ISSUED RFQ.pdf

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

THIS RFQ IS IS NOT A SMALL BUSINESS SET-ASIDE

15. DATE OF QUOTATION

16. SIGNER

a. NAME (Type or print)

c. TITLE (Type or print)

b. TELEPHONE

AREA CODE

NUMBER

STANDARD FORM 18 (REV. 6-95) Prescribed by GSA-FAR (48 CFR) 53.215-1(a)

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition not usable

8. TO:

b. COMPANYa. NAME

c. STREET ADDRESS

d. CITY e. STATE f. ZIP CODE

9. DESTINATION

a. NAME OF CONSIGNEE

b. STREET ADDRESS

c. CITY

d. STATE e. ZIP CODE

7. DELIVERY

FOB DESTINATION

OTHER

(See Schedule)

10. PLEASE FURNISH QUOTATIONS TO THE

ISSUING OFFICE IN BLOCK 5a ON OR BEFORE CLOSE OF BUSINESS (Date)

IMPORTANT: This is a request for information and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5a. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or service. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotation must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NUMBER

(a)

SUPPLIES/ SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS (%) b. 20 CALENDAR DAYS (%) c. 30 CALENDAR DAYS (%) d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER

a. NAME OF QUOTER

b. STREET ADDRESS

c. COUNTY

d. CITY e. STATE f. ZIP CODE

14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

PAGE OF PAGES

1. REQUEST NUMBER 2. DATE ISSUED 3. REQUISITION/PURCHASE REQUEST NUMBER 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY 6. DELIVER BY (Date)

5b. FOR INFORMATION CALL (NO COLLECT CALLS)

NAME TELEPHONE NUMBER

AREA CODE NUMBER

Attachment Page

PAGE 2 OF 70 1333ND21QNB640184

1. Type of Order:

This is a request for quotation for Standard Reference Materials. The Contractor shall provide ampoules of SRM 956e and supporting documentation, in accordance with the statement of requirements, including all attachments. A firm fixed price contract is anticipated.

The request for quotation is 100% set-aside for small business.

2. Contractor’s Point of Contact:

Name: (TO BE IDENTIFIED AT THE TIME OF AWARD) Phone Number:

Email:

3. NIST Technical Point of Contact Name: (TO BE IDENTIFIED AT THE TIME OF AWARD) Phone Number:

Email:

4. NIST Contracting Officer’s Representative (COR) if Applicable:

Name: (TO BE IDENTIFIED AT THE TIME OF AWARD) Phone Number:

Email:

5. NIST Contracting Officer Name: Carol Wood Phone Number: 301-975-8172 Email: carol.wood@nist.gov

5. Designated Government Official (Reference NIST SOP 01-14):

a. ______ Technical Point of Contact /Administrative Officer

b. ____ COR/ACOR

c. __XX___ Contracting Officer

6. Extended Test/Acceptance Period: N/A

7. Additional Information:

PAYMENT SCHEDULE

Partial payments may be authorized. The Government will negotiate a payment schedule with the Contractor prior to or immediately following award.

The Government notes the following points relevant to the payment schedule:

-The Government cannot pay any amount “up front” or as a “deposit”;

-Payments will be tied to tangible deliverables;

-Payment in full will not be made until all work has been successfully completed by the Contractor and accepted by the Government;

-The Contractor is invited to include a payment schedule in their quotation for consideration by the Government.

The final payment schedule will be negotiated and agreed upon by both parties.

This information will be held as confidential in the contract file and utilized solely for price comparison by the Contracting Officer to determine the quoted prices fair and reasonable.

SCHEDULE Continued

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

The Contractor shall provide the following ampoules of SRM 956e and supporting documentation, in accordance with the statement of requirements, including all attachments.

0001 6,000 ampoules of SRM 956e, Electrolytes in serum from whole human blood at concentration Level 1.

1.00 LO

0002 6,000 ampoules of SRM 956e, Electrolytes in serum from whole human blood at concentration Level 2

0003 6,000 ampoules of SRM 956e, Electrolytes in serum from whole human blood at concentration Level 3.

PAGE 3 OF 70 1333ND21QNB640184

Table of Contents

STATEMENT OF REQUIREMENTS AND ATTACHMENT III

EVALUATION CRITERIA AND INSTRUCTIONS

52.213-4TERMS AND CONDITIONS--SIMPLIFIED ACQUISITIONS (OTHER THAN COMMERCIAL ITEMS) (FEB 2021)

52.243-1 CHANGES--FIXED-PRICE (AUG 1987)

52.245-1 GOVERNMENT PROPERTY (JAN 2017)

52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (MAR 2020)

52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018)

52.204-16COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (AUG 2020)

52.204-17OWNERSHIP OR CONTROL OF OFFEROR (AUG 2020)

52.225-1BUY AMERICAN--SUPPLIES (JAN 2021)

52.219-6NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE (NOV 2020)

52.219-28POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (NOV 2020)

52.219-33 NONMANUFACTURER RULE (MAR 2020)

52.225-2BUY AMERICAN CERTIFICATE (FEB 2021)

1352.235-73 RESEARCH INVOLVING HUMAN SUBJECTS - AFTER INITIAL CONTRACT AWARD (APR 2010)

1352.235-72 PROTECTION OF HUMAN SUBJECTS - INSTITUTIONAL APPROVAL (APR 2010)

1352.235-71 PROTECTION OF HUMAN SUBJECTS -- EXEMPTION (APR 2010)

