SOW.docx

STATEMENT OF WORK

TITLE: Procurement of Prenatal Serum for SRM production LAB REQUESTING SERVICE: Material Measurement Laboratory, Chemical Sciences Division, Environmental Chemical Sciences Group

I. BACKGROUND INFORMATION

The Environmental Chemical Sciences Group in the Chemical Services Division, part of the National Institute of Standards and Technology (NIST)/Material Measurement Laboratory, serves as the Nation's reference laboratory for chemical measurements and standards to enhance U.S. industry's productivity and competitiveness, assure equity in trade, and provide quality assurance for chemical measurements used for assessing and improving public health, safety, and the environment.

The Chemical Sciences Division is also responsible for development and characterization of Standard Reference Materials (SRMs) to enhance chemical measurement comparability within the U.S. and to provide a basis for measurement comparability with other nations. SRMs are provided to support clinical, food, environmental, fuel, metal alloy, cement, and advanced materials analyses.

NIST is developing an SRM for clinical biomarkers in frozen human prenatal serum. A need for an SRM to be developed for prenatal serum has been discussed by NIST scientists and collaborators including the National Institutes of Health’s Office of Dietary Supplements (NIH-ODS), Centers for Disease Control and Prevention (CDC), the Medical University of South Carolina (MUSC) and iodine assessment national experts. The measurement of important biomarkers, including hormones, in pregnant women is a challenge due to the increased complexity of matrix components compared to non-pregnant individuals. Therefore, a critical need for quality assurance materials for analyses during pregnancy has been identified. To conduct this study, NIST will require donor serum material from female human donors that are at different stages of pregnancy (as specified below). NIST will procure the serum from a vendor with the appropriate requirements. The vendor will ship serum to CDC for bottling and packaging, as CDC is better equipped to accomplish the bottling. Once CDC has packaged the serum it will be shipped to NIST for value assignment of important biomarkers.

II. SCOPE OF WORK

The contractor shall provide 8.0 L of serum total at 4 different stages of pregnancy. Specifically, the contractor shall need to acquire 2.0 L of serum from donors at each of the varying stages of pregnancy including: (1) non-pregnant females, (2) first trimester (6-10 weeks), (3) second trimester (18-21 weeks), and (4) third trimester (32-35 weeks). The contractor shall ship the material on dry ice overnight to CDC.

III. SPECIFICATIONS

The Contractor shall acquire a total of approximately 8.0 L of human serum at specific levels of pregnancy. The target levels for the four human serum stages are listed below:

Level 1: Non-pregnant female, of child birthing age; 2.0 L Level 2: First trimester (6-10 weeks); 2.0 L Level 3: Second trimester (18-21 weeks); 2.0 L Level 4: Third trimester (32-35 weeks); 2.0 L

The Contractor shall test the serum pools for biosafety. All sera shall be demonstrated to be non-reactive when tested for hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus, and human immunodeficiency virus antigen 1 by tests licensed by the U.S. Food and Drug Administration. The Contractor shall provide test results with the serum pools.

The Contractor shall provide NIST with details of the steps involved in material preparation not later than 180 days after award of this requirement to ensure documentation of any deviations as well as to provide information that shall be utilized in the NIST material acquisition Report of Analysis.

Boxes shall be labeled to indicate their contents. Materials shall be stored frozen (-80 °C) prior to overnight shipment on dry ice to CDC (See Section IX – Shipping), where pooling, bottling, packaging, and shipment to NIST for measurement certifications will be completed by CDC. Delivery is required within 180 days after contract is awarded.

IV. PERIOD OF PERFORMANCE

The period of performance shall be 180 days after award for delivery of the requirements.

V. DELIVERABLES AND DELIVERABLE DUE DATES

The Contractor shall provide NIST with details of the steps involved in material preparation not later than 180 days after award of this requirement to ensure documentation of any deviations as well as to provide information that shall be utilized in the NIST material acquisition Report of Analysis. Documentation indicative of biosafety shall be required with shipment of the final material not later than 180 days after award of this requirement to ensure all sera were demonstrated to be non-reactive when tested for hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus, and human immunodeficiency virus antigen 1 by tests licensed by the U.S. Food and Drug Administration.

The Contractor shall provide NIST with 2.0 L of each stage of pregnancy. Delivery of the 8.0 L total serum of donor serum is required within 180 days after the requirement is awarded.

VI. PROTECTION OF HUMAN SUBJECTS

Research involving human subjects is not permitted under this award unless expressly authorized in writing by the NIST Contracting Officer. Such writing will specify the details of the approved research involving human subjects and will be incorporated by reference into this Contract.

