FDA-SOL-1135050.pdf

FDA- SOL-1135050

Solicitation Number: FDA-SOL-1135050

Subject: Round Robin Testing

Description

This is a combined synopsis/solicitation for commercial items 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; quotes are being requested and a written solicitation will not be issued.

Solicitation FDA-SOL-1135050 is being issued as a Request for Quotation (RFQ). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-76. This requirement is being solicited under full and open competition using Simplified Acquisition Procedures per FAR Subpart 13. The associated North American Industrial Classification System (NAICS) code for this procurement is 541712, with a small business size standard of 500 employees.

The U. S. Food & Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) is procuring to a contract to conduct a round robin testing program to validate diagnostic laboratory capabilities.

1.1 Contract Type

The government intends to award a firm-fixed price contract.

1.2 Pricing

CLIN Description Qty Unit of

Issue Total

0001 Base Year: Round Robin Testing 1 JB $ 0002 Option Year One: Round Robin Testing 1 JB $ 0003 Option Year Two: Round Robin Testing 1 JB $ 0004 Option Year Three: Round Robin Testing 1 JB $ 0005 Option Year Four: Round Robin Testing 1 JB $ Total $

SECTION 2 - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

Statement of Work for Round Robin Testing

2.1 Background:

This contract is to assist Vet-LIRN laboratories to fulfill requirements put forth in the Food Safety Modernization Act – SEC. 422. LABORATORY ACCREDITATION FOR ANALYSES

OF FOODS. The contractor shall work closely with VET-LIRN and AAVLD’s accreditation committee to help laboratories provide data to support continuing proficiency in their Vet-LIRN methods (AAVLD accreditation requirements – i.e.: 5.4.2.2 Analysts shall have a record of documented proficiency in the performance of the test. Proficiency shall be documented on an ongoing basis, at appropriate intervals. Assessment of proficiency shall be based on objective data, using blind samples of appropriate number and composition. These samples should be well characterized. See requirements at this link:

http://www.aavld.org/assets/Accreditation/aavld%20requirements%20v6%201%206-1- 12%20final.pdf . The contractor’s laboratory shall facilitate interactions between AAVLD and develop a joint program to accomplish the goals.

2.2 Specific Requirements:

The contractor shall provide selected control animal biologic samples to Vet-LIRN for the preparation of the test samples. The biologic samples requested should be readily available to veterinary diagnostic laboratories that conduct animal necropsy examinations.

The contractor shall assist Vet-LIRN administer the round robin proficiency testing program to participating Vet-LIRN laboratories. Prior experience administering or coordinating proficiency testing programs is required, as is familiarity with the AAVLD proficiency testing program and the activities of the AAVLD Toxicology Working Group.

The contractor shall facilitate interactions with Vet-LIRN network laboratories and provide training, support and technical expertise for adapting methods to prepare network laboratories to participate in these Round Robin exercises. The contractor shall help ensure that test methods are harmonized by the laboratories to demonstrate actual capabilities to conduct the analysis adequately.

The contractor shall interact with the other Vet-LIRN laboratories to distribute samples (provided by FDA), facilitate and trouble-shoot method transfer, collect test results, collate data, and report results to Vet-LIRN personnel. The contractor shall coordinate Vet-LIRN Round Robin exercises with the needs of AAVLD to ensure that these exercises fulfill both VET-LIRN and AAVLD needs.

2.3 Deliverables:

The contractors shall be required to participate in monthly conference calls and make an in-person presentation to Vet-LIRN at a public meeting up to twice during the contract period (during the 5 year period if all options are exercised).

1. The contractor and Vet-LIRN administration (CVM) will ensure testing will demonstrate competencies required for laboratory accreditation.

2. The contractor shall work with the Vet-LIRN laboratories to identify which laboratories will participate in the different round robin challenges. This involves determining which laboratories have the capability for a specific challenge analyst and can schedule the testing.

http://www.aavld.org/assets/Accreditation/aavld%20requirements%20v6%201%206-1-12%20final.pdf http://www.aavld.org/assets/Accreditation/aavld%20requirements%20v6%201%206-1-12%20final.pdf

3. The contractor shall provide control samples to Vet-LIRN administration directly.

4. These samples will be tissues/fluids routinely available to veterinary diagnostic laboratories that conduct animal necropsy examinations. Example include: Horse blood (500-1000mls), horse liver (3 pounds), dog feces shown to be free of Salmonella spp. or Listeria spp. (2 pounds), dog urine (25 ml samples from up to 15 dogs), rumen contents (10 lbs). Contractor will be required to pay for shipping costs for these items.