1352.209-74 ORGANIZATIONAL CONFLICT OF INTEREST (APR 2010)

1352.209-73 COMPLIANCE WITH THE LAWS (APR 2010)

1352.208-70 RESTRICTIONS ON PRINTING AND DUPLICATING (APR 2010)

1352.201-70 CONTRACTING OFFICER?s AUTHORITY (APR 2010)

1352.215-72 INQUIRIES (APR 2010)

1352.237-75 KEY PERSONNEL (APR 2010)

NIST LOCAL-53CONTRACT PERFORMANCE DURING CHANGES IN NIST OPERATING STATUS

NIST LOCAL-54ELECTRONIC BILLING INSTRUCTIONS

ATTACHMENT I

ATTACHMENT II

PAGE 4 OF 70 1333ND21QNB640184

CLAUSES

STATEMENT OF REQUIREMENTS AND ATTACHMENT III

PAGE 5 OF 70 1333ND21QNB640184

Standard Reference Material 956e: Serum from Whole Human Blood Frozen for Storage at –70oC

BACKGROUND

The Inorganic Chemical Metrology Group (ICMG) of the National Institute of Standards and Technology

(NIST), is responsible for developing, critically evaluating, and applying techniques for the identification and measurement of inorganic and organometallic species using X-ray, optical, and mass spectrometric techniques, classical analytical methods, pH, and electroanalytical methods. Standard Reference Materials

(SRMs) and analytical methods development support a variety of industries including advanced materials, cement, ores, fossil fuels, food, and clinical analyses. The Group develops and maintains primary national standards for elemental and anionic concentrations, pH, electrolytic conductivity, and isotopic abundance.

For the past 30 years the National Institute of Standards and Technology has developed a number of biological fluid and tissue SRMs primarily for clinically important analytes (e.g., cholesterol, glucose, creatinine, and electrolytes, and trace elements). Electrolytes in serum are important biomarkers for skeletal and cellular health. The levels of electrolytes are monitored by measuring the electrolyte elements such as Ca, Mg, K, and

Na in blood serum.

SRM 956 provides a critical link in the accuracy and traceability of the clinical measurement. Now in its 6th iteration, SRM 956e must be developed to succeed SRM 956d that is expected to be out of stock in 2022.

Historically, SRM 956 has been produced according to NIST specifications by an external contractor. It takes approximately one year for the procurement of the materials and certification for SRM 956. Following successful requisition of the material, the electrolyte elements and species in the material are measured at NIST and at external collaborating laboratories for the certification of the SRM.

GENERAL REQUIREMENTS

The Contractor shall provide the following ampoules of SRM 956e and supporting documentation, in accordance with this statement of requirements, including all attachments:

1. 6,000 ampoules of SRM 956e, Electrolytes in serum from whole human blood at concentration Level 1.

2. 6,000 ampoules of SRM 956e, Electrolytes in serum from whole human blood at concentration Level 2.

3. 6,000 ampoules of SRM 956e, Electrolytes in serum from whole human blood at concentration Level 3.

SPECIFIC REQUIREMENTS

-The Contractor shall furnish the necessary personnel, material, equipment, and facilities (except as otherwise specified), to deliver the required 956e SRM at Levels 1, 2, and 3.

-Historically, this project has been deemed as non-human subjects research, however, depending on the

Contractor’s techncial quotation, may be subject to Institutional Review Board review. Reference Attachment

III, Paragraph 9(d).

-The Contractor may utilize commercial units of serum, without identifiers, in the production of the SRM.

-The Contractor shall comply with all requirements and procedures set forth in Attachment I, Clinical and

Library Standards Institute (CLSI) Document C29-A2, Attachment II CLSI C39-A Flowchart, and Attachment

III . This procedure is based upon international standards and has been used successfully to produce SRMs

956b, 956c and 956d.

-The Government reserves the right to review the Contractor’s production records & notebooks and/or discuss the production process with Contractor personnel, to verify that the required procedures have been followed.

Reference Attachment III, Paragraph 9(c).

PAGE 6 OF 70 1333ND21QNB640184

-The Contractor shall submit all deliverables, identified herein, in addition to SRM 956e, Levels I, II and III.

Reference the SOR Supplement for details regarding each deliverable.

-The pilot/validation data package shall include access to or copies of pertinent records in the laboratory notebooks of details of the sources and amounts of analytes added, etc., as defined in Attachment III Paragraph

9 (c). This will provide NIST with details concerning the preparation of the material in the event of personnel changes at the site of production. The Contractor shall include the names of those individuals in the laboratory so that detailed questions for that individual can be directed to the Contractor's point of contact.

PLACE OF PERFORMANCE

Performance will be at the Contractor’s facility.

GOVERNMENT FURNISHED PROPERTY

NIST will provide 6,000 labels each for Level 1, Level 2, and Level 3 SRM 956e.

DELIVERY

Delivery terms shall be FOB DESTINATION. Delivery of the SRM, including all supporting documentation, must be completed not later than 120 calendar days after award.

Prior to shipment, the Contractor must ensure NIST's campus is open and accepting deliveries. Due to current site access restrictions, the Contractor shall not ship the SRM until the Contractor coordinates with the NIST

Technical Point of Contact (TPOC) that will be identified at the time of award.

If the restrictions of access to the campus, and/or any other delivery delay, impacts the Contractor’s delivery schedule, a modification may be executed by the Contracting Officer (CO) to establish an extended delivery timeframe.

