Combined_FBO_post.pdf

CLASSIFICATION CODE: 65 Medical, Dental and Veterinary Equipment and Supplies.

TITLE: Combined Synopsis – SRM 956d Blood Serum

SOLICITATION NUMBER: SB1341-13-RQ-0032

RESPONSE DATE: December 20, 2012

CONTACT POINTS: Michael Szwed, Contract Specialist, (301) 975-6330 Cheryl Rice, Contracting Officer, (301) 975-3696

DESCRIPTION:

The National Institute of Standards and Technology (NIST) has a requirement for Standard Reference Material 956d: Specifications for Serum from Whole Human Blood Frozen for Storage at –70oC.

The Government intends to award a firm-fixed price purchase order as a result of this solicitation.

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL

ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-

STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION

FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION

INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY

SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A SEPARATE

WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THE SOLICITATION IS

BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES UNDER THE

AUTHORITY OF FAR 13.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-61

1352.215-72 INQUIRIES (APR 2010)

Offerors must submit all questions concerning this solicitation in writing to michael.szwed@nist.gov. Questions should be received no later than 10 calendar days after the issuance date of this solicitation. Any responses to questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation.

The associated North American Industrial Classification System (NAICS) code for this procurement is 325413 with a size standard of 500 employees.

This acquisition is set aside 100% for small business.

All offerors shall provide a quotation for the following line items:

CLIN 0001: Candidate SRM 956d Level 1 (6,000 ampoules per concentration level), Price per ampoule and total price of CLIN.

CLIN 0002: Candidate SRM 956d Level 2 (6,000 ampoules per concentration level), Price per ampoule and total price of CLIN.

CLIN 0003: Candidate SRM 956d Level 3 (6,000 ampoules per concentration level), Price per ampoule and total price of CLIN.

STATEMENT OF WORK

TITLE: Standard Reference Material 956d: Specifications for Serum from Whole Human Blood Frozen for Storage at –70oC LAB REQUESTING SERVICE: Material Measurement Laboratory, Chemical Sciences Division

I. BACKGROUND INFORMATION

The Inorganic Chemical Metrology Group 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 spectrometries as well as nuclear analytical techniques, classical analytical methods, pH, and electroanalytical methods. Standard Reference Materials (SRMs) and analytical methods development support a variety of industries including advanced materials, cements, ores, and fossil fuels, as well as clinical, food, and environmental analyses. The group develops and maintains primary national standards for elemental and anionic concentrations, pH, electrolytic conductivity, and isotopic abundance.

For the past 25 years NIST has developed a number of biological fluid and tissue Standard Reference Materials (SRMs) primarily for clinically important analytes (e.g., cholesterol, glucose, creatinine, and trace elements). The Centers for Disease Control and Prevention (CDC) and the New York (NY) State Department of Health along with other state agencies are conducting studies such as the National Health and Nutrition Examination Survey (NHANES) that require the analysis of a large number of samples obtained from study subjects for clinically important analytes and for contaminants.

NIST and CDC are collaborating on the development of a wide variety of SRMs that will be useful to the biomonitoring community. These include organic contaminants in human serum, human milk, and human urine, lead in caprine blood (with input from the NY State Department of Health), elements in bovine liver and animal serum, arsenic species in human urine, and toxic elements in human urine. Methods have been developed at NIST and at CDC for these measurements, and the results from the independent methods are being combined to provide certified concentration values for contaminants in the different materials.

II. SCOPE OF WORK

The Contractor shall furnish the necessary personnel, material, equipment, and facilities (except as otherwise specified), to comply with the requirements and procedures set forth in Attachment (A). The Contractor shall provide:

1. 6,000 ampoules of Standard Reference Material (SRM) 956d, Electrolytes in serum from whole human blood at concentration Level 1.

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

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

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 Primary Container Specification Section for Ampoule 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 NCCLS 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 (A), NCCLS 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 NCCLS 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 – 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 this document) and frozen according to the specifications given in Appendix A2.5 of NCCLS Document C29-A2. A copy of Appendix F. SRM 956a Process Flow Chart from NCCLS Document C39-A is attached.

