Final_SOL__2013_RFP_Rodent_Testing.pdf

RFP

FOR

Laboratory Animal Diagnostic Testing Services

TABLE OF CONTENTS

SECTION A –Instructions to Offerors………………………………………………………………………………………

SECTION B – Supplies or Services and Prices/Costs………………………………………………………………..

SECTION C – Description/Specification………………………………………..……………………………………..

SECTION D – Packaging and Marking……………………………………………………………………………………

SECTION E – Inspection and Acceptance……………………………………………………………………………...

SECTION F – Deliveries of Performance……………………………………………………………………………..…

SECTION G – Contract Administration Data……………………………………………………………………..…..

SECTION H – Special Contract Requirements……………………………………………………………………..…

SECTION I – List of Attachments……………………………………………………………………………………………

SECTION J – Additional items …………………………………………………………………………………………

SECTION K – Representations, certifications, and other statements of offerors. ………………..

SECTION L– Instructions, conditions, and notices to offerors or respondents ………

SECTION M – Evaluation factors for award……………………………………………………………………………

NIH/National Institute of Environmental Health Sciences (NIEHS)

Solicitation No:NIEHS06172013 Date Issued:06/17/2013

Due Date: Tuesday July 16, 2013 by 3:00 pm EST

Issued by: Brian Souter, Contract Specialist

Email: brian.souter@nih.gov

Telephone: 919-541-0401

Overnight Delivery USPS Mail Delivery

NIH/NIEHS/Office of Acquisitions NIH/NIEHS

Attn: Brian Souter Attn: Brian Souter

Keystone Office Bldg., Rm. 1045 Office of Acquisitions

530 Davis Drive P.O. Box 12874, MD K1-04

Morrisville, NC 27560 Research Triangle Park, NC 27709

Please provide 3 paper copies along with a CD.

Goods/Services to be purchased: Laboratory Animal Diagnostic Testing Services

FAR 52.212-1, Instructions to Offerors -- Commercial Items (FEB, 2012), is incorporated by reference.

ADDENDUM TO 52.212-1

Place of Performance:

NIEHS, 111 TW Alexander Drive, Research Triangle Park, NC 27709

NOTICES:

1. This is a Combined Synopsis/Solicitation.

2. ISSUED as Full and Open The NAICS Code/Size Standard: 541380/ $12.0 Million

3. Any questions regarding this announcement must be submitted in writing no later than Wednesday July 1 , 2013 4 pm EST to Brian Souter via email at brian.souter@nih.gov

I. Combined Synopsis Solicitation.

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The Solicitation Number is NIEHS06172013. This solicitation document incorporates all mandatory commercial item provisions and clauses that are in effect through Federal Acquisition Circular (FAC) 2005-64 dated January 13, 2013.

Full and Open - NAICS Code/Size: 541380 $14Million

1. 52.216-1 TYPE OF CONTRACT (APR 1984)

The Government contemplates award of an Indefinite Delivery / Indefinite Quantity contract, with fixed unit prices resulting from this solicitation. (End of provision)

Section A- Instructions to Offerors:

For any questions regarding this announcement or requests for additional information must be submitted in writing to Brian Souter via email at brian.souter@nih.gov. Notification of any changes shall be made only via email. Quotations submitted in response to this solication shall include the solicitation number, DUNS and Tax ID/Employer Identification Numbers, payment terms, and be signed, dated and submitted to an address shown on page 1 of this Solicitation.

Vendors not registered in the System Award Management (SAM) database at the time the requirement is to be awarded will not be considered, for those previously entered into

Contractor central Registration CCR no change is needed. Vendors may register with SAM by calling 1-888-606-8220 or (334)206-7828, or by accessing www.sams.gov.

FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (DEC 2012) is included by reference (full text is available electronically at http://www.acquisition.gov/far. A completed copy of this provision must be included with response. Offeror shall complete only paragraph (j) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (b) through (i) of this provision.

Section B - Supplies or services and prices/costs. Include a brief description of the supplies or services; e.g., item number, national stock number/part number if applicable, nouns, nomenclature, and quantities. (This includes incidental deliverables such as manuals and reports.) SEE ATTACHMENT 01 – Supplies/Services/Price

B – 1. This is a Laboratory Test Service Contract for various tests as stated in the line items and in accordance with a commercial price list.

B – 2. The price list for each performance period will be provided as an attachment to the contract.

B – 3. The services which the Offeror shall provide specifically include those tasks described in the Statement of Work (SOW) and/or specified herein. However, the performance as described and specified shall not be deemed to constitute a detailed specification having the effect of excluding other needed work not specifically mentioned that will be necessary for the successful completion of this project as generally described. The Contractor is required to furnish all effort necessary to successfully fulfill the overall objective set out in the contract.

B – 4. Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and services (except as otherwise specified herein) and perform the work set forth below.

B – 5. This is a Commercial Contract with Firm Fixed Unit Prices, Estimated Quantities with Not to Exceed (NTE) Extended Amounts with Over & Above and Outbreak line items that will be determined as required and/or as needed.