Delivery Address:

National Institute of Standards and Technology

Attention: (TO BE IDENTIFIED AT THE TIME OF AWARD)

Building 301

100 Bureau Drive

Gaithersburg, MD 20899

MARKING DELIVERABLES

(a) The contract number shall be placed on or adjacent to all exterior mailing or shipping labels of deliverable items called for by the contract.

(b) Mark deliverables, except for reports that can be delivered by e-mail. For reports delivered by e-mail, the contract number shall be included in the subject line of the e-mail, and the contract number shall be included in any attachment.

PACKING/SHIPPING SPECIFICATIONS

The ampoules shall be packaged in fill order in trays or containers in an upright fashion. The packaging shall be of a nature to prevent breakage with the three levels kept separate and identifiable.

The material must be transported under conditions that will prevent it from reaching temperatures greater than

–50 °C prior to reaching NIST or each case shall contain 4 to 5 pounds (1.8 to 2.3 kg) dry ice to ensure the products reaching the intended recipient at NIST at the specified temperatures via overnight shipping.

PAGE 7 OF 70 1333ND21QNB640184

Concentration Levels 1, 2, and 3 shall be packaged separately. Packaging for shipment shall conform to industry standards.

DELIVERABLES

All performance periods are specified as calendar days unless noted otherwise.

Description Quantity/Format Due Date Responsible Party

Documentation of compliance with the Common Rule for the Protection of Human Subjects (15 C.F.R. Part 27) and as described in Attachment III Paragraph 9 (d).

One/E-mail to the NIST

Technical Point of Contact and the Contracting

Officer

30 days

After

Contract

Award

Contractor

Report of Analysis (ROA) from pilot/validation run

The Government will complete its review of the ROA data package from pilot/validation run and, via email,

(1) Authorize the production of 6,000 ampoules each of

Level 1, Level 2, and Level 3 of SRM 956e. Not later than 10 days after the TPOC authorizes production, the

Government will provide 6,000 each of Level 1, Level1 and Level 3 labels to the Contractor

OR

(2) Advise the Contractor to redo the pilot run if the specification shown in Attachment III Paragraph 5 PILOT/VALIDATION RUN is not met.

One/E-mail to the NIST TPOC

45 days After

Contract

Award

Contractor

Certificate of analysis (COA) for levels 1, 2 and 3 of

SRM 956e.

Include in or with the COA must be copies of

CERTIFICATES OF TEST OF HUMAN SERUM and

ANALYTES USED IN SPIKING as described in

Attachment III Paragraphs 3. CERTIFICATES OF

TEST OF HUMAN SERUM and 4. ANALYTES USED

IN SPIKING.

One/E-mail with attachments sent to the NIST

TPOC

105 days

After contract award

Coordinate shipment with the TPOC.

Package and ship overnight ampoules of SRM 956e

6,000 ampoules each of Level 1, Level 2, and

Level 3 SRM

956e to FOB

Destination

Address below

120 days

After contract award

ACCEPTANCE REQUIREMENT SUMMARY

Final Deliverable

Production of 6,000 ampoules each of Level 1, Level 2, and Level 3 of SRM 956e.

Acceptance Standard

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

2. Certificate of Analysis indicating the electrolyte concentrations by standard clinical methods as described in Attachment III Paragraph 7.

3. 6,000 ampoules of SRM 956e, Electrolytes in serum from whole human blood at concentration Level 1.

Shipped frozen as individual units for receipt within 24 hours of processing.

PAGE 8 OF 70 1333ND21QNB640184

4. 6,000 ampoules of SRM 956e, Electrolytes in serum from whole human blood at concentration Level 2.

5. 6,000 ampoules of SRM 956e, Electrolytes in serum from whole human blood at concentration Level 3.

6. See Attachment III and Attachment I for other performance standards.

Acceptable Quality Level

The ampoules of Level 1, Level 2, and Level 3 SRM 956e with the associated physical and chemical properties specified in Supplement clauses 1 and 2, referred to in the following as 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 Attachment III Paragraph 9) are found, or if less than the stated number of ampoules are received intact, the Contractor shall have 30 days from when the deficiencies are reported by the NIST

TPOC, to correct the deficiency at no additional cost to the Government.

Monitoring Method

The NIST TPOC will verify the SRMs were successfully prepared and acceptable when they are analyzed as part of NIST SRM certification process. This will be completed 180 days after receipt of the ampoules due to laboratory access limitations due to COVID-19.

MINIMUM CONTRACTOR QUALIFICATIONS

The Contractor must be ISO 13485:2016, “Medical devices -- Quality Management Systems -- Requirements for

Regulatory Purposes” and have ISO accreditation for the analyses specified in Attachment III.

Alternatively, the Contractor shall include calibration records, quality control results (e.g., blank, spike amounts, spike recovery, minimum detection limit determination, etc.) for each analyte in each of Level 1, Level 2, and Level 3 of SRM 956e when submitting the data package for the pilot validation run and for the certificate of analysis.

ATTACHMENTS

Attachment I: CLSI Document C29-A2

Attachment II: Appendix F. SRM 956a Process Flow Chart from CLSI Document C39-A

Attachment III: SOR Supplement: Specification for Performances

PAGE 9 OF 70 1333ND21QNB640184

SOR SUPPLEMENT: Specification for Performances

1. QUANTITY OF SERUM

The contractor shall provide a total of 18,000 ampoules of (2.00 0.04) mL per ampoule of three (3) different concentration levels, 6,000 ampoules per concentration level. The (2.00 0.04) mL aliquot of serum is to be dispensed into 5 mL glass ampoules (See Appendix III Paragraph 6 Primary Container Specifications). The 2.0 mL aliquot of serum and the 5 mL ampoule deviates from the container requirement as specified in section

A2.5(2) of the CLSI Document C29-A2. The new primary container requirement shall be strictly adhered to or breakage of the glass ampoules under –70 C storage conditions will result.