2.1 Additional pool preparation precautions to observe concerning NCCLS 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.

Table 1. Target Electrolyte Concentrations (mmol/L)

Na K Tot Ca Tot Mg Li Phosphate Level 1 120 ± 3 6.0 ± 0.2 3.0 ± 0.2 1.5 ± 0.1 2.0 ± 0.1 2.0 ± 0.1 Level 2 140 ± 3 4.0 ± 0.2 2.5 ± 0.2 1.0 ± 0.1 1.25 ± 0.1 1.5 ± 0.1 Level 3 160 ± 3 2.0 ± 0.2 2.0 ± 0.2 0.5 ± 0.1 0.5 ± 0.1 1.0 ± 0.1

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 which 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 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, and lithium 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 NCCLS Document C29-A2 for more information on pool formation.

The Contractor shall provide NIST with a report of analysis (ROA) indicating the electrolyte concentrations by standard clinical methods. A minimum of five samples shall be measured for each analyte at each level. In addition, a minimum of five samples of serum in 5 mL ampoules or 2 mL to 5 mL cryovials from each level shall be shipped overnight on dry ice to NIST for inspection and analysis. Each sample must contain at least 2 g of serum.

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

Na K Tot Ca Tot Mg Li Phosphate 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 (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 (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 (175)

*For report of analysis, a minimum of five (5) replicate analytical measurements is required for each analyte and level (i.e., 7 analytes x 3 levels x 5 replicates = 105 analytical measurements).

For certificate of analysis, duplicate analytical measurements on a minimum of five ampoules at each level for each analyte (i.e., 7 analytes x 3 levels x 5 ampoules x 2 aliquots/ampoule = 210 analytical measurements).

6. PRIMARY CONTAINER SPECIFICATIONS

Ampoule Specification: Wheaton Science Products number 176779 or better regarding low temperature storage. The ampoules are made of Wheaton 33 low extractable borosilicate glass that conforms to USP Type I and ASTM 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://www.wheatonsci.com/b2cwhn/b2c/display/(xcm=B2C_NA_LAB&cpgsize=10&layout=5.

1- 6_1_56_59_5_8_2&uiarea=2&carea=DDC14773B75E41F1AB7A001EC9FCDFBA&cpgnum= 1&citem=DDC14773B75E41F1AB7A001EC9FCDFBA4609F21772CC70F3E10000000AC028 22)/.do?rf=y

The Contractor 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 contractor 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 956d. The order of the sampling should be evenly distributed throughout the production. (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 50 % of 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, and ionic S by standard clinical methods (i.e., the total number of values reported = 2 aliquots x 5 vials x 3 levels x 7 analytes = 210). The results shall be provided to NIST in the Certificate of Analysis before shipment of the entire production lot as specified elsewhere. 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 956d 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.

