SOW (Final).pdf

STATEMENT OF WORK

POOLING, BLENDING, AND BOTTLING OF HUMAN PLASMA MATERIALS FOR

CANDIDATE RM 8121 – CARDIAC TROPONIN I IN FROZEN HUMAN PLASMA

I. BACKGROUND

The National Institute of Standards and Technology (NIST) Biomolecular Measurement

Division of the Material Measurement Laboratory (MML) provides measurement science and reference materials to promote innovation and confidence in measurements needed to advance clinical diagnostics, bioscience research, and precision medicine. The

International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working

Group for the Standardization of Cardiac Troponin I (WG-cTnI) has identified a need for a reference material to support the accuracy and comparability of routine clinical measurements for ruling in or ruling out myocardial infarction. NIST is meeting this clinical measurement need by developing a reference material intended to facilitate the harmonization of cTnI quantification in human plasma.

II. SCOPE OF WORK

This Statement of Work (SOW) describes the requirements for production of a multi-Level

(Level A-D) pooled, human plasma reference material (RM) for cTnI based on specifications developed from a collaboration with the IFCC WG. RM 8121 (cTnI in

Frozen Human Plasma) is a four (4)-component material with target cTnI concentrations within the following intervals: Level A = 20 ng/L (range 10 ng/L – 30 ng/L); Level B = 65 ng/L (range 50 ng/L – 80 ng/L); Level C = 265 ng/L (range 220 ng/L – 310 ng/L); Level

D = 6500 ng/L (range 6000 ng/L – 7000 ng/L) based on Atellica measurements using

Siemens’ Atellica IM TNIH high sensitivity immunoassay (in this document the Levels are referred to as “Level A”, “Level B”, “Level C”, and “Level D”). The respective levels may also be described more broadly as LOQ < Level A < female 99th percentile; Level B = male

99th percentile + 20%; Level C = male 99th percentile * 5; Level D = male 99th percentile

* 20.

The Contractor shall blend, aliquot, and vial the candidate reference material (Levels A-D) in accord with the specifications outlined in this SOW. Briefly, the tasks include:

1) Thaw single donor plasma samples (supplied by the NIST-identified supplier), pool to achieve a plasma pool of ~ 10 L total volume, and blend to ensure homogeneity;

2) Filter plasma pool sequentially through 1 µm or 2 µm cartridge filter, followed by 0.22 µm filter;

3) Thaw cTnI-positive serum pool (supplied by the NIST-identified supplier) and blend with appropriate volume of plasma pool to achieve ~ 3 L total volume of Level A, according to blending protocol provided below in section E1;

4) Test blended pool (Level A) with a high sensitivity cTnI immunoassay to ensure specified cTnI concentration has been achieved;

5) Label 2 mL cryovials with labels provided by NIST, aliquot (0.7 mL) Level A pool into cryovials, and freeze at ≤ -70 ºC;

6) Repeat steps 3-5 to prepare Levels B-D;

7) Ship all frozen materials and all documentation including fill order number, immunoassay results, and shipping information to NIST Gaithersburg as specified below under “Deliverable 3” in section IV. Deliverables & Deliverable Due Dates.

III. SPECIFIC TASKS

A. Requirements for Handling Human Plasma Specimens

The Contractor shall at all times handle the individually-packaged plasma specimens in accordance with standard practice for Biosafety Level 2 materials as defined in: CDC/NIH;

Biosafety in Microbiological and Biomedical Laboratories, 5th ed.; Richardson, J.;

Barkley, W.E.; Richmond, J.; McKinney, R.W., Eds.; U.S. Department of Health and

Human Services, Public Health Service, Centers for Disease Control and Prevention and

National Institutes of Health; US Government Printing Office: Washington, DC (2007);

available at http://www.cdc.gov/biosafety/publications/bmbl5/.

The Contractor shall receive frozen individual plasma samples by mail (each containing approx. 200 mL) from a NIST-identified supplier sufficient to produce a ~ 10 L plasma pool. Plasma samples will be collected with lithium heparin as the anticoagulant by a

NIST-identified supplier and shall have low endogenous cTnI concentration (< LOQ of the

Atellica TNIH assay; 2.5 ng/L), as determined by the NIST-identified supplier. All individual plasma units will be previously tested by the NIST-identified supplier for biosafety and shall be demonstrated to be non-reactive when tested for hepatitis B surface antigen, hepatitis C virus (non-reactive or evidence of no viral antigen), and human immunodeficiency virus 1 and 2, and P24 antigen by tests licensed by the U.S. Food and

Drug Administration. Each plasma sample will also be previously tested by the NIST-identified supplier for cTnI concentration and by collaborators in Finland for the presence of cTnI autoantibodies.