2. DESCRIPTION OF SERUM AND ELECTROLYTE CONCENTRATION LEVELS

Only native human serum (not ACD plasma) that has been tested and found negative for HIV and hepatitis is to be used. The values of sodium, potassium, and other analytes in this pooled sera should 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 specimens shall be shipped frozen as individual units for receipt within 24 hours of processing.

The contractor shall prepare the three (3) concentration level material employing the specifications as detailed in (Attachment I, CLSI Document C29-A2, Appendix A). The serum should be defibrinated, filtered, and partitioned into three (3) subpools. The target electrolyte concentration levels are given in Table 1 that includes phosphate in addition to the electrolytes listed in C29-A2. Refer to Appendix A2.3 of CLSI Document C29-A2 for details of production considerations.

CHLORIDE: It is recognized that the concentration of chloride in the three levels of the serum material may be difficult to accurately control depending on the types and quantities of salts added to the base pools. The chloride concentrations in the finished serum material must fall within the range 90 mmol/L – 130 mmol/L with increasing concentration from Level 1 through Level 3.

Blending will be done such that the levels will show no greater variability than 1 % sample to sample in analyte concentration, defined as the standard deviation of sample replication (n>5) divided by the sample mean. The serum shall be filled into pre-labeled ampoules (see Primary Container Specifications in this document) and frozen according to the specifications given in Appendix A2.5 of CLSI Document C29-A2. A copy of

Appendix F. SRM 956a Process Flow Chart from CLSI Document C39-A is attached as Appendix II of this document package.

2.1 Additional pool preparation precautions to observe concerning CLSI Document C29-A2 Appendix

A2.5.

As this material is intended for use as an ionized calcium control material, it is critical that pH and pCO2 be closely monitored on a blood gas analyzer during the formulation and adjustment process. A pH of 7.4 0.05

@ 37 C and pCO2 of 35 mm Hg must be maintained during the manufacturing process as well as during storage prior to filling into the ampoules. During storage, the serum should be overlayed with 3 % CO2, 97 %

N2. Caution must be exercised to minimize restrictions to airflow out of the formulation chamber. Ambient air pressure must be maintained in the chamber. Too small of a filter on the venting tube on the formulation chamber can cause a buildup of the air pressure in the chamber. (A 0.22 micron filter is too small.) If the air pressure is too great the pCO2 can increase over time, causing an increase of carbonic acid in the serum and consequently a lowering of the pH which will nullify the use of the material for ionized calcium.

PAGE 10 OF 70 1333ND21QNB640184

Table 1. Target Electrolyte Concentrations (mmol/L) and pH

Na K Tot Ca Tot Mg Li Phosphate pH

Level 1 120 ± 3 6.0 ± 0.2 3.0 0.2 1.5 0.1 2.0 0.1 2.0 ± 0.1 7.40 ± 0.05

Level 2 140 ± 3 4.0 ± 0.2 2.5 0.2 1.0 0.1 1.25 0.1 1.5 ± 0.1 7.40 ± 0.05

Level 3 160 ± 3 2.0 ± 0.2 2.0 0.2 0.5 0.1 0.5 0.1 1.0 ± 0.1 7.40 ± 0.05

3. CERTIFICATES OF TEST OF HUMAN SERUM

The following shall be presented for each unit collected:

(a) Donor center name and address.

(b) Purchase order number

(c) Certification that no anticoagulant was used

(d) Hepatitis B, using hBsAg and hB core antibody

(e) Hepatitis C, using a hepatitis C antibody test

(f) HIV-1, using an HIV-1 antibody test

(g) HIV-2, using an HIV-2 antibody test

(h) HTLV-1

(i) Syphilis

(j) Blood donor record forms for raw materials used in human serum, base matrix shall be included.

(k) Materials that tested positive in infectious disease related tests beyond those which may have been specifically delineated in the items above shall not be accepted by NIST.

4. ANALYTES USED IN SPIKING

The contractor shall use ACS reagent or better grade chemicals for the production, and specify the source of added analytes.

5. PILOT/VALIDATION RUN

A pilot/validation run shall be performed. The testing of sodium, potassium, total calcium, phosphate, chloride, magnesium, lithium, and pH using standard clinical methods is required, with results falling within the low, mid, and high subpool limits as listed in Table 2. See also Appendixes A2.3-4 of CLSI Document C29-A2 for more information on pool formation. The Contractor shall provide NIST with a report of analysis (ROA) indicating the electrolyte concentrations and pH by standard clinical methods. A minimum of five samples shall be measured for each analyte at each level. In addition, five samples of serum in 5 mL ampoules from each level shall be shipped overnight on dry ice to NIST for inspection and analysis by NIST personnel. Each sample must contain 2 g of serum.