http://www.wheatonsci.com/b2cwhn/b2c/display/(xcm=B2C_NA_LAB&cpgsize=10&layout=5.1-6_1_56_59_5_8_2&uiarea=2&carea=DDC14773B75E41F1AB7A001EC9FCDFBA&cpgnum=1&citem=DDC14773B75E41F1AB7A001EC9FCDFBA4609F21772CC70F3E10000000AC02822)/.do?rf=y http://www.wheatonsci.com/b2cwhn/b2c/display/(xcm=B2C_NA_LAB&cpgsize=10&layout=5.1-6_1_56_59_5_8_2&uiarea=2&carea=DDC14773B75E41F1AB7A001EC9FCDFBA&cpgnum=1&citem=DDC14773B75E41F1AB7A001EC9FCDFBA4609F21772CC70F3E10000000AC02822)/.do?rf=y http://www.wheatonsci.com/b2cwhn/b2c/display/(xcm=B2C_NA_LAB&cpgsize=10&layout=5.1-6_1_56_59_5_8_2&uiarea=2&carea=DDC14773B75E41F1AB7A001EC9FCDFBA&cpgnum=1&citem=DDC14773B75E41F1AB7A001EC9FCDFBA4609F21772CC70F3E10000000AC02822)/.do?rf=y http://www.wheatonsci.com/b2cwhn/b2c/display/(xcm=B2C_NA_LAB&cpgsize=10&layout=5.1-6_1_56_59_5_8_2&uiarea=2&carea=DDC14773B75E41F1AB7A001EC9FCDFBA&cpgnum=1&citem=DDC14773B75E41F1AB7A001EC9FCDFBA4609F21772CC70F3E10000000AC02822)/.do?rf=y http://www.wheatonsci.com/b2cwhn/b2c/display/(xcm=B2C_NA_LAB&cpgsize=10&layout=5.1-6_1_56_59_5_8_2&uiarea=2&carea=DDC14773B75E41F1AB7A001EC9FCDFBA&cpgnum=1&citem=DDC14773B75E41F1AB7A001EC9FCDFBA4609F21772CC70F3E10000000AC02822)/.do?rf=y

(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) The Contractor shall provide a Report of Analysis for electrolyte concentration in samples of the PILOT/VALIDATION RUN.

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

(c) The 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 956d. 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. The contractor shall include the names of those individuals in the laboratory developing the ampoules.

(d) The 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 contractor without identifying information, the use of human subjects may be exempt from the requirement of review by an Institutional Review Board (IRB). The 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 Quote. 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.

III. PERIOD OF PERFORMANCE

The delivery date shall be 120 days after award of this purchase order with a period of performance of 150 days from purchase order award.

IV. PLACE OF PERFORMANCE

Performance will be at the Contractor’s facility.

V. NIST FURNISHED PROPERTY

NIST shall provide 6,000 labels each for Level 1, Level 2, and Level 3 ampoulized SRM 956d.

VI. DELIVERABLES

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 section II 9 (d).

One/E-mail to the NIST COR

30 days after PO award

Contractor

Report of Analysis (ROA) from pilot/validation run One/E-mail to the NIST COR

45 days after PO award

Contractor

Complete review of ROA data package from pilot/validation run and authorize the production of 6,000 ampoules each of Level 1, Level 2, and Level 3 of SRM 956d, or re-perform the pilot run if the specification shown in section II 5 is not met.

One/E-mail from NIST COR to the contractor

50 days after PO award

NIST COR

Provide labeling to Contractor 6,000 each of Level 1, Level 2, and Level 3 labels to contractor point of contact.

10 days after approval of the ROA

NIST COR

Certificate of analysis (COA) for levels 1, 2 and 3 of SRM 956d. Include in or with the COA copies of CERTIFICATES OF TEST OF HUMAN SERUM and ANALYTES USED IN SPIKING as described in sections II 3 and II 4.

One/E-mail with attachments sent to the COR

105 days after PO award

Contractor

Package in dry ice and ship overnight ampoules of SRM 956d (Final Deliverable), CLINs 0001-0003.

6,000 ampoules each of Level 1, Level 2, and Level 3 SRM 956d to NIST technical contact identified in

SOW

120 days after PO award

Contractor

Note: 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 section II 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 in order that detailed questions can be directed to the contractor point of contact.

VII. ATTACHMENTS

Attachment (A): NCCLS Document C29-A2

Attachment (B): Appendix F. SRM 956a Process Flow Chart from NCCLS Document C39-A

VIII. PERFORMANCE REQUIREMENT SUMMARY

Required Service and Final Deliverable

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

Performance Standard

1. Materials will be prepared and packaged as described in the Statement of Work (SOW) and meet all specifications set forth in the SOW.

2. Certificate of Analysis indicating the electrolyte concentrations by standard clinical methods as described in Attachment (A). The certificate of analysis shall include the logo for ISO 13485:2003, “Medical devices -- Quality Management Systems -- Requirements for Regulatory Purposes” if applicable. Refer to Section XI of this SOW.

