SOW - Newborn Screening.docx

STATEMENT OF WORK (SOW)

FOR

Newborn Screen Testing

I. BACKGROUND

Two newborn screenings are required for all babies born in Nevada and tested at the State Public Health Laboratory as mandated by Nevada Administrative Code (NAC) 442.020 - 442.050.

II. SCOPE

The overall purpose of this requirement is to obtain certification of operational standards of the following: provide all personnel, labor, equipment, tools, materials, supervision, and transportation necessary to perform metabolic newborn screening test with necessary confirmation for newborns at Mike O’Callaghan Military Medical Center (MOMMC) at Nellis Air Force Base, NV.

The contractor shall provide all supplies required for specimen collection.

III. PERIOD OF PERFORMANCE

Base contract with X option years.

CONTRACT PERFORMANCE PERIOD:

a. Base Year: 15 September 2025 –14 September 2026

b. Option Year 1: 15 September 2026- 14 September 2027

c. Option Year 2: 15 September 2027- 14 September 2028

d. Option Year 3: 15 September 2028- 14 September 2029

e. Option Year 4: 15 September 2029- 14 September 2030 -8 Extension: 15 September 2030- 14 March 2031

IIII. WORK REQUIREMENT

The contactor shall provide all personnel, labor, equipment, tools, materials, supervision, and transportation necessary to perform metabolic newborn screening test with necessary confirmation for newborns at Mike O’Callaghan Military Medical Center (MOMMC) at Nellis Air Force Base, NV. Two newborn screenings are mandated by Nevada Administrative Code (NAC) 442.020 - 442.050. Samples must be placed in a newborn screening test kit obtained from the State Public Health Laboratory and must be mailed to the address indicated on the kit within 24 hours after the sample is taken.

The contractor shall provide all supplies required for specimen collection. Results shall be returned by the contractor to MOMMC with a turn-around-time of no greater than 14 days.

HOURS OF OPERATION: The MOMMC laboratory operates on a 24-hour basis. Normal work hours are from 7:00 am to 4:00 pm, Monday thru Friday, excluding holidays.

POINT OF CONTACT: The laboratory point of contact shall be the Shipping Supervisor, Non-Commissioned Officer in Charge or laboratory officer: 702-653-2241, 702-653-2828.

SHIPPING AND HANDLING: The mode of shipment used shall be appropriate for the product being shipped to arrive within manufacturer’s specifications. Temperature controlled products that are restricted from shipping over weekends and holidays shall be sent to arrive during normal duty hours (Monday thru Friday, 7:00am to 4:00pm).

IV. TECHNICAL

Confirmation analyses must be as follows:

Ensure that newborn screening occurs for all newborn babies delivered at MOMMC for the disorders mandated by state regulation NAC 442.020-442.050.

Verify that each newborn has had access to screening and if not, taking action to assure screening is available.

Provide appropriate follow up and referrals to health care providers for newborns with abnormal screening results to facilitate time sensitive repeat/confirmatory testing and treatment services.

Initial Notification and Assessment:

The Follow-Up Coordinator receives notification from the laboratory and formally acknowledges the pre-positive determination.

Review the abnormal newborn screening (NBS) results to assess the urgency of the suspected disorder. Evaluate the appropriate actions to be taken by the primary care provider (PCP), and modify the recommended response based on the newborn’s clinical presentation.

Notify the disorder-specific consultant of the pre-positive results and provide the proposed plan of action.

Contact the newborn's primary care provider to communicate the pre-positive findings, discuss next steps, and advise on any interim precautions. Follow up with a faxed instruction packet. Verify the newborn’s insurance information and confirm the preferred laboratory for confirmatory testing.

Consult with health care providers and sub-specialists regarding test implications and appropriate follow up actions.

Provide consultation, technical assistance, and education about the newborn screening program to hospitals, health care providers, submitting laboratory, parents/families of affected newborns, and community partners.

Monitoring Confirmatory Sample Collection.

Analyze and disseminate data on newborn screening requirements, including cost effectiveness of the system and health outcome.

Clinical Assessment, Monitoring, and Coordination.

Evaluate outcomes of the program, ongoing quality improvement, and promoting continued access to appropriate specialty health care.

The contractor shall provide up to date CLIA #, CAP #, State License #, and Medical Director’s name and contact info to MOMMC laboratory for accreditation purposes.

V. CONSTRAINTS

COMPLIANCE WITH APPLICABLE FEDERAL, STATE AND LOCAL REQUIREMENTS: In performing work under this agreement, the contractor shall comply with all relevant federal, state and local statutes, ordinance, laws and regulation. Two newborn screenings tested by the State Public Health Laboratory are mandated by Nevada Administrative Code (NAC) 442.020 - 442.050. Samples must be placed in a newborn screening test kit obtained from the State Public Health Laboratory and must be mailed to the address indicated on the kit within 24 hours after the sample is taken.