B – 6. The Contractor shall bill for test services performed monthly.

B – 7. Option Prices.

(a) Unless the Government exercises its option(s) pursuant to the option clause(s) referenced in the contract, the contract consists only of the Base Year specified in the SOW, for the prices set in the contract.

http://www.acquisition.gov/far

(b) Upon delivery and acceptance of the Option Services described in the SOW and identified in the schedule of charges below, the Government shall pay the Contractor the unit price(s) set forth in the option year line items.

B – 8. Laboratory Animal Diagnostic Testing:

(a) Independently, and not as an agent of the Government, the Contractor shall perform all testing as listed in the attached TESTING SERVICES LIST and outlined in the Statement of Work (SOW) in accordance with standard laboratory practices, and state of the art microbiological procedures.

The contractor shall confirm each positive serological assay result via an alternate test [e.g., immunoflourescent antibody (IFA) or Western blot] prior to final reporting at no additional cost to the Government.

To be completed by the offeror.

II. Minimum/Maximum Quantities

For each effective year of the contract, the U.S. Government guarantees a minimum order of $ 1000 under this purchase order. The maximum amount $ 550, 000.

Orders may be issued written/electronic by the Contracting Officer Representative (COR).

Section C - Description/specifications/statement of work. Include any description or specifications needed in addition to Section B (see part 11, Describing Agency Needs).

Statement of Work

A. Background Information

The Comparative Medicine Branch (CMB) maintains the animal facility for the National Institute of Environmental Health Sciences (NIEHS) and is responsible for the health and well-being of the research animal population. The health and well-being of these animals are a critical factor in many research projects. Laboratory animals are susceptible to many different diseases, which may be symptomatic or subclinical but still have profound effects on research. Some of these diseases can be zoonotic (contagious to humans). Diagnosis of these animal diseases is very important in maintaining the quality of the NIEHS research animals as well as ensuring the safety of the researcher and animal care staff. The Quality Assurance Laboratory (QAL) within CMB is responsible for monitoring the health status of incoming and resident animal colonies and making appropriate decisions based on the results of this monitoring. The animals used as sentinels for colony health status are evaluated by the QAL staff. This evaluation may include, as appropriate, a complete necropsy, examination for ecto- and endoparasites, bacterial cultures, Polymerase Chain Reaction (PCR) and/or serological assays. QAL is responsible for reporting the health status of the animal or tissue specimens back to the appropriate veterinarian(s) and researchers. The primary scope of the contract will be to perform the serology and PCR testing necessary to complete the animal health monitoring process. Bacterial species identification by PCR and partial genomic sequencing of submitted samples may be requested. Other assays, such as Western Blot and/or Immunofluorescent Antibody (IFA) may be requested to confirm initial equivocal serological results.

The purpose of this acquisition is to obtain the services of a commercial laboratory to conduct the above mentioned assays on rodent sera, rodent tissues, rodent fecal specimens or cell cultures.

B. OBJECTIVES

1) The purpose of the proposed contract is to provide a readily available source for serological, PCR and sequencing diagnostic services as a part of the QAL overall diagnostic and health monitoring programs at NIEHS.

2) The specific objective is to have a Offeror receive the biological samples, perform requested testing on these samples and report all results to the Contracting Officer Representative (COR) via e-mail, telephone or other electronic source (e.g., online access). Results of requested services shall be reported as follows:

• Results of all serological tests shall be reported within three (3) working days from the date of receipt of the samples and a final written report within ten (10) working days.

• Results of PCR tests shall be reported to the COR within seven (7) working days after receipt of samples by the Contractor and a final written report within ten (10) working days.

• Results of bacterial species identification shall be reported within 15 working days after receipt of samples by the Contractor and a final written report within 20 working days.

Services to Be Performed

a. General Requirements

All work under this contract shall be monitored by the Contracting Officer Representative (COR) whose position is defined elsewhere in the contract.

b. Specific Requirements

Contractor shall perform serological and/or PCR testing for all of the agents listed in the TESTING SERVICES LIST and perform species identification of submitted bacterial in accordance with standard laboratory practices and state of the art microbiological procedures. The number of tests requested per sample will depend upon the nature of the individual sample.

1) Detailed Specification Requirements (for all testing):

(a) The Contractor shall provide submission forms and instructions for preparation of biological samples submitted for serological or PCR analysis and packaging of the same.

(b) The Government will prepare all samples as instructed and package in styrofoam container(s).

(c) The Government will deliver the styrofoam container(s) to an acceptable overnight delivery service.

(d) The styrofoam containers will be delivered to the Contractor by express overnight delivery service at the Contractor’s own expense. Routine samples will be shipped by the Government by 4:00 p.m. with an anticipated arrival time of 10:00 a.m. the following morning. All samples should be delivered to the Contractor's testing laboratory within twenty (20) hours following pickup.

(e) If the samples are not received within the designated time-frame the Contractor will immediately contact the COR by email or phone for further instructions.