3. 6,000 ampoules of SRM 956d, Electrolytes in serum from whole human blood at concentration Level 1. Shipped frozen as individual units for receipt within 24 hours of processing.

4. 6,000 ampoules of SRM 956d, Electrolytes in serum from whole human blood at concentration Level 2. Shipped frozen as individual units for receipt within 24 hours of processing.

5. 6,000 ampoules of SRM 956d, Electrolytes in serum from whole human blood at concentration Level 3. Shipped frozen as individual units for receipt within 24 hours of processing.

6. See Attachment (A) and Attachment (B) for other performance standards.

Acceptable Quality Level

The ampoules of Level 1, Level 2, and Level 3 SRM 956d with the associated physical and chemical properties specified in section II 1 and II 2, referred to in the following as the material, shall be suitable for use as a certified reference material (CRM). If deficiencies or inconsistencies between the material and the documentation (defined in section II 9) 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.

Monitoring Method

The NIST COR will verify the SRMs were successfully prepared and acceptable when they are analyzed as part of NIST SRM certification process. This will be completed no later than 30 days after receipt and acceptance of the ampoules.

IX. TRAVEL: None

X. DELIVERY

Delivery shall be FOB DESTINATION.

Delivery Address:

National Institute of Standards and Technology Attention: Mark Cronise Building 301

100 Bureau Drive Gaithersburg, MD 20899

At the time of shipment, the contractor shall notify the COR by email, providing the date the deliverables are shipped, shipping method, tacking number, method of delivery and the anticipated delivery date it will arrive at NIST.

XI. MINIMUM CONTRACTOR QUALIFICATIONS

The Contractor must provide documentation that he is currently certified for ISO 13485:2003, “Medical devices -- Quality Management Systems -- Requirements for Regulatory Purposes” and has experience analyzing Sodium, Potassium, Total Calcium, Total Magnesium, Lithium, and Ionic Sulfur in blood 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, the Contractor may provide not less than three (3) each of the following records for each of the analytes (i.e., Sodium, Potassium, Total Calcium, Total Magnesium, Lithium, and Ionic Sulfur) in blood serum for a total of 90 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.

SITE VISIT TO CONTRACTORS SITE

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

10. 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 as described in SOW section VI. 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.

11. PACKING/SHIPPING SPECIFICATIONS

The ampoules shall be packaged in trays or containers in an upright fashion. The packaging shall be of a nature to prevent breakage and keep the three levels separate and identifiable. The material will 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.

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

13. PAYMENT:

One payment will be made for the final deliverables in CLINs 0001-0003 which is the total value of the contract. NIST will test and accept the final deliverables no later than 30 days from receipt of the total quantity of 18,000 ampoules of Blood Serum. The contractor will invoice for the total price of the contract upon written acceptance from the COR.

(End of Statement of Work)

INSTRUCTIONS:

Addendum to FAR 52.212-1, Quotation Preparation Instructions

Central Contractor Registration

In accordance with FAR 52.212-4 (t) the awardee must be registered in the Central Contractor Registration (www.sam.gov) prior to award. Refusal to register shall forfeit award.

All Offeror's quotations shall cite the RFQ Order Number and project title. The quotation shall also list the Offeror's point of contact for this project including name, title, address, phone number, and email address on the title page.

All Offerors must submit with their quotes a completed Offeror Representations and Certifications - Commercial Items (FAR 52.212-3) form. If the Offeror's Representations and Certifications are registered on the SAM website, it must be indicated in the quote.

All quotes must be signed.

Due Date for Quotation

Venders shall submit their quotations electronically via Federal Business Opportunities thru the FBO Bid Module for this requirement not later than 11:59 a.m. Eastern Time on Thursday, December 20, 2012. FAX quotations shall not be accepted. E-mail quotations http://www.sam.gov/ shall not be accepted. Quotations shall not be deemed received by the Government until the quotation is entered into the FBO Bid Module set forth above.

