Statement of Work (SRM 967b).pdf

STATEMENT OF WORK

TITLE: SRM 967b Creatinine in Frozen Human Serum (Low and High Level)

LAB REQUESTING SERVICE: Material Measurement Laboratory, Chemical

Sciences Division

I. BACKGROUND INFORMATION

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

Standard Reference Material (SRM) 967 Creatinine in Frozen Human Serum since 2007.

This material supports the measurements of in vitro diagnostics manufacturers, reference laboratories, and clinical laboratories in the United States and globally. The current batch of SRM 967a Creatinine in Frozen Serum is expected to be out of stock in less than three years and the procurement of SRM 967b is required to provide continuous availability of this important SRM. The creatinine measurement community has also requested that the lower level of SRM 967b possess a target value of ≈0.4 mg/dL, which addresses the critical measurement of creatinine in pediatric serum samples. The low level will be based on a serum pool without dilution and the high level will be based on a normal serum pool that is spiked with creatinine.

II. SCOPE OF WORK

The contractor shall produce 4,000 vials each of two serum materials at the creatinine concentrations specified below, with each vial containing (1.1 ± 0.1) mL of serum. The

Contractor shall acquire a minimum of 4,000 mL of serum pooled at each level 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) for a total of approximately 8 L of serum. The pool of serum for the low level must not be diluted or stripped to achieve the target (0.4 ± 0.05) mg/dL creatinine. The low-level serum pool must be discreet from the high-level pool. A separate, normal human serum pool must be spiked with crystalline creatinine to achieve an elevated level of creatinine (4.0 mg/dL ± 0.2 mg/dL). 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: Low Level: Contractor shall provide 4,000 vials containing (1.1 ± 0.1) mL pooled human serum containing (0.4 ± 0.05) mg/dL creatinine

Task 2: High Level: Contractor shall provide 4,000 vials containing (1.1 ± 0.1) mL pooled human serum containing (4.0 ± 0.2) mg/dL creatinine

The High Level must be prepared by augmenting a normal serum pool (with a starting creatinine level of approximately 0.6 mg/dL to 1.2 mg/dL) with crystalline creatinine.

The contractor is responsible for obtaining the creatinine used to spike the High Level.

LINE ITEM 0001

RFQ# 1333ND21QNB640187

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

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

The Contractor shall provide the NIST Technical Point of Contact (TPOC) with vial stress test results prior to filling and the Certificate of Analysis, including pilot/validation results, prior to shipping of 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 TPOC with the material preparation report, including the source of the added creatinine (brand, catalog number, and lot) and any deviations from the specified standard, and the Biosafety Report 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.

This information must be provided to the TPOC 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 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 967b 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.

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

After the 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 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 (catalogue # 62413PV-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 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 TPOC 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 60 days after award.

The contractor must use two different color aluminum crimp caps to differentiate between the two specified serums for easy identification. 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 degrees °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 COR, 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 days after award. The contractor shall notify the

NIST TPOC, 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: Technical Point of Contact (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 with an enzymatic-based assay instead of cholesterol. The method used to assay creatinine must have a within-run coefficient of variation (CV) < 2 % for creatinine values of 0.8 mg/dL and higher. The CLSI document includes statistics and acceptance criteria.

The contractor shall follow the guidelines set forth for base pool specifications as detailed in CLSI C37-A Guideline for the preparation of this two-level creatinine in serum material. The target creatinine concentration levels are given in the Specific Tasks above. The low-level material must be based only on pooling of serum and must not be diluted or stripped to obtain the target creatinine level. The high-level material must be prepared by spiking a normal serum pool with crystalline creatinine. 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 creatinine concentrations of individual vials by an enzymatic clinical method 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) from each level of material. This data must be provided by NIST as a pdf via email to the

TPOC before shipment of the entire production lot.IV. DELIVERABLES AND

DELIVERABLE DUE DATES

Biosafety Report

Due Date: 48 hours prior to shipment

Vial Stress Test Results

Due Date: Prior to vial filling

Material Preparation Detail Report

Notification of Shipment

Certificate of Analysis

Low Level SRM – 4000 vials

Due Date: 180 days from the date of award

High Level SRM – 4000 vials

Due Date: 180 days from the date of award

V. PROTECTION OF HUMAN SUBJECTS

The contractor is required to draw the serum specimens or obtain serum 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 Work 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 days from notification by the TPOC to correct the deficiency at no additional cost to the Government.

VII. MONITORING METHOD

The NIST TPOC will verify that the materials meet all requirements of the statement of work. Acceptance will be based upon the delivery of 4,000 vials of each pooled serum material (8,000 vials total) intact and unbroken, accompanied by screening results for creatinine which indicate that the two levels of material possess creatinine levels within the specified target ranges. Verification and acceptance will be completed no later than

30 days after receipt of the vials at NIST.

For the purpose of this statement of work, verification shall consist of physically inspecting vials to ensure they are intact and reviewing the pilot analysis results provided by the Contractor.

VIII. MINIMUM CONTRACTOR QUALIFICATIONS

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

Management Systems -- Requirements for Regulatory Purposes”; and

-Experience in analyzing the compounds in section III of this SOW in human serum.

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.