The Federal Policy for the Protection of Human Subjects (the “Common Rule”), adopted by the Department of Commerce at 15 CFR Part 27, requires Contractors to maintain appropriate policies and procedures for the protection of human subjects in research. The Common Rule defines a “human subject” as a living individual about whom an investigator conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information. The term “research” means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

The Common Rule also sets forth categories of research that may be considered exempt from this policy. These categories may be found at 15 CFR 27.101(b).

In the event the human subjects research involves pregnant women, prisoners, or children, Contractor is also required to follow the guidelines set forth at 45 CFR Part 46 Subpart B, C and D, as appropriate, for the protection of members of a protected class.

Should research involving human subjects be included in the proposal, prior to issuance of an award, Contractor shall submit the following documentation to the NIST Contracting Officer:

No less than sixty days prior to starting any research involving human subjects, Contractor shall submit appropriate documentation to the Contracting Officer for NIST institutional review and approval. This documentation shall include:

(1) Copies of the human subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms approved by the cognizant IRB;

(2) Documentation of approval for the human subjects research protocol, questionnaires, surveys, advertisements, and informed consent forms by the cognizant IRB;

(3) Documentation of continuing IRB approval by the cognizant IRB at appropriate intervals as designated by the IRB, but not less than annually;

(4) Documentation to support an exemption for the project from the Common Rule [NOTE: this option is not available for activities that fall under 45 CFR Part 46 Subpart C]; and/or

(5) Documentation to support a request for a deferral of review for research involving human subjects beginning after year 1 of the project;

In addition, if Contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed consent form approved by the cognizant IRB, Contractor shall submit a copy of all modified material along with documentation of approval for said modification by the cognizant IRB to the NIST Contracting Officer for NIST Institutional review and approval. Contractor may not implement any IRB approved modification without written approval by the NIST Contracting Officer.

No work involving human subjects may be undertaken, conducted, or costs incurred and/or charged to the project, until the NIST Contracting Officer approves the required appropriate documentation in writing.

VII. PERFORMANCE REQUIREMENT SUMMARY

Required Service

1. Submit donor information including sex, race, age and gestation time.

2. Acquire 2.0 L of each of Levels 1, 2, 3, and 4 of Prenatal Serum.

3. Test the serum pools for biosafety.

4. Document details of the steps involved in material preparation.

5. Ship frozen serum on dry ice to the CDC.

Performance Standard

1. Donor information is complete and well-documented.

2. Materials will be prepared as described in the SOW and meet all specifications set forth in the SOW.

3. Biosafety reports will be prepared as described in the SOW and meet all specifications set forth in the SOW.

4. Documentation is complete and describes any deviations as well as provides information that shall be utilized in the NIST material acquisition Report of Analysis.

5. A minimum of 2.0 L of each of the four levels will arrive intact, unbroken, frozen, and meeting all specifications set forth in the SOW.

Acceptable Quality Level The serum of Level 1, Level 2, Level 3, and Level 4 of Prenatal Serum with the associated properties specified in section III of this Statement of Work shall meet the specified requirements without any deficiencies or inconsistencies between the material and the documentation. If deficiencies or inconsistencies between the material and the documentation (defined in section III) are found, or if less than the stated amount of serum is received intact, the contractor will have 30 days to correct the deficiency at no additional cost to the Government.

Monitoring Method The NIST Technical Point of Contact (TPOC) will verify that the materials were successfully prepared and acceptable. Acceptance will be based upon the delivery of a minimum of 2.0 L of each donor serum material intact and unbroken. This will be completed no later than 45 days after receipt and acceptance of the vials.

VIII. DELIVERY

Delivery shall be FOB DESTINATION.

Prior to the time of shipment, the contractor shall notify the TPOC and Denise Tevis (CDC) by email, providing the date the deliverables will be shipped, shipping method, tacking number, method of delivery and the anticipated delivery date it will arrive at CDC.

IX. SHIPPING

Boxes shall be labeled to indicate their contents. Materials shall be stored frozen (-80 C) prior to overnight shipment on dry ice to CDC. Delivery is expected within 180 days after award of contract.

Delivery Address:

Center of Disease Control and Prevention Attention: Denise Tevis

NCEH/DLS/IRAT

4770 Buford Hwy NE MS: F-18 Atlanta, GA 30341

X. MINIMUM CONTRACTOR QUALIFICATIONS

The Contractor must provide documentation that it is currently certified for ISO 13485:2003, “Medical devices -- Quality Management Systems -- Requirements for Regulatory Purposes”. Documentation may be a certificate from ISO or from a certification organization or a letter authorizing the Contractor to use the ISO logo.

XI. PAYMENT

One payment will be made for the final deliverables of 8.0 L of serum which is the total value of the contract. NIST requires 45 days for acceptance testing of the serum and associated documentation. NIST will accept the final deliverables no later than 45 days from receipt of the total quantity of 8.0 L of blood serum. The Contractor may invoice for the total price of the contract upon written acceptance from the TPOC.