Upon receipt, the frozen, individually-packaged single-donor human plasma specimens shall be stored and maintained at ≤ -70 ºC until further processed by the Contractor. The

Contractor shall be available to receive the shipment during regular business hours, which http://www.cdc.gov/biosafety/publications/bmbl5/ shall be Tuesday to Friday from 8am-5pm EST, except Federal Holidays. Upon receipt, the Contractor shall notify the NIST TPOC by email and provide the following information: shipment delivery date, total number of specimens and condition of specimens and specimen containers. Once thawed on ice or at 4 oC, plasma samples shall not be exposed to temperatures above 25 ºC (room temperature).

B. Requirements for Handling Human Serum Pools

The Contractor shall at all times handle the human serum pools in accordance with standard practice for Biosafety Level 2 materials as defined in: CDC/NIH; Biosafety in

Microbiological and Biomedical Laboratories, 5th ed.; Richardson, J.; Barkley, W.E.;

Richmond, J.; McKinney, R.W., Eds.; U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention and National Institutes of Health; US Government Printing Office: Washington, DC (2007); available at http://www.cdc.gov/biosafety/publications/bmbl5/.

The Contractor shall receive four (4) frozen pools of human serum, with pools ranging in volume from ~ 100 mL to 1 L, collected and pooled from individual serum units by the

NIST-identified supplier. Frozen serum pools will have a known concentration of human cardiac troponin I (hcTnI) determined previously by the NIST-identified supplier.

All individual serum units used in preparing the serum pools will be previously tested by the NIST-identified supplier for biosafety and shall be demonstrated to be non-reactive when tested for hepatitis B surface antigen, hepatitis C virus (non-reactive or evidence of no viral antigen), and human immunodeficiency virus 1 and 2, and P24 antigen by tests licensed by the U.S. Food and Drug Administration. Upon receipt, the frozen serum pools shall be stored and maintained at ≤ -70 ºC until further processed by the Contractor. The

Contractor shall be available to receive the shipment during regular business hours, which shall be Tuesday to Friday from 8am-5pm, except Federal Holidays. Upon receipt, the

Contractor shall notify the NIST TPOC by email and provide the following information:

shipment delivery date, total number of specimens and condition of specimens and specimen containers. Once thawed on ice or at 4 oC, the serum pools shall not be exposed to temperatures above 25 ºC (room temperature).

C. Plasma and Serum Material Delivery (Specified Instruction)

The Contractor shall use the protocol (stated in the SOW) to process (pool, blend, and vial)

Levels A-D of the candidate reference material. The Contractor shall receive the plasma specimens and serum pools from the NIST-specified institution beginning with contract award and up to 90 days after award. The NIST TPOC will provide the Contractor a key indicating which specific serum pool and what plasma pool concentrations shall comprise each pool of Level A-D of the reference material. With the exception of a single thawing http://www.cdc.gov/biosafety/publications/bmbl5/ necessary to prepare Levels A-D of the reference material, freeze-thaw cycles must be avoided unless discussed with the TPOC. No vortexing shall be performed on any individual plasma specimen or on any of the pooled materials.

The Contractor shall not process materials until the Contractor receives all shipments from the NIST-specified institution, the NIST TPOC provides the pool composition for each RM

Level, and the Contractor receives approval from the NIST TPOC to process the single-donor plasma specimens. by email, from NIST, to start processing will occur no later 90 days after award.

D. Specific Requirements: Materials and Equipment

The Contractor shall acquire the specified materials and submit the following specifications to the NIST TPOC prior to processing (pooling and vialing) the specimens: product name, product manufacturer, product number (serial and model number), lot number, expiration date.

