Notice of Intent to Sole Source - Newborn Screening Services

Notice of Intent to Sole SourceThe Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division (WMCD), San Diego, intends to negotiate and award a firm fixed price contract for newborn metabolic screening services in accordance with Federal Acquisition Regulation (FAR) 13.501(a) Sole source acquisitions and FAR 13.106-1(b)(1)(i), only one source being available to meet the Government’s needs, to:MARYLAND DEPARTMENT OF HEALTH21770 ASHLAND AVE.BALTIMORE, MD 21205Newborn metabolic screening tests for inherited disorders in newborns and has been performed since the 1960s. The screen is collected at birth and later in infancy to ensure a proper sample distribution. If left undetected or untreated, these disorders can impede mental and physical development or can lead to death of the child.The objective of this sole source award is to procure non-personal services to provide newborn metabolic screening services and clinical counseling or assistance to the

healthcare provider as required for an average quantity of 200 infants per year at Yokota Air Base, Japan, that meet the following minimum requirements:The Contractor shall test for all of the following:Congenital Hypothyroidism Congenital Adrenal HyperplasiaCystic Fibrosis Hemoglobinopathy Biotinidase(pdx) GalactosemiaAmino Acid Profile Fatty Acid Oxidation Organic Acid DisorderSevere Combined ImmunodeficiencyThe Contractor shall also:Be responsible for all necessary testing supplies necessary to test samples for Yokota Air Base.Provide accreditation certification(s) (ex. College of American Pathologists) and applicable state licensure upon request. Report “normal” results in a timely manner (within three weeks) and will contact Yokota Air Base as soon as possible with any “abnormal” results.Provide clinical counseling or assistance to the healthcare provider as required. The counseling entails a certifying provider be available to discuss findings and treatment options with the ordering provider at no extra cost to the Government. Provide repeat testing, in the case of poor specimen quality or faulty kits, at no additional cost to the Government. Dispose of all samples in accordance with all applicable laws & regulations.Inform the Government prior to the changes being made if changes to the type of test are needed. Based on market research, Maryland Department of Health is the only source that can meet the Government’s minimum requirements to provide newborn screening services at Yokota Air Base, Japan.There are not set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) code 621511 – Medical Laboratories; the business size standard is $36.5 (in millions of dollars). The Product Service Code (PSC) is Q403 – Medical - Evaluation/Screening. The anticipated period of performance is for one base year and four option years (January 2023 – January 2028).This notice of intent is not a request for competitive proposals, and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability to provide the required services for Yokota Air Base, Japan. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or Adobe PDF attachment to Michelle Sanders at michelle.e.sanders6.civ@health.mil and Mariangela Monsalve at mariangela.j.monsalve.civ@health.mil. The closing date for challenges is no later than 1000 Pacific Time, 30 December 2022. No phone calls will be accepted.