Table 2. Target Electrolyte Concentrations for Production Pools (mmol/L) and pH*

Na K Tot Ca Tot Mg Li Phosphate pH Ionic

S

Level 1 120 ± 3 6.0 ± 0.2 3.0 0.2 1.5 0.1 2.0 0.1 2.0 ± 0.1 7.40 ± 0.05 (145)

Level 2 140 ± 3 4.0 ± 0.2 2.5 0.2 1.0 0.1 1.3 0.1 1.5 ± 0.1 7.40 ± 0.05 (160)

Level 3 160 ± 3 2.0 ± 0.2 2.0 0.2 0.5 0.1 0.5 0.1 1.0 ± 0.1 7.40 ± 0.05 (175)

PAGE 11 OF 70 1333ND21QNB640184

*For report of analysis, a minimum of five (5) replicate analytical measurements is required for each analyte and level (i.e., 8 analytes x 3 levels x 5 replicates = 120 analytical measurements). For certificate of analysis, duplicate analytical measurements on a minimum of five ampoules at each level for each analyte (i.e., 8 analytes x 3 levels x 5 ampoules x 2 aliquots/ampoule = 240 analytical measurements).

6. PRIMARY CONTAINER SPECIFICATIONS

Ampoule Specification: Wheaton products number W651469 5 mL Cryule Clear shall be used as the primary container. The Cryule ampoules are made from low extractable borosilicate glass that conforms to USP Type I and ASTM E 438 Type I, Class A requirements. The special design allows for storage at low temperatures as well as rapid thawing. The product and order information is available at http://wheaton.com/5-ml-cryule-clear-

41551.html. Vendor shall use specifications as indicated – NO SUBSTITUTIONS- and perform the stated quality control procedure for ensuring the integrity of the glass ampoules in the following manner.

While holding 2.0 mL of serum and sealed, a representative sampling of the ampoules at each concentration level shall withstand three freeze-thaw cycles. The ampoules are frozen at –70 C, removed and thawed at room temperature; refrozen at -70 C, removed and thawed; refrozen at -20 C for 3 hours, removed and thawed. After each thawing cycle, once the contents are liquid, swirl the ampoules to re-suspend the protein.

Repeat these steps two times. At the end of the third cycle, count the number of broken ampoules. Inspect 100

% of the ampoules. The ampoule breakage must be demonstrated to be less than 2% of those tested.

7. ORDER OF AMPOULE FILLING AND LABELING OF AMPOULES FOR FINAL

PRODUCTION

The order in which the ampoules are filled from first to last is to be maintained and the ampoules and the exterior of the packaging carton are to be labeled accordingly. If there is more than one fill head, ampoules from each fill head shall also be labeled accordingly.

The ampoules shall be pre-labeled before freezing with labeling stock provided by NIST.

NOTE: No vendor labels or markings shall be placed on the ampoules.

8. CERTIFICATE OF ANALYSIS

A minimum of five ampoules shall be sampled from the production sequence at each level of SRM 956e. A minimum of three ampoules shall be sampled from each fill head. The order of the sampling should be evenly distributed throughout the production for each fill head. (For example, if a single fill head was used in the production, the first ampoule, the last ampoule, and the ampoules at approximately 25%, 50%, and 75% of the total production should be sampled. If two fill heads were used, then for each fill head the first ampoule, the last ampoule, and the ampoule at approximately 50 % of the production of the fill head should be sampled.)

Two aliquots should be taken from each ampoule sampled from the production. Each aliquot of serum should be measured for total Ca, Mg, K, Na, Li, phosphate, pH, and ionic S by standard clinical methods (i.e., the total number of values reported = 2 aliquots x 5 (minimum) vials x 3 levels x 8 analytes = 240 (minimum). The results shall be provided to NIST TPOC through NIST AMD in the Certificate of Analysis before shipment of the entire production lot as specified in SOR section IX. DELIVERY. The Certificate of Analysis is acceptable if all following requirements are met:

(a) The analyte values in Level 1, Level 2, and Level 3 of SRM 956e shall be within 5% of the respective target values listed in Table 2.

(b) For each analyte at each level, there shall be no detectable inhomogeneity at 95 % confidence level as defined by the p-value for a one-way analysis of variance of the results from duplicate aliquots of all sampled ampoules of the level to be greater than 0.05.

PAGE 12 OF 70 1333ND21QNB640184

(c) For each analyte at each level, the variation (defined as the standard deviation of sample replication divided by the sample mean) shall be less than 1 %.

9. DOCUMENTATION REQUIRED BY NIST

(a) Contractor shall provide a Report of Analysis for electrolyte concentrations and pH in samples of the

PILOT/VALIDATION RUN.

(b) Contractor shall provide a Certificate of Analysis for the electrolyte concentration levels and pH in the sampled production ampoules using standard clinical methods.

(c) Contractor shall provide access to or provide copies of records pertaining to the material requisition, pilot run, production procedure, and certification analysis for the production of SRM 956e. The records include, but are not limited to, the laboratory notebooks containing details of the production process, sources and amounts of analytes added, and measurement procedures used to verify the analyte in the products, etc. This will provide NIST with details concerning the preparation of the material in the event of personnel changes at the site of production. The contractor shall include the names of those individuals involved in the production process so that detailed questions can be directed to the individuals through the contractor’s point of contact.

(d) Contractor shall provide documentation of compliance with the Common Rule for the Protection of

Human Subjects (15 C.F.R. Part 27) as follows:

i. If the contractor purchases previously drawn blood from a vendor without identifying information, the use of human subjects may be exempt from the requirement of review by an Institutional Review Board (IRB).