1) Price Quotation: The contractor shall propose a firm-fixed-price, FOB Destination, for CLIN. 0001 - 0003. Price quotations shall remain valid for a period of 60 days from the date quotations are due.

2) Technical Quotation: The contractor shall submit technical information with pricing information. The technical quotation shall address the following:

(a) Minimum qualifications stated in section XI of the statement of work.

(b) Information requested in section II 9(d)(i) and (ii)

QUOTATION EVALUATION:

Evaluation Factors

Award shall be made to the contractor whose product meets or exceeds the technical specifications and is the lowest price.

Award will be made, if at all, to the responsible contractor whose offer conforming to the requirements of the solicitation and meets the minimum qualification requirements.

Minimum requirement: Evaluation of minimum requirement shall be based on the information provided in the quotation. NIST will evaluate whether the contractor has demonstrated that its proposed quotation meets or exceeds all minimum requirements. Quotations that do not demonstrate they meet the Scope of Work on all requirements will not be considered further for award. If a contractor does not indicate whether its quotation meets a certain minimum requirement, NIST will determine that it does not.

Price: The Government will evaluate price for reasonableness.

Acceptance of Terms and Conditions: This is an open-market solicitation for the service and supply of Human Serum as defined herein. The Government intends to award a Purchase Order as a result of this solicitation that will include the clauses set forth herein.

“The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition.”

The contractor must state any exceptions to the terms of this purchase order clearly stated on the quotation.

Note: This procurement is not being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If a contractor submits a quotation based upon an FSS or GWAC contract, the Government will accept the quoted price.

However, the terms and conditions stated herein will be included in any resultant Purchase Order, not the terms and conditions of the contractor’s FSS or GWAC contract, and the statement required above shall be included in the quotation.

PROVISIONS AND CLAUSES:

The following provisions and clauses apply to this acquisition and are hereby incorporated by reference. All FAR clauses may be viewed at http://acquisition.gov/comp/far/index.html.

FAR Provisions that apply to this solicitation

52.212-1, Instructions to Offerors-Commercial Items 52.212-3 Offeror Representations and Certifications-Commercial Items

Offerors shall complete annual representations and certifications on-line at http://SAM.gov in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items.

If paragraph (j) of the provision is applicable, a written submission is required.

FAR Clauses by Reference that apply to this solicitation

52.212-4 Contract Terms and Conditions—Commercial Items 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders— Commercial Items (APR 2010)

52.203-6, Restrictions on Subcontractor Sales to the Government 52.204-10 – Reporting Executive Compensation and First-Tier Subcontract Awards.

2.223-18, Contractor Policy to Ban Text Messaging while Driving- 52.219-6 Notice of Total Small Business Set-Aside 52.219-8, Utilization of Small Business Concerns 52.222-3, Convict Labor;

52.222-19 Child Labor – Cooperation with Authorities and Remedies;

52.222-21, Prohibition of Segregated Facilities;

52-222-26, Equal Opportunity;

52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans 52.222-36, Affirmative Action for Workers with Disabilities;

52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans http://acquisition.gov/comp/far/index.html

52.223-18, Contractor Policy to Ban Text Messaging while Driving 52.225-1, Buy American Act-Supplies 52.225-13 Restriction on Certain Foreign Purchases;

52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration.

52.232-99, Providing Accelerated Payment to Small Business Subcontractors

(DEVIATION)

52.247-34 F.O.B. Destination

FAR Clauses - Full text

52.252-1 Solicitation Provisions Incorporated by Reference.

SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137568]

(End of provision)

52.252-2 Clauses Incorporated by Reference.

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):

https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137568

52.232-99, Providing Accelerated Payment to Small Business Subcontractors

(DEVIATION)

PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS

(DEVIATION)(AUG 2012)

This clause implements the temporary policy provided by OMB Policy Memorandum M-12-16, Providing Prompt Payment to Small Business Subcontractors, dated July 11, 2012.

(a) Upon receipt of accelerated payments from the Government, the contractor is required to make accelerated payments to small business subcontractors to the maximum extent practicable after receipt of a proper invoice and all proper documentation from the small business subcontractor.