(f) Upon receipt, the Contractor will log all sample information into a computerized database at the Contractor’s laboratory.

(g) Results of testing shall be recorded in a database and reports generating these results shall be published.

(h) The Contractor shall provide these data in electronic form to be delivered by email or available on an internet website within the time frame specified in the contract three (3) working days from receipt for serological testing, five (5) working days from receipt for PCR testing, and 15 working days from receipt for sequencing analysis).

(i) The COR shall be notified by email or phone of all results as soon as they are available. The Contractor will quickly and clearly alert the COR of any positive results obtained in serological or diagnostic PCR assays including specific sample numbers.

(j) The COR may also request that the questionable sample(s) be sent at the Contractor’s expense to another laboratory specified by the Government for confirmatory testing.

(k) Final reporting of data shall be returned to the COR within ten (10) working days from receipt or samples for serological and PCR testing and 20 working days from receipt of samples for sequencing analysis. The timeframe for these reporting requirements will include and confirmatory testing performed by the Contractor.

Extensions to these reporting requirements may only be granted by written consent (email acceptable) of the COR.

2) Special Requirements for all testing (as applicable):

(a) The Contractor’s lab shall be fully equipped to provide state-of-the-art serological testing, PCR assays and sequencing prior to bidding on this contract. Equipment used in these testing procedures shall be maintained in good working order.

Calibration of all devices and testing equipment shall be done with sufficient frequency as to ensure accurate results. No further instrumentation shall be purchased with the contract funds.

(b) The COR may request expedited processing of specimens for PCR deemed critical by the COR. The COR will notify the Contractor regarding sample number and tests required prior to shipment. These samples shall be processed by the Contractor and resulting data transmitted to the COR within 4 working days.

(c) In the event of a disease outbreak affecting the NIEHS research animal population, the Contractor shall be able to perform or assist in research to help elucidate the cause, pathogenesis, and epidemiology of the causative agent as requested by the

COR.

(d) After completion of the serological, PCR or genomic sequencing, the test samples (if sufficient quantity remains) shall be stored for six months at -70°C. During this period, stored samples shall be returned to the COR (or authorized designee) if so requested. After six months the samples may be discarded.

3) Serological Tests:

(a) The Contractor shall, as a minimum, be prepared to perform serological assays by appropriate methods such as Multiplex Fluorescent Immunoassay (MFI), Immunofluorescent Antibody (IFA), Enzyme-Linked Immunosorbent Assay (ELISA), or Hemagglutination Inhibition (HAI), as appropriate. IFA and/or Western Blot methodology should also be available for confirmatory testing. Should new, more sensitive or efficient testing methodology become available or new pathogenic agents discovered during the course of this offering, it will be incorporated through modification of the Contract.

(b) Rodent sera shall be processed by the Government (diluted 1:5 and heat inactivated at 56°C for 30 minutes), frozen in 2 ml cryotubes labeled with the QAL's identification number and shipped in styrofoam containers with ice packs or dry ice.

(c) The Contractor shall perform the appropriate tests requested by the QAL and provide the COR with reports of the serological results within 3 working days from the date of receipt of the samples and a final written report within 10 working days of receipt of the samples.

4) PCR Assays:

1. The Contractor shall be prepared to perform PCR assays for a variety of agents.

Cell lines, tissues, fecal samples, bacteria and environmental swabs will be shipped in a leak proof, styrofoam containers with ice or dry ice if necessary.

2. The Contractor shall perform the appropriate requested analysis and provide the

COR with reports of the PCR results within 5 working days after receipt of specimens by the Contractor and a final report within 10 working days after receipt of the specimens.

5) Speciation of bacterial samples

(a) The Contractor shall be prepared to perform bacterial species identification by PCR and partial genomic sequencing analysis of submitted samples. The government will inform the contractor if the genus of the submitted sample is known (e.g., Mycoplasma or Staphylococcus spp.). If the genus of the submitted sample is not known, the contractor will PCR amplify and sequence a universal bacterial gene such as the 16S rRNA, compare sequence homology with available databases (e.g., GeneBank) and report percent homology to known bacterial sequences.

(b) Samples will be shipped in a leak proof, styrofoam containers with ice or dry ice if necessary.

(c) The Contractor shall perform the appropriate requested tests and provide the COR with reports of the sequence identification results within 15 working days after receipt of specimens by the Contractor and a final report within 20 working days after receipt of the specimens.

6) Training

The Contractor shall provide a training program for employees involved with the contract. A copy of the training program shall be furnished to the COR.

7) Site Visit

The COR and/or an authorized representative may make an annual visit to the Contractor’s place of work at the Government’s expense to inspect and review all procedures covered in the contract. The COR shall tour the facility with a representative of the Contractor. The COR may observe all of the procedures mentioned in the contract while visiting the Contractor’s facility.