Contractor must submit a written justification of their determination that the use of human subjects meets the requirements for one of the exemptions found at 15 C.F.R. 27.101(b). THE WRITTEN JUSTIFICATION

MUST ACCOMPANY THE PROPOSAL. An official determination as to whether the research is exempt will be made by NIST as part of the review process for the proposal.

ii. If the contractor proposes to draw the blood themselves or obtain the blood via a custom collection specifically for this project, the protocol for blood collection must be reviewed and approved by an appropriate IRB.

Contractor must submit a copy of the protocol and informed consent forms approved by the IRB, documentation of the IRB’s approval of the protocol, and the IRB’s Federal-wide assurance number from the

Department of Health and Human Services.

10. SITE VISIT

NIST reserves the right to have its representative present at the time of production and testing of the material to ensure product conformance to the SOR.

EVALUATION CRITERIA AND INSTRUCTIONS

PAGE 13 OF 70 1333ND21QNB640184

The Government will award a purchase order, resulting from this solicitation, to the responsible quoter whose quotation, conforming to the solicitation, results in the best value to the Government, price and other factors considered.

The following will be used to evaluate quotations:

Technical Capability

Experience

Past Performance

Price

Technical Capability, Experience, and Past Performance, when combined, shall be equal in importance to price.

TECHNICAL CAPABILITY

Technical capability will be evaluated to determine that the quoter meets the minimum

Contractor qualifications; That the quoter demonstrates the capability to produce and deliver the SRMs and supporting documentation in accordance with all solicitation requirements; and that the quoter possesses or has access to the facilities necessary to produce the SRMs.

EXPERIENCE

The quotation shall be evaluated to determine the depth and breadth of experience the

Contractor, including proposed subcontractors, possess with any or all of the following:

-Serum production

-Electrolyte content and pH adjustment of the serum pool;

-Measurement of electrolyte content in serum;

-Carbon dioxide layering on serum pool to maintain pH; and/or

-Layering carbon dioxide on the final product sealed in ampoules.

In determining best value, preference shall be given to quoters with a broader depth and breadth of experience in the areas identified herein.

PAST PERFORMANCE

Past Performance shall be evaluated to determine the overall quality of the product and service provided by the Contractor. Evaluation of Past Performance shall be based on the references provided and/or information provided by NIST and its affiliates.

Quoters with no relevant past performance shall receive a neutral rating.

PRICE

Price shall be evaluated for all quoters whose quotations are determined technically acceptable. Price will be evaluated to determine that the proposed price is consistent with the technical portion of the quotation and is an overall fair and reasonable price to the Government.

PAGE 14 OF 70 1333ND21QNB640184

ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERICAL ITEMS

(a) General Instructions

Quotations are required to conform to solicitation provisions and be prepared in accordance with this section. To aid in evaluation, the quotation must be clearly and concisely written as well as being neat, indexed (cross-indexed as appropriate) and logically assembled. All pages of each part shall be appropriately numbered and identified with the name of the quoter, the date, and the solicitation number.

Quoters shall submit one original of their quotation, via email, not later than

May 5, 2021, at 3:30 PM Eastern Time. Fax quotations shall not be accepted. E-mail quotations will be considered received when the e-mail enters into the electronic inbox of Carol Wood.

Only information received on or before the due date and time shall be considered for award. Any quotation, or part thereof, received after the due date and time, shall be deemed late and not considered for award.

Each volume shall be clearly marked by volume number and title.

(b) Overall Arrangement of the Quotation

(1) BUSINESS QUOTATION

(A)(i) The Standard Form 18, must be executed fully and used as the cover sheet.

Include one (1) originally signed copy of the form.

(ii) Acceptance Period - The acceptance period shall not be less than 120 days.

(iii) Concurrence with all terms and conditions of the solicitation.

(iv) The Dun and Bradstreet Number for the quoter’s active registration at the

System for Award Management, (www.SAM.Gov) website. An active registration at the SAM.Gov website is required for the quotation to be considered for award.

(v) If the quoter’s representations and certifications do not reflect the

NAICS code governing this solicitation, quoters must submit documentation of their business size under the NAICS code governing this solicitation.

(vi) Signature Authority - The person signing the form must have the authority to commit the quoter to all of the provisions and clauses of the solicitation, fully recognizing that the Government has the right, by terms of the solicitation, to make an award without further discussion if it so elects.

(vii) THIS REQUIREMENT IS BEING PROCURED 100% SET-ASIDE FOR SMALL BUSINESS. The quoter must be a small business and must provide the end product of a small business.

Reference the following Federal Acquisition Regulation (FAR) Provisions and Clauses:

-52.225-1 Buy American—Supplies

-52.225-2 Buy American Certificate

Quoters must complete the certificate and include it in with their quotation.

-52.219-33 Non-Manufacturer Rule

(2) TECHNICAL QUOTATION

(A) General

(1) The technical quotation consists of the quoter’s technical and management aspects of the acquisition. It must indicate your company's capabilities and the means to be used to satisfy the requirements of the Statement of Work. It will be evaluated in accordance with the evaluation criteria and must be specific and complete in every detail. The quotation must be practical and be prepared simply and economically, providing straightforward, concise delineation of what it is the quoter will do to satisfy the requirements of the Statement of Work.

(2) In order that the technical quotation may be evaluated strictly on the merit of the material submitted, no price information shall be included.

(3) The quotation shall not merely offer to perform work in accordance with the statement of work but shall outline the actual work proposed as specifically as practical. The Statement of Work reflects the problems and objective of the program under consideration; therefore, repeating the Scope of Work without sufficient elaboration will not be acceptable.

