Statement of Work (SRM 965c).pdf

STATEMENT OF WORK

TITLE: SRM 965c Glucose in Frozen Human Serum

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) 965 Glucose in Frozen Human Serum since 1996.

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 965b Glucose in Frozen Serum is expected to be out of stock within approximately three years and the procurement of SRM 965c is required to provide continuous availability of this important SRM.

II. SCOPE OF WORK

The contractor shall produce 6,000 ampoules each of four serum materials at the glucose concentrations specified below, with each ampoule containing (1.1 ± 0.1) mL of serum.

The contractor shall acquire a minimum of 6,000 mL of serum pooled at each level from whole blood serum according to the CLSI C29-A2 Standard

(https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c29/) for a total of approximately 24 L of serum. Glucose can be either added or removed from portions of the master pool to achieve the desired concentrations of glucose. The serum shall be aliquoted into ampoules that are capable of withstanding long-term storage at -80

°C.

III. SPECIFIC TASKS AND REQUIREMENTS

TASKS

Task 1: Level 1: Contractor shall provide 6,000 ampoules containing (1.1 ± 0.1) mL pooled human serum from whole blood containing (30-40) mg/dL glucose

Task 2: Level 2: Contractor shall provide 6,000 ampoules containing (1.1 ± 0.1) mL pooled human serum from whole blood containing (70-90) mg/dL glucose

Task 3: Level 3: Contractor shall provide 6,000 ampoules containing (1.1 ± 0.1) mL pooled human serum from whole blood containing (115-135) mg/dL glucose

Task 4: Level 4: Contractor shall provide 6,000 ampoules containing (1.1 ± 0.1) mL pooled human serum from whole blood containing (290-310) mg/dL glucose

LINE ITEM 0002

RFQ# 1333ND21QNB640187

https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c29/

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

The Contractor shall provide the NIST Technical Point of Contact (TPOC) with ampoule stress test results prior to filling and the Certificate of Analysis, including pilot/validation results, prior to shipping of the ampoules to NIST.

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

Task 7: Material Preparation Detail Report

The Contractor shall provide the TPOC with the material preparation report, including the source of the added glucose (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 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 965c preparation. Donor units testing positive for any of the stated infectious agents shall 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

The contractor shall provide a total of 24,000 ampoules of (1.1 ± 0.1) mL per ampoule of four (4) different concentration levels, 6,000 ampoules per concentration level. The (1.1 ±

0.1) mL aliquot of serum must be dispensed into 2 mL pre-scored glass ampoules. The

1.1 mL aliquot of serum and 2 mL ampoule size deviates from the container requirement that is specified in section A2.5(2) of CLSI C29-A2

(https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c29/).

The adjusted container requirement MUST be strictly adhered to or breakage of the glass ampoules under –70 °C storage conditions will result.

Only native human serum (not plasma) that has been tested by the contractor and found negative for HIV and hepatitis shall be used. The values of sodium, potassium, and other analytes in this pooled sera must be within the usual reference intervals for a “healthy” adult population, as defined in CLSI C29-A2, Table A1

(https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c29/).

The addition of gentamicin sulfate is required for long term storage of this material and mixed into the base pool to give a final concentration of 50 mg/L. Specimens shall be drawn and processed and frozen within eight hours of the time of collection.

The contractor shall follow the guidelines set forth for base pool specifications as detailed in CLSI Document C29-A2, Appendix A (https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c29/) for the preparation of this four-level glucose in serum material. The serum must be defibrinated or off clot, filtered, and partitioned into four (4) volumes. The target glucose concentration levels are given in the Specific

Tasks above.

Spike one or both of the normal levels to achieve the high-level glucose, spiking and depleting as necessary to achieve the desired glucose levels. Blending must be done such that the levels will show no greater variability than 1 % sample to sample in analyte concentration. The serum shall be filled into pre-labeled ampoules (labels will be provided to the Contractor by NIST) flushed and sealed under an inert gas, and frozen according to the specifications given in Appendix A2.5 of CLSI Document C29-A2

(https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c29/).

The containers must be Wheaton, 2 mL Cryule, Clear borosilicate glass that conforms to

USP Type 1 and ASTM E 438 Type I, Class A requirements, diameter 11mm, height 70 mm, Prescored, Gold Band, Wheaton Item #651486 or equivalent.

The Contractor must stress test the lot of serum ampoules prior to filling by picking 10 ampoules 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 Technical Point of Contact

(TPOC) prior to moving forward with vial filling.

Prior to filling, the Contractor shall label ampoules with labels that are appropriate for use at low temperature; these labels will be provided by NIST, to the contractor, within 60 days after award.

https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c29/ https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c29/ https://clsi.org/standards/products/clinical-chemistry-and-toxicology/documents/c29/

Ampoules shall be transferred, in fill order, from the bottling equipment to a box with ampoule dividers in a "Z" pattern, filling each row left to right. The location of the first bottle in each box shall be noted on each side of the outside corner of the box, and boxes must 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 Monday

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 ampoules 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

A pilot/validation run shall be performed after ampoule filling and prior to shipment of vials to NIST. The Contractor shall provide NIST with a Certificate of Analysis indicating glucose concentrations by standard clinical methods (direct hexokinase is acceptable) from 10 ampoules randomly selected by the Contractor from each level to be shipped to NIST for inspection and analysis.

Measurement of the glucose concentrations of representative samples from each level by standard clinical methods is required for acceptance. The target values shall be within

5% of those required herein. The results shall be provided to NIST before shipment of the entire production lot.

IV. DELIVERABLES AND DELIVERABLE DUE DATES

Biosafety Report

Due Date: 48 hours prior to shipment

Ampoule Stress Test Results

Due Date: Prior to ampoule filling

Material Preparation Detail Report

Notification of Shipment

Certificate of Analysis

Level 1 SRM – 6000 ampoules

Due Date: 180 days from the date of award

Level 2 SRM – 6000 ampoules

Level 3 SRM – 6000 ampoules

Level 4 SRM – 6000 ampoules

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 ampoules of all pooled serum, with the associated physical and chemical properties specified in this Statement of Work, shall 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 ampoules are received intact, the contractor has 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 were successfully prepared and acceptable.

Acceptance will be based upon the delivery of 6,000 ampoules of each pooled serum material (24,000 ampoules total) intact and unbroken, accompanied by screening results for glucose which indicate that the four levels of material possess glucose levels within specified target ranges. Verification and acceptance will be completed no later than 30 days after receipt of the ampoules at NIST.

For the purpose of this statement of work, verification shall consist of physically inspecting ampoules 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 must be a certificate from ISO or a certificate from a certification organization.

VIII. RIGHTS IN DATA

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