C. DELIVERABLES

1. Technical Reports. In addition to the required reports set forth elsewhere in the contract, the preparation and submission of regularly recurring Technical Reports will be required. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be in accordance with deliveries/delivery schedules mentioned below.

a. Monthly Reports: The Contractor shall provide the COR with a detailed description of the activities during the reporting period. These reports, that include recommendations, must be delivered, with a report due once a month. Monthly reports will also include a cumulative total of tests performed for each 12-month period of the contract (base year followed by each option year).

b. Final Report: A formal, comprehensive, written, report, suitable for external distribution that can be understood by non-technical personnel shall be submitted within 30 days of the last business day of the Period of Performance to the COR. The report shall be typed, double-spaced and shall include a summation of the results furnished to the Comparative Medicine Branch (CMB), National Institute of Environmental Health Sciences (NIEHS). The report shall include any problems in testing that were incurred during the contract, the number of positive samples detected for each agent, the number of confirmed positive by other laboratories, the number determined to be negative by other laboratories (false positives). This report shall include all necessary tables, charts, drawings and data sheets.

The report shall include, at a minimum:

1) Preface: Brief Introduction

2) Acknowledgements: Name, title, and responsibilities of each key staff member on the project; of Subcontractors and of consultants; as well as recognition of committee members; etc.

3) Abstract of main text: A concise summary of the entire project that does not exceed 750 words. This abstract is not to appear in the executive summary.

4) Project Summary: The text should include, but need not be limited to:

a) The purpose of the project

b) A background including discussion of issues and pertinent historical facts and other information essential to full understanding of the project

c) The methodology designed and used, and its execution, including any major difficulties and their resolution

d) Appropriate other aspects of the total contract efforts

e) A summary of the salient results achieved during the performance period

f) Conclusions

g) Recommendations, with supporting rationale, as appropriate to the Government and/or the private sector

h) An assessment of the degree of success in achieving the goals of the project.

5) Appendices

2. Other Reports/Deliverables.

a. The Contractor shall maintain a computerized database to store the results of the requested testing and be used to report the findings. The Contractor shall furnish to the COR (or designated designee) preliminary results of completed assays upon request.

b. Completed test results shall be published on the internet at a site available to the Government (the NIEHS) or electronically mailed or sent on transportable media (CD) at the Contractor’s expense to the COR within three (3) workdays following receipt of the specimen for serology samples and within seven (7) workdays for PCR samples.

c. The computerized data shall be provided as ASCII files prepared for importation into NIEHS’s computer system. Information regarding field layout for these files shall be made available to the Contractor. The final report shall be mailed or delivered to the COR within 10 workdays following receipt of the specimen for serology or PCR samples.

d. As it relates to Green requirements the Contractor shall provide to the CO and COR an annual report that tracks their use of green purchasing in their task, process, packaging, marking, delivery, training, and environmentally preferable products.

D. KEY PERSONEL

1. Project Supervisor - This individual shall be responsible for overseeing all aspects of this contract including serological and PCR testing, genomic sequence analysis, reporting and contract personnel.

a. Educational requirements: This individual shall have a Ph.D. in microbiology or DVM/VMD from an accredited school of veterinary medicine and be board certified by the American College of Laboratory Animal Medicine (ACLAM) or the American College of Veterinary Pathologists (ACVP).

b. Experience: This individual shall have a minimum of five years in laboratory rodent serology testing, PCR assays and genomic sequencing.

2. Serology Laboratory Supervisor - This individual is responsible for supervision of personnel performing serological assays and will serve as the principle contact with the COR for serological assays.

a. Educational requirement: This individual shall have a minimum of a Bachelor’s degree.

b. Experience: This individual shall have a minimum of one year supervisory experience in laboratory serology testing.

3. PCR Laboratory Supervisor. This individual is responsible for supervision of personnel performing PCR assays and genomic sequence analysis and will serve as the principle contact with the COR for PCR based assays.

a. Educational requirement: This individual shall have a minimum of a Bachelor’s degree.

b. Experience: This individual shall have a minimum of one year supervisory experience in laboratory PCR testing.

4. Three Full Time Technicians. These individuals shall be responsible for performing all serological and/or PCR testing and partial genomic sequencing.

a. Educational requirement: Individuals must be a high school graduate and have completed a minimum of one year of college.

b. Experience: These individuals must have a minimum of six months experience performing serologic or PCR assays.

5. Clerk Typist. This individual shall be responsible for data processing and transmittal of accurate serological test results to the COR.

a. Educational requirements: This individual must be a high school graduate.

b. Experience: This individual shall have 6 months experience in word processing and/or data entry with the ability to type 40 – 50 wpm.

6. Billing Specialist. This individual shall be responsible for processing and transmittal of invoices to the COR for approval.

a. Educational requirements: This individual must be a high school graduate.

b. Experience: This individual shall have 6 months experience in word processing and spreadsheet or optional billing invoice preparation software.

Section D - Packaging and marking. Provide packaging, packing, preservation, and marking requirements, if any.

D – 1. Done by the Government (NIEHS): Rodent sera shall be processed (diluted 1.5 and heat inactivated at 56°C for 30 minutes), frozen in 2 ml cryotubes labeled with the Quality Assurance Laboratory’s (QAL's) identification number and contract number and shipped in styrofoam containers with ice or dry ice (if necessary). The styrofoam container will be delivered to the Contractor by express overnight delivery service by NIEHS personnel. The Contractor shall acknowledge receipt of these shipments electronically.

