for the state program avoiding the need for transition of care. As a part of the continuum of care for the newborn, using the state's newborn screening program would reduce the vulnerability of communication and coordination of specialty care. This in turn avoids the risk of impacting major life duties as a result of a missed diagnosis.

Market Research was conducted by technical experts, December 2019 - February 2020. This research consisted of reviews of previous procurements of Newborn Screening contracts awarded by the Navy, Army, Air Force and Defense Health Agency (DHA). Additionally, state focused websites specializing in Newborn Screening were used to view/contact each respective state Newborn Screening program to consider the technical capability of meeting the Navy's requirement for Newborn Screening services. Based on the market research conducted, there are no commercial vendors that can provide all three requirements of the Navy ' s Newborn Screening program outlined in paragraph 3 except for the state governments. Commercial contractors provide screening services (lab testing only) but they do not provide follow-up care as required by the Navy. Only state department of health programs provide screening services and all supporting follow-up care required by the Navy.

The Department of the Navy issued a memorandum on 23 July 2015 stating that state laboratories satisfy the Navy ' s Newborn Screening requirements and , as a result , mandated their use. The follow-up care provided by state newborn screening programs only support beneficiaries located within the state. Therefore, only one source is capable of providing services within a state and a sole source contract must be awarded with each state to provide services to the MTFs with labor and delivery department located California, Florida, North Carolina, Virginia, and Washington.

Research was conducted by subject matter experts and specialty leaders to identify the most appropriate state based on expertise and location to manage cases from MTFs Outside the Continental United States (OCONUS). An agreement was reached with the stat e health departments of Oregon, Maryland, and Florida to support Navy labor and delivery units at MTFs OCONUS.

The Oregon State Public Health Laboratory provides support to United States Naval Hospital Guam; United States Naval Hospital Yokosuka, Japan; and United States Naval Hospital Okinawa, Japan, because the state of Hawaii contracts Oregon State Public Health Laboratory for testing its Newborn Screening specimens. After the screening process is complete, military beneficiaries who require more complex consultations for a positive condition, are flown to Tripler Army Medical Center in Hawaii, as Tripler is the designated military medical center that is closest to Japan /Guam and therefore more cost effective to utilize. Thus, if care is required for a military beneficiary diagnosed with a positive condition, utilizing Oregon State Public Health Laboratory would ensure uniformity of the Newborn Screening panel and access to the network of care at Tripler Army Medical Center, Hawaii.

The Florida Department of Health provides support to Naval Hospital Jacksonville, Naval Hospital Pensacola, and United States Naval Hospital Guantanamo Bay, Cuba. Military personnel stationed in Guantanamo Bay, Cuba are not allowed off base so everything is coordinated through Naval Hospital Jacksonville, FL and the only flights available for military beneficiaries are through Naval Station Jacksonville. If care is required for a military beneficiary diagnosed with a positive condition, utilizing Florida Department of Health would ensure uniformity of the Newborn Screening panel and access to the network of care at Naval Hospital Jacksonville, FL. It would be cost prohibitive and risk the health of a newborn seeking care to continue transportation beyond Florida.

The Maryland Department of Health and Mental Hygiene provides support for United States Naval Hospital Naples, I ta ly; United States Naval Hospital Sigonella, Italy and associated Branch Health Clinic Bahrain ; and United States Naval Hospital Rota, Spa i n. The Maryland Department of Health and Mental Hygiene has experience with OCON US Newborn Screening and managing newborn screening samples from other states. With regards to beneficiaries located in Spa i n, Italy and Bahrain, all services members and families requiring specialty care are sent to Walter Reed National Military Medical Center (WRNMMC) for care; it is the designated CON US MTF to support these locations. If care is required for a military beneficiary diagnosed with a positive condition, utilizing Maryland Department of Health and Mental Hygiene would ensure uniformity of the Newborn Screening panel and would provide access to the network of care at WRNMMC MD. It would be cost prohibitive and risk the health of a newborn seeking care to continue transportation beyond Maryland.

Therefore, only one source is capable of providing the required services to each Navy OCONUS location.

Considering the market research and the mandated policy from the Navy awarding a sole source contract to the public health departments of the states of California, Florida, Maryland, North Carolina, Oregon, Virginia, and Washington is justified.

Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

A Sources Sought notice was posted on 24 March 2020 and a Notice of Intent to Sole Source was posted on 09 April 2020 on FedBizOps' website at .gov." www.fbo.gov. No other sources have expressed interest in response to either notice. This requirement will be posted to FedBizOpps in accordance with FAR 5.203. Market research was conducted in accordance with FAR part IO for the purposes of identifying other potential sources. No other sources were identified that met the Navy's requirements. The results of the market research and the lack of responses to the posted notices validates NMLC's determination to sole source this requirement.

Determination of Fair and Reasonable Cost.

The Contracting Officer has determined the anticipated cost to the government of the services covered by this CJ&A will be fair and reasonable based on a comparison to an IGCE and market research

Actions to Remove Barriers to Future Competition.

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the types of services covered by this document. This requirement will be synopsized in accordance with FAR 5.203. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.

This justification is for a non-competitive follow-on to a previous award for the same services supported by justification #16-10 I 08 for other than full and open competition citing the authority at FAR 6.302-1. The actions to remove barriers listed in the previous justification (posting a sources sought for 30 days and posting a notice of intent to sole source) have not been met. Based on market research a sources sought was posted for a shorter timeframe. This follow-on justification will be approved by the approval authority one-level above the approval authority for the previous justification; the approval requirement listed PG I 206.304(a)(S- 70)(ii) will be met.