(b) Include the substance of this clause, including paragraph (b), in all subcontracts with small business concerns.

(c) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

Commerce Acquisition Regulation (CAR) Provisions and Clauses – Full Text

The following provisions and clauses apply to this solicitation:

1352.235-70 Protection of human subjects.

Protection of Human Subjects (APR 2010)

(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 the 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.

(End of provision)

Representation by Corporations Regarding an Unpaid Delinquent Tax Liability or a Felony Conviction Under Any Federal Law (Class Deviation) (March 2012)

1) In accordance with Sections 543 and 544 of Public Law 112-55 Commerce, Justice, Science, and Related Agencies Appropriations Act 2012, Title V (General Provisions) none of the funds made available by that Act may be used to enter into a contract with any corporation that-

a) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, unless the agency has considered suspension or debarment of the corporation and made a determination that this further action is not necessary to protect the interests of the Government.

b) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, unless the agency has considered suspension or debarment of the corporation and made a determination that this further action is not necessary to protect the interests of the Government.

2) The Offeror represents that, as of the date of this offer-

a) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

b) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreements with the authority responsible for collecting the tax liability.

(End of provision)

1352.201-70 Contracting Officer's Authority.

CONTRACTING OFFICER'S AUTHORITY.

The Contracting Officer is the only person authorized to make or approve any changes in any of the requirements of this contract, and, notwithstanding any provisions contained elsewhere in this contract, the said authority remains solely in the Contracting Officer. In the event the contractor makes any changes at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract terms and conditions, including price.

(End of clause)

[75 FR 10570, Mar. 8, 2010; 75 FR 14496, Mar. 26, 2010]

1352.201-72 Contracting Officer's Representative (COR).

CONTRACTING OFFICER'S REPRESENTATIVE (COR) (APR 2010)

(a) (TBD ) is hereby designated as the Contracting Officer's Representative (COR). The COR may be changed at any time by the Government without prior notice to the contractor by a unilateral modification to the contract. The COR is located at:

Phone Number:

E-mail:

(b) The responsibilities and limitations of the COR are as follows:

(1) The COR is responsible for the technical aspects of the contract and serves as technical liaison with the contractor. The COR is also responsible for the final inspection and acceptance of all deliverables and such other responsibilities as may be specified in the contract.

(2) The COR is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the contract price, terms or conditions. Any contractor request for changes shall be referred to the Contracting Officer directly or through the COR. No such changes shall be made without the express written prior authorization of the

Contracting Officer. The Contracting Officer may designate assistant or alternate COR(s) to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the contractor.

(End of clause)

[75 FR 10570, Mar. 8, 2010; 75 FR 14496, Mar. 26, 2010]

1352.208-70 Restrictions on printing and duplicating.

RESTRICTIONS ON PRINTING AND DUPLICATING (APR 2010)

(a) The contractor is authorized to duplicate or copy production units provided the requirement does not exceed 5,000 production units of any one page or 25,000 production units in the aggregate of multiple pages. Such pages may not exceed a maximum image size of 103⁄4 by 141⁄4 inches. A “production unit” is one sheet, size 81⁄2 x 11 inches (215 x 280 mm), one side only, and one color ink. Production unit requirements are outlined in the Government Printing and Binding Regulations.

(b) This clause does not preclude writing, editing, preparation of manuscript copy, or preparation of related illustrative material as a part of this contract, or administrative duplicating/copying (for example, necessary forms and instructional materials used by the contractor to respond to the terms of the contract).

(c) Costs associated with printing, duplicating, or copying in excess of the limits in paragraph (a) of this clause are unallowable without prior written approval of the Contracting Officer. If the contractor has reason to believe that any activity required in fulfillment of the contract will necessitate any printing or substantial duplicating or copying, it shall immediately provide written notice to the Contracting Officer and request approval prior to proceeding with the activity. Requests will be processed by the Contracting Officer in accordance with FAR 8.802.