1. Sterile, flat-bottomed, straight-walled 2.0 mL cryotubes for reference material

(RM) production compatible with long-term storage at ≤ -70 ºC (up to 4000 vials per pool-Level; 16000 total vials). The vial must have a polypropylene screw cap; the caps must not be tethered to the vials; the screw cap must have an O-ring made from silicone. The vials must be skirted such that the vials are flat-bottomed. The caps for each RM Level vial (A-D) shall be a distinct color for a visual differentiation of the four Levels (same as storage box label color).

a) Manufacturer: Fisher or equivalent

b) Product Description: Fisherbrand (or equivalent) Screw Cap

Microcentrifuge Tubes, 2.0 mL, PP, natural, skirted, with assembled (untethered) cap, without knurls, without printing space, without graduation, sterile. Fisher Part number 02-681-343

(FisherSci.com 519-GRD-FIS), or equivalent.

c) Cap color for each plasma cTnI Level, four (4) colors coincide with the plasma cTnI Levels (Level A-D). Available through Sarstedt or equivalent.

▪ RM 8121 Level A: purple (product number: 72.694.008)

▪ RM 8121 Level B: yellow (product number: 72.694.011)

▪ RM 8121 Level C: blue (product number: 72.694.047)

▪ RM 8121 Level D: red (product number: 72.694.035)

Different color caps may be used but must be first discussed and approved by the NIST TPOC.

2. Vial Labels: The labels will be provided on a roll and supplied by NIST, but the

Contractor will apply the labels to the vials prior to filling.

i. The labels may be applied manually or using a robotic system.

ii. The vial labels must be placed in the same direction on each vial (left to right).

3. Cryogenic vial boxes with lids, compatible with long-term storage at ≤ -70 ºC and sufficient quantity to accommodate up to 16,000 2.0-mL vials (up to 4,000 vials per plasma cTnI Level).

4. Colored storage container labels compatible with the cryogenic vial boxes and long-term storage at ≤ -70 ºC. The color of the container labels shall be consistent with the color specified for the vial cap of each RM Level (outlined above, item

#1).

5. Sterile 1 or 2 μm filtration cartridge and 0.22 μm PVDF (low-protein binding) filtration device for the bulk plasma pooled material (described below).

6. Single-use 20 L polyethylene or Teflon low-binding carboys.

7. Centrifugation instrumentation.

8. Magnetic stirrer or equivalent gentle mixing technique.

9. Liquid handling instrumentation to be used during processing of the plasma material.

10. Labelling Method

i. The labelling method must be compatible with specified vials and NIST-provided labels.

ii. The Contractor shall provide the NIST TPOC the transfer format of the labels to the vials (manual or automated application-provide manufacturer and product number).

iii. The Contractor is required to apply the NIST-provided labels to empty vials in advance, prior to processing, pooling or aliquoting the plasma material.

E. Specific Requirements: Pooling, Blending, and Vialing of Single-donor Plasma

Specimens and cTnI-positive serum pools

Upon approval from the NIST TPOC, in order to process the plasma specimens and serum pools, the Contractor shall:

1. Thaw all single-donor plasma specimens at 4 oC or on ice and blend thoroughly by a magnetic stirrer or equivalent gentle mixing technique at 2-5 oC. Filter the bulk plasma pool sequentially through a sterile 1 μm or 2 μm cartridge filter

(Parker.com; part # ZEGFB-1.0TT-PN3; or equivalent) and sequentially filter through a 0.22 µm PVDF (low protein binding) filter (Parker.com; part #

ZESGE-020TT-PS3; or equivalent). The filtered pool shall be collected into a single-use 20 L polyethylene or Teflon low-binding carboy. The Contractor shall maintain homogeneity of the bulk pooled plasma at a temperature between 2-5

ºC at all steps during and after filtration and throughout blending with serum pools.

2. Thaw each cTnI-positive serum pool at 2-5 ºC for a minimum-required time.

Note: Only thaw cTnI-positive serum pools when ready to blend with prepared plasma pool. Once thawed, all blending steps, cTnI immunoassay testing, vialing, and freezing of each Level (A-D) must be completed promptly (within 24 hours maximum – shorter times are preferred).

Additionally, all sera and plasma specimens shall be kept at 4 oC throughout all steps including, but not limited to, thawing, pooling, filtering, blending, testing, and vialing.

3. Mix each thawed cTnI-positive serum pool by at least 10 gentle inversion cycles while maintaining temperature at 2-5 ºC. Mix the bulk cTnI-positive serum pools thoroughly by a magnetic stirrer or equivalent gentle mixing technique at

2-5 ºC. The time for this step should be as short as possible to minimize potential cTnI degradation but sufficient to ensure homogeneity.

4. Each Level (A-D) of the candidate reference material shall be prepared by mixing a portion of the plasma pool with the appropriate cTnI-positive serum pool, as indicated by documentation provided from the NIST TPOC. Mix each of the four RM Levels, so as to limit the total time that serum and plasma specimens are subjected at 4 oC.