D – 2. Done by the Government (NIEHS): Cell lines, tissues, fecal samples, and environmental swabs will be shipped in a leak proof, styrofoam containers with ice or dry ice (if necessary) and the contract number. The styrofoam container will be delivered to the Contractor by express delivery service by NIEHS personnel. The Contractor shall acknowledge receipt of these shipments electronically.

D – 3. Done by the Contractor: All samples must be properly maintained and handled by the Contractor for determining accurate test results. After completion of the requested testing, the test sample (if sufficient samples remain) shall be stored for six months at -70°C. During this period stored samples shall be returned to the COR (or authorized designee) if so requested. After six months the samples may be discarded.

D – 4. Standard Practice for Packaging and Marking

(a) All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications, unless otherwise specified.

(b) The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

(c) All containers, data, and correspondence exterior shipping containers and items not shipped in containers shall be clearly marked on an external surface as follows:

(1) Name of Contractor

(2) Contract number

(3) Itemized list of contents including quantity and CLIN/Line Item

(4) Consignee’s name, title, address and telephone number

(5) Package number of multiple package (e.g., 1 of 5)

D – 5. Applicable Green Requirements shall be followed as it relates to packaging and marking (e.g.

minimizing packaging; recycled content in packaging; reusable containers; take back program;

recyclability of packaging and/or reduction/elimination of toxics in packaging).

SECTION E – Inspection and Acceptance

E – 1. 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. The full text of a clause may be accessed electronically at: http://www.arnet.gov/far/.

FAR Ref. No. Clauses Title and Date

(1) 52.246-1 -- Contractor Inspection Requirements (Apr 1984)

(2) 52.246-2 -- Inspection of Supplies -- Fixed-Price (Aug. 1996)

(3) 52.246-4 -- Inspection of Services -- Fixed-Price (Aug. 1996)

(4) 52.246-15 -- Certificate of Conformance (Apr 1984)

(5) 52.246-16 -- Responsibility for Supplies (Apr 1984)

E – 2. Inspection and Acceptance Terms

a. Inspection and acceptance of all work, reports, deliverables and services performed under this contract will be in accordance with the inspection/acceptance FAR clauses incorporated and/or as specified herein.

a. Reports, documents and narrative type deliverables will be accepted when all discrepancies, errors or other deficiencies identified in writing by the Government have been corrected.

b. Non-conforming products or services will be rejected. Unless otherwise agreed by the parties deficiencies must be corrected within thirty (30) calendar days of the rejection notice. If the deficiencies cannot be corrected within thirty (30) calendar days, the Contractor shall immediately notify the CO of the reason for the delay and provide a proposed corrective action plan within ten (10) working days of the date of notifications, unless otherwise specified herein.

c. The basis for acceptance shall be in accordance with the requirements set forth http://www.arnet.gov/far/ herein.

d. The Government requires a period not to exceed thirty (30) days after receipt of final deliverable item(s) for inspection and acceptance or rejection, unless otherwise specified herein.

E – 3. Contract Quality Assurance (CQA)

The words “conform to contract” relates to quality and to the quantity of the items.

The Certificate of Conformance is in accordance with FAR Clause 52.246-15 in Section I.

The Contractor shall attach or include the appropriate contractor signed and dated certificate as well as enter in capital letters “CERTIFICATE OF CONFORMANCE” accordingly on the inspection and receiving report.

E – 4. For this contract David Kurtz is the authorized representatives of the Contracting Officer (CO) and will perform inspection and acceptance at the National Institution of Environmental Health Sciences (NIEHS), Research Triangle Park (RTP), NC and/or as specified herein.

Section F - Deliveries or performance. Specify the requirements for time, place, and method of delivery or performance (see subpart 11.4, Delivery or Performance Schedules, and 47.301-1).

(ADDENDA)

F – 1. 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. The full text of a clause may be accessed electronically at:

http://www.arnet.gov/far/.

FAR Ref. No. Clauses Title and Date http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/11.htm#P159_24969 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/47.htm#P278_43324 http://www.arnet.gov/far/

52.211-11 -- Liquidated Damages -- Supplies, Services, or Research and Development (Sept2000) (Pay to the Government Liquidated Damages of $150.00 per calendar day of delay)

52.211-17 -- Delivery of Excess Quantities (Sep 1989)

52.242-15 -- Stop-Work Order (Aug. 1989)

52.242-17 -- Government Delay of Work (Apr 1984)

52.247-29 -- F.o.b. Origin (Feb 2006)

52.247-31 -- F.o.b. Origin, Freight Allowed (Feb 2006)

52.247-58 -- Loading, Blocking, and Bracing of Freight Car Shipments (Apr 1984)

F – 2. Period of Performance (PoP) for this contract.