5. The contractor shall ensure that participating Vet-LIRN laboratories understand the test method and that the method is harmonized throughout the participants. This requires that the laboratory test the method prior to the round robin test. This also could involve training or trouble-shooting if the laboratories that wish to participate in that round experience difficulties preparing for the round robin exercise.

6. The contractor shall distribute the sample set to the participating laboratories.

7. The contractor shall collect and interpret the test results.

8. The contractor shall issue written reports to the Contracting Officer’s Representative

(COR) which summarizes the testing results and interpretations. All testing results will be provided to the COR.

9. The contractor shall make an in-person presentation of the results of the Round Robin program up to twice during the period of performance to take place at a conference stipulated by Vet-LIRN NPO/COR.

2.4 Period of Performance:

Period of Performance Start Date

Period of Performance End Date

Base Year 9/15/14 9/14/15 Option 1 9/15/15 9/14/16 Option 2 9/15/16 9/14/17 Option 3 9/15/17 9/14/18 Option 4 9/15/18 9/14/19

2.5 Place of Performance:

The place of performance shall be at the Contractor’s facility.

SECTION 3 - CONTRACT CLAUSES

3.1 FAR Clause 52.212-4 –Contract Terms and Conditions -- Commercial Items (May 2014) and below addendum is applicable

3.1.1 FAR 52.252-2 -- Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

www.acquisition.gov/far/index.html and http://www.hhs.gov/policies/hhsar/subpart301-1.html.

http://www.acquisition.gov/far/index.html http://www.hhs.gov/policies/hhsar/subpart301-1.html

FAR Clause Title Date Reference 52.217-8 Option to Extend Services within one (1) day Nov 1999 17.208(f)

52.227-14 Rights in Data -- General May 2014 27.409(b)(1) 52.232-40 Providing Accelerated Payments to Small

Business Subcontractors Dec 2013 32.009-2

HHSAR Title Date Reference 352.222-70 Contractor Cooperation in Equal Employment

Opportunity Investigations Jan 2010 322.810(h)

3.1.2 FAR 52.217-9 -- Option to Extend the Term of the Contract. (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within five (days); provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least ten (10) days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

3.1.3 HHSAR 352.242-70 Key Personnel (January 2006)

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

The Key Personnel under this Contract are:

Principal Investigator – must have a doctoral degree (PhD, MD, DVM or equivalent) with experience conducting proficiency tests and with the requirements of AAVLD accreditation, similar to that described in this solicitation.

3.1.4 Contracting Officer’s Representative (COR)

The following COR will represent the Government for the purpose of this contract:

http://www.hhs.gov/policies/hhsar/subpart322.html#322.810Solicitationprovisionsandcontractclauses.

TBD at Time of Award.

FDA

Street 1 Street 2 City/State/Zip Code

a. The COR may be changed at any time by the Government without prior notice to the Contractor by a unilateral modification to the Contract.

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

(1) The COR is responsible for the technical aspects of the project and serves as technical liaison with the Contractor. The COR is also responsible for the final inspection and acceptance of all reports, 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 expressed prior authorization of the Contracting Officer (CO). The CO may designate assistant or alternate CORs to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the Contractor.

3.1.5 Contracting Officer (CO)

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in a task order; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is:

Gina Jackson Gina.Jackson@fda.hhs.gov

Tel: (240) 402-7590; Fax: (301) 827-7101

The contact information for the Contract Specialist is:

Tomeka Evans 5630 Fishers Lane Rockville, MD 20852 Tomeka.Evans@fda.hhs.gov;

Tel: (240) 402-7575; Fax: (301) 827-7101

3.1.6 Security and Privacy

mailto:Gina.Jackson@fda.hhs.gov mailto:Tomeka.Evans@fda.hhs.gov

Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems.

The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA or upon written approval from the Government.

Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contact;

provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation.

The contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the contract that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the COR, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change.

Each contractor/subcontractor employee who may have access to non-public Department information and/or sensitive information under this contract may be required to sign a Confidentiality form and/or a FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the COR or designee prior to performing any work under the contract. The COR or designee will inform the contractor of the forms and training that are required. However, it is the responsibility of the Contractor to assure that such forms have been signed.

3.1.7 Invoice Submission

The Contractor shall submit one (1) original copy of each invoice to the address specified below:

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave W032 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 Attn: Vendor Payments

301.827.3742 or 866.807.3742 E-mail: fdavendorpaymentsteam@fda.gov

Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award Management) and/or other applicable FAR Clause specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the Contractor;

(II) Invoice date and invoice number;

(III) Purchase order/Award number;

(IV) Description, quantity, Unit of Measure, Unit Price, and Extended Price Supplies delivered or services performed, including: (a) Period of performance for which cost are claimed; (b) Itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(VI) Terms of any discounts for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (Must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title, and phone number of person to notify in event of defective invoice;

(IX) Taxpayer identification number (TIN);

(X) Electronic funds transfer (EFT) banking information including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer’s Representative(COR) or other Program Center/Office Point of Contact, as referenced on the Purchase Order; and (XII) Any other information or documentation required by the Purchase Order/Award.

An electronic invoice is acceptable if submitted in Adobe Acrobat (pdf) format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

Questions regarding invoice payments should be directed to the FDA Payment Office at a telephone number provided above.

(End of Addendum to FAR 52.212-4)

3.2 FAR 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jul 2014) applies to this acquisition. The following clauses are applicable.

52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note).

52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C.

632(a)(2)).

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

52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126).

52.222-21, Prohibition of Segregated Facilities (Feb 1999).

52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).

52.222-36, Affirmative Action for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).

52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011).

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

52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

(End of Clause)

SECTION 4 – SOLICITATION PROVISIONS

4.1 FAR 52.212-1 Instructions to Offerors -- Commercial Items (Apr 2014) and below addendum applies to this acquisition

4.2.1 Offeror Response Dates and Time

RFQ Due Date: All quotations shall be submitted electronically via email to Tomeka.Evans@fda.hhs.gov before 4:30 Eastern Time on August 29, 2014. Offerors that fails to submit all required documentation/information, complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

4.2 FAR 52.212-2 Evaluation -- Commercial Items (Jan 1999) applies to this acquisition

The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

The Government will award a contract resulting from this solicitation to the responsible quoter whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: Technical Approach/Capability, Past Performance, and Price.

When combined, technical capability and past performance are more important than price in determining the best value to the Government. If the Government determines non-price factors to be essentially equal, price becomes more important as the discriminating factor.

Technical Capability

The Government will evaluate technical capability based on the degree to which the quotation meets the Statement of Work identified in Section 2 and below requirements.

Proposals shall describe the approach for accomplishment of the work. Include direct cost and resources information, such as the type and number of proposed labor categories and mailto:Tomeka.Evans@fda.hhs.gov number of hours, list of materials, subcontracts, etc., so that understanding of the project may be evaluated. Proposals shall demonstrate the ability to provide diagnostic samples for controls for round robin testing (necropsy, tissue or diagnostic samples from large animals

– horses, cattle, and pet - dogs, cats. Samples include liver, or other organs, serum, plasma, blood, urine, feces). Proposals shall also demonstrate the ability to conduct preliminary testing using Inductively Coupled Plasma (ICP) for metals or Gas chromatography–mass spectrometry (GC-MS) for other analytes.

Note: Contractor shall be a Vet-LIRN laboratory and have AAVLD accreditation.

Limit Technical Approach/Capability Section to 10 pages.

Recent and Relevant Past Performance

Recent and relevant past performance evaluation will take into account the currency, relevancy, type, scope, complexity, duration, and price of past projects. Identify all ongoing and completed work (within the last 3 years from date of this solicitation). Identify experience with Vet-LIRN Proficiency Testing program and conducting proficiency tests. For each of these past performance references, provide a detailed description of the work, the period of performance, the dollar value of the work, your role and responsibilities as either a prime or subcontractor, the client name and address and client point of contact name, phone number, and email address. Demonstrate capability to provide the types of samples outlined in this solicitation. Provide this same information for any proposed subcontractor who will be performing a critical aspect of the required work or will otherwise be performing more than 25% of the total proposed price. Do not include actual subcontract price for this effort or total proposed price information in the past performance section of your quotation.

Limit Past Performance to 10 pages.

Price

The Government will evaluate offers for award purposes based on the total price inclusive of options. Offerors shall detail all direct and indirect costs supporting their firm fixed price, ensuring that the price proposal is consistent with the technical proposal in all respects since the price proposal may be used as an aid to further determine the Offeror's understanding of the technical requirements. Discrepancies may be viewed as a lack of understanding. The pricing structure provided in the price proposal shall easily tie back to the Technical Capabilities.

4.3 FAR 52.212-3 Offeror Representations and Certifications -- Commercial Items (May 2014) applies to this acquisition

An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision.

(End of Provisions)

3.1.6 Security and Privacy