SRM_965c.doc

STATEMENT OF WORK

SRM 965c Glucose in Frozen Human Serum

I. BACKGROUND INFORMATION

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

Level 1: The Contractor shall provide 6,000 ampoules containing (1.1 ± 0.1) mL pooled human serum from whole blood containing (30-40) mg/dL glucose Level 2: The Contractor shall provide 6,000 ampoules containing (1.1 ± 0.1) mL pooled human serum from whole blood containing (70-90) mg/dL glucose Level 3: The Contractor shall provide 6,000 ampoules containing (1.1 ± 0.1) mL pooled human serum from whole blood containing (115-135) mg/dL glucose Level 4: The Contractor shall provide 6,000 ampoules containing (1.1 ± 0.1) mL pooled human serum from whole blood containing (290-310) mg/dL glucose 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. The contractor will provide written documentation stating the negative results of all donor units utilized for SRM 965c preparation. Donor units testing positive for any of the stated infectious agents will not be included in the serum pools. The identity of donors must not be disclosed to NIST.

1.

QUANTITY OF SERUM

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 is to be dispensed into 2 mL prescored glass ampoules (See Primary Container Specification Section for ampoule specifications). The 1.1 mL aliquot of serum and 2 mL ampoule size deviates from the container requirement as specified in section A2.5(2) of CLSI C29-A2. The new primary container requirement MUST be strictly adhered to or breakage of the glass ampoules under –70 °C storage conditions will result.

2.

DESCRIPTION OF SERUM AND GLUCOSE CONCENTRATION LEVELS

Only native human serum (not plasma) that has been tested and found negative for HIV and hepatitis be used. The values of sodium, potassium, and other analytes in this pooled sera shall be within the usual reference intervals for a “healthy” adult population. 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 8 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 for the preparation of this four-level glucose in serum material. The serum shall 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 will 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 (see Primary Container Specifications); labels will be provided to the Contractor by the Technical Point of Contact (TPOC) flushed and sealed under an inert gas, and frozen according to the specifications given in Appendix A2.5 of CLSI Document C29-A2.

The containers must be 2 mL prescored glass ampoules as stated in the Primary Container Specifications. 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 five (5) freeze and thaw cycles at -80 °C to ensure that there is no breakage.

Prior to filling, the Contractor shall label ampoules with labels that are appropriate for use at low temperature; these labels will be provided to the contractor by the TPOC within 60 days after award. Ampoules shall be transferred, in fill order, from the bottling equipment to a box in a "Z" pattern, filling each row left to right. The box shall provide separation between each vial to prevent breakage. The location of the first bottle 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 shall not be sent on Friday/Saturday or before a Monday Federal Holiday. Delivery is expected within 180 days after award.

The Contractor shall provide the TPOC 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.

ANALYTES USED IN SPIKING

The contractor shall specify the source of added glucose at the time of serum delivery.

3.

PILOT/VALIDATION RUN

The Contractor shall perform a pilot/validation run. The Contractor shall provide the TPOC with a Certificate of Analysis indicating glucose concentrations by standard clinical methods (direct hexokinase is acceptable) from randomly selected ampoules from each level to be shipped to NIST for inspection and analysis at the time of serum delivery.

Measurement of the glucose concentrations of representative samples from each level by standard clinical methods is required for acceptance. The target values must be within 5 % of those requested in the Description of Serum and Glucose Concentration Levels Section. The results shall be provided to the TPOC upon shipment of the entire production lot.

4.

PRIMARY CONTAINER SPECIFICATIONS

Ampoules: Wheaton, 2 mL Cryule, Clear, Prescored, Gold Band, Wheaton Item #651486

5.

PACKING/SHIPPING SPECIFICATIONS

The material shall be packaged in trays or containers in an upright fashion. The packaging shall be of a nature to prevent breakage and keep the four levels separate and identifiable. The material shall be transported overnight on dry ice to NIST.

IV.

DELIVERABLES AND DELIVERABLE DUE DATES

The contractor shall deliver the ampoules, Certificate of Analysis for the glucose concentration levels, and Biosafety report to NIST, using FOB Destination shipping terms not later than 180 days after award.

At the time of shipment, the contractor shall notify the TPOC and the Contracting Officers Representative (COR) 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.

V.

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 are found, or if less than the stated number of ampoules are received intact, the contractor has 30 days to correct the deficiency at no additional cost to the Government.

VII.

MONITORING METHOD

The NIST Technical Point of Contact 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. This will be completed no later than 30 days after receipt and acceptance of the ampoules.

VII.

PERIOD OF PERFORMANCE

The period of performance shall be 180 days after award.

VIII.

MINIMUM CONTRACTOR CERTIFICATIONS

The Contractor shall provide documentation showing current certification for ISO 13485:2003, “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 from a certification organization or a letter authorizing the Contractor to use the ISO logo.

Alternatively, if the Contractor is not ISO 13485:2003 certified, they must provide not less than three (3) each of the following records for glucose for a total of 15 records:

· Calibration records

· Quality control (QC) blank results

· QC spike amounts

· QC spike recovery

· Minimum detection limit determination data

The records shall be no older than three (3) years from the date of the solicitation. The Offerors shall provide the above records in hardcopy or as a pdf file.

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