5. Mix the blended Level (A, B, C, or D) thoroughly by a magnetic stirrer or equivalent gentle mixing technique at 2-5 ºC to ensure homogeneity.

6. Remove a small aliquot of each RM Level for immediate cTnI concentration determination.

i. A minimum amount of the RM material shall be removed while the remaining bulk material continues mixing at 4 oC. No freeze/thaws of the bulk material shall be performed.

ii. Contractor shall perform one or more high-sensitivity immunoassays in-house, or shall sub-contract immunoassay testing immediately (within four hours), without freeze/thaw steps. High sensitivity tests that are acceptable for this step include: Siemens’ Atellica high sensitivity TNIH or Siemens’

ADVIA Centaur high sensitivity TNIH (XP or XPT).

iii. Contractor shall ensure that results from the immunoassay(s) agree with the specified ranges for each RM Level, as provided in Section I above, or

Section IV, Deliverable 2, below.

iv. If results are in agreement, proceed to step 7 below.

v. If results are not in agreement, continue to dilute and blend/mix the bulk materials to achieve agreement based on the immunoassay(s). The NIST

TPOC must be contacted immediately (within 2 hours) with the immunoassay results prior to continuing to step 7.

7. Fill a minimum of 2500, and up to 4000, pre-labeled (labels supplied by NIST) sterile polypropylene vials (as specified above) with 0.7 mL (± 0.05 mL) of blended, pooled lithium heparin plasma, per Level (A-D). The Contractor shall perform the vialing and capping process of each RM Level at a temperature between 2-5 ºC. The pools (Levels A-D) shall be continuously stirred during dispensing.

8. The vials shall be transferred, in fill order, to a cryogenic vial box compatible with long-term storage at ≤ -70 ºC. The Contractor shall indicate the fill order direction and label each storage container with the start and end fill order (mark the storage container with “Start” and “End”). Each storage container label shall contain the following format: “NIST RM 8121 Cardiac Troponin I in Frozen

Human Plasma, Level #X, Box #X” (“X” denotes the exact Level and box number). The color scheme of the storage container labels shall be consistent with the color scheme of the vial caps for each plasma cTnI Level (as specified above). The vials for each of the RM Levels shall be separately packaged for storage, and shipping to NIST.

9. The Contractor shall provide the NIST TPOC with information needed to determine the fill-order and approximate date and time each Level was pooled, aliquoted and stored at ≤ -70 ºC. The Contractor shall also provide the results of cTnI immunoassay testing for each Level.

10. Storage and Shipping: Once packaged, all vials shall be stored at ≤ -70 ºC until they are shipped. All vials shall be shipped overnight on dry ice (sufficient dry ice to maintain frozen conditions during shipment) to NIST in biospecimen shipping containers. Boxes shall be labeled to indicate their contents. To ensure timely receipt of the package(s) by NIST and minimize the risk of environmental damage incurred during transit, the Contractor shall ensure the package is shipped on Monday through Wednesday for delivery to NIST from Tuesday to

Thursday between 8am and 5pm EST. Shipment or delivery on Federal Holidays must be avoided. The Contractor shall notify the NIST TPOC two (2) weeks prior to shipping and provide the following: shipment date, expected delivery date, shipping method, shipment tracking information, and contents of the package.

F. Progress Reports

The Contractor shall supply NIST with progress reports every month, supplied by e-mail to the NIST TPOC, describing the status of all tasks accomplished, any issues encountered while carrying out tasks, and future planned tasks.

IV. DELIVERABLES AND DELIVERABLE DUE DATES

Deliverable 1. The Contractor shall provide a progress report (in Word, Excel, or

PowerPoint) every month and the report shall be delivered via e-mail to the NIST

TPOC. The Contractor shall provide the reports no later than the last day of each month after award. The reports shall summarize tasks accomplished, any issues, and planned work for the next reporting period.