PAGE 15 OF 70 1333ND21QNB640184

(4) The quotation must be typed, on 8-1/2" by 11" paper, not exceeding 15 pages, single sided, single spaced, exclusive of experience and past performance references.

(B) Specific areas to be addressed:

i. For the purpose of evaluation of Technical Capability, the quotation must include:

-A summary, in the quoter’s own words, of the production process required by Attachments

I through III;

-A list of steps that the quoter will take to produce the SRM;

-Documentation of how the quoter will maintain compliance with the Common Rule for the

Protection of Human Subjects (15 C.F.R. Part 27) relevant to acquiring the serum required for the SRM and the quoter’s proposed approach; and

-A discussion of perceived risks associated with the required work and how the quoter will mitigate these risks.

If the quoter is utilizing a subcontractor for any work, the same information must be provided for the subcontractor relevant to the work the subcontractor will perform.

ii. For the purpose of evaluation of Experience, the quotation must include:

Project descriptions, products with specifications, publications, research papers, or other documentation which clearly demonstrate the quoter’s experience with any or all of the following:

*Serum production

*Electrolyte content and pH adjustment of the serum pool;

*Measurement of electrolyte content in serum;

*Carbon dioxide layering on serum pool to maintain pH; and/or

*Layering carbon dioxide on the final product sealed in ampoules.

iii. For the purpose of evaluation of Past Performance, the quotation must include:

Past Performance information regarding relevant contracts over the past three (3) years with Federal, state, or local governments, or commercial customers.

If the quoter intends to subcontract with another firm(s) for any part of this requirement, that firm’s past performance information shall also be provided. If the quoter has no relevant past performance, it shall include a statement to that effect in its quotation.

The Government reserves the right to consider data obtained from sources other than those described by the quoter its quotation.

The description of each contract described in this section shall not exceed one-half page in length.

For each contract, the quoter shall provide the following information:

-Contract number;

-Description and relevance to solicitation requirements include dollar value;

-Period of Performance – indicate by month and year the state and completion (or

“ongoing”) dates for the contract;

-Reference Contact – If a non-Government contract, identify the name and address of the client with current telephone number and email address of a point of contact of the client responsible for the contract;

-Contracting Office – If a Government contract (Federal or state), identify the Procuring

Contracting Officer (PCO), Administrative Contracting Officer (ACO), and Contracting

Officer’s Representative (COR), and their names, current telephone numbers and email addresses;

-Problems Encountered – include information regarding information regarding any problems encountered on the contracts described above and corrective actions taken to resolve those problems.

PAGE 16 OF 70 1333ND21QNB640184

iv. Quoters must provide a statement that they concur with all terms and conditions of the solicitation without change, addition, deletion or exception. Any exceptions must be clearly documented.

PRICE QUOTATION

-The quoter shall provide a firm fixed price for all line items. The price must be inclusive of all costs to complete all work required by the statement of work for each line item.

-The quoter must have the financial capacity, working capital and other resources to perform work under the resultant contract.

-The Government anticipates that the contract will be awarded based upon adequate price competition. However, in order to determine that prices are fair and reasonable, the

Government reserves the right to request the quoter provide further cost breakdown to support proposed prices.

-The Service Contract Labor Standards (formerly Service Contract Act) does not cover bona fide executive, administrative, or professional employees. If Contractor employees performing under this requirement fall within this exemption, offerors must state the applicable exemption. Reference Fact Sheet 17a at http://www.dol.gov/whd/regs/compliance/fairpay/fs17a.

52.213-4 TERMS AND CONDITIONS--SIMPLIFIED ACQUISITIONS (OTHER THAN COMMERCIAL ITEMS) (FEB 2021)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses that are incorporated by reference:

(1) The clauses listed below implement provisions of law or Executive order:

(i) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(ii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L. 115-91).

(iii) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(iv) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).

(v) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(vi) 52.222-26, Equal Opportunity (SEP 2016) (E.O. 11246).

(vii) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008)(E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(viii) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(ix) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Pub. L. 108-77, 108-78 (19 U.S.C. 3805 note)).

(2) Listed below are additional clauses that apply:

(i) 52.232-1, Payments (APR 1984).

(ii) 52.232-8, Discounts for Prompt Payment (FEB 2002).

(iii) 52.232-11, Extras (APR 1984).

(iv) 52.232-25, Prompt Payment (JAN 2017).

(v) 52.232-39, Unenforceability of Unauthorized Obligations (JUN 2013).

(vi) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (DEC 2013).

(vii) 52.233-1, Disputes (MAY 2014).

(viii) 52.244-6, Subcontracts for Commercial Items (NOV 2020).

(ix) 52.253-1, Computer Generated Forms (JAN 1991).

(b) The Contractor shall comply with the following FAR clauses, incorporated by reference, unless the circumstances do not apply:

(1) The clauses listed below implement provisions of law or Executive order:

(i) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note) (Applies to contracts valued at or above the threshold specified in FAR 4.1403(a) on the date of award of this contract).

(ii) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (JAN 2020) (E.O. 13126) (Applies to contracts for supplies exceeding the micro-purchase threshold, as defined in FAR 2.101 on the date of award of this contract).

(iii) 52.222-20, Contracts for Materials, Supplies, Articles, and Equipment (JUN 2020) (41 U.S.C. chapter 65) (Applies to supply contracts over the threshold specified in FAR 22.602 on the date of award of this contract, in the United States, Puerto Rico, or the U.S. Virgin Islands).