Base Year: October 1 2013 through September 30 2014

Option Period 1: October 1 2014 through September 30 2015 Option Period 2: October 1 2015 through September 30 2016

Option Period 3: October 1 2016 through September 30 2017

Option Period 4: October 1 2017 through September 30 2018

Option Period to extend: October 1 2018 through March 30 2019

F – 3. Deliveries or Performance

a. All deliverables submitted in electronic format shall be free of any known computer virus or defects. If a virus or defect is found, the deliverable will not be accepted. The replacement file shall be provided within two (2) business days after notification of the presence of a virus.

b. In the event the Contractor anticipates difficulty in complying with any delivery schedule, the Contractor shall immediately provide written notice to the CO and COR. Each notification shall give pertinent details, including the date by which the Contractor expects to make delivery; PROVIDED, that this data shall be informational only in character and that receipt thereof shall not be construed as a waiver by the Government of any contract delivery schedule, or any right or remedies provided by law or under this

c. Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in the Statement of Work (SOW) and upon delivery and acceptance by the CO, or the duly authorized representative, in accordance with the stated delivery schedule described herein.

d. The items specified below as described in the “Reporting Requirements of the SOW” will be required to be delivered F.O.B. Destination and in accordance with and by the date(s) specified below and any specifications stated in packaging, marking and shipping of this contract:

Reporting Requirements, Data Management, Required Documents and Reports.

(i) General Provisions. The Contractor shall prepare and deliver all reports and documents to the Contracting Officer Representative (COR) and/or the Contracting Officer (CO) unless specified otherwise herein. All reports shall be delivered electronically in spreadsheet or database format by email or posted on a NIEHS site as instructed by the COR. Reports delivered by the Contractor shall be complete, accurate and prepared in a professional manner. These reports shall become a part of the NIEHS official records and subject to review by regulatory authorities and the general public. Unless otherwise specified herein the format for all reports shall be subject to the approval of the COR.

(ii) Ownership and Security of Data and Documents. All NIEHS and Contractor collected, maintained and delivered data files, reports, logs or other documents developed relative to contractual operations are the sole proprietary of the NIEHS and shall not be released or given to other parties in any form without the prior written consent of the CO. The Contractor shall take all necessary measures to secure and safely protect all hardware, software, data and documents from theft, destruction and unauthorized access. The Contractor shall report all information security or privacy incidents/violations to the NIEHS Help Desk, COR and CO within one hour of the incident/violation. Contractor staff shall comply with all NIEHS privacy policies and procedures including NIEHS Information Technology General Rules of Behavior.

F – 4. Deliverables

Item No.

Description Deliver To Schedule

1 Serological and PCR Assays COR IAW SOW 2 Preliminary Test Results COR • Serology – within 3 working days following receipt

• PCR – within 7 work days following sample receipt

• Bacterial ID – within 15 working days following sample receipt

3 Final Test Results COR • Serology & PCR – within 10 working days following receipt

• Bacterial ID – within 20 working days following sample receipt

4 Technical Reports COR Monthly (Electronically) 5 Monthly Reports COR Monthly (Electronically) 6 Final Written Report COR & CO End of the Contract period (Electronically) 7 Summary of Salient Results COR & CO End of the Contract period (Electronically) 8 Commercial Product Catalog CO Annually (Electronically) 9 A List of Supervisory Personnel authorized to act on behalf of the Contractor with Contact Information COR & CO Annually (Electronically) or as changes occur 10 Training Program COR & CO With proposal, annually and/or as changes occur (Electronically)

F – 5. Deliverables shall be in accordance with the SOW/contract to the following individuals unless otherwise stated:

(i)National Institute of Environmental Health Sciences (NIEHS) Attn: David Kurtz (COR), Email: david.kurtz@niehs.nih.gov; Phone: (919) 316-4607; and Attn: Gordon Caviness (Alternate COR), Email: cavines@nih.gov; Phone: (919) 541-3880 111 TW Alexander Drive

MD C1-06

Bldg. 101 Room C128B Research Triangle Park (RTP), NC 27709

(ii)NIEHS OM, OA, Contracts Branch C Attn: Brian Souter /Contracting Officer (CO) 530 Davis Drive 1st Floor, 1049 Morrisville, NC 27560 Email:brian.souter@nih.gov mailto:cavines@nih.gov

Phone: (919) 541-0401

F – 6. Green Requirements shall apply if applicable to Deliveries of supplies and/or services, such as:

• Services -Require electronic deliverables -Limit number of hard copes -Favor black/white, double-sided, soy based ink

F – 7. Performance Requirements Summary

Task Deliverable Performance Indicator

Acceptable Quality Level

(AQL)

Monitoring Method

Maximum Payment

% for Meeting or Exceeding the

AQL

(Incentives)

Serological Testing

Tests Results on Rodent sera and tissue

% processed and delivered at specified times

100% testing on Rodent sera and tissues

Project Officer’s (PO’s) oversight and feedback from end user

100% payment in meeting Government requirements for testing in accordance with good laboratory practices

PCR Assays and Identification of Agents

Test Results on cell line tissues, fecal samples and environmental swabs

% processed and delivered at specified times

100% testing on PCR Assays and Identification of Agents

Project Officer’s (PO’s) oversight and feedback from end user

100% payment in meeting Government requirements for testing conduct in accordance with good laboratory practices

Timeliness in Delivery of Telephonic and/or Electronic Mail Results

Telephonic and/or written tests results

% Samples items tested and delivered as requested

100% items tested and delivered

PO’s oversight, review, and acceptance – only minor edits required

100% payment for meeting requirement.

