6-Attachment B - Scope of Work KR27-107 Redacted.pdf

SCOPE OF WORK

Article 1

PURPOSE

1.1 Purpose. The purpose of this contract is to enable DHHS Blood Spot newborn screening (“NBS”) staff to screen for life-threatening Hemoglobinopathies using dried Blood Spot (“DBS”) samples utilizing capillary zone electrophoresis for the identification of normal (Hb A, F) and abnormal (Hb S, C, E, D, Bart's) hemoglobins.

Article 2

DEFINITIONS

2.1 Definitions. In this contract, the following definitions apply:

“Blood Spot” means a clinical specimen submitted on the paper of the NBS form using the heel stick method.

“Capillary Zone Electrophoresis” means an analytical technique that separates charged molecules inside a narrow tube using an electric field and a buffer solution and sorts of particles into distinct zones based on their electrical charge and size

“Hemoglobinopathies” means any conditions caused by changes to hemoglobin that affect the shape or amount of red blood cells in the body in an unhealthy way.

Article 3

SERVICE REQUIREMENTS

3.1 Services. The Contractor shall:

(1) ship two CAPILLARYS 3 DBS instruments, two UPS systems and two processing instrument computers;

(2) install the instruments, configure the system, and verify that everything is fully operational;

(3) perform the instrument validation for each CAPILLARYS 3 DBS NBS platforms;

(4) provide comprehensive training for, up to, two (2) DHHS NBS laboratory staff specific to the screening of Hemoglobinopathies using the CAPILLARYS 3 DBS instrument with any associated Sebia software;

(5) ensure an adequate response time of forty-eight (48) hours of request for emergency repair services Monday through Friday local time; and

Attachment B

(6) provide two preventative maintenance visits per calendar year and per instrument.

Article 4

OUTCOMES

4.1 Expected Outcomes. DHHS NBS staff will be able to screen for life-threatening

Hemoglobinopathies using DBS samples and utilizing capillary zone electrophoresis for the identification of normal (Hb A, F) and abnormal (Hb S, C, E, D, Bart's) hemoglobins.

Identifying newborns at risk for Hemoglobinopathies is essential for early preventive measure or treatment which can improve quality of life and may reduce child mortality of infant under the age of one year old. Because NBS for Hemoglobinopathies is universal, this service will support and serve all individuals and communities throughout Utah.

4.2 Outcome Measures. The Contractor shall:

(1) ensure the contract with DHHS is properly executed by completing service requests in a timely manner and by shipment, as ordered, of all the necessary reagents for the duration of the contract period; and

(2) provide subject matter expertise as requested by DHHS NBS staff.

4.3 Reporting Requirement. The Contractor shall:

(1) submit a price quote for the duration of the contract period:

(2)

(A) pricing should describe unit price; and

(B) an estimated annual reagent commitment; and

(3) provide proper documentation in a timely manner for any service requested by

DHHS NBS.

Article 5

BILLING REQUIREMENTS

5.1 Billing. The Contractor shall:

(1) submit an invoice for all Goods shipped on the first business day following the shipment of such Goods. DHHS designee that include:

(A) Contractor’s name, payment address, and phone number;

(B) contract number / PO number;

(C) invoice number;

(D) invoice date; and

(E) details of services billed including hours worked on this contract.

(2) submit all invoices to for services performed on or before

June 30th of a given fiscal year no later than July 14th of the following fiscal year, regardless of the Contractor’s billing period or the expiration or termination date of this contract. The State of Utah’s fiscal year is from July 1st through June 30th.