(d) The contractor shall include in each subcontract which may involve a requirement for any printing, duplicating, and copying in excess of the limits specified in paragraph (a) of this clause, a provision substantially the same as this clause, including this paragraph (d).

(End of clause)

[75 FR 10570, Mar. 8, 2010; 75 FR 14496, Mar. 26, 2010]

1352.209-73 Compliance with the laws.

COMPLIANCE WITH THE LAWS (APR 2010)

The contractor shall comply with all applicable laws, rules and regulations which deal with or relate to performance in accord with the terms of the contract.

(End of clause)

[75 FR 10570, Mar. 8, 2010; 75 FR 14496, Mar. 26, 2010]

1352.209-74 Organizational conflict of interest.

ORGANIZATIONAL CONFLICT OF INTEREST (APR 2010)

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. The restrictions described herein shall apply to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest

(hereinafter collectively referred to as “contractor”) in the activities covered by this clause as a prime contractor, subcontractor, co-sponsor, joint venturer, consultant, or in any similar capacity.

For the purpose of this clause, affiliation occurs when a business concern is controlled by or has the power to control another or when a third party has the power to control both.

(c) Warrant and Disclosure. The warrant and disclosure requirements of this paragraph apply with full force to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement at any tier expected to exceed the simplified acquisition threshold. The terms “contract,” “contractor,” and “Contracting Officer” shall be appropriately modified to preserve the Government's rights.

(f) Prime Contractor Responsibilities. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507-1, and shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk.

(g) Waiver. The parties recognize that this clause has potential effects which will survive the performance of this contract and that it is impossible to foresee each circumstance to which it might be applied in the future. Accordingly, the contractor may at any time seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

1352.233-70 AGENCY PROTESTS (APR 2010)

(a) An agency protest may be filed with either: (1) the contracting officer, or (2) at a level above the contracting officer, with the appropriate agency Protest Decision Authority. See 64 Fed. Reg. 16,651 (April 6, 1999)

(b) Agency protests filed with the Contracting Officer shall be sent to the following address: NIST/ACQUISITION MANAGEMENT DIVISION ATTN: Cheryl Rice, CONTRACTING OFFICER

100 Bureau Drive, MS 1640 Gaithersburg, MD 20899

(c) Agency protests filed with the agency Protest Decision Authority shall be sent to the following address: NIST/ACQUISITION MANAGEMENT DIVISION

ATTN: HEAD OF THE CONTRACTING OFFICE (HCO)

100 Bureau Drive, MS 1640

Gaithersburg, MD 20899

(d) A complete copy of all agency protests, including all attachments, shall be served upon the Contract Law Division of the Office of the General Counsel within one day of filing a protest with either the Contracting Officer or the Protest Decision Authority.

(e) Service upon the Contract Law Division shall be made as follows:

U.S. Department of Commerce Office of the General Counsel Chief, Contract Law Division Room 5893 Herbert C. Hoover Building 14th Street and Constitution Avenue, N.W.

Washington, D.C. 20230.

FAX: (202) 482-5858

1352.233-71 GAO and Court of Federal Claims protests.

(a) An agency protest may be filed with either: (1) the contracting officer, or (2) at a level above the contracting officer, with the appropriate agency Protest Decision Authority. See 64 Fed. Reg.

16,651 (April 6, 1999)

(b) Agency protests filed with the Contracting Officer shall be sent to the following address: NIST/ACQUISITION MANAGEMENT DIVISION ATTN: Cheryl Rice, CONTRACTING OFFICER

100 Bureau Drive, MS 1640 Gaithersburg, MD 20899

(c) Agency protests filed with the agency Protest Decision Authority shall be sent to the following address: NIST/ACQUISITION MANAGEMENT DIVISION

ATTN: HEAD OF THE CONTRACTING OFFICE (HCO)

100 Bureau Drive, MS 1640

Gaithersburg, MD 20899

(d) A complete copy of all agency protests, including all attachments, shall be…