Non-delivery is unacceptable

Timeliness in Delivery of final Written Report

Final Written Report

% accuracy of written report

100% accuracy of final written report

PO’s oversight, review and acceptance

100% payment for meeting requirement.

Non-delivery is unacceptable

Section G - Contract administration data. Include any required accounting and appropriation data and any required contract administration information or instructions other than those on the solicitation form. Include a statement that the offeror should include the payment address in the proposal, if it is different from that shown for the offeror.

G – 1. Accounting and Appropriation Data

AWARD ESTIMATED TOTAL

PERIOD/ AWARD ACCOUNTING LINE DOLLARS CHANGE IN OBLIGATED

ACTION AMOUNT RQM # INFO & CAN ITEM OBLIGATED OBLIGATION AMOUNT

G – 2. Contract Management. The administration of the contract will require maximum coordination between the Government and the Contractor. The following Government point of contact for administration during the performance of the contract is as follows.

(A) The Contracting Officer (CO) for the contract is identified as:

Brian Souter, Contract Specialist (CS)/Contracting Officer (CO)

NIEHS

530 Davis Drive Morrisville, NC 27560 Tel: (919) 541-0401 Fax: 919-541-5117 Email: brian.souter@nih.gov

Alternate: Steven L. Cannon, Supervisory Contracting Officer

NIEHS

530 Davis Drive Morrisville, NC 27560 Tel: (919) 541-0423 Fax: 919-541-5117 Email: cannons@niehs.nih.gov

(B) The CO is designated on the contract face pages. The CO will affect all contract administration.

Communications pertaining to contractual administrative matters will be addressed to the CO. The word “government” as used throughout this contract or its attachments refers specifically to the CO/CS/COR and/or the PO/COTR. The only person authorized to approve changes in any of the requirements of this contract, and notwithstanding any provisions contained elsewhere in this contract, the said authority remains solely with the CO. No changes of deviation from the scope of work shall be effected without a written modification to the contract executed by the CO. The PO/COTR will be designated by letter of appointment from the CO in the technical phase of the work, but the PO/COTR will not be authorized to change any of the terms and conditions of the contract.

mailto:cannons@niehs.nih.gov

G – 3. Responsible Officials.

(A) The Contracting Officer Representative (COR).

1. Dr. David M. Kurtz is hereby designated as the COR for this contract.

2. Mr. Gordon Caviness is the Alternate COR. The Alternate COR has the same authority as the COR and may exercise that authority at the discretion of the Government, to the extent described below. All references to the COR throughout this contract shall be construed as applying equally to the Alternate COR.

3. The Government may unilaterally change its COR and/or Alternate COR designations.

a) The COR will be responsible for coordinating with the Contractor in administering the technical aspects of the contract. The PO/COTR is not authorized to make any changes which affect the contract amount, terms, or conditions. Such changes shall be only by the CO. Services performed under this contract shall be subject to inspection and approval by the COR at any time.

b) The COR is specifically responsible for:

(1) Monitoring the Contractor’s technical progress, including the surveillance and assessment of performance in conjunction with the Performance Requirement Summary (PRS);

(2) Recommending changes in requirements to the CO;

(3) Perform technical evaluations as needed;

(4) Performing technical inspections and acceptance required by this contract, in accordance with the PRS;

(5) Consulting with the Contractor relative to the resolution of technical problems encountered during performance;

(6) Providing technical information to the Contractor (at the option of the Government) which assists in the interpretation of specifications, or technical portions of the work description;

(7) Reviewing and approving or disapproving technical reports, specifications, technical information, etc. when the contract provides that such items will be delivered by the Contractor to the Government under subject contract.

c) The COR cannot authorize or direct any work or actions outside the express terms and conditions of the contract. For guidance to the Contractor to be valid, it must:

(1) Be consistent with the description of work set forth in this contract;

(2) Not constitute new assignments of work;

(3) Not constitute any change to the expressed terms, conditions, or specifications incorporated into this contract.

(4) Not constitute a basis for an extension to the period of performance or contract delivery schedule;

(5) Not constitute a change as defined in the contract clause entitled “Changes”;

(6) Not constitute a basis for any increase or decrease in the contract price, or any extension or other change to the contract delivery schedules or performance periods.

(B) Contractor’s Responsibilities.