Deliverable 2. The Contractor shall deliver to NIST no later than 90 days after all shipments are received from the NIST-specified institution:

Minimum of 2,500 labeled vials (up to 4,000 vials) filled with 0.7 mL (± 0.05 mL) of pooled plasma in each of these plasma cTnI concentration ranges based on Siemens’

Atellica TNIH high sensitivity immunoassay:

1) (total minimum of 10,000 vials, up to 16,000 total vials):

i. Level A = 20 ng/L (range 10 ng/L – 30 ng/L); 2500 – 4000 vials

• LOQ (2.6 ng/L) < Level A < female 99th percentile (34 ng/L)

ii. Level B = 65 ng/L (range 50 ng/L – 80 ng/L); 2500 – 4000 vials

• Level B = male 99th percentile (53 ng/L) + 20%

iii. Level C = 265 ng/L (range 220 ng/L – 310 ng/L); 2500 – 4000 vials

• Level C = male 99th percentile (53 ng/L) * 5

iv. Level D = 6500 ng/L (range 6000 ng/L – 7000 ng/L); 2500 – 4000 vials

• Level D = male 99th percentile (53 ng/L) * 125

2) The Contractor shall return to the NIST TPOC excess pooled plasma material labeled, frozen and on dry ice with the appropriate documentation that specifies the specimen identification and/or the RM Level.

Deliverable 3. Documentation specified in SOW for the following:

1) Information for receipt of shipped plasma and serum materials from NIST-specified institution (SOW Section III. B). The Contractor shall notify the

NIST TPOC by email or phone no later than one (1) week after receipt of each shipment and provide the following information: shipment delivery date, specimen identification, total number of specimens and condition of specimens and specimen containers.

2) Information for what materials and specific equipment will be used for immunoassay testing, and for pooling, blending, and bottling of the materials shall be provided prior to processing the plasma material

3) Information for material fill-order due no later than two (2) weeks after completion (processing, aliquoting and storage) of each RM Level.

4) Tracking information for material shipment. The Contractor shall notify by email the NIST TPOC two (2) weeks prior to shipping the material and provide the following: shipment date, expected delivery date, shipping method, shipment tracking information and contents of the package.

V. PERIOD OF PERFORMANCE

The period of performance shall be 210 days after award. However, due to current access restrictions, performance shall not take place until the contractor coordinates with the designated Technical Point of Contact (TPOC) and Contracting Officer (CO).

Prior to commencement of performance, the Contractor must ensure NISTs campus is open and performance can occur. If the access restrictions to the campus impact the period of performance, a modification may be executed by the CO to establish a revised period of performance.

VI. PROTECTION OF HUMAN SUBJECTS

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.

Research Activities Involving Human Subjects, Human Tissue, Data or Recordings

Involving Human Subjects Including Software Testing. Any tasks that includes research activities involving human subjects, human tissue/cells, or data or recordings from or about human subjects, must satisfy the requirements of the Common Rule for the

Protection of Human Subjects (“Common Rule”), codified for the Department of

Commerce at 15 C.F.R. Part 27. Research activities involving human subjects who fall within one or more of the classes of vulnerable subjects found in 45 C.F.R. Part 46, Subparts B, C and D must satisfy the requirements of the applicable subpart(s). In addition, any such application that includes research activities on these subjects must be in compliance with all applicable statutory requirements imposed upon the Department of

Health and Human Services (DHHS) and other Federal agencies, all regulations, policies and guidance adopted by DHHS, the Food and Drug Administration (FDA), and other

Federal agencies on these topics, and all Executive Orders and Presidential statements of policy on applicable topics.

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). In the event 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.

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 Contractor shall submit the following documentation to the NIST TPOC prior to issuance of the award: verification of a relationship with an Institutional Review Board

(cognizant IRB), located within the United States and within the community in which the human subjects research will be conducted; valid registration of IRB with United States

Department of Health and Human Services' Office for Human Research Protections

(OHRP); and valid Federal-wide Assurance (FWA) issued by OHRP of the Contractor.

A. Determination of Not Research: If a task involves human subjects as defined in the

Common Rule, but the Contractor indicates to NIST that the task is not research as determined by the cognizant IRB, the following information shall be submitted to NIST prior to starting the research:

(1) Justification, including the rationale for the determination and such additional documentation as deemed necessary by NIST to review and/or support a determination that the task is not research as defined in the Common Rule.

(2) If the Contractor used a cognizant IRB that provided a determination that the task is not research, a copy of that determination documentation must be provided to

NIST.

NIST will review the information submitted and may coordinate further with the

Contractor before determining whether the task will be defined as research under the

Common Rule in the applicable NIST project.

B. Determination of Research Not Involving Human Subjects: If a task is determined to be research and involves human subjects, but the Contractor indicates to NIST that the task was determined to be not human subjects research (or research not involving human subjects) by the cognizant IRB, the Contractor shall submit the following documentation to NIST prior to starting the research:

(1) Justification, including the rationale for the determination and such additional documentation as may be deemed necessary by NIST to review and/or support a determination that the task is not research as defined in the Common Rule.