(iv) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212) (Applies to contracts valued at or above the threshold specified in FAR 22.1303(a) on the date of award of this contract).

(v) 52.222-36, Equal Employment for Workers with Disabilities (JUN 2020) (29 U.S.C. 793) (Applies to contracts over the threshold specified in FAR 22.1408(a) on the date of award of this contract, unless the work is to be performed outside the United States by employees recruited outside the United States). (For purposes of this clause, "United States" includes the 50 States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S.

Virgin Islands, and Wake Island.)

(vi) 52.222-37, Employment Reports on Veterans (JUN 2020)(38 U.S.C. 4212) (Applies to contracts valued at or above the threshold specified in FAR 22.1303(a) on the date of award of this contract).

(vii) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67) (Applies to service contracts over $2,500 that are subject to the Service Contract Labor Standards statute and will be performed in the United States, District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, Johnston Island, Wake Island, or the outer Continental Shelf).

(viii)(A) 52.222-50, Combating Trafficking in Persons (OCT 2020) (22 U.S.C. chapter 78 and E.O.

13627) (Applies to all solicitations and contracts).

(B) Alternate I (MAR 2015) (Applies if the Contracting Officer has filled in the following information with regard to applicable directives or notices: Document title(s), source for obtaining document(s), and contract performance location outside the United States to which the document applies).

(ix) 52.222-55, Minimum Wages Under Executive Order 13658 (NOV 2020)(Applies when 52.222-6 or 52.222-41 are in the contract and performance in whole or in part is in the United States (the 50 States and the District of Columbia)).

PAGE 17 OF 70 1333ND21QNB640184

(x) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706) (Applies when 52.222-6 or 52.222-41 are in the contract and performance in whole or in part is in the United States (the 50 States and the District of Columbia.))

(xi) 52.223-5, Pollution Prevention and Right-to-Know Information (MAY 2011) (E.O. 13423) (Applies to services performed on Federal facilities).

(xii) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN, 2016)(E.O. 13693)(applies to contracts for products as prescribed at FAR 23.804(a)(1)).

(xiii) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN, 2016) (E.O. 13693) (Applies to maintenance, service, repair, or disposal of refrigeration equipment and air conditioners).

(xiv) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b) (Unless exempt pursuant to 23.204, applies to contracts when energy-consuming products listed in the ENERGY STAR(R)Program or Federal Energy Management Program (FEMP) will be--

(A) Delivered;

(B) Acquired by the Contractor for use in performing services at a Federally-controlled facility;

(C) Furnished by the Contractor for use by the Government; or

(D) Specified in the design of a building or work, or incorporated during its construction, renovation, or maintenance).

(xv) 52.223-20, Aerosols (JUN, 2016) (E.O. 13693) (Applies to contracts for products that may contain high global warming potential hydrofluorocarbons as a propellant or as a solvent; or contracts for maintenance or repair of electronic or mechanical devices).

(xvi) 52.223-21, Foams (JUN, 2016) (E.O. 13693) (Applies to contracts for products that may contain high global warming potential hydrofluorocarbons or refrigerant blends containing hydrofluorocarbons as a foam blowing agent; or contracts for construction of buildings or facilities).

(xvii) 52.225-1, Buy American--Supplies (JAN 2021) (41 U.S.C. chapter 67) (Applies to contracts for supplies, and to contracts for services involving the furnishing of supplies, for use in the United States or its outlying areas, if the value of the supply contract or supply portion of a service contract exceeds the micro-purchase threshold, as defined in FAR 2.101 on the date of award of this contract, and the acquisition--

(A) Is set aside for small business concerns; or

(B) Cannot be set aside for small business concerns (see 19.502-2), and does not exceed $25,000).

(xviii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792) (Applies to contracts greater than the threshold specified in FAR 26.404 on the date of award of this contract, that provide for the provision, the service, or the sale of food in the United States).

(xix) 52.232-33, Payment by Electronic Funds Transfer--System for Award Management (OCT 2018) (Applies when the payment will be made by electronic funds transfer (EFT) and the payment office uses the System for Award Management (SAM) as its source of EFT information).

(xx) 52.232-34, Payment by Electronic Funds Transfer--Other than System for Award Management (JUL 2013) (Applies when the payment will be made by EFT and the payment office does not use the SAM database as its source of EFT information.)

(xxi) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C. App. 1241) (Applies to supplies transported by ocean vessels (except for the types of subcontracts listed at 47.504(d).)

(2) Listed below are additional clauses that may apply:

(i) 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (JUN 2016) (Applies to contracts when the contractor or a subcontractor at any tier may have Federal contract information residing in or transiting through its information system.

(ii) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (JUN 2020) (Applies to contracts over the threshold specified in FAR 9.405-2(b) on the date of award of this contract).

(iii) 52.211-17, Delivery of Excess Quantities (SEP 1989) (Applies to fixed-price supplies).

(iv) 52.247-29, F.o.b. Origin (FEB 2006) (Applies to supplies if delivery is f.o.b. origin).

(v) 52.247-34, F.o.b. Destination (NOV 1991) (Applies to supplies if delivery is f.o.b.

destination).

(c) FAR 52.252-2, Clauses Incorporated by Reference (FEB 1998). This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): WWW.ACQUISITION.GOV

(d) Inspection/Acceptance. The Contractor shall tender for acceptance only those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. The Government must exercise its postacceptance rights-

PAGE 18 OF 70 1333ND21QNB640184

(1) Within a reasonable period of time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(e) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without…