(i) Contractor’s responsibility with regard to Interaction with the COR or other individuals.

a. The following procedures shall be applicable to directions provided during the term of this contract with the exception of directions provided by Government personnel in emergency situations. (1) Emergency situations shall be deemed to include only those unanticipated emergency conditions which impose a threat to the safety of individuals or have the potential for significant damage to Government property if not immediately corrected. (2) In other words, this clause shall be applied to instructions which could be temporarily postponed and do not require immediate reaction by the Contractor to insure the protection of life and/or property from extensive harm.

(ii) If, in the opinion of the Contractor, any instructions, interpretations, directions, or other actions of the COR or any other individual create a condition or conditions described in paragraph (A)(iii) above, or will create situations during the term of the contract which will fall within one of the categories defined in paragraph((A)(iii) above, the Contractor shall not proceed. The Contractor shall immediately notify the CS/CO of its concerns in this regard. Verbal notifications shall be followed by a written notification to the CS/CO documenting the information or actions taken by the COR or other individuals, and the basis for the Contractor’s opinion that those actions, instructions, directions, or interpretations will impact on the contract terms and conditions. The written notice shall be due within five working days after the receipt of the COR’s actions which stimulated the concern(s). The CO will gather available information, and will determine whether or not the input actually constitutes a change or other condition prohibited by paragraph (A) (iii) above. If it is determined that a change or other, prohibited conditions will occur, the CO will so notify the Contractor, and either negotiate and award a formal supplemental agreement, issue a change order, or cancel the directions. If the action by the COR is not determined to by the CO to be a “Change” to the existing contract’s terms and conditions, the CO will so notify the Contractor of this decision and the reasons therefore, and the Contractor would be expected to immediately comply. The Contractor would retain the rights provided under the “Changes” clause of this contract in the event that proper actions, as described above, are taken to notify the CO and obtain CO approval before proceeding with directions from any individual that is deemed to be questionable under paragraph (A)(iii) above.

a. The COR is responsible for monitoring progress and overall management of Contractor performance hereunder. In no event, however, shall any understanding or agreement, modification, change order, or other matter deviating from the terms of subject contract between the Contractor and any person other than the CO be effective or binding upon the Government, unless formalized by proper contractual documents executed by the CO prior to completion of this contract.

b. On all matters that pertain to contract terms, the Contractor shall contact the CO. When, in the opinion of the Contractor, the COR/COTR/PO request effort outside the existing scope of the order or contract, the Contractor shall promptly notify the CO in writing. The Contractor under such request shall take no action unless and until the CO has issued a contractual modification.

(iii)On occasion, the Contractor’s services may not be required, or may be required at a different level of service (i.e. disaster situations, breakouts, emergency dismissals, and closure of the Institute due to weather conditions). Unless specifically changed by formal modification in advance, the Contractor shall be paid the full monthly charge as agreed upon in the contract, and shall be expected to compensate its employees in full for such “administrative leave” situations. The PO/COTR will notify the Contractor if this should occur.

(End of Narrative) G – 4. Post Award Evaluation of Contractor Performance

a. Contractor Performance Evaluations. (i) Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted annually to coincide with the anniversary date of the contract.

(ii) Interim and final evaluation will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reach between the parties, the matter will be referred to an individual one level above the CO, whose decision will be final.

(iii) Copies of the evaluation(s), Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluation. (i) Contractors that have internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

http://oamp.od.nih.gov/OD/CPS/cps.asp. (ii) The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the Contractor will be required to identify an alternate point of contact that will be responsible for notifying the Cognizant Contracting Official in the event the primary point of contact is unavailable to process the evaluation within the required 30-day time frame.

(End of Narrative) http://oamp.od.nih.gov/OD/CPS/cps.asp

G – 5. Invoice Information/Instructions (4/2012)

a. The Contractor shall identify the PRISM/NBS Line Item Number(s) and associated PRISM/NBS Line Item Period of Performance (PoP) on each invoice. This contract requires the following as applicable:

Fully Funded Contracts: Payments will be made from PRISM/NBS Line Item(s) and/or for Performance Period 28 Mar 2012 up to 27 Apr 2013. (Note: It may be necessary to require a separate invoice page for each line item).

b. Invoice Submission/Contract Financing Request. In addition to the requirements specified in FAR 32.905 for proper invoice, the Contractor shall include the following information on the face page of all payment requests:

(i) Name of the Office of Acquisitions (OA). The OA for this contract is: NIEHS.

(ii) Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is: NIEHS OA Invoices-BranchC@mail.nih.gov.

(iii) Invoice Matching Option. This contract requires a 2-Way Match.

(iv) Unique Invoice Number: Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

(v) PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance (PoP).

(vi) Inquiries regarding payment of invoices shall be directed to the designated billing office,

(301) 496-6452 or (301) 496-6088.

(vii) Make payments to:

mailto:Invoices-BranchC@mail.nih.gov

NIH Commercial Accounts/Commercial Accounts Branch

2115 E. Jefferson St.

MSC 8500 Suite 4B 432

Bethesda, MD 20892-8500

G – 6. Invoice Submission

a. Invoice instructions for NIH Fixed Price Type Contracts, NIH(RC)-2, are attached (See Attachment 09) and made part of this contract.