(2) If the Contractor used a cognizant IRB that provided a determination that the task is research not involving human subjects, a copy of that determination documentation must be provided to NIST.

C. Determination of Research Involving Human Subjects: If the task is determined to be research that involves human subjects by the cognizant IRB, the Contractor shall submit the following documentation to NIST prior starting the research:

(1) The name(s) of the institution(s) where the research will be conducted.

(2) The name(s) and institution(s) of the cognizant IRB(s), and the IRB registration number(s) with OHRP.

(3) The FWA number of the Contractor linked to the cognizant IRB(s);

(4) If the IRB review(s) is pending, the estimated start date for research involving human subjects.

(5) The IRB approval date and the final IRB-approved protocol.

a. This includes the human subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms approved by the cognizant IRB

(7) A signed and dated approval letter from the cognizant IRB(s) that includes the name of the institution housing each applicable IRB, provides the start and end dates for the approval of the research activities, and any IRB-required interim reporting or continuing review requirements.

(8) A brief description of what portions of the IRB submitted protocol are specifically associated with the task outlined in this SOW NIST

(9) Documentation of continuing IRB approval by the cognizant IRB at appropriate intervals as designated by the IRB, but not less than annually

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.

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.

VII. GOVERNMENT-FURNISHED PROPERTY, DATA, AND/OR INFORMATION

NIST will provide the Contractor with labels for the 2.0-mL screw-cap polypropylene vials

(sterile) appropriate for long-term storage at ≤ -70 ºC not later than 30 days after award.

To ensure the NIST-provided labels are compatible with the Contractor-specified labelling method, the Contractor shall provide the NIST TPOC the delivery format of the labels to the vials (manual or automated application-provide manufacturer and product number).

The Government will also arrange for the plasma samples and the serum pools to be delivered to the Contractor no later than 90 days after award.

VIII. PERFORMANCE REQUIREMENT SUMMARY

Required Service:

Produce 2,500 (up to 4,000) aliquots of 0.7 mL (± 0.05 mL) of pooled human plasma at four concentration Levels for human cTnI (in total 10,000 vials, up to 16,000 vials in total).

Performance Standard:

1. Materials shall be prepared and packaged as described in the SOW and meet all specifications set forth in the SOW.

2. 2,500 (up to 4,000) aliquots of 0.7 mL (± 0.05 mL) of pooled human plasma at four cTnI Levels, A-D, (in total 10,000 vials, up to 16,000 vials in total) shall arrive intact, frozen, and unbroken (≤ 10 broken vials, in total).

Acceptable Quality Level:

The material must be kept clean and maintained at specified temperatures throughout. All efforts must be made to ensure minimal thaw times for plasma and serum samples. The material must be suitable for use as a certified reference material (CRM). If deficiencies or inconsistencies between the material and the documentation (defined in section IV) are found, or if less than the stated number of bottles are received intact, the Contractor has 30 days to correct the deficiency. The Contractor shall correct all deficiencies at no additional cost to the Government.

Acceptance Method:

Acceptance will be based upon the delivery of a minimum of 2,500 vials at each of the four human plasma pool Levels frozen, intact, and unbroken. The NIST TPOC will know that the single-donor plasma specimens were successfully pooled, blended, and aliquoted when they are analyzed as part of the material acceptance process. NIST requires a 90-day acceptance testing period. A minimum of 10 vials at each of the four pool Levels will be tested by NIST to ensure suitable endogenous plasma cTnI content, material homogeneity, and adequate volume (all vials containing 0.7 mL as determined by calibrated pipette) for use as a NIST reference material.

IX. DELIVERY

Delivery shall be FOB DESTINATION and be completed in accordance with the due date stated in Section IV above. However, due to current access restrictions, delivery shall not take place until the contractor coordinates with the designated Technical Point of Contact

(TPOC) and Contracting Officer (CO).

Prior to shipment, the Contractor must ensure NISTs campus is open and accepting deliveries. If the access restrictions to the campus impact delivery schedules, a modification may be executed by the CO to establish an extended delivery timeframe.

Delivery Address:

Attn: Dr. Mark Lowenthal (building 227/B144)

National Institute of Standards and Technology (NIST)

NIST Shipping and Receiving Building 301

100 Bureau Drive

Gaithersburg, MD 20899