Statement of Requirement (Final).pdf

STATEMENT OF REQUIREMENTS

TITLE: SRM 1950a Metabolites in Frozen Human Plasma

LAB REQUESTING SERVICE: Material Measurement Laboratory, Chemical

Sciences Division

I. BACKGROUND INFORMATION

The National Institute of Standards and Technology (NIST) has provided Standard

Reference Material (SRM) 1950 Metabolites in Frozen Human Plasma since 2011. This material supports the metabolite measurements of in vitro diagnostics manufacturers, reference laboratories, clinical laboratories, and research laboratories in the United States and globally.

II. SCOPE OF WORK

The Contractor shall produce 20,000 vials of one normal plasma pool material, with each vial containing (1.1 ± 0.1) mL of plasma, and four 500-mL containers with an addition 2 L bulk of the same plasma pool material. The Contractor shall acquire a minimum of 22 L of plasma pooled according to the specifications listed in the “Task Requirements” section.

The plasma shall be aliquoted into one bottle (bulk) and into vials, specified in Section III, that are capable of withstanding long-term storage (5 to 10 years) at -80 °C.

III. SPECIFIC TASKS AND REQUIREMENTS

Task 1: Contractor shall provide 20,000 vials containing (1.1 ± 0.1) mL pooled normal human plasma according to specifications

Task 2: Contractor shall provide 4 bottles, each containing 500 mL pooled normal human plasma

Task 3: Vial stress test results in accordance with the following and the requirements herein.

The Contractor shall provide the NIST Subject Matter Expert (SME)with vial stress test results prior to filling and the Certificate of Analysis, including pilot/validation results, prior to shipping the vials to NIST.

Task 4: Certificate of Analysis, including pilot/validation study results in accordance with the requirements herein.

Task 5: Material Preparation Detail Report

The Contractor shall provide the SME with the material preparation report, including any deviations from the specified standard, and the Biosafety Report not later than 180 calendar 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. The material preparation report shall contain demographic information (male/female, racial and ethnic distribution), as well as individual donor glucose levels, and be provided to NIST without personal identifiers.

This information must be provided to the SME as a pdf file, via email.

The NIST Report of Analysis is an internal NIST report. NIST is starting a new process whereby information is compiled from these internal reports and edited for eventual presentation as an external NIST Special Publication.

NIST intends to publish the Contractor’s responses to the solicitation and any Certificates of Analysis provided by the Contractor. NIST does not intend to publish proprietary information and will work with the Contractor to further redact information from internal

NIST reports to assemble the related external Special Publication.

Task 6: Biosafety Report in accordance with the requirements herein.

TASK REQUIREMENTS

The contractor shall test the plasma units for biosafety. All plasma 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

(https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm).

The contractor shall provide a written Biosafety Report stating the negative results of all single donor plasma units utilized for SRM 1950a preparation. Donor units testing positive for any of the stated infectious agents must not be included in the plasma pool.

Personal identifiers of donors must not be disclosed to NIST. For the purpose of this statement of requirement, “Donor units” are plasma volumes collected from individual human donors. The Contractor shall draw samples or shall obtain samples from a secondary blood collection site that follows the requirements as stated in the Statement of

Requirement.

The Contractor shall obtain plasma from approximately 100 different people who have undergone an overnight fast prior to blood draw. A rapid glucose oxidase test shall be used to exclude individuals who did not adhere to the fasting requirement. Plasma from an equal number of men and women (non-pregnant) in an adult age range (30 to 50 years) shall be used. The racial distribution of donors shall reflect the distribution in the U.S.

population: approximately 76 % white, 14 % African American or Black, 2 % American

Indian or Alaskan Native, 6 % Asian, 2 % “Other,” with approximately 19 % of the total taken from individuals of Hispanic origin.

Plasma will not be obtained from individuals 1.) who are extreme exercisers (e.g., marathon runners), 2.) with body-mass indices outside the 95th percentile, or 3.)

who adhere to extreme dietary regimens.

https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm

Individuals shall not have taken medication for at least 72 hours prior to blood draw and shall be free from overt conditions (e.g., diabetes), diseases, and disorders. Demographic information (male/female, racial and ethnic distribution) will be collected and provided to

NIST without personal identifiers.

Plasma shall be collected cold with lithium heparin used as an anticoagulant. Samples will be placed on ice immediately following collection and will be centrifuged at 4 °C at

8000 x G for 25 minutes. Start of processing to -80 °C within 30 min to 1 h following collection will provide for adequate sample integrity. Red blood cell contamination shall be avoided because heme-contaminated samples must not be pooled for the SRM.

Milky/lipemic and heme-containing samples will be excluded by visual inspection.

Collection vessels will be chosen to minimize sample contamination.

The contractor must stress test the lot of glass vials prior to filling by picking 10 vials randomly from the lot and subjecting them to five (5) freeze and thaw cycles at -80 °C to ensure that there is no breakage, including small cracks or fissures. The Contractor must provide the results of the stress test, via email, to the SME prior to moving forward with vial filling.

Prior to filling, the Contractor shall label vials with labels that are appropriate for use at low temperature; these labels will be provided to the Contractor by NIST within 90 calendar days after award.

The Contractor shall thaw the plasma pools at 4 °C once prior to blending or can use cold grinding to produce the pooled plasma. The Contractor shall thoroughly blend the pooled plasma at 4 °C and under nitrogen, if possible, to minimize degradation. The Contractor shall first dispense 500 mL into each of four pre-cleaned 500-mL Nalgene bottles (2 L total plasma). These pre-cleaned bottles will be provided to the Contractor by NIST within 14 calendar days after the award. The Contractor shall then dispense the remaining 20 L of plasma into the labeled, amber glass cryovials capable of withstanding ultracold temperatures (-80 °C), each containing nominally 1.0 mL of plasma (1.1 mL dispensed with an accuracy better than 0.1 mL), and seal under nitrogen with a Teflon-faced butyl rubber stopper and an aluminum crimp cap. The Contractor shall provide vials that shall be filled with an accuracy of 0.1 mL or better. The vials must be 3 mL amber serum vials, 17 x 37 mm, USP Type 1 borosilicate glass, 13 mm crimp finish, available from Voigt Global Distribution (catalog # 72413S-3) or equivalent.

Vials must be transferred, in fill order, from the bottling equipment to a box with vial dividers in a "Z" pattern, filling each row left to right. The location of the first vial in each box shall be noted on each side of the outside corner of the box, and boxes will be numbered sequentially. Boxes shall be labeled to indicate their contents. As boxes are filled, each box shall be stored at 4 °C until all vials are boxed and collected in 4 °C storage.

The final prepared materials shall be stored frozen (-80 °C) prior to overnight shipment on dry ice to NIST. Overnight shipments must not be sent on Friday/Saturday or before a federal holiday. In addition, the Contractor must notify the SME, at least 48 hours in advance of the shipment, to be sure that NIST staff are available to receive the shipment.

Delivery must be completed not later than 180 calendar days after award. The Contractor shall notify the NIST SME by e-mail, providing the date the deliverables are shipped, shipping method, tracking number, method of delivery, and the anticipated delivery date it will arrive at NIST.

The vials shall be shipped to:

National Institute of Standards and Technology

ATTN: Subject Matter Expert (SME) (To be identified at the time of award)

100 Bureau Drive

Bldg. 301/Shipping and Receiving

Gaithersburg, MD 20899

The Contractor shall assess homogeneity after vial filling and prior to shipment of vials to

NIST, as defined in CLSI C37-A (Appendix A, page 9)

(https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c37/;

Clin Chem Lab Med. 2020 Feb 25;58(3):368-374. doi: 10.1515/cclm-2019-0732), measuring creatinine and cholesterol. The method used to assay creatinine and cholesterol must have a within-run coefficient of variation (CV) < 2 %. The CLSI document includes statistics and acceptance criteria.

A pilot/validation run shall be performed by the Contractor after vial filling and prior to shipment of the vials to NIST. The Contractor shall provide NIST with a Certificate of

Analysis indicating creatinine and cholesterol concentrations of individual vials from vials selected by the Contractor according to CLSI C37-A

(https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c37/;

Clin Chem Lab Med. 2020 Feb 25;58(3):368-374. doi: 10.1515/cclm-2019-0732. This data must be provided by NIST as a pdf via email to the SME before shipment of the entire production lot.

IV. DELIVERABLES AND DELIVERABLE DUE DATES

Deliverable Due Delivery Method Biosafety report 48 hours prior to shipment PDF email to SME Vial stress test results Prior to vial filling PDF email to SME Material preparation detail report

48 hours prior to shipment PDF email to SME

Notification of Shipment 48 hours prior to shipment Email to SME Certificate of analysis 48 hours prior to shipment PDF email to SME SRM 1950a -20,000 1-mL vials and four 500-mL bottle

180 calendar days from date of award

Overnight shipment on dry ice

V. PROTECTION OF HUMAN SUBJECTS

https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c37/ https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c37/

The contractor is required to draw the plasma specimens or obtain plasma specimens from an appropriate source. Human Subjects Clearance may be required. The contractor shall be responsible to satisfy all human subjects requirements prior to performing work relevant to this clearance. Reference the following requirements.

1352.235-70 Protection of Human Subjects

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

(b) 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 data through intervention or interaction with the individual, or 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 15 CFR part 27. These categories may be found at 15 CFR 27.101(b).

(c) In the event that human subjects research involves pregnant women, prisoners, or children, the 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.

(d) Should research involving human subjects be included in the proposal, prior to issuance of an award, the contractor shall submit the following documentation to the Contracting

Officer:

(1) Documentation to verify that contractor has established a relationship with an appropriate Institutional Review Board (“cognizant IRB”). An appropriate IRB is one that is located within the United States and within the community in which the human subjects research will be conducted;

(2) Documentation to verify that the cognizant IRB possesses a valid registration with the United States Department of Health and Human Services' Office for Human

Research Protections (“OHRP”);

(3) Documentation to verify that contractor has a valid Federal-wide Assurance

(FWA) issued by OHRP.

(e) Prior to starting any research involving human subjects, the contractor shall submit appropriate documentation to the Contracting Officer for institutional review and approval.

This documentation may 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; and/or

(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].

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

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

VI. ACCEPTABLE QUALITY LEVEL

The vials and bottles of all pooled plasma with the associated physical and chemical properties specified in this Statement of Requirement must be suitable for use as reference materials. If deficiencies or inconsistencies between the material and the documentation listed in Section III are found, or, if less than the stated number of vials are received intact, the contractor shall have 30 calendar days from notification by the SME to correct the deficiency at no additional cost to the Government.

VII. MONITORING METHOD

The NIST SME will verify that the materials meet all requirements of the Statement of

Requirement. Acceptance will be based upon the delivery of 20,000 vials and four 500-mL bottles of pooled plasma material (22 L total plasma) intact and unbroken, and homogeneity screening results performed at NIST. Verification and acceptance will be completed no later than 30 calendar days after receipt of the vials at NIST.

For the purpose of this Statement of Requirement, verification shall consist of physically inspecting vials to ensure they are intact and reviewing homogeneity screening results provided by NIST.

VIII. MINIMUM CONTRACTOR QUALIFICATIONS

-Documented compliance with ISO 13485:2016 “Medical devices -- Quality

Management Systems -- Requirements for Regulatory Purposes”; and

Documentation may be a certificate from ISO or a certificate from a certification organization.

VIII. RIGHTS IN DATA

The Government will retain unlimited data rights to all required deliverables in accordance with the data rights clause, incorporated by reference, herein.