Statement of Requirements.pdf

STATEMENT OF REQUIREMENTS

SRM 972b Vitamin D Metabolites in Frozen Human Serum

I. BACKGROUND INFORMATION

The National Institute of Standards and Technology (NIST) has provided Standard Reference Material (SRM) 972/972a Metabolites in Frozen Human Plasma since 2009. This material supports the accuracy and traceability of vitamin D 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 4,000 vials of each of the four serum materials at the concentrations specified below, with each vial containing (1.1 ± 0.1) mL of serum. The Contractor shall acquire a minimum of 16 L of serum pooled according to the CLSI C37-A Guideline (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). All vitamin D metabolite levels must be native and not achieved through dilution or fortification of any of the serum samples, except for Level 4, which will require fortification with 3-epi-25(OH)D3. The serum shall be aliquoted 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 4,000 vials containing (1.1 ± 0.1) mL pooled human serum containing 65 nmol/L ± 15 nmol/L 25(OH)D3 (26 ng/mL ± 6 ng/mL) and containing less than 10 nmol/L 25(OH)D2 (less than 4 ng/mL)

Task 2: Contractor shall provide 4,000 vials containing (1.1 ± 0.1) mL pooled human serum containing 25 nmol/L ± 10 nmol/L 25(OH)D3 (10 ng/mL ± 4 ng/mL) and containing less than 10 nmol/L 25(OH)D2 (less than 4 ng/mL)

Task 3: Contractor shall provide 4,000 vials containing (1.1 ± 0.1) mL pooled human serum containing 50 nmol/L ± 20 nmol/L 25(OH)D3 (20 ng/mL ± 8 ng/mL) and containing 50 nmol/L ± 20 nmol/L 25(OH)D2 (20 ng/mL ± 8 ng/mL)

Task 4: Contractor shall provide 4,000 vials containing (1.1 ± 0.1) mL pooled human serum containing 65 nmol/L ± 15 nmol/L 25(OH)D3 (26 ng/mL ± 6 ng/mL) and fortified with pure 3-epi-25(OH)D3 to achieve an equivalent concentration of 3-epi-25(OH)D3

Task 5: Vial stress test results in accordance with the following and the requirements herein.

The Contractor shall provide the NIST Subject Matter Expert (SME) with the vial stress test results prior to filling.

Task 6: Certificate of Analysis, including pilot/validation study results in accordance with the requirements herein.

The Contractor shall provide the SME with the Certificate of Analysis, including pilot/validation results, prior to shipping the vials to NIST.

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

Task 7: 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 240 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.

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 8: Biosafety Report in accordance with the requirements herein.

TASK REQUIREMENTS

The contractor shall test the serum units 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 (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 serum units utilized for SRM 972b preparation. Donor units testing positive for any of the stated infectious agents must not be included in the serum pools. Personal identifiers of donors must not be disclosed to NIST. For the purpose of this statement of work, “Donor units” are serum volumes collected from individual human donors. The Contractor shall draw samples or obtain samples from a secondary blood collection site that follows the stated guidelines (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).

Each unit of single-donor serum shall be analyzed to ascertain the 25(OH)D2, 25(OH)D3, and total 25(OH)D concentrations, using a method that can distinguish between 25(OH)D2 and 25(OH)D3, to determine serum donor units suitable to fulfill the specified range. Acceptable methods for these analyses include liquid chromatography with UV/visible detection (LC-UV), liquid chromatography-mass spectrometry (LC-MS), or liquid chromatography-tandem mass spectrometry (LC-MS/MS). The contractor is responsible for this analysis, but the analysis can be subcontracted out. The results of these analyses must be submitted to NIST.

After the serum donor units are selected, they must be pooled. The contractor shall thoroughly blend and filter the pools (0.22 µm PVDF) as defined in 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). The contractor must dispense the serum into labeled amber glass serum bottles capable of withstanding ultracold temperatures (-80 °C), each containing nominally 1 mL of serum (1.1 mL dispensed with an accuracy better than 0.1 mL), and sealed under nitrogen with a butyl rubber stopper and an aluminum crimp cap. The aluminum crimp caps shall be a different color for each of the four different materials. The vials must be 3 mL amber serum vials, 17 x https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm

37 mm, USP Type 1 borosilicate glass, 13 mm crimp finish, available from Voigt Global Distribution (catalog # 72413S-3) or equivalent.

The contractor must stress test the lot of serum 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 days after award.

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.

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 240 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 Contractor shall follow the guidelines set forth for base pool specifications as detailed in CLSI C37-A Guideline for the preparation of this serum material. The serum shall be filled into pre-labeled vials, (labels will be provided to the Contractor by NIST), flushed and sealed under an inert gas, and frozen according to the specifications given in CLSI Document 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).

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 25(OH)D2 and 25(OH)D3 concentrations of each Level of SRM 972b. This data must be provided to 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 972b -16,000 1-mL vials

240 calendar days from date of award

Overnight shipment on dry ice

IV. PROTECTION OF HUMAN SUBJECTS

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 of all pooled serum with the associated physical and chemical properties specified in this Statement of Requirements 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 Requirements. Acceptance will be based upon the delivery of 16,000 intact and unbroken vials of pooled serum material (16 L total serum), target range screening measurements performed as NIST, and homogeneity screening measurements performed at NIST.

Verification and acceptance will be completed no later than 90 calendar days after receipt of the vials at NIST.

For the purpose of this Statement of Requirements, verification shall consist of physically inspecting vials to ensure they are intact